US006200570B1

(12) United States Patent (10) Patent N0.: US 6,200,570 B1

Diwan et al. (45) Date of Patent: Mar. 13, 2001

(54) HERBAL FORMULATION USEFUL AS A OTHER PUBLICATIONS

THERAPEUTIC AND COSMETIC
APPLICATIONS FOR THE TREATMENT OF Sundarraj et al. Indian Phytophathol. vol. 49 (4), pp.
GENERAL SKIN DISORDERS 398—403, abstract enclosed, 1996.
Product Alert Bulletin of Jul. 22, 1996—Abra Therapeutic
(75) Inventors: Prakash Vaman Rao DiWan; Lotion.
Bhamidipalli Subrahmanya
Sitaramam; Sistla Ramakrishna; Primary Examiner—Christopher Tate
Kondapuram Vijaya Raghavan, all of (74) Attorney, Agent, or Firm—Pearne & Gordon LLP
Hyderbad (IN) (57) ABSTRACT
(73) Assignee: Counsel of Scienti?c and Industrial The invention provides a herbal formulation useful as a
Research, New Delhi (IN) therapeutic and cosmetic applications for the treatment of
general skin disorders, the composition comprising at least
(*) Notice: Subject to any disclaimer, the term of this tWo or more plant extracts in the form of oil or poWder or
patent is extended or adjusted under 35 mixtures thereof, the plant extracts being selected from the
USC 154(b) by 0 days. group consisting of Gymnena sylvestrae Water extract 3 to 6
Wt. %; Tria'ax procumbens Water extract 3 to 6 Wt. %; its
(21) Appl. No.: 09/199,588 methanolic extract 4 to 6 Wt. %, Allium sativum oil hexane
(22) Filed: Nov. 25, 1998 extract 1 to 3 Wt. %; dried juice of Aloe vera 2 to 6 Wt. %;
Gum Olibanum poWder in the natural form 4 to 7 Wt. %;
(30) Foreign Application Priority Data Gum Olibanum resinoid organic solvent extract 3 to 8 Wt. %;
and resinoid free Gum Olibanum meal 5 to 10 Wt. %.,
Dec. 8, 1997 (IN) ................................................... .. 3519/97
optionally, including any drug having anti-in?ammatory and
(51) Int. Cl.7 .......................... .. A61K 35/78; A61K 7/00; Wound healing property or mixture thereof, the drug being
A61K 7/40 selected from the group consisting of Disclofenac sodium
(52) US. Cl. ..................... .. 424/195.1; 424/401; 514/858; 1—3 Wt. %, Salicyclic acid 1 to 4 Wt. %, Piroxicam 1 to 2 Wt.
514/860; 514/861; 514/886; 514/969 %, Turmeric poWder 0.1 to 1 Wt. %, a base containing
(58) Field of Search ............................... .. 424/1951, 401; aqueous cream or a gel containing carbopol ranging betWeen
514/858, 860, 861, 886, 969 1 to 4 Wt. %, emulsifying ointment ranging betWeen 20 to 40
Wt. %, preservatives ranging betWeen 0.05—0.3% and a
(56) References Cited humecant ranging betWeen 1—4 Wt. %, and remaining Water
to make 100 Wt. %.
FOREIGN PATENT DOCUMENTS
9833494 8/1998 (WO) . 12 Claims, No Drawings
 US 6,200,570 B1
1 2
HERBAL FORMULATION USEFUL AS A oxide—5.0% W/W and Lanolin base to —100% W/W., Which
THERAPEUTIC AND COSMETIC is also claimed as stainfree. “Link ointment” by Link,
APPLICATIONS FOR THE TREATMENT OF Hyderabad contains: Madhuchist—19.5%, Erandi Thail—
GENERAL SKIN DISORDERS 58.5%, Karpoor—2.5% and Base—19.5%.
FIELD OF THE INVENTION SUMMARY OF THE INVENTION
Accordingly, studies Were undertaken to develop cream
The present invention relates to a herbal cream formula
tion useful for therapeutic and cosmetic applications: formulations containing herbal drugs and synthetic ingredi
ents for topical application over the affected areas Which Will
cracked heels, dry skin disorder, skin allergies, depigmen 10 help healing of cracks on heels and also minor burn Wounds
tation and anti fungal activity. In the formulation of the
and cuts on the skin. These formulations have proven
present invention, the herbs that are used are knoWn to
usefulness in removal of pigmentation on surface of the skin
possess anti-in?ammatory, antiallergic and Wound healing
and reducing the allergic reactions and can also be used in
properties. The formulation may also be useful in treating
chopped hands, hyperkeratosis and minor cuts and burn cosmetic therapy.
15
Wounds. OBJECTS OF THE INVENTION
BACKGROUND OF THE INVENTION The objective of the present invention is to provide a
herbal formulation useful for therapeutic and cosmetic appli
Skin acts as a barrier betWeen body and its environment cations such as cracked heels, dry skin disorder, skin
maintaining a controlled dynamic equilibrium. Stresses 20 allergies, depigmentation and anti fungal activity, Which
imposed by environment can cause changes in skin and obviates the draWbacks of the present formulations available
major purpose of creams under consideration is to help in the market.
reverse these changes and maintain a normal healthy skin. Another object of the present invention is to prepare a
Cracking of heels is a common problem, Which is observed herbal cream using the formulations of the present inven
in almost all individuals in extreme Winter and summer 25 tion.
seasons in tropical climates. Skin is a protein gel hydrated in
its inner most layers and largely dehydrated in its surface DETAILED DESCRIPTION OF THE
layer. The purpose of Water in the outer corneous layer of INVENTION
skin is of great physiological importance in that (1) certain Accordingly, the present invention provides a herbal
amount of desiccation from skin surface minimises bacterial 30
cream formulation useful for therapeutic and cosmetic appli
multiplication and assists in maintaining integrity. (2) The cations such as cracked heels, dry skin disorder, skin
