油茶皂苷-干酪素控释片的制备及其性能研究

以油茶皂苷为主药,采用干酪素和瓜尔豆胶为控释辅料,制备油茶皂苷-干酪素控释片。研究油茶皂苷-干酪素片中油茶皂苷含量的测定方法、溶出介质对油茶皂苷-干酪素控释片释放度的影响及油茶皂苷-干酪素控释片的红外光谱,并对油茶皂苷-干酪素片体外释放动力学方程进行拟合。用香草醛-浓硫酸显色法测定pH 6.8的磷酸盐缓冲溶液作为释放介质时油茶皂苷-干酪素片中油茶皂苷的含量,回收率为98.59%。油茶皂苷-干酪素控释片在pH 6.8的磷酸盐缓冲液中,释放时间分别为3,6和12h时,其释放度分别为:23.80%,51.26%和94.77%。体外释药曲线与零级方程拟合相关性较好,相关系数(R2)为0.996。油茶皂苷、干酪素和瓜尔豆胶之间可能形成了化学键。

Preparation and performance of controlled-release tablets of sasanquasaponin-casein

The controlled-release tablets of sasanquasaponin (SQS)-casein were prepared by using SQS, casein and guar gum as the main drug and accessory materials respectively. The method of determination of SQS in the controlled-release tablets of SQS-casein, and the effects of release media on the release rate and IR spectra of the controlled-release tablets of SQS-casein were studied, respectively. The release rate curve of the controlled-release tablets of SQS-casein was fitted as zero order, one order and Higuchi equation. The recovery was 98.59% when the content of SQS in the controlled-release tablets of SQS-casein in phosphate buffer solution (pH 6.8) as release media was determined with chromogenic reaction of vanillin- sulfuric acid. The release rates are 23.80%, 51.26% and 94.77% at release times 3, 6 and 12 h, respectively in phosphate buffer solution (pH 6.8) as release media. The controlled-release tablets of SQS-casein release SQS by slowness and constant in 12 h. The chemical bonds are formed among SQS, casein and guar gum.