the herbal atc project in japan the 12th …utdpm/poster/2007/taipei-icom-class...18. ancillary...

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1 1 The history and current situation of the classification of traditional Chinese medicine in China and Kampo drugs in Japan The 14th International Congress of Oriental Medicine (14 th ICOM) Taipei, 3 December 2007 Kiichiro TSUTANI 1 TU YA 1,2 津谷喜一郎, 图娅 1) Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo 2) Beijing University of Chinese Medicine 2 Contents 1. Background for the study 2. HATC project 3. Other standardization projects on characterization of herbal medicines 4. History of classification of herbs in China 5. History of classification of herbs in Japan 3 Cars O, et.al. Variation in antibiotic use in the European Union. Lancet 2001; 357: 1851-3 Wider use of Chinese drugs and Kampo drugs is not always good Is it rational ? - Over use - Under use - Appropriate use Which perspective ? - industry perspective - ethnocentric/nationalistic - public health 4 Total expenditure for CAM in Japan: US$ 35 billion 10% of total health expenditure in Japan Plan to publish in early 2008 6

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Page 1: The Herbal ATC project in Japan The 12th …utdpm/poster/2007/Taipei-ICOM-class...18. Ancillary analysis 19. Adverse events 20. Interpretation 21. Generalizability 22. Overall evidence

1

1

The history and current situation of the classification

of traditional Chinese medicine in China and Kampo

drugs in Japan

The 14th International Congress of Oriental Medicine (14th ICOM)

Taipei, 3 December 2007

Kiichiro TSUTANI1 TU YA1,2

津谷喜一郎, 图娅

1) Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo

2) Beijing University of Chinese Medicine

2

Contents1. Background for the study

2. HATC project

3. Other standardization projects on characterization of herbal medicines

4. History of classification of herbs in China

5. History of classification of herbs in Japan

3

Cars O, et.al. Variation in antibiotic use in the European Union. Lancet 2001; 357:

1851-3

Wider use of Chinese drugs and Kampo drugs is not always good

Is it rational ?- Over use - Under use - Appropriate use

Which perspective ?- industry perspective- ethnocentric/nationalistic- public health

4

・ Total expenditure for CAM in Japan: US$ 35 billion

・ 10% of total health expenditure in Japan

Plan to publish

in early 2008

6

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2

7

Herbal “drug” products(2001, US$ mil)

type Ethical OTC/others Total

A: Kampo drug 820 163 983

B: Crude herbal product 35 20 55

C: Finished herbal product 7 38 45

Total 862 222 1,083

Herbal “drug” product: US$ 1 bil. (1/70=1.3% of drug exp.)

Japanese spent US$10 for herbal “drug” product per capita8

Type A: Kampo drug

9

Type B: Crude herbal product

10

Type C: Finished herbal product

11

医療用漢方エキス製剤の出荷金額とその内訳の推移

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12Asahi Shimbun 1996.3.2

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3

13

Emergency safety information

on Shosaikoto 小柴胡湯 (1996.3)

14

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16

医療用漢方エキス製剤のKDDDを用いた使用量とその内訳の推移

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18

84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00

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17

Contents1. Background for the study

2. HATC project

3. Other standardization projects on characterization of herbal medicines

4. History of classification of herbs in China

5. History of classification of herbs in Japan

18http://www.whocc.no

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4

19

WHO Collaborating Centre for Drug Statistics Methodology, Oslo

20

Uppsala Reports 2003; 22 :16

21UMC Second Herbal Reviewers Meeting , RSM, London, 29 April 2005 222004 2005 2005

Key documents in PV of HM and HATC

23 24

9 members for HATC project in Japan

(Since 2002)

1. 東京大学大学院薬学系研究科医薬経済学講座 津谷喜一郎

2. 国立医薬品食品衛生研究所生薬部 合田幸広

3. 日本生薬学会 相見則郎

4. 日本東洋医学会 山田享弘, 鳥居塚和生

5. 日本漢方生薬製剤協会 (日漢協) 篠原 宣

6. 北里研究所東洋医学総合研究所 山田陽城, 伊藤剛

(WHO伝統医学協力センター)

7. 富山医科薬科大学医学部和漢診療部門 引網宏彰

(WHO伝統医学協力センター)

