杜仲平压分散片的制备及其质量标准研究

目的:制备杜仲平压分散片并建立其质量标准。方法:以崩解时间、分散均匀性和可压性为指标,优选辅料配比。采用研磨法制备杜仲平压分散片。采用高效液相色谱法测定制剂中绿原酸含量。结果:优选的辅料配比为甘露醇60g、微晶纤维素40g、低取代羟丙基纤维素30g、微粉硅胶20g、交联聚乙烯吡咯烷酮4g、硬脂酸镁2g、甜味剂2g、聚乙烯吡咯烷酮适量。制备的杜仲平压分散片为棕褐色,分散均匀度符合要求。绿原酸的进样量在1.882～18.820μg范围内与峰面积积分值呈良好线性关系(r=0.9999);平均加样回收率为99.2%,RSD=1.63%(n=6)。结论:该辅料配比符合制备工艺要求,所建质量标准可用于杜仲平压分散片的质量控制。

Preparation and Quality Control of Duzhong Pingya Dispersible Tablets

OBJECTIVE： To prepare Duzhong pingya dispersible tablets and establish their quality control. METHODS： The ratios of the excipients were optimized with disintegrating time, dispersible uniformity and compressibility as indexes. The Duzhong pingya dispersible tablets were prepared by trituration, and the content of chlorogenic acid was determined by HPLC. RESULTS： The optimized ratios of the excipients were as follows： manicol 60 g, microcry stalline cellulose 40 g, low-substituted hydroxypropyl cellulose 30 g,gum arabic 20 g, erospovidone 4 g, magnesium stearate 2 g, edulcorant 2 g, and plasdone vis quantum. The optimized Duzhong pingya dispersible tablets were brown in color and up to the standard in dispersible uniformity. The linear range of chlorogenic acid was-1.882-18.820μg（r = 0.999 9） and its average recovery rate was 99.2% （RSD = 1.63%, n=6） .CONCLUSION： The ratios of the excipients were up to the standard required for the preparation technology, and the established quality standard is applicable for the quality control of Duzhong pingya dispersible tablets.