Studies on the Stability of Salvianolic Acid B as Potential Drug Material
Studies on the Stability of Salvianolic Acid B as Potential Drug Material
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DOI：
10.1002/pca.1291
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发表时间：
2011-07-01
影响因子：
3.3
通讯作者：
You, Song
中科院分区：
文献类型：
--
作者：
Zhou, Li-Na;Zhang, Xin;You, Song
丹参酸B（SalB）是从丹参根中分离出的主要水溶性化合物之一，丹参被广泛用作传统中药。虽然已经进行和报道了关于Sal B的一般稳定性的许多研究，但是仍然需要进一步研究作为潜在药物材料所需的稳定性。目的-研究Sal B在固态和在生理盐水（NS）溶液中储存期间的稳定性，按照ICH指导原则（2003年）和中国药典（2005年）的要求。方法学-采用中国药典中描述的高效液相色谱法（HPLC）分析Sal B稳定性。采用高效液相色谱-飞行时间质谱联用技术（HPLC-TOFMS）对Sal B的降解产物进行分离和鉴定。结果-在固态下，铝箔袋包装的Sal B在“加速条件”（40 ℃，75%相对湿度，RH）下可稳定储存6个月。然而，在高温（60 ℃）或高湿度（92.5或75%RH）的应力条件下，在开放暴露条件下观察到固体Sal B降解。在NS溶液中，Sal B在加速条件下发生严重降解。通过HPLC-TOFMS，9个降解产物进行了鉴定和可能的降解pathways wereduced.Conclusion -结果表明，潜在的药物材料Sal B可以用于固体制剂，但不适合用作液体制剂。版权所有（C）2011约翰威利父子有限公司
Introduction - Salvianolic acid B (Sal B) is one of the major water-soluble compounds isolated from the roots of Salvia miltiorrhiza, which is widely used as a traditional Chinese medicine. Although much research on the general stability of Sal B has been undertaken and reported, there is still a need for further study of the stability required as a potential drug material.Objective - To study the stability of Sal B in the solid state and in normal saline (NS) solution during storage, as required in the ICH guidelines (2003) and Chinese Pharmacopoeia (2005).Methodology - Sal B stability was analysed using the high-performance liquid chromatography (HPLC) method described in the Chinese Pharmacopoeia. HPLC coupled with time-of-flight mass spectrometry (HPLC-TOFMS) was applied for the separation and identification of the degradation products of Sal B.Results - In the solid state, Sal B packaged in aluminium foil bags was stable for 6 months under 'accelerated conditions' (40 degrees C, 75% relative humidity, RH). However, solid Sal B degradation was observed under open exposure to stress conditions of high temperature (60 degrees C) or high humidity (92.5 or 75% RH). In NS solution, Sal B underwent severe degradation under accelerated conditions. Through HPLC-TOFMS, nine degradation products were identified and the possible degradation pathway was deduced.Conclusion - The results demonstrate that the potential drug material Sal B could be used in a solid formulation, but is not suitable for use as a liquid formulation. Copyright (C) 2011 John Wiley & Sons, Ltd.