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【目的】建立中药XJ复方(由制草乌、当归、地龙、乳香、没药等组成)全粉末缓释片混悬液的取样方法及其体外释放度的评价方法。【方法】取样采用注射器冲混悬液的方法,使其粉末均匀分布于混悬液中取得均匀的样品;释放度评价采用浆法,以水为溶出介质,100 r/min,以高效液相色谱法测定累积溶出百分率,绘制XJ的累积溶出曲线,并进行样品的释放度评价。【结果】以10 m L注射器冲混悬液5次并于液面以下2/3位置作为最佳取样方法;在溶出2、4、8 h取出片剂后的0~15 min,峰1、峰2、峰3的释放基本符合Ritger-Peppas释放模型;体外释放溶蚀为主,溶散的粉末、颗粒释放约15min,取出粉末前即片剂总释放2~6 h符合零级方程,除去溶散的粉末后片剂溶蚀释放符合Higuchi方程。片剂溶出8 h累计溶出百分率达97.47%。【结论】全粉末XJ复方缓释片的释放属于溶蚀—溶散过程,实现了均衡释放,建立的方法可用于XJ体外释放度的评价。
【OBJECTIVE】 To establish a sampling method for the suspension of Chinese traditional medicine XJ (an extract of Radix Aconiti Kusnezoffii, Angelica Sinensis, Radix Angelicae Sinensis, Marjoram, myrrh, etc.) and to evaluate its in vitro release. 【Method】 The sample was collected by syringe and the suspension was uniformly dispersed in the suspension to obtain a uniform sample. The release degree was evaluated by the slurry method with water as the dissolution medium at 100 r / min, The cumulative dissolution percentage was determined by chromatography, the cumulative dissolution curve of XJ was plotted, and the release of the sample was evaluated. 【Results】 The suspension was washed 5 times with 10 m L syringe and 2/3 position below the liquid surface as the best sampling method. After the tablets were taken out for 2 to 8 h, the peak 1, Peak 2, peak 3 released basically consistent with the Ritger-Peppas release model; in vitro release of dissolution-based dissolution of the powder, particle release of about 15min, remove the powder before the tablet release of 2 to 6 h consistent with the zero-order equation, remove the dissolution Dissolution after dissolution of the powder powder agrees with the Higuchi equation. The dissolution rate of tablet in 8 h was 97.47%. 【Conclusion】 The release of all-powder XJ sustained-release tablets belongs to dissolution-dissolution process, and the equilibrium release is achieved. The established method can be used to evaluate the in vitro release of XJ.