曲安奈德凝胶剂的研制及质量控制  

Preparetion and Determination of triamcinolone acetonide in gel

作　　者：韩珍[1] 张秀芝[1] 王荣环[2] 陈建[3] 

机构地区：[1]天津市东丽医院 [2]天津医科大学第二医院 [3]天津市药品检验所

出　　处：《天津药学》2008年第6期25-27,共3页Tianjin Pharmacy

摘　　要：目的：制备曲安奈德凝胶剂，并建立高效液相色谱法测定曲安奈德凝胶剂中曲安奈德和苯酚含量的方法。方法：采用uBondapak C18色谱拄，以甲醇-水（70：30）为流动相，流速0．8ml／min，检验波长240nm，柱温为室温。结果：曲安奈德和苯酚的质量浓度分别在25—75mg／L（r=0．9995）和1000～3000mg／L（r=0．9993）范围内线性关系良好；凝胶剂中曲安奈德和苯酚的平均回收率分别为98．38％和100．56％；RSD分别为1．54％和1．16％。结论：本方法制备工艺简单，性质稳定，质量控制方法快速、准确，适用于该制剂的含量测定及质量控制。OBJECTIVE To prepare a gel of the triameinolone acetonide and determine the contents of triamcinolone aeetonide and phenol in a gel of the triamcinolone acetonide by HPLC. METHODS A HPLC method was used. The mobile phase consisted of methanol -water （70： 30） ,at a flow-rate of 0.8 ml/min . The detection wavelength was 240 nm , column temperature： indoor temperature. RESULTS The linear relationship of the triamcinolone aeetonide and phenol was obtained well which the quality consistence is 25 - 75 mg/L（ r = 0.999 5 ） , 1 000 - 3 000 mg/L （ r = 0. 999 3） , respectively . The average recovery of triamcinolone acetonide and phenol was 98.38% （ RSD = 1.54% ） and 100.56% （ RSD = 1.16% ） respectively. CONCLUSION The method was simple, rapid and accurate. It was suitable for detecting the content of triamcinolone aeetonide in gel and quality eontrolment.

关 键 词：曲安奈德凝胶 高效液相色谱法 含量测定 

分 类 号：R944.1[医药卫生—药剂学] R927[医药卫生—药学]