林可霉素利多卡因凝胶微生物限度检查方法的探究
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摘要
目的:探索消除林可霉素利多卡因凝胶抑菌活性的适宜方法,并建立该品种微生物限度检查方法。方法:根据2015年版《中华人民共和国药典》(以下简称中国药典)四部通则1105非无菌产品微生物限度检查:微生物计数法、通则1106非无菌产品微生物限度检查:控制菌检查法和通则1107非无菌药品微生物限度标准,利用3%氯化钡溶液能与林可霉素利多卡因凝胶中的主要基质卡波姆形成钡盐沉淀达到破胶目的的原理,自然沉降5 min,取上部溶液进行薄膜过滤,采用薄膜过滤法测定林可霉素利多卡因凝胶对5种试验菌株的回收率,并对控制菌检查方法进行适用性试验。结果:在对样品进行需氧菌总数、霉菌和酵母菌计数方法适用性试验中,稀释剂对照组与菌液对照组的比值均在0.5~2之间,试验组与菌液对照组的比值均在0.5~2之间;在进行控制菌检查方法适用性试验中,试验组检出阳性试验菌。结论:该方法可消除林可霉素利多卡因凝胶的抑菌作用,可用于林可霉素利多卡因凝胶的微生物限度检查。
Objective:To explore a suitable method for elimination of the antimicrobial activity of lincomycin hydrochloride and lidocaine hydrochloride gel.Methods:According to the appendices volume Ⅳ of Chinese Pharmacopeia(edition 2015),barium chloride was added into lincomycin hydrochloride and lidocaine hydrochloride gel to destroy the gel.Membrane-filter method was used in suitability test of microbial limit method.Results:The ratio between diluent group and microorganism solution group in 3 preparations were between 0.5 and 2.The ratio between test group and microorganism solution group were between 0.5 and 2.In the control bacteria tests,the control bacteria was found in the test group.Conclusion:The established method can eliminate the antimicrobial in lincomycin hydrochloride and lidocaine hydrochloride gel and can be used for microbial limit test.
Objective:To explore a suitable method for elimination of the antimicrobial activity of lincomycin hydrochloride and lidocaine hydrochloride gel.Methods:According to the appendices volume Ⅳ of Chinese Pharmacopeia(edition 2015),barium chloride was added into lincomycin hydrochloride and lidocaine hydrochloride gel to destroy the gel.Membrane-filter method was used in suitability test of microbial limit method.Results:The ratio between diluent group and microorganism solution group in 3 preparations were between 0.5 and 2.The ratio between test group and microorganism solution group were between 0.5 and 2.In the control bacteria tests,the control bacteria was found in the test group.Conclusion:The established method can eliminate the antimicrobial in lincomycin hydrochloride and lidocaine hydrochloride gel and can be used for microbial limit test.
引文
[1]国家药品监督管理局国家药品标准.第2册[S].2002:147National drug standards.Vol 2[S].2002:147
[2]余小平.高效液相色谱法测定林可霉素利多卡因凝胶中盐酸利多卡因的含量[J].中国医院药学杂志,2005,25(8):723YU XP.Determination of the content of lidocaine hydrochloride in lincomycin hydrochloride and lidocaine hydrochloride gel by HPLC[J].China J Hosp Pharm,2005,25(8):723
[3]李芳,刘冬玲,刘浩,等.氟罗沙星胶囊微生物检查方法的研究[J].中国抗生素杂志,2016,41(6):445LI F,LIU DL,LIU H,et al.Study on microbial limit test method of fleroxacin capsules[J].Chin J Antibiot,2016,41(6):445
[4]中华人民共和国药典2015年版.四部[S].2015:附录140Ch P 2015.VolⅣ[S].2015:Appendix 140
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[6]钱文静,张玫,袁耀佐.盐酸特比萘芬凝胶微生物限度检查方法的验证[J].药物分析杂志,2008,28(12):2135QIAN WJ,ZHANG M,YUAN YZ.Validation of microbial limit tests of terbinafine hydrochloride gel[J].Chin J Pharm Anal,2008,28(12):2135
