3种不同剂型银杏叶制剂中总黄酮醇苷的溶出度考察

Study on the dissolution of total flavonoid glycoside in three different formulations of Ginkgo leaves

目的研究并比较3种不同剂型银杏叶制剂中总黄酮醇苷的溶出度。方法采用HPLC法测定溶出液中总黄酮醇苷的含量,色谱柱为Novapak C18柱(150 mm×3.9 mm,5μm),流动相为甲醇-0.4%磷酸溶液(50∶50),流速为1.0 m L·min-1,检测波长为378 nm,柱温为35℃,进样量10μL。采用转篮法测定溶出度,实验数据按威布尔分布模型处理。结果 3种不同剂型的银杏叶制剂的体外溶出度有显著差异,银杏叶片剂、胶囊剂、软胶囊剂的平均累积溶出度分别为98.25%、99.32%、96.13%,其中,T50最大的是最小的11.1倍。结论银杏叶片剂、胶囊剂、软胶囊剂的体外溶出度存在较大差异。

OBJECTIVE To study and compare the dissolution of the total flavonoid glycoside in three different formulations of Ginkgo leaves. METHODS HPLC method was applied to determine the total flavonoid glycoside in different formulations of Ginkgo leaves. The analytical column was Novapak C18（ 150 mm ×3. 9 mm,5 μm）. The mobile phase was consisted of methanol and 0. 4% phosphoric acid solution（ 50∶50） at a flow rate of 1. 0 m L·min- 1. The wavelength was 378 nm and column temperature were 35 ℃. The injection volume was 10 μL. The stirring basket method was used to determine the dissolution and the experimental data was fitted by using the Weibull distribution model. RESULTS There were significant differences in the in vitro dissolution performance of three different formulations of Ginkgo leaves. The average accumulative dissolution of three formulations of Ginkgo leaves was respectively 98. 25% in the tablets,99. 32% in capsules and 96. 13% in soft capsules. Maximum T50 in which,dissolution parameters was 11. 1 times of the minimum.CONCLUSION Different formulations of Ginkgo leaf tablets,capsules and soft capsules differed significantly from one another in in vitro dissolution.