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| 注射用大豆油微生物限度检查方法学验证
摘要：目的：对于供注射用大豆油建立微生物限度检查方法，确认苯甲醇微生物限度检查方法的适用性，以此确保本实验的方法完整性，保证此检验的结果可靠性。方法：采用平皿法检测供注射用大豆油中的需氧菌、霉菌和酵母菌及控制菌的微生物限度。结果：本次实验适用性试验结果与方案要求比较，与检测结果符合要求，检验误差在允许范围内。结论：由此可以得出此处采用的方法适合本样品的微生物限度检验。
关键词：供注射用大豆油；微生物限度检查法；水酶法；水代法；溶剂浸出法
Abstract：Objective：To establish the microbial limit test method for soybean oil for injection and confirm the applicability of the microbial limit test method for benzyl alcohol,so as to ensure the integrity of the experiment method and ensure the reliability of the test results. Methods：It is advisable to use plate method to detect aerobic bacteria,mold and yeast in soybean oil for injection and the microbial limit of controlling bacteria. The volume of peptone liquid medium was 100 mL in the method of bacteria-enhancing culture.Results：The applicability test results of this experiment were comparedwith the requirements of the scheme,and the test results were in line with the requirements, and the test error was within the allowable range. Conclusion：It can be concluded that the method used here is suitable for microbial limit test of this sample.
Key words：Soybean oil for injection; Microbial limit test; Enzymatic water; Water generation method
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