pdf24 Merged
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formulation”
CERTIFICATE
Co- Supervisor:
Mr. Jaydeep Singh Baghel
Asst. professor, CDIP Indore
Supervisor:
Dr. Gaurav Jain
Professor, CDIP Indore
                                                                           Principal
                                                              Dr. Arun Kumar Gupta
Date:                                               Supervisor
Place: Indore                                    Dr. Gaurav Jain
                                               Professor, CDIP Indore
                                                 Co- Supervisor:
                                             Mr. Jaydeep Singh Baghel
                                         Asst. professor, CDIP Indore
                              DECLARATION
I hereby declare that the project work incorporated in the present thesis entitled is
“Phytopharmaceutical Preparation: A step by step guide to herbal syrup
formulation”is the outcome of my own un-aided efforts except the guidance
received from my supervisors. The work has been carried out in Chameli Devi
Institute of Pharmacy, Indore and has not been submitted elsewhere by me for the
award of any degree.
Firstly, I would like to express my heartfelt gratitude to my project guide Dr. Gaurav Jain, for
guiding me throughout the course of the project. I am highly indebted to his invaluable guidance
and ever-ready support, which was necessary for the successful completion of the project in,
stipulates time. His deep knowledge of Pharmacy field made me realize that theoretical
knowledge always helps to develop efficient educational projects, which are a blend of all
core subjects of the field. Working under his guidance has been a fruitful experience, which
will be very valuable for me.
I would like to give a warm expression of thanks to Principal, Dr. Arun Kumar Gupta for
providing the facilities and academic environment for my project work.
I am also thanking M r . Jaydeep Singh baghel , Mr. Ashwin sharma for his time to time
and valuable guidance and all the CDIP staff members for their encouragement and support
throughout this project and all those who have embedded me with technical knowledge of
Pharmacy.
I sincerely thank to all our friends and well-wishers for directly or indirectly helping me during
the work.
Sr no            Subject              Page No
  1            Introduction             1-4
8 Conclusion 21
 9              References             22-26
                  LIST OF TABLES
2 2 Boiling of Sample 9
3 3 Filtration Process 9
4 4 Extract Product 9
5 5 Simple Syrup 12
9 9 Vasaka root 16
10 10 Vasaka Leaf 17
11 11 Vasaka flower 18
     i.   AV – Adhatoda vasica
    ii.   Kg – Kilogram
   iii.   NaOH – Sodium Hydroxide
   iv.    HCL – Hydrogen Chloride
    v.    NH3 – Ammonia
   vi.    H2SO4 – Sulfuric acid
  vii.    K–       Potassium
 viii.    Na – Sodium
   ix.    Ca – Calcium
    x.    Mg – Magnesium
   xi.    Zn – Zinc
  xii.    Cu – Copper
 xiii.    Cr – Chromium
  xiv.    Ni – Nickel
   xv.    Co – Cobalt
  xvi.    Cd – Cadmium
 xvii.    Pb – Lead
xviii.    Mn - Manganese
  xix.    S. epidermis – Staphylococcus epidermis
   xx.    B.subtilis – Bacillus subtilis
  xxi.    E.coli – Escherichia coli
 xxii.    P. aeruginosa – Pseudomonas aeruginosa
xxiii.    K. pneumoniae – Klebsiella pneumoniae
xxiv.     C. albicans – Candida albicans
INTRODUCTION
“Phytopharmaceutical Preparation: A step by step guide to herbal syrup formulation”               2025
         1. INTRODUCTION:
         Adhatoda vasica Linn (family Acanthaceae), commonly known as Vasaka or Arusha is a well-
         known herb in indigenous systems of medicine for its beneficial effects. Vasaka, also called as
         Malabar nut tree, is well known throughout India [1, 2]. The vasaka plant perennial, evergreen
         and highly branched with unpleasant smell and bitter taste, the plant lives for multiple seasons
         and retains its leaves throughout the year. It is a shrub 1.0 m to 2.5 m in height, with opposite
         ascending branches. It grows all over the India and in the lower Himalayan ranges. Beside
         India, it is found in Myanmar, Sri Lanka, Burma and Malaysia. In Ayurvedic medicine,
         Adhatoda vasica has been used for a variety of disorders including; bronchitis, leprosy, blood
         disorders, heart troubles, thirst, asthma, fever, vomiting, loss of memory, leucoderma, jaundice,
         tumors, mouth troubles, sore-eye, fever, and gonorrhea(3,4). An extract of the leaves showed
         significant antifungal activity against ringworm. This plant contains alkaloids, tannins,
