摘要
研制双氯芬酸缓释片，日服一次，为临床提供安全、有效的片剂。用正交试验筛选处方，选择乙基纤维素、硫酸钙、糊精、羟丙甲基纤维素为辅料，与主药一起压制成片，每片含主药１００ｍｇ。自制片的溶出度试验以进口产品为对照，测得数据经一元回归处理，并进行了方差分析。同时考察了片剂的稳定性。结果：自制片及进口片的溶出数据经一元回归处理，求得其一级释药速度常数分别为０．１４４、０．１３７（Ｐ＞０．０５）。表明两者无显著性差异。稳定性初步考察结果表明，自制的双氯芬酸缓释片在一般条件下可保存两年。结论：双氯芬酸缓释片为一新剂型，其稳定性及溶出度接近国外水平，值得开发。
PURPOSE A diclofenac sustained release tablets were developed for the safty, effective clinical use.METHODS Formulations were creened by means of the orthogonal design,resulting that ethylcellulose,calcium sulfate,dextrin and hydroxypropyl methylcellulose were chosen to be the excipients of the selective formulation. The tablet containing 100 mg of the drug was prepared by wet granulation,The dissolution test of the tablet was performed with the comparison of imported product and the preliminary stability data were also inspected.RESULTS The coefficients of release rate for the self-prepared and imported tablets were determined to be 0.144 and 0.137 respectively (P>0.05) obtained from the dissolution data by the simple linear regression and the analysis of variance, indicating the similar release behavoir for the two kinds of tablets.The results of the preliminary stability implied that the self-prepared tablet could be stored for more than two years under the general storage conditions. CONCLUSIONS The self-prepared diclofenac sustained release tablet could be provided as a novel dosage form for the clinical use. Both the stability and the disslution of the tablet are approximate to those imported products,and it is of value in further development.
出处
《上海医科大学学报》
CSCD
1996年第6期443-445,共3页
Journal of Fudan University(Medical Science)
