Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

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Pharmacopoeial Standards for Ayurvedic Formulations and Raw Materials DEFINITION ASVAGANDHADYARISTA (API, PART – II, VOL –II) Asvagandhadyarista is fermented liquid preparation made with the ingredients in the Formulation composition given below. It contains not more than 10 per cent, and not less than 5 per cent of alcohol that is self generated in the preparation over a period of time. FORMULATION COMPOSITION 1 Asvagandha API Withania somnifera Rt. 2.4 kg 2 Musali API Chlorophytum tuberosum Rt. 960 g 3 Manjistha API Rubia cordifolia Rt. 480 g 4 Haritaki API Terminalia chebula P. 480 g 5 Haridra API Curcuma longa Rz. 480 g 6 Daruharidra API Berberis aristata St. 480 g 7 Madhuka (Yasti API) Glycyrrhiza glabra Rt. 480 g 8 Rasna API Pluchea lanceolata Rt./Lf.* 480 g 9 Vidari API Pueraria tuberosa Rt. Tr. 480 g 10 Partha (Arjuna API) Terminalia arjuna St. Bk. 480 g 11 Mustaka (Musta API) Cyperus rotundus Rz. 480 g 12 Trivrt (API) Ipomoea turpethum Rt. 480 g 13 Ananta (Sveta sariva API) Hemidesmus indicus Rt. 384 g 14 Syama (Krsna sariva API) Cryptolepis buchanani Rt. 384 g 15 Sveta candana API Santalum album Ht. Wd. 384 g 16 Rakta candana API Pterocarpus santalinus Ht. Wd. 384 g 17 Vaca API Acorus calamus Rz. 384 g 18 Citraka API Plumbago zeylanica Rt. 384 g 19 Jala API for decotion reduced to Praksepa dravyas Water info Ayurveda, Volume 2, No.5, July - Sept’ 2013 98.304 l 12.2881 20 Maksika (Madhu API) Honey 14.4 21 Dhataki API Woodfordia fruticosa Fl. 768 g 22 Sunthi API Zingiber officinale Rz. 96 g 23 Marica API Piper nigrum Fr. 96 g 24 Pippali API Piper longum Fr. 96 g 25 Tvak API Cinnamomum zeylanicum St. Bk. 192 g 26 Ela (Suksmaila API) Elettaria cardamomum Sd. 192 g 27 Patra (Tejapatra API) Cinnamomum tamala Lf. 192 g 28 Priyangu API Callicarpa macrophylla Fl. 192 g 29 Nagakesara API Mesua ferrea Stmn. 96 g *Actual part used in the formulation METHOD OF PREPARATION Take the raw materials of pharmacopoeial quality. Wash, dry and powder the ingredients numbered 1 to 18 (Kvatha dravya) of the formulation composition individually and pass through the sieve number 44 to obtain coarse powder. Clean, dry and powder the ingredients numbered 22 to 29 (Praksepa dravya) of the formulation composition individually and pass through the sieve number 85 to obtain fine powder. Add specified amounts of water to the Kvatha dravya, soak overnight, heat, reduce to one eighth and filter through muslin cloth to obtain Kvatha. Allow to cool. Transfer the filtrate to clean container; add ingredient numbered 20, 21, of the formulation composition. Finally add the finely powdered Praksepa dravyas and seal the mouth of the container. Shift the container to the fermentation room and constantly check for the signs of completion of fermentation process. Filter the fermented material through a clean muslin cloth. Pack in air tight containers and allow for maturation. DESCRIPTION Clear, dark brown liquid without frothing and significant sedimentation; with astringent taste IDENTIFICATION Thin Layer Chromatography: Dry 50 ml of the formulation in vacuum to remove the self generated alcohol. Add 50 ml water to dissolve the extract and partition successively with n-hexane (50 ml x3) and chloroform (50 ml x 3). Filter and concentrate the chloroform extract under vacuum and weigh. Dissolve 20 mg of residue in ml of chloroform and carry out the thin layer chromatography. Apply separately 10 µl of solution prepared as above an 5 µl of standard solution of withanolide D prepared by dissolving 1 mg in 1 ml of methanol, on TLC plate and develop the plate to a distance of 8 cm using toluene: ethyle acetate: acetic acid (5:4:1) as mobile phase. After development, allow the plate to dry in air and spray with anisaldehyde-sulphuric acid reagent followed by heating at 105º for about 10 minutes and examine under ultraviolet light (366 nm). It shows major spots at R f 0.27 (dark purple), 0.44 (purple, corresponding to withanolide D), 0.61 (light grey), and 0.70 (dark brown). PHYSICO-CHEMICAL PARAMETERS Total phenolic content: Total solids: Specific gravity (at 2500): 1.05 to 1.20 pH: 3.50 to 4.50 Reducing sugars: Non-reducing sugars: Alcohol content: Methanol: 0.104 to 0.260 per cent w/v equivalent to tannic acid Not less than 18.5 per cent w/v Not less than 13 per cent w/v Not more than 0.70 per cent w/v 5 to 10 per cent v/v Absent Other requirements: Microbial limit: & Aflatoxins: (As per Appendix mention in API) 6
