参芪妇康颗粒质量标准研究  

Study on Quality Standard for Shenqi Fukang Granules

作　　者：孙臻 黎俊禹 汪杰[2] 钟莹 黄祖光[2] 高华宏 SUN Zhen;LI Junyu;WANG Jie;ZHONG Ying;HUANG Zuguang;GAO Huahong(Sanya Maternal and Child Health Care Hospital,Sanya 572000,China;Sanya Traditional Chinese Medicine Hospital,Sanya 572000,China;Guangdong Institute of Traditional Chinese Medicine,Guangzhou 510000,China)

机构地区：[1]三亚市妇幼保健院,海南三亚572000 [2]三亚市中医院,海南三亚572000 [3]广东省中药研究所,广州510000

出　　处：《中国现代应用药学》2020年第12期1463-1467,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：三亚市医疗卫生科技创新项目(2016YW03)。

摘　　要：目的建立医疗机构制剂参芪妇康颗粒的质量标准。方法采用薄层色谱法(TLC)对制剂中党参、当归、赤芍进行定性鉴别;采用HPLC测定颗粒中毛蕊异黄酮葡萄糖苷、党参炔苷的含量。结果党参、当归、赤芍TLC图谱斑点清晰,其阴性对照图谱显示无干扰。毛蕊异黄酮葡萄糖苷、党参炔苷进样量分别在18.04~360.80mg×mL^-1(r=0.9999)、22.04~440.80mg×mL^-1(r=0.9996)内线性关系良好,平均加样回收率分别为毛蕊异黄酮葡萄糖苷98.50%(RSD=2.18%)、党参炔苷100.33%(RSD=1.63%)。结论建立的参芪妇康颗粒质量标准考察方法灵敏、准确、可靠,可用于制剂质量控制。OBJECTIVE To establish the quality standards for the preparation of Shenqi Fukang granules in medical institutions.METHODS TLC was used to identify Codonopsis Radix,Angelicae Sinensis Radix and Paeoniae Radix Rubra in the preparation;HPLC was used to determine calycosin7-O-β-D-glucopyranoside and lobetyolin.RESULTS The TLC of Codonopsis Radix,Angelicae Sinensis Radix and Radix Paeoniae Rubra showed clear pots and well-separated,their negative control showed no interference.Calycosin7-O-β-D-glucopyranoside,lobetyolin showed good linear relationships within the ranges of 18.04-360.80 mg×mL^-1(r=0.9999),22.04-440.80 mg×mL^-1(r=0.9996),whose average recoveries were 98.50%and 100.33%with the RSDs of 2.18%and 1.63%,respectively.CONCLUSION The quality standard of Shenqi Fukang granules is sensitive,accurate and reliable,which can be used for quality control of preparations.

关 键 词：参芪妇康颗粒 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R917.101[医药卫生—药物分析学]