Xue Mei, Yang Lin, Shi Da-zhuo, Radauer Christian, Breiteneder Heimo, Ma Yan
Center of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Molecular Research in Traditional Chinese Medicine Group, Department of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology & Immunology, Medical University of Vienna, Vienna, Austria.
Chin J Integr Med. 2015 Oct;21(10):772-7. doi: 10.1007/s11655-015-2311-2. Epub 2015 Nov 3.
To develop a reliable method to assess the stability of xinyue capsules containing Panax quinquefolius saponins according to European quality standards.
An efficient high-performance liquid chromatography ultraviolet (HPLC-UV) method was established to analyse six main ginsenosides (Rb1, Rb2, Rc, Rd, Re and Rg1) in six different batches (120 capsules/batch) from the same lot of xinyue capsules and in one batch measured six times within one day. The six ginsenosides were separated on a Hypersil BDS-C18 column (3 μm, 100 mm×3 mm) at a flow rate of 0.5 mL/min. Gradient elution was performed using a mobile phase gradient of acetonitrile-water modified with 0.01% formic acid. The HPLC chromatograms were analyzed with "LC data comparison" using Lab Solutions software.
The HPLC peaks were identified by comparing their retention times (Rg1: 23.44 min, Re: 23.77 min, Rb1: 35.24 min, Rc: 36.18 min, Rb2: 38.55 min and Rd: 40.88 min) with those of the standards under the same chromatographic conditions, which showed similar results among the samples of six different batches and among the samples from one batch detected six times within one day.
Xinyue capsules have good drug intra-day consistency at room temperature and exhibit a consistent quality between different batches. This study established a reliable method to assess the stability of xinyue capsules, which is suitable for further qualitative analysis and may assist in promoting the safe and effective use of Chinese herbal medicine.
根据欧洲质量标准，开发一种可靠的方法来评估含西洋参皂苷的心悦胶囊的稳定性。
建立高效液相色谱 - 紫外检测法（HPLC - UV），分析同一批次心悦胶囊的六个不同批次（每批次120粒胶囊）中的六种主要人参皂苷（Rb1、Rb2、Rc、Rd、Re和Rg1），并在一天内对一批样品进行六次测定。六种人参皂苷在Hypersil BDS - C18柱（3μm，100mm×3mm）上以0.5mL/min的流速分离。采用含0.01%甲酸的乙腈 - 水流动相梯度进行梯度洗脱。使用Lab Solutions软件通过“LC数据比较”对HPLC色谱图进行分析。
通过在相同色谱条件下将保留时间（Rg1：23.44分钟，Re：23.77分钟，Rb1：35.24分钟，Rc：36.18分钟，Rb2：38.55分钟，Rd：40.88分钟）与标准品的保留时间进行比较来鉴定HPLC峰，六个不同批次的样品以及一天内对一批样品进行六次检测的结果显示相似。
心悦胶囊在室温下具有良好的日内药物一致性，不同批次间质量表现一致。本研究建立了一种可靠的方法来评估心悦胶囊的稳定性，适用于进一步的定性分析，并可能有助于促进中药的安全有效使用。
