硫普罗宁缓释片的制备及体外释放度考察

目的制备硫普罗宁缓释片并对其体外释放度进行考察。方法以HPLC法为分析方法,采用相似因子法评价硫普罗宁缓释片体外释放行为。结果硫普罗宁缓释片的体外释放行为符合Highuchi方程。KollidonSR用量、填充剂的种类与用量及种类对药物的释放速度有较大影响,而硬度和释放介质的离子强度对药物的释放速度无显著影响。结论体外释放度符合缓释制剂要求,可进一步进行体内释药行为考察。

The preparation and studies on the release characteristics of the sustained-release tablets of tiopronin

Objective To prepare the sustained-release tablets of tiopronin and investigate the release profile in vitro of the sustained-release tablets. Methods HPLC method was used as analytical approach. The similarity factor was used to evaluate release profile of sustained-release tablets in vitro. Results The tiopronin release performance from the tablets followed the Higuchi equation. The content of the Kollidon® SR, the amount and the type of additives in the tablets, as well as the dissolution media had significant influence on drug release profile, while the hardness and ionic strength of dissolution media had little influence on drug release profile. Conclusions The drug release profile in vitro follows the requirements of the sustained release formulation and the drug release profile in vivo can be investigated in the future experiment.