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新时代,中药制剂传承发展要注重这三点
时间:2018-02-02 点击率 : 931

新时代,中药制剂传承发展要注重这三点

作者:吴守恭

单位:山西黄河中医药研究所

提要:建议新时代中药制剂传承发展方略为:科学思维,精准发力;医彰圣道,药聚善德;药选道地,炮制适中;组方科学,量剂合理;标准煎液,质量基准;悟道觅法,精工智造。


      中医药是我国各族人民在几千年生产生活实践中,在与疾病作斗争中逐步形成并不断丰富发展的医学科学。党的十九大报告中提出“坚持中西医并重,传承发展中医药事业”,充分体现了以习近平总书记为核心的党中央对中医药发展的高度重视,为我们在新时代推动中医药振兴发展提供了遵循,指明了方向。健康是美好生活的基石。全面推进中药制剂健康有序发展是落实“传承发展中医药事业”战略部署的战术举措。其主旨是着力推进中医药健康养生文化的创造性转化、创新性发展;着力发挥中医药在治未病中的主导作用,在治疗重大疾病中的协同作用,在疾病康复过程中的核心作用;着力服务健康中国建设。

      建议新时代中药制剂传承发展方略为:科学思维,精准发力;医彰圣道,药聚善德;药选道地,炮制适中;组方科学,量剂合理;标准煎液,质量基准;悟道觅法,精工智造。

效用最大风险最小

       “科学的发展史,就是一部思维的发展史,在人们的社会实践中正是思维提供了客观世界的真实情况和运动规律,从而推动了科学的发展,而科学的发展,又对人类的思维提出了更高的要求”。以“博学之、审问之、慎思之、明辨之、笃行之”的治学精神,辨析中药制剂及相关药物概念内涵,有利于推动中医药事业的健康发展。

中药制剂是中医药临床应用的主要形式和手段。中药制剂研究是方剂研究概念内涵的拓展延伸。旨在研究以中药饮片为主要原料,由无形的“方”制成有形的“药”的技术、方法、规律,寻求处方、剂量、剂型、工艺四要素各自安全有效的最佳契合点。追求药物效用最大化、安全风险最小化的目标。

       医疗机构临方制剂(简称临方制剂)是中医执业医师遵循“辨证论治、四诊合参、理法方药、君臣佐使”的原则,遣药组方制成的一人一方制剂。常用剂型包括汤、丸、散、膏、丹等传统剂型,其中,汤剂是主要剂型。医师对临方制剂质量负总责,药房调剂或委托加工方承担相应的质量责任。

       医疗机构制剂(简称医院制剂)是指医疗机构根据本单位临床需要,经批准而配制、自用的固定处方制剂。剂型以现代剂型(颗粒剂、胶囊剂、片剂、合剂)及传统剂型(丸、散、膏、丹)常用。医疗机构对医院制剂质量负总责,委托配制医院制剂,委托方和受托方对配制的医院制剂的质量安全分别承担相应责任。

       中成药(亦称成方制剂)是指在中医药理论指导下,经过药学和临床研究,获得国家药品管理部门的批准,以中医处方为依据,以中药饮片为原料,按照规定的生产工艺和质量标准制成一定剂型,质量可控,安全有效的药品。

多点着力传承发展

       处方组成多元化是中药制剂传承发展的必然选择。处方组成多元可追溯至阿胶在汤剂中的应用。现行国家规定是2008年国家药品监督管理局颁布的《中药注册管理补充规定》中第五条,即“中药复方制剂应在中医药理论指导下组方,其处方组成包括中药饮片(药材)、提取物、有效部位及有效成分。”组织专题研究、制定实施细则,将其适用范围拓展到医院制剂、临方制剂,将有利于提高临方制剂特别是汤剂的质量疗效,有利于提高医院制剂的质量疗效,有利于“支持以中药制剂为基础研制中药新药”的落实,避免重复性研究。

       在临方制剂传承发展方面,修订相关规定,健康有序推进煎药标准化、智能化,提高汤剂质量疗效。受患者委托、按医师处方(一人一方)提供定制煮散剂、丸剂、散剂、膏剂、酒剂等服务。受患者委托,按医师处方(一人一方)应用中药传统工艺定制合剂、颗粒剂、胶囊剂(原粉)、糖浆剂、穴位贴膏剂等服务。

