盐酸曲马多制剂的溶出度考察

Study on the dissolution of tramadol hydrochloride by RP-HPLC

目的:考察不同药厂盐酸曲马多制剂的溶出度,评价其内在质量。方法:采用反相高效液相色谱法测定含量,色谱柱:YWGC1810μm,4.6mm×250mm;流动相:0.05mol·L-1磷酸二氢钾内含0.5%三乙胺(用磷酸调pH2.5)甲醇(6∶4);检测波长:215nm;流速:1.5ml·min-1;进样量:10μl。缓释制剂以0.1mol·L-1盐酸溶液为溶出介质,普通制剂以水为溶出介质,采用转篮法,对4种不同制剂进行溶出度比较,提取溶出参数。结果:普通胶囊溶出最快,15min即溶出85%以上;缓释片与缓释胶囊16h累积释药均为80%以上;复方片剂20min曲马多溶出75%,溶出稍差。结论:4个厂家的盐酸曲马多制剂,除一个批号的缓释胶囊外,其余均符合中华人民共和国卫生部标准及中国药典1995年版标准之规定。

OBJECTIVE:To evaluate the dissolution of tramadol hydrochloride preparations from different manufactories.METHODS:The content of tramadol hydrochloride was determined by RP HPLC with YWG C 18 column(10μ, 4.6 mm×250mm).The detection wavelength of the UV detector was at 215 nm.The mobile phase was composed of 0.05 mol·L -1 potassium dihydrogen phosphate with 0.5% triethylamine (pH 2.5) methanol(6∶4).The flow rate was 1.5ml·min -1 .To extract and compare the dissolution parameters of four kinds of samples,rotating basket method at the speed of 100 r·min -1 was used.900ml of 0.1mol·L -1 hydrochloric acid was used as dissloution medium for the sustained release tablets and capsules.900ml water was used instead for the common capsules and composite tablets.RESULTS:The dissolution rate of common capsules was the fastest with more than 85% within 15 minutes.The dissolution of the sustained release tablet and capsule were more than 80% within 16 hours and the composite tablet was 75% within 20 minutes.The sustained release capsule with the lot No.981003 was out of the sideline over the different time phases.CONCLUSIONS:Four kinds of the tramadol hydrochloride prepatation samples,except one lot of the sustained release capsule,were all come up to the standard of CHP(95) and Ministory of public health.