复方丹参多元释药双层片的处方优化

Improvement in compound salvia double-layer tablet

目的:优选复方丹参多元释药双层片的制备处方。方法:以崩解时限为指标,采用正交设计优化双层片速释层混合崩解剂的用量;以人参皂苷Rg1的体外释放度为指标,采用均匀设计优化双层片缓释层骨架材料的用量。结果:速释层混合崩解剂用量优选组合为交联聚乙烯吡咯烷酮(PVPP)15%、微晶纤维素(MCC)20%、低取代羟丙基纤维素(L-HPC)2%;缓释层中卡波姆934p(Cb934p)、羟丙基纤维素(HPC)、羟丙甲基纤维素k4m(HPMCk4m)的用量分别为6%、24%和5.6%。结论:正交设计、均匀设计优化片剂处方预测性良好,结果准确可靠,达到了剂型设计要求。

AIM ： To improve the drug-release efficiency of compound salvia tablet （ Radix et Rhizoma ginseng, Radix et Rhizoma notoginseng and Borueolum syntheticum）. METHODS： Water-soluble part in salvia and part of borueol made up the quick-release layer of compound salvia under the guidance of orthogonal design that adopted disintegration as index. Lipo-soluble part in salvia, part of borueol and total sanchinoside made up the sustained-release layer under the guidance of uniform design that adopted dissolution of ginsenoside Rgl as index. RESULTS ： Optimized combination of quick-release layer comprised 15% of PVPP, 20% of MCC, 2% of L-HPL, optimized combination of sustained-release layer comprised 6% of cb934p, 24% of HPC and 5.6% of HPMCK4M. CONCLUSION： Orthogonal experiment design and homogeneous design are successful in optimizing the preparation of tablets with accurate and reliable results.