复方珍珠口疮口崩片的制备工艺和制剂中没食子酸的测定(1)
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[摘要] 目的：筛选复方珍珠口疮口崩片的制剂处方和制备工艺，建立HPLC法测定制剂中没食子酸的含量。方法：以口感、外观和崩解时限为指标，采用单因素试验法筛选最佳处方。采用HPLC法测定制剂中没食子酸的含量，色谱柱为Kromasil C18柱(4.6 mm×250 mm，5 μm)，柱温30℃，测定波长270 nm，流动相采用甲醇-1%磷酸(15∶85)，流速1.0 ml/min。结果：按最佳制备工艺制得的复方珍珠口疮口崩片外观及口感良好，在1 min内能崩解完全。HPLC法测定没食子酸在0.048~0.768 μg范围内线性关系良好，平均回收率为98.6%。结论：复方珍珠口疮口崩片达到设计要求。建立的含量测定方法简便、快速、准确及重现性良好。
[关键词] 口疮；口腔崩解片；没食子酸；高效液相色谱法
[中图分类号]R944.4 [文献标识码]A [文章编号]1673-7210(2008)08(b)-027-03
Preparation of Fufangzhenzhu Orally Disintegrating Tablets and content determination of gallic acid in the tablets
GUO Wei-zhong1,MA Zai-hong1,CHEN Chu-xiong1*, CHEN Mao-ling2
(1.Department of Pharmacy, the Second Affiliated Hospital of Zhongshan University, Guangzhou 510120, China;2. Department of Pharmacy, Ophthalmic Hospital Affiliated to Zhongshan University, Guangzhou 510060, China)
[Abstract] Objective: To optimize the formulation of Fufangzhenzhu Oral Disintegrating Tablets and preparation process and establish HPLC method for determination of gallic acid in the tablets ......
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