Central Laboratory of German Pharmacists, Eschborn, Germany.
Clin Pharmacokinet. 2011 Jun;50(6):349-69. doi: 10.2165/11586800-000000000-00000.
Non-steroidal anti-inflammatory drug (NSAID) intake is associated with high prevalence of gastrointestinal or cardiovascular adverse effects. All efforts to develop NSAIDs that spare the gastrointestinal tract and the cardiovasculature are still far from achieving a breakthrough. In the last two decades, preparations of the gum resin of Boswellia serrata (a traditional ayurvedic medicine) and of other Boswellia species have experienced increasing popularity in Western countries. Animal studies and pilot clinical trials support the potential of B. serrata gum resin extract (BSE) for the treatment of a variety of inflammatory diseases like inflammatory bowel disease, rheumatoid arthritis, osteoarthritis and asthma. Moreover, in 2002 the European Medicines Agency classified BSE as an 'orphan drug' for the treatment of peritumoral brain oedema. Compared to NSAIDs, it is expected that the administration of BSE is associated with better tolerability, which needs to be confirmed in further clinical trials. Until recently, the pharmacological effects of BSE were mainly attributed to suppression of leukotriene formation via inhibition of 5-lipoxygenase (5-LO) by two boswellic acids, 11-keto-β-boswellic acid (KBA) and acetyl-11-keto-β-boswellic acid (AKBA). These two boswellic acids have also been chosen in the monograph of Indian frankincense in European Pharmacopoiea 6.0 as markers to ensure the quality of the air-dried gum resin exudate of B. serrata. Furthermore, several dietary supplements advertise the enriched content of KBA and AKBA. However, boswellic acids failed to inhibit leukotriene formation in human whole blood, and pharmacokinetic data revealed very low concentrations of AKBA and KBA in plasma, being far below the effective concentrations for bioactivity in vitro. Moreover, permeability studies suggest poor absorption of AKBA following oral administration. In view of these results, the previously assumed mode of action - that is, 5-LO inhibition - is questionable. On the other hand, 100-fold higher plasma concentrations have been determined for β-boswellic acid, which inhibits microsomal prostaglandin E synthase-1 and the serine protease cathepsin G. Thus, these two enzymes might be reasonable molecular targets related to the anti-inflammatory properties of BSE. In view of the results of clinical trials and the experimental data from in vitro studies of BSE, and the available pharmacokinetic and metabolic data on boswellic acids, this review presents different perspectives and gives a differentiated insight into the possible mechanisms of action of BSE in humans. It underlines BSE as a promising alternative to NSAIDs, which warrants investigation in further pharmacological studies and clinical trials.
非甾体抗炎药(NSAID)的摄入与胃肠道或心血管不良影响的高患病率有关。开发可避免胃肠道和心血管副作用的 NSAIDs 的所有努力仍远未取得突破。在过去的二十年中,乳香树(一种传统的阿育吠陀药物)的树胶树脂制剂和其他乳香属植物制剂在西方国家越来越受欢迎。动物研究和初步临床试验支持乳香树胶树脂提取物(BSE)治疗各种炎症性疾病的潜力,如炎症性肠病、类风湿关节炎、骨关节炎和哮喘。此外,2002 年,欧洲药品管理局将 BSE 归类为治疗肿瘤周围脑水肿的“孤儿药”。与 NSAIDs 相比,预计 BSE 的给药具有更好的耐受性,这需要在进一步的临床试验中得到证实。直到最近,BSE 的药理作用主要归因于通过抑制两种乳香酸,11-酮-β-乳香酸(KBA)和乙酰-11-酮-β-乳香酸(AKBA)来抑制白三烯的形成,从而抑制 5-脂氧合酶(5-LO)。这两种乳香酸也被选为欧洲药典 6.0 中印度乳香的专论中的标志物,以确保乳香树干燥胶树脂渗出物的质量。此外,几种膳食补充剂宣传富含 KBA 和 AKBA。然而,乳香酸未能抑制人全血中的白三烯形成,药代动力学数据显示 AKBA 和 KBA 在血浆中的浓度非常低,远低于体外生物活性的有效浓度。此外,吸收研究表明 AKBA 经口服给药后吸收不良。鉴于这些结果,以前假设的作用模式 - 即 5-LO 抑制 - 值得怀疑。另一方面,已经确定β-乳香酸的血浆浓度高出 100 倍,β-乳香酸抑制微粒体前列腺素 E 合酶-1 和丝氨酸蛋白酶组织蛋白酶 G。因此,这两种酶可能是与 BSE 的抗炎特性相关的合理分子靶标。鉴于 BSE 的临床试验结果和体外研究的实验数据,以及乳香酸的可用药代动力学和代谢数据,本综述提出了不同的观点,并对 BSE 在人类中的可能作用机制进行了区分。它强调了 BSE 作为 NSAIDs 的有前途的替代品,值得在进一步的药理学研究和临床试验中进行研究。
Clin Pharmacokinet. 2011-6
Planta Med. 2006-5
Phytomedicine. 2010-8-8
Adv Exp Med Biol. 2016
Inflammopharmacology. 2025-7-21
Pharmaceutics. 2024-8-16
Phytomedicine. 1996-5
BMJ. 2008-12-17
Trends Mol Med. 2008-10