6种医院制剂微生物限度检查方法适用性试验研究

Validation of microbial limit test for six hospital preparations

目的建立6种医院制剂微生物限度检查方法。方法根据《中华人民共和国药典》2015年版四部通则1105、1106、1107具体规则作为检测依据。采用薄膜过滤法对供试品进行处理,对加菌顺序、冲洗量体积和供试液稀释级别进行摸索。结果通过薄膜过滤法可消除供试品溶液的抑菌作用。需氧菌总数、霉菌和酵母菌总数测定中6种供试品均可在供试液环节加菌,5种试验菌种的回收比值均达到0.5~2.0;控制菌测定中6种供试品采用薄膜过滤法,控制菌均可检出。结论检查方法均符合《中华人民共和国药典》2015年版的要求,可用于药品质量控制检查工作。

Objective To establish microbial limit test methods for 6 hospital preparations.Methods The tests were carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese pharmacopoeia 2015 edition.Test samples were treated by membrane filtration.Experiments were made on microorganism introduction method,the volume of rinsing solution and dilution ratio of the test solution.Results The method of membrane filtration could eliminate the bacteriostasis of samples.Introduction of validation strains in the sample solution worked for 6 samples in the test of total number of aerobic bacteria,molds and yeasts.The recovery ratios of five tests bacterial were within a range from 0.5 to2.0.The membrane filtration was used for control bacteria in all preparations,and the control bacteria could be detected.Conclusion The methods met the requirements of Chinese pharmacopoeia(2015 edition),which could be used for routine work of drug quality control.