舒肝颗粒质量标准提升研究  

Improvement of Quality Standard of Shugan Qranules

作　　者：殷世宁 杨晓云 傅超 单秀明 祝波 YIN Shining;YANG Xiaoyun;FU Chao;SHAN Xiuming;ZHU Bo(Qingdao Institute for Food and Drug Control·NMPA Key Laboratory for Quality Research and Evaluation of Traditional Marine Chinese Medicine,Qingdao,Shandong,China 266071)

机构地区：[1]山东省青岛市食品药品检验研究院·国家药品监督管理局海洋中药质量研究与评价重点实验室,山东青岛266071

出　　处：《中国药业》2025年第9期70-74,共5页China Pharmaceuticals

基　　金：《中国药典》药品标准提高项目[508]。

摘　　要：目的提升舒肝颗粒的质量标准。方法采用薄层色谱法对制剂中牡丹皮、栀子、白芍、甘草、柴胡、白术进行定性鉴别;采用高效液相色谱法同时测定制剂中栀子苷、芍药苷的含量,色谱柱为Agilent Zorbax SB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(86∶14,V/V),流速为1.0 mL/min,检测波长为242 nm,柱温为35℃,进样量为10μL。结果牡丹皮、栀子、白芍、甘草、柴胡、白术的薄层色谱斑点显色清晰,且阴性对照无干扰。栀子苷、芍药苷的质量浓度分别在23.09~369.51μg/mL、13.82~221.16μg/mL范围内与峰面积线性关系良好(r=1.0000,n=5);精密度、稳定性、重复性试验结果的RSD均小于1.5%(n=6);平均加样回收率分别为97.90%和97.39%,RSD分别为0.61%和0.66%(n=6)。10批样品中栀子苷、芍药苷的平均含量分别为1.08,1.52 mg/g(n=2)。结论所建立的方法操作简单、结果准确、专属性良好,可用于舒肝颗粒的质量控制。Objective To improve the quality standard of Shugan Granules.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Moutan Cortex,Gardeniae Fructus,Paeoniae Radix Alba,Glycyrrhizae Radix and Rhizoma,Bupleuri Radix,and Atractylodis Macrocephalae Rhizoma.High-performance liquid chromatography(HPLC)method was used for the simultaneously determination of geniposide and paeoniflorin in the preparation,the chromatographic column was Agilent Zorbax SB-C_(18)column(250 mm×4.6 mm,5µm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(86∶14,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 242 nm,the column temperature was 35℃,and the injection volume was 10µL.Results The TLC spots of Moutan Cortex,Gardeniae Fructus,Paeoniae Radix Alba,Glycyrrhizae Radix and Rhizoma,Bupleuri Radix,and Atractylodis Macrocephalae Rhizoma were clear,and the negative control had no interference.The linear ranges of geniposide and paeoniflorin were 23.09-369.51µg/mL and 13.82-221.16µg/mL,(r=1.0000,n=5)respectively.The RSDs of precision,stability,and repeatability test results were all lower than 1.5%(n=6).The average recoveries of geniposide and paeoniflorin were 97.90%and 97.39%,with RSDs of 0.61%and 0.66%(n=6),respectively.The average contents of geniposide and paeoniflorin in 10 batches of samples were 1.08 mg/g and 1.52 mg/g(n=2),respectively.Conclusion The established method is simple,accurate,and has good specificity,which can be used for the quality control of Shugan Granules.

关 键 词：舒肝颗粒 薄层色谱法 高效液相色谱法 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