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四种医院制剂微生物限度检查方法的适用性研究 被引量:8

Study on the applicability of the methods of microbial limits examination for four kinds of hospital preparations
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摘要 目的:建立四种医院制剂的微生物限度检查方法。方法:通过计算各试验菌株的回收比值,对四种医院制剂的需氧菌、真菌和酵母菌总数计数法及控制菌的检查法进行验证。结果:参术健胃胶囊和十七味大活血胶囊具有抑菌性,供试液需要进一步稀释后采用平皿法对其计数。玉夏胶囊和腰痹康颗粒均无抑菌性,常规法检验即可。以上四种制剂控制菌检验均采用常规法。结论:建立了四种医院制剂的微生物限度检查方法,有效控制质量安全。 Objective:To set up methods for microbial limit test of four kinds of hospital prearations.Methods:By calculating the recovery ratio of each test strain,the total number of molds and yeasts and the check method of controlling bacteria were verified.Results:Shenshujianwei capsule and shiqiwei dahuoxue capsule have antibacterial properties,there test liquids need to be further diluted and then counted by a flat dish method.Yuxia capsule and yaobikang granule have no inhibitory properties,the conventional method can be tested.Conclusion:A method of microbial limit inspection for four kinds of hospital preparations was established to control quality effectively and safety.
作者 余静 刘亮镜 徐斌 YU Jing;LIU Liangjing;XU Bin(The Hospital of Wuhu Traditional Chinese Medicine,Wuhu 241000,China)
机构地区 芜湖市中医医院
出处 《临床医药实践》 2020年第6期445-447,共3页 Proceeding of Clinical Medicine
关键词 医院制剂 微生物限度检查 适用性研究 hospital preparation microbiological limit inspection applicability study
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