往复筒法测定麝香缓释微片的体外释放度  

Determination of in vitro release of musk sustained-release mini-tablets by reciprocating cylinder method

作　　者：黄潘雯 陈菥 张永太[1] 刘颖[1] 冯年平[1] 王志[1] HUANG Pan-wen;CHEN Xi;ZHANG Yong-tai;LIU Ying;FENG Nian-ping;WANG Zhi(Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学,上海201203

出　　处：《药物分析杂志》2024年第6期1074-1081,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金项目(81603308);上海高水平地方高校创新团队支持项目(SZY20220315);上海中医药大学预算内科研项目(2021LK106)。

摘　　要：目的:应用往复筒法测定麝香缓释微片的体外释放度。方法:采用气相色谱法建立缓释微片主要活性成分麝香酮的体外分析方法,比较其在不同浓度吐温-80、十六烷基三甲基溴化铵(CTAB)及十二烷基硫酸钠(SDS)中的平衡溶解度,确定释放介质的种类,考察停留时间、滴水时间、往复速率和筛网孔径等因素对麝香酮释放行为的影响,并与桨法进行比较,同时对其释药机制进行了初步探究。结果:所建分析方法线性良好,精密度、重复性、稳定性的RSD均小于3%,加样回收率合格。往复筒法释放介质为0.05%吐温-80 200 mL,停留和滴水时间为20 s,往复速率15 dip·min^(-1),上、下筛网目数分别为20和40。与桨法相比,往复筒法中麝香酮在不同pH条件下能完全释放,且释放曲线平稳递增。结论:本研究可为往复筒法在中药缓释制剂的体外评价提供一定的参考和借鉴。Objective:To determine the in vitro release degree of musk sustained-release mini-tablets by reciprocating cylinder method.Methods:Gas chromatography was used to establish the in vitro analysis of muscone,which is the main active ingredient of sustained-release mini-tablets.Comparing its equilibrium solubility in different concentrations of Tween-80,hexadecyl trimethyl ammonium bromide(CTAB)and sodium dodecyl sulfate(SDS),to determine the type of release medium.The effects of residence time,drip time,reciprocation rate,and screen mesh sizes on the release behaviours of muscone were investigated.Results were compared with that of the paddle method.Meanwhile,a preliminary investigation into the mechanism of its release was also carried out.Results:The linearity of the constructed analytical method was better,the RSD values of precision,repeatability and stability were less than 3%,and the spiked sample recovery was qualified.The release medium for the reciprocating cartridge method was 200 mL of 0.05%Tween-80,with a dwell and drip time of 20 s,a reciprocation rate of 15 dip·min^(-1),and upper and lower screen mesh sizes of 20 and 40 respectively.Compared with the paddle method,Muscone was completely released under different pH conditions in the reciprocating cylinder method,and the release curve increased smoothly.Conclusion:The study can provide some references for the reciprocating cylinder method in the in vitro evaluation of sustained-release prescriptions of traditional Chinese medicine.

关 键 词：麝香缓释微片 往复筒法 桨法 麝香酮 体外释放度 

分 类 号：R917[医药卫生—药物分析学]