银杏达莫分散片的质量考察

Oualitv Observation of Ginkgo Leaf Extract and Dipynidamoie Dispersible Tablets

目的:考察银杏达莫分散片的制剂质量。方法:采用高效液相色谱法对分散片中双嘧达莫进行含量测定,并参照中国药典对分散片质量要求进行评价。结果:双嘧达莫在20～400μg(r=0.9992)内与峰面积呈良好的线性关系,平均回收率为99.9%(RSD=1.73%,n=9)。3批样品的平均含量分别为99.6%,94.6%,95.2%。分散片外观、片重差异、硬度测定、分散均匀度、体外溶出度均符合标准要求。结论:银杏达莫分散片的制剂工艺处方设计合理,银杏达莫分散片分散均匀度及体外溶出度性能良好。

Objective： To investigate the quality of Ginkgo leaf extract and dipyridamole dispersible tablets. Method ： The disper- sible tablets were assayed by HPLC and evaluated according to the Chinese pharmacopoeia. Result： Dipyridamole had a good linear re- lationship within the range of 20-400 μg （r = 0. 999 2） and the average recovery was 99. 9% （RSD = 1.73% ,n = 9）. The average content of 3 batches was 99. 6% ,94. 6% and 95.2%, respectively. The appearance, table weight variation, hardness, disperal uniformity and dissolution in vitro all met the requirements in the criterion. Conclusion： The design of Ginkgo leaf extract and dipyridamole dis- persible tablets is reasonable, and the results of disperal uniformity and dissolution in vitro are satisfied.