小麦纤维素颗粒微生物限度检查方法适用性研究  

Study on Applicability of Microbial Limit Test Method for Testa Triticum Tricum Purif

作　　者：张威存 黄丽华 ZHANG Weicun;HUANG Lihua(The Third Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510360,China;Guangdong Institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广州中医药大学第三附属医院,广州510360 [2]广东省药品检验所,广州510663

出　　处：《药品评价》2020年第13期29-32,共4页Drug Evaluation

摘　　要：目的:建立小麦纤维素颗粒的微生物限度检查方法。方法:参照《中国药典》2015年版四部通则1105和1106收载的微生物限度检查方法检查小麦纤维素颗粒微生物限度。结果:实验证明采用1∶20平皿法(倾注法)对小麦纤维素颗粒进行微生物限度检查,能有效检出该药品中污染的需氧菌、霉菌和酵母菌。各试验菌回收比值均在0.5~2.0范围内。控制菌检查中阳性试验菌生长良好,供试品对照组及阴性对照组均无菌生长。结论:建立的方法适用于小麦纤维素颗粒的微生物限度检查。Objective:To establish a microbial limit test method for Testa Triticum Tricum Purif.Methods:The microbial limit verification test of Testa Triticum Tricum Purif was established according to the general guidelines of 1105 and 1106 in Chinese Pharmacopoeia 2015 edition.Results:The results showed that the microbial limit test on Testa Triticum Tricum Purif by the 1∶20 plate-count method(pour-plate method)was carried out with the recovery rate between 0.5 and 2.0,which was proved to effectively detect the contaminated aerobic bacteria,molds and yeasts within the drugs.All positive test bacteria grew well and all negative control bacteria grew aseptically.Conclusion:The validated method of microbial limit test for Testa Triticum Tricum Purif is feasible.

关 键 词：小麦纤维素颗粒 微生物限度检查法 适用性试验 

分 类 号：R975.3[医药卫生—药品] R917[医药卫生—药学]