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目的 :探讨元胡止痛微丸制备工艺及元胡止痛片改型为胶囊剂 (内装微丸 )的合理性。方法 :对 3个批号元胡止痛微丸的制备工艺研究、TLC分析、崩解度及体外溶出度的测定 ,并与元胡止痛片作比较。结果 :定性鉴别斑点一致 ;崩解时限胶囊剂为 5min ,片剂为 30min。 3批胶囊均有较快溶出 ,溶出参数T50 ,Td,m无显著差异性 (P >0 .0 5 ) ,而与元胡止痛片之间的溶出参数T50 ,Td,m均存在显著差异性 (P <0 .0 1)。结论 :将元胡止痛片改型为元胡止痛胶囊是可行的
Objective: To explore the rationality of the preparation process of yuanhuzhitong pellets and the modification of Yuanhu analgesic tablets into capsules (built-in pellets). Methods: The preparation process, TLC analysis, disintegration degree and in vitro dissolution of 3 batches of Yuanhu Zhitong Pellets were determined and compared with Yuanhu Analgesic Tablets. Results: Qualitative identification of spots was the same; disintegration time capsules were 5 min and tablets were 30 min. All three batches of capsules eluted quickly. The dissolution parameters T50 and Td,m were not significantly different (P > 0.05). However, there were significant differences in the dissolution parameters T50, Td, and m between Yuanhu analgesic tablets. (P < 0.01). Conclusion : It is feasible to modify yuanhuzhitong tablets into yuanhuzhitong capsules