红景天口腔崩解片的制备及质量控制  

The preparation and quality control of orally disintegrating tablets of Rhodiola

作　　者：张伟民[1] 吴强[2] 李瑞芳[3] 方伟进[3] 曹珊珊[3] 

机构地区：[1]河南科技大学第一附属医院,河南洛阳471003 [2]河南大学药学院药剂教研室,河南开封475004 [3]河南科技大学医学院,河南洛阳471003

出　　处：《中国医院药学杂志》2012年第8期603-606,共4页Chinese Journal of Hospital Pharmacy

摘　　要：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 technology of Rhodiola orally disintegrating tablet and evaluate its quality. METHODS The tablets were prepared by the direct compression methods. Orthogonal design was used to optimize the disintegration time, taste and other parameters of the tablets, including the content of disintegrating agents and the ratio of flavoring agents in the formulation. The contents of rhodioside were determined by high performance liquid chromatography （HPLC）. RESULTS The Rhodiola orally disintegrating tablets had been successfully prepared. The optimal disintegrating agents were 2% low substituted hydrongpropyl cellulose （L-HPC）, 1 0% carboxymethyl starch sodium （CMS-Na） and 10 % crosslinking polyvingypyrrolidone （PVPP） according to the disintegration time. The best ratio of Rhodiola, flavoring agent aspartame and citric acid was 41 ： 1 ： 1. The contents of rhodioside of orally disintegrating tablets was （99. 8 ± 0. 5） %. CONCLUSION Rhodiola oral disintegrating tablets with rapid disintegration, uniform distribution, good oral taste and small weak stimulation will hopefully contribute to the dissolution of Chinese medicine and drug administration to patients.

关 键 词：红景天 口腔崩解片 正交设计 处方工艺 质量控制 

分 类 号：R944[医药卫生—药剂学]