沙丁胺醇气雾剂微生物限度检查供试液制备方法的探讨

目的: 改进沙丁胺醇气雾剂的供试液制备方法,提高检出率。 方法: 参考中国药典和美国药典32版等进行试验,将沙丁胺醇气雾剂的原液进行薄膜过滤后,检查其微生物限度,并对所采用的方法进行方法学验证。 结果: 本方法满足中国药典2010年版验证试验的基本要求。5株验证菌株的回收率均大于90%。 结论: 用该法进行微生物限度检查能达到检测目的。对同类局部给药制剂的微生物限度有借鉴作用。

Objective: To explore the method to prepare salbutamol pressurized metered-dose inhalers probational liquid,and impoove the detectable rate. Method: Membrance filtration was provided microbial limit test of salbutamol pressurized metered-dose inhalers and validation methods were adopted according to the Chinese pharmacopoeia,American pharmacopoeia and other literatures. Result: The method could pass the validation test of Chinese pharmacopoeia 2010 version.By filtration membrane,the ratios of five validation strains were >90%. Conclusion: The method of filtration membrane is simple,feasible and accurate.The method may be useful for microbial limit tests of the parallel local administration drugs.

[1] DU Xiao-li(杜小莉),ZHU Zhu(朱珠),LI Da-kui(李大魁).Bioequivalence evaluation of two salbutamol MIDI sinasthmatic patients by pharmacokinetic and pharmacodynamic methods(药动学和药效学考察沙丁胺醇气雾剂的生物学等效性).Chin Pharm J(中国药学杂志),2003,38(4):282
[2] YAN Ju(言炬),ZHANG Yong-dong(张永东).Clinical effect of budesonide suspension and salbutamol aerosol on children with asthma(沙丁胺醇气雾剂与布地奈德混悬液治疗儿童哮喘的临床观察).Cent South Pharm(中南药学),2008,6(4):483
[3] ChP(中国药典).2010.Vol Ⅱ(二部):Appendix(附录)107
[4] BP.2002.315
[5] EP 5.2.2613
[6] USP 32/NF 27.2009.1714
[7] JP 14.2000.60
[8] GUO Jian-ming(郭建明),ZHANG Shu-li(张书礼).The supervision for the suspended particulates and settlement bacteria of pharmaceutical production environment(药品生产环境的悬浮粒子及沉降菌监测).Asia-Pacific Tradit Med(亚太传统医药),2011,7(1):29
[9] XIANG Dong(向东),FAN Bing(范兵),LI Hong-ying(李红缨).Microbial limit test for Fengjiao Yatai spray by using filtration membrane(薄膜过滤法检查蜂胶牙泰喷雾剂中微生物的限度).West China J Pharm Sci(华西药学杂志),2006,21(3):299
[10] YI Da-wei(易大为),CHEN Ye(陈野),PAN Qiang(潘强).Application of membrance filtration for microbial limit tests of local administration drugs(薄膜过滤法在局部给药制剂微生物限度检查中的应用).Chin Pharm Aff(中国药事),2008,22(4):342
[11] LI Mei-xia(黎美霞).Membrane filtration method in bacteric control test on norfloxacin eyedrop(用薄膜过滤法检查诺氟沙星滴眼液的控制菌).Strait Pharm(海峡药学),2004,16(1):60
[12] GUANG Xin-lan(光新兰),ZHANG Hong(张洪),DAI Peng-fei(戴鹏飞).Application of membrance filtration for drug inspection(薄膜过滤法在药品检验中的应用).Her Med(医药导报),2006,25(3):253