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5

25 26

7 members for Standard Kampo Formula

Nomenclature (SKFN), Since 2003

1. 東京大学大学院薬学系研究科医薬経済学講座 津谷喜一郎

2. 国立医薬品食品衛生研究所生薬部 合田幸弘

3. 日本生薬学会 佐竹元吉

4. 日本東洋医学会 鳥居塚和生,山田和男

5. 和漢医薬学会 引網宏彰

27 28

29

Ex. anchusan 安中散

• Herb H

• Anatomy

Alimentary tract and metabolism HA

• Therapeutic/pharmacological

Antiacids, Drugs for Treatment of

pepic ulcer and flatulence HA02

Herbal Remedies for Treatment of

Peptic Ulcer HA02W

Other herbal remedies for treatment

of peptic ulcer HA02WX

• Chemical HA02WX 9xxx

30

HA02WX (not final)

HA02WX9xxx 安中散 anchusan

HA02WX9xxx 茯苓沢瀉湯 bukuryotakushato

HA02WX9xxx 附子理中湯 bushirichuto or bushininjinto

(附子人参湯)HA02WX9xxx 半夏瀉心湯 hangeshashinto

HA02WX9xxx 平胃散 heiisan

HA02WX9xxx 堅中湯 kenchuto

HA02WX9xxx 香砂六君子湯 kosharikkunshito

HA02WX9xxx 柴胡桂枝湯 saikokeishito

HA02WX9xxx 柴芍六君子湯 saishakurikkunshito

HA02WX9xxx 四逆散 shigyakusan

漢方処方名ローマ字表記法, 2005

Standard Kampo Formula Nomenclature (SKFN), 2005

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6

31

The number of HATC codes of

Kampo Formulae in Japan

48 74 106

1 code 2 codes 3 codes

78.9 % (180/228) of Kampo formulae has two or more codes

32

Level 1 of Herbal ATC Classification

HA: Alimentary tract and metabolism 消化管・代謝系

HB : Blood and blood forming organs 血液・造血系

HC: Cardiovascular system 心血管系

HD: Dermatologicals 皮膚系

HG: Genito urinary system and sex hormones 泌尿生殖器系・性ホルモン

HH : Systemic hormonal preparations excl. sex hormones 性ホルモンを除く全身性ホルモン製剤

HJ : Antiinfectives for systemic use 全身性抗感染症薬

HL: Antineoplastic and immunomodulating agents 抗潰瘍剤・免疫調整剤

HM: Musculo-skeletal system 筋・骨格系

HN: Nervous system 神経系

HP : Antiparasitic products, insecticides and repellents 抗寄生虫薬・殺虫剤・駆散薬

HR: Respiratory system 呼吸器系

HS : Sensory organs 感覚器官

HV : Various その他

33

•Classification by ATC system is not

suitable for drugs originated in east Asia

• Other system is needed

• Formula/Prescription 方剤 処方

• Single herb 中薬 生薬

34

35

Contents1. Background for the study

2. HATC project

3. Other standardization projects on characterization of herbal medicines

4. History of classification of herbs in China

5. History of classification of herbs in Japan

36

3. Other standardization projects on

characterization of herbal medicines

(1) IST (WHO/WPRO International Standardization of Terminology of Traditional Medicine)

(2) FHH (Forum for Herbal Harmonization)

(3) CONSORT statement: herbal / TCD extension(Characterization of HM products in reporting RCT)

(4) ICH M5: Data elements and standards for drug dictionaries

(5) ISO (International Organization for Standardization)

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7

37 38

http://www/wpro.who.intUS$ 21.55

(US$ 15.09 for developing countries)

In Introduction…

• During the 2nd Informal Consultation on Development of International Standard Terminologies on Traditional Medicine held in Tokyo, Japan from 27 to 29 June 2005, there were discussions regarding the inclusion of herbal drugs and formula.

• Participants concluded that those sets of terms can be included in future edition in appropriate ways.

• Radix Ginseng or Ginseng Radix ? - in pharmacopeia

• Formulae

39 40

Other coding system of herbal medicine in east Asia

1. 解表薬

2. 清熱薬

3. 瀉下薬

4. 怯風湿薬

5. 化湿薬

6. 利水滲湿薬

7. 温裏薬

8. 理気薬

9. 消食薬

10. 駆蟲薬

11. 止血薬

12. 活血怯瘀薬

13. 化痰止咳平喘薬

14. 安神薬

15. 平肝息風薬

16. 開窮薬

17. 補虚薬

18. 収渋薬

19. 湧吐薬

20. 殺蟲止痒

21. 提膿怯腐薬

East Asian Herbal Classification (EAHC)

41

3. Other standardization projects on

characterization of herbal medicines

(1) IST (WHO/WPRO International Standardization of Terminology of Traditional Medicine)

(2) FHH (Forum for Herbal Harmonization)

