基于标准汤剂一致性的海桐皮(刺酮)配方颗粒质量标准研究

Development of quality standards for Erythrina variegata L. bark formula granules based on consistency of standard decoction

关键词:  海桐皮（刺酮）  标准汤剂  配方颗粒  质量标准  特征图谱  化学模式识别

Key words:  Erythrina variegata?L. bark  standard decoction  formula granules  quality standards  characteristic chromatogram  chemical pattern recognition

摘要:

目的 建立标准汤剂一致性为指导的海桐皮（刺酮）配方颗粒质量标准。方法 基于标准汤剂的出膏率，绿原酸、隐绿原酸和新绿原酸总量以及特征图谱，建立海桐皮（刺酮）配方颗粒的质量标准。对3批配方颗粒与15批标准汤剂进行相似度评价与化学模式识别。结果 15批海桐皮（刺酮）标准汤剂出膏率平均值为9.7%；特征图谱含8个特征峰；绿原酸、隐绿原酸和新绿原酸总量平均值为140.5 mg/g。控制海桐皮（刺酮）配方颗粒出膏率为7.0%~12.6%，制定配方颗粒绿原酸、隐绿原酸和新绿原酸总量限度为68.5~127.4 mg/g。海桐皮（刺酮）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；通过主成分分析、偏最小二乘辨别分析与热图聚类分析可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 该研究可为海桐皮（刺酮）配方颗粒的标准的制定和质量控制提供参考依据。

Abstract:

OBJECTIVE To establish a quality standard for Erythrina variegata L. bark formula granules guided by the consistency of its standard decoction. METHODS The quality standard was developed based on the extraction yield, total content of chlorogenic acid, cryptochlorogenic acid, and neochlorogenic acid, and characteristic chromatographic profile of the standard decoction. Similarity evaluation and chemical pattern recognition were performed on three batches of formula granules and 15 batches of standard decoctions. RESULTS The average extraction yield of 15 batches of E. variegata L. bark standard decoctions was 9.7%. The characteristic chromatogram contained 8 characteristic peaks. The total content of chlorogenic acid, cryptochlorogenic acid, and neochlorogenic acid averaged 140.5 mg/g. For formula granules, the extraction yield was controlled within 7.0%–12.6%, and the total content of the three chlorogenic acids was limited to 68.5–127.4 mg/g. The similarity between the characteristic chromatograms of formula granules and the reference standard decoction exceeded 0.95. Principal component analysis (PCA), partial partial least squares discrimination analysis (PLS-DA), and heatmap cluster analysis effectively distinguished standard decoctions from different geographical origins, while formula granules clustered closely with their corresponding standard decoctions. CONCLUSION This study provides a reference framework for establishing quality standards and controlling the consistency of E. variegata L. bark formula granules.