Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：生脉公式(SMF)，治疗气阴两虚的经典配方，由人参（GRR）组成，麦冬（OR），五味子（SC），并已开发成各种剂型，包括生脉饮口服液（SMY），生脉胶囊(SMC),生脉注射液（SMI）。复方中药的药理作用归因于多种成分的整合。然而，SMF的质量标准仅限于监测五味子醇A或人参皂苷Rg1和Re，但没有或。由于原料和制剂的复杂性，建立一种经济、统一的SMF方法具有挑战性。迫切需要使用通用的SMF质量控制方法同时量化具有不同结构的多种成分。电荷气溶胶探测器(CAD)由于其响应性高的特点,克服了上述缺点,不歧视,和低成本。
目的：我们旨在使用HPLC-CAD建立一种通用的分析策略，以同时定量SMF从原料到制剂的质量控制中的结构多样性标记。
方法：通过优化色谱柱，流动相,柱温,流量,和CAD参数，一种整合了多组分表征的HPLC-CAD方法，真实性鉴定，建立了生脉制剂的原料信息传递和定量测定。
结果：表征了来自SMF的总共50个成分（GRR为28，13在SC，和9inOR)。SC和五味子（SS）的原料差异，人参（GR）和GRR的加工方法，比较了四川（ORS）和浙江（ORZ）的OR位置。19批SMY中的14个组件，来自不同制造商的SMC和SMI进行了量化，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生脉制剂中Rb1、Rg1和Ro是主要差异。
结论：基于HPLC-CAD建立的多功能分析策略被证明是灵敏的，简单,方便,克服了紫外检测器的判别作用，揭示SMF的成分和传输信息，适用于成分草药的认证和提高生脉制剂的质量。
目的：我们旨在使用HPLC-CAD建立一种通用的分析策略，以同时定量SMF从原料到制剂的质量控制中的结构多样性标记。
方法：通过优化色谱柱，流动相,柱温,流量,和CAD参数，一种整合了多组分表征的HPLC-CAD方法，真实性鉴定，建立了生脉制剂的原料信息传递和定量测定。
结果：表征了来自SMF的总共50个成分（GRR为28，13在SC，和9inOR)。SC和五味子（SS）的原料差异，人参（GR）和GRR的加工方法，比较了四川（ORS）和浙江（ORZ）的OR位置。19批SMY中的14个组件，来自不同制造商的SMC和SMI进行了量化，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生脉制剂中Rb1、Rg1和Ro是主要差异。
结论：基于HPLC-CAD建立的多功能分析策略被证明是灵敏的，简单,方便,克服了紫外检测器的判别作用，揭示SMF的成分和传输信息，适用于成分草药的认证和提高生脉制剂的质量。