(3) CONSORT statement: herbal / TCD extension(Characterization of HM products in reporting RCT)

(4) ICH M5: Data elements and standards for drug dictionaries

(5) ISO (International Organization for Standardization)

42

FHH: early stage of pharmacovigilance

FHH established in 2002

Sub-committee I:

Nomenclature and Standardization

Sub-committee II:

Quality Assurance and Information

Sub-committee III

Adverse Drug Reaction (since 2005)

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8

43 44

Previous presentation at FHH2004

The Herbal ATC project for Kampo Formulae in Japan. First HFF International Forum,

22 September 2004, Shanghai, China

2005

The HATC Project and Standard Kampo FormulaNomenclature

FHH 3rd Standard Committee MeetingTokyo, 30 June 2005 (established ADR Sub-Committee)

2006

Estimation of number of users of Kampo product and

characterization of herbal medicine products in

reporting clinical trial

Second FHH International Forum

Tokyo, 17 November 2006

45

3. Other standardization projects on

characterization of herbal medicines

(1) IST (WHO/WPRO International Standardization of Terminology of Traditional Medicine)

(2) FHH (Forum for Herbal Harmonization)

(3) CONSORT statement: herbal / TCD extension(Characterization of HM products in reporting RCT)

(4) ICH M5: Data elements and standards for drug dictionaries

(5) ISO (International Organization for Standardization)

46http://www.consort-statement.org

47

CONSORT Statement (2001)

1. Title and Abstract

2. Background

3. Participants

4. Intervention

5. Objectives

6. Outcomes

7. Sample size

8. Sequence generation

9. Allocation concealment

10.Implementation

11.Blinding

12.Statistical methods

13. Participants flow

14. Recruitment

15. Baseline data

16. Number analyzed

17. Outcomes and estimation

18. Ancillary analysis

19. Adverse events

20. Interpretation

21. Generalizability

22. Overall evidence

The CONSORT Statement: Revised recommendations for Improving the quality

of reports of parallel-group randomized trials. JAMA 2001; 285: 1987-91 48

CONSORT statement and herbal medicines

• 1986 CONSORT statement. JAMA

2001 CONSORT statement revised. JAMA

• 2006

- Gagnier JJ, et.al. Reporting randomized controlled trials of

herbal interventions: An elaborated CONSORT statement. Annals of Internal Medicine, March 2006

- Bian ZX, et.al. Improving the quality of randomized controlled trials in Chinese herbal medicine, Part IV: applying a revised CONSORT checklist to measure reporting quality. J of Chinese Integrative Medicine, May 2006

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9

49

3. Other standardization projects on

characterization of herbal medicines

(1) IST (WHO/WPRO International Standardization of Terminology of Traditional Medicine)

(2) FHH (Forum for Herbal Harmonization)

(3) CONSORT statement: herbal / TCD extension(Characterization of HM products in reporting RCT)

(4) ICH M5: Data elements and standards for drug dictionaries

(5) ISO (International Organization for Standardization)

50

ICH M5 step 2 (10 May 2005)(International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use)

2.2.2 Active ingredients controlled Vocabulary

Definitions: An active ingredient is defined as a substance that alone or in combination with one or more other ingredients produced the intended activity of a medicinal product

Herbal substances will be mapped on the following principles:

- Botanical scientific name according to the Latin bionomial system (genus + species);

- The author (e.g., Linnaeus, abbreviated L.) if knows;

- The plant parts (if known); and

- The process (when applicable, and if knows)

Herbal preparations will be mapped on the basis of the standardized treatments (for instance extraction, distillation, expression, fractionation, purification, concentration or fermentation) as described in the official Pharmacopeia of the three regions. For extractions, the solvent will also be specified.

51http://www.ich.org/cache/compo/276-254-1.html 52

SUBSTANCE INGREDIENT MED.PROD.

ATC/HATC

BOTANICAL PREFERRED

NAME

SYNONYMS

ADR REPORT

HCN

ID ID

ID

Valeriana officinalis

root

dry extract

Valeriana officinalis root dry extract

9012300502

Valeriana officinalis root dry extract

(as a serial number)

Valeriana officinalis root dry extract

015616 03 001

(Filenumber)

HA02DW – Herbal carminatives

HN05CM – Other hypnotics and sedatives

Baldrian-dispert

015616 03 002

Valeriana sylvestris root dry extract

Extractum siccum valerianae radix

90123

005

02

WHO herbal ADR database

ID

Frempong W, Ericsson J (UMC). Herbal Singaling.