continual desquamation of skin is nature’s method of remov allergies, depigmentation and anti fungal activity. Which
ing debris and foreign matter, Which are generally embedded comprises plant parts or oils from medicinal plants or any
in skin apertures. drug or their mixture thereof having anti-in?ammatory and
It is not desirable that drying of skin layer should proceed 35
Would healing property like Gymnena sylvestrae Water
to such an extent that corneous layer prematurely ?akes extract 3 to 6%, Tria'ax procumbens Water extract 3 to 6% or
aWay and cracks develop on the skin surface. methanolic extract 4 to 6%, Allium sativum (garlic) oil
Cracks on the heels, in extreme Winter season, develop (Hexane extract) 1 to 3%, Aloe vera (dried juice) 2 to 6%,
because of the closure of the pores in the outermost layers. Gum olibanum poWder in the natural state 4 to 7%, Gum
40
This problem Worsens if the atmosphere has loW humidity. olibanum resinoid hexane extract 4 to 6% or ethanol extract
Cracks on heels are also developed in extreme summer 4 to 6% or methanol extract 3 to 8% and Gum olibanum
seasons because of migration of Water from innermost layers meal, resinoid free, (Resin extracted With methanol or
and subsequent evaporation from outer skin surface in loW ethanol or n-hexane) 5 to 10%, cream or gel bases contain
humid environment. In both cases, it is necessary to main ing carbopol-934 1 to 4% , emulsifying ointment 20 to 40%,
45
tain the integrity of the skin by balancing Water content in preservatives such as methyl and propyl parabens 0.1 to
skin layers and to promote healing of ?ssures that develop 0.3% and p-chloro cresol 0.05 to 0.2%, humectants such as
upon prolonged exposure. propylene glycol 1 to 3%, and Glycerine 1 to 4%, Diclofenac
sodium 1—3%, Salicylic Acid 1 to 4%, Piroxicam 1 to 2%,
PRIOR ART DISCUSSION Turmeric poWder 0.1 to 1%.
50
In the market, at present, a number of formulations are In the embodiment of the present invention, plant extracts
available for cracked heels. The composition in all the used may be Gymnema sylvestrae, Ocimium sanctum, Gum
preparations are different and some of them contain syn olibanum, Tria'ax procumbens, Allium sativum, Aloe Vera,
thetic drugs like Salicylic acid as one of the ingredients. All Turmeric, from any part of the plant such as leaf, root, bark,
the preparations are required to be used continuously for 55 natural exudation of the bark, ?oWer, fruit, stem or branch.
better performance of healing of the cracks developed on In another embodiment of the present invention the
heels. There are some preparations, Which are used for skin knoWn drugs having anti-in?ammatory and Wound healing
rashes and fungal infections betWeen ?ngers and toes. Fol property used may be such as Salicylic acid, Piroxicam,
loWing are the preparations available With their ingredients. Diclofenac sodium.
“Vaseline Heal Guard” of Ponds India ltd. contains the 60 In still another embodiment of the present invention the
active ingredients: Salicylic Acid IP—1.5 W/W, Lactic base used may be such as aqueous cream base (containing
Acid—8.0 W/W, Triclosan—0.1 W/W and Cream base-QS. emulsifying ointment BP 1993, preservative and Water) or
“Krack” of Paras Pharmaceuticals, Kalol contains: Dodishak gel base (containing propylene glycol, carbopol 934 and
and Sarjaras-ab35.4%, Raktapuraka-ab3.6%, Base to make monoethanol amine).
100%. “Lichensa” by Dollar Co.P. Ltd. Chennai, contains: 65 In yet another embodiment of the present invention the
ClotrimaZole—0.50% W/W, Menthol—1.0% W/W, Ichtham preservatives used may be such as Methyl paraben, Propyl
mol IP66—0.20% W/W, Boric acid—1.0% W/W, Zinc paraben, p-Chlorocresol.
 US 6,200,570 B1
3 4
In still another embodiment of the present invention the pyl paraben and p-chlorocresol. Methyl paraben and propyl
humectants used may be as Glycerine and Propylene glycol. paraben used as preservatives ranges betWeen 0.1—0.3 Wt. %,
As a result of intensive study conducted by the inventors p-chlorocresol used may ranges betWeen 0.05—0.2%, Gum
With the aim of achieving afore mentioned objectives, neW olibanum resinoid hexane extract ranges betWeen 4—6 Wt. %,
processes for the preparation of cream formulations for Gum olibanum resinoid methanol extract ranges betWeen
topical use Were developed employing herbal drugs Which 3—8 Wt. %, Gum olibanum resinoid ethanol extract ranges
are from natural origin, incorporating them into cream bases betWeen 4—6 Wt. %, glycerine used as humectant ranges
along With synthetic materials Which are knoWn to possess betWeen 1—4 Wt. % and propylene glycol used as humectant
Water retaining properties. ranges betWeen 1—3 Wt. %.
Accordingly, the present investigation deals With cream 10 The preferred source of plant material used in the present
and gel based topical formulations. Each formulation has invention is from Gymnema sylvestrae leaf (R. Br), Ocimum
been described in detail giving the formula of the ingredients sanctum, Gum olibanum, Tridax procumbens, Allium
along With method of preparation. sativum, Aloe Vera, Turmeric.
Another embodiment of the present invention provides a
The ?rst step in the preparation of these formulations
involves a process for making the plant material suitable for
15 herbal formulation useful for enhancing healing of burns and
