基于质量源于设计理念研究不同地区余甘子的关键性状

Quality by Design approach for the investigation of critical characteristics of Phyllanthus emblica from different vicinities

  • 摘要:
    目的探讨质量源于设计(QbD)工具在评估印度5个不同地区余甘子地理变异中的应用。
    方法在本实验中,采用简化四次模型的 Box-Behnken 设计,运行105次,结合使用 Design Expert 软件进行随机响应面映射。本研究使用了三种不同的浸提方法(索氏浸提、浸渍浸提和超声浸提)以及三种溶剂 蒸馏水、甲醇和水-甲醇混合物(50 : 50 v/v)。采用气相色谱-质谱法(GC-MS)测定并分析余甘子的抗氧化活性、总黄酮含量(TFC)和总酚含量 (TPC),以鉴定其主要成分。
    结果QbD叠加图显示余甘子的提取值不低于30% w/w,2,2-二苯基-1-三硝基苯肼(DPPH)不低于60% mcg/mL(微克每毫升),TFC 不低于75 mg QE/g (毫克槲皮素当量每克干原料),TPC不低于80 mg GAE/g (毫克没食子酸当量每克干原料)。此外,(GC-MS)数据证实了余甘子的生物活性存在变异。
    结论本研究模型能较好的描述浸提值、DPPH、TFC和 TPC 的变化。QbD方法可能倾向于在浸提过程中优先考虑彻底性,最终提高浸提产品的质量。

     

    Abstract:
    ObjectiveTo explore the application of Quality by Design (QbD) tools in assessing geographical variations of Phyllanthus emblica (P. emblica) from five distinct Indian states.
    MethodsIn the current experiment, the Box-Behnken design with a reduced quartic model and 105 runs was employed with the use of the Design Expert software for randomized response surface mapping. Three different extraction methods (Soxhlet, maceration, and sonication) along with three solventst distilled water, methanol, and water-methanol mixture (50 : 50 v/v) were considered in the present study. The anti-oxidant activities, total flavonoid content (TFC), and total phenolic content (TPC) in the P. emblica were determined and analysed by gas chromatography-mass spectrometry (GC-MS) to identify the major components.
    ResultsThe QbD overlay plot showed that the extractive value of the P. emblica was no less than 30% w/w, 2,2-diphenyl-1-picrylhydrazyl (DPPH) no less than 60% mcg/mL (micrograms per millilitre), TFC no less than 75 mg QE/g (milligrams of quercetin equivalents per gram), and TPC no less than 80 mg GAE/g (milligrams of gallic acid equivalents per gram). Moreover, the GC-MS data confirmed the presence of variation in the bioactives of P. emblica extracts.
    ConclusionThe model was significant in describing the variation in extractive value, DPPH, TFC, and TPC. The QbD approach may tend to prioritize thoroughness in the extraction process, ultimately resulting in improved quality in the extracted products.

     

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