ISO/TS 5044:2023 健康情報学 | ページ 6

3.1.1

コンセプト

特徴のユニークな組み合わせによって作成された知識の単位

注記 1: 概念には1 つ以上の名前を付けることができます。それは、1 つ以上の用語、画像、アイコン、または音声を使用して表すことができます。

3.1.2

カテゴリー

特定の特徴を共有するとみなされる実体の集合を分割すること

注記 1:カテゴリは多かれ少なかれ一般的です。あるカテゴリが別のカテゴリに包含される場合、関係が主張され、より具体的なまたは包含されるカテゴリと、より一般的なまたは包含されるカテゴリとの間の階層が取得されます。たとえば、「非経口ルート」は「静脈内ルート」よりも一般的です。

3.1.3

情報モデル

エンティティとそれらの間の関係のグラフィックおよびテキスト表現

注記 1:データ・モデル、概念データ・モデル、論理データ・モデル、エンティティー関係モデル、オブジェクト・クラス図、またはデータベース定義とも呼ばれます。

[出典:ISO/IEC 19763-12:2015, 4.2.24]

3.1.4

特性

オブジェクトまたはオブジェクトのセットのプロパティの抽象化

注記 1:特性は、 概念の説明 (3.1.1) および カテゴリーの区別 (3.1.2) に使用されます。

3.1.5

セマンティックリンク

2 つの概念間の有向結合関係または部分関係の形式的表現

注記 1: これには、一般的な関係を除くすべての関係が含まれます。

注記 2: セマンティック リンクには常に逆方向、つまり反対方向の別のセマンティック リンクがあります。

[出典:ISO 17115:2020, 3.2.5, 修正済み — 例が変更されました。]

3.1.6

漢方薬

医療および病気の予防と治療のために伝統的な中国医学 (TCM) 理論の指導の下で使用される物質または物質の組み合わせ

注記 1: これには、漢方薬、煎じ薬、顆粒状の個別処方箋医薬品 (GFIMP) および中国特許医薬品 (CPM) が含まれます。

[出典:ISO 18668-1:2016, 3.1]

3.2.1

chemical analysis

qualitative and quantitative analysis based on the chemical reactions of substances

3.2.2

bioanalysis

analysis of the biological activity (including efficacy and toxicity) of drugs using organisms including whole animals, in vitro tissues, organs, cells and microorganisms

3.2.3

character analysis

simple physical and chemical test method used to distinguish the true and the false by the apparent characters of the objects

3.2.4

impurity

substance that has no therapeutic effect or damages to the body

3.2.5

effective constituent

chemical constituents of Chinese materia medica, intermediates and Chinese patent medicine that are efficacious

3.2.6

endogenous toxic component

substance in medicine that causes adverse effects and damage to the body

3.2.7

exogenous harmful substance

harmful ingredients in medicine including pesticide residue, heavy metals, etc.

3.2.8

heavy metal

metal usually of relatively high density, atomic weight, or atomic number

Note 1 to entry: In metallurgy, for example, a heavy metal can be defined on the basis of density, whereas in physics, the distinguishing criterion can be the atomic number, while a chemist would likely be more concerned with chemical behaviour. More specific definitions have been published, but none of these have been widely accepted. A density of more than 5 g/cm3 is sometimes quoted as a commonly used criterion.

3.2.9

pesticide residue

chemical agent that remains in organisms, harvests, soil, water, pesticide progenitor in the atmosphere, toxic metabolites, degradation products and impurities

3.2.10

microbiological detection

process of active data-gathering with appropriate analysis and interpretation of biosphere data that can relate to disease activity and threats to human or animal health – whether infectious, toxic, metabolic, or otherwise, and regardless of intentional or natural origin – in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity

3.2.11

index

standard by which the level of something can be judged or measured

3.2.12

active ingredient

chemical or biological component that is included in the formulation of a health care product to achieve the intended purpose

3.2.13

moisture content

ratio of the mass of the quantity of water in a material to the mass of the dry material

[SOURCE:ISO 15206:2010, 3.24]

3.2.14

ash content

measure of the total amount of minerals present within traditional Chinese medicinal products

3.2.15

residual solvent

chemicals that pharmaceutical companies use to manufacture different prescription drugs

Note 1 to entry: They have various degrees of toxicity that are classified according to three levels. In order to adhere to national safety guidelines and ethics regarding human exposure to chemicals, manufacturers can only allow certain levels of solvents to remain in their finished products

3.2.16

pH value

measure of the concentration of acidity or alkalinity of a material in an aqueous solution

Note 1 to entry: The pH value is expressed on a logarithmic scale numbered from 0 to 14 with 7,0 as a neutral point, numbers higher than 7 denoting alkalinity and numbers lower than 7 denoting acidity.

