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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。
Development of diclofenac sustained-release tablets, served on a daily basis to provide a safe and effective tablet. Orthogonal test screening prescription, select ethyl cellulose, calcium sulfate, dextrin, hydroxypropylmethyl cellulose as an adjuvant, together with the main drug into tablets, each containing the main drug 100mg. The dissolution test of self-made tablets was compared with the imported ones. The measured data were processed by one-dimensional regression and analyzed by ANOVA. The stability of the tablets was also examined. Results: The first-order drug release rate constants of self-made tablets and imported tablets were 0.144,0.137 (P> 0.05), respectively. Indicating no significant difference between the two. The preliminary investigation of stability showed that homemade diclofenac sustained-release tablets can be stored under normal conditions for two years. CONCLUSION: Diclofenac sustained-release tablets are a new dosage form with stability and dissolution approaching those of foreign countries and deserved to be developed.