金胆胶囊质量标准的研究

Studies on quality standard of Jindan Capsule

目的建立金胆胶囊质量标准。方法采用TLC法对处方中金钱草、虎杖、龙胆、猪胆膏进行定性鉴别,并用HPLC法对制剂中山柰素、槲皮素进行含量测定。结果薄层色谱特征明显,阴性无干扰。山柰素在0.018μg^0.539μg,槲皮素在0.00538μg^0.1614μg范围内呈良好的线性关系(r=0.9999),平均加样回收率分别为101.1%、91.3%,RSD分别为1.4%、1.9%(n=5)。结论本方法具有简便易行、重现性好,结果可靠、专属性强等特点,可用于该制剂的质量控制。

OBJECTIVE To establish the standard for the quality control of Jindan Capsule.METHODS Jinqiancao and Huzhang and Longdan and Zhudangao were identified qualititatively by thin-layer chromatography（TLC）;Kaempferol and quercetin in Jindan Capsule were determined by HPLC.RESULTS The TLC Spots were highly clear without the interference of negative control.The calibration curve for Kaempferol was linear（r=0.9999） in the range of 0.018μg～0.539μg.and the mean recovery was 101.1% 、91.3%,RSD was 1.4%（n=5）;for quercetin the calibration curve was linear（r=0.9999） in the range of 0.00538μg～0.1614μg,and the mean recovery was 91.3%,RSD was 1.9%（n=5）.CONCLUSION This method is accurate,simple,sensitive and reliable and it can be used for the quality control of Jindan Capsule.