中药宫灵肠溶片的制备及其质量控制  

Preparation and Quality Control of Gongling Enteric-coated Tablets

作　　者：李江林[1] 谢刚[1] 

机构地区：[1]广东省深圳市人民医院暨南大学第二临床医学院,深圳市518020

出　　处：《中国医院用药评价与分析》2009年第7期520-521,共2页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:研究宫灵肠溶片的制备工艺和质量控制方法。方法:采用TLC法对处方中的黄芪进行了定性;用高效液相色谱法测定了黄芪甲苷的含量。结果:定性鉴别分离度好,专属性强,含量测定黄芪甲苷的平均回收率为[z1]97.19%,RSD为1.39%。结论:本制备工艺合理可行,质量控制方法重现性好[z2],能有效地控制该制剂的质量。OBJECTIVE：To study the preparation technology and the quality control method of Gongling enteric-coated tablets.METHODS：Astragalus in the formulation was identified qualitatively by TLC and the content of Astragaloside was determined by HPLC.RESULTS：The qualitative identification achieved a good separation and specificity.The average recovery rate of Astragalus was 97.19%（RSD=1.39%）.CONCLUSION：This preparation technology is reasonable and feasible;the quality control method achieved a good reproducibility and it is effective in the quality control of Gongling enteric-coated tablets.

关 键 词：宫灵肠溶片 制备 质量控制 

分 类 号：R932[医药卫生—生药学]