| 柯红梅,李春雨,王杨,等.高效液相色谱法测定淡豆豉中 10种生物胺含量[J].安徽医药,2025,29(2):268-274. |
| 高效液相色谱法测定淡豆豉中 10种生物胺含量 |
| Determination of ten kinds of biogenic amines in sojae semen praeparatum by HPLC |
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| DOI：10.3969/j.issn.1009-6469.2025.02.011 |
| 中文关键词: 淡豆豉 生物胺 高效液相色谱法 安全性 |
| 英文关键词: Sojae semen praeparatum Biogenic amines HPLC Security risks |
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| 中文摘要: |
| 目的建立柱前衍生高效液相色谱法测定淡豆豉中 10种生物胺含量，为评估淡豆豉中生物胺的安全性提供数据。方法 2023年 6―8月，按《中国药典》 2020年版规定检测淡豆豉性状和含量(大豆苷元和染料木素)；对符合《中国药典》 2020年版规定的淡豆豉采用高效液相色谱法测定其生物胺含量，以 Agilent 5 TC-C18(4.6 mm×250 mm，5 μm)为色谱柱，以乙腈 -水为流动相，梯度洗脱，检测波长 254 nm，柱温 35 ℃，流速 0.8 mL/min。结果 20批淡豆豉有 3批次不符合《中国药典》 2020年版规定。 17批次符合《中国药典》 2020年版规定的淡豆豉均检出酪胺、尸胺及腐胺，均未检出多巴胺；每批淡豆豉至少含有 5种生物胺。不同批次生物胺总量差别很大，范围为 27.688～8 936.9 μg/g。样品中各生物胺含量范围为:色胺 0～343.6 μg/g、2-苯乙胺 0～1 067 μg/g、腐胺 12.42～1 819 μg/g、尸胺 2.278～4 812 μg/g、组胺 0～320.3 μg/g、5-羟色胺 0~11.94 μg/g、酪胺 4.936～2 684 μg/g、亚精胺 0~185.9 μg/g、精胺 0～28.64 μg/g。结论符合《中国药典》 2020年版规定的部分淡豆豉中组胺、酪胺、 2-苯乙胺的含量超过了最大推荐限量， 6批(35%)生物胺总量超过了研究建议值，存在一定的安全风险。 |
| 英文摘要: |
| Objective To develop a method for the determination of ten kinds of biogenic amines in sojae semen praeparatum (SSP)by HPLC with precolumn derivatization, and to provide data for evaluating the safety status of SSP.Methods The properties and con-tents ( daidzein and genistein) of SSP were detected according to the provisions of Chinese Pharmacopoeia 2020 edition from June to Oc-tober 2023. The content of biogenic amines in SSP conforming to pharmacopoeia regulations was determined by HPLC. The separationwas achieved using a Agilent C18 analytical column (4.6mm×250 mm,5 μm). Using ACN and ultra-pure water as the mobile phase solu-tion, a gradient elution was conducted at a flow rate of 0.8 mL/min. The detector was adjusted to 254 nm, with a column temperature of35 ℃.Results Three samples did not meet the requirements of Chinese Pharmacopoeia 2020 edition. Tyramine, cadaverine, and pu-trescine were detected in 17 samples that comply with pharmacopoeia regulations, but dopamine was not detected. The total content ofbiogenic amines varies greatly among different batches, ranging from 27.688 to 8 936.9 μg/g. The content range of tryptamine, 2-phenethylamine, putrescine, cadaverine, histamine, 5-hydroxytryptamine, tyramine, spermidine and spermine was 0-343.6, 0-1 067, 12.42-1 819, 2.278-4 812, 0-320.3, 0-11.94, 4.936-2 684, 0-185.9, and 0-28.64 μg/g.Conclusion The content of histamine, tyra-mine, and 2-phenylethylamine in some SSP that meet the requirements of Chinese Pharmacopoeia 2020 edition exceeds the maximum recommended limit,and the total content of biogenic amines in 6 batches (35%) of SSP exceeded research recommendations, posing acertain safety risk. |
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