基于HPLC指纹图谱和含量测定的半边莲饮片与标准汤剂量值传递规律研究

Study on the transmission law of quantity value of Lobeliae Chinensis Herba decoction pieces and standard decoction based on HPLC fingerprint and content determination

研究半边莲标准汤剂量值传递规律,为半边莲配方颗粒及其相关制剂质量标准的制定提供参考。将21批半边莲饮片制成标准汤剂,测定标准汤剂的出膏率和浸出物,建立半边莲饮片和标准汤剂指纹图谱,通过相似度评价和化学计量学分析,研究共有峰从饮片到标准汤剂的变化规律;测定半边莲饮片和标准汤剂中地奥司明和蒙花苷的含量,并计算转移率。结果显示,21批半边莲标准汤剂出膏率在29.91%~47.94%,浸出物在22.19%~36.36%;饮片和标准汤剂指纹图谱均标定出11个相同的共有峰,说明共有峰均能从饮片传递到标准汤剂中,饮片指纹图谱的整体相似度较高,而标准汤剂的相似度变化较大,主成分分析(PCA)显示,21批饮片和标准汤剂各自归为一类,正交偏最小二乘法-判别式分析(OPLS-DA)共找到5个相对峰面积变化较为显著的色谱峰。21批标准汤剂地奥司明的含量在0.15~0.54 mg/g,转移率在1.53%~4.99%;蒙花苷的含量在0.06~0.15 mg/g,转移率在4.27%~8.98%。该研究能够为半边莲配方颗粒及其相关制剂质量标准的制定提供一定的参考。

To provide reference for the formulation of quality standards of Lobeliae Chinensis Herba formula granules and related preparations,the transmission law of quantity value of Lobeliae Chinensis Herba standard decoction was studied.Twenty-one batches of Lobeliae Chinensis Herba decoction pieces were made into standard decoction.Paste yield and extracts were measured.The fingerprints of Lobeliae Chinensis Herba decoction pieces and standard decoction were established.Through similarity evaluation and chemometric analysis,the change rules of common peaks from decoction pieces to standard decoction were studied.The contents of diosmin and linarin were measured and the transfer rates were calculated.The results showed that paste yield of 21 batches of Lobeliae Chinensis Herba ranged from 29.91%to 47.94%and the extracts ranged from 22.19%-36.36%.Eleven identical common peaks were identified in the fingerprints of Lobeliae Chinensis Herba decoction pieces and standard decoction,indicating that the common peaks can be transferred from the decoction pieces to the standard decoction.The overall similarity of the fingerprint of the decoction pieces was relatively high,while the similarity of the standard decoction varied greatly.Principal component analysis(PCA)showed that 21 batches of decoction pieces and standard decoction were classified into one group respectively.Five chromatographic peaks with significant changes in relative peak area were found by orthogonal partial least squares discriminant analysis(OPLS-DA).The content range of diosmin in 21 batches of standard decoction was 0.15-0.54 mg/g and the transfer rate range was 1.53%-4.99%.The content range of linarin was 0.06-0.15 mg/g and the transfer rate range was 4.27%-8.98%.This study can provide a certain reference for the formulation of quality standards of Lobeliae Chinensis Herba formula granules and related preparations.