石楠叶药材-饮片-标准汤剂-配方颗粒量值传递规律研究

目的 以标准汤剂的绿原酸含量和特征图谱为基准,研究石楠叶配方颗粒的量值传递规律。方法 制备石楠叶标准汤剂样品,建立其指标成分绿原酸含量及特征图谱测定方法;收集不同来源15批次石楠叶药材、饮片及3批中试配方颗粒,检测绿原酸含量及特征图谱,分析药材-饮片-标准汤剂-配方颗粒特征图谱的相关性及指标成分绿原酸量值传递规律。结果 15批标准汤剂的出膏率平均值为21.5%(20.0%~22.4%);绿原酸的平均质量分数为21.63 mg·g^-1(20.04~22.81 mg·g^-1);共标定9个特征峰,以绿原酸(2号峰)为S1峰,芦丁(4号峰)为S2峰。石楠叶药材、饮片、配方颗粒中绿原酸质量分数分别为5.91~7.33、5.79~6.98、15.61~15.72 mg·g^-1,药材-饮片绿原酸转移率为91.94%~99.05%,饮片-标准汤剂绿原酸转移率为64.22%~81.36%,饮片-配方颗粒绿原酸转移率为55.31%~61.71%。石楠叶药材、饮片、配方颗粒特征图谱中均检测出9个特征峰,且相对保留时间均在规定范围内。结论 以石楠叶标准汤剂为基准,其药材-饮片-标准汤剂-配方颗粒中9个特征峰相对保留时间、绿原酸量值传递规律稳定,含量均在标准汤剂范围内,表明石楠叶配方颗粒制备工艺合理,质量稳定。

Study and analysis on transmission law of quantity value between Photinia serrulata medicinal materials-decoction pieces-standard decoctions-formula granules

Objective To investigate the quantitative transfer relationship of Photinia serrulata Lindl. formula granules, considering factors such as the extraction rate, chlorogenic acid content, and the characteristic chromatogram of the standard decoction.Methods Standard decoction samples of P. serrulata were prepared, and methods for determining indicator content and establishing characteristic chromatograms were developed. Fifteen batches of P. serrulata herbs and herbal pieces, along with three batches of pilot formula granules from various sources, were collected and analyzed for the content and characteristic chromatogram of chlorogenic acid in P. serrulata. Analyze the correlation between the characteristic maps of medicinal herbs-decoction piecesstandard decoctions-formula granules.Results The extraction rates for 15 batches of standard decoction fell within the range of 20.0% to 22.4%, the average yield was 21.5%. The chlorogenic acid content in standard decoction exhibited variation from 20.04 to 22.81 mg·g^-1, the average mass was 21.63 mg·g^-1. A total of nine characteristic peaks were designated, with chlorogenic acid(peak 2) labeled as the S1 peak and rutin(peak 4) as the S2 peak. The range of chlorogenic acid content in P. serrulata herbs was between 5.91 to 7.33 mg·g^-1. The chlorogenic acid content in P. serrulata decoction pieces ranged from 5.79 to 6.96 mg·g^-1. The content of chlorogenic acid in P. serrulata formula granules fell within the range of 15.61 to 15.72 mg·g^-1. The transfer rate from herbal pieces to herbs varied from 91.94% to 99.05%. The transfer rate from standard decoction to herbal pieces ranged from 64.22% to 81.36%.The transfer rate from formula granules to herbal pieces ranged from 55.31% to 61.71%. Nine characteristic peaks were detected in P. serrulata herbs, herbal pieces and formula granules, and the relative retention time was within the specified range.Conclusion Using standard decoction of Photinia serrulata. as the reference, the relative retention time of the nine characteristic peaks in the herb-herbal pieces-standard decoction-formula granules is stable, and the transmission law of chlorogenic acid values is stable,and the content is all within the range of standard decoction. This indicates that the preparation process of Photinia serrulata formula granules is meticulous, ensuring stable quality and equivalence to the standard decoction.