摘要
目的:建立吗替麦考酚酯片溶出度测定方法,评价自研制剂与原研制剂溶出行为的一致性。方法:采用了紫外-可见分光光度法,测定了自研吗替麦考酚酯片与原研制剂分别在pH值1.0盐酸溶液、pH值4.5醋酸盐缓冲液、pH值6.8磷酸盐缓冲液(含0.8%SDS)和水(含0.8%SDS)四种溶出介质中的溶出曲线,并评价其一致性。结果:自研制剂与原研制剂在四种不同溶出介质中溶出曲线均相似。结论:自研制剂与原研制剂体外溶出一致,保证了自研制剂的安全性和有效性。
Objective:To establish a method for determining the dissolution of mycophenolate mofetil tablets and evaluate the consistency of dissolution behavior between the self-prepared preparation and the original preparation.Methods:The dissolution curves of the self-developed mycophenolate mofetil tablets and the original preparation were determined by UV-VIS in pH value 1.0 hydrochloric acid solution,pH value 4.5 acetate buffer,pH value 6.8 phosphate buffer(containing 0.8%SDS)and water(containing 0.8%SDS)respectively,and their consistency was evaluated.Results:The dissolution curves of the self-developed preparation and the original preparation in four different dissolution media are similar.Conclusion:The dissolution of the selfdeveloped preparation was consistent with that of the original preparation in vitro dissolution,ensuring the safety and effectiveness of the self-developed preparation.
作者
伊磊
刘庆晓
郑华
卢红华
张贵民
Yi Lei;Liu Qingxiao;Zheng Hua;Lu Honghua;Zhang Guimin(Lunan Pharmaceutical Group Co.,Ltd.,National Chiral Pharmaceuticals Engineering and Technology Research Center,Linyi 273400,China)
出处
《山东化工》
CAS
2023年第13期152-154,共3页
Shandong Chemical Industry
关键词
吗替麦考酚酯片
原研制剂
溶出曲线
一致性评价
mycophenolate mofetil tablets
original preparation
dissolution curves
consistency evaluation
