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目的滋肾还少膏为医院制剂,是肝肾双补的传统中药制剂,分析研究该品种微生物限度检查方法。方法按中国药典2005年版的规定,对3个批次滋肾还少膏进行了微生物限度检查方法验证。结果滋肾还少膏对5株阳性代表菌株有不同程度的抑菌活性。结论通过方法验证实验,认为建立本品微生物限度检查极为必要,根据方法验证实验结果,建议采用薄膜过滤法进行本品的微生物限度检查。
Objective Zi Shen Shao Shao Ointment is a hospital preparation. It is a traditional Chinese medicine preparation for liver and kidney supplementation. It analyzes and studies the methods for limiting microorganisms in this species. Methods According to the provisions of the 2005 edition of the Chinese Pharmacopoeia, three batches of Zi Shen Shao Shao Ointment were verified by microbial limit test method. Results Zishen Huaishao had different degrees of antibacterial activity against 5 positive representative strains. Conclusion Through the method validation experiment, it is considered that establishment of microbiological limit test of this product is extremely necessary. According to the method validation test results, it is recommended to adopt the membrane filtration method to conduct the microbial limit test of this product.