三种蒙药制剂微生物限度检查方法验证 |
| 1.内蒙古自治区药品检验研究院，内蒙古呼和浩特，010020
2.内蒙古自治区药品检查中心，内蒙古呼和浩特，010020 |
| 摘要：目的 确立三种蒙药制剂微生物限度检查方法。方法 分别采用常规法、培养基稀释法、薄膜过滤法对三种蒙药制剂进行细菌、霉菌及酵母菌计数方法的验证；采用阳性菌与阴性菌对照的方法进行控制菌检查方法的验证。结果 确立了三种蒙药制剂的微生物限度检查方法。结论 确立了沙棘口服液细菌数检查用常规法，额勒更口服液细菌数检查用培养基稀释法，当呼很17 味丸细菌数检查用离心薄膜过滤法，三种蒙药的霉菌、酵母菌和控制菌检查均采用常规法。 |
| 关健词：蒙药制剂；微生物限度检查；方法验证 |
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| Verification of the Microbial Limit Test Method for Three Mongolian Medicine Preparations |
| Hailing Hou Gang Zhou Feng Han Xiaoqian Fan Gang Hao |
| 1.Inner Mongolia Autonomous Region Institute for Drug Control, Hohhot, Inner Mongolia, 010020，China
2.Inner Mongolia Autonomous Region Drug Inspection Center, Hohhot, Inner Mongolia, 010020，China |
| Abstract：Objective To establish the microbial limit test methods for three Mongolian medicine preparations. Methods The verification of counting methods for bacteria, molds and yeasts in the three Mongolian medicine preparations was carried out by using the conventional method, culture medium dilution method and membrane filtration method respectively; the verification of the control bacteria test method was conducted by means of positive and negative bacteria control. Results The microbial limit test methods for the three Mongolian medicine preparations were established. Conclusion The conventional method is used for the bacterial count test of Seabuckthorn Oral Liquid; the culture medium dilution method is adopted for the bacterial count test of Elgen Oral Liquid; the centrifugal membrane filtration method is employed for the bacterial count test of Danghuhen 17-flavor Pills. The conventional method is used for the tests of molds, yeasts and control bacteria in all three Mongolian medicines. |
| Keywords：Mongolian medicine preparations; microbial limit test; method validation |
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