蜂珍膏微生物限度检查方法适用性研究
|
摘要
目的:建立蜂珍膏的微生物限度检查方法。方法:按照《中国药典》2015年版四部通则进行蜂珍膏微生物限度检查方法适用性试验。以试验菌株的回收率为指标,考察需氧菌总数、霉菌和酵母菌总数计数方法;建立控制菌金黄色葡萄球菌和铜绿假单胞菌的检查方法。结果:采用平皿法通过增加供试品稀释液法(1∶100)检查需氧菌数;采用平皿法通过增加供试品稀释液法(1∶50)检查霉菌、酵母菌计数;采用培养基稀释法检查金黄色葡萄球菌,控制菌检查常规法检查铜绿假单胞菌。结论:所建立的方法适用于蜂珍膏的质量控制。
Objective:To establish a microbial limit test method for Honeyzheng ointment. Methods: According to the general principles on the Chinese Pharmacopoeia 2015 edition volume IV, the applicability of microbial limit test method for honeyzheng ointment was established. The total aerobic bacteria, mold and yeast counting methods were investigated with the recovery rate of the tested strains as the index, and the detection methods for controlling bacteria Staphylococcus aureus and Pseudomonas aeruginosa were established. Results: The number of aerobic bacteria, mold and yeast, Pseudomonas aeruginosa and Staphylococcus aureus were detected by increasing diluent method(1∶100),(1∶50), medium dilution method and routine method, respectively. Conclusion: The established method is suitable for the quality control of Honeyzheng ointment.
Objective:To establish a microbial limit test method for Honeyzheng ointment. Methods: According to the general principles on the Chinese Pharmacopoeia 2015 edition volume IV, the applicability of microbial limit test method for honeyzheng ointment was established. The total aerobic bacteria, mold and yeast counting methods were investigated with the recovery rate of the tested strains as the index, and the detection methods for controlling bacteria Staphylococcus aureus and Pseudomonas aeruginosa were established. Results: The number of aerobic bacteria, mold and yeast, Pseudomonas aeruginosa and Staphylococcus aureus were detected by increasing diluent method(1∶100),(1∶50), medium dilution method and routine method, respectively. Conclusion: The established method is suitable for the quality control of Honeyzheng ointment.
引文
[1]华玉玲,张建玲,贺祝英,等.蜂珍膏制备工艺的研究[J].贵阳中医学院学报,2009,31(1):81-83.
[2]华玉玲,贺祝英,张建玲,等.中药复方制剂蜂珍膏质量标准的研究[J].贵阳中医学院学报,2011,3(5):142-144.
[3]张晓.中药蜂珍膏对创面毛细血管增生情况的影响[J].世界最新医学信息文摘,2013,13(6):402.
[4]张晓.中药蜂珍膏对小鼠创面毛细血管血栓数影响的实验研究[J].贵阳中医学院学报,2014,36(5):140-141.
[5]何峰,姚媚方,符中柱.蜂珍膏治疗Ⅱ期肛裂40例观察[J].实用中医药杂志,2015,31(6):528-529.
[6]华玉玲,张建玲,于佳,等.蜂珍膏的稳定性研究[J].贵阳中医学院学报,2013,35(3):6-7.
[7]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:145-147.
[8]李趣娥,江艳芳.《中国药典》2010版与2015版微生物限度检查法对四种药物检测结果的比较[J].中国药品标准,2015,16(2):86-90.
[9]景荣先,张国林. 2015年版《中国药典》微生物限度检查法洁净环境及计数培养基修订分析探讨[J].中国卫生产业,2015,12(5):184.
[10]杨晓莉,李辉,马英英,等.《中国药典》2015年版非无菌产品微生物限度检查:控制菌检查法解读与对策[J].中国药师,2016,19(04):748-752.
[11]庞云娟,樊文研,刘康连,等.药品微生物限度检查方法学验证的研究进展[J].中成药,2017,39(10):2137-2139.
[2]华玉玲,贺祝英,张建玲,等.中药复方制剂蜂珍膏质量标准的研究[J].贵阳中医学院学报,2011,3(5):142-144.
[3]张晓.中药蜂珍膏对创面毛细血管增生情况的影响[J].世界最新医学信息文摘,2013,13(6):402.
[4]张晓.中药蜂珍膏对小鼠创面毛细血管血栓数影响的实验研究[J].贵阳中医学院学报,2014,36(5):140-141.
[5]何峰,姚媚方,符中柱.蜂珍膏治疗Ⅱ期肛裂40例观察[J].实用中医药杂志,2015,31(6):528-529.
[6]华玉玲,张建玲,于佳,等.蜂珍膏的稳定性研究[J].贵阳中医学院学报,2013,35(3):6-7.
[7]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:145-147.
[8]李趣娥,江艳芳.《中国药典》2010版与2015版微生物限度检查法对四种药物检测结果的比较[J].中国药品标准,2015,16(2):86-90.
[9]景荣先,张国林. 2015年版《中国药典》微生物限度检查法洁净环境及计数培养基修订分析探讨[J].中国卫生产业,2015,12(5):184.
[10]杨晓莉,李辉,马英英,等.《中国药典》2015年版非无菌产品微生物限度检查:控制菌检查法解读与对策[J].中国药师,2016,19(04):748-752.
[11]庞云娟,樊文研,刘康连,等.药品微生物限度检查方法学验证的研究进展[J].中成药,2017,39(10):2137-2139.