妇炎康分散片的辅料处方优化及体外释药特性

Formulation optimization and the in vitro release characteristics of Fuyankang Dispersible Tablets

目的:优化妇炎康分散片的辅料处方,并考察最佳处方的体外释药特性。方法:以崩解时间、硬度及片重为综合指标,采用L9(34)正交实验筛选出妇炎康分散片的最佳处方。同时,采用水溶液分散法及RP-HPLC法分别考察了最佳处方的分散均匀性和体外释药特性。结果:最终确定优选处方的辅料比例为:10%微晶纤维素(MCC),4%低取代羟丙基纤维素(L-HPC)和12%交联聚微酮(PVPP);所制备的分散片的崩解时间(60±2)s,硬度(5.24±0.32)kg,平均片重(0.407±0.010)g;分散均匀性好、外观为较均匀的混悬液,沉降速率方程为:logF=-0.028-1.001×10-3t,沉降速率常数k=2.305×10-3min-1,并呈均匀分散;分散片体外释药参数为T50=3.0 min和Td=4.0 min,明显小于市售普通片的溶出参数T50=14.28 min和Td=16.62 min(P<0.01)。结论:妇炎康分散片具有溶散快,分散均匀,有效成分溶出速率快的特性。

AIM： To optimize the formulation of Fuyankang Dispersible Tablets and study the in vitro release characteristics of them. METHODS： The orthogonal design was used to obtain the optimal formulation with the disintegration, hardness and weight of tablets as markers, and then dispersible uniform and the in vitro release characteristics of the optimal formulation were studied with dispersed experiment and PR-HPLC, respectively. RESULTS：The proportion of each adjuvant in the optimal formulation consisted of 10% MCC ,4% L-HPC, 12% PVPP. The optimized dispersible tablets disintegrated in 1 min, the hardness was 5.24 kg, the average weight was 0. 407 g;the dispersible uniform was excellent, and the settling velocity equation was logF = -0.028 - 1. 001 ×10^-3 t ; The released rate parameters of Fuyankang Dispersible Tablets were T50 = 3.0 min and TO = 4.0 min, which were remarkly less than that of the control group,T50 = 14.28 min and TO = 16.62 min （P 〈 0. 01 ）. CONCLUSION： Fuyankang Dispersible Tablets had the characteristics of the fast and homogeneously dispersing, and the quick releasing of the active constituents