the ayurvedic pharmacopoeia of india - ccras ( pdfdrive ), страница 29

Apply 20 µl on TLC plate. Develop the plate to a distanceof 8 cm using toluene : ethyl acetate (7 : 3) as mobile phase. After development allow theplate to dry in air and examine under ultraviolet light (254 nm). It shows major spots atRf 0.29, 0.35, 0.50, 0.60, 0.75, 0.82 and 0.90. Under ultraviolet light (366 nm), the plateshows fluorescent spots at Rf 0.10 (light blue), 0.13 (light blue), 0.30 (light green), 0.35(yellow), 0.53 (blue), 0.68 (light blue), 0.75 (light green), 0.86 (blue). Spray the plate withanisaldehyde-sulphuric acid reagent followed by heating at 1100 for about 10 min. Itshows major spots at Rf 0.15 (light violet), 0.35 (brown), 0.50 (light violet), 0.60 (lightviolet), 0.70 (light blue violet), 0.80 (red), 0.87 (light brown) and 0.97 (light violet) undervisible light.Physico-chemical parameters:Refractive index at 250:Weight per ml at 250:1.473 to 1.478,0.950 to 0.951 g,Appendix 3.1.Appendix 3.2.Saponification value:3.10.Iodine value:3.11.Acid value:3.12.Peroxide value:3.13.185 to 200,Appendix.100 to 115,AppendixNot more than 5.0,AppendixNot more than 6,AppendixAbsent,AppendixOther requirements:Mineral oil3.15.Microbial limits:Aflatoxins:Appendix 2.4.Appendix.

2.7.Storage: Store in a cool place in tightly closed containers, protected from light andmoisture.Therapeutic uses: Kaphavātaja nā²ī vra´a (Sinus due to Kapha do¾a and Vāta do¾a).Dose: As prescribed by the physician for Abhya¬ga (External use).LEPALepas are semi-solid preparations intended for external application to the skin orcertain mucous membranes for emollient, protective, therapeutic or prophylactic purposeswhere a degree of occlusion is desired. They usually consist of solutions or dispersions ofone or more medicaments in suitable bases.The base should not produce irritation or sensitization of the skin, nor should itretard wound healing; it should be smooth, inert, odourless, physically and chemicallystable and compatible with the skin and with incorporated medicaments.The proportions of the base ingredients should be such that the ointment is not toosoft or too hard for convenient use.

The consistency should be such that the ointmentspreads and softens when stress is applied.DĀRVĪ MALAHARA (GEL)(Based on Carak Chikitsa 25/93)Definition:Dārvī Malahara is a semisolid preparation made with the ingredients given in theFormulation composition.Formulation Composition:1.Rasā®jana APIBerberis aristata / B. asiatica / B. lycium2.Spha°ikāAlum or Potable Alums3.Tragacanth4.Xanthan gum FF5.Propylene glycolml6.Methyl paraben0.17 g .7.Propyl paraben0.03 g8.Disodium edentate0.01 g9.Peppermint oil0.05 ml10. Jala APIWatergroot extract 2 g1g2g1g4100Method of Preparation:Preparation of Rasanjana:Rasā®jana is the dried aqueous extract of the roots of Dāruharidrā, (Berberis aristata orB. asiatica or B.

lycium, Fam. Berberidaceae), and is prepared by the following method.Chop Dāruharidrā into small pieces of about 1 cm thickness. Powder the chopped rootsto a yavkuta (powder whose all particles pass through sieve number 22 and not more than10 per cent pass through sieve number 44). Weigh the powder and transfer to a suitableextraction vessel. Add Purified water (5 times the weight of drug), allow to soakovernight (12 h), followed by gentle boiling for 4 h. Stop the boiling and allow thecontents to settle down. Separate the water layer and filter while hot. Repeat theextraction two times more using fresh Purified water (4 times the weight of drug).Remove the water from the combined extract as completely as possible.

At this stage theextract solidifies on cooling. Dry the solidified extract further in an oven, preferably avacuum oven at a temperature below 600.Pack it in tightly closed containers to protect from light and moisture.Preparation of Dārvī Malahara:Weigh all the ingredients separately. Mix well the powders of tragacanth and xanthangum. Take 50 ml of purified water in a 250-ml container and transfer gum mixture withcontinuous stirring to avoid formation of lumps.

Keep it aside for 6 h for completedispersion and hydration. Dissolve powder of Sphatikā (potash alum) in 10 ml of warm(600) purified water and add this solution after cooling to gum mixture with stirring.Dissolve methyl paraben, propyl paraben, disodium edetate in a mixture of 4 ml ofpropylene glycol and 6 ml of purified water and heat for 5 min at 600. Cool and add thissolution with continuous stirring to the mixture of gums and alum.

Dissolve Rasā®jana in10 ml of purified water and add to the gel (mixture of gum and alum) and mix well.Adjust the weight of gel to 100 g with purified water. Adjust the pH between 3.7 and 4.2with sufficient triethanolamine (approximately 3 to 4 drops). Add 0.1 ml of peppermintoil or other permissible flavour to the prepared gel and mix well. Fill the gel inaluminium / plastic tubes.Description:Yellowish-brown, non-gritty, smooth gel.Identification:Test for Berberine: Dissolve about 2 g of Dārvī Malahara in 20 ml of water and filter.Take about 2 ml of the filtrate and add 1 ml of concentrated nitric acid. A dark red colouris formed.Test for Spha°ikā: Dip a spatula in the water solution of Dārvī Malahara.

Take it out andlet it dry. Hold spatula in a nonluminous flame; a violet colour is imparted to the flame.Physico-chemical parameters:pH (5% aqueous solution) : 3.7 to 4.2Appendix 3.3.Assay:Sample contains not less than 0.08 per cent of berberine when assayed by the followingmethod.Estimation of Berberine: Dissolve about 25 mg of accurately weighed Berberinehydrochloride in water and makeup the volume to 25 ml in a volumetric flask. Transfer1,2,3,4,5 and 6 ml of this stock solution separately to six 25 ml- volumetric flasks andmakeup the volume in each to 25 ml.Apply in triplicate 1 µl of each dilution on a TLC plate. Develop the plate to a distance of8 cm using n-propanol : formic acid : water (8.1: 0.1: 1.8) as mobile phase.

Afterdevelopment, dry the plate in air and scan at 343 nm in a TLC scanner. Note the areaunder the curve for peak corresponding to berberine and prepare the calibration curve byplotting peak area vs amount of berberine hydrochloride.Dissolve accurately weighed about 1 g of Dārvī Malahara in 5 ml of distilled water andmake up the volume to 25 ml in a volumetric flask with distilled water. Filter thesolution and discard the first 5 ml of the solution. Collect the next 5 ml of solution anduse for analysis. Apply 1 µl of solution in triplicate on a TLC plate and develop, dry andscan the plate as described in preceding paragraph for calibration curve of berberine.Calculate the amount of berberine in the test solution from the calibration curve ofberberine hydrochloride and determine the concentration of berberine in the DārvīMalahara.Other requirements:Microbial limits:Aflatoxins:Appendix.

2.4.Appendix. 2.7.Dose: 2g twice a day to be applied with applicator in vagina.Storage: At room temperature.Therapeutic uses: Sveta Pradara (Leucorrhoea), Yonika´²ū (Itching), Yoni sotha,(Vaginitis and other wounds and ulcers).Precaution: Discontinue if there is any irritation or discomfort..