摘要
目的:对明胶空心胶囊进行微生物限度检查方法适用性试验研究,为药品企业制订药用胶囊壳的质量控制验收标准以及胶囊生产企业建立明胶空心胶囊的微生物限度检查方法提供参考。方法:依据《中国药典》2020年版四部通则1105、1106,对30批明胶空心胶囊进行计数方法和控制菌检查方法的适用性试验。结果:需氧菌总数、霉菌和酵母菌总数均采用平皿法,控制菌大肠埃希菌有28批采用常规法,2批采用培养基稀释法,控制菌沙门菌有27批采用常规法,3批采用培养基稀释法。有2批明胶空心胶囊对金黄色葡萄球菌、大肠埃希菌、沙门菌等细菌有着异常强的抑菌作用。结论:不同生厂厂家的明胶空心胶囊抑菌作用有一定差异,需进一步完善和规范明胶空心胶囊的微生物限度检查方法及其质量安全控制标准。
Objective:To conduct a study on the applicability of microbial limit testing methods for vacant gelatin capsules,in order to provide reference for pharmaceutical enterprises to formulate quality control acceptance standards for medicinal capsule shells and for capsule production enterprises to establish microbial limit testing methods for vacant gelatin capsules.Method:According to the General Principles 1105 and 1106 of the 2020 edition of the Chinese Pharmacopoeia,applicability tests were conducted on 30 batches of gelatin hollow capsules for counting methods and controlling bacterial testing methods.Result:The total number of aerobic bacteria,mold,and yeast were all measured using the petri dish method.For controlling Escherichia coli,28 batches used the conventional method,2 batches used the culture medium dilution method,and for controlling Salmonella,27 batches used the conventional method and 3 batches used the culture medium dilution method.Two batches of vacant gelatin capsules have exceptionally strong antibacterial effects on bacteria such as Staphylococcus aureus,Escherichia coli,and Salmonella.Conclusion:There are certain differences in the antibacterial effects of gelatin hollow capsules produced by different manufacturers,and further improvement and standardization of the microbial limit testing method and quality and safety control standards for vacant gelatin capsules are needed.
作者
陈大建
刘康连
庞云娟
樊文研
梁晓玲
周德华
Chen Dajian;Liu Kanglian;Pang Yunjuan;Liang Xiaoling;Fan Wenyan;Zhou Dehua(Yulin Food and Drug Inspection and Testing Center,Yulin 537000,China)
出处
《广东化工》
CAS
2024年第17期46-48,80,共4页
Guangdong Chemical Industry
关键词
胶囊剂
明胶空心胶囊
微生物限度
适用性试验
计数方法
capsule preparations
vacant gelatin capsules
microbial limit
suitability test
counting method
