| 摘要: |
| [摘要]目的：建立儿童专用医院制剂紫黄软膏微生物限度检查方法。方法：按照《中国药典》2015年版要求，采用供试品溶液稀释法（1∶100）进行需氧菌总数的测定；采用常规倾注平皿法进行霉菌和酵母菌总数的测定；采用供试品溶液稀释法（100 mL）进行金黄色葡萄球菌、铜绿假单胞菌的控制检查。结果：需氧菌总数、霉菌及酵母菌总数实验菌株回收比值均落在0.5~2.0的范围内；金黄色葡萄球菌、铜绿假单胞菌的控制检查实验组菌株生长良好，阴性对照组和样品组均无菌株生长。结论：本实验所建立的方法经过方法学验证，符合《中国药典》2015年版规定，可为医院制剂紫黄软膏质量标准的修订提供科学依据。 |
| 关键词: 紫黄软膏 医院制剂 微生物限度检查 稀释法 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2020.09.016 |
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| 基金项目:昆明市科技计划项目,编号2016鄄2鄄S鄄06644。 |
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| Establishment of Microbial Limit Test Method for Zihuang Ointment of Hospital Preparation |
| Li Huiying, Qin Lifen, Li Dan, Yang Xiaofeng |
| (Children’s Hospital Affiliated to Kunming Medical University, Yunnan Kunming 650228, China) |
| Abstract: |
| [Abstract] Objective: To establish the microbial limit test method for Zihuang ointment of hospital preparation. Methods: By reference to Chinese Pharmacopoeia (2015 Edition), the total number of aerobic bacteria was determined by the dilution method of the test solution (1∶100). The total number of mold and yeasts were determined by the pouring plate method. The control bacteria of Staphylococcus aureus and Pseudomonas aeruginosa were examined by using the test solution dilution method (100 mL). Results: The recovery ratios of the total aerobic bacteria, mold and yeasts experientmental bacteria were all within the range from 0.5 to 2.0. S. aureus and P. aeruginosa showed good growth in the experimental group, but no growth in the negative control group and the sample group. Conclusion: The method established in this experiment has been verified by methodology, the results are in line with the specifications of the Chinese Pharmacopoeia (2015 Edition), which can provide the scientific basis for the revision of the quality standard of Zihuang ointment of hospital preparation. |
| Key words: Zihuang ointment hospital preparation microbial limit test dilution method |
