新型玉叶清火缓释片的体外释放度评价

Evaluation of Releasing Rates for New Types of Sustained-release Tablets of Yuyie Qihuo in Vitro

以不同比例的羟丙甲纤维素(HPMC)为骨架材料,制备中成药玉叶清火缓释片.通过精确的HPLC法监测玉叶清火缓释片中主要成分穿心莲内酯的释出量,并计算其体外释放度.结果表明玉叶清火普通片在1.5 h段,累积释出率为49.47%±2.21(x—±s),同时段的10%和20%HPMC玉叶清火缓释片的累积释出率仅为41.94%±1.53和29.50%±2.51(P<0.01).按回归曲线计算累积释放率50%及95%时所需时间:玉叶清火普通片为1.52 h和3.89 h;10%和20%HPMC玉叶清火缓释片则分别为:2.07 h,5.98 h及3.13 h,8.48 h.新型中药制剂10%和20%HPMC玉叶清火缓释片的体外释出率显著低于同时段的玉叶清火普通片(P<0.01),实际测定值与计算结果相符.所研制的缓释片的缓释效果良好.

After Yujie Qihuo general and sustained-release tablets were made, high performance liquid chro- matogram （HPLC） were used to investigate the main effective ingredient andrographolide concentration in the release medium for their releasing rates. The results showed that the cumulative releasing rate of 10 % and 20 % Yujie Qihuo HPMC sustained-release tablets were 41.94 %± 1.53 （ x± s） and 29.50 % ± 2.51 at 1.5 hours respectively and significantly lower than the rate of Yujie Qihuo general tablet which was 49.47% ±2.21, （P〈0.01）. Both HPMC sustained-release tablets took much longer time to reach 50% and 95% of cumulative releasing rates comparing with Yujie Qihuo general tablet （P〈0.01）. So the new types of 10% and 20% Yujie Qihuo HPMC sustained-release tablets have slower releasing rates than that of the general tablet significantly.