Study on dissolution test method of silybin solid dispersion capsules 水飛薊賓卵磷脂分散體膠囊劑溶出度測(cè)定方法的研究
Operating methods for the tests and assays of drugs . part 10 : methods of the dissolution test and the drug release for the preparations 藥品檢驗(yàn)操作規(guī)程.第10部分:制劑溶出度和釋放度測(cè)定法
Generally dissolution test for active ingredients or chemical medicines should be listed in the specification , while the dissolution test for effective parts depends on the situation 其中含有有效成分、化學(xué)藥物的口服固體制劑溶出度檢查一般應(yīng)列入質(zhì)量標(biāo)準(zhǔn),含有效部位的口服固體制劑溶出度檢查可視情況列入質(zhì)量標(biāo)準(zhǔn)。
Considering the actuality of oral solid preparation of tcm , experts suggest to do dissolution test for oral solid preparations that contain active ingredients , effective parts and chemical medicines 考慮到目前中藥口服固體制劑的現(xiàn)狀,專家提出了如下建議:含有有效成分、有效部位、化學(xué)藥物的口服固體制劑需要提供溶出度檢查研究資料。