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脾肾双补丸质量控制方法的研究
引用本文:郝建明,郭文宾,安双生,等. 脾肾双补丸质量控制方法的研究[J]. 甘肃中医学院学报, 2014, 0(2): 28-32
作者姓名:郝建明  郭文宾  安双生  
作者单位:[1]酒泉市中医院,甘肃酒泉735000 [2]甘肃河西制药有限责任公司,甘肃张掖734000 [3]沈阳药科大学,辽宁沈阳110016
摘    要:目的对脾肾双补丸的质量控制方法进行研究。方法对脾肾双补丸处方中的陈皮采用薄层色谱法进行定性鉴别,对牡丹皮中的丹皮酚采用高效液相色谱法进行含量测定。结果薄层鉴别中,橙皮苷斑点清晰,且阴性无干扰;含量测定中,丹皮酚在4.64~16.24μg/mL范围内,峰面积与对照品质量浓度呈良好的线性关系;平均回收率为102.4%,RSD=1.80%(n=6)。结论所建立的方法操作简单,专属性强,重现性良好,可作为该制剂的质量控制方法。

关 键 词:脾肾双补丸  橙皮苷  丹皮酚  薄层色谱法  高效液相色谱法

Study on the quality control method of Pishenshuangbu Pill
Hao Jianming,Guo Wenbin,An Shuangsheng,Fan Fuyuan,Fan Xiaoyu. Study on the quality control method of Pishenshuangbu Pill[J]. Journal of Gansu College of Traditional Chinese Medicine, 2014, 0(2): 28-32
Authors:Hao Jianming  Guo Wenbin  An Shuangsheng  Fan Fuyuan  Fan Xiaoyu
Affiliation:1. Jiuquan Hospital of TCM, Jiuquan 735000, China; 2. Hexi Pharmaceutical Co, Ltd. , in Gansu, Zhangye 734000, China ; 3. Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract:Objective To study the quality control methods of the Pishenshuangbu Pill. Methods Pericar- pium citri reticulate in the Pishenshuangbu Pill was qualitatively identified by thin layer chromatography (TLC). The content of paeonol in moutan was determined by high performance liquid chromatography (HPLC). Results By TLC, hesperidin spots were clear and showed no interference negatively. Content of paeonol was in the range of 4.64 - 16.24 μg/mL range. Peak area and the concentration of control article showed a good linear relationship. The average recovery was 102.4%, RSD = 1.80% (n = 6). Conclusion The method is easy to perform and has high specificity and good reproducibility. It can be popularized and applied.
Keywords:Pishenshuangbu Pill  hesperidin  paeonol  TLC  HPLC
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