痤疮散质量标准的建立

Study on the Quality Standard for Cuochuang Powder

目的:建立痤疮散质量控制方法。方法:采用薄层色谱法对制剂中的大黄、白芷和防风进行定性鉴别;采用气相色谱法同时测定制剂中百秋李醇、薄荷脑和冰片的含量。结果:薄层色谱显色清晰且阴性对照无干扰。百秋李醇、冰片、薄荷脑分别在0.020 1~0.805 6 mg·ml^(-1)、0.010 0~0.401 6 mg·ml^(-1)、0.005 1~0.202 8 mg·ml^(-1)浓度范围内呈良好的线性关系,平均回收率(n=6)分别为102.03%(RSD=0.91%)、100.10%(RSD=1.94%)、103.15%(RSD=1.68%)。结论:本法操作简便,结果准确、重现性好,可用于痤疮散的质量控制。

Objective： To develop a method for the quality control of Cuoehuang powder. Methods： Rhei Radix et Rhizoma, An- gelicae Dahuricae Dadix and Saposhnikoviae Radix were identified by TLC. GC was used for the determination of patchouli alcohol, menthol and borneol. Results： The TLC spots were clear without any interference from the negative control. The linear range of pat- chouli alcohol was 0.020 1-0. 805 6 mg·ml-1, that of borneol was 0.010 0-0.401 6 mg·ml-1, and that of menthol was 0.005 1 - 0,202 8mg·ml-1. The average recovery （ n = 6 ） was 102.03% （ RSD = 0.91% ）, 100.10% （ RSD = 1.94% ） and 103.15% （RSD = 1.68% ） ,respectively. Condusion： The method is simple, accurate and repeatable, which can be used for the quality control of Cuoehuanu nowder.