| 复方阿奇霉素葡萄糖注射液无菌检查法方法学研究 |
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| 引用本文： | 潘强,王巍,李宏志.复方阿奇霉素葡萄糖注射液无菌检查法方法学研究[J].中国药品标准,2008,9(1):51-53. |
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| 作者姓名： | 潘强 王巍 李宏志 |
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| 作者单位： | 辽宁省食品药品检验所,沈阳,110023 |
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| 基金项目： | 国家高技术研究发展计划(863计划)
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国家自然科学基金 |
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| 摘 要： | 目的：建立复方阿奇霉素葡萄糖注射液的无菌检查方法。方法：本试验取复方阿奇霉素葡萄糖注射液，按《中国药典》2005年版二部（附录ⅪH）（以下简称“CP2005”）所载“无菌检查方法”项下进行试验。结果：样品管无菌生长，六珠阳性对照菌生长良好。结论：采用方法验证试验Ⅲ进行复方阿奇霉素葡萄糖注射液无菌检查，可行。
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| 关 键 词： | 复方阿奇霉素葡萄糖注射液 无菌检查法(薄膜过滤法) 方法验证 |
| 文章编号： | 1009-3656(2008)11-0051-03 |
Studies on Sterility Test of Compound Azithromy and Glucose Injection |
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| Authors: | Pan Qiang Wang Wei and Li Hong-zhi |
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| Institution: | ( Liaoning Provincial Institute for Drug and Food Control, Shenyang 110023) |
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| Abstract: | Objective：A test method for Compound Azithromy and Glucose Injection was established. Methods：The test method was carried out according to the method in volume two, Chinese Pharmacopoeia Edition 2005. Results： Three validation tests were engaged, and the third one show that all of six strains positive control tubes reveal growth of microorganism and the control gives no evidence of growth. Conclusin：The third one method could be used for sterility test of this preparation. |
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| Keywords: | Compound Azithromy and Glucose Injection sterility Test Method validation tests |
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