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[摘要]
目的 选取对冠心病有治疗作用的川芎嗪和三七总皂苷组成芎七复方为模型药物,以羟丙甲纤维素(HPMC)为包衣材料,控制释药时滞为4 h,采用压制包衣法制备复方芎七脉冲片。方法 采用粉末直接压片法制备复方芎七脉冲片的片芯;通过星点设计-效应面法优选包衣最佳处方,采用压制包衣法制备复方芎七脉冲片。用DDsolver软件进行释药模型拟合,并对药物同步释放进行研究。结果 复方芎七脉冲片剂的体外累积释放率拟合度顺序为Logistic模型>Higuchi模型,Logistic模型的拟优合度(Rsqr-adj)为0.950 1,拟合度(AIC)为29.432 0,因此该复方芎七脉冲片的释药机制为S型的溶蚀过程,且体外累积释放率模型为Logistic模型。结论 通过对复方芎七脉冲片制备工艺和释药机制的研究,制得的复方芎七脉冲片性质稳定,释药时滞为4 h,不同成分累积释放率均达到90%以上,符合脉冲制剂的释药标准。
[Key word]
[Abstract]
Objective To prepare Compound Xiongqi Maichong Tablets (CXMT) by selecting ligustrazine and Panax notoginseng saponins (PNS) in the treatment of coronary heart disease as a model drug, using hypromellose (HPMC) as coating material, and control of drug release delay as 4 h. Methods The core system of CXMT was prepared by direct powder compression method; The best coating prescription and preparation of CXMT by press coated was optimized by central composite design and response surface method. The release model was fitted by DDsolver software, and the synchronous release of drug was studied. Results The in vitro cumulative release fitting order of CXMT preparation was Logistic > Higuchi; Logistic model fitting degree was 0.950 1, and AIC was 29.432 0. So the drug release mechanism of CXMT was type S dissolution process, and the in vitro cumulative release model was the Logistic model. Conclusion Through the study of CXMT preparation technology and the drug release mechanism, the quality of the prepared CXMT is stable, and the lag time is 4 h; Different components of the cumulative dissolution rate are over 90%, which reach the pulse drug release standard.
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[基金项目]
河南省高等学校重点科研项目“基于渗透泵原理的脉冲释药系统研究”(15A360047);呼吸疾病诊疗与新药研发河南省协同创新中心“复方芎七脉冲控释制剂的研究”(14104225)