| 冰硼散微生物限度检查方法学验证 |
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| 引用本文： | 卢文斌. 冰硼散微生物限度检查方法学验证[J]. 中国药房, 2007, 18(18): 1396-1397 |
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| 作者姓名： | 卢文斌 |
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| 作者单位： | 福建省泉州市药品检验所,泉州市,362000 |
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| 摘 要： | 目的:确定冰硼散微生物限度的检查条件和方法,确保其检查方法的科学性和检验结果的准确性。方法:采用2005年版《中国药典》(一部)附录“微生物限度检查法”项下相关内容进行方法学验证。结果:确定中和法作为冰硼散微生物限度的检查方法。结论:本试验为冰硼散微生物限度检查提供了方法学依据,对药品的生产及检验有较大的实用价值。
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| 关 键 词： | 冰硼散 微生物限度检查法 中和法 验证 |
| 文章编号： | 1001-0408（2007）18-1396-02 |
| 收稿时间： | 2007-01-23 |
| 修稿时间： | 2007-01-232007-03-28 |
Method Verification for Microbil Limit Test of Bingpeng Powder |
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| LU Wenbin. Method Verification for Microbil Limit Test of Bingpeng Powder[J]. China Pharmacy, 2007, 18(18): 1396-1397 |
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| Authors: | LU Wenbin |
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| Affiliation: | Fujian Provincial Quanzhou Institute for Drug Control,Quanzhou 362000,China |
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| Abstract: | OBJECTIVE: To determine the test condition and method in the microbial limit test of Bingpeng powder and to ensure a scientific test method and accurate test results. METHODS: The method verification was carried out in accordance with the microbial limit test recorded in the appendix of China Pharmacopeia ( 2005 edition, Volume I) . RESULTS: The neutralization method was determined as microbial limit test method for Bingpeng powder. CONCLUSION: This experiment provided scientific bases for the microbial limit test of Bingpeng powder, which is of great practical value for the production and test of this drug. |
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| Keywords: | Bingpeng powder Microbial limit test method Neutralization method Validation |
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