摘要
目的:建立5种医院制剂微生物限度检查和无菌检查抑菌性消除的方法学研究。方法:以大肠埃希杆菌、金黄色葡萄球菌和白念珠菌等菌株为试验菌株,对感冒安颗粒、愈肠颗粒、护肤粉刺霜、碘氯己定溶液和复方乳酸依沙吖啶散5种医院制剂,进行样品抑菌性消除方法研究,以菌落计数回收率>70%的样品处理方法为微生物限度检查抑菌性消除方法;试验菌落生长状况良好的样品处理方法为无菌检查的抑菌性消除方法。结果:感冒安颗粒、愈肠颗粒和护肤粉刺霜分别采用常规法和供试品稀释法,大肠埃希杆菌、金黄色葡萄球菌和白念珠菌的菌落回收率>70%;碘氯己定溶液联用中和法和薄膜过滤法,复方乳酸依沙吖啶散联用离心沉淀法和薄膜过滤法,消除它们对所研究的3种试验菌株的抑菌性。结论:5种制剂所抑制的菌株不同,抑制作用的强度也不同,需采用不同的方法进行抑菌性消除。
Objective： To establish the methods to eliminate antibacterial effects in microbial limit check and sterility check of 5 kinds of hospital preparations. Methods： In the study of eliminating antibacterial effects, ,5 kinds of hospital preparations including Ganmao＇an granules, Yuehang granules, acne cream for skin care,iodine chlorhexidine solution and compound etbaeri dine lactate powder,and some test strains, such as Escheriehia coli ,Staphylococcus aureus and Candida albican. were used. The methods of handling samples of the recoveries of bacterial colony counts over 70% were used to eliminate antibacterial effects in microbial limit check. Meanwhile,the methods of handling samples of test strains growing well were used to eliminate antibacterial effects in sterility check. Results： Conventional method and test sample dilution method were used for Ganmao＇an granules, Yuchang granules and aene cream for skin care, respectively. The recoveries of bacterial colony counts were over 70% for Escherichia coli, Staphylococcus aureus and Candida albicans. In the study of eliminating antibacterial effects of three test strains, eombinative method of neutralization and membrane filtration was used for iodine chlorhexidine solution. Combinative method of centrifagal precipitation and membrane filtration was used for compound ethacridine laclate powder. Conclusion： Five preparations have different sensitivity to 3 strains and bacteriostasis strenglhs are different. Therefore, every preparation needs different method to eliminate antibacterial effects.
出处
《药学服务与研究》
CAS
CSCD
2011年第6期450-452,共3页
Pharmaceutical Care and Research
关键词
微生物限度检查
无菌检查
感冒安颗粒
愈肠颗粒
护肤粉刺霜
碘氯己定溶液
复方乳酸依沙吖啶散
microbial limit cheek
sterility check
Ganmao＇an granules
Yuchang granules acne cream for skin care iodine chlorhexidine solution
compound ethacridine lactate powder
作者简介
高鸿彬（男），硕上，主管药师．E—mail：gaohongbin1981@163．com。
通讯作者：宋洪杰，Email：hjsong123@yahoo．com．cn