STORAGE Store in a cool place in tightly closed amber coloured bottle, protect from light and moisture. THERAPEUTIC USES Murccha (syncope), Apasmara (epilepsy), Sosa (cachexia), Unmada (mania/psychosis), Karsya (emaciation), Arsa (piles), Agnimandya (digestive impairment), Vataroga (neurological disorders). DOSE 15-30 ml orally with equal amount of water after meals twice a day. ASVAGANDHA (API, PART – I, VOL – I ) Asvagandha consists of dried mature roots of Withania somnifera Dunal. (Fam. Solanaceae); a perennial shrub, found in waste land, cultivated filed and open ground throughout India; widely cultivated in certain areas of Madhya Pradesh and Rajasthan; roots collected in winter, washed and cut into short pieces SYNONYMS Sansk : Hayagandha, Vajigandha Assam : Ashvagandha Beng. : Ashvagandha Guj. : Asgandha Hindi : Asgandh Kan. : Angarberu, Hiremaddina-gida Kash. : Asagandh Mal. : Amukkuram Mar. : Asagandha, Askagandha Ori. : Aswagandha Punj. : Asgandh Tam. : Amukkaramkizangu Tel. : Pennerugadda Urdu : Asgand DESCRIPTION (a) Macroscopic – Roots straight, unbranched, thickness varying with age, roots bear fiber-like secondary roots, outer surface buff to greyyellow with longitudinal wrinkles; crown consists of 2-6 remains of stem base; variously thickened; nodes prominent only on the side from where petiole arises, cylindrical, green with longitudinal wrinkles; fracture, short and uneven, Odour, characteristic; taste, bitter and acrid. IDENTITY, PURITY AND STRENGTH Foreign matter Not more than 2%, Total ash Not more than 7%, Acid-insoluble ash Not more than 1%, Alcohol (25%) soluble extractive Not less than 15%, (As per Appendix mention in API) ASSAY Aswagandha consists of not less than 0.2 per cent of total alkaloids, when assayed as follows:- Take about 30g accurately weighed of the powdered drug, cover with Alcohol (90 per cent) and allow to stand overnight. Extract for 6 hours so wet apparatus and concentrate to syrup residue. Treat with 25, 20, 15 and 10 ml portions of 5 per cent Sulphuric Acid until complete extraction of alkaloid is affected. To the combined acid extract add an excess of Dragandorf’s reagent. Filter under suction and dissolve the residue in Acetone, Shake the acetone solution with freshly prepared suspension of 2g Silver Carbonate in 10 ml of Water. Filter the solution and wash the precipitate with Acetone, Alcohol and water in that order. Pass sufficient Hydrogen Sulphide through the filtrate. Boil the solution for 10 minutes, filter and evaporate under vacuum in a tared flask. Add to the residue 5 ml of Ethyl Alcohol, evaporate to dryness, repeat the process once again and weight the residue to constant weight in vacuum dessicator. CONSTITUENTS Alkaloids and withanolides. PROPERTIES AND ACTION Rasa : Tikta, Kasaya Guna : Laghu Virya : Usna Vipaka : Madhura Karma : Vatakaphapaha, Balya, Rasayana, Vajikarana IMPORTANT FORMULATIONS Asvagandhadyarista, Asvagandhadi leha, Balasvagandha laksadi taila. THERAPEUTIC USES Ksaya, Daurbalya, Vataroga, Sotha, Klaibya. DOSE 3-6g of the drug in powder form (b) Microscopic – Transverse section of root shows cork exfoliated or crushed; when present isodiamatric and non-lignified; cork cambium of 2-4 diffused rows of cells; secondary cortex about twenty layers of compact parenchymatous cells; phloem consists of sieve tubes, companion cells, phloem parenchyma; cambium 4-5 rows of tangentially elongated cells; secondary xylem hard forming a closed vascular ring separated by multiseriate medullary rays; a few xylem parenchyma. Picture 1: Ashwagandha Fruiting Twig info Ayurveda, Volume 2, No.5, July - Sept’ 2013 7
Page 1 and 2: Volume 2, No.5, July to September
Page 3 and 4: Regulatory Update REGISTRATION OF C
Page 5: GOOD CLINICAL PRACTICE GUIDELINES F
Page 9 and 10: BRIEF REVIEW ON ASHWAGANDHA (Withan
Page 11 and 12: urinary stones and hemorrhagic dise
Page 13 and 14: Double Blind Randomized Placebo Con
Page 15 and 16: 3.6. TOLERANCE The drug was well to

Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

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