| 汤茜,潘震宇,李瑞莲.需氧菌总数计数方法研究示例与讨论[J].中国药事,2017,(3):305-311 |
| 需氧菌总数计数方法研究示例与讨论 |
| On the Method of Total Aerobic Microbial Count |
| 投稿时间：2016-05-10 |
| DOI：10.16153/j.1002-7777.2017.03.013 |
| 中文关键词: 厄贝沙坦氢氯噻嗪片 丙酸氟替卡松鼻喷雾剂 需氧菌总数 平皿法 |
| 英文关键词: irbesartan and hydrochlorothiazide tablets Fluticasone Propionate Nasal Spray total aerobic microbial count pour plate method |
| 基金项目:湖南省自然科学基金（编号2015JJ6053） |
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| 摘要点击次数: 904 |
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| 中文摘要: |
| 目的： 比较《中国药典》2015年版和2010年版应用平皿法进行药品微生物计数的异同，探讨药典改版对方法建立的影响。方法：按照《中国药典》2015年版和2010年版对厄贝沙坦氢氯噻嗪片和丙酸氟替卡松鼻喷雾剂的微生物计数方法进行方法适用性或验证试验。结果：确立了两种药物按新旧两版药典进行需氧菌总数和细菌数计数的方法。按照《中国药典》2010年版，两种药物均可采用培养基稀释法；按照《中国药典》2015年版，确立两种药物采用薄膜过滤法进行需氧菌总数计数。结论：两版药典试验结果相差较大,表明药典改版后加强了方法的科学性和准确性；平皿法尤其是培养基稀释法在2015年版药典实施以后，实际应用有明显改变。 |
| 英文摘要: |
| Objective: To compare the similarities and differences in application of pour plate method between the 2015 and the 2010 edition of Chinese Pharmacopoeia, and discuss the influence of pharmacopoeia revision on the method establishment. Methods: Suitability or verification tests on microbial count methods of irbesartan and hydrochlorothiazide tablets and Fluticasone Propionate Nasal Spray were carried out according to the 2015 and the 2010 edition of Chinese Pharmacopoeia. Results: The methods of total aerobic microbial count and bacteria count for two drugs were established according to the new and the old edition of Pharmacopoeia. For both drugs, culture media dilution method could be used for bacteria count according to the CP 2010 edition, and membrane filtration method could be used for total aerobic microbial count according to the CP 2015 edition. Conclusion: The test results differed greatly according to the two editions of Pharmacopoeia and it showed that the new edition was more scientific and accurate. After the implementation of the 2015 edition of Pharmacopoeia, there were great changes in the practical application of pour plate method, especially for medium dilution method. |
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