         flavonoids, terpenes, sugars, and glucosides. The principle constituents of vasaka are its several
         alkaloids, the chief one being vasicine. The leaves contain two major alkaloids called vasicine
         and vasicinone. The leaves of vasaka are rich in vitamin C, carotene and essential oil. The roots
         are known to contain vasicinolone, vasicol, peganine, sitosterol, ³-glucoside-galactose and
         deoxy vasicine and 2'- hydroxy-4- glucosyl-oxychalcone(5,6,7). The flowers contain b-
         sitosterol-D-glucoside, kaempferol, its glycosides and quercetin Minor alkaloids include
         Adhatonine, Vasinol (8). Adhatoda vasica (AV) belong to the family Acanthaceae. The leaves,
         roots and young plants of AV contain the quinazoline alkaloids vasicine, 7- hydroxyvasicine,
         vasicinolone, ´deoxyvasicine, vasicol, vasicoline, vasicolinone, triterpenes, anisotine) betaine,
         steroids carbohydrate and alkanes. In the flowers triterpenes (a-amirine), and flavonoids
         (Apigenin, astragalin, kaempferol, quercetin, vitexin) have been found [1, ³] Adhatoda vasica,
         also known as Malabar nut tree is part of the Acanthaceae plant family (9). Adhatoda is
         obtained from commercial sources or collected from open fields. Propagation is primarily by
         means of seeds, can also propagate from cuttings in springs early summer with hardwoods
         cuttings . Medicinal plants play a key role in world health care systems . Charaka Samhita has
         classified the drug under mucolytic and expectorant drug. The roots, leaves & flowers are
         active principles of the plant possess a number of pharmacological properties & are used in
         cough, chronic bronchitis, rheumatism, asthma & bronchial asthma. Majority of medicinal
         plant species are rich in biomolecules contents which can cope with health hazards and
         recently, antibacterial activity of many plant species has been reported. The leaves and roots
         contain several alkaloids (chief principle being quinazoline alkaloid, vasicine and vasicinone,
         vasicinolone and vasicol), which may have a bronchodilator effect of the bronchii. These
         alkaloids are said to exist in combination with an acid that has been named adhatoda acid. It
         acts as a sedative, expectorant, antispasmodic, anthelmintic, bronchial antiseptic and
         bronchodilator. The leaf extract has been used for the treatment of bronchitis and asthma for
         many centuries. It relieves cough and breathlessness. It is also prescribed commonly for
         bleeding due to idiopathic thrombocytopenic purpura, local bleeding due to peptic ulcer, piles,
         menorrhagia. Its local use gives relief in pyorrhea and in bleeding gums . As the alkaloid
         content of plant varies with genotype therefore, it is recommended to propagate A. vasica plant
         using vegetative method . Adhatoda zeylanica Medicus also known as A. Vasica Nees. Justicia
         adhatoda Linn(10,11). Adhatoda vasica nees (Acanthaceae) commonly known as vasaka
         distributed throughout India up to an attitude of 1300m the leaves, flowers, fruit, and roots are
         extensively used for treating cold cough, whooping cough, chronic bronchitis and asthma as
         sedative, expectorant and antispasmodic (12) . Adhatoda vasica has been used as a well-known
         drug in the unani and ayurvedic medicine (13) and the plant has been used in the indegenous
         system of medicine in India for more than 2000 years (14) . A. vasica is known for its
         antibacterial, antispamodiac, anti-arthritis, antiseptic, expectorant and antituberculosis
         properties . The phytochemical studies of the various parts of Adhatoda vasica revealed the
         presence of alkaloids, phytosterols, polyphenolics and glycosides as a major class of
         compounds. Its principal constituents are quinazoline alkaloids with vasicine as its chief
         alkaloid. The leaves are rich in Vitamin C and carotene and yield an essential oil. Chemical
         compounds found in leaves and roots of this plant includes essential oils, fats, resins, sugar,
         gum, amino acids, proteins and vitamin C etc . In the present work we have selected A. vasica
         as herbal medicine to screen its medicinal properties in reference. This study emphasizes upon
         the in vitro antibacterial activity, antioxidant property, anticancer potential and phytochemical
         anlaysis leading to the identification of phytoconstituents responsible for medicinal
         Activity(13,14).
