复方珍珠口疮口崩片制备工艺及制剂中没食子酸测定.doc

复方珍珠口疮口崩片制备工艺及制剂中没食子酸测定[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. Methods: To adopt the single factor design to optimize the preparation prescription. Disintegrating time, appearance and taste as the assessment index. The analytical column was packed with Kromasil Cl8(250 mm × 4.6 mm, 5 μm ) and performed at 30℃. The mobile phase consisted of methanol -1% phosphate acid (15∶85). The flow rate was 1.0 ml/min. The detector operated at 270 nm. Results：The tablets prepared were fine in appearance，disintegrated within 1 min with desirable taste.The calibration curve was linear over the range of 0.048~0.768 μg with the correlation coefficient of 0.999 9. The average recovery was 98.6%. Conclusion: Fufangzhenzhu Oral Disintegrating Tablets achieve the goal of design and it is easy to operate. HPLC assay is simple, rapid, accurate and specific. [Key words] Aphthous ulcer; Orally disintegrating tablets; Gallic acid; HPLC 本品处方源于原剂型复方珍珠口疮颗粒，由珍珠粉、苍术、五倍子、甘草和辅料组成，具燥湿、生肌止痛功能。用于心脾湿热证口疮（复发性口腔溃疡），症见口疮，周围红肿，中间凹陷，表面黄白，灼热疼痛，口干口臭