风寒感冒颗粒质量标准的建立

Establishment of Quality Standard for Fenghan Ganmao Granules

目的:完善风寒感冒颗粒的药品质量标准,更好地控制产品的质量。方法:建立处方药味葛根、紫苏叶、白芷、防风、陈皮、甘草的TLC鉴别法;建立盐酸麻黄碱、盐酸伪麻黄碱、葛根素含量测定的HPLC法,盐酸麻黄碱、盐酸伪麻黄碱含量以乙腈-0.02 mol·L^(-1)磷酸二氢钾溶液(含0.2%三乙胺,用磷酸调pH至2.7)(3∶97)为流动相,检测波长:210 nm,柱温:30℃;葛根素含量以甲醇-水(24∶76)为流动相;检测波长:250 nm,柱温:30℃。结果:建立的TLC鉴别图谱均与相应的对照药材或对照品在相同位置上显现相同颜色的斑点,且阴性样品无干扰。HPLC法测定盐酸麻黄碱和盐酸伪麻黄碱含量、葛根素含量,进样量分别在0.023~0.451,0.017~0.336,,0.167~1.252μg范围内线性关系良好(r为0.999 8~1.000 0);平均回收率分别为99.91%,99.79%,101.51%,RSD均小于3%(n=9)。结论:新建立的方法专属性强,稳定性好,重复性好,能够有效评价和控制风寒感冒颗粒的质量。

Objective: To improve the quality standard for Fenghan Ganmao granules to better control the product quality. Methods: TLC identification methods were established for Puerariae lobatae radrix,Perilla frutescens leaves,Dahurian angelica root,Saposhnikovia divaricate,Citri reticulatae pericarpium and Glycyrrhiza uralensis Fisch. HPLC was adopted for the content determination of ephedrine hydrochloride,pseudoephedrine hydrochloride and puerarin. The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were determined with acetonitrile-0.02 mol·L^(-1) potassium dihydrogen phosphate solution( containing 0.2% triethylamine,and pH was adjusted to 2.7 with phosphoric acid)( 3 ∶ 97) as the mobile phase,the detection wavelength was 210 nm,and the column temperature was 30 ℃.The content of puerarin was detected with methanol-water( 24 ∶ 76) as the mobile phase,the wavelength was 250 nm and the column temperature was 30℃.Results: TLC showed the same color spot in the same position as the corresponding substance control or reference medicinal material,and the negative samples had no interference. For HPLC determination,the linear range of ephedrine hydrochloride,pseudoephedrine hydrochloride and puerarin was 0.023-0.451 μg,0.017-0.336 μg and 0.167-1.252 μg( r = 0.999 8-1.000 0),respectively. The average recovery was 99.91%,99.79% and 101.51%( RSD<3%,n = 9),respectively.Conclusion: The newly revised and established methods are highly specific,stable and reproducible,which can be used for the quality evaluation and control of Fenghan Ganmao granules.