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目的:考察马钱子散物质组体外释放度,为马钱子的临床应用提供数据参与。方法:参照2010年版中国药典桨法70 r/m in测定释放度。运用中药物质组释放动力学理论,以马钱子散理论全溶出供试液的紫外光谱为标准谱,经Kalm an滤波计算,得到各样本的物质组释放度,并绘制释放曲线,采用零级释放、一级释放、W e ibu ll分布、H iguch i和R itger-Peppas方程等模型进行曲线拟合。结果:各样本的物质组释放度在15m in时均可达到85%以上,马钱子散物质组的体外释药符合W e ibu ll分布模型。结论:以中药物质组释放度为评价理论,研究马钱子散体外释放特征,该方法精密度高,稳定性好。表明中药物质组释放/溶出动力学相关理论具有较好的实用性和科学性,可以推广和应用到中药给药系统设计、评价中,并在药物动力学水平赋予传统剂型新的内涵。
OBJECTIVE: To investigate the in vitro release rate of the random substance group of Maqinzi, and to provide data for the clinical application of Maqinzi. Method: The release rate was determined according to the 2010 Chinese Pharmacopoeia paddle method 70 r/min. Using the kinetic theory of release of TCM material groups, the UV spectrum of the test solution was completely extracted using the method of Ma Qianzisan. The Kalium filter was used to calculate the release rate of each sample group, and the release curve was plotted. Release, first-order release, W eibull distribution, H iguch i, and R itger-Peppas equations are used for curve fitting. RESULTS: The release rate of the substance group in each sample could reach 85% or more at 15m in. The in vitro release of drug in the Maqin scattered material group was in accordance with the W eibull distribution model. Conclusion: With the release theory of TCM substances group as the evaluation theory, the in vitro release characteristics of the Moxiezisan are studied. The method has high precision and good stability. It shows that the theory related to the release/dissolution kinetics of TCM material group has good practicability and scientificity. It can be applied to the design and evaluation of TCM drug delivery system, and give new connotation of traditional dosage form at the level of pharmacokinetics.