      在医院制剂传承发展方面,医疗机构应用传统工艺配制中药制剂实施备案管理,按相关规定积极开展备案制医院制剂品种研发工作,真正做到“低准入、高标准、严管理”,促进其健康有序发展。

在中成药传承发展方面,组分中药是以中医药理论为指导,遵循方剂配伍理论与原则,吸收现代药物研制方法和技术,由有效组分配伍而成的现代中药,是创新中药研究的一种途径。对促进中药事业发展,实现中药现代化、国际化具有重要意义。

       随着《中药经典名方复方制剂简化注册审批管理规定》征求意见,落实《中医药法》第三十条之规定将加快进入实施阶段,应按规定开展“标准煎液”研制与制剂研制。

科学指导保证疗效

       医彰圣道、药聚善德是中药制剂传承发展的核心价值观。道法自然,道为德之体,德为道之用,“道”通过“德”方彰自然之威力。天人合一,医为药之体,药为医之用,“医”通过“药”方显岐黄之神效。寻求社会主义核心价值观的融通之“道”,有利于推动社会主义核心价值观真正内化于心,外化于行。医彰圣道、药聚善德是将社会主义核心价值观融入中医药领域的具体体现。旨在彰显“勤求古训、博采众长、神圣工巧、仁心仁术”的大医精诚精神;弘扬“科学求真、人文求善、穷理尽微、精工智造”的大国工匠精神。

       药选道地、炮制适中是中药制剂质量疗效的基础。“药材好、炮制好、药才好。”药选道地,炮制适中是对制剂原料药中药饮片质量的概括。《中医药法》做出明确规定,多次以“国家支持”“国家鼓励”表述,表明药选道地、炮制适中已不仅仅是企业承诺,而应是落实“国家意志”的自觉行动。

       组方科学、量剂合理是中药制剂质量疗效的保证。组方科学、量剂合理是追求处方、剂型、剂量、疗效最大化,安全风险最小化目标的高度概括。处方是制剂疗效的理论基础,应遵循八条原则组方遣药;剂型是制剂疗效发挥的关键,其选择应据科学性、依从性、先进性;剂量是制剂疗效的物质保证。量,是决定疗效的关键,应科学解开“传方传药不传量”之谜,推进中药制剂进入“量化时代”。

      “中药药性组合量效量化分析方法”是以中药“药性理论”为指导、以“药为本体”,以研究处方配伍及剂量规律为主要内容、以“药材最大用量”为依据,以“药量效”为核心指标,通过对制剂的等效量效、配伍量效、剂量量效,以及药性组合的“四气”“四气五味”“四气五味归经”“升降浮沉”量化分析,对处方组成、用法用量及主治病症、病机、病位、治则治法的关联度、合理性、科学性进行评价的一种分析方法。

      标准煎液、质量基准是中药制剂质量稳定均一的检测依据。复方制剂“标准煎液”的概念内涵,一是标准煎液中的“标准”指制剂质量的基准,是作为衡量是否与中医临床所使用的药用物质一致的标准参照;二是“标准煎液”中的“煎液”形象地还原了中药临床用药方式,以此强调与中医临床传统用药方式的一致。“复方制剂标准水溶性可浸出物测定法”是以确保制剂与临床所使用的药用物质基本一致为目标设计的“标准煎液”制备方法。

      悟道觅法、精工智造是中药制剂传承发展的技术支撑。提煎之道指中药提取浓缩原创思维、哲学底蕴、内涵原理、核心技术、应用价值的概括。提煎之道旨在传承中医药哲学智慧、人文精神、医学科学价值的精髓,发扬数理实验科学的优势,践行质量源于设计“以终为始”的新理念。充分利用现代科学技术和方法成功地破解了中药提取浓缩过程中“质量均一稳定”难以控制的技术难题。

       悟道觅法是针对备案制医疗机构制剂与简化注册审批的中药经典名方复方制剂,以“水提取”的特殊性,以保证与原汤剂“药效物质”基本一致为目标,量身定制的水提取浓缩工艺技术。

       精工智造是指工欲善其事,必先利其器。利器善事工乃精,利器善用工可精,利器智能工必精。智能制造是中药制剂实现现代化、产业化、国际化的战略选择。



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