概念/名词区分：中间体、中间态、中间产品。。。

概念/名词区分：中间体、中间态、中间产品。。。

注册申报

哪位老师是否能总结这块类似概念，希望看到又全又精的对比和解释。

包括英文名称、中文名称、名词解释、权威的出处。

涉及范围希望跨越原料药的中间体、中间态、到制剂的中间产品，是否涉及分子变化或者纯化分离，等等。

2022-07-02 14:59 匿名

评论回答 

6个回答

下面列出了中、美、欧、WHO、ICH、PIC/S中关于中间产品、Intermediate、Intermediate product、In-process materials的术语定义和出处。

比较发现，在制药行业中，关于中间产品的术语使用存在一定的差异。具体来说，美国21CFR中用词为In-process materials，EU/WHO/PICS GMP 通则中用词为 Intermediate product，ICH/EU/WHO/PICS 原料药GMP中用词为Intermediate。其中，EU/WHO/PICS API GMP内容均源于ICH Q7A，并且在术语定义中已明确说明“只涉及生产企业定义为原料药生产起点以后生产的中间体”。

另外，可以发现，EU/PICS、WHO文件中Intermediate product术语定义用词又略有不同，EU/PICS用词为“Partly processed material which……（完成部分加工步骤的物料……）”，WHO 用词为“Partly processed product that……（完成部分加工步骤的产品……）”。

根据以上内容，可以认为以制剂产品为终点的完成部分步骤的物料或产品可以称为中间产品；以API为终点的完成部分步骤的物料可以称为中间体。在实际生产中，可以认为Intermediate product和In-process materials，以及中国GMP中的中间产品含义相同。

**各机构GMP文件中对应术语定义**
机构	术语
中国 GMP	中国GMP 第十四章附则第三百一十二条（四十一）中间产品：指完成部分加工步骤的产品，尚需进一步加工方可成为待包装产品。
FDA cGMP	21 CFR 210 In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. 中间产品是指所有为了药品制备而制造、复合、混合或由化学反应衍生，并在药品制备中使用的物料。
EU GMP	EU GMP Part I - Basic Requirements for Medicinal Products Intermediate product：Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
	EU GMP Part II - Basic Requirements for Active Substances used as Starting Materials （同ICH Q7A） Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) API生产阶段中得到的物料，该物料需经进一步的分子改变或纯化才能成为API。中间体可能可以分离，也可能无法分离（注：本指南仅阐述企业确定的 API生产起点之后所产生的中间体）。
	EU GMP Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use Intermediate product: see definitions in GMP Glossary and in Part II.
	EU GMP IV: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Intermediate: Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
ICH Q7A	ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) 原料药工艺步骤中产生的、须经进一步分子变化或精制方可成为原料药的物料。中间体可以分离也可以不分离（注：本指南只涉及生产企业定义为原料药生产起点以后生产的中间体。）
WHO GMP	Good Manufacturing Practices for pharmaceutical products: main principles (TRS 986, Annex 2, 2014) Intermediate product: Partly processed product that must undergo further manufacturing steps before it becomes a bulk product.
WHO GMP	WHO good manufacturing practices for active pharmaceutical ingredients (TRS 957, Annex 2, 2010) （同ICH Q7A）
PICS GMP	PIC/S GMP Guide Glossary Intermediate product: Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
PICS GMP	PICS GMP Guide Part II: Basic Requirements for Active Pharmaceutical Ingredients Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) API生产阶段中得到的物料，该物料需经进一步的分子改变或纯化才能成为API。中间体可能可以分离，也可能无法分离（注：本指南仅阐述企业确定的 API生产起点之后所产生的中间体）。

2023-02-23 18:12 史地小学生

评论 

现在有一种说法，基本都是叫中间体。

而不在区分，原料药中叫中间体，制剂叫中间产品

2023-09-11 14:47 陆云

评论 

下面列出了中、美、欧、WHO、ICH、PIC/S中关于中间产品、Intermediate、Intermediate product、In-process materials的术语定义和出处。

通过观察比较发现，在制药行业中，关于中间产品的术语使用存在一定的差异。具体来说，美国21CFR中用词为In-process materials，EU/WHO/PICS GMP 通则中用词为 Intermediate product，ICH/EU/WHO/PICS 原料药GMP中用词为Intermediate。其中，EU/WHO/PICS API GMP内容均源于ICH Q7A，并且在术语定义中已明确说明“只涉及生产企业定义为原料药生产起点以后生产的中间体”。

