摘要
目的提升稚儿灵颗粒的质量标准。方法采用薄层色谱(TLC)法对制剂中的党参、太子参、白术(麸炒)、制何首乌和陈皮进行定性鉴别;采用高效液相色谱(HPLC)法对其中多组分进行定量分析。结果TLC图中可检出党参、太子参、白术(麸炒)、制何首乌和陈皮的特征斑点,且阴性对照无干扰。没食子酸、芍药苷和橙皮苷进样量分别在0.7453~44.7172μg、1.9627~117.7622μg、3.3054~198.3259μg范围内与峰面积线性关系良好(r>0.999);精密度、稳定性、重复性试验的RSD均小于2.0%(n=6),加样回收率分别为99.59%,103.30%,103.87%,RSD分别为2.00%,0.70%,1.12%(n=6)。结论该方法简便快速,结果准确,专属性强,重复性好,可更全面地控制稚儿灵颗粒的质量。
Objective To improve the quality standard of Zhi’erling Granules.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Codonopsis Radix,Pseudostellariae Radix,Atractylodis Macrocephalae Rhizoma(stir-fried with bran),Polygoni Multiflori Radix and Citri Reticulatae Pericarpium in the preparation.High-performance liquid chromatography(HPLC)method was used for the quantitative analysis of multiple components.Results The characteristic spots of Codonopsis Radix,Pseudostellariae Radix,Atractylodis Macrocephalae Rhizoma(stir-fried with bran),Polygoni Multiflori Radix and Citri Reticulatae Pericarpium could be detected by TLC,and the negative control had no interference.Gallic acid,paeoniflorin and hesperidin showed a good linear relationship in the ranges of 0.7453-44.7172μg,1.9627-117.7622μg and 3.3054-198.3259μg(r>0.999),respectively.The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6).The recoveries of gallic acid,paeoniflorin and hesperidin were 99.59%,103.30%,103.87%with RSDs of 2.00%,0.70%and 1.12%(n=6),respectively.Conclusion The method is simple,rapid,accurate,specific and reproducible,which can comprehensively control the quality of Zhi’erling Granules.
作者
李佳
王萍
金华
LI Jia;WANG Ping;JIN Hua(Jiangsu Huai'an Institute for Food and Drug Control,Huai'an,Jiantgsu,China 223300)
出处
《中国药业》
CAS
2021年第20期64-68,共5页
China Pharmaceuticals
