羌藿蒲蓝胶囊质量标准的建立  

Establishment of Quality Standard of Qianghuopulan Capsules

作　　者：彭艺飞 李佳霖[1] 周蔚[1] PENG Yifei;LI Jialin;ZHOU Wei(Leshan Hospital of Traditional Chinese Medicine,Leshan,Sichuan,China 614000)

机构地区：[1]四川省乐山市中医医院,四川乐山614000

出　　处：《中国药业》2022年第20期80-83,共4页China Pharmaceuticals

基　　金：四川省乐山市科技局重点研究项目[20ZDYJ0123]。

摘　　要：目的建立羌藿蒲蓝胶囊的质量标准。方法采用薄层色谱(TLC)法对制剂中板蓝根、蒲公英、羌活、广藿香进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中(R,S)-告依春的含量,色谱柱为Waters Symmetry Shield C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(15∶85,V/V),流速为1.0 mL/min,检测波长为250 nm,柱温为30℃,进样量为10μL。结果板蓝根、蒲公英、羌活、广藿香的TLC图斑点清晰,分离度好,且阴性对照无干扰。(R,S)-告依春质量浓度在0.64~12.80μg/mL范围内与峰面积线性关系良好(r=0.9995,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均加样回收率为100.86%,RSD为1.55%(n=6)。结论所建立的标准可用于羌藿蒲蓝胶囊的质量控制。Objective To establish a quality standard of Qianghuopulan Capsules.Methods Thin-layer chromatography(TLC)method was adopted for the qualitative identification of Isatidis Radix,Taraxaci Herba,Notopterygii Rhizoma et Radix,and Pogostemonis Herba in the preparation.High-performance liquid chromatography(HPLC)method was adopted for the content determination of(R,S)-goitrin in the preparation.The chromatographic column was Waters Symmetry Shield C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was methanol-water(15:85,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 250 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC spots of Isatidis Radix,Taraxaci Herba,Notopterygii Rhizoma et Radix,and Pogostemonis Herba were clear and well separated,and the negative control had no interference.The linear range of(R,S)-goitrin was 0.64-12.80μg/mL(r=0.9995,n=6).The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6).The average recovery of(R,S)-goitrin was 100.86%with an RSD of 1.55%(n=6).Conclusion The established standard can be used for the quality control of Qianghuopulan Capsules.

关 键 词：羌藿蒲蓝胶囊 薄层色谱法 高效液相色谱法 (R S)-告依春 质量控制 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]