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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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Petrifilm测试片法在药品微生物检验中的应用研究

Application of petrifilm paper disk method in drug microbioassay

分类号:
出版年·卷·期(页码):2012,32 (12):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 讨论Petrifilm测试片在药品微生物检查中的应用。 方法: 通过人工接种试验菌株,比较平皿法和Petrifilm测试片法在20个药品品种微生物检验中的应用。 结果: 平皿法与Petrifilm测试片法用于药品检验,结果无显著性差异。 结论: Petrifilm测试片法操作简单方便,可以用于某些药品品种的微生物检查。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To discuss the application of petrifilm paper disk method in microbial limit tests of drugs. Methods: Working strains were inoculated in the tests in which results of petrifilm paper disk method for 20 species were compared with those of petri dish method. Results: There were no significant differences between the two methods when them have been applied in drug inspection. Conclusion: Petrifilm paper disk method is simple and easy to handle which can be applied in microbial tests for certain varieties of drugs.

-----参考文献:---------------------------------------------------------------------------------------
1 USP.ⅩⅩⅧ:2752
2 EP 6.0.156
3 BP.Appendix ⅩⅥ AA407
4 ChP(中国药典).2010.Vol Ⅱ(二部):Appendix(附录)107
5 YANG Lan-hua(杨兰花),WANG Xu-qiang(王旭强),LU Li(卢力),et al.Comparison of GB standard with 3M petrifilm method to test aerobic bacterial count in cosmetics(GB标准和3M Petrifilm法检测化妆品中细菌总数的比较).Chin J Health Lab Technol(中国卫生检验杂志),2008,18(11):2297
6 GB/T 4789.2-2008,Microbiological Examination of Food Hygiene(食品卫生微生物学检验)
7 WANG Zhi-jian(王知坚),LI Jue(李珏).Validation of alternative bacterial count method of erdosteine capsules(厄多司坦胶囊菌落计数替代方法的验证).Chin J Pharm Anal(药物分析杂志),2011,31(11):2146
8 National Institute for the Control of Pharmaceutical and Biological Products(中国药品生物制品检定所).National Control of Pharmaceutical Standard Operation Procedure(中国药品检验标准操作规范).Beijing(北京):China Medico-Pharmaceutical Science and Technology Publishing House(中国医药科技出版社),2010.351
9 MA Yue(马越),TE Yu-xiang(特玉香),DU Ping-hua(杜平华),et al.Validation method used for microbial limits of 16 kinds of traditional Chinese medicine(16种中成药微生物限度检查法方法验证).Drug Stand China(中国药品标准),2005,6(6):12
10 YU Hong(俞虹),LING Ming(凌明),YING Jia(应佳), et al.Method and validation of the microbial limit tests on capsules of antibacterial activity(具抗菌活性胶囊剂的微生物限度检查方法及验证).Chin J Pharm Anal(药物分析杂志),2006,26(9):1328
9 MA Yue(马越),TE Yu-xiang(特玉香),DU Ping-hua(杜平华),et al.Validation method used for microbial limits of 16 kinds of traditional Chinese medicine(16种中成药微生物限度检查法方法验证).Drug Stand China(中国药品标准),2005,6(6):12
10 YU Hong(俞虹),LING Ming(凌明),YING Jia(应佳), et al.Method and validation of the microbial limit tests on capsules of antibacterial activity(具抗菌活性胶囊剂的微生物限度检查方法及验证).Chin J Pharm Anal(药物分析杂志),2006,26(9):1328

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