incorporating into cream/gel bases. The speci?ed portion of Wounds comprising the folloWing ingredients.
the plant is collected and dried under shade at room tem (a) plant extracts or oils from medicinal plants selected
perature in an enclosed room for 72 hrs or more until the form Tria'ax procumbens Water extract 3 to 6 Wt. % and
material gets dried. A speci?ed amount of material is then Gum olibanum poWder in the natural form 4—7 Wt. %;
20
extracted With solvents like n-hexane, chloroform, ethanol, (b) a base containing aqueous cream or a gel containing
methanol and Water, in cold/hot condition. The choice of the carbopol ranging betWeen 1 to 4 Wt. %, emulsifying
solvent depends upon the type of material expected at the ointment ranging betWeen 20 to 40 Wt. %, preservatives
end of extraction process. Extraction process Was carried out ranging betWeen 0.05—0.3% and a humecant ranging
in a closed container immersing speci?ed amount of the betWeen 1—4 Wt. %;
plant material in respective solvents for 72 hrs. At the end of (c) humectants selected from propylene glycol ranging
this stage, solvent is decanted and ?ltered if necessary to betWeen 1 to 3 Wt. % and Glycerine ranging betWeen 1
make it free from the plant debris. The solvent is then to 4 Wt. %; and
concentrated by evaporating under vacuum at room tem (d) the balance being Water to mark 100 Wt. %.
perature. If the solvent used is Water, then concentrated Yet another embodiment of the invention provides an
solution is freeZe dried to obtain the ?nal product in poWder antifungal herbal formulation comprising the folloWing
form. If the solvent used is a non-polar solvent then ?nal ingredients:
product Would be an oily and viscous substance With speci?c
(a) plant extracts or oils from medicinal plants, the said
physico-chemical properties. This ?nal product is made into plant extracts or oils being selected form Tria'ax proc
a formulation intended for topical use by using it as an
35 umbens Water extract 3 to 6 Wt. % or Gum olibanum
ingredient for making creams and gels. Suitable preserva
poWder in the natural form 4 to 7 Wt. %;
tives like methyl paraben, propyl paraben and p-chlorocresol
have been used. Humectants such as propylene glycol and (b) optionally any drug having anti-in?ammatory and
glycerol have been used in appropriate quantities. Wound healing property or mixture thereof, the said
drug being selected from drugs such as Disclofenac
One embodiment of the invention provides a herbal 40 sodium 1—3 Wt. %, Salicyclic acid 1 to 4 Wt. %,
formulation useful as a therapeutic and cosmetic applica
Piroxicam 1 to 2 Wt. %, Turmeric poWder 0.1 to 1 Wt.
tions for the treatment of general skin disorders, said com
position comprising the folloWing ingredients: %;
(a) at least tWo or more plant extracts in the form of oil or
(c) a base containing aqueous cream or a gel containing
poWder or mixtures thereof, the said plants extracts carbopol ranging betWeen 1 to 4 Wt. %, emulsifying
45 ointment ranging betWeen 20 to 40 Wt. %, preservatives
being selected from the group consisting of Gymnena
sylvestrae Water extract 3 to 6 Wt. %; Tria'ax procum
ranging betWeen 0.05—0.3% and humecant ranging
betWeen 1—4 Wt. %.
bens Water extract 3 to 6 Wt. %; its methanolic extract
4 to 6 Wt. %,Allium sativum oilhexane extract 1 to 3 Wt. (d) humectants selected from propylene glycol ranging
%; dried juice ofAloe vera 2 to 6 Wt. %; Gum olibanum betWeen 1 to 3 Wt. %, and Glycerine ranging betWeen
poWder in the natural form 4 to 7 Wt. %; Gum olibanum 1 to 4 Wt. %; and
resinoid or its organic extract 3 to 8 Wt. %; and resinoid (e) the balance being Water to make 100 Wt. %.
free Gum olibanum meal 5 to 10 Wt. %.; Still another embodiment of the invention provides an anti
(b) optionally, including any drug having anti allergic herbal formulation comprising the folloWing ingre
in?ammatory and Wound healing property or mixture dients:
thereof, the said drug being selected from the group (a) plant extracts or oils from medicinal plants, the said
consisting of Disclofenac sodium 1—3 Wt. %, Salicyclic plant extracts or oils being selected form Tria'ax proc
acid 1 to 4 Wt. %, Piroxicam 1 to 2 Wt. %, Turmeric umbens Water extract 3 to 6 Wt. % and Gum olibanum
poWder 0.1 to 1 Wt. %; poWder in the natural form 4 to 7 Wt. %;
(c) a base containing aqueous cream or a gel containing (b) a base containing aqueous cream or a gel containing
carbopol ranging betWeen 1 to 4 Wt. %, emulsifying carbopol ranging betWeen 1 to 4 Wt. %, emulsifying
ointment ranging betWeen 20 to 40 Wt. %, preservatives ointment ranging betWeen 20 to 40 Wt. %, preservatives
ranging betWeen 0.05—0.3% and a humecant ranging ranging betWeen 0.05—0.3% and a humecant ranging
betWeen 1—4 Wt. %; and betWeen 1—4 Wt. %;
(d) remaining Water to make 100 Wt. %. (c) humectants selected from propylene glycol ranging
The preservatives used in the above composition may be betWeen 1 to 3 Wt. %, and Glycerine ranging betWeen
selected from the group consisting of methyl paraben, pro 1 to 4 Wt. %; and
 US 6,200,570 B1
5 6
(d) the balance being water to make 100 wt. %. 1. All the ingredients are expressed in % w/w basis.
One more embodiment of the invention provides a herbal 2. Emulsifying ointment used in these formulations is
formulation useful for cosmetic applications as moisturiser prepared as per the procedure given in the official
