| 复方氨酚烷胺制剂的微生物限度检查方法的建立 |
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| 引用本文： | 朱会琴,邓树勇,王银兰,沈小华,王建宁. 复方氨酚烷胺制剂的微生物限度检查方法的建立[J]. 中国药事, 2006, 20(12): 739-741 |
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| 作者姓名： | 朱会琴 邓树勇 王银兰 沈小华 王建宁 |
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| 作者单位： | 1. 宁夏回族自治区药品检验所,银川,750001
2. 固原市药品检验所 |
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| 摘 要： | 本文建立复方氨酚烷胺制剂的微生物限度检查方法。按《中国药典》2005年版微生物限度检查法进行验证和试验。经方法学验证试验得出的检查方法可用于复方氨酚烷胺片剂、胶囊剂和颗粒剂的微生物限度检查。
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| 关 键 词： | 复方氨酚烷胺制剂 微生物限度检查 验证 |
| 文章编号： | 1002-7777（2006）12-0739-03 |
Establishment of Microbial Limit Test for Compound Paracetamol and Amantadine Hydrochloride Preparations |
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| Zhu Huiqin,Deng Shuyong,Wang Yinlan,Shen Xiaohua,Wang Jianning. Establishment of Microbial Limit Test for Compound Paracetamol and Amantadine Hydrochloride Preparations[J]. Chinese Pharmaceutical Affairs, 2006, 20(12): 739-741 |
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| Authors: | Zhu Huiqin Deng Shuyong Wang Yinlan Shen Xiaohua Wang Jianning |
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| Affiliation: | Ningxia Institute for Drug Control, Yinchuan 750001 ; Guyuan Institute for Drug Control |
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| Abstract: | The method of microbial limit test for compound paracetamol and amantadine hydrochloride preparations was established according to microbial limit test method, Appendix XI J, Edition 2005 of Chinese Pharmacoepia. The validation results showed that the method can be used for microbial limit test of compound paracetamol and amantadine hydrochloride tablets and capsules. |
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| Keywords: | compound paraeetamol and amantadine hydrochloride preparations microbial limit test validation tests |
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