Study On Quality Standard Of Kangfuling Tablets

Study on Quality Specification of Kangfuling TabletsObjective:The medicine Kangfuling Capsules has been widely usedin the clinical treatment of gynecological diseases, Itsprescription is mainly composed of bar plate, bitter ginseng,cortex phellodendri, caulis spatholobi, motherwort,safflower, radix geutianae, glabrous greenbrier rhizome andChinese angelica, etc. The function of Kangfuling Capsulesplays an important role in clinical effect includes heatingdrying dampness, promoting blood circulation to remove bloodstasis, regulating the menstrual function check belt; it isalso appropriate for cervicitis, vaginitis, menstruation tobe not moved, leucorrhea with red and white, dysmenorrhea,adnexitis and other symptoms.My company through market research that KangfulingCapsules scientific formula, broad market prospects, wantto change in accordance with the Drug Free Classified Class8-listed domestic sales of traditional Chinese medicine,natural medicine, dosage forms for quality research. Iintend to research and development of pharmaceutical dosageforms for the film-coated tablets, specifications fortablets each weighing0.4g. Process research and qualityof the product. The original quality standards improved. Methods:1. Technology studyExtraction technology optimization1. Water content is one of the important factors that affectswater decoction extraction yield. We adopt single factortest to investigate the effect on water content of theextraction yield. Take prescription medicine; add water tomedicinal herbs6,8,10times the amount. According to theprescriptions, take in2copies each of the seven herbsexcept the Chinese angelica poles, then soaking decoctionrespectively, filtration enrichment, decompression, dryingto dry paste. Take about2g dry paste respectively todetermine the content of berberine hydrochloride. Exceptwith six times the amount of water in dry paste rate (%) andthe content of berberine hydrochloride (%) is low, add8times amount of water and add10times the amount of water,the content of berberine hydrochloride was not significantlyincreased. So to save energy, add water for8times.2. According to the prescription proportion (1,10,20times),take Chinese angelica, crushed into powder, and studies onthe herbs amount rate, with an average of98.2%.3. The confirmation of the amount of starchAccording to powder, starch3:1or4:1and5:1granulating,observe the granulating effect, then inhibit and finallyobserve its finished appearance. 4. The preparation is half of agents and the viscosity isstronger, so we chose ethanol as a wetting agent, usingdifferent concentrations of ethanol to granulatingexperiments, and then observe.5. Take prescriptions of20times the raw material feeding,according to the preparation process, quality standard tenbatches of pilot trial products. We have drawn up inaccordance with the quality standard of10batches of samplesfor testing.2. Quality study1. Because it is generic varieties,[name][prescription]with Kangfuling which is already on the market.2.[Method] With technology research, we have determined thespecific process parameters.3.[Properties] This product which is a tablet is describedaccording to the actual circumstance of multiple samples.4.[Identify]4.1Take this product for3g to porphyrization, add n-hexane20mL, ultrasonic treatment for30minutes, filtration, thefiltrate concentrated to0.5mL, as the test solution.Another1g angelica from contrast medicinal materials, add10mL n-hexane in the similar method to make a controlleddrug solution. According to thin layer chromatography (TLC)(Chinese pharmacopoeia2010edition a appendix VI (B) test,take the two above solution, respectively in the same sodium carboxymethyl cellulose as the adhesive on a silica G thinlayer plate, with n-hexane, ethyl acetate (9:1) asdeveloping agent, and taken out, dried, then examined undera UV lamp (365nm).4.2Take this product for1g, grind fine; add5mL of methanol,ultrasonic treatment for30minutes, do the filtration andthe filtrate are used as the test solution. Another matrinereference substance, add methanol1mL contains0.5mg inthe solution, as a reference substance solution. Accordingto thin layer chromatography (TLC)(Chinese pharmacopoeia2010edition a appendix VI (B) test, take the above testsample solution10μL and reference solution2μL on the samesilica G thin layer plate respectively, with acetone andtoluene-ethyl acetate-concentrated ammonia solution(3:2:1:0.1) as developing agent, do the expansion, removeand dry, with iodine vapor smoked for10minutes and thenobserve the results.4.3Take bebeerines hydrochloric acid reference substance;add methanol to make1mL contains0.5mg in the solution,as a reference substance solution. According to thin layerchromatography (TLC)(Chinese pharmacopoeia2010edition aappendix VI (B) test, take [identify](2) sample solution10μL, the above reference substance solution2μL, put onthe same sodium carboxymethyl cellulose as the adhesive ona silica G thin layer plate respectively, take out the n-butyl alcohol-water-acetic acid (3:1:1) as developingagent, dry it and examine under a UV lamp (365nm).5.[Check] According to "Chinese pharmacopoeia"2010versionID in the appendix, we examined the pilot product weightdifference, the time limit disintegration and the microbiallimit respectively. In addition, we checked the heavy metalamount of the pilot product, also the arsenic salt check inthe ancient Chua’s method.6.[Content text] Use island ferry10A N2000chromatographicworkstation, with the column temperature of40℃; In0.033mol/L of potassium dihydrogen phosphate solution:acetonitrile=65:35as mobile phase; Flow rate is1.0mL/minto345nm wavelength measurement. Theoretical plate numbercalculated on berberine hydrochloride peak should be notless than2000.Results:1. After we test, when the starch for powder rate is5:1,the effect is good. According to the average extract rate,the prescription should add starch70g. The rest Angle ofthe particles made is36.1°which explains the liquidityis quite good.Application results show that70%ethanol is the bestoption for wetting agent.2. Ten batches of pilot product’s character, content, checkitems all conform to the requirements. 3. In the chromatogram of the test, to the angelicachromatography corresponding position, the same light blueand white fluorescent spots.4. In the chromatogram of the test, with matrine referencesubstance chromatography corresponding position, show thesame yellow brown spots.5. In the chromatogram of the test, with berberinehydrochloric acid reference substance chromatographycorresponding position, show the same color of thefluorescent spots.6. The weight difference, disintegration time limit andmicrobial limit inspection shall conform to the2010editionof pharmacopoeia standards. Heavy metals content below tenppm, lower than the official limits, arsenic salt contentof less than two ppm, lower than the official limits, check,the heavy metal content of arsenic salt content is notincluded in the examination.7. Berberine hydrochloride injection quantity, within therange of0.084~0.504g sample and had good linearrelationship between peak area (r=0.9995), the averagerecovery was99.32%, RSD was1.46%(n=6).Conclusion:1. In the process of Kang fu ling quality conform to the draftstandard.2. The draft standard method is accurate and reliable whichcan be used for quality control of this preparation.