         Different names for the plant in different regions/languages of India have been reported as:
         English (Arusa, adusa, rusa, baansa, adulsa), Hindi (Baansa, adulsa), Bengali (Basak, bakas),
         Gujrati (Aradusi, adulso), Kannada (Adusoge, kurchigida, pavate, bansa), Malayalam
         (Adalodakam), Manipuri (Nongmangkha-agouba), Marathi (Adulsa), Punjabi (Bhekkar, bansa,
         basuti), Tamil (Adhatadai, Pavettai), Telugu (Adasaramu), Kashmiri (Bahekar, baikar, bansuth,
         babading), Konkani (Adusogae), Sanskrit (Vasaka), Oriya (Arusa, basung), Sinhala (Pawatta)
         and Peasian (Bansa}{lS,l6}. The botanical description of the plant is as follows:
Kingdom: Planta
Division : Angiosperms
Class : Eudicots
Order : Lamiales
Family : Acanthaceae
Genus : Justicia
               Innumerable natural products with inherent potential biological activity procured from
         plants have played a significant role in improving the human health since the dawn of
         civilisation. As more than 50% of modern clinical drugs originate from natural products ,
         therefore based on latter, the approach to new drug discovery and its development in the
         pharmaceutical industry has emerged significantly(17,18).
      Research performed over the last three decades has revealed that the alkaloids, vasicine and
      vasicinone (quinazoline ring derivatives) present in the leaves, possess respiratory stimulant
      activity whereas its roots contain vasicinolone, vasicol and peganine . Vasicine (1,2,3,9 -
2. LITERATURE REVIEW
          Srinivasan et al 2014; Adhatoda vasica (AV), an official drug in the Indian Pharmacopoeia has
          been used for the treatment of cold, cough, bronchitis and asthma. In present investigation,
          optimization of drying conditions of AV leaves based on qualitative analysis and the retention of
          phenols, antioxidants and alkaloids was carried out to lay down the standards which could be useful
          in future experimental studies.
          Singh et al 2016 ; . It present in class of herbal drug with very strong conceptual or traditional base.
          Adhatoda vasica is an important source of vasicine, vasicinone, vasicolone and some other
          Alkaloids
          AM et al 2017; It can be concluded that physiochemical properties of adulasa leaf and dried extract
          were studied. The extraction was carried out by using different
          solvents in which aqueous extraction was found much better than other solvents.
          Chauhan et al 2018; The screening of A. vasica leaves extracts results have shown significant
          antibacterial, antioxidant and anticancer properties due to the presence of therapeutically important
          constituents which can be used in the development of herbal
          formulations in treating respiratory diseases
          Rahaman et al 2018; Medicinal plants like Adhatoda vasica Nees. are used traditionally in Tripura
          to cure pneumonia, cough and cold. Pneumonia is a lung infection with cough, fever and hard time
          breathing. Pneumonia is mainly caused by bacteria like Streptococcus pneumoniae. Moreover, many
          of these pathogenic strains are showing acute resistant to many commercially available antibiotics
          due to the formation of biofilms
          Singh et al 2018; Leaf of Adhatoda vasica (Vasaka) is an important drug of Ayurveda, prescribed
          as an expectorant. Quinazoline alkaloids present in the leaves are established as active principles.
          Sharma et al 2018 ; It has been revealed from the literature that the quinazoline
          based alkaloids have been the major constituents present in the different parts of A.
          vasica, which have been mainly responsible for their wide range of pharmacological
          potential. A. vasica has been an important medicinal herb well known for its
          applications in different traditional medicinal system such as Ayurveda, Siddha and
          Unani etc
          Ansari et al 2020; Overall, the study suggests that the model obtained in the present
          study can be applied for large scale production of extract for further use in
          pharmacy/food industries.
