美国植物药开发和审评-寇秀静.ppt

* * * 每个成分的特征及化学成分不完全明确，也不是所有活性成分都清楚。增加了CMC控制和临床药理学研究的难度 由于植物药通常不是来自于原药材的高纯化药，痕量重金属污染、农药残留以及传染性微生物是主要的质量关注点，对于这些杂质的控制比在高纯化化学药中更为复杂。此外，由于植物药的生物学属性，保持其稳定性也有一定困难。 批次间的不一致性是常见问题。生产者可以通过应用FDA的植物药指南中的要点，以及遵循药用植物种植与采集质量管理规范，达到对植物药原药材的充分质量控制 栽培后加工方法的改变及其对于治疗效果的潜在影响进一步使植物性药材的质量问题复杂化。FDA要求所有的植物药产品都应详尽说明和描述原药材及其加工过程，而不只是针对原料药和最终的药品 Veregen? was clinically developed by Medigene. Subsequently, Medigene was responsible for bringing the drug successfully through the approval process. Veregen? is the first, and to date the only, innovative botanical drug approved by the US Food and Drug Administration (FDA). Furthermore, Medigene is the first German biotech company to have a drug on the US market. In Europe, marketing authorization for Germany, Austria, Spain, France, Denmark, Norway, Poland, Slovenia, Sweden, Finland, Netherlands, Belgium, Hungary, Slovenia, Romania, Bulgaria and Cyprus has been granted to date. On the basis of the regulatory decision in March 2012 to grant marketing authorization for Veregen? in numerous European countries, the respective national marketing authorizations for the Czech Republic, Greece, and Luxembourg are expected within the next few months. Outside the EU, Veregen? has been approved in Switzerland, Israel and Serbia. Applications for approval have been submitted in further countries. Veregen? is also listed in recognized treatment guidelines. Sinecatechins 15% ointment (Veregen?) is recommended in the US Department of Health and Human Services Center for Disease Control and Preventions Sexually Transmitted Diseases Treatment Guidelines 2010 as a possible option for treating genital warts. * * 。在这些治疗领域中， 肿瘤及其相关疾患受到较多的关注，其次是炎症和疼痛、内分泌和代谢性疾病、病毒感染以 及皮肤和口腔科适应症。这些资料表明，植物药在临床审评严格的几个治疗领域有增长的兴 趣，并且主要集中于对新的治疗有明确医疗需求的适应症（例如，肿瘤、炎性疾病和病毒感 染）。 * 从Camellia sinensis(L.) O Kuntze绿茶叶中提取的以茶多酚为主的植物制剂 茶多酚 85－95% （8种已知儿茶素） 55％的Epigallocatechin gallate(EGCg) 其它3种主要儿茶酚 4种儿茶酚衍生物 其他已知成分 2.5% 未确定成分 Veregen TM * 终产品含90%儿茶酚和10%未知成分 整体临床有效，质量可控 单一植物单一部位 无需提供每种主要成分是否都与安全性或有效性有