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目的:研究复方丹参脉冲片的处方因素对制剂体外释放度的影响,确定最佳的片芯和包衣处方。方法:以丹参总酚酸、人参皂苷Rg1、冰片的释放度为指标,考察片芯中崩解剂和填充剂的种类与用量,以及包衣处方中增塑剂和致孔剂的种类与用量对复方丹参脉冲片体外释放度的影响。结果:片芯处方中崩解剂选用低取代羟丙基纤维素(L-HPC),填充剂为微晶纤维素(MCC),黏合剂为聚维酮(PVP)乙醇溶液;包衣处方中选用乙基纤维素(EC)为主要包衣材料,增塑剂为枸橼酸三乙酯(TEC),致孔剂为乳糖。按最佳处方制备的样品指标成分释放曲线可用Weibull分布函数模型拟合。结论:确定的复方丹参脉冲片处方制剂能达到很好的体外脉冲释药效果,为复方丹参脉冲片的进一步研究奠定了基础。
OBJECTIVE: To study the influence of prescription factors of Salvia miltiorrhiza compound tablet on the in vitro release of the preparation and to determine the best tablet core and coating prescription. Methods: Based on the release of salvianolic acid, ginsenoside Rg1 and borneol, the type and amount of disintegrants and fillers in the core and the types and amount of plasticizer and porogen Effect of Fufang Danshen Pulse on Release in. Results: L-HPC, the microcrystalline cellulose (MCC) and polyvinylpyrrolidone (PVP) ethanol were used as the disintegrating agents in the tablets core. Ethyl cellulose (EC) was chosen as the main coating material. The plasticizer was triethyl citrate (TEC) and the porogen was lactose. According to the best prescription prepared sample index component release curve fitting Weibull distribution function model. Conclusion: The prescription compound prescription of Radix Salviae Miltiorrhizae can achieve good effect of pulsatile drug release in vitro, which lays the foundation for the further study of compound Radix Salviae miltiorrhizae.