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目的:建立伤科黑药膏微生物限度检查方法。方法:选择微生物限度检查方法验证实验所规定的试验菌株,采用5种阳性对照菌回收率实验测定其是否含抑菌成份。结果:按照供试液制备方法,分别污染5种代表试验菌株,回收率均可达70%以上。结论:伤科黑药膏所采用的验证方法可以消除药品的抑菌作用,可以有效检出污染的微生物,使测定结果准确,药品质量安全有效。
Objective: To establish a method for microbiological limit examination of traumatic black ointment. METHODS: The test strains specified in the microbial limit test method validation experiment were selected and tested for the presence of antibacterial components using five positive control bacterial recovery tests. Results: According to the preparation method of the test solution, 5 representative strains were contaminated, and the recovery rate was over 70%. Conclusion: The verification method used in the traumatic black ointment can eliminate the antibacterial effect of the drug, effectively detect the contaminating microorganisms, make the measurement result accurate, and the drug quality safe and effective.