摘要
目的:对影响妇炎愈合剂质量安全性的项目进行研究。方法:采用高效液相色谱法(HPLC)对制剂中防腐剂的含量进行测定;采用气相色谱法(GC)对其乙醇残留量进行进行检测;采用电感耦合等离子质谱法(ICP-MS)对其可能含有的重金属及有害元素进行检测。结果:6批样品苯甲酸含量均小于0.3%;4批样品乙醇残留量超过0.5%;仅有一批样品的总汞含量超过15μg·d^(-1),其余样品铅、镉、铬、砷、镍、铜含量均符合美国药典新通则<232>的规定。结论:建立的方法准确,可靠;根据检测结果,亟需改进制剂工艺从而降低乙醇残留量;建议增加以上影响制剂安全性的检测项目以便严格控制制剂质量。
Objective：To study the safety factors of Fuyanyu mixture. Methods： The contents of antiseptic and residual ethanol were determined by HPLC and GC, respectively, and those of heavy metals and harmful elements were detected by ICP-MS. Results：The contents of benzoic acid in 6 batches of samples were less than 0. 3%. In two thirds of samples, ethanol residue was more than 0. 5%. The total mercury exceeded 15μg/day in one of the samples, and the contents of Pb, Ge, Gr, As, Ni and Cu met the limits described in USP〈232〉 in all of the last samples. Conclusion： The methods are accurate and reliable. It is urgent to improve the preparation process so as to reduce the residual amount of ethanol according to the detection results. It is recommended to increase the testing items that affect the safety of the preparation so as to control the preparation quality strictly.
出处
《中国药师》
CAS
2017年第10期1723-1727,共5页
China Pharmacist
基金
浙江省食品药品监督管理与产业发展研究会课题项目(编号:ZYH2016010)
