黄连痔疮膏处方的筛选及含量测定

Screening of coptis chinensis prescription hemorrhoid cream and determination

目的优选黄连痔疮膏的制剂处方以及含量测定。方法用正交设计法对黄连痔疮膏的制剂处方进行筛选,以耐热,耐寒实验,涂展性,稳定性,释药速度的综合评分为指标。并用高效液相法对筛选出来的最佳软膏剂测定含量。结果黄连痔疮膏的最佳制剂处方为浸膏∶基质=1∶3,硬脂酸：（液体石蜡＋三乙醇胺）=2∶1,液体石蜡：三乙醇胺=2∶1,且其含量测定指标成分盐酸小檗碱在0.252~2.252μg范围内呈良好线性,R2=0.9998;平均回收率为99.55%,RSD=0.4%。结论该处方设计合理,制剂工艺可行,且含量测定结果准确,重现性好。

OBJECTIVE Coptis chinensis preferred prescription hemorrhoids ointment preparations and determination.METHODS Orthogonal design method using hemorrhoid cream formulations Coptis prescription screening,to heat,cold test,coating ductility,stability,release rate of the composite score for the index.And screened by HPLC for determination of the best ointments content.RESULTS Hemorrhoids ointment preparation Coptis chinensis best prescription for the extract： substrate=1∶3,Stearic Acid：（liquid paraffin ＋ triethanolamine）=2∶1,liquid paraffin：2∶1 triethanolamine,and the determination of index components berberine hydrochloride in the range of 0.252～2.252μg was linear,R2=0.9998;The average recovery was 99.55%,RSD=0.4%.CONCLUSION The formulation is reasonable,feasible and preparation process,and the determination of accurate and reproducible.