鞣花酸片剂的制备及其含量测定  

Preparation and Content Determination of Ellagic Acid Tablet

作　　者：张华[1] 裴桂珍[1] 李桂华[1] 孙丽[1] 陈文[1] 

机构地区：[1]石河子大学药学院,新疆石河子832002

出　　处：《中国实验方剂学杂志》2012年第13期39-42,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：兵团医药专项课题(2011BA056)

摘　　要：目的:制备鞣花酸片剂,建立片剂中鞣花酸的含量测定方法。方法:以片剂的外观、硬度、脆碎度、崩解时间为指标,通过正交试验优选鞣花酸片剂处方;采用高效液相色谱法进行含量测定,流动相乙腈-0.1%磷酸水溶液(23∶77),流速0.8mL·min-1,检测波长254 nm。结果:鞣花酸片剂辅料最佳配比为淀粉-乳糖-羟甲淀粉钠-硬脂酸镁(4∶9∶0.5∶0.2);鞣花酸片剂在10.21～102.10 mg·L-1线性关系良好,回归方程Y=28 010X-92 942(r=0.999 9),其加样回收率为98.12%,RSD 1.28%。结论:该测定方法准确,方便,可靠,可用于鞣花酸片剂中鞣花酸的含量测定。Objective： To prepare ellagic acid tablet, and to establish determination method for ellagic acid. Method： With appearance, hardness, friability and disintegration time of the tablet as indexes,prescription of ellagic acid tablet was optimized by orthogonal test; HPLC was adopted for determination of the content of ellagic acid, mobile phase of acetonitrile-0. 1% phosphoric aid 23 ： 77, flow rate of 0. 8 mL. min^- 1, detection wavelength of 254 nm. Result： The best ratio of excipients from ellagic acid tablet was starch-lactose- hydroxymethyl starch sodium-magnesium stearate 4： 9： 0.5：0.2 ;There was a good linear relationship for ellagic acid tablet within the concentration of 10.21-102. 10 mg. L^-1, regression equation was Y = 28 010X - 92 942 （r = 0. 999 9）, average recovery rate was 98.12% , RSD 1.28%. Conclusion： This determination method was accurate, convenient, reliable, and it could be used for determination of ellagic acid from ellagic acid tablet.

关 键 词：鞣花酸 正交设计 片剂 HPLC 

分 类 号：R283.6[医药卫生—中药学]