comprising the following ingredients: compendium (British Pharmacopoeia, 1993).
(a) plant extracts or oils from medicinal plants, the said
plant extracts or oils being selected form Gymnena EXAMPLE-1
sylvestrae water extract 3 to 6 wt. % Aloe vera (dried
juice) 206%, Tridax procumbens water extract 3 to 6
wt. %, Gum olibanum meal and Gum olibanum pow
der; 10
Tridax procumbens leaf extract 5%
(b) optionally any drug having anti-in?ammatory and Carbopol 934 3%
Methyl paraben 0.15%
wound healing property or mixture thereof, the said Propyl paraben 0.15%
drug being selected from drugs such as Turmeric pow Monoethanolamine q.s to bring pH to 6
der 0.1 to 1 wt. %; Propylene glycol:water(50:50) q.s to make 100%
(c) a base containing aqueous cream or a gel containing 15
carbopol ranging between 1 to 4 wt. %, emulsifying
ointment ranging between 20 to 40 wt. %, preservatives The leaves of Tria'ax procumbens were shade dried for 48
ranging between 0.05—0.3% and a humecant ranging hrs at room temperature. The crushed leaves (500 gms) were
between 1—4 wt. %; then soaked with water (one liter) for 72 hrs at room
(d) humectants selected from propylene glycol ranging 20 temperature. At the end of this period, water is decanted and
between 1 to 3 wt. %, and Glycerine ranging between then concentrated to 100 ml by evaporating under vacuum at
1 to 4 wt. %; and room temperature. This concentrated solution is then lyo
(e) the balance being water to make 100 wt. %. philised to obtain powder.
Another preferred embodiment of the invention relates to Tria'ax procumbens leaf extract is dispersed in pure pro
a herbal formulation useful for therapeutic and cosmetic 25 pylene glycol along with propyl paraben (0.15%). The
applications particularly discoloration comprising the fol mixture is thoroughly agitated to get a clear solution. Car
lowing ingredients: bopol 934 is dispersed in propylene glycol and water (50:50)
(a) plant extracts or oils from medicinal plants, the plant mixture along with methyl paraben in another vessel. The
extracts or oils being selected form Gum olibanum mixture is stirred continuously at 300 rpm for 2—3 hrs.
resinoid, Tria'ax procumbens water extract 3 to 6 wt. % 30 Tria'ax procumbens solution was then added and stirring was
Gum olibanum powder; continued for about 1 hr until a gel preparation is obtained.
(b) a base containing aqueous cream or a gel containing The pH of this gel is adjusted to 6 using monoethanolamine.
carbopol ranging between 1 to 4 wt. %, emulsifying The gel preparation obtained is clear, transparent and non
ointment ranging between 20 to 40 wt. %, preservatives sticky.
ranging between 0.05—0.3% and a humecant ranging 35
EXAMPLE-2
between 1—4 wt. %;
(c) humectants selected from propylene glycol ranging
between 1 to 3 wt. %, and Glycerine ranging between
1 to 4 wt. %; and Gum olibanum powder 5%
40 Emulsifying ointment 26%
(d) the balance being water to make 100 wt. %.
Methyl paraben 0.15%
The invention also, preferably, provides a process for the Propyl paraben 0.15%
pre-treatment of plant material to be used as an ingredient in Water q.s to make 100%
the herbal formulation useful as a therapeutic cosmetic
application comprising: 45
(a) drying the plant material under shade at room tem The naturally occurring Gum olibanum exudate in dry
perature for a period of about 72 hrs; state is taken as it is. The lumps (1 Kg) were powdered in an
(b) extracting the dried plant material with an appropriate edge runner mill for 30 minutes. The powdered raw Gum
solvents selected from the group consisting of olibanum was passed through 100 mesh sieve. Weighed
h-hexane, chloroform, ethanol, methanol and water 50 quantity of the powder was dispersed in appropriate quantity
under hot or cold conditions by immersing the appro of water along with methyl paraben (0.15%). Weighed
priate amount of plant material in the respective solvent quantity of emulsifying ointment is melted in another vessel,
for a period about 72 hrs; and propyl paraben (0.15%) in dispersed in it (Oily phase).
(c) decanting the solvent and ?ltering, if required, to make The dispersion containing Gum olibanum powder & methyl
it free from plant debris; 55
paraben was also heated to the same temperature as that of
(d) concentrating the solvent by evaporation at room emulsifying ointment. The aqueous dispersion containing
temperature or freeZe drying the concentrated solution Gum olibanum powder is added to the molten emulsifying
in case the solvent is water; and ointment and the mixture is stirred continuously at 10,000
(e) obtaining the ?nal product in oil phase or powder form rpm for 1 hr using homogeniser, to obtain cream consis
from step (d) capable of being used as an ingredient for 60 tency.
making a herbal formulation for therapeutic and cos
metic application. EXAMPLE-3
The following examples are given by way of illustration
and should not be construed to limit the scope of the
invention. 65 Gum olibanum powder 6%
The following are to be noted while making these for Tridax procumbens leaf extract 4%
mulations.
 US 6,200,570 B1
8
oily phase containing resinoid and emulsifying ointment in
-continued hot condition while under stirring for 1 hr at 10,000 rpm
until a cream consistency is obtained.
Emulsifying ointment 25%
Propylene glycol 2% EXAMPLE-5
p-Chlorocresol 0.1 %
Water q.s. to make 100%

