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炮制前后地骨皮药材与饮片质量相关性分析

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目的 研究炮制前后地骨皮药材与饮片的质量相关性.方法 建立地骨皮乙素含量和特征图谱的高效液相色谱(HPLC)测定方法.照《中国药典》2020年版(四部)相关规定测定浸出物、总灰分和酸不溶性灰分.结果 地骨皮乙素在0.041 2~4.116 0mg·mL-1范围内线性关系良好,相关系数0.999 9,精密度、稳定性和重复性的RSD均小于等于1.11%,平均加样回收率为96.18%,RSD为2.85%;除地骨皮乙素峰(S峰)外,供试品色谱图中共呈现6个特征峰.22批地骨皮药材及对应饮片测定结果表明,炮制前后,地骨皮乙素、浸出物、总灰分和酸不溶性灰分的平均转移率分别为43.70%、84.55%、98.91%和96.97%,RSD 分别为48.39%、9.01%、8.69%和29.49%;以峰面积计算,特征图谱6个特征峰平均转移率在43.32%~86.85%之间,RSD在31.94%~78.24%之间.结论 检测方法合理,结果准确可靠.与浸出物转移率比较,总灰分和酸不溶性灰分的转移率较高,地骨皮乙素转移率较低且差异较大,6个特征峰转移率有高有低.研究结果可为相关中药研究和生产中质量设计空间确定、炮制工艺研究、药材和饮片质量控制等提供参考.
Analysis of the correlation between the quality of Lycii Cortex and its decoction pieces before and after processing
Objective To study the correlation between the quality of Lycii Cortex and its decoction pieces before and af-ter processing.Methods To establish an HPLC method for the determination of the content of kukoamine B and the charac-teristic chromatogram.Extract,total ash and acid insoluble ash were determined according to the Chinese Pharmacopoeia(Vol-ume 4,2020 Edition).Results The linear range of kukoamine B was 0.041 2~4.116 0 mg·mL-1,the correlation coefficient was 0.999 9.The RSD of precision,stability and repeatability were less than 1.11%.The average recovery was 96.18%,RSD was 2.85%.There were 6 characteristic peaks in the chromatogram except for the peak of kukoamine B.The results of 22 batches of Lycii Cortex and its decoction pieces showed that the average transfer rates of kukoamine B,extract,total ash and acid insolu-ble ash were 43.70%,84.55%,98.91%and 96.97%,respectively,and RSD were 48.39%,9.01%,8.69%and 29.49%,respec-tively.According to the peak area,the average transfer rate of the six characteristic peaks was between 43.32%and 86.85%,and the RSD was between 31.94%and 78.24%.Conclusion The detection method is reasonable and the results are accurate and reliable.Compared with the transfer rate of extract,the transfer rate of total ash and acid insoluble ash was higher,kukoam-ine B was lower,six characteristic peaks were high and low.The results can provide reference for the draw up of design space,processing technology,quality control of Lycii Cortex and its decoction pieces in the research and production of related tradi-tional Chinese medicine.

Lycii CortexProcessing drugsDecoction piecesCorrelationKukoamine BCharacteristic chromatogram

董汛、周林、牛延菲、谢佳颖、陆雪萍、李小辉、杨增明

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云南省药物研究所,云南昆明 650111

云南省中药和民族药新药创制企业重点实验室,云南昆明 650111

地骨皮 炮制 饮片 相关性 地骨皮乙素 特征图谱

云南省工信厅2019年中药饮片产业发展专项

2019-YG-010

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(1)
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