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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。
Objective: To determine the conditions and methods for checking the microbiological limits of ice boron, to ensure the scientificity of the inspection method and the accuracy of the test results. METHODS: Methodological validation was carried out using the relevant contents of the “Microbial Limit Test” appendix of the 2005 edition of the “Chinese Pharmacopoeia” (Part 1). Results: The neutralization method was determined as the inspection method for the microbial limit of ice boron. Conclusion: This test provides a methodological basis for the inspection of the microbiological limits of borbic boron, and has great practical value for the production and testing of drugs.