健脾降脂颗粒质量标准提升研究  

Improvement of Quality Standard of Jianpi Jiangzhi Granules

作　　者：李成森 周春玲 王晓月 童冰妮 孔令锋 麦志雄 LI Chengsen;ZHOU Chunling;WANG Xiaoyue;TONG Bingni;KONG Lingfeng;MAI Zhixiong(Liaoning Institute for Drug Control·Liaoning Inspection,Examination&Certification Centre,Shenyang,Liaoning,China 110000;Guangxi Wuzhou PharmaceuticalCo.,Ltd.,Wuzhou,Guangxi,China 543000)

机构地区：[1]辽宁省检验检测认证中心·辽宁省药品检验检测院,辽宁沈阳110000 [2]广西梧州制药<集团>股份有限公司,广西梧州543000

出　　处：《中国药业》2023年第11期67-70,共4页China Pharmaceuticals

基　　金：国家药典委员会标准提高项目[2021Z020];广西梧州市科技计划项目[202102016]。

摘　　要：目的提升健脾降脂颗粒的质量控制标准。方法采用高效液相色谱法对党参,以及薄层色谱法对远志、丹参进行定性鉴别;采用高效液相色谱法测定丹参素钠的含量,色谱柱为Diamonsil^(TM)C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-1%冰醋酸溶液(6∶94,V/V),流速为1.0 mL/min,检测波长为280 nm,进样量为20μL。结果色谱中能明显检出远志、丹参、党参,且阴性对照无干扰,专属性强。丹参素钠质量浓度在0.542~54.200μg/mL范围内与峰面积线性关系良好(R2=0.9999,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均加样回收率为101.86%,RSD为1.68%(n=6)。结论所建立的方法简便、准确、专属性强,可为健脾降脂颗粒质量标准的提升提供参考。Objective To improve the quality control standard of Jianpi Jiangzhi Granules.Methods The high-performance liquid chromatography(HPLC)method was used for the qualitative identification of Codonopsis Radix,and the thin-layer chromatography(TLC)method was used for the qualitative identification of Polygalae Radix and Salviae Miltiorrhizae Radix et Rhizoma.The HPLC method was used for the content determination of Sodium Danshensu,the chromatographic column was Diamonsil^(TM)C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was methanol-1%glacial acetic acid solution(6∶94,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 280 nm,and the injection volume was 20μL.Results Polygalae Radix,Salviae Miltiorrhizae Radix et Rhizoma and Codonopsis Radix could be clearly detected in the chromatography,and the negative control has no interference,with strong specificity.The linear range of Sodium Danshensu was 0.542-54.200μg/mL(R2=0.9999,n=6).The RSDs of precision,repeatability,and stability test results were all lower than 2.0%(n=6).The average recovery rate of Sodium Danshensu was 101.86%with an RSD of 1.68%(n=6).Conclusion The established method is simple and accurate with strong specificity,which can provide a reference for improving the quality standard of Jianpi Jiangzhi Granules.

关 键 词：健脾降脂颗粒 丹参素钠 党参炔苷 远志 党参 丹参 质量标准 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0