棵芒降压颗粒的质量标准研究

Study on Quality Standard of KeMang JiangYa Granules

目的创建棵芒降压颗粒的质量标准。方法采用中国药典2020版四部通则0502方法(TLC)对颗粒中姜黄、决明子、广山楂进行了薄层鉴别;采用中国药典2020版四部通则0512方法(HPLC)对颗粒中姜黄素成分进行了含量测定。色谱柱:Welch Xtimate C 18色谱柱(5μm,4.60×250 mm);流动相:乙腈-4%冰醋酸溶液(48∶52);检测波长:430 nm;柱温:30℃;流速:1.0 mL·min^(-1);进样量:10μL。结果姜黄、决明子、广山楂的TLC专属性强、斑点清晰,阴性对照无干扰。HPLC测定结果表明姜黄素在5.922~47.376μg·mL^(-1)范围内线性良好(r=0.9998),精密度、稳定性、重复性的RSD分别为0.15%、0.35%、0.55%,平均加样回收率为99.33%,RSD=0.78%(n=9)。结论该法简单易行、准确可靠、灵敏度高和重现性好,可做为棵芒降压颗粒的质量控制。

OBJECTIVE To establish the quality standard of KeMang JiangYa granules.METHODS Turmeric,cassia seed and hawthorn were identified by TLC in China Pharmacopoeia(2020 edition).The content of curcumin in granules was determined by the method of China Pharmacopoeia(2020 edition)0512.Column:Welch Xtimate C 18 column(5μm,4.60×250 mm);mobile phase:acetonitrile-4%glacial acetic acid solution(48∶52);detection wavelength:430 nm;column temperature:30℃;flow rate:1.0 mL·min^(-1);sample volume:10μL.RESULTS The TLC of curcuma rhizome,semen cassiae and fructus crataegi was specific and the spots were clear,and the negative control had no interference.The results of HPLC showed that curcumin had a good linearity in the range of 5.922-47.376μg·mL^(-1)(r=0.9998),and the RSD of precision,stability and repeatability were 0.15%,0.35%and 0.55%,respectively.The average recovery rate was 99.33%and RSD was 0.78.CONCLUSION The method is simple,accurate,reliable,sensitive and reproducible,and can be used for the quality control of Kemang Jiangya granules.