医院胶囊制剂微生物限度检查方法的建立及结果分析  

Establishment of Microbial Limit Test for Capsule Preparations and Analysis of Test Results

作　　者：李亚楠 李甜甜 沙淼 杨莉娜 杨晓东 LI Yanan;LI Tiantian;SHA Miao;YANG Lina;YANG Xiaodong(Microbiology Room,Xi’an Institute for Food and Drug Control,Shaanxi Xi’an 710054,China)

机构地区：[1]西安市食品药品检验所微生物室,陕西西安710054

出　　处：《中国医院用药评价与分析》2020年第2期228-231,共4页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:探讨3种医院胶囊制剂(黄参胰生胶囊、祛风宁胶囊和松萜灵胶囊)的微生物限度检查方法。方法:根据《中华人民共和国药典:四部》(2015年版)通则1105、1106,对需氧菌总数、霉菌及酵母菌总数和控制菌进行适用性检查。结果:3种医院胶囊制剂采用1∶100供试液平皿法测定需氧菌总数,铜绿假单胞菌、金黄色葡萄球菌和枯草芽孢杆菌的回收率均为0;培养基稀释法无法消除供试品对控制菌的抑菌性。胶囊壳平皿法回收率测定结果显示,胶囊壳浓度稀释至1∶200,胶囊壳的抑菌性仍未消除,铜绿假单胞菌、金黄色葡萄球菌及枯草芽孢杆菌的回收率为0。去除胶囊壳后,药品内容物可用1∶20供试液平皿法进行需氧菌总数、霉菌及酵母菌总数测定;直接接种法进行控制菌检查。结论:胶囊壳显著抑制微生物生长,建议关注胶囊壳质量安全。OBJECTIVE:To probe into the microbial limit test for three kinds of capsule preparations(Huangshen Yisheng capsules,Qufengning capsules and Songteringling capsules).METHODS:According to General Principles1105,1106 of Chinese Pharmacopoeia:VolumeⅣ(2015 Edition),the suitability of the total number of aerobic bacteria,mold and yeast and control bacteria was examined.RESULTS:Three kinds of hospital capsule preparations were tested for the total number of aerobic bacteria by the 1∶100 test solution plate method.The recoveries of Pseudomonas aeruginosa,Staphylococcus aureus and Bacillus subtilis were 0.The culture medium dilution method could not eliminate the bacteriostasis of the test product to the control bacteria.The results showed that when the concentration of capsule shell was diluted to 1∶200,the bacteriostasis of capsule shell was not eliminated,and the recoveries of Pseudomonas aeruginosa,Staphylococcus aureus and Bacillus subtilis were 0.After removing the capsule shells,the content of the drug can be determined by the 1∶20 test liquid plate method for the total number of aerobic bacteria,the total number of mold and yeast determination,and direct inoculation method was used for control bacteria inspection.CONCLUSIONS:Capsule shells can significantly inhibit the growth of microorganisms,it is recommended to pay attention to the quality and safety of capsule shells.

关 键 词：胶囊制剂 微生物限度 空心胶囊质量 

分 类 号：R927.1[医药卫生—药学]