Tridax procumbens powder 5%

The naturally occurring Gum olibanum exudate in dry Gum olibanum resinoid 5%
state is taken as it is. The lumps (1 Kg) were powdered in an 10
(Ethyl alcohol extract)
Tulsi Oil (Ocimum sanctum) 0.5%
edge runner mill for 30 minutes. The powdered raw Gum Salicylic acid 2%
olibanum was passed through 100 mesh sieve. Methyl paraben 0.15%
The leaves of Tria'ax procumbens were shade dried for 48 Propyl paraben 0.15%
Propylene glycol 2%
hrs at ambient temperature. The leaves (500 gms) were then Emulsifying ointment 25%
soaked with water (1 liter) for 72 hrs at room temperature. 15 Water q.s. to make 100%
At the end of this period, water is decanted and then
concentrated to 100 ml by evaporating under vacuum at
room temperature. This concentrated solution is then lyo The leaves of Tria'ax procumbens were shade dried for 48
philised to obtain powder. hrs at room temperature. The crushed leaves were then
Weighed quantity of emulsifying ointment is taken in a 20 soaked with water for 72 hrs at room temperature. At the end
tarred vessel along with p-chlorocresol and heated until the of this period water is decanted and then concentrated to 100
ointment melts. In a separate container, Gum olibanum ml by evaporating under vacuum. This concentrated solution
powder and Tria'ax procumbens leaf extract were dispersed is then lyophyllised to obtain a powder.
in water. Required quantity of propylene glycol is also The leaves of Tulsi (Ocimum sanctum) were shade dried
added. This aqueous mixture is heated to the same tempera 25 for 48 hrs and the dried leaves (1 Kg) were steam distilled
ture as that of emulsifying ointment. The aqueous phase is to get the essential oil (yield 0.3 to 0.4%).
then added to the oily phase, in hot condition and the mixture Gum olibanum lumps were powdered in 5 Kg lots in an
is stirred at 10,000 rpm for 1—3 hrs until a cream consistency edge runner mill for 30 minutes. The powdered raw Gum
is obtained. olibanum (250 Gms) was then extracted at 30° C. using ethyl
30 alcohol (1.5 liters) as solvent in a vertical churner for 8 hrs.
EXAMPLE-4 The solvent containing resinoid was then decanted and
solvent was distilled off at atmospheric pressure. The res
inoid (120 gms) obtained will have a density 0.940 and
Gymnema Sylvestrae Powder 5% surface tension (N/M) 0.300.
Salicylic Acid 2% 35 Weighed quantities of Gum olibanum resinoid, Tulsi oil,
Gum olibanum 5% propyl paraben and emulsifying ointment are taken in a
(n-Hexane extract) container and the mixture is heated until all the ingredients
Emulsifying ointment 23%
Glycerol 2% melt. Tridaxprocumbens leaf extract powder, salicylic acid,
p-Chlorolcresol 0.1% methyl paraben and propylene glycol are taken along with
Water q.s. to make 100% 40 water in a separate container and were homogenised until a
homogenous dispersion is obtained. This aqueous dispersion
is heated to the same temperature as that of the molten oily
The leaves of Gymnema Sylvestrae were shade dried for phase containing emulsifying ointment and other ingredi
48 hrs at room temperature. The leaves were cut into small
ents. The aqueous phase is added to the oily phase while in
portions and immersed in water in a suitable vessel for 72 45 hot condition and dispersed using a homogeniser at 10,000
hrs. At the end of this period, water is decanted, ?ltered. This rpm for 2—3 hrs, until a cream consistency is obtained.
aqueous portion is then concentrated by evaporating under
vacuum at 45° C. this concentrated portion is lyophilised to EXAMPLE-6
obtain a powder.
Gum olibanum lumps were powdered in 5 Kg lots in an
edge runner mill for 30 minutes. The powdered raw Gum Diclofenac sodium 2%
olibanum (250 gms) was then extracted at 30° C. using Gum olibanum Resinoid 4%
n-hexane (1.5 liters) as solvent in a vertical churner for 8 hrs. (Methyl alcohol extract)
The solvent containing resinoid was then decanted and was Emulsifying ointment 29%
p-Chlorocresol 0.15%
distilled off at atmospheric pressure. The resinoid (100 gms) 55 Water q.s. to make 100%
was obtained which is pale yellow and having a refractive
index of 1.5160, density 0.9287 gms/cc and surface tension
0.0290 N/M at 30° C. Gum olibanum lumps were powdered in 5 kg lots in an
Weighed quantities of Gum olibanum resinoid, edge runner for 30 minutes. The powdered raw Gum oli
p-chlorocresol and emusifying ointment are taken in a banum (250 gm) was extracted at 30° C. using methyl
container and the mixture is heated under stirring until both alcohol (1.5 lt.) as solvent in a vertical churner for 8 hrs. The
resinoid and emulsifying ointment melt (oil phase). Gym solvent containing resinoid was then decanted and distilled
nema sylvestrae powder, salicylic acid, glycerol are dis off at atmospheric pressure. The resinoid (120 gm) was
persed in water, in a suitable container and the mixture is obtained having density 0.940 and surface tension (N/M)
kept for homogenisation until a homogenous dispersion is 65 0.300.
obtained. This dispersion is heated to the same temperature Weighed quantities of Gum olibanum resinoid, emulsify
as that of oil phase. This aqueous dispersion is added to the ing ointment and p-chlorocresol were melted until the mix
 US 6,200,570 B1
9 10
ture lique?es (oil phase). Diclofenac sodium was dissolved EXAMPLE-9
in water and heated to the same temperature as that of oil
phase. The aqueous phase was then added to the oil phase
while stirring in a homogeniZer at 10,000 rpm, until the mass
Gum olibanum powder 5%
congeals and gives cream consistency. Aloe vera 4%
Emulsifying ointment 31%
EXAMPLE-7 Glycerine 3%
p-Chlorocresol 0.15%
Water q.s. to make 100%

10
Piroxicam 1%
Gum olibanum resinoid 7% The naturally occurring Gum olibanum exudate in dry
(Methyl alcohol extract) state is taken as it is. The lumps (1 kg) were powdered in an
Aloe vera 5%
edge runner for 30 minutes. The powdered raw Gum oli
Emulsifying ointment 26%
Glycerine 2% banum was passed through 100 mesh sieve. The expressed
Propyl Paraben 0.15% 15 juice of Aloe vera is dried and dried juice is used in this
Methyl Paraben 0.15% formulation.
Water q.s. to make 100% The dried juice of Aloe vera, emulsifying ointment and
p-chlorocresol were taken in a vessel and melted while
stirring occasionally (oily phase) to give a homogenous
Gum olibanum lumps were powdered in 5 kg lots in an 20 dispersion. Gum olibanum powder was dispersed in water
edge runner for 30 minutes. The powdered raw Gum oli along with glycerine. This dispersion was brought to the
banum (250 gm) was extracted with ethyl alcohol (1.5 lts) at same temperature as that of oily phase. The aqueous dis
30° C. using a vertical churner for 8 hrs. The solvent persion was added to the oily phase while in hot condition
containing resinoid was then decanted and distilled off at and mixed thoroughly at 10,000 rpm using homogeniZer,
atmospheric pressure to obtain pure resinoid. 25 until the mass congeals to cream consistency.
Weighed quantities of Piroxicam, Gum olibanum resinoid, EXAMPLE- 10
dried juice of Aloe vera and emulsifying ointment are taken
in a clean vessel along with propyl paraben and melted while
stirring until a homogenous molten dispersion is obtained.
Gum olibanum resinoid 5%
(oil phase). 30
(Methyl alcohol extract)
Required quantities of water, methyl paraben and glycer Aloe vera 3%
ine were taken in a separate vessel and the mixture is heated Garlic (Allium sativum) Oil 2%
to the same temperature as that of oily phase. The aqueous Glycerine 2%
p-Chlorocresol 0.15%
phase was then added to oily phase in hot condition and Emulsifying ointment 26%
35
mixed in a homogeniZer for 1—3 hrs at 10,000 rpm, until the Water q.s to make 100%
resultant mass congeals to cream consistency.