          Singh et al 2021; This study will help to find specific bioactive compounds of
          vasaka, and their suitable use for human welfare. The bioactive compound vasicine
          have been isolated from alcoholic extract of vasica leaves using column
          chromatography
          Sharma et al 2021; Adathoda vasica Nees well known in the indigenous systems of
          medicine for its beneficial effects, effective in the treatment of infectious diseases
          while simultaneously many of the side effects of synthetic antimicrobials.
         3. WORK PROCEDURE :
         Materials and Methods
                       a.   Plant collection : 1 kg fresh vasaka leaves were collected and
                       leaves are washed in fresh water.
                1. Infusion
                2. Decoction
                3. Maceration
                4. Percolation
                5. Soxhlet Apparatus
                        We are mainly used in decoction process extraction.
Powdered drug
Filtration
         This is a process that involves continuous hot extraction using specified volume of water as a
         solvent. A dried, grinded, and powdered plant material is placed into a clean container. Water
         is then poured and stirred. Heat is then applied throughout the process to hasten the extraction.t.
         The ratio of solvent to crude drug is usually 4:1 or 16:1. It is used for extraction of water soluble
         and heat stable plant material.
          100 gm vasaka leaf powder placed in a clean container and added to 400 ml of water . Then
         we stirring for good mixing. The container is placed in hot plate for boiling. The boiling time
         is 30-40 min. after 40 min stop the boiling . then filtered the product. The decoction process is
         ready (23,24).
4 Glycosides Positive(+)
5 Triterpenoids Positive(+)
6 Carbohydrate Positive(+)
10
                 Principle:
                    Syrups are sweetened, viscous, concentrated solutions of sucrose or, other sugars
                    in water or any other suitable aqueous vehicles. These are further classified into 2
                    classes.
                            1. Simple flavoured syrups
                            2. Medicated syrups
                    Simple flavour syrups: Do not contain any medicament or drug. These syrups are
                    used as a vehicle for other Liquid preparation to mask the disagreeable taste of the
                    drug.
                    Medicated syrups: These contain some medicinal substances along with their other
                    additives. Sucrose concentration in simple syrup is a 66.7%w/w.
                    Vasaka is native to India. It grows all around the plains of India and in the lower
                    Himalayan range. The leaves contain an alkaloid vasicine besides a volatile oil.
                    Vasaka soothes bronchial inflammation and open airways, help phlegm discharge
                    and relieves chest congestion.
11
                     Rose Bengal Dye is a stain. Rose Bengal belongs to the class of organic compounds
                     called Xanthene. It is used as Colouring agent.
                 PROCEDURE:
                     1) PREPARATION OF SIMPLE SYRUP (50%):
                      Weighing the sucrose properly and add water to sucrose in a beaker and heat on
                      hot plate until sucrose dissolves add Sufficient boiling water to produce the final
                      volume.
 COMPOSITION:
                                                                   OFFICIAL            REQUIRED
                           SL.NO            INGREDIENTS           QUANTITIES          QUANTITIES
                                                                    (100ML)              (50ML)
12
 COMPOSITION:
                                                               OFFICIAL            REQUIRED
                          SL.NO         INGREDIENTS           QUANTITIES          QUANTITIES
                                                                (100ML)              (20ML)
                                           ROSE
                                        BENGAL DYE                 1GM                0.2GM
                             1
                                          DISTILLED
                             2             WATER                  100ML               20ML
13
Transfer to a measuring cylinder and make up the volume with simple syrup
Fill the preparation in a suitable container, cork it, attach the label and submit.
