解热颗粒质量标准研究  

Quality Standard of Jiere Granules

作　　者：翟巧利 麦格皮热提·阿不力米提 李媛[1] 刘娟[1] 范伟 时扣荣[1] ZHAI Qiaoli;Magpyghetti ABEREMITE;LI Yuan;LIU Juan;FAN Wei;SHI Kourong(The Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine,Shanghai,China 200137;Shache Uygur Medical Hospital,Kashgar,Xinjiang,China 844700)

机构地区：[1]上海中医药大学附属第七人民医院,上海200137 [2]新疆维吾尔自治区莎车县维吾尔医医院,新疆喀什844700

出　　处：《中国药业》2023年第1期72-75,共4页China Pharmaceuticals

基　　金：上海市浦东新区卫生健康委员会学科建设计划项目[PWXx2020-04];上海中医药附属第七人民医院“七院新星(中医类)”人才培养计划项目[XX2021-19]。

摘　　要：目的建立解热颗粒的质量标准。方法采用薄层色谱法对制剂中大青叶和四季青进行定性鉴别;采用高效液相色谱法测定制剂中长梗冬青苷的含量,色谱柱为Agilent Zorbax SB-C_(18)柱(250 mm×4.6 mm,5µm),流动相为10%异丙醇甲醇-10%异丙醇水溶液(梯度洗脱),流速为1.0 mL/min,柱温为30℃,进样量为10µL和20µL。结果大青叶及四季青薄层色谱鉴别专属性强,斑点清晰,阴性对照无干扰。长梗冬青苷的进样量在0.7154~3.5575µg范围内与峰面积线性关系良好(r=0.9997,n=5);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106.20%,RSD为1.20%(n=6)。3批样品中长梗冬青苷的含量分别为7.90,7.60,7.40 mg/g(n=2)。结论所建立的标准操作简便、专属性强、准确度高、重复性好,可用于解热颗粒的质量控制。Objective To establish the quality standard of Jiere Granules.Methods Isatidis Folium and Ilicis Chinensis Folium in the preparations were identified qualitatively by the thin-layer chromatography(TLC)method.The content of pedunculoside in the preparations was determined by the high-performance liquid chromatography(HPLC)method.The chromatographic column was Agilent Zorbax SB-C_(18) column(250 mm×4.6 mm,5µm),the mobile phase was methanol containing 10%isopropyl alcohol-aqueous solution containing 10%isopropyl alcohol(gradient elution),the flow rate was 1.0 mL/min,the column temperature was 30℃,and the injection volumes were 10µL and 20µL.Results The TLC chromatograms of Isatidis Folium and Ilicis Chinensis Folium had strong specificity and clear spots,and the negative reference had no interference.The linear range of pedunculoside was 0.7154-3.5575µg(r=0.9997,n=5).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery of pedunculoside was 106.20%with an RSD of 1.20%(n=6).The contents of pedunculoside in the three batches of samples were 7.90,7.60 and 7.40 mg/g(n=2),respectively.Conclusion The established standard is simple,specific,accurate and repeatable,which can be used for the quality control of Jiere Granules.

关 键 词：解热颗粒 薄层色谱法 高效液相色谱法 大青叶 四季青 长梗冬青苷 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