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目的:建立和验证碘注射液的无菌检查方法。方法:按中国药典2005年版规定,采用薄膜过滤法对碘注射液的无菌检查方法进行试验。结果:碘注射液具有抑菌作用,但在每培养器用300mL冲洗液冲洗的试验条件下,抑菌作用可消除。结论:通过方法学验证的无菌检查方法可行,结果准确可靠。
Objective: To establish and validate the sterile test method of iodine injection. Methods: According to the provisions of Chinese Pharmacopoeia 2005 edition, the method of sterilizing iodine injection by membrane filtration was tested. Results: The iodine injection has bacteriostasis effect, but bacteriostasis can be eliminated under the experimental conditions of washing with 300mL rinse solution per incubator. Conclusion: The method of sterility test verified by method is feasible and the result is accurate and reliable.