                      COMPOSITION:
                                                                        OFFICIAL              REQUIRED
                      SL.NO               INGREDIENTS                  QUANTITIES            QUANTITIES
                                                                         (100ML)                (50ML)
                        1                   VASAKA
                                            EXTRACT                         50ML               25ML
                        2
                                           GLYCERINE                        10ML                5ML
                        3                   METHYL
                                            PARABEN                        0.2GM               0.1GM
14
                      4                ROSE BENGAL
                                            DYE                           5ML                         2.5ML
                      5                SIMPLE SYRUP
                                          (Q.S) TO                       100ML                         50ML
 LABEL:
15
         5. Traditional uses :
         Adhatoda vasica, an ayurvedic medicinal plant has been used in various chest and respiratory
         track infection (26)viz.- whooping cough, chronic bronchitis, asthma and has been employed
         as sedative expectorant in the treatment of excessive phlegm (mucus with bacteria, debris, and
         sloughed-off inflammatory cells) and menorrhagia (abnormal blood clotting, disruption of
         normal hormonal regulation of periods, or disorders of the endometrial lining of the uterus) in
         Sri Lanka. It is also used for the treatment of bleeding piles, impotence and sexual disorders
         (27). I, antispasmodic and anthelmintic drug (28). Glycodin, which is a famous product used
         for the cure of bronchitis has been a product extracted from the leaves of Adhatoda vasica. It
         has also been reported that 70% of the pregnant women in the Gora village of Lucknow (Uttar
         Pradesh, India) use the leaves of plant to induce abortion (29). Further, the extracts have been
         found to be quite effective against tuberculosis. Various parts of the plant have been used in
         Indian traditional medicine for the treatment of asthma, joint pain, lumber pain, sprains, cold,
         cough, eczema, malaria, rheumatism, swelling and venereal diseases (30).
         Root: In India paste of the fresh root applied on abdomen and vagina minutes before childbirth
         facilitates easy delivery (31,32). The extract of roots of Adhatoda vasica has commonly been
         used by rural population against diabetes, cough and certain liver disorders (33).whereas its
         paste has been used for curing tuberculosis, diphtheria, malarial fever, leucorrhoea, eye
         diseases, acute nightfall [(paste mixed with sugar) in Sitapur district, Uttar Pradesh, India] (34).
         Further, the root’s decoction has been used for gonorrhoea (35) and as an expectorant,
         antispasmodial / anthelmintic agent (36).
16
         Leaves: The various preparations of leaves has been used for curing bleeding, hemorrhage,
         skin diseases, wounds, headache and leprosy (chronic infection) while their infusion or the
         solvent extract has been observed to be an excellent agent for the destruction of white ants,
         flies, and mosquitoes (37). The fresh juice of leaves mixed with honey and ginger juice cures
         all types of acute cough, chronic bronchitis, breathlessness and liquefies sputum and asthma
         (38). The extract obtained by decoction of its leaves along with fruit of Phyllanthus emblica,
         mixed with honey has been effective against asthma (39). The crushed fresh leaves of the plant
         have been used to treat snake bites (India and Sri lanka) (40). Macerated extract from leaves/
         Yellow leaves/smoke from dry leaves acts against cough and phlegm blockage during cold
         (Bangladesh) and an infusion protects from headache (Myanmar and Pakistan) (41-43). The
         leaf powder boiled in sesame oil stops bleeding, earaches as well as pus from ears and jaundice
         (44). Leaf juice has been used as the best medicine to enhance platelet count during dengue
         like viral fevers, postpartum hemorrhage, urinary trouble, acidity and belching and its mixture
         with jaggery reduces excessive mensutrual flow get cured (45,46). Externally warmed leaves
         have been used for rheumatic pains and dislocation of joint, stomach catarrh with constipation,
         rheumatism, gout, fever and urinary stone (47,48,49). Juice made from the bark and leaves help
         against vomiting (50).
         Flowers: The flowers have been known to possess expectorant and antiasthmatic, antiseptic
         properties (51)nd have been used against of opthalmia, cold, phthisis, asthma, bronchitis,
17
         cough, antispasmodic, high fever and gonorrhoea. Also the fowers improve blood circulation
         and hectic heet of blood(52,53,54).
         Fruits: Fruits of the Adhatoda vasica are four seeded capsules. In Pakistan, fruits of the plant
         are used for cold, antispasmodic and bronchitis (54). The fruit of the plant are also used for
         Diarrhea, Dysentery, Fever and as laxative (42,54). The some herbal preparation made from
         Adhatoda vasica which have been used for the treatment of different disorders are Kan Jang
         (used for alleviation of symptoms of cold, antitussive, mucolytic occasional and irritation of
         the respiratory track in Sweden), Spirote (used for alleviation of symptoms of colds, occasional
         cough in Sweden), Salus Tuss (used for dry cough, bronchitis, cold, smoker cough in
         Germany), Kada (used for Asthma in India) and Fermiforte (used for Leucorrhoea in
         India)(53).
