清火片质量标准研究  

Study on Quality Standard of Qinghuo Tablets

作　　者：汤新兰 

机构地区：[1]漳州片仔癀药业股份有限公司,漳州363000

出　　处：《海峡药学》2006年第5期20-22,共3页Strait Pharmaceutical Journal

摘　　要：目的建立清火片的质量标准。方法采用薄层色谱法对处方中大青叶,大黄进行定性鉴别及对土大黄苷进行检查;并采用HPLC方法对清火片中大黄的有效成分大黄素及大黄酚含量测定。结果薄层色谱鉴别专属性强,无阴性干扰。含量测定大黄素线性范围为0.056μg^0.224μg,相关系数r=1,平均回收率为97.2%,RSD为2.3%;大黄酚线性范围为0.049μg^0.192μg,相关系数r=1,平均回收率为96.2%,RSD为1.7%。结论此质量标准可有效控制清火片药品的质量,方法专属性强,灵敏度高,重现性好。OBJECTIVE To Establish Quality Standard for Qinghuo tablets. METHODS The components of Folium Isatidis,Rheum officinale Baill in Qinghuo tablets were identified by TLC;The two main compounds （Rheumemodin and Chrysophanol） in Rheum officinale Baill were determined by HPLC：RESULTS The TLC spots developed were fairly clear,and the blank test showed no interference. The Rheumemodin showed a good linear correlation in the range of 0. 056 to 0. 224μg（r= 1.0）,the average recorvery was 97.2 %, RSD 2.3 % ;The Chrysophanol showed a good linear correlation in the range of 0. 049 to 0. 192μg（r=： 1.0） ,the average recorvery was 96.2 %,RSD1.7 % ; CONCLUSION The Quality Standard of this method is quite simple, It Can be used for Quality control of Qinghuo tablets.

关 键 词：清火片 质量标准 高效液相色谱 大青叶 大黄 土大黄苷 

分 类 号：R927.11[医药卫生—药学]