银杏叶总黄酮脉冲缓释胶囊体外释放度实验研究

Experimental Research on the Release Degree in Vitro of Pulse Sustained-Release Capsules of Total Flavonoids of Ginkgo Biloba Leaf

通过建立了银杏总黄酮缓释胶囊体外释放度测定方法,确定该胶囊体外释放度测定条件为：0.2%吐温80的2%盐酸溶液为溶剂,转速为每分钟50转,2h后向操作容器中补加磷酸盐缓冲液调节pH值至5.8,4h后加磷酸盐缓冲液调节pH至7.0;共计测定5批样品8h内银杏总黄酮释放量。规定本品每粒在2h、4h与8h银杏总黄酮的释放量应为样品实测量的15%~45%、45%~75%和70%以上。

In this paper, we have established a method of total flavonoids of Ginkgo biloba in vitro release of sustained- release capsule, a comfirmative method of determine conditions of capsule release in vitro： 0.2% tween 80 of 2% hydrochloric acid as the solvent, speed 50 per minute, reinforced the phosphate buffer added to the operation of container after 2 hours and adjusted pH value to 5.8, put in the phosphate buffer after 4 hours and adjusted pH value to 7.0 ; determined 5 approved sample in total of flavonoids of Ginkgo biloba release amount in 8 hours. Defined any pill total flavonoids of Ginkgo release amount which measured up to 15% -45% ,45% ~ 75% and 70% above of the sample fact measured at 2 hour,4 hour and 8 hour.