6. Biological activity :
          The medicinal properties of Adathoda Vasica Nees (Natural Order: Acanthaceae) have been
         known in India and several other countries for thousands of years. A few of the biological
         activities of the plant has been enumerated.
(a)Antibacterial Activity :
          Water, ethanolic and petroleum ether extracts of Adhatoda leaves enriched with alkaloids,
         phenols, tannins and reducing sugars, main constituent vasicine etc. have been found to
         possess antibacterial activity (singularly or in combination) against S. epidermidis, S. aureus
         B. subtilis, E. faecalis, E. coli, P aeroginosa, P. vulgaris, K. pneumoniae and C. Albicans
         (54,55).
18
Anti-diabetic Activity:
         The extracts of roots and leaves of A. vasica are commonly used by rural population against
         diabetes and certain liver disorders (56). The methanolic extract from the leaves of A. vasica
         (Acanthaceae) showed excellent sucrase inhibitory activity with sucrose as a substrate (55). A
         different study by highlights the role of vasicine which is the main constituent of the plant, in
         sucrose metabolism. Epidemiological studies and clinical trials strongly support that, control
         of hyperglycemia is critical in treatment of not only, diabetic patients but also, persons with
         impaired glucose acceptance. This current report explains that, vasicine can also act as
         irreversible α-glucosidase (sucrose). Thus, A. vasica can be explored as a potent natural
         antidiabetic agent.
Antioxidant Activity:
         The significant characteristic of an antioxidant is its potential to trap free radicals generated in
         the body. These free radicals may oxidize proteins, lipids or nucleic acids and can initiate
         verious degenerative disease. All A. vasica plant extracts showed antioxidant potential
         (337μg/ml). Besides this, the antioxidant, antidiabetic and antibacterial activity of various
         extracts of Adhatoda vasica has also been investigated. Among hexane, chloroform and
         methanolic extracts of the plant, the methanolic extract had shown to have maximum
         antioxidant activity and blood cholesterol lowering activity. Adhatoda vasica alsoshows the
         antioxidant and anti-clastogenic efficacy against cadmium chloride (CdCl2) induced renal
         oxidative stress and genotoxicity induced by cadmium chloride (CdCl2) in Swiss albino mice
         supports its anti-mutagenic efficacy (57).
Hepatoprotective Activity:
19
Macroscopic character :
          Leaf are pale green, fruity in odor, bitter taste, oblong shape, 8.0-14.2 cm length and 4-5 cm
         width.
Phytochemical Screening :
          Preliminary phytochemical screening was performed in the extract of Adhatoda vasica in the
         presence of Glycosides, Alkaloids, Tannins, Flavonoids, Carbohydrates, Titerpenoids.
20
8. CONCLUSION:
          It can be concluded that physiochemical properties of vasaka leaf and dried extract were studied. The
         extraction was carried out by using decoction method. It has been revealed from the literature that the
         quinazoline based alkaloids have been the major constituents present in the different parts of Adhatoda
         vasica, which have been mainly responsible for their wide range of pharmacological potential like other
         herbal chemical constituents , alkaloid, glycosides, flavonoids, tannins , titerpenoids etc. Since encient
         period Adhatoda vasica has been an important medicinal herbs well known for its applications in
         different traditional medicinal system such as Ayurveda, Siddha and Unani etc. Adhatoda vasica also
         showed many pharmacological activities Viz. hepatoprotective, antiulcer, abortifacient, antiviral, anti-
         inflammatory, thrombolytic, antibacterial, antifungal, radiomodulation, hypoglycaemic, antitubercular,
         antioxidant and antitussive. Thus, the current review would be helpful in the advancement of today’s
         research in the development of new novel bioactive components derived from medicinal plants which
         would find a large number of applications in modern pharmaceuticals, cosmetics and agricultural fields
               It is concluded that using vasaka leaf extract in different kind of herbal cough / antitussive
         preparation has a wide scope of cough therapy in compare to modern medicaments.
21
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