基于指纹图谱与化学计量学的藿香正气软胶囊质量控制方法研究
Quality Control Method of Huoxiang Zhengqi Soft Capsules Based on Fingerprint and Chemometrics
马宿杉 1苏建 2李舒琪 3苏紫藤 4王常顺 2刘永利2
作者信息
- 1. 河北科技大学,河北 石家庄 050000;河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室,河北 石家庄 050000
- 2. 河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室,河北 石家庄 050000
- 3. 河北中医学院,河北 石家庄 050000
- 4. 河北科技大学,河北 石家庄 050000
- 折叠
摘要
目的:建立藿香正气软胶囊的高效液相色谱法(HPLC)指纹图谱及多指标成分测定方法,结合化学计量学方法评价藿香正气软胶囊的质量.方法:采用HPLC,SHIMADZU VP-ODSC18 色谱柱(250 mm×4.6 mm,5 µm),以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速为 1.0 mL·min-1,梯度波长为 254、283 nm,柱温为 30℃,进样量为 10 μL,建立指纹图谱及多指标成分测定方法,结合化学计量学方法对不同批次藿香正气软胶囊质量进行分析和评价.结果:建立了藿香正气软胶囊的HPLC指纹图谱,共标定了 22 个共有峰,15 批藿香正气软胶囊指纹图谱的相似度均在 0.8 以上;对甘草苷、柚皮芸香苷、橙皮苷、水合氧化前胡素、白当归脑、欧前胡素、和厚朴酚、珊瑚菜素、异欧前胡素、厚朴酚 10 个成分进行了含量测定;化学计量学分析表明,不同企业生产的藿香正气软胶囊质量存在一定差异,区分各样品的质量差异标志物为水合氧化前胡素、和厚朴酚、异欧前胡素、珊瑚菜素、厚朴酚和甘草苷.结论:建立的HPLC指纹图谱及多指标成分测定方法准确、简便,结合化学计量学方法可用于评价藿香正气软胶囊的质量.
Abstract
Objective:To establish a high performance liquid chromatography(HPLC)fingerprint and multi-index component determination method for Huoxiang Zhengqi Soft Capsules,and to evaluate the quality of the prescription by chemometrics.Methods:HPLC was performed using a SHIMADZU VP-ODS C18 column(250 mm×4.6 mm,5 μm)with acetonitrile-0.1%phosphoric acid aqueous solution as mobile phase in gradient elution.The flow rate was 1.0 mL·min-1,and the gradient wavelength was 254 nm and 283 nm.The column temperature was 30 ℃ and the injection volume was 10 μL.Then the fingerprint and multi-index component determination method were established for analyzing and evaluating the quality of different batches of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.Results:The HPLC fingerprint of Huoxiang Zhengqi Soft Capsules was established,and 22 common peaks were calibrated.The similarity of the fingerprints of 15 batches of samples was above 0.8.Liquiritin,narirutin,hesperidin,oxypeucedanin hydrate,byakangelicol,imperatorin,honokiol,phellopterin,isoimperatorin and magnolol were determined.Chemometrics showed that there were some differences in the quality of Huoxiang Zhengqi Soft Capsules produced by different enterprises,and the quality markers were oxypeucedanin hydrate,honokiol,isoimperatorin,phellopterin,magnolol and liquiritin.Conclusion:The established HPLC fingerprint and multi-index component determination method were accurate and simple,and could be used to evaluate the quality of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.
关键词
藿香正气软胶囊/指纹图谱/化学计量学/聚类分析/主成分分析/正交偏最小二乘法-判别分析/质量评价Key words
Huoxiang Zhengqi Soft Capsules/fingerprint/chemometrics/cluster analysis/principal component analysis/orthogonal partial least squares-discriminant analysis/quality evaluation引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据