枸杞子标准汤剂制备及质量标准研究

Study on Preparation and Quality Evaluation of Lycii Fructus Standard Decoction

目的:制备15批枸杞子饮片标准汤剂,并进行总黄酮含量检测,建立指纹图谱,为枸杞子标准汤剂的质量控制提供可靠的方法。方法:收集来自三大产区的共15批枸杞子饮片,依据相关技术要求制备成标准汤剂,以总黄酮为含量指标,计算其转移率和出膏率;并建立其高效液相指纹图谱,采用液质联用技术对共有峰进行指认。结果:15批枸杞子标准汤剂出膏率为63.7%~73.5%,平均值68.7%;总黄酮含量范围为0.57%~0.86%,平均值0.75%,平均转移率为67.73%。指纹图谱中稳定呈现5个特征峰,经结构确认分别为绿原酸、隐绿原酸、对-香豆酸、阿魏酸、芦丁;15批枸杞子标准汤剂指纹图谱相似度均大于0.9。结论:建立的总黄酮含量测定方法与指纹图谱方法可靠,准确性和重现性试验RSD均小于3%,可用于枸杞子标准汤剂的质量评价,也为枸杞子配方颗粒成品的质量控制提供参考依据。

Objective:To prepare 15batches of standard decoction of Lycaii Fructus,determine the contents of total flavonoids and establish the fingerprint.Methods:15batches of Chinese wolfberry slices from three producing areas were collected and prepared into standard decoction according to the technical requirements,The transfer rate and extract rate were calculated with the content of total flavonoids as the index;The HPLC fingerprint was established and the common peaks were identified by LC-MS.Results:The range of 15batches of Lycaii Fructus standard decoction was 63.7%~73.5%,with an average of 68.7%;The content of total flavonoids ranged from 0.57%~0.86%,the average value was 0.75%,and the average transfer rate was 67.73%.The fingerprint showed five characteristic peaks,namely chlorogenic acid,cryptochlorogenic acid,4-coumaric acid,ferulic acid and rutin.The similarity of 15batches of Lycaii Fructus standard decoction was greater than 0.9.Conclusion:The method for the determination of total flavonoids and fingerprint method are reliable,and the RSDof accuracy and reproducibility are less than 3%.It can be used for the quality evaluation of Lycaii Fructus standard decoction,and also provide a reference basis for the quality control of Lycaii Fructus formula granules.