[SOURCE:ISO 5127:2017, 3.12.2.29, modified — Note 2 to entry deleted.]

3.2.17

fingerprint

chromatogram that can identify the chemical characteristics of CMM, decoction piece, extractive and traditional Chinese medicinal products

Note 1 to entry: It is a comprehensive and quantifiable identification method, which is based on the systematic study of the chemical components of traditional Chinese medicine, and mainly used to evaluate the authenticity, superiority and stability of the quality of Chinese materia medica and semi-finished Chinese medicine products.

Note 2 to entry: Chinese medicine fingerprint technique has involved many methods, HPLC, TLCS and GC have been recognized as three conventional analytical methods.

3.2.18

Chinese materia medica

CMM

medicinal parts of medicinal plants, animals, and minerals after preliminary processing, which are used as raw materials in Chinese medicines

Note 1 to entry: This refers to the raw materials used to make decoction pieces.

[SOURCE:ISO 18668-1:2016, 3.2]

3.2.19

decoction piece

prescription medicinal processed from Chinese materia medica under the guidance of traditional Chinese medicine and processing methods for Chinese medicines

[SOURCE:ISO 18668-1:2016, 3.3, modified — Note 2 to entry deleted.]

3.2.20

extractive

single component or mixed component having a definite index component extracted from Chinese materia medica by a suitable method

3.2.21

traditional Chinese medicinal products

class of drugs made from raw material under the guidance of Chinese medicine theory, according to the provisions of the prescription and methods of processing

Note 1 to entry: Traditional Chinese medicinal products are used for clinical treatment or prevention of adverse health problems.

3.2.22

quality

essential identifying nature or character of somebody or something

3.2.23

formula

prescription of dispensing decoction pieces or active pharmaceutical ingredients (API) according to certain methods or rules

[SOURCE:WHO Western Pacific Region, 2007^[7]]

3.2.24

prescription dosage

quantity of each tablet in the formula issued by a Chinese medicine physician

3.2.25

production

act of manufacturing pharmaceutical goods

3.2.26

equipment

machinery, tools, etc. needed to complete drug production

3.2.27

critical process parameter

process parameter whose variability has an impact on a critical quality attribute and therefore needs to be monitored or controlled to ensure the process produces the desired quality

Note 1 to entry: A manufacturing parameter is considered “critical” and necessary for production of Substance or Specified Substance e.g. inclusion of chromatographic step for removal or reduction of impurities, viruses etc.

Note 2 to entry: The critical process is tied to the Production Method type.

[SOURCE:ISO 11238:2018, 3.20]

3.2.28

adjuvant material

substance added during processing in order to enhance the therapeutic usefulness of pharmaceutical herbal medicament treatment

Note 1 to entry: “Adjuvant” in this context does not mean the adjuvant in modern scientific parlance, rather, is used to support elution of bioactive substrates, enhancing efficacy and reducing toxicity, flavouring and taste masking, or as a filler.

[SOURCE:ISO/TS 18062:2016, 3.4]

3.2.29

environment

surroundings in which an organization operates, including air, water, land, natural resources, flora, fauna, humans and their interrelationships

[SOURCE:ISO 14001:2015, 3.2.1, modified — Notes removed.]

3.2.30

storage

complete process of production from the acquisition of all materials through all processing stages and including final packaging

3.2.31

efficacy

effect of drugs on the prevention and treatment of disease under prescribed indications, dosage and administration

Note 1 to entry: See ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) efficacy guidelines^[13].

3.2.32

safety

extent to which a Chinese medicine produces a toxic side effect under prescribed indications and dosage and administration

Note 1 to entry: See ICH safety guidelines^[14].

3.2.33

stability

ability of a drug to maintain physical, chemical, biological and microbial characteristics

Note 1 to entry: See ICH guidelines^[15].

3.2.34

quality control

part of quality management focused on fulfilling quality requirements

Note 1 to entry: The quality control of traditional Chinese medicinal products includes both efficacy, safety and stability.

[SOURCE:ISO 9000:2015, 3.3.7, modified — Note to entry added.]