清肺消痤颗粒的质量控制标准研究  

Study on quality control standard of Qingfeixiaocuo Granules

作　　者：曾志兰 周建寅 戴颖[1,2] 戴薇 ZENG Zhilan;ZHOU Jianyin;DAI Ying(Jiangsu Province Academy of Traditional Chinese Medicine,Nanjing 210028,China;Department of Pharmacy,Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210028,China)

机构地区：[1]江苏省中医药研究院,南京210028 [2]南京中医药大学附属中西医结合医院药学部,南京210028

出　　处：《中国处方药》2025年第5期23-26,共4页Journal of China Prescription Drug

基　　金：“南京药学会——常州四药医院药学科研基金”资助项目(2021YX011)。

摘　　要：目的通过薄层色谱法(TLC)对黄芩、栀子和丹参定性鉴别;高效液相色谱(HPLC)法测定清肺消痤颗粒制剂中黄芩苷、栀子苷和丹酚酸B的含量,建立清肺消痤颗粒的质量控制标准。方法以Alltima C18(250 mm×4.6 mm,5μm)为色谱柱,甲醇(A)-0.4%磷酸溶液(B)为流动相进行HPLC测定,检测波长:黄芩苷280 nm、栀子苷238 nm、丹酚酸B 286 nm,流速1.0 ml/min,柱温35℃,进样量20μl。结果定性鉴别中,黄芩苷、栀子苷、丹酚酸B的薄层色谱斑点清晰,分离度好。定量测定中,黄芩苷、栀子苷、丹酚酸B的线性范围分别在0.0891~1.427 mg/ml(r=0.9999)、0.0327~0.524 mg/ml(r=1.0000)、0.0273~0.436 mg/ml(r=0.9991)内与色谱峰面积呈良好的线性关系,平均加样回收率分别为102.5%(RSD=2.56%)、106.1%(RSD=0.67%)、105.0%(RSD=2.25%)。结论所建方法灵敏度、专属性、重复性等均符合清肺消痤颗粒的质控研究。Objective To develope a quality control standard for Qingfeixiaocuo Granules via thin layer chromatography(TLC)(qualitative identification of Scutellaria baicalensis,Gardeniae Fructus,Salvia miltiorrhiza)and high performance liquid chromatography(HPLC)(quantitation of baicalin,geniposide,salvianolic acid B).Methods The chromatographic column was Alltima C18(250 mm×4.6 mm,5μm).The mobile phase was methanol(A)-0.4%phosphoric acid solution(B)and gradient elution was performed.The detection wavelength was 280 nm for baicalin,238 nm for geniposide and 286 nm for salvianolic acid B.The flow rate was 1.0 ml/min.The column temperature was 35℃.The injection volume was 20μl.Results In the TLC,the spots of baicalin,geniposide,and salvianolic acid B were well-separated and distinct.In the quantitative research,baicalin,geniposide,and salvianolic acid B demonstrated good linear correlations with their respective chromatographic peak areas within the linear ranges of 0.0891-1.427 mg/ml(r=0.9999),0.0327-0.524 mg/ml(r=1.0000),and 0.0273-0.436 mg/ml(r=0.9991).The average recoveries were 102.5%,106.1%and 105.0%withRSDs of 2.56%,0.67%and 2.25%.Conclusion The method is sensitive,specific and reproducible,which can be used for the quality control of Qingfeixiaocuo Granules.

关 键 词：清肺消痤颗粒 质量标准 薄层色谱 高效液相色谱 

分 类 号：R28[医药卫生—中药学]