[1]杨育儒,沈秋莲,王庆芬.六种中药制剂微生物限度检查方法验证[J].西部中医药,2017,30(11):59-61.
　YANG Yuru,SHEN Qiulian,WANG Qingfen.Validation of Microbial Limit Test Method of Six Kinds of Traditional Chinese Medicine Preparations[J].Western Journal of Traditional Chinese Medicine,2017,30(11):59-61.
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六种中药制剂微生物限度检查方法验证()
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
30
期数:
2017年11期
页码:
59-61
栏目:
出版日期:
2017-11-15

文章信息/Info

Title:
Validation of Microbial Limit Test Method of Six Kinds of Traditional Chinese Medicine Preparations
文章编号:
1004-6852(2017)11-0059-03
作者:
杨育儒，沈秋莲，王庆芬
中国人民解放军第一七五医院/厦门大学附属东南医院制剂科，福建 漳州 363000
Author(s):
YANG Yuru, SHEN Qiulian, WANG Qingfen
Department of Pharmacy, the 175th Hospital of PLA/the Affiliated Southeast Hospital of Xiamen University, Zhangzhou 363000, China
关键词:
微生物限度检查; 方法验证试验; 中药制剂
Keywords:
microbial limit test;  methodology volidation;  TCM preparations
分类号:
R927
摘要:
目的：建立6种中药制剂微生物限度的检查方法。方法：参照《中国药典》(2015年版)微生物限度检查法，进行各品种的微生物限度检查方法验证。结果：复方黄连灌肠液、蒲地灌肠液、复方茵陈合剂和气血双补口服液无抑菌作用，回收率均在0.5～2.0范围内，可采用常规法进行微生物计数；复方大黄灌肠液对枯草芽孢杆菌有抑菌作用，可采用培养基稀释法进行微生物计数；五味子酊需采用薄膜过滤法进行微生物计数；所有品种的控制菌检查均可采用常规法测定。结论：确立了6种中药制剂微生物限度检查方法，可有效控制其质量。
Abstract:
Objective: To establish the microbial limit test for six kinds of traditional Chinese medicine preparations. Methods: Microbial limit tests for six kinds of traditional Chinese medicine preparations were validated by consulting the microbial limit tests in Chinese Pharmacopoeia (2015 edition). Results: Compound berberine enema, PuDi enema, compound YinChen mixture and Qi-blood ShuangBu oral liquid had no bacteriostasic activity, recovery rate was ranged from 0.5 to 2.0, and the routine method could be used to determine the number of bacteria; compound berberine enema showed antibacterial activity to Bacillus subtilis, culture medium dilution method could be used for bacterial counting; membrane-filter procedure could be used for microbial counting of WuWeiZi tincture; the tests for control bacteria in all the preparations could be tested by routine method. Conclusion: Microbial limit tests for six kinds of traditional Chinese medicine preparations are confirmed, which could effectively control the quality of the preparations.

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[1]霍玲玲,冯健科.消肿止痛洗液微生物限度检查法的研究[J].西部中医药,2015,28(06):34.[doi:2015/6/16 0:00:00]
[2]梁欣健,姜倩娥,王叶茗.乳疾清合剂的质量标准提高研究[J].西部中医药,2022,35(05):25.[doi:10.12174/j.issn.2096-9600.2022.05.06]
　LIANG Xinjian,JIANG Qian'e,WANG Yeming.Study on the Quality Standard Improvement of Rujiqing Mixture[J].Western Journal of Traditional Chinese Medicine,2022,35(11):25.[doi:10.12174/j.issn.2096-9600.2022.05.06]

备注/Memo

备注/Memo:
收稿日期：2017-03-27 作者简介：杨育儒(1988—)，男，药师。研究方向：制剂生产与质量控制。
更新日期/Last Update: 2017-11-15