Na-Bangchang Kesara, Plengsuriyakarn Tullayakorn, Karbwang Juntra
Chulabhorn International College of Medicine, Thammasat University, Phaholyothin Rd, Khlong Luang, Pathum Thani 12120, Thailand.
Clinical Product Development, Nagasaki Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan.
Evid Based Complement Alternat Med. 2017;2017:5929234. doi: 10.1155/2017/5929234. Epub 2017 Nov 14.
Treatment and control of cholangiocarcinoma (CCA): the bile duct cancer is limited by the lack of effective chemotherapeutic drugs and alternative drugs are needed, particularly those from natural sources. This article reviews steps of research and development of (Thunb) DC. (AL) as potential candidate for CCA chemotherapy, with adoption of the reverse pharmacology approach. Major steps include (1) reviewing of existing information on its phytochemistry and pharmacological properties, (2) screening of its activities against CCA, (3) standardization of AL, (4) nonclinical studies to evaluate anti-CCA activities, (5) phytochemistry and standardization of AL extract, (6) development of oral pharmaceutical formulation of standardized AL extract, and (7) toxicity testing of oral pharmaceutical formulation of standardized AL extract. Results from a series of our study confirm anti-CCA potential and safety profiles of both the crude extract and the finished product (oral pharmaceutical formulation of the standardized AL extract). Phases I and II clinical trials of the product to confirm tolerability and efficacy in healthy subjects and patients with advanced stage CCA will be carried out soon.
胆管癌因缺乏有效的化疗药物而受到限制，需要替代药物，尤其是来自天然来源的药物。本文采用反向药理学方法，综述了（Thunb）DC.（AL）作为胆管癌化疗潜在候选药物的研发步骤。主要步骤包括：（1）回顾其植物化学和药理学特性的现有信息；（2）筛选其对胆管癌的活性；（3）标准化AL；（4）进行非临床研究以评估抗胆管癌活性；（5）AL提取物的植物化学和标准化；（6）开发标准化AL提取物的口服药物制剂；（7）标准化AL提取物口服药物制剂的毒性测试。我们一系列研究的结果证实了粗提物和成品（标准化AL提取物的口服药物制剂）的抗胆管癌潜力和安全性。该产品的I期和II期临床试验即将开展，以确认其在健康受试者和晚期胆管癌患者中的耐受性和疗效。
