柳氮磺吡啶肠溶片在不同溶出介质中的溶出曲线比较研究

摘要

Objective: To evaluate the similarity of dissolution profiles of sulfasalazine enteric-coated tablets produced by old or new preparation process and a commercial ones. Methods: Dissolution was determined by rotating basket method and UV spectrophotometry and the dissolution similarity among those tablets was evaluated by the similarity factor approach. Results: The dissolution of all the products was less than 50% at pH 6.0. In the dissolution medium of pH 6.8 and pH 7.5 phosphate buffer solution, ƒ2 similarity factors of the tablets produced by new preparation process and the commercial product were 43 and 43 while they were 39 and 22 for the tables produced by old preparation process and the commercial ones. Conclusion: The dissolution profiles of the tables produced by new or old preparation process in 3 different media were not similar to those of commercial ones, but they were much better for the tablets produced by the new preparation process than the ones by the old process, suggesting that the preparation process for sulfasalazine enteric-coated tablets needs to be further optimized.%目的：评价柳氮磺吡啶肠溶片新老工艺与市售产品体外溶出曲线的相似度。方法：转篮法测定溶出度，紫外分光光度法检测，采用ƒ2相似因子法评价受试制剂和市售参比制剂溶出曲线的相似度。结果：pH 6.0条件下各个厂家柳氮磺吡啶肠溶片的溶出度均小于50。在溶出介质 pH 6.8与 pH 7.5磷酸盐缓冲液下，新工艺与市售制剂的相似因子为43、43，老工艺与市售制剂的相似因子为39、22。结论：新老工艺与市售制剂在3种不同介质下溶出曲线不相似，但是新工艺比老工艺有所改进，提示该试验药品处方需要继续优化。