浊度法测定硫酸链霉素效价

Determination of Streptomycin Sulfate by Turbidimetric Method

目的:建立浊度法测定硫酸链霉素及其制剂的方法,并对其进行评价。方法:以金黄色葡萄球菌为试验菌,加菌量为1.0%～4.0%(V/V),(37±0.5)℃培养3～4 hr测定。结果:链霉素抗生素线性浓度为2.4～10.8 IU.mL-1,一剂量法原料的平均回收率为102.0%,RSD为2.6%(n=9),一剂量法注射用硫酸链霉素的平均回收率为99.4%,RSD为2.2%(n=9)。结论:本方法灵敏、快速、影响因素较少,可作为测定硫酸链霉素及其制剂效价的方法。

Objective： To establish a turhidimetric method for the content determination of Streptomycin Sulfate and Streptomycin Sulfate for Injiection. Method： The test organism was Staphylococcus anreus, adjusted spore suspension of Staphylococcus aureus inoculating with a 1.0% -4. 0% （V/V）ratio,cultivated at（37 ±0. 5）℃ for about 3 -4 h. Results： The liner range of Streptomycin Sulfate was 0. 8 -4. 8 IU · mL^-1. The average recovery of Streptomycin Sulfate was 102. 0% （RSD =2. 6% ,n =9）. The average recovery of Streptomycin Sulfate for Injection was 99.4% （ RSD = 2. 2% , n = 9 ）. Conclusion： The method was sensitive, rapid and feasible to de- termine Streptomycin Sulfate and Streptomycin Sulfate for Injection.