应用于多组分中药制剂释药评价的基于数学集合的释放动力学评价方法与Kalman滤波法的比较研究

Comparative study on mathematical set-based drug release kinetics method and kalman filter method applied in evaluating drug release of multi-component traditional Chinese medicine preparations

目的:提供一种评价多组分中药的基于数学集合的释药动力学方法。方法:以扶正化瘀方为研究模型,通过建立的基于数学集合的释放动力学评价方法指导扶正化瘀复方释药系统的制备,对其多组分释放特征进行量化评价,并采用Kalman滤波法验证方法的准确性。结果:两者比较结果均表明,扶正化瘀复方释药系统样本4与参比制剂扶正化瘀胶囊显示出释药同步。结论:此结果不仅验证了基于集合的方法的准确性和合理性,而且通过异步系数参数整体表征目标制剂的释放情况,并能从各特征峰信息的相对误差参数中找到释药单元剂量调整改进的方向,指导相关成分有目的性地调整,以使目标制剂满足与参比制剂释药同步性的要求,同时为多组分中药复方制剂的定量表征和评价中药多组分释放行为的同步性提供一种行之有效的评价手段。

Objective： To provide a mathematical set-based method for evaluating drug release kinetics of multi-component tra- ditional Chinese medicine preparations. Method： With Fuzheng Huayu prescription as the study model, a mathematical set-based method for evaluating drug release kinetics was established to guide the preparation of drug release system of Fuzheng Huayu prescrip- tion, and a quantitative evaluation was made for its multi-component drug release characteristics. Its accuracy was verified by Kalman filtering method. Result： The comparison between the two showed that the sample No. 4 of Fuzheng Huayu drug release system showed synchronized drug release with its reference preparation Fuzheng Huayu capsules. Conclusion： The results verified the accuracy and rationality of the evaluation method based on mathematics set. Meanwhile, it displayed the release of target preparations according to asynchronous coefficient （k） and other parameters, and found the orientation of regulating and improving the unit drug release dosage from relevant error parameters of various characteristic peak information, in order to purposefully regulate relevant components, and en- able target preparations to meet the synchronized drug release requirements of the reference preparation. Meanwhile, it provided an ef- fective measure for evaluating the quantitative characterization and synchronized release behavior of multi-component traditional Chinese medicines.