10种中成药微生物限度检查法的建立

20071830ChinaPharmacy2007Vol.18No.302357*::020-83827812-10140E-mail:Linqx10@sohu1com#:::020-83827812-60234101*,1#,2,1(11,510080;21,510020)R283;R927112A1001-0408(2007)30-2357-03:10:5,:;;;:;;+;;MicrobialLimitTestMethodsfor10ChinesePatentMedicinesLINQiuxiao,LIUQiuqiong,LIUXiaoqi(GuangdongProvincialPeople’sHospital,Guangzhou510080,Chi-na)LINLiying(GuangdongInstituteforDrugControl,Guangzhou510020,China)ABSTRACTOBJECTIVE:Toestablishmicrobiallimittestmethodfor10ChinesepatentmedicinesincludingHuangbocapsule1METHODS:Therecoveryratesof5stipulatedtestmicroorganismstreatedrespectivelyby10Chinesemedicinesweredetectedbyroutinemethod;andthemicrobiallimittestmethodforthespecifiedmicro-organismswasvalidated1RESULTS:Renshenshouwucapsuleshowednobacteriostaticaction,butGengnianletablet,Xiao’erjiebiaogranule,Xiao’aipingtablet,Jiexintongcapsule,Xiaokecapsule,Manshen’angranule,JieguqilidispersibletabletandBaoyingdandidhavebacteriostaticactions;Huangbocapsuleshowedpotentantibacterialaction1Jieguqilidispersibletablet,BaoyingdanandHuangbocapsuleshowedbacteriostaticactiononmould1CONCLUSION:Routinemethodcanbeappliedforthemicrobiallimittestforthosekindswithoutbacteriostaticaction;culturemediumdilutedmethodisapplicableforthosewithantibacterialaction;sedimen2tationplusmembranefiltrationmethodisapplicableforthosewithpotentantibacterialaction1Routinemethodissuitableforallkindsofspecifiedmicroorganisms1KEYWORDSMicrobiallimittest;Establishmentandverificationofmethod;Chinesepatentmedicine2005[1],,,,,,,,10,1111(:051003)(:051011)(:050501)(:20051102)(:051016);(:050110);(:050604);(:66802)();(:050801);(:20051001)112[CMCC(B)44102][CMCC(B)63501][CMCC(B)26003][CMCC(B)50094][CMCC(F)10123];[ATCC16404]2211[1]2005(),50100cfumL-121210g,019%-100mL,11021321311::1101mL(2358ChinaPharmacy2007Vol.18No.3020071830110(%)Tab1Recoveryratesofeachkindoftestmicroorganismtreatedrespectivelyby10ChineseMedicines(%)123x123x123x123x123x92898689937088848494848789788082938481868787797465695363616953619584999392919593969681917969757478796173998495939186798587857683445753518394959179987283929184899582798570466360857469768789838683809586748287816967425956567964919996958892768585737176695154584341203586727477748379797994818584959892577068658686818445304339789495897586788058675560707371716455535785728079221735251025161745314139717172714(015mL)Tab4Effectofdilutiondegreeofculturemediumontherecoveryrateofmicroorganisms(015mLperdish)/%123x123x71757172--------788586831,570%,;;,242(015mL)Tab2Effectofdilutiondegreeofculturemediumontherecoveryrateofmicroorganisms(015mLperdish)/%123x123x1008170848473737791908288818892877995908880949991988188898297728481899287727285767781797967686165----9888869188948890837490823(012mL)Tab3Effectofdilutiondegreeofculturemediumontherecoveryrateofmicroorganisms(012mLperdish)/%123x123x9173898583728680483739413529463724:,;1mL2(015mL),,1mL5(012mL),,1mL5(012mL),,+3,,383%78%81%;70%,55+3Tab5Recoveryratesof3bacterialisolatestreatedbyHuangbocapsuleanddeterminedrespectivelybysedimenta2tionpolusmembranefiltrationmethod/%/%839178858186214[2]2005,1g;1g100;10g,21411:10100cfu(),,21412:10100cfu:015mL012mL)1mL1,1520mL452mL,303548h,232872h,,+:1105min,1mL100mL,,300mL3,1mL,,,,;121312:1mL,,,2,21313:,,()21314:5,1(%)=[()/]100%20071830ChinaPharmacy2007Vol.18No.302359*,::025-80865307E-mail:caiying1967@1261com*,(454,210002)R283164;R92711A1001-0408(2007)30-2359-04::(TLC),(HPLC):;0194571560011625113000013825310640g;99198%100153%100122%,RSD118%211%212%:;;;QualityStandardsofLiyanBuccalTabletsCAIYing,JIYongzhang(No1454HospitalofPLA,Nanjing210002,China)ABSTRACTOBJECTIVE:ToestablishthequalitystandardsforLiyanbuccaltablets1METHODS:TheRadixPlatycodo2nis,RadixEtRhizomaGlycyrrhizae,RadixOphiopogonisandRadixAdenophoraeinLiyanbuccaltabletswereidentifiedbyTLC,andthecontentsofChlorogenicacid,BaicalinandGlycyrrhizicacidweredeterminedbyHPLC1RESUTLS:Thequali2tativeidentificationofRadixPlatycodonis,RadixGlycyrrhizae,RadixOphiopogonisandRadixAdenophoraeshowedgoodsen2sitivityandspecificity1ThelinearrangesofChlorogenicacid,BaicalinandGlycyrrhizicacidwere0194571560,011625113000,and013825310640g,respectively1Theaveragerecoveriesofthethreewere99198%,100153%and100122%,respectivelywithRSDat118%,211%,and212%,respectively1CONCLUSION:TheestablishedstandardscanbeusedforthequalitycontrolofLiyanbuccaltablets1KEYWORDSLiyanbuccaltablets;TLC;HPLC;Qualitystandard,21413:,,1021521511:370%,,,10:;(015mL),(012mL);+21512:(015mL);21513:32005[1],,,,,[25],2005,10,,,,,,,,,,,,,[1]1()[S]120051:,2005:71741[2],,,1[J]1,2006,29(3):2991[3],,,116[J]1,2005,6:121[4],,1[J]1,2003,3:1801[5],,,1[J]1,2004,14(1):201(:2007-01-06:2007-06-01)