克林霉素磷酸酯注射液的质量考察及临床用药条件下的稳定性研究  

Quality monitoring of clindamycin phosphate injections and their stability in dextrose and saline solutions

作　　者：刘刚[1] 张华[1] 姜韧[1] 张捷[1] 薛克昌[1] 谭生建[1] 

机构地区：[1]解放军第306医院,北京市100101

出　　处：《总装备部医学学报》2008年第1期3-6,共4页Medical Journal of General Equipment Headquarters

摘　　要：目的考察不同厂家生产的克林霉素磷酸酯注射液的质量及临床用药条件下的稳定性,为临床用药提供参考。方法测定不同厂家生产的克林霉素磷酸酯注射液和有关物质含量;在临床用药条件下稀释样品后,考察其6h内的含量和有关物质的变化。色谱柱用辛烷基硅烷键合硅胶为填充剂(Agilent ZORBAX Eclipse XDB-C8,4.6mm×150mm,5μm);以磷酸二氢钾溶液(取磷酸二氢钾10.54g,加水775ml使之溶解,以磷酸调节pH值至2.5)∶乙腈(78∶22)为流动相;流速1ml/min;检测波长210nm。结果克林霉素磷酸酯与相邻峰的分离度、理论板数均符合要求。7批克林霉素磷酸酯注射液质量均符合要求。临床用药采用氯化钠注射液和5%葡萄糖注射液稀释后,克林霉素磷酸酯在6h内稳定。结论本实验中六个厂家生产的7批克林霉素磷酸酯注射液的质量均符合国家药品标准,临床采用氯化钠注射液和5%葡萄糖注射液稀释后6h内克林霉素磷酸酯稳定。Objective To investigate the contents and related substance of clindamycin phosphate injections manufactured in different companies and their stability in 0.9% sodium chloride injection and 5% glucose injection. Methods The contents and related substance of clindamycin phosphate injections were detected by HPLC, chromatographed on an Agilent ZORBAX Eclipse XDB-C8 column (4.6 mm ID×250 mm, 5 μm) using a mixture of acetonitrile and potassium dihydrogen phosphate solution (78∶22, v/v), and monitored at 210 nm with a flow rate of 1 ml/min. Results The resolution and number of theoretical plates of clindamycin phosphate were consistent with the requirement. 7 batches of clindamycin phosphate injections were all qualified. Clindamycin phosphate was stable in 6 hours in 0.9% sodium chloride injection and 5% glucose injection. Conclusions Seven batches of clindamycin phosphate injections manufactured in 6 different companies are all consistent with the national drug standard. Clindamycin phosphate is stable in 6 hours in 0.9% sodium chloride injection and 5% glucose injection as clinical medication.

关 键 词：克林霉素磷酸酯注射液 质量考察 临床用药 稳定性 

分 类 号：R927[医药卫生—药学]