首页|超高效液相色谱指纹图谱结合化学模式识别评价白蒲黄胶囊质量

超高效液相色谱指纹图谱结合化学模式识别评价白蒲黄胶囊质量

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目的 建立评价白蒲黄胶囊质量的超高效液相色谱(UPLC)指纹图谱和化学模式识别方法。方法 色谱柱为Waters Acquity BEH C18 柱(150 mm×2。1 mm,1。7µm),流动相为乙腈-0。02mol/L磷酸二氢钾溶液(梯度洗脱),流速为 0。3 mL/min,柱温为 35℃,切换检测波长 210 nm及 323 nm,进样量为 2µL。建立 2 个厂家 10 批样品的指纹图谱,并进行相似度评价、聚类分析(CA)和正交偏最小二乘判别分析(OPLS-DA),筛选不同批次样品的差异性标志物。结果 方法学考察结果显示,精密度、重复性、稳定性试验结果的RSD均小于 2。0%。10 批样品共标定了 19 个共有峰;通过与对照品比对,指认 7 个成分,分别为盐酸黄柏碱(4 号峰)、绿原酸(6 号峰)、咖啡酸(10 号峰)、菊苣酸(11 号峰)、黄芩苷(13 号峰)、盐酸小檗碱(17 号峰)、白头翁皂苷B4(19 号峰)。10 批样品的指纹图谱相似度均不低于 0。978。10 批样品按厂家聚为 2 类;在OPLS-DA模型下,以变量重要性投影值大于 1 筛选出 4 个差异性标志物,分别为白头翁皂苷B4(19号峰)、5号峰、菊苣酸(11号峰)、绿原酸(6号峰)。结论 该方法操作简单、结果准确,可客观评价白蒲黄胶囊的质量。
Quality Evaluation of Baipuhuang Capsules by UPLC Fingerprint Combined with Chemical Pattern Recognition
Objective To establish an ultra-high performance liquid chromatography(UPLC)fingerprint and chemical pattern recognition method for evaluating the quality of Baipuhuang Capsules.Methods The chromatography column was Waters Acquity BEH C18 column(150 mm×2.1 mm,1.7 µm),the mobile phase was acetonitrile-0.02 mol/L potassium dihydrogen phosphate solution(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 35℃,the switching wavelengths were 210 nm and 323 nm,and the injection volume was 2 µL.The fingerprints of ten batches of samples from two manufacturers were established,and the similarity evaluation,clustering analysis(CA),and orthogonal partial least squares-discriminant analysis(OPLS-DA)were conducted to screen for differential biomarkers in different batches of samples.Results The methodological examination results showed that the RSDs of the precision,repeatability,and stability test results of the seven components were all lower than 2.0%.Nineteen common peaks were calibrated in ten batches of samples.By comparing with the reference substance,seven components were identified,namely phellodendrine hydrochloride(peak 4),chlorogenic acid(peak 6),caffeic acid(peak 10),chicoric acid(peak 11),baicalin(peak 13),berberine hydrochloride(peak 17),and pulchinenoside B4(peak 19).The similarity of the fingerprints of ten batches of samples was 0.978 or above.Ten batches of samples were classified into two categories according to the manufacturers.Under the OPLS-DA model,four differential biomarkers were screened based on the variable importance in projection(VIP)value greater than 1,namely pulchinenoside B4(peak 19),peak 5,chicoric acid(peak 11),and chlorogenic acid(peak 6).Conclusion The method is simple and accurate,which can objectively evaluate the quality of Baipuhuang Capsules.

Baipuhuang CapsulesUPLCfingerprintchemical pattern recognitionquality evaluation

王蕙、陈姨

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中国人民解放军联勤保障部队第九○○医院,福建 福州 350000

白蒲黄胶囊 超高效液相色谱法 指纹图谱 化学模式识别 质量评价

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(15)