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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 quality of clindamycin phosphate injection produced by different manufacturers and the stability under clinical conditions for clinical application. Methods The content of clindamycin phosphate injection and related substances produced by different manufacturers were determined. After the samples were diluted under clinical conditions, the contents of clindamycin phosphate and related substances within 6 hours were investigated. The column was treated with octylsilane bonded silica gel (Agilent ZORBAX Eclipse XDB-C8, 4.6 mm × 150 mm, 5 μm); potassium dihydrogen phosphate (10.54 g potassium dihydrogen phosphate, 775 ml water) Adjust the pH to 2.5 with phosphoric acid): acetonitrile (78:22) as mobile phase; flow rate 1ml / min; detection wavelength 210nm. Results Clindamycin phosphate with the adjacent peak resolution, the number of theoretical plates are in line with requirements. 7 batches of clindamycin phosphate injection quality are met. Clindamycin phosphate was stable within 6 hours after clinical medication was diluted with sodium chloride injection and 5% glucose injection. Conclusions In this experiment, the quality of seven batches of clindamycin phosphate injection produced by six factories are in line with the national drug standards. Clinical application of clindamycin phosphate ester in 6 hours after dilution with sodium chloride injection and 5% glucose injection stable.