[7]赫爱平,张亚杰,郎非,等.加替沙星眼用凝胶中微生物检查法的建立[J].华西药学杂志,2008,23(6):701HE AP,ZHANG YJ,LANG F,et al.Establishment of the method for microbial limit test of gatifloxacin gel for eyes[J].West China J Pharm Sci,2008,23(6):701
[8]唐菱,侯晓军,周剑.硫酸新霉素凝胶微生物限度检查方法的适用性试验[J].中国抗生素杂志,2016,41(9):680TANG L,HOU XJ,ZHOU J,et al.Operational test of methodology on the microbial limit test for neomycin sulphate gel[J].Chin J Antibiot,2016,41(9):680
[9]李伟.睾酮凝胶微生物限度检查方法适用性试验的研究[J].天津药学,2015,27(4):24LI W.Study on the applicability of testosterone gel microbial limit test method[J].Tianjin Pharm,2015,27(4):24
[10]毛腾霄,熊雯,秦玉花.氧氟沙星凝胶微生物限度检查方法研究[J].中国药房,2015,26(18):2559MAO TX,XIONG W,QIN YH.Research on the method of microbial limit test for ofloxacin gel[J].China Pharm,2015,26(18):2559
[11]钱桂英,季大伟.克林霉素磷酸酯凝胶微生物限度检查方法验证[J].海峡药学,2012,24(12):75QIAN GY,JI DW.Verification of methodology on the microbial limit test for clindamycin phosphate gel[J].Strait Pharm J,2012,24(12):75
[12]严佳,檀巧婷,钟桂香,等,盐酸普萘洛尔凝胶的微生物限度检查方法学验证[J].儿科药学杂志,2015,21(5):43YAN J,TAN QT,ZHONG GX,et al.Methodology validation of microbial limit tests of propranolol hydrochloride gel[J].J Pediatr Pharm,2015,21(5):43
[2]余小平.高效液相色谱法测定林可霉素利多卡因凝胶中盐酸利多卡因的含量[J].中国医院药学杂志,2005,25(8):723YU XP.Determination of the content of lidocaine hydrochloride in lincomycin hydrochloride and lidocaine hydrochloride gel by HPLC[J].China J Hosp Pharm,2005,25(8):723
[3]李芳,刘冬玲,刘浩,等.氟罗沙星胶囊微生物检查方法的研究[J].中国抗生素杂志,2016,41(6):445LI F,LIU DL,LIU H,et al.Study on microbial limit test method of fleroxacin capsules[J].Chin J Antibiot,2016,41(6):445
[4]中华人民共和国药典2015年版.四部[S].2015:附录140Ch P 2015.VolⅣ[S].2015:Appendix 140
[5]曲萍,仇丽霞,赵思俊.卡波姆抑菌凝胶剂微生物限度检查方法的建立[J].药物分析杂志,2013,33(8):1317QU P,QIU LX,ZHAO SJ.Establishment of the method for microbial limit test of carbomer antibacterial gel[J].Chin J Pharm Anal,2013,33(8):1317
[6]钱文静,张玫,袁耀佐.盐酸特比萘芬凝胶微生物限度检查方法的验证[J].药物分析杂志,2008,28(12):2135QIAN WJ,ZHANG M,YUAN YZ.Validation of microbial limit tests of terbinafine hydrochloride gel[J].Chin J Pharm Anal,2008,28(12):2135
[7]赫爱平,张亚杰,郎非,等.加替沙星眼用凝胶中微生物检查法的建立[J].华西药学杂志,2008,23(6):701HE AP,ZHANG YJ,LANG F,et al.Establishment of the method for microbial limit test of gatifloxacin gel for eyes[J].West China J Pharm Sci,2008,23(6):701
[8]唐菱,侯晓军,周剑.硫酸新霉素凝胶微生物限度检查方法的适用性试验[J].中国抗生素杂志,2016,41(9):680TANG L,HOU XJ,ZHOU J,et al.Operational test of methodology on the microbial limit test for neomycin sulphate gel[J].Chin J Antibiot,2016,41(9):680
[9]李伟.睾酮凝胶微生物限度检查方法适用性试验的研究[J].天津药学,2015,27(4):24LI W.Study on the applicability of testosterone gel microbial limit test method[J].Tianjin Pharm,2015,27(4):24
[10]毛腾霄,熊雯,秦玉花.氧氟沙星凝胶微生物限度检查方法研究[J].中国药房,2015,26(18):2559MAO TX,XIONG W,QIN YH.Research on the method of microbial limit test for ofloxacin gel[J].China Pharm,2015,26(18):2559
[11]钱桂英,季大伟.克林霉素磷酸酯凝胶微生物限度检查方法验证[J].海峡药学,2012,24(12):75QIAN GY,JI DW.Verification of methodology on the microbial limit test for clindamycin phosphate gel[J].Strait Pharm J,2012,24(12):75
[12]严佳,檀巧婷,钟桂香,等,盐酸普萘洛尔凝胶的微生物限度检查方法学验证[J].儿科药学杂志,2015,21(5):43YAN J,TAN QT,ZHONG GX,et al.Methodology validation of microbial limit tests of propranolol hydrochloride gel[J].J Pediatr Pharm,2015,21(5):43