吉他霉素制剂的浊度法考察评价  

Evaluation of Determination of Kitasamycin Preparation by Turbidimetric Method

作　　者：高燕霞[1] 姜建国[1] 韩彬[1] 

机构地区：[1]河北省药品检验所,石家庄050011

出　　处：《中国药事》2009年第9期872-874,共3页Chinese Pharmaceutical Affairs

基　　金：河北省科技厅(编号06276445)

摘　　要：目的建立浊度法测定吉他霉素制剂的方法,并对其进行考察评价。方法以金黄色葡萄球菌为试验菌,加菌量1.0%-2.5%（V/V）,37℃±0.5℃培养4-5h左右测定。结果抗生素线性浓度为0.5~4.0IU·mL^-1,一剂量法片剂的平均回收率为101.7%,RSD为1.9%;注射用粉针剂的平均回收率为102.0%,RSD为1.7%。结论本方法灵敏、快速,影响因素较少,可作为吉他霉素制剂效价的测定方法。Objective To establish a turbidimetric method for determination of kitasamycin preparation. Methods The test organism was Staphylococcus aureus and cultured 37℃±0.5℃ for about 4-5h. Adjust spore suspension of Staphylococcus aureus inoculate with a 1.0 %--2.5 % （V/V）ratio. Results The linear range of kitasamycin was 0.5-4.0IU ·mL^-1. The average recovery of Kitasamycin Tablets was 101.7%, （RSD= 1.9%）. The average recovery of Kitasamycin Tartrate for Injection was 102.0%, （RSD= 1.7%）. Conclusions The method is sensitive, feasible to determine kitasamycin preparation.

关 键 词：效价 浊度法 吉他霉素片 注射用酒石酸吉他霉素 

分 类 号：R927.32[医药卫生—药学]