目的 以標準湯劑的綠原酸含量和特征圖譜為基準,研究石楠葉配方顆粒的量值傳遞規(guī)律。方法 制備石楠葉標準湯劑樣品,建立其指標成分綠原酸含量及特征圖譜測定方法;收集不同來源15批次石楠葉藥材、飲片及3批中試配方顆粒,檢測綠原酸含量及特征圖譜,分析藥材-飲片-標準湯劑-配方顆粒特征圖譜的相關性及指標成分綠原酸量值傳遞規(guī)律。結果 15批標準湯劑的出膏率平均值為21.5%(20.0%~22.4%);綠原酸的平均質(zhì)量分數(shù)為21.63 mg·g^-1(20.04~22.81 mg·g^-1);共標定9個特征峰,以綠原酸(2號峰)為S1峰,蘆丁(4號峰)為S2峰。石楠葉藥材、飲片、配方顆粒中綠原酸質(zhì)量分數(shù)分別為5.91~7.33、5.79~6.98、15.61~15.72 mg·g^-1,藥材-飲片綠原酸轉移率為91.94%~99.05%,飲片-標準湯劑綠原酸轉移率為64.22%~81.36%,飲片-配方顆粒綠原酸轉移率為55.31%~61.71%。石楠葉藥材、飲片、配方顆粒特征圖譜中均檢測出9個特征峰,且相對保留時間均在規(guī)定范圍內(nèi)。結論 以石楠葉標準湯劑為基準,其藥材-飲片-標準湯劑-配方顆粒中9個特征峰相對保留時間、綠原酸量值傳遞規(guī)律穩(wěn)定,含量均在標準湯劑范圍內(nèi),表明石楠葉配方顆粒制備工藝合理,質(zhì)量穩(wěn)定。

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.

R284.1

河北省自然科學基金資助項目(H2023423005); 河北省中醫(yī)藥管理局科研計劃項目(2023114,2020130); 河北中醫(yī)學院優(yōu)秀青年基金項目(YQ2020006)