基于标准汤剂的苍术配方颗粒质量标准研究

Quality Study of Atractylodis Rhizoma Dispensing Granules Based on Standard Decoction

目的:建立基于标准汤剂的苍术配方颗粒的质量评价方法。方法:收集14批不同产地的苍术药材,根据技术要求,制备14批苍术标准汤剂及3批配方颗粒,分别以出膏率、绿原酸的含量、转移率及指纹图谱的相似度,对苍术配方颗粒进行质量评价。结果:标准汤剂出膏率均值为32.68%;3批配方颗粒的出膏率分别为27.47%、28.38%、28.13%;标准汤剂中绿原酸的含量均值为0.547mg/g,转移率均值为48.29%;3批配方颗粒中绿原酸的含量分别为0.826mg/g、0.994mg/g、0.809mg/g,转移率分别为32.9%、48.2%、40.9%。标准汤剂和配方颗粒指纹图谱均标识出19个共有峰,通过比对对照品指认出其中两个特征峰分别为绿原酸和苍术素。配方颗粒与标准汤剂对照指纹图谱的相似度分别为0.994、0.994、0.990。结论:3批苍术配方颗粒的质量指标与标准汤剂基本一致,该方法能够为苍术配方颗粒质量标准的制定提供依据。

Objective:To establish quality evaluation method of Atractylodis rhizoma dispensing granules based on standard decoction.Methods:Fourteen batches of Atractylodis rhizoma were collected from different habitats.According to technical requirements,fourteen batches of Atractylodis rhizoma standard decoction and three batches of dispensing granules were prepared.The quality evaluation of Atractylodis rhizoma dispensing granules based on paste rate,similarity values of fingerprints,content and transfer rate of Chlorogenic acid.Results:Average paste rate of Atractylodis rhizoma standard detection was 32.68%.The paste rates of three batches of dispensing granules were 35.64%,31.10%and 36.72%respectively.The average content and transfer rate of Rosmarinic acid in standard decoction was 0.546 mg/g and 48.29%.The contents of three batches of dispensing granules were 0.826 mg/g,0.994 mg/g and 0.809 mg/g and the transfer rates were 45.75%,36.92%and 54.08%,nineteen common fingerprint peaks were identified in the fingerprints of standard decoction and dispensing granules and two of them were identified as Chlorogenic acid and Atractylodin by comparison of reference substance.The similarity of fingerprint between formula granule and standard decoction was 0.994,0.994 and 0.990,respectively.Conclusion:The quality indexes of three batches of dispensing granules are consistent with standard decoction.This method can provide basis for the establishment of quality standard of Atractylodis hizoma dispensing granules.