参芪妇康颗粒质量标准研究

Study on Quality Standard for Shenqi Fukang Granules

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.