陈香露白露片质量标准研究  

Studies on quality standard of Chenxiang Lubailu tablets

作　　者：徐旭[1] 倪友洪 

机构地区：[1]绵阳市中心医院药剂科,绵阳621000 [2]成都华大爱康医药技术有限公司,成都610041

出　　处：《药物分析杂志》2008年第5期790-792,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立陈香露白露片中橙皮苷的含量测定方法及与疗效相关的制酸力检查方法。方法:采用高效液相色谱法测定陈香露白露片中橙皮苷的含量,色谱柱为 Penomencx C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-醋酸-水(35:4:61),流速1.0 mL·min^(-1),在283 nm的波长处检测;制酸力检查采用酸消耗剩余量回滴法、结果:橙皮苷进样浓度在0.03～0.40 mg·mL^(-1)的浓度范围内,与其峰面积呈良好的线性关系(r=0.9999,n=5);平均回收率(n=6)为99.2%,RSD 为0.71%;制酸力要查结果显示每片酸中和量均约为15 mL。结论:建立的方法简便快速,准确可靠,可用于陈香露白露片的质量控制。Objective：To establish the content determination method of hesperidin and the test method of acid - neutralizing capacity in Chenxiang Lubailu tablets, nethods：HPLC analysis was carried out with the Penomenex C18 column（250 mm × 4.6 mm,5μm）and methanol- acetic acid- water（35：4：61 ）as the mobile phase, the flow rate was 1.0 mL · min^-1 ; the detection wavelength was 283 nm ; Neutral titration as the test method of acid - neutralizing capacity. Results： The calibration curves were linear in the range of 0. 03 - 0. 40 mg · mL^-1 （ r = 0. 9999, n = 5 ） ; the average recovery（ n = 6 ） of hesperidin was 99.2% , and RSD was 0. 71% ; the acid - neutralizing capacity was 15 mL. Conclusion：The method is simple, reliable and accurate, and it can be used for the quality control of Chenxiang Lubailu tablets.

关 键 词：高效液相色谱法 陈香露白露片 橙皮苷 制酸力 质量控制 

分 类 号：R917[医药卫生—药物分析学]