自制依普黄酮片与参比制剂的体外溶出行为一致性评价  

Evaluation of similarity of dissolution profiles between self-made ipriflavone tablets and reference drug

作　　者：张凯[1,2] 冯巧巧[3] 咸磊 丁平田[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]北京诚济制药有限公司,北京101318 [3]山东省食品药品监督管理局审评认证中心,济南250013

出　　处：《中南药学》2016年第9期928-932,共5页Central South Pharmacy

摘　　要：目的建立自制依普黄酮片溶出度测定方法,并与原研制剂进行溶出曲线比较,评价两者体外溶出行为的一致性。方法筛选溶出度试验参数,采用紫外-可见分光光度法在300 nm波长处测定吸光度并计算溶出度;测定自制依普黄酮片与参比制剂(OSTEN)在含2%十二烷基硫酸钠(SDS)水溶液、含2%SDS的p H=4.5乙酸盐缓冲液、含2%SDS的p H=6.8磷酸盐缓冲液、含2%SDS的0.1mol·L^(-1)盐酸溶液4种溶出介质中的溶出曲线,并进行一致性评价。结果自制片与参比制剂在上述4种溶出介质中的相似因子分别为74.57(水,2%SDS)、71.03(p H=4.5乙酸盐缓冲液,2%SDS)、74.83(p H=6.8磷酸盐缓冲液,2%SDS)、70.34(0.1 mol·L-1盐酸,2%SDS),且全部有效点的AV值均≤15.0。提示自制依普黄酮片与参比制剂体外溶出行为相似。结论建立的溶出度试验方法专属性强、灵敏、简便,能有效控制依普黄酮片的质量;自制依普黄酮片与参比制剂的体外溶出行为一致。Objective To establish the dissolution test of ipriflavone tablets and to compare dissolution curves of self-made product and reference drug and evaluate the consistency of dissolution behaviors in vitro. Methods The dissolution parameters were selected, and the absorbance of ipriflavone tablets was determined by ultra- violet-visible speetrophotometry at 300 nm. The dissolution behaviors of the self-made product and reference drug （OSTEN） in 4 dissolution media, namely water （2% SDS）, acetate buffer （pH ： 4.5, 2% SDS）, phosphate buffer （pH = 6.8, 2% SDS） and hydrochloric acid （0.1 mol · L - 1 2% SDS） were determined. The similarity of the in vitro dissolution profiles between the self-made product and reference drug was evaluated. Results The similarity factor was 74.57 for water （2% SDS）, 71.03 for acetate buffer （pH = 4.5, 2% SDS）, 74.83 for phos- phate buffer （pH = 6.8, 2% SDS）, 70.34 for hydrochloric acid （0.1 mol · L - 1, 2% SDS）, and each AV value was less than 15.0. The dissolution behaviors of the self-made product were similar to those of reference drug. Conclusion The dissolutiont method is sensitive, specific and simple. It can be used for the quality control of ipriflavone tablets. The dissolution behaviors of self-made product and reference drug are similar.

关 键 词：依普黄酮片 参比制剂 溶出行为 相似因子法 AV值 一致性评价 

分 类 号：R94[医药卫生—药剂学] R927[医药卫生—药学]