朝药桑黄的质量标准研究

Study on quality standard of Sanghuang of North Korea medicine

目的建立朝药桑黄的质量标准。方法采用微波消解-电感耦合等离子体质谱法(ICP-MS)测定桑黄中26种元素的含量,薄层色谱法鉴别桑黄,紫外-可见分光光度法测定桑黄多糖和总黄酮的含量。结果ICP-MS测定26种元素的标准曲线r值、加样回收率和相对标准偏差(n=6),均符合《中华人民共和国药典》(2020年版·四部)规定。10批不同产地桑黄中,5种高含量有益元素分别为钾(2772.0-6514.7 mg/kg)、镁(1299.9-1938.2 mg/kg)、钙(523.62-1753.90 mg/kg)、钠(19.886-359.370 mg/kg)和铁(38.469-534.440 mg/kg)。薄层色谱法能对桑黄有效鉴别。桑黄多糖的含量在0.024-0.120 mg范围内,线性关系良好(r=0.9982),总黄酮的含量在0.2-1.2 mg范围内,线性关系良好(r=0.9996)。结论参照《中华人民共和国药典》(2020年版·一部),10批不同产地桑黄中5种重金属及有害元素含量的检测结果均符合规定;5种高含量有益元素,可能与桑黄的功效相关;其他16种低含量元素,目前未发现安全风险。通过考察10批不同产地样本,建立有效可控的质量标准,对其研究与开发有重要意义。

Objective To establish the quality standard for Sanghuang of North Korea medicine.Methods Microwave digestion-inductively coupled plasma mass spectrometry(ICP-MS)was used to determine the content of 26 elements in Sanghuang,thin layer chromatography(TLC)was used to identify Sanghuang,the content of Sanghuang′s polysaccharide and total flavonoids were determined by ultraviolet-visible spectrophotometry.Results The r value of standard curve,recovery rate and relative standard deviation(n=6)of 26 elements by ICP-MS met the requirements of Pharmacopoeia of the People′s Republic of China(2020,VolumeⅣ).The five high content beneficial elements in 10 batches of Sanghuang from different areas were kalium(2772.0-6514.7 mg/kg),magnesium(1299.9-1938.2 mg/kg),calcium(523.62-1753.90 mg/kg),sodium(19.886-359.370 mg/kg)and iron(38.469-534.440 mg/kg).The TLC method was effective in the identification of Sanghuang.There were a good linear relationship of Sanghuang′s polysaccharide in the range of 0.024-0.120 mg(r=0.9982)and the total flavonoids of total flavonoids in the range of 0.2-1.2 mg(r=0.9996).Conclusion According to the Pharmacopoeia of the People′s Republic of China(2020,VolumeⅠ),the content of five heavy metals and harmful elements in 10 batches of Sanghuang from different places do meet regulations;five high content beneficial elements may be related to the efficacy of Sanghuang;the other 16 low content elements have no safety risk so far.Ten batches of samples from different places are investigated.The established standard can effectively control the quality,which is of great significance to its research and development.