Department of Pharmaceutical Analysis, School of Pharmacy, Hebei Medical University, 361 East Zhongshan Road, Shijiazhuang 050017, PR China.
Phytochem Anal. 2012 Jul-Aug;23(4):365-72. doi: 10.1002/pca.1366. Epub 2011 Oct 21.
The Kang-nao-shuai (KNS) capsule is a combined herbal prescription used in the treatment of insomnia, amnesia, neurasthenia, age-related dementia and brain injuries. Multiple constituents are considered to be responsible for the therapeutic effects of this herbal prescription. However, the quality control of the multicomponents is limited.
To establish a liquid chromatography-electrospray ionisation-mass spectrometry method for the analysis of 40 constituents in KNS capsules.
The optimal chromatographic conditions were achieved on an Agilent C₁₈-column with a gradient elution that consisted of methanol and 0.1% formic acid in water. The precursor and product ions of analytes were monitored on a hybrid quadrupole linear ion trap mass spectrometer in positive and negative mode respectively using multiple-reaction monitoring.
A total of 40 constituents including organic acid, flavonoid, quinone, terpene, alkaloid and saponin were quantified, most of the 40 components were determined for the first time in the KNS capsule. A quantitative HPLC-ESI-MS/MS method allowing the quantification of 40 marker compounds was optimised and validated for linearity, precision, accuracy, stability, specificity and limits of detection and quantification. The method was successfully applied to analyse 10 batches of KNS capsule.
The established method is simple and can be used as a tool for quality evaluation and control of this natural product.
抗脑衰胶囊是一种复方草药制剂，用于治疗失眠、健忘、神经衰弱、老年痴呆症和脑损伤。多种成分被认为是该草药处方发挥治疗作用的原因。然而，该复方的多成分质量控制是有限的。
建立一种液相色谱-电喷雾离子化-质谱法分析抗脑衰胶囊中 40 种成分的方法。
采用 Agilent C₁₈ 柱，以甲醇和 0.1%甲酸水溶液为流动相进行梯度洗脱，优化了色谱条件。采用混合四极杆线性离子阱质谱仪，在正负离子模式下，分别对分析物的前体离子和产物离子进行监测，采用多反应监测模式进行定量分析。
共定量分析了 40 种成分，包括有机酸、黄酮、醌、萜类、生物碱和皂苷，其中大部分成分是首次在抗脑衰胶囊中检测到。优化并验证了一种用于定量分析 40 种标记化合物的 HPLC-ESI-MS/MS 方法，该方法具有良好的线性、精密度、准确度、稳定性、特异性和检测限及定量限。该方法成功地应用于 10 批抗脑衰胶囊的分析。
所建立的方法简单，可用于该天然产物的质量评价和控制。
