<br>采用 HPLC-CAD 的多功能经济策略，用于生脉方从原料到制剂的质量控制中对结构多样性标记物进行定量,Phytomedicine

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采用 HPLC-CAD 的多功能经济策略，用于生脉方从原料到制剂的质量控制中对结构多样性标记物进行定量
Phytomedicine ( IF 6.7 ) Pub Date : 2024-04-10 , DOI: 10.1016/j.phymed.2024.155625
Longchan Liu ₁ , Wenxiang Fan ₁ , Haoyue Zhang ₁ , Linhong Fan ₁ , Yuqi Mei ₁ , Ziying Wang ₁ , Linnan Li ₁ , Li Yang ₁ , Zhengtao Wang ₁

Affiliation

生脉方（SMF）是治疗气阴虚证的经典方剂，由人参赤根（GRR）、麦冬（OR）、五味子（SC）组成，已开发成多种剂型，包括：生脉饮口服液（SMY）、生脉胶囊（SMC）、生脉注射液（SMI）。中药复方的药理作用是多种成分的综合作用。然而，SMF 的质量标准仅限于监测五味子 A 或人参皂苷 Rg1 和 Re，但没有监测 OR。由于原料和制剂的复杂性，建立经济且统一的 SMF 方法具有挑战性。迫切需要使用通用方法同时量化具有不同结构的多种成分，以进行 SMF 的质量控制。电荷气溶胶检测器（CAD）以其高响应性、非歧视性和低成本的特点克服了上述缺点。我们的目标是使用 HPLC-CAD 建立一种多功能分析策略，用于同时量化 SMF 从原材料到制剂的质量控制中结构多样的标记物。通过优化色谱柱、流动相、柱温、流速和CAD参数，建立了集多组分表征、真伪鉴别、原料信息传递和生脉制剂定量测定于一体的HPLC-CAD方法。总共对 SMF 的 50 种成分进行了表征（GRR 中 28 种，SC 中 13 种，OR 中 9 种）。比较了SC和华中五味子(SS)的原料差异、人参(GR)和GRR的炮制方法以及四川(ORS)和浙江(ORZ)的OR产地的差异。对不同厂家19批次SMY、SMC、SMI中的14种成分进行了定量分析，其中人参皂苷11种，木脂素3种。多因素统计分析结果进一步提示Rb1、Rg1和Ro是生脉制剂之间的主要差异。所建立的基于HPLC-CAD的通用分析策略灵敏、简单、方便，克服了紫外检测器的歧视效应，揭示了SMF的成分和传递信息，适用于中药材的鉴定和提高生脉制剂的质量。

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A versatile economic strategy by HPLC–CAD for quantification of structurally diverse markers in quality control of Shengmai Formula from raw materials to preparations

Shengmai Formula (SMF), a classic formula in treating Qi-Yin deficiency, is composed of Ginseng Radix et Rhizoma Rubra (GRR) Ophiopogon Radix (OR), and Schisandra chinensis Fructus (SC), and has been developed into various dosage forms including Shengmai Yin Oral Liquid (SMY), Shengmai Capsules (SMC), and Shengmai Injection (SMI). The pharmacological effects of compound Chinese medicine are attributed to the integration of multiple components. Yet the quality criteria of SMF are limited to monitoring schisandrol A or ginsenosides Rg1 and Re, but none for OR. Since the complexity of raw materials and preparations, establishing a economical and unified method for SMF is challenging. It is urgent to simultaneously quantify multiple components with different structures using a universal method for quality control of SMF. Charged aerosol detector (CAD) overcame the above shortcomings owing to its characteristics of high responsiveness, nondiscrimination, and low cost. We aimed to establish a versatile analysis strategy using HPLC–CAD for simultaneously quantifying the structurally diverse markers in quality control of SMF from raw materials to preparations. By optimizing the column, mobile phase, column temperature, flow rate, and CAD parameters, a HPLC-CAD method that integrated multi-component characterization, authenticity identification, transfer information of raw materials and quantitative determination of Shengmai preparations was established. In total 50 components from SMF were characterized (28 in GRR, 13 in SC, and 9 in OR). The differences in raw materials between species of SC and Schisandrae sphenantherae Fructus (SS), processing methods of Ginseng Radix (GR) and GRR, and locations of OR from Sichuan (ORS) and Zhejiang (ORZ) were compared. Fourteen components in 19 batches of SMY, SMC and SMI from different manufacturers were quantified, including 11 ginsenosides and 3 lignans. The multivariate statistical analysis results further suggested that Rb1, Rg1 and Ro were the main differences among Shengmai preparations. The established versatile analysis strategy based on HPLC–CAD was proven sensitive, simple, convenient, overcoming the discriminatory effect of UV detector, revealing the composition and transfer information of SMF and applicable for authentication of the ingredient herbs and improving the quality of Shengmai preparations.

更新日期：2024-04-10

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