首页|感冒退热颗粒质量标准提升研究

感冒退热颗粒质量标准提升研究

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目的:完善感冒退热颗粒质量标准,以确保其疗效稳定与用药安全.方法:运用薄层色谱法(TLC)对处方中板蓝根和大青叶、拳参进行定性鉴别;运用高效液相色谱-二极管阵列检测器技术(HPLC-DAD)测定处方板蓝根和大青叶中尿苷、鸟苷、腺苷的含量.结果:薄层色谱中特征斑点清晰,分离度好,阴性无干扰.尿苷、鸟苷和腺苷分别在0.051 4~2.055 7 µg、0.045 9~1.837 6μg、0.052 5~2.101 3 μg范围内线性关系良好,平均回收率为94.88%~105.0%,RSD为1.25%~1.63%.结论:所建立的薄层色谱法和高效液相色谱法操作方便,专属性和准确度好,为感冒退热颗粒质量标准的进一步优化与提升提供了参考和依据.
The Improvement of Quality Standard for Ganmao Tuire Keli
Objective:To improve the quality standard of Ganmao Tuire Keli,To ensure the stability of its efficacy and the safety of medication.Methods:The qualitative identification of Bistort Rhizome,Radix and Folium were conducted by Thin-layer chromatography(TLC).The content of uridine,guanosine and adenosine in Radix and Folium were determined by high performance liquid chromatogra-phy with Diode Array Detection(HPLC-DAD).Results:The characteristic spots in TLC were clear,with good separation and no interfer-ence in the negative control.The linear relationships for uridine,guanosine,and adenosine were good within the ranges of 0.051 4-2.055 7 µg,0.045 9-1.837 6 µg,and 0.052 5-2.101 3 µg,respectively.The average recoveries were 94.88%-105.0%with the RSD of 1.25%-1.63%.Conclusion:The established thin-layer chromatography and high-performance liquid chromatography methods are easy to operate,with good specificity and accuracy,providing a reference and basis for the further optimization and improvement of the quality standards for Ganmao Tuire Keli.

Ganmao Tuire KeliThin-Layer Chromatography(TLC)High-Performance Liquid Chromatography(HPLC)Quality standard

王琪、许妍、张妍、张玉、杨毅生、洪挺

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景德镇市市场监督管理综合检验检测中心,江西景德镇 333000

江西省药品检验检测研究院/国家药品监督管理局中成药质量评价重点实验室/江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029

江西中医药大学,江西南昌 330004

感冒退热颗粒 薄层色谱法(TLC) 高效液相色谱法(HPLC) 质量标准

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(6)