EXAMPLE-8 Gum olibanum lumps were powdered in 5 kg lots in an

edge runner for 30 minutes. The powdered raw Gum oli
40 banum (250 gm) was extracted at 30° C. using methyl
alcohol (1.5 lt). The solvent containing resinoid was
Tridax Procumbens 5% decanted and distilled off at atmospheric pressure to obtain
(Methyl alcohol extract) the resinoid.
Aloe vera 4%
Gum olibanum Powder 5% Weighed quantities of, Gum olibanum resinoid, dried
Emulsifying ointment 30% 45 juice of Aloe vera, garlic oil and emulsifying ointment were
p-Chlorocresol 0.15% taken in a clean vessel along with p-chlorocresol. The
Water q.s. to make 100% ingredients were melted while mixing to get a homogeneous
molten dispersion (oily phase). Speci?ed quantity of glyc
erine was added to water and this aqueous phase was
The leaves of Tria'ax Procumbens were dried under shade 50 brought to the same temperature as that of oily phase. The
for 72 hrs. The dried leaves were powdered, 300 gms of aqueous phase was added to the oily phase in hot condition
powder was extracted with 1 lt of methanol in a soxhlet and mixed thoroughly at 10,000 rpm using a homogeniser,
extractor for 6 hrs. The methanolic extract was ?ltered and until the resultant mass congeals and solidi?es to cream
evaporated to dryness using Rotavapor. consistency.
The naturally occurring Gum olibanum exudate in dry 55 EXAMPLE-11
state is taken as it is. The lumps (1 kg) were powdered in an
edge runner for 30 minutes. The powdered raw gum was
passed through 100 mesh screen. The methanolic extract of
Gum olibanum powder 5%
Tria'ax procumbens, the dried juice ofA loe vera, emulsifying Salicylic Acid 3%
ointment and p-chlorocresol were taken in a vessel and 60 Aloe vera 3%
heated while stirring until a molten homogenous dispersion Glycerine 2%
is obtained (oily phase). Weighed quantity of Gum olibanum Emulsifying ointment 27%
p-Chlorocresol 0.15%
is dispersed in water and this dispersion is heated to the same Water q.s. to make 100%
temperature as that of oily phase. The aqueous phase is then
added to the oily phase and stirred at 10,000 rpm using a 65
homogeniZer, until the resultant mass congeals to cream The naturally occurring Gum olibanum exudate is taken
consistency. as it is. The lumps (1 kg) were powdered in an edge runner
 US 6,200,570 B1
11 12
for 30 minutes. The powdered raw Gum olibanum was Gum olibanum powder, dry powder of tria'ax procumbens
passed through 100 mesh screen. were dispersed in water along with turmeric powder and
Weighed quantities of salicylic acid dried juice of aloe glycerine. The temperature of this aqueous dispersion was
vera, emulsifying ointment and p-chlorocresol were taken in brought to that of oily phase. The aqueous phase was then
a clean vessel. The ingredients were melted while stirring. added to the oily phase in hot condition, while stirring at
Gum olibanum powder was dispersed in water along with 10,000 rpm using homogeniZer, until the resultant mass
glycerine. The temperature of this aqueous dispersion was congeals and solidi?es to cream consistency.
brought to that of molten oily phase. The aqueous dispersion
was added to the oily phase in hot condition and mixed
thoroughly at 10,000 rpm using a homogeniZer until the 10 EXAMPLE- 14
mass congeals and solidi?es to cream consistency.
EXAMPLE-12
Tridax Procumbens 5%
(Water extract)
15 Aloe vera 4%
Carbopol 934 3%
Tridax Procumbens 5% Methyl Paraben 0.15%
(water extract) Propyl Paraben 0.15%
Aloe vera 3% Manoethanolamine q.s to bring pH to 6
Garlic Oil (Allium sativum) 2% Propyleneglycol:water(50 :50) q.s to make 100%
Emulsifying ointment 26% 20
Glycerine 2%
p-Chlorocresol 0.15%
Water q.s. to make 100%
The leaves of Tridaxprocumbens were dried under shade
for 72 hrs. The dried leaves were crushed to obtain powder.
The leaves of Tria'ax procumbens were dried under shade 25 The crushed leaf powder (250 g) was soaked in water (1 lt)
for 72 hrs. The leaves were crushed to powder (500 gms) and for a week.
soaked with water for a week at room temperature. Water is Water is then decanted and concentrated to 100 ml by
decanted and concentrated to 100 ml by evaporation. This
evaporating under vacuum at room temperature. The con
concentrated solution was then lyophiliZed to a powder.
centrated solution is then lyophiliZed to obtain powder.
Weighed quantities of emulsifying ointment, dried juice 30
ofAloe vera, Garlic oil and p-chlorocresol were taken in a The dried leaf extract of Tridax Procumbens, the dried
clean vessel and melted while stirring until a homogenous juice of Aloe vera, propyl paraben were dissolved in pure
molten mixture is obtained (oil phase). The freeze dried leaf propylene glycol by vigorous mixing using a stirrer. Car
extract of Tria'ax procumbens was dissolved in water along bopol 934 was dispersed separately in propylene glycol and
with glycerine. The temperature of this aqueous solution was 35
water mixture (50:50) along with methyl paraben in another
brought to that of oily phase. The aqueous phase was then vessel. The mixture is stirred continuously for 1—3 hrs at 300
