垂葛酒肝丸质量标准研究  

Study on Quality Standard of Chuigejiugan Pills

作　　者：王刚[1] 陈向东[1] 罗海龙 李永佳[1] 李敏清[1] Wang Gang;Chen Xiangdong;Luo Hailong;Li Yongjia;Li Minqing(Dazhou Central Hospital, Dazhou, Sichuan, China 635000;Di＇ao Group Tianfu Pharmaceutical Co., LTD, Dazhou, Sichuan, China 635000)

机构地区：[1]四川省达州市中心医院,四川达州635000 [2]成都地奥集团天府药业股份有限公司,四川达州635000

出　　处：《中国药业》2018年第9期13-16,共4页China Pharmaceuticals

基　　金：四川省科技计划项目[2015JY0170];2015年全国中药特色技术传承人才培训项目[国中医药人教函[2015]168号]

摘　　要：目的建立垂葛酒肝丸的质量标准。方法采用薄层色谱(TLC)法对垂葛酒肝丸中丹参、山楂、泽泻进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中葛根素的含量,色谱柱为赛分C_(18-H)柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(25∶75),柱温为30℃,流速为1 mL/min,检测波长为250 nm。结果丹参、山楂、泽泻的薄层色谱斑点清晰,分离度好,阴性对照无干扰;葛根素进样量在0.025 6～0.153 6μg范围内与峰面积线性关系良好,r=0.999 5(n=6),平均加样回收率为100.08%,RSD为0.44%(n=6)。结论该方法简便、准确、重复性好,可用于垂葛酒肝丸质量标准控制。Objective To establish the quality standard for Chuigejiugan Pills. Methods TLC method was used for qualitative identification of Salvia miltiorrhizae Radix et Rhizoma, Crataegi Fructus and Alismatis Rhizoma, the content of puerarin in the preparation was determined by HPLC method. The chromatographic column was Amethyst C18-H column（ 250 mm × 4. 6 mm,5 μm）,the mobile phase was methanol-water（25 ∶ 75）,the column temperature was 30 ℃,the flow rate was 1 mL/min,and the detection wavelength was 250 nm.Results The Salvia miltiorrhizae Radix et Rhizoma, Crataegi Fructus and Alismatis Rhizoma were identified qualitatively by TLC with clear spots, the degree of separation was good without negative interference. Puerarin showed a good linear relationship within the range of 0. 025 6-0. 153 6 μg, r = 0. 999 5（ n = 6）. The average recovery rate was 100. 08 %, the RSD was 0. 4 4 %（ n = 6）.Conclusion The established method is simple, accurate and reproducibility, which can be used for the quality standard control of Chuigejiugan Pills.

关 键 词：垂葛酒肝丸 葛根素 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]