当归调经颗粒(无糖型)的质量标准研究

Study on quality standards of Angelica regulatinggranule (sugar-free type)

目的:建立当归调经颗粒(无糖型)的质量标准,有效地控制产品质量。方法:采用薄层色谱法对制剂中当归、川芎、甘草、黄芪、白芍进行定性鉴别,以白芍中芍药苷作为指标性成分,采用高效液相色谱法测定其含量。色谱柱为Agilent TC-C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(12∶88),流速为1.0 mL/min,检测波长为230 nm,柱温为25℃,进样量为10μL。结果:当归、川芎、甘草、黄芪、白芍的TLC法鉴别专属性强,且阴性均无干扰;含量测定结果显示,芍药苷浓度在(4.38~140.16)μg/mL内与峰面积呈良好的线性关系(r=0.9998),平均加样回收率为99.45%,RSD=1.97%(n=6)。结论:该方法操作简单、结果准确、专属性强、重复性好,可用于当归调经颗粒(无糖型)的质量控制。

Objective The quality standard of Angelica regulating granule(sugar-free type)was established to effectively control the quality of products.Methods TLC was used to identify the radix angelicae sinensis,rhizoma chuanxiong,radix glycyrrhiza root,radix astragalus root and radix paeoniae alba.The content of paeoniflorin in radix paeoniae alba was determined by HPLC.The column was Agilent TC-C18(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(12∶88,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 230 nm,the column temperature was 25℃,and the injection volume was 10μL.Results The TLC method of angelica sinensis,ligusticum chuanxiong,licorice root,astragalus root and paeoniae alba has strong specificity and no interference.The results showed that the concentration of paeoniflorin in(4.38~140.16)μg/mL had a good linear relationship with the peak area(r=0.9998),and the average recovery rate was 99.45%,RSD=1.97%(n=6).Conclusions The method is simple,accurate,specific and repeatable,and can be used for the quality control of Angelica regulating granule(sugar-free type).