中药、天然药物药学研究资料综述撰写格式与要求技术指导原则

1、（第二稿草稿）二OO 五年三月2目录一、概述··············································&#

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3、183;·································· 1二、撰写格式和要求· · · · · · · · · · · 

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11、183;········· 11.1.1 剂型选择及规格的确定依据·····································

12、··········································· 11.1.2 制备工艺及研究内容····&

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14、#183;································· 11.1.3 质量研究及质量标准·············&#

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38、药和天然药物制剂的申请········································· 51、主要研究结果综述·····&

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43、.2 质量研究及质量标准················································

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47、#183;············ 51.4 说明书、包装、标签··································

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56、3;············· 6附：中药、天然药物药学研究资料综述撰写格式和要求技术指导原则的起草说明······························

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58、83;··········· 74一、概述本指导原则是根据药品注册管理办法的有关要求，结合我国中药、天然药物研发的实际情况而制订。本指导原则的制订旨在指导注册申请人规范对药学研究综述资料的撰写，引导注册申请人对药学研究结果及药学与药理毒理、临床等相关研究之间的相互联系进行分析与评价，关注药品研究的整体性、系统性和科学性，从而提高药品研究开发的水平。药学研究包括原料的鉴定与前处理、剂型选择、制备工艺研究、中试研究、质量研究和质量标准的制订、稳定性研究（包括直接接触药品的包装材料或容器的研

59、究）等几个部分。药学研究资料综述则是注册申请人对所进行 的药学研究结果的总结、分析与评价。本指导原则主要内容包括：新药申请和已有国家标准的中成药和天然药 物制剂的申请；新药申请又包括申请临床研究和申请生产。二、药学研究资料综述的格式和要求（一）中药、天然药物新药申请1、申请临床研究1.1 主要研究结果综述1.1.1 剂型选择及规格的确定依据根据文献和/或试验研究结果，简述剂型选择及规格确定的依据。1.1.2 制备工艺及研究内容简述【制法】。若为改剂型或/和改变工艺的品种，还需简述现工艺和原 工艺的不同之处及参数的变化情况。5简述工艺路线。简述制备工艺参数及确定依据，如：提取、分离、纯化、浓缩、

60、干燥、 成型工艺的试验方法、考察指标等。简述中试研究结果和质量检测结果，包括批次、规模以及投料量、辅料 量、中间体得量（得率）、成品量和成品率。说明中试用药材的含量测定结 果及含量测定成分的转移率。评价工艺的合理性。1.1.3 质量研究及质量标准原料、辅料的质量标准：说明原料、辅料法定标准出处、药材检验的依据，说明对原药材建立的质量控制方法。说明已建立的药材的含量测定方法 及含量限度。无法定标准的药材或辅料，说明是否按照法规进行了相关研究 及申报，说明是否研究建立了质量标准。说明是否建立了中间体的质量标准，并简述其主要检测项目。简述质量标准的内容，说明未列入质量标准的研究内容。鉴别：简述质量标

61、准中列入的鉴别项目，简述方法及结果，包括所采用的鉴别方法、鉴别药味、对照药材和/或对照品，阴性对照结果，方法是否具 有专属性。对未列入质量标准中的药味所进行的研究工作，说明不列入标准 （草案）正文的理由。说明对照品和对照药材的来源。检查：说明检查项目、检查方法及结果。说明特殊检查的检查方法、依据及结果。说明与安全性有关的指标是否建立了质量控制方法和限度，如： 重金属及有害元素的检查方法和结果、有机溶剂残留量、大孔树脂残留物等 6检查方法和限度。含量测定：说明含测指标和方法确定的依据、测定样品的批次、含量限度制定及依据等。对照品的来源及纯度。非法定来源的对照品尚需简述结构 确证的研究与结果。说明

62、自检样品的结果。评价质量标准可控性。说明质量标准与安全性、有效性的相关性。1.1.4 初步稳定性考察简述稳定性考察结果，包括考察样品的批次、时间、方法、拟定的贮藏条件、考察指标、考察结果、直接接触药品的包装材料和容器。评价产品的稳 定性。1.2 分析与评价对剂型选择、工艺研究、质量控制研究、稳定性考察的结果进行总结，分析各项药学研究工作之间的联系，结合临床应用背景、药理毒理研究结果 及文献资料等，分析药学研究工作与产品的安全性、有效性之间的相关性， 评价工艺合理性、质量可控性，初步判断稳定性。2、申报生产除与申请临床研究相同的上述要求外，尚需明确：2.1 主要研究结果综述2.1.1 临床批件情况简述临床批件号和获得时间，临床批件中的遗留问题，针对批件要求所 进行的工作。2.1.2 生产工艺7明确临床研究前、后工艺的一致性。若有改变，需要说明改变的内容及 依据。简述中试样品的批次、规模、检查结果等，说明工艺是否稳定。若申请减免临床研究的改剂型品种，需说明原工艺的合理性，比较现工 艺和原工艺的异同，初步判断工艺变化的程度。2.1.3 质量研究与质量标准明确质量标准与临床前是否一致，说明改变的内容、理由及依据。简述质量标准内容。说明含量测定的批次、拟定的含量限度及确定依据。2.1.4 稳定性考察简述稳定性研究情况，包括考察样品的批次、时间、方法（室温、加速）、 拟定的贮藏条件、考