摘要
探讨UPLC—MS法在克林霉素磷酸酯葡萄糖注射液高温灭茵后的药物成分检测中的应用。方法:对克林霉素磷酸酯葡萄糖注射液高温灭茵后的药物,主要采用uPLC—MS法进行检测,对该药物成分进行探讨。结果:通过采用UPLC—MS法检测得出,克林霉素磷酸酯葡萄糖注射液高温灭菌后的药物主要由3种药物成分组成:林可霉素、克林霉素磷酸酯以及克林霉素,其中在克林霉素磷酸酯葡萄糖注射液高温灭菌后最大杂质就是克林霉素。结论:在克林霉素磷酸酯葡萄糖注射液高温灭菌后的药物成分检测中,主要采用UPLC-MS法进行检测,具有灵敏度高和选择性强等特点,该方法在检测中取得了良好的效果。同时,保证了克林霉素磷酸酯葡萄糖注射液的安全性与质量可靠性,是避免药品发生不良事件的前提。
Objective : to study the UPLC - ms method in clindamycin phosphate glucose injection after high temperature sterilization of the appli- cation of pharmaceutical ingredients. Method: clindamyein phosphate glucose injection drug after high temperature sterilization, mainly adopts UPLC - ms method, discusses the drug ingredients. Results: by using UPLC -ms method to detect, clindamycin phosphate glucose injection after high tempera- ture sterilization of drugs mainly consists of three components : lincomycin, clindamycin phosphate and clindamycin, clindamycin phosphate glucose in- jection, in the biggest impurities after high temperature sterilization is clindamycin. Conclusion: the clindamycin phosphate glucose injection after high temperature sterilization of ingredient detection, mainly adopts UPLC - ms method for testing, has characteristics of high sensitivity and selectivity. The method has obtained the good effect in the test. At the same time, make sure the safety of clindamycin phosphate glucose injection with quality, reliabili- ty is the premise to avoid drug adverse events.
关键词
UPLC—MS法
药物成分
UPLC -ms method
Clindamyein phosphate ester
High temperature sterilization
Pharmaceutical ingredients