**各机构GMP文件中对应术语定义**
机构	术语
中国 GMP	中国GMP 第十四章附则第三百一十二条（四十一）中间产品：指完成部分加工步骤的产品，尚需进一步加工方可成为待包装产品。
FDA cGMP	21 CFR 210 In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. 中间产品是指所有为了药品制备而制造、复合、混合或由化学反应衍生，并在药品制备中使用的物料。
EU GMP	EU GMP Part I - Basic Requirements for Medicinal Products Intermediate product：Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
	EU GMP Part II - Basic Requirements for Active Substances used as Starting Materials （同ICH Q7A） Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) API生产阶段中得到的物料，该物料需经进一步的分子改变或纯化才能成为API。中间体可能可以分离，也可能无法分离（注：本指南仅阐述企业确定的 API生产起点之后所产生的中间体）。
	EU GMP Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use Intermediate product: see definitions in GMP Glossary and in Part II.
	EU GMP IV: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Intermediate: Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
ICH Q7A	ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) 原料药工艺步骤中产生的、须经进一步分子变化或精制方可成为原料药的物料。中间体可以分离也可以不分离（注：本指南只涉及生产企业定义为原料药生产起点以后生产的中间体。）
WHO GMP	Good Manufacturing Practices for pharmaceutical products: main principles (TRS 986, Annex 2, 2014) Intermediate product: Partly processed product that must undergo further manufacturing steps before it becomes a bulk product.
WHO GMP	WHO good manufacturing practices for active pharmaceutical ingredients (TRS 957, Annex 2, 2010) （同ICH Q7A）
PICS GMP	PIC/S GMP Guide Glossary Intermediate product: Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
PICS GMP	PICS GMP Guide Part II: Basic Requirements for Active Pharmaceutical Ingredients Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) API生产阶段中得到的物料，该物料需经进一步的分子改变或纯化才能成为API。中间体可能可以分离，也可能无法分离（注：本指南仅阐述企业确定的 API生产起点之后所产生的中间体）。

2023-02-23 17:51 史地小学生

评论 

回答：

做个补充

中间体 intermediate

又称有机中间体。用煤焦油或石油产品为原料以制造染料、农药、医药、树脂、助剂、增塑剂等的中间产物。因最初用于制造染料，也称染料中间体。

中间体是指半成品，是生产某些产品中间的产物，比如要生产一种产品，可以从中间体进行生产，节约成本。

最初指用煤焦油或石油产品为原料合成香料、染料、树脂、药物、增塑剂、橡胶促进剂等化工产品的过程中，生产出的中间产物。现泛指有机合成过程中得到的各种中间产物。

所谓医药中间体，实际上是一些用于药品合成工艺过程中的一些化工原料或化工产品。这种化工产品，不需要药品的生产许可证，在普通的化工厂即可生产，只要达到一些的级别，即可用于药品的合成。

-----来源：

百度词条

王镜岩朱圣庚徐长法．生物化学（第三版上册）．北京：高等教育出版社，2002：6

龚跃法，郑炎松，陈东红等编著. 有机化学. 武汉：华中科技大学出版社, 2012.02

中间态：

暂时未找到相关描述，个人同意楼上说的应该是某一产品或者物体的中间状态，比如水在零度以下是固态，零度是固液共存态，零度以上是液态。

中间产品 Intermediate

指完成部分加工步骤的产品，尚需进一步加工方可成为待包装产品。

-----中国GMP 第十四章附则

In-process material 是指所有为了药品制备而制造、复合、混合或由化学反应衍生 , 并在药品制备中使用的物料。

means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.

-----FDA CFR 210

Bulk product

散装产品（个人理解：即包含中国GMP中中间产品和待包装产品，既可以用于原料药的中间体也可用于制剂的中间产品）

Any product which has completed all processing stages up to, but not including, final packaging.

完成所有加工阶段直至（但不包括）最终包装的任何产品。

-----欧盟GMP

2022-07-12 18:10 漆白雪黑

评论 

需要这些信息做什么呢？

想解决什么问题呢？

这个问题看了很久，不知道该怎么回答。

中间体或者中间产品，一般是为了最终控制成品而对中间环节进行控制的。那么中间环节的东西，通常有这两种叫法

至于中间态，是中间体或者中间产品的状态吧，比如液体，固体，或者气体呢？

难道是为了写论文？

2022-07-11 19:41 牧魂

评论 

用于销售的中间体称为中间产品。[医药]中间体一般用来合成API，所以中间体可以作为API的原料。

商品中间体：生产原料药过程中产生的可以被下游厂家用于进一步加工为原料药的中间产品。

一般中间体也叫中间产品。

2022-07-04 17:13 阳光蒲照

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