摘要
目的 建立中药复方制剂大黄[庶虫]虫胶囊HPLC指纹图谱,采用化学模式识别技术对其质量进行评价。方法 采用Kromat Universil C(250 mm×4.6 mm,5μm)色谱柱,以0.1%磷酸水-甲醇为流动相,梯度洗脱,流速1 mL·min^(-1);检测波长270 nm;柱温30℃。采用“中药色谱指纹图谱相似度评价软件”对10批胶囊进行相似度评价,并对特征峰进行指认。采用SPSS 22.0和SIMCA-P13.0软件进行聚类分析(cluster analysis,CA)、主成分分析(principal component analysis,PCA)和正交偏最小二乘判别分析(orthogonal partial least square discriminate analysis,OPLS-DA)。结果 所建立的大黄[庶虫]虫胶囊指纹图谱的HPLC方法具有良好的精密度、重复性及稳定性;10批大黄[庶虫]虫胶囊的指纹图谱的相似度的值为0.996~0.999。聚类分析将10批胶囊分为两类,OPLS-DA筛选出14个差异标记物。结论 所建立的指纹图谱能够反映大黄[庶虫]虫胶囊不同批次间的差异,结合化学模式识别技术,可用于大黄[庶虫]虫胶囊的质量评价。
Objective To establish an HPLC fingerprint of Rhubarb Aphid Capsules, and to evaluate the quality through chemical pattern recognition.Methods Kromat Universil C(250 mm×4.6 mm, 5 μm)column was used to elute with 0.1% phosphoric acid aqueous solution(A)-methanol(B);the flow rate was 1 mL·min^(-1);the detection wavelength was 270 nm;the column temperature was 30 ℃.The fingerprint common pattern and similarity calculation were established using traditional Chinese medicine chromatographic fingerprint similarity evaluation system.The cluster analysis(CA),principal component analysis(PCA),and orthogonal partial least square discriminate analysis(OPLS-DA) models were established using SPSS22.0 and SIMCA-P13.0 software to perform statistical analysis.Results The HPLC method for the fingerprint of Rhubarb Aphid capsules had good precision, repeatability and stability;the similarity of the 10 batches of Rhubarb Aphid capsules was range from 0.996 to 0.999;The results of cluster analysis showed that 10 batches of capsules were grouped into 2 groups.Orthogonal partial least squares discriminant analysis showed that 14 components were the main indicators of quality difference among different batches.Conclusion The established method can be used for the quality control of Rhubarb Aphid capsules.The fingerprint can reflect the differences between different batches, combining chemical pattern recognition can provide reference for the quality evaluation of Rhubarb Aphid capsules.
作者
邱旭
阎旭
赵旻
王淼
赵春杰
QIU Xu;YAN Xu;ZHAO Min;WANG Miao;ZHAO Chunjie(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,Liaoning,China;Astellas Pharma China,Inc.,Shenyang 110020,Liaoning,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2022年第8期931-937,共7页
Journal of Shenyang Pharmaceutical University
关键词
大黄[庶虫]虫胶囊
指纹图谱
高效液相色谱法
化学模式识别
Rhubarb Aphid Capsules
Chinese medicine fingerprint
high performance liquid chromatography
chemical pattern recognition