added to oily phase in hot condition and stirred at 10,000 rpm using mechanical stirrer or homogeniZer. The pure
rpm using homogeniZer, until the resultant mass congeals propylene glycol solution containing tria'ax procumbens,
and solidi?es to cream consistency. Aloe vera and propyl paraben was then added and stirring
40
EXAMPLE-13 was continued for 1 hr until a gel preparation was obtained.
The pH of this gel is adjusted to 6.0 using monoethanol
amine. The ?nal gel preparation will be clear, transparent
and non-sticky.
Gum olibanum powder 5%
Tridax procumbens 4% 45
(water extract) EXAMPLE- 15
Aloe vera 5%
Turmeric powder 0.5%
Glycerine 3%
p-Chlorocresol 0.15% Gum olibanum Meal 9%
Emulsifying ointment 25%
Water q.s. to make 100% (Resinoid free Gum olibanum)
Aloe vera 5%
Salicylic Acid 2%
Emulsifying ointment 25 %
The naturally occurring Gum olibanum exudate in dry Methyl paraben 0.15%
state is taken as it is. The lumps (1 kg) were powdered in an Propyl paraben 0.15%
55 Water q.s. to make 100%
edge runner for 30 minutes. The powdered raw gum was
passed through 100 mesh screen.
The leaves of Tria'ax procumben were dried under shade
at room temperature for 72 hrs. The leaves were crushed to Weighed quantities of Gum olibanum Meal (resinoid
powder and the powder (500 gm) was soaked with water (1 60 free), Aloe Vera, Emulsifying ointment and Propyl paraben
lt) for a week. Water is then decanted, ?ltered and concen were taken in a tarred vessel and melted while stirring (Oily
trated to 100 ml. The concentrated solution was then lyo phase). Speci?ed quantities of salicylic acid and methyl
philiZed to get powder. paraben were dispersed in water with the aid of heating until
Weighed quantities of emulsifying ointment, dried juice the temperature reaches to that of oily phase. This dispersion
of Aloe vera, and p-chlorocresol were taken in a clean vessel 65 is added to molten oily phase while stirring at 10,000 rpm
and the mixture was melted while stirring to get a molten using homogeniZer until the mass congeals and solidi?es to
homogenous mixture. cream consistency.
 US 6,200,570 B1
13 14
EXAMPLE-16 The herbal cream of the present invention was applied
twice daily (morning and evening) to the crack heel of a
patient for about 17 days and it was observed that the cracks
Gum Olibanum Meal 9% on the heel were cured.
(Resinoid free) Likewise, another patient having badly cracked sole was
Tridax procumbens 5%
Turmeric Powder 0.5% treated with the herbal composition of the present invention
p-Chlorocresol 0.15% for about 21 days. The herbal cream was applied twice daily
Propylene glycol 2%
Emulsifying ointment 27% i.e. once in the morning and once in the evening after
Water q.s. to make 100% 10 cleaning the sole with soap and water. The cracked sole was
healed after the period.
Weighed quantities of Gum olibanum Meal (resinoid Another patient was treated for cracked heel for 4 days
free), Emulsifying ointment and p-Chlorocresol were taken with the herbal composition of the present invention. The
in a clean tarred vessel and melted (Oily phase). 15 patient’s heel was cleaned with soap and water before
The leaves of Tria'ax procumbens were shade dried for 48 applying the herbal cream twice daily. The cracks appeared
hrs. at room temperature. The crushed leaves (500 gms) on the sole were healed after the treatment.
were then soaked with water (1 litter) for 72 hrs. at room
temperature. At the end of this period, water is decanted and
A female patient having badly cracked sole was treated
then concentrated to 100 ml by evaporating under vacuum at 20 with the herbal composition of the present invention for 15
room temperature. This concentrated solution is then lyo days. At the end of the treatment period, it was observed that
philised to obtain powder. cracks on the sole disappeared.
Tria'ax procumbens extract and Turmeric powder were Yet another patient having a deep crack on a toe was
dispersed in water along with Propylene glycol. The tem 25 treated with the herbal composition for 17 days and at the
perature of this aqueous dispersion was brought to that of end of the treatment, it was observed that the crack on a toe
oily phase. This aqueous dispersion was added to molten healed completed.
oily phase and stirred continuously at 10,000 rpm until the
mass congeals and solidi?es to cream consistency. Another patient having fungal infection on sole was
The formulations have a varied degree of therapeutic treated with the herbal composition of the present invention
30
activity on cracked heels, dry skin disorders, skin allergies, for 50 days and during the course of the treatment, it was
depigmentation on the surface of skin and anti-fungal action. observed that the infection was gradually reduceing. At the
The formulations of the present invention are not a mere
end of the period of the treatment, the fungal infection on the
admixture resulting in mere aggregation of the properties of sole has completely disappeared.
individual ingredients but in a synergistic mixture resulting 35 The following table 2 provides a few more illustrations of
in enhanced curative properties. treating cracked heels:

TABLE 1
Case studies for the herbal ointment formulation 16

Totals Number of
Formulations selected number of cured
Parameters from the example patients patients Results Remarks
Cracked heels Formulations 2-16 for 125 124 15-30 days Rough skin becomes smooth and
cracked heels healthy. Recurrence observed in
only one case.
Pain associated with Formulations 2-16 for 6 6 4-8 days Relives pain quickly
cracked hells cracked heels
Irritation and bleeding Formulations 2-16 for 10 10 2-4 days Quick relief from bleeding and
associated with cracked cracked heels lessens irritation
heels
Depigmentation Formulations 3, 8, 9, 13 4 4 30-60 days Cure depends on the extent of
and 14 pigmentation
Anti fungal property Formulations 1, 3, 8 8 20-40 days Healing depends on severity
and ?ssures between 8, 9, 12 and 13
toes
Moisturising effect Formulations 4, 5, 8, 9, 30 30 Immediate effect Effect is observed immediately
11, 14, 15 and 16. after the application on skin surface
Insect bite and allergy Formulations 1, 5, 9 and 10 10 Quick response Reduces irritation caused to the
13 skin
Super?cial burns Formulations 1, 3, 9, 12 5 5 Quick Patent feels cool after the
and 14 application and smoothern the
surface of skin
Wound healing Formulations 1, 3, 9, 12 6 6 Complete healing of Excision wounds heal by
property in animals and 14 excision wounds 12 contraction and epithelization
14 days
 US 6,200,570 B1
16
5. The present formulations provide excellent protection
TABLE 2 from darkening of skin due to minor cuts, burns, wounds
and pimples.
Number of Patents. Complete cure 6. The present formulations have good antiallergic activity
(2) 26.3.97 11.4.97 5 in case of insect bites, rashes and reduce itching on the
(3) 26.3.97 18.4.97 skin.
(17) 07.4.97 10.4.97 7. The present formulations can be used as base material in
(25) 27.3.97 10.04.97 which ingredients have analgesic and antiin?ammatory
property can be incorporated for potentiation of their
Table 3 given herebelow provides further examples of activities.
treatment fungal infection on human beings: What is claimed is:
1. An herbal formulation useful for therapeutic and cos
metic applications for the treatment of general skin disorders
TABLE 3
comprising the following ingredients:
Number of Patents Start Complete cure 15 (a) at least two or more plant extracts in the form of an oil
(60) 21.7.97 10.9.97 or powder or mixtures thereof, the plant extracts being
selected from the group consisting of Gymnena Sylves
tre water extract 3 to 6 wt. %; Tria'ax procumbens water
The following details provide data of clinical trials con
extract 3 to 6 wt. %; Tridax procumbens methanolic
ducted in respect of the present invention. The herbal
ointment of the present invention has been tried for healing extract 4 to 6 wt. %; Allium sativum oil-hexane extract
of cracked heels, depigmentation of skin, skin rashes and 1 to 3 wt. %; dried juice ofAloe vera 2 to 6 wt. %; Gum
fungal infections. olibanum powder in the natural form from 4 to 7 wt. %;
Human studies: Gum olibanum resinoid organic solvent extract 3 to 8
(1) Cracked heels: wt. %; and resinoid-free Gum olibanum meal 5 to 10
The effect of the ointment is observed in terms closure of 25 wt. % wherein at least one of the two or more plant
cracks relieving pain, bleeding in severe cracks and smooth extracts is either an extract from Tridaxprocumbens or
ening of hardened surface. The effect was observe within 2 from Gum olibanum;
days of application. The pain completely subsided within (b) optionally, including a drug having anti-in?ammatory
3—4 days and surface becomes very smooth. and wound healing properties, the drug being selected
The reappearance of cracks was not observed after the from the group consisting of Disclofenac sodium 1 to
discontinuation of medicine during the observation period of 3 wt. %, Salicylic acid 1 to 4 wt. %, Piroxicam 1 to 2
12 months except in 3 cases our of 136 cases. wt. % and Turmeric powder 0.1 to 1 wt. %, or a mixture
(2) Depigmentation: thereof;
The black spot on the face, knee, forearm was completely
cured in a period of 2 to 3 months in six individuals. (c) a base containing an aqueous cream or a gel containing
(3) Skin rashes, minor cuts and burns:
carbopol ranging between 1 to 4 wt. %, emulsifying
The irritation caused by insect bite (Mosquito) was nul ointment ranging between 20 to 40 wt. %, one or more
li?ed by the ointment in couple of minutes in about 20 preservatives ranging between 0.05 to 0.3 wt. % and a
patients. It was also observed that the ointment is effective 4 O humectant ranging between 1 to 4 wt. %; and
against minor cuts and burns. (d) the balance being water to make 100 wt. %.
(4) Fungal infection: 2. An herbal formulation as claimed in claim 1 wherein
In 6 cases the fungal infection involving irritation, painful the one or more preservatives are selected from the group
open wounds on the foot and ?ssures in between ?ngers consisting of methyl paraben, propyl paraben and
were subsided within 4 to 5 days and took about 2—3 months 45 p-chlorocresol.
for the complete relief from open wounds and ?ssures. 3. An herbal formulation as claimed in claim 2 wherein
Animal stuides: the preservative is p-chlorocresol and ranges between 0.05
The topical application on excision wounds on dorsal to 0.2 wt. %.
surface of wistar rats reduced the time taken for healing 5 4. An herbal formulation as claimed in claim 1 wherein
when compared to control wounds with respect to the the preservatives are methyl paraben and propyl paraben and
parameters such as wound contraction, epithelisation and range between 0.1 to 0.3 wt. %.
scar formation. The above study indicates that the ointment 5. An herbal formulation as claimed in claim 1 wherein
has pro healing property. the Gum olibanum resinoid organic solvent extract is Gum
55 olibanum resinoid hexane extract and ranges between 4 to 6
ADVAN GAGES
wt. %.
. The present formulations, apart from healing the cracks on 6. An herbal formulation as claimed in claim 1 wherein
heels, are useful in arresting the bleeding due to cracks the Gum olibanum resinoid organic solvent extract is Gum
and reducing the pain. olibanum resinoid methanol extract and ranges between 3 to
2. Once the cracks on heels are cured, the recurrence of 8 wt. %.
cracks is minimum, compared to commercially available 7. An herbal formulation as claimed in claim 1 wherein
products in the market.
3. The present formulations have moisturising effect on skin the Gum olibanum resinoid organic solvent extract is Gum
and hence can be used for dry skin disorders in cosmetic olibanum resinoid ethanol extract and ranges between 4 to 6
therapy. 65 wt. %.
4. The present formulations have antifungal activity and 8. An herbal formulation as claimed in claim 1 wherein
hence can be used for fungal infections on skin. the general skin disorders are selected from the group
 US 6,200,570 B1
17 18
consisting of cracked heels, discoloration, dry skin 11. An herbal formulation as claimed in claim 1 Which is
disorders, fungal infections and skin allergies. in the form of an emulsion of cream for application to the
9. An herbal formulation as claimed in claim 1 Wherein skin.
12. An herbal formulation as claimed in claim 1 useful in
the humectant is glycerine and ranges betWeen 1 to 4 Wt. %.
enhancing the healing of cracked heels With minimum
10. An herbal formulation as claimed in claim 1 Wherein recurrences.
the humectant is propylene glycol and ranges betWeen 1 to
3 Wt. %.
 UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION

PATENT NO. : 6,200,570 B1 Page 1 0f 1

DATED : March 13, 2001
INVENTOR(S) : DiWan et al.

It is certified that error appears in the above-identi?ed patent and that said Letters Patent is
hereby corrected as shown below:

Title page,
Item [73], delete “Counsel of Scienti?c and Industrial Research” and insert
-- Council of Scienti?c and Industrial Research

Signed and Sealed this

Eighth Day of April, 2003

JAMES E. ROGAN
Director ofthe United States Patent and Trademark O?‘ice