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目的:研究红景天口腔崩解片的制备工艺,并评价其质量。方法:用直接压片法制备口腔崩解片,以崩解时限、口感等为指标采用正交设计法对崩解片中崩解剂含量、矫味剂比例进行筛选并进行处方优化;高效液相色谱法(HPLC)测定红景天苷的含量。结果:成功制备红景天口腔崩解片;根据崩解时限选用的崩解剂方案为2%低取代羟丙基纤维素(L-HPC)、10%羧甲基淀粉钠(CMS-Na)、10%交联聚维酮(PVPP);红景天与矫味剂阿斯帕坦、柠檬酸的最佳比例为41∶1∶1;口腔崩解片处方优化的结果为含35%微晶纤维素(MCC)、8%PVPP、0.5%微粉硅胶;口腔崩解片中红景天苷含量为(99.8±0.5)%。结论:红景天口腔崩解片崩解快、分布均匀、口感好、刺激小,有利于中药成分的快速溶出和方便患者服用。
Objective: To study the preparation process of Rhodiola orally disintegrating tablets and to evaluate its quality. Methods: Orally disintegrating tablets were prepared by direct compression method. The disintegration time, taste and other indicators were used to determine the content of disintegrators and the proportion of flavoring agent in the disintegrating tablet by orthogonal design. Determination of Salidroside by HPLC. Results: The preparation of Rhodiola orally disintegrating tablets was successful. The disintegration agents were selected according to the disintegration time limit. The solutions of 2% L-HPC, 10% sodium carboxymethyl starch (CMS-Na) , And 10% crospovidone (PVPP). The optimal ratio of Rhodiola rosea and flavoring agent aspartame and citric acid was 41: 1: 1. The optimized prescription of oral disintegrating tablets was 35% Crystalline cellulose (MCC), 8% PVPP, 0.5% silica powder; Salidroside content in oral disintegrating tablets was (99.8 ± 0.5)%. Conclusion: Rhodiola orally disintegrating tablets disintegrate fast, evenly distributed, taste good, stimulate small, is conducive to rapid dissolution of traditional Chinese medicine ingredients and convenient for patients to take.