微生物浊度法与管碟法测定乙酰麦迪霉素制剂的效价  

Comparison of Antimicrobial Activity of Acetyl Midecamycin Preparations by Turbidimetric Method and Cylinder-plate Method

作　　者：王淑娟[1] 高燕霞[2] 程桂茹[1] 

机构地区：[1]长春工业大学,长春130012 [2]河北省药品检验所,石家庄050011

出　　处：《中国药房》2012年第5期437-439,共3页China Pharmacy

基　　金：河北省2006年科学技术研究与发展指导计划(06276445)

摘　　要：目的:建立浊度法测定乙酰麦迪霉素制剂(片剂与干混悬剂)效价的方法,并与管碟法进行比较。方法:浊度法以金黄色葡萄球菌为试验菌,加菌量为1.2%,(37±0.5)℃培养3～4h后于抗生素比浊法测量仪530nm波长处测定吸光度,与管碟法比较片剂与干混悬剂样品效价结果。结果:浊度法乙酰麦迪霉素检测浓度线性范围为0.3～3.0u.mL-(1r=0.9983);片剂和干混悬剂样品的平均回收率分别为101.99%(RSD=1.94%,n=9)、101.68%(RSD=1.68%,n=9);2种测定方法效价比较无显著性差异(t=1.473<4.303)。结论:与管碟法比较,本文建立的浊度法准确、可靠、快捷,检测限更低,影响因素较少,与管碟法均可作为测定乙酰麦迪霉素制剂效价的方法。OBJECTIVE： To establish turbidimetric method for the antimicrobial activity of Acetyl midecamycin preparations （tablet and suspension）, and to compare turbidimetric method with cylinder-plate method. METHODS： The test organism was Staphylococcus aureus with adding amount of 1.2% and cultured at （37 ± 0.5）℃ for about 3-4 h. The detection wavelength was set at 530 nm. The antimicrobial activity of tablets and suspension detected by turbidimetric method were compared with those by cylinder-plate method. RESULTS： The liner range of acetyl midecamycin was 0.3~3.0 u. mL-~ （r=0.998 3）. Average recoveries of tablets and suspension were 101.99% （RSD= 1.94%, n=9） and 101.68% （RSD= 1.68%, n=9）. There was no significant dif- ference between 2 kinds of methods （t = 1.473 〈 4.303）. CONCLUSION： Compared with cylinder-plate method, turbidimetric meth- od is accurate, reliable, rapid with lower detection limit and less influencing factors. Both methods can be used for detecting acetyl midecamycin preparations.

关 键 词：乙酰麦迪霉素 片剂 干混悬剂 效价 浊度法 管碟法 

分 类 号：R978.15[医药卫生—药品]