清喉咽颗粒的质量标准的提升研究  

Study on Improvement and Promotion of Quality Standard of Qinghouyan Granules

作　　者：姚世霞 牛钰婷 刘东升 杨泳琳 朱旭江 YAO Shi-xia;NIU Yu-ting;LIU Dong-sheng;YANG Yong-lin;ZHU Xu-jiang(Gansu Institute for Drug Control,Lanzhou 730070,China;Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces of the State Drug Administration,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070

出　　处：《时珍国医国药》2021年第7期1653-1656,共4页Lishizhen Medicine and Materia Medica Research

基　　金：国家药典委员会2019年标准提高项目(2019Z063)。

摘　　要：目的全面提升清喉咽颗粒的质量标准。方法在原标准的基础上,增加处方中麦冬、玄参、连翘、黄芩的TLC鉴别项;增加采用双波长HPLC法同时测定处方中连翘苷、黄芩苷的含量的方法并拟定限度;对22批次样品的检验结果进行了评价分析。结果在TLC色谱鉴别中,斑点清晰,阴性无干扰,能够检视出相应的成分。黄芩苷在5.6210~281.0484μg/mL浓度范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为96.9%,RSD(%)为2.6%;连翘苷在0.4960~24.8021μg/mL浓度范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为98.2%,RSD(%)为2.3%。结论建立的质量控制方法专属性,准确度、稳定性、耐用性符合中药质量标准方法起草的要求,能够用于对清喉咽颗粒的质量控制。Objective To improve the quality standard of Qinghouyan Granules.Methods On the basis of the original standard, the TLC identification items of Ophiopogon japonicus, Scrophulariaceae, Forsythia suspensa, and Scutellaria baicalensis were added to the new standard;a dual-wavelength HPLC method was added to simultaneously determine the content of forsythin and baicalin in the prescription. The limits of the method were drawn up;22 batches of samples were measured by the established method, and the test results were evaluated and analyzed. Results In the TLC chromatographic identification, the spots are clear, negative sample has no interference, and the corresponding components can be identified. Baicalin showed a good linear relationship in the concentration range of 5.6210~281.0484μg/mL(r=0.9999), the average recovery rate was 96.9%, and the RSD(%) was 2.6%;forsythin was 0.4960~24.8021μg/mL(r=0.9999), the average recovery rate was 98.2%, and the RSD(%) was 2.3%. Conclusion The established quality control method has good specificity, accuracy, stability and durability meet the requirements of the quality control method, and can be used for the quality control of Qinghouyan Granules.

关 键 词：清喉咽颗粒 薄层色谱 高效液相色谱法 质量标准 

分 类 号：R283.6[医药卫生—中药学]