蟾蜍油炮制工艺及质量评价方法研究
Research on the Processing Technology and Quality Evaluation Methods of Bufonis Oviductus
牟丽燕 1高萌 1陆兔林 1毛春芹 1季德 1苏联麟 1郭志俊 2高波 2罗川 3殷放宙1
作者信息
- 1. 南京中医药大学 药学院,江苏 南京 210000;江苏省中药炮制重点实验室,江苏 南京 210000
- 2. 华润三九现代中药制药有限公司,广东 惠州 516000
- 3. 安徽华润金蟾药业有限公司,安徽 淮北 235000
- 折叠
摘要
目的:优化蟾蜍油干燥工艺,并建立以高效液相色谱法(HPLC)指纹图谱及氨基酸含量测定为主的质量评价方法.方法:以氨基酸和浸出物为指标,进行蟾蜍油热风干燥、自然阴干、冷冻干燥及真空干燥工艺的优选,分别考察了热风干燥的加热温度、加热时间、物料厚度,冷冻干燥的预冻时间、冷冻干燥时间,真空干燥的温度及时间对蟾蜍油的影响.采用HPLC建立 15 批蟾蜍油的指纹图谱,确定共有峰并进行相似度评价;同时,采用柱前衍生化法测定氨基酸含量.结果:蟾蜍油最佳工艺为不叠加样本,50℃热风干燥 11 h.HPLC指纹图谱中共确定 7 个共有峰,相似度均大于 0.99;异亮氨酸、亮氨酸、苯丙氨酸、赖氨酸质量分数分别为 0.40%～0.57%、0.57%～0.78%、0.54%～0.75%、0.26%～0.86%.结论:所确定的工艺及质量评价方法简便、重复性好,可为蟾蜍油的加工炮制及质量评价提供参考.
Abstract
Objective:To optimize the drying process technology of Bufonis Oviductus,and establish a quality evaluation method based on high-performance liquid chromatography(HPLC)fingerprint and amino acid content determination.Methods:Amino acids and extracts were used as indicators in the optimization of hot-air-drying,nature-shadow-drying,freeze-drying and vacuum-drying for Bufonis Oviductus.The impacts of several factors on the Bufonis oviductus were investigated including,heating temperature,heating time,material thickness,pre-freezing time,freeze-drying time,vacuum drying temperature,and vacuum drying time.The fingerprints of 15 batches samples were established by HPLC.Common peaks were determined and their similarities were evaluated.Pre-column derivatization was also used to determine the content of amino acids.Results:The optimum conditions for processing Bufonis Oviductus were determined as hot-air-drying at 50 ℃ for 11 h with the samples placed in a single layer.A total of 7 common peaks were identified in the HPLC fingerprint of Bufonis Oviductus,and the similarities of 15 samples were greater than 0.99.The contents of isoleucine,leucine,phenylalanine and lysine are 0.40%-0.57%,0.57%-0.78%,0.54%-0.75%,0.26%-0.86%,respectively.Conclusion:The determined drying process of Bufonis Oviductus as well as quality evaluation methods are simple and reproducible,which can provide a reference for the processing and quality evaluation of Bufonis Oviductus.
关键词
蟾蜍油/干燥工艺/高效液相色谱法/指纹图谱/氨基酸Key words
Bufonis Oviductus/drying processing technology/HPLC/fingerprint/amino acid引用本文复制引用
基金项目
国家重点研发计划(2018YFC1707000)
出版年
2024
国家科技期刊平台
NSTL
万方数据