微生物浊度法与管碟法测定乙酰麦迪霉素制剂的效价

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。

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

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-1(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 difference between 2 kinds of methods(t=1.473<4.303).CONCLUSION:Compared with cylinder-plate method,turbidimetric method is accurate,reliable,rapid with lower detection limit and less influencing factors.Both methods can be used for detecting acetyl midecamycin preparations.