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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。
Objective To select the ligustrazine and the total saponins of Panax notoginseng that have the therapeutic effect on coronary heart disease and to make the model drug of the rhizoma ligustici cortex.METHOD Using HPMC as the coating material, the time delay of controlled release was 4 h, Clothing method to prepare compound xiang pulse seven tablets. Methods The core of Fufang Xionggi pulse tablet was prepared by powder direct compression method. The optimal prescription of coating was optimized by star-spot design-effect surface method. The compound Xiongqi pulse tablet was prepared by compression coating method. DDsolver software was used to model drug release and drug release was studied. Results The cumulative cumulative release rate of compound Xiongqi pulse tablet in vitro was Logistic model> Higuchi model. The Logistic model showed a good fit (Rsqr-adj) of 0.950 1 and a good fit (AIC) of 29.432 0 The mechanism of drug release of compound Xiongian Pulp Tablet was S-type dissolution process, and the model of cumulative release rate in vitro was Logistic model. Conclusion The preparation of compound Xionggi pulse tablets and its drug release mechanism were studied. The obtained compound Xiongqimi pulse tablets were stable in nature with a delayed release time of 4 h, and the cumulative release rates of different components reached more than 90% Release standard.