八种医院中药制剂微生物限度检查方法的研究
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摘要
目的建立皮痒宁洗剂、参榆结肠康灌肠液、痔瘘宝洗剂、妇炎宁洗剂、钩蝉头痛宁胶囊、伤科祛瘀片、舒肝行气胶囊、壮腰健步丸等八种含抑菌成分的医院中药制剂微生物限度检查方法。方法根据2015版《中国药典》第四部"1105、1106、1107"项下方法,以八种包含抑菌成分的中药制剂为研究对象,分别选取3个批次实施微生物限度检测。结果微生物计数方法适用性试验结果提示,采用稀释法消除抑菌活性,可以采用平皿法测定,亦可采用薄膜过滤法进行微生物计数,两者微生物计数回收比值均在0.5～2.0。控制菌检查适用性试验结果提示,经过稀释处理抑菌成分,结果均为阳性。结论建立的方法准确可行,可用于八种医院中药制剂微生物限度检查。
Objective To stablish the microbial limit test method for eight hospital Chinese materia medica preparations such as Piyangning Lotion, Shenyu Jiechangkang Enema, Zhiloubao Lotion, Fuyanning Lotion, Gouchan Toutongning Capsules, Shangke Quyu Tablets, Shugan Xingqi Capsules, Zhuangyao Jianbu Pills, etc. which contain antibacterial components. Methods According to the methods mentioned under Part Ⅳ "1105, 1106 and 1107" of Version 2015 Chinese Pharmacopoeia, the 8 Chinese materia medica preparations which contain antibacterial components were taken as the research objects, and 3 batches were selected for implementing the microbial limit test. Results The results of the applicability test of the microbial count method suggest that the antibacterial activity can be eliminated by dilution method, which can be determined by plate method or by membrane filtration method. The recovery ratio of the microbial count of both methods was 0.5-2.0. The results of the suitability test of the control bacteria showed that all the bacteriostatic components were positive after dilution treatment. Conclusion Establishing method is correct and feasible, which could be used for microbial limit test of eight hospital Chinese materia medica preparations.
Objective To stablish the microbial limit test method for eight hospital Chinese materia medica preparations such as Piyangning Lotion, Shenyu Jiechangkang Enema, Zhiloubao Lotion, Fuyanning Lotion, Gouchan Toutongning Capsules, Shangke Quyu Tablets, Shugan Xingqi Capsules, Zhuangyao Jianbu Pills, etc. which contain antibacterial components. Methods According to the methods mentioned under Part Ⅳ "1105, 1106 and 1107" of Version 2015 Chinese Pharmacopoeia, the 8 Chinese materia medica preparations which contain antibacterial components were taken as the research objects, and 3 batches were selected for implementing the microbial limit test. Results The results of the applicability test of the microbial count method suggest that the antibacterial activity can be eliminated by dilution method, which can be determined by plate method or by membrane filtration method. The recovery ratio of the microbial count of both methods was 0.5-2.0. The results of the suitability test of the control bacteria showed that all the bacteriostatic components were positive after dilution treatment. Conclusion Establishing method is correct and feasible, which could be used for microbial limit test of eight hospital Chinese materia medica preparations.
引文
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[21]倪玉佳,戈煜,汤露,等.六种中药胶囊剂微生物限度检查方法验证[J].实用药物与与研究,2018,18(4):300-303.
[2]李趣嫦,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.
[3]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:微生物计数法解读[J].药物分析杂志,2016,36(6):1101,1107.
[4]陈震尧,谢锴标,姚伟生,等.乌芪舒筋通络片微生物限度检查方法学研究[J].中国当代医药,2017,24(18):93-96
[5]刘广文,苑艳飞.养肝解毒丸微生物限度检查法的验证实验[J].中国医药科学,2016,6(13):54-57.
[6]黄家乐,王玥,何睿,等.制药企业微生物实验室菌种保存方法的探讨[J].中国药事,2017,31(9):1007-1011.
[7]刘茜,姜俊慧,张慧慧,等.药品检验用培养基配制及灭菌后贮存有效期的研究[J].药学研究,2015,34(2):80-83.
[8]国家药典委员会.中国药典[M].一部.北京:中国医药科技出版社,2015:140-151.
[9]田冬梅,史春辉,娄志红,等.药品微生物计数方法及方法适用性探讨[J].评价技术与方法,2017,34,(2):97-103.
[10]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):2137-2140.
[11]刘素如.药品微生物计数方法及方法适用性试验探讨[J].中国处方药,2018,16(2):36-37.
[12]马德宁,金桂花,崔铉,等.药品微生物计数方法及方法适用性探析[J].中国卫生标准管理,2017,20(8):106-107.
[13]易伟,李思,吴晶晶,等.4种大黄制剂微生物限度检查方法验证及分析[J].中国药业,2018,27(22):33-37.
[14]李思,易伟,吴晶晶,等.不同中药制剂微生物限度检查方法学的研究[J].中国医药导报,2018,15(27):98-101.
[15]肖甜甜,王明翠,刘洋,等.利胆止痛片微生物限度检查方法的建立[J].中国处方药,2018,16(12):30-31.
[16]王志君,梅莉倩,王晓君,等.六种中药制剂微生物限度检查法适用性研究[J].药学服务临床,2018,21(11):1283-1287.
[17]田怀平,杜毅,李超,等.氧化锌滑石粉洗剂微生物限度检查的方法适用性研究[J].药物评价研究,2017,40(10):1432-1435.
[18]汪琦,李雄英,吴智娟,等.肤宁洗剂微生物限度检查方法的建立及验证[J].浙江中西医结合杂志,2017,27(8):713-716.
[19]杨燕,蒋波,鲍英,等.四种药品微生物快速鉴定技术的方法学一致性评价[J].中国药学杂志,2016,51(22):1967-1971.
[20]李力,杨柳,解小霞,等.妇科洗剂微生物限度检查法的适用性考察[J].中国药师,2018,21(9):1678-1680.
[21]倪玉佳,戈煜,汤露,等.六种中药胶囊剂微生物限度检查方法验证[J].实用药物与与研究,2018,18(4):300-303.