西部中医药
西部中醫藥
서부중의약
GANSU JOURNAL OF TRADITIONAL CHINESE MEDICINE
2015年
5期
36-39
,共4页
中药口服制剂%微生物限度检查法%控制菌%方法验证
中藥口服製劑%微生物限度檢查法%控製菌%方法驗證
중약구복제제%미생물한도검사법%공제균%방법험증
oral preparations of Chinese medicine%microbial limit checking method%control germs%method verification
目的：建立9种中药口服制剂微生物限度与控制菌检查的方法并进行验证。方法：按2010年版《中国药典》，用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉和白色念珠菌对健胃清肠合剂等9个中药口服制剂进行微生物限度检查方法学验证，采用直接接种法进行控制菌检查方法验证。结果：按供试品制备方法，各阳性菌样品的回收率均高于70%。结论：健胃清肠合剂、复方萱草颗粒、健胃消食合剂、健胃止泻合剂、健胃止血合剂、痛风平颗粒可按常规法进行细菌、霉菌及酵母菌的检查；通窍鼻渊丸、清热解毒合剂可用培养基稀释法(0.5 mL/皿)进行细菌检查，姜石肠炎康颗粒可用培养基稀释法(0.2 mL/皿)进行细菌检查，霉菌及酵母菌的检查均可按常规法进行。各品种控制菌均可用常规法进行检查。
目的：建立9種中藥口服製劑微生物限度與控製菌檢查的方法併進行驗證。方法：按2010年版《中國藥典》，用大腸埃希菌、枯草芽胞桿菌、金黃色葡萄毬菌、黑麯黴和白色唸珠菌對健胃清腸閤劑等9箇中藥口服製劑進行微生物限度檢查方法學驗證，採用直接接種法進行控製菌檢查方法驗證。結果：按供試品製備方法，各暘性菌樣品的迴收率均高于70%。結論：健胃清腸閤劑、複方萱草顆粒、健胃消食閤劑、健胃止瀉閤劑、健胃止血閤劑、痛風平顆粒可按常規法進行細菌、黴菌及酵母菌的檢查；通纖鼻淵汍、清熱解毒閤劑可用培養基稀釋法(0.5 mL/皿)進行細菌檢查，薑石腸炎康顆粒可用培養基稀釋法(0.2 mL/皿)進行細菌檢查，黴菌及酵母菌的檢查均可按常規法進行。各品種控製菌均可用常規法進行檢查。
목적：건립9충중약구복제제미생물한도여공제균검사적방법병진행험증。방법：안2010년판《중국약전》，용대장애희균、고초아포간균、금황색포도구균、흑곡매화백색념주균대건위청장합제등9개중약구복제제진행미생물한도검사방법학험증，채용직접접충법진행공제균검사방법험증。결과：안공시품제비방법，각양성균양품적회수솔균고우70%。결론：건위청장합제、복방훤초과립、건위소식합제、건위지사합제、건위지혈합제、통풍평과립가안상규법진행세균、매균급효모균적검사；통규비연환、청열해독합제가용배양기희석법(0.5 mL/명)진행세균검사，강석장염강과립가용배양기희석법(0.2 mL/명)진행세균검사，매균급효모균적검사균가안상규법진행。각품충공제균균가용상규법진행검사。
Objective: To establish the methods of microbial limit and control germ for nine kinds of oral preparations of Chinese medicine, and to test the methods. Methods:According to 2010 edition of Chinese Pharma-copoeia, microbial limit checking methods for nine kinds of oral preparations of Chinese medicine were testified by observing Escherichia coli, bacillus subtilis, Staphylococcus aureus, Aspergillus niger and Candida albicans, control germ by direct inoculation method. Results:The recovery rates of positive bacteria samples were higher than 70%according to sample preparation methods. Conclusion:Conventional method could be used to check bacteria, mold and yeast in JianWei QingChang mixture, compound XuanCao Granules, JianWei XiaoShi mixture, JianWei ZhiXie mixture, JianWei ZhiXue mixture, TongFengPing granules;culture medium dilution (0.5 mL/medium) could be ap-plied to test bacteria in TongQiao BiYuan pills and QingRe JieDu mixture, culture medium dilution (0.2 mL/medium) to examine bacteria in JiangShi ChangYanKang granules while conventional methods for mold and yeast. Conven-tional method could be used for all varieties of control germs.
