大山楂颗粒质量标准提升研究  

Improvement of Quality Standard for Dashanzha Granules

作　　者：陈培武 邓仁华 黄贵平 蒋艳萍 阙海华 吴求艺 CHEN Peiwu;DENG Renhua;HUANG Guiping;JIANG Yanping;QUE Haihua;WU Qiuyi(Jiangxi Nanchang Jisheng Pharmaceutical Co.,Ltd.,Nanchang,Jiangxi,China 330115)

机构地区：[1]江西南昌济生制药有限责任公司,江西南昌330115

出　　处：《中国药业》2024年第10期90-92,共3页China Pharmaceuticals

基　　金：江西省中医药管理局科技计划项目[2022B1088]。

摘　　要：目的提升大山楂颗粒的质量标准。方法采用薄层色谱(TLC)法对样品中山楂进行定性鉴别;采用紫外-可见分光光度(UV)法在500 nm波长处测定样品中金丝桃苷的含量。结果山楂的TLC图特征斑点显色清晰,分离度好,且阴性对照无干扰。金丝桃苷质量浓度在0.0049~0.0490 mg/mL范围内与吸光度线性关系良好(R^(2)=0.9997,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为100.10%,RSD为0.64%(n=6)。样品中金丝桃苷平均含量为每袋38.26 mg。结论所建立的方法操作简便,结果准确可靠,可用于大山楂颗粒的质量控制。Objective To improve the quality standard of Dashanzha Granules.Methods Crataegi Fructus in the samples was identified qualitatively by the thin-layer chromatography(TLC)method.The content of hyperoside in the samples was determined by the ultraviolet-visible spectrophotometry at a wavelength of 500 nm.Results The TLC chromatograms of Crataegi Fructus showed clear characteristic spots,good resolution,and there was no interference from the negative reference.The linear range of hyperoside was 0.0049-0.0490 mg/mL(R^(2)=0.9997,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of hyperoside was 100.10%with an RSD of 0.64%(n=6).The average content of hyperoside in the samples was 38.26 mg per bag.Conclusion The established method is simple,accurate and reliable,which can be used for quality control of Dashanzha Granules.

关 键 词：大山楂颗粒 金丝桃苷 山楂 紫外-可见分光光度法 薄层色谱法 质量标准 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]