基于特征图谱对葛根配方颗粒过程控制的质量分析

Quality analysis of Pueraria Formula Granules process control based on specific chromatogram

关键词:  葛根标准汤剂  特征图谱  葛根素  葛根  葛根配方颗粒

Key words:  Pueraria standard decoction  specific chromatogram  puerarin  Pueraria  Pueraria Formula Granules

摘要:

[目的] 通过特征图谱分析葛根饮片、标准汤剂、配方颗粒之间的相关性，以实现葛根配方颗粒过程控制的质量分析。[方法] 采用UPLC建立特征图谱，测定葛根饮片、标准汤剂、配方颗粒中葛根素含量，同时以UPLC特征图谱为对照，建立三者特征峰共有模式，进行相关性评价。[结果] 24批葛根饮片、标准汤剂、配方颗粒中葛根素平均含量分别为5.8%、10.3%、7.8%，其特征图谱中均呈现8个共有特征峰，特征图谱相似度均大于0.90，表明这三者之间的物质成分一致。[结论] 经方法学考察，建立的特征图谱方法稳定、含量测定准确度高，既可用于对葛根配方颗粒和葛根临床汤剂一致性评价，又可对葛根配方颗粒过程控制质量分析提供依据。

Abstract:

[Objective] The correlation among Pueraria piece, standard decoction and Formula Granules was analyzed by the specific chromatogram, which to realize the quality analysis of Pueraria Formula Granules process control.[Methods] The specific chromatogram was established by UPLC, the UPLC methods was used to determine the content of puerarin in Pueraria piece, standard decoction and Formula Granules. Meanwhile, the common pattern of the three specific chromatogram was established and the correlation was evaluated through the control specific chromatogram.[Results] The average content of puerarin in 24 batches of Pueraria piece, standard decoction, Formula Granules was 5.8%, 10.3%, 7.8%, respectively. There were 8 common peaks in all specific chromatogram of 24 batches of Pueraria pieces, standard decoction and Formula Granules. The similarity of the three was greater than 0.90, indicating that the material components of the three were basic consistency.[Conclusion] After methodological investigation, the established UPLC specific chromatogram method is stable and accurate. It can evaluate the consistency of Pueraria formula granules and clinical decoction, and provide basis for quality analysis of Pueraria Formula Granules process control.