摘要
探究芸香科和十字花科7种中药配方颗粒微生物限度检查方法适用性。根据《中国药典》2020年版四部通则1105非无菌产品微生物限度检查中的微生物计数法,通则1106非无菌产品微生物限度检查中的控制菌检查法和通则1107非无菌药品微生物限度标准,进行方法适用性试验。需氧菌总数检查中,香橼(香圆)配方颗粒、陈皮配方颗粒、青皮(个青皮)配方颗粒、大青叶配方颗粒、莱菔子配方颗粒采用平皿倾注法(稀释法)[1∶20,(每皿1 mL)]消除抑菌性;橘红配方颗粒需采用平皿倾注法(稀释法)[1∶50,(每皿1 mL)]消除抑菌性。霉菌和酵母菌总数检查中,莱菔子配方颗粒选择平皿倾注法(稀释法)[1∶20(每皿1 mL)]消除抑菌性,控制菌检查采用常规法。该方法稳定可靠、准确度高,可用于芸香科和十字花科7种中药配方颗粒质量控制,为行业提供方法学参考,帮助制定有效的标准化操作流程。
This study aimed to explore the applicability of the microbiological limit test method for 7 kinds of Chinese medicine formula granules from rutaceae and cruciferae according to the microbe count method in the microbe limit test of non-sterile products in the fourth General Rule 1105 of the 2020 edition of Chinese Pharmacopoeia,the control bacteria test method in the microbe limit test of non-sterile products in the General Rule 1106 and the microbe limit standard of non-sterile drugs in the General Rule 1107.In the total number of aerobic bacteria,the antibacterial activity of Citron(Xiangyuan)formula granules,Orange peel formula granules,Qingpi(Zqingpi)formula granules,Daqingye formula granules and Raphani seed formula granules was eliminated by plate pouring method(dilution method)[1∶20,(1 mL/dish)].Juhong formula granules should be diluted by plate pouring method[1∶50,(1 mL/dish)]to eliminate bacteriostasis.In the test of the total number of mold and yeast,the antibacterial activity of Raphani seed formula granules was eliminated by plate pouring(dilution method)[1∶20(1 mL/dish)].Plate pouring method(conventional method)was used to check the control bacteria.The method is stable,reliable and accurate,and can be used for particle quality control of 7 Chinese medicine formulations of rutaceae and cruciferae.
作者
王春林
田霞
刘琪雯
郑霖露
周春红
WANG Chunlin;TIAN Xia;LIU Qiwen;ZHENG Linlu;ZHOU Chunhong(Chongqing Qianjiang Institute for Food and Drug Control,Chongqing 409000,China)
出处
《药物生物技术》
2025年第5期643-647,共5页
Pharmaceutical Biotechnology
关键词
芸香科
十字花科
中药配方颗粒
微生物限度
方法适用性试验
平皿倾注法
Rutaceae
Cruciferous family
Chinese medicine formula granules
Microbial limits
Suitability test
Pour plate method
