摘要
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
Objective: To study the reasonableness of the preparation procedure of Rhizoma Corydalis Analgesic Pellets and the dosage form change from tablets into capsules. Methods: The preparation procedure of 3 batches of Rhizoma corydalis Analgesic Pellets was studied by TLC analyzing and determining of their disintegration time and dissolution rate in vitro,and comparing of the results between pellets and tablets.Results: The qualitative identification spots of capsales and tablets were the same. The disintegration time was 5 min for capsules or 3 min for tablets. The dissolution rates of 3 batches were all quick. There were no significant differences in the dissolution parameters T 50 、 T d and m among them ( P <0.05),but there were significant differences in these parameters between capsules and tablets ( P <0.01).Conclusion: It is feasible for the dosage form change from tablets into capsules of Rhizoma corydalis Analgesic.
出处
《中成药》
CAS
CSCD
北大核心
2001年第4期240-243,共4页
Chinese Traditional Patent Medicine
