基于标准汤剂的麸木香配方颗粒质量标准研究

Quality standard of bran Radix Aucklandiae formula granules based on standard decoction

目的建立基于标准汤剂的麸木香配方颗粒质量标准。方法以标准汤剂的出膏率、特征图谱、木香烃内酯和去氢木香内酯总含量为依据,制订麸木香配方颗粒的质量标准。对15批标准汤剂与4批配方颗粒进行相似度评价与化学模式识别。结果15批麸木香标准汤剂出膏率平均值为54.4%;特征图谱含11个特征峰;木香烃内酯和去氢木香内酯总含量平均值为1.50 mg·g^(-1)。控制麸木香配方颗粒出膏率在40%~65%,设定木香烃内酯和去氢木香内酯总含量限度为0.40~1.52 mg·g^(-1)。麸木香配方颗粒特征图谱与标准汤剂对照特征图谱相似度均大于0.95;主成分分析、热图聚类分析与偏最小二乘-辨别分析可有效区分不同产地标准汤剂,标准汤剂与同批次配方颗粒聚集性较好。结论该研究可为配方颗粒质量标准的制订提供过程参考。

Objective To establish quality standard for bran Radix Aucklandiae formula granules based on standard decoction.Methods Based on the paste yield rate,characteristic spectra,costunolide and dehydrocostuslactone content in the standard decoction,the quality standard for bran Radix Aucklandiae formula granules was established.The similarity of 15 batches of standard decoctions and 4 batches of formula granules was evaluated and chemical patterns recognized.Results The average paste yield rate of the 15 batches of bran Radix Aucklandiae standard decoction was 54.4%,and 11 feature peaks were detected in the characteristic spectra.The average total content of costunolide and dehydrocostuslactone was 1.50 mg·g^(-1).The yield rate of bran Radix Aucklandiae formula granules was controlled at 40%~65%,and the total content limit of costunolide and dehydrocostuslactone was set at 0.40~1.52 mg·g^(-1).Similarity between the characteristic spectra of bran Radix Aucklandiae formula granules and control characteristic spectra of standard decoction was greater than 0.95.By principal component analysis,heat-map clustering analysis,and partial least squares discriminant analysis,the standard decoctions from different origins were effectively distinguished.Fine aggregation was achieved in the standard decoction and formula granules in the same batch.Conclusion This study provides reference for the quality standard of formula granules.