基于标准汤剂的断血流(风轮菜)配方颗粒质量标准研究

Quality Standard of Clinopodii Herba(Clinopodium chinense)Formula Granules Based on Standard Decoction

目的:建立基于标准汤剂的断血流(风轮菜)配方颗粒质量标准,为其质量控制提供数据参考。方法:根据《中药配方颗粒质量控制与标准制定技术要求》,制备15批断血流(风轮菜)标准汤剂,测定其出膏率、指标成分迷迭香酸含量、转移率,构建高效液相色谱法特征图谱,并进行相似度评价及化学计量学分析;制备3批断血流(风轮菜)配方颗粒,基于标准汤剂出膏率、迷迭香酸含量和特征图谱一致性,多维验证工艺与标准的合理性。结果:15批断血流(风轮菜)标准汤剂出膏率为13.2%~21.1%,迷迭香酸质量分数为7.37~15.95 mg·g^(-1)、转移率为20.2%~57.0%,特征图谱共标定7个共有峰,指认峰2和峰5分别为芸香柚皮苷和迷迭香酸,且批次间相似度>0.8。计量学分析表明,不同批次标准汤剂成分存在一定差异且具有一定地域聚集性;3批断血流(风轮菜)配方颗粒出膏率分别为18.3%、20.4%、19.2%,迷迭香酸质量分数分别为5.23、5.91、5.32 mg·g^(-1),转移率分别为21.4%、24.0%、17.9%,其特征图谱与标准汤剂对照特征图谱相似度均大于0.9。结论:3批断血流(风轮菜)配方颗粒质量指标与标准汤剂基本一致,建立的基于标准汤剂的断血流(风轮菜)质量标准合理可行,可为其配方颗粒的制备及质量控制提供数据支撑。

Objective:To establish the quality standard of Clinopodii Herba(Clinopodium chinense)formula granules based on the standard decoction and provide data reference for the quality control of the dispensing granules.Methods:According to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules,15 batches of Clinopodii Herba standard decoction were prepared.The extraction rate,rosmarinic acid(index component)content,and transfer rate were determined,and the high performance liquid chromatography(HPLC)fingerprints were established,evaluated for the similarity,and used for chemometrics.Three batches of Clinopodii Herba formula granules were prepared,and the rationality of the process and standard was evaluated in multiple dimensions based on the consistency of the extraction rate,rosmarinic acid content,and HPLC fingerprint compared with those of the standard decoction.Results:The 15 batches of standard decoction showed the extraction rates of 13.2%-21.1%,rosmarinic acid content of 7.3-16.0 mg·g^(-1),and the transfer rate of 20.2%-57.0%.Seven common peaks were identified in the HPLC fingerprints,among which peaks 2 and 5 were naringin and rosmarinic acid,respectively.The fingerprint similarity between different decoction batches was>0.8.The chemometric analysis showed that the chemical composition had differences between different batches of the standard decoction and the samples presented a clustering trend regarding the source regions.The three batches of formula granules showed the extraction rates of 18.3%,20.4%,and 19.2%,the rosmarinic acid content of 5.23,5.91,and 5.32 mg·g^(-1),and the transfer rates of 21.4%,24.0%,and 17.9%,respectively.Moreover,the fingerprint similarity between the formula granules and the standard decoction was>0.9.Conclusion:The three batches of Clinopodii Herba formula granules present consistent quality indexes with the standard decoction.The established quality standard of Clinopodii Herba based on the standard decoction is reasonable and feasible,which can provide data support for the preparation and quality control of Clinopodii Herba formula granules.