背景:来自植物药的膳食补充剂通常在生物医学研究中被消费和研究,因为它们具有潜在的健康益处。植物成分中关键化学成分的准确识别和定量对于一致的产品制备和可重复的研究结果是必要的。制造商需要感兴趣的化学成分的定量参考材料来验证成分和产品的含量。通过彻底表征机械中使用的干预措施,可以增强生物医学研究的严谨性和可重复性。临床,和安全调查。定量参考材料可实现可靠的产品质量评估和可重复的研究结果。
目的:开发了基于解决方案的认证参考材料(CRM)混合物,作为生姜和卡瓦植物化学物质的校准剂。卡瓦CRM包含扬戈宁,去甲氧基扬子蛋白,dihydrokavain,DL-kavain,methysticin,二氢甲基霉素,flavokawainA,flavokawainB,和flavokawainC.GingerCRM含有6-姜辣素,8-姜辣素,10-姜辣素,6-shogaol,8-shogaol,还有10-shogaol.
方法:每种植物化学物质作为分离的化合物来源,并通过考虑残余杂质的质量平衡方法指定纯度因子。溶液标准混合物是通过重量法添加每种植物化学物质来配制的,这些植物化学物质包含纯度因子,并用乙腈稀释至姜酚和姜酚的目标浓度为500µg/mL。Kavalactone为250µg/mL,flavokawains为25µg/mL。
结果:通过与独立制备的校准溶液的HPLC-UV测定比较,分析验证了溶液混合物中每种组分的浓度准确性。生姜和卡瓦CRM中的每种成分均在目标浓度的5%和7%以内,分别。
结论:生产的均相卡瓦和生姜植物化学溶液混合物具有准确的成分浓度,并在两年内表现出良好的稳定性。这些溶液混合物作为市售CRM推出。
结论:这些混合物可用作精确的浓度储备溶液,以制备用于植物膳食补充剂产品测试和标准化的校准器和对照。
BACKGROUND: Dietary supplements derived from botanicals are commonly consumed and investigated in biomedical studies for their potential health benefits. Accurate identification and quantification of key chemical constituents from botanical ingredients is necessary for consistent product preparations and reproducible research results. Manufacturers need quantitative reference materials of the chemical constituents of interest to verify the content of ingredients and products. The rigor and reproducibility of biomedical research is enhanced through thorough characterization of the interventions used in mechanistic, clinical, and safety investigations. Quantitative reference materials enable reliable product quality assessments and reproducible research results.
OBJECTIVE: Solution-based certified reference material (CRM) mixes were developed as calibrants for phytochemicals in ginger and kava. The kava CRM contained yangonin, desmethoxyyangonin, dihydrokavain, DL-kavain, methysticin, dihydromethysticin, flavokawain A, flavokawain B, and flavokawain C. The ginger CRM contained 6-gingerol, 8-gingerol, 10-gingerol, 6-shogaol, 8-shogaol, and 10-shogaol.
METHODS: Each phytochemical was sourced as an isolated compound and assigned a purity factor by a mass balance approach accounting for residual impurities. The solution standard mixes were formulated by gravimetric addition of each phytochemical incorporating the purity factor and diluting with acetonitrile to the target concentrations of 500 µg/mL for the gingerols and
shogaols, 250 µg/mL for the kavalactones, and 25 µg/mL for the flavokawains.
RESULTS: The concentration accuracy of each component in the solution mixes was analytically verified by ultra high performance liquid chromatography with ultraviolet detection (UHPLC-UV) assay comparison to an independently prepared calibration solution. Each component in the ginger and kava CRMs were within 5 and 7% of the target concentrations, respectively.
CONCLUSIONS: Homogeneous kava and ginger phytochemical solution mixes were produced with accurate constituent concentrations and demonstrated good stability over 2 years. These solution mixes were launched as commercially available CRMs.
CONCLUSIONS: These mixes can be used as accurate concentration stock solutions to prepare calibrators and controls for botanical dietary supplement product testing and standardization.