消旋山莨菪碱凝胶的研制及治疗静脉炎临床疗效观察

Preparation and quality control of raceanisodamine gels and it's effect of phlebitis

目的:制备消旋山莨菪碱凝胶剂,建立其质量控制方法,并观察其治疗静脉炎的临床疗效。方法:以卡波姆-940为凝胶基质,月桂氮(艹卓)酮为透皮促进刘,甘油为保湿剂制备消旋山莨菪碱凝胶,并采用高效液相色谱法(HPLC)测定其主药的含量,并对100例肿瘤病人进行临床疗效观察。结果:消旋山莨菪碱检测浓度线性范围为20～80μg·mL^(-1)(r=0.9994),平均回收率为100.2%,RSD为0.62%,日内RSD为0.74%,日间RSD为1.21%。本品临床疗效确切,不良反应少。结论:本制剂工艺简单,质量可控,无刺激性,临床疗效可靠。

Objective ：To prepare the reeeanisodamine （654-2） gel and establish a standard for quality control and to observe its effect on phlebitis. Methods： Carbomer was used as the gel matrix, lauroeapram was used as penetration enhancer and glueerol was used as wetting agent in the preparation. HPLC was used to determine the content of （654-2） ,and 100 tumor patient were involved in the clinical observation. Results： The linear range of receanisodamine was 20-80 ug·mL^-1 （ r = 0. 999 4） , the average recovery was 100. 2%, and RSD was 0.62%, the intra-day was 0.74% and inter-day was 1.21%. The therapeutic effects were valid with few adverse reaction. Conclusion： The preparation method is easy and the quality control method is feasible, without irritation, the clinical effect is reliable.