复方甘草酸苷片中三种活性成分在四种不同溶出介质中溶出曲线的测定  

Determination of dissolution curve of three active components in compound glycyrrhizin tablets in four different dissolution media

作　　者：张亮 唐城 薛红瑞 谢湘云[1,3] 刘晓航 单宇 高晓黎 ZHANG Liang;TANG Cheng;XUE Hongrui;XIE Xiangyun;LIU Xiaohang;SHAN Yu;GAO Xiaoli(College of pharmacy,Xinjiang Medical University,Urumqi 830017,China;Xinjiang Tefeng pharmaceutical Co.,Ltd.,Urumqi 830000,China;Engineering Research Center of Xinjiang and Central Asian Medicine Resources,Ministry of Education,Urumqi 830017,China;Xinjiang Second Medical College,Karamay Xinjiang 834000,China)

机构地区：[1]新疆医科大学药学院,乌鲁木齐830017 [2]新疆特丰药业股份有限公司,乌鲁木齐830000 [3]新疆及中亚特色医药资源教育部工程研究中心,乌鲁木齐830017 [4]新疆第二医学院,新疆克拉玛依834000

出　　处：《新疆医科大学学报》2023年第1期9-15,共7页Journal of Xinjiang Medical University

基　　金：新疆维吾尔自治区重点研发计划项目(2020B03007-2)。

摘　　要：目的测定复方甘草酸苷片(美能)中甘草酸苷、甘氨酸和DL-蛋氨酸分别在pH1.2盐酸溶液、pH4.0磷酸氢二钠-柠檬酸缓冲溶液、pH6.8磷酸盐缓冲溶液和水介质中的溶出曲线。方法采用浆法,转速为50 r/min,以pH 1.2盐酸溶液、pH4.0磷酸氢二钠-柠檬酸缓冲溶液、pH6.8磷酸盐缓冲溶液和水为溶出介质,溶出介质体积为900 mL进行溶出实验;采用高效液相色谱法检测甘草酸苷、甘氨酸和DL-蛋氨酸的含量,计算累积溶出百分率,绘制溶出曲线。结果通过分析方法验证,溶出曲线测定法的精密度、重复性、加样回收率及稳定性试验的RSD均小于2%;甘草酸苷在pH4.0、pH6.8缓冲溶液和水中60 min内平均累积溶出率均达到85%以上,但在pH1.2盐酸溶液中溶出较慢,120 min时平均累积溶出率为70%;溶出前10~20 min具有延迟释放现象。甘氨酸和DL-蛋氨酸在四种溶出介质中60 min内平均累积溶出率均达到85%以上。结论所建立的溶出测定方法准确可靠,测得3个批次复方甘草酸苷片中3种活性成分在4种不同溶出介质中的溶出曲线,为其仿制药的溶出曲线相似性评价提供了参考。Objective To determine the dissolution profiles of glycyrrhizin,glycine and DL-methionine in compound glycyrrhizin tablets(Stronger Neo-Minophagen C)in four different kinds ofdissolution mediums:pH1.2 hydrochloric acid solution,pH4.0 disodium hydrogen phosphate-citrate acid buffer solution,pH6.8 phosphoric acid buffer and water.Methods The paddle method of dissolution determination method was adopted;the rotation speed was 50 r/min;and the dissolution media was 900 mL pH1.2 hydrochloride acid,pH4.0 disodium hydrogen phosphate-citrate acid buffer solution,pH6.8 phosphate buffer solution and water,respectively.The content of three components were determined by high performance liquid chromatography;the cumulative dissolution was calculated;and the release curves was drawn.Results The analytical method was validated and RSDs of precision,repeatability,recovery and stability in this method were all less than 2%.The average cumulative dissolution amount of glycyrrhizin in pH4.0,pH6.8 buffer solution and water all reached more than 85%in 60 minutes,but in pH1.2 hydrochloric acid solution was slow,the dissolution amount of glycyrrhizin for 120 minutes was 70%.Delayed release occurred from 10 to 20 min in the dissolution test.The average cumulative dissolution amount of glycine and DL-methionine in four different dissolution media all reached more than 85%in 60 minutes.Conclu-sion This method is simple and reliable.The dissolution curves of three active components in three batches of compound glycyrrhizin tablets in four different dissolution media were obtained,which can provide the reference for the similarity of dissolution profiles evaluation of generic drug.

关 键 词：复方甘草酸苷片 溶出曲线 一致性评价 

分 类 号：R943[医药卫生—药剂学]