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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 To optimize the prescription and content determination of Coptis chinensis hemorrhoids ointment. Methods Orthogonal design method was used to screen the formulation prescriptions of Coptis chinensis hemorrhoids ointment. The indexes of heat-resistant, cold-resistant experiments, spreadability, stability and drug release rate were selected as indexes. The optimal ointment was screened out by HPLC. Results Coptis chinensis hemorrhoids ointment best preparation prescription extract: matrix = 1: 3, stearic acid: (liquid paraffin + triethanolamine) = 2: 1, liquid paraffin: triethanolamine = 2: 1, and the content of indicators The content of berberine hydrochloride showed a good linearity in the range of 0.252-2.252μg, R2 = 0.9998; the average recovery was 99.55% and RSD was 0.4%. Conclusion The prescription is reasonable in design, preparation process is feasible, and the content determination results are accurate and reproducible.