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目的通过对药品微生物限度检查法的影响因素进行分析,并采取相应的对策,提高药品微生物限度检查结果的准确性。方法根据《中国药典2005年版》微生物限度检查法制定相关的检验技术操作规程。结果基本消除了各个环节的影响因素。结论检验结果的准确性提高,药品质量得到保证。
Objective To analyze the influencing factors of the limit test method of pharmaceutical micro-organisms and take corresponding countermeasures to improve the accuracy of the test results of the limit of micro-organisms. Methods According to the “Chinese Pharmacopoeia 2005 edition” microbial limit test method to develop the relevant test technology operating procedures. The results basically eliminate all aspects of the influencing factors. Conclusion The accuracy of test results is improved, and the quality of medicines is guaranteed.