桑菊感冒颗粒质量标准完善研究  

Quality standard of Sangju Ganmao granules

作　　者：董秋香[1] 张月寒[1] 刘翀 王腾 姚辉[1] 桑皖怡 付萍萍[1] DONG Qiu-xiang;ZHANG Yue-han;LIU Chong;WANG Teng;YAO Hui;SANG Wan-yi;FU Ping-ping(Baoding Institute for Food and Drug Control,Baoding Hebei 071000;The Queen’s University of Belfast Joint College,China Medical University,Shenyang 110000)

机构地区：[1]保定市食品药品检验所,河北保定071000 [2]中国医科大学中英联合学院,沈阳110000

出　　处：《中南药学》2023年第2期520-525,共6页Central South Pharmacy

基　　金：河北省市场监督管理局科研计划重点项目(No.2020ZD37)。

摘　　要：目的完善桑菊感冒颗粒质量标准并考察市售样品的质量现状。方法建立薄层色谱法鉴别菊花、连翘及甘草;建立高效液相色谱法测定连翘酯苷A、连翘苷和甘草酸的含量,色谱柱为Waters SunFire C_(18)(4.6 mm×250 mm,5μm),流动相:0.1%磷酸溶液-乙腈,梯度洗脱,流速:1.0 mL·min^(-1),柱温:30℃;检测波长:237 nm;进样量:10μL。结果薄层色谱方法分离度好、斑点清晰且专属性强;连翘酯苷A、连翘苷、甘草酸的线性范围分别为3.02~96.71μg·m L^(-1)(r=1.000),2.38~76.08μg·mL^(-1)(r=1.000),2.37~75.87μg·mL^(-1)(r=1.000);平均加样回收率在97.57%~103.06%,RSD均小于2.0%;法定检验显示23批桑菊感冒颗粒合格率为100%;探索性研究结果表明,样品质量差异较大。结论桑菊感冒颗粒质量现状不容乐观,质量标准亟待提高。该研究建立的方法操作简便、准确可靠,可用于桑菊感冒颗粒的质量控制与分析。Objective To improve the current quality standard of Sangju Ganmao granules and determine the quality status of domestic samples. Methods A thin-layer chromatography (TLC)method was established to identify Chrysanthemi Flos, Forsythiae Fructus and Glycyrrhizae Radix Et Rhizoma. HPLC method was established to determine the content of forsythoside A, forsythin and glycyrrhizic acid. The samples were analyzed on a Waters Sun Fire C18column with the mobile phase of acetonitrile-0.1% phosphoric acid solution with gradient elution. The flow rate was 1.0 mL·min^(- 1),the temperature was 30 ℃ , the detection wavelength was 237 nm, and the injection volume was 10μL. Results The characteristic spots of Chrysanthemi Flos, Forsythiae Fructus and Glycyrrhizae Radix Et Rhizoma were detected by TLC. The spots were clear and specific, with no interference in the negative reference solution. The linear ranges of forsythoside A, forsythin and glycyrrhizic acid were 3.02 ~ 96.71 μg·mL^(-1)(r = 1.000), 2.38 ~ 76.08 μg·mL^(- 1)(r = 1.000), 2.37 ~ 75.87μg·mL^(-1)(r = 1.000). The average sampling recovery rates was 97.57% ~ 103.06%, with RSD all less than 2.0%. The legal qualification rate of 23 batches of the samples was 100%. There were obvious differences in the samples. Conclusion The overall quality of Sangju Ganmao granules is not satisfactory, and the quality standard should be improved urgently. This method is simple, accurate and reliable, it can be used for the quality control of Sangju Ganmao granules.

关 键 词：桑菊感冒颗粒 质量标准 质量分析 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]