2nd Herbal Reviewers Meeting , London, 29 April 2005

herbal code number (HCN)

53

Lexicon table * for “Part” of herbal drug

1. AERIAL ROOT

2. BARK

3. BUD

4. BULB

5. CAPSULE

6. CONE

7. CORM

8. DEBARKED ROOT

9. DESEEDED FRUIT

10. DRY FRUIT

・・・81. YOUNG LEAF

* Currently under revision 54

Contents1. Background for the study

2. HATC project

3. Other standardization projects on characterization of herbal medicines

4. History of classification of herbs in China

5. History of classification of herbs in Japan

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10

Different system between traditional Chinese

medicine and Japanese Kampo medicine

China

• Syndrome differentiation

辨证论治

• Therapy method

依法统方

• Half are in traditional

decoction form and the rest

are in industrialized form

Japan

• Formula responding

syndrome

方証相対

• Mostly in industrialized

form

55

The evolvement of Chinese herb record

In China, traditional Chinese Herbs has

been recorded by two methods:

• Chinese materia medica 本草

- single herb 单味药物

• Formulae 方剂

- prescription including kinds of herbs

处方组成

Chinese materia medica 本草

• Shanhai Jing 山海经(BC4-AD1ce)

- recorded 120 herbs and part of their efficacy.

• Shennong’s herbal classic 神农本草经 (AD2ce)

- monograph recorded 365 herbs

- divide them into three grades:

First grade (上品) : preserving one„s health 君薬養命

Second grade(中品): balance one‟s body 臣薬養性

Third grade (下品): treat diseases 佐使治病

Herbal Classification according to their attribute

新修本草xin-xiu-ben-cao

唐代 蘇敬su-jing,850种

• 659 年

• 物品分類 9類

• 玉石

• 草

• 木

• 獣

• 禽

• 虫魚

• 菓

• 菜

• 米谷

本草綱目ben-cao-gang-mu 明代李时珍li-shi-zhen 1892种

• 1578 年

• 物品分類 16類

• 水 服器

• 火 虫

• 土 鱗

• 金石 介

• 草 禽

• 谷 獣

• 菜 人

• 菓 木

• 以及七方、十剂、气味归经、阴阳脏腑、七情、引经报使等等药性和组方理论。

Herbal Classification according to their efficacy

本草求真 ben-cao-qiu-zhen

520種 清代黄宮綉huang-

gong-xiu.1769年

• 7種類: 補

• 渋

• 散

• 瀉

• 血

• 雑

• 食べ物

薬性賦 yao-xing-fu

248種 著作人不明.清代以前

• 4種類: 寒

• 熱

• 温

• 涼

As for the formulae

• The usage of formulae combing two or more

herbs is published not later than the single

Chinese materia medica.

• The first herbal formulae classic existed now

is 五十二病方Formulae for Fifty-two Diseases

(BC5-2ce)

• This book classifies formulae according to

diseases or symptoms. 10

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11

汉书.艺文志 Han Shu’ Yi Wen Zhi

• It takes the formulae as that herbs in harmony

acting in concert with each other.

• Harmony is a representative concept of

Chinese culture. The attitude that everything

on earth roots in harmony is reflected in

medicine field and advances the development

of the formulae.

五十二病方Wu-shi-er-bing-fang

197/119方 著作人不明 BC5-2 病・症状に分類

52種類

諸傷狂犬噛人など

黄帝内経Huang-di-nei-jing

13種類 著作人不明 BC5-2 病・症状に分類

13類

治百病方Zhi-bai-

bing-fang

傷寒雑病論Shang-han-za-bing-lun

12

36種類

113種

著作人不明

漢代の張仲景

AD1-3

AD2-3

不詳

弁証に分類初めての弁証論治

11類

傷寒例六経病霍乱陰陽易発汗不可など

The formulae classic can be sorted as

follows:

1. Comprehensive formulae books

2. Synoptic formulae books

3. Specialized formulae books

13

Comprehensive formulae books:

1、備急千金要方・千金翼方qian-jin-yao-fang 7500方唐代の孫思邈sun-si-miao

652-682年分科に基づいて病症に対応30卷232・189門類

4.普済方pu-ji-fang61739方明代の朱橚zhu-su1406年弁証論治に疾病のよって分類する

426卷諸疾に2175類

歴史の一番の大型方剤全書方剤と理論

3、太平聖惠方tai-ping-sheng-hui-fang16834方宋代の政府992年

分科に基づいて病症に対応弁証論治

100卷1670門

大型方剤全書,方剤と理論

2. 外台秘要wai-tai-mi-yao

6000方唐代の王焘wang-tao

AD752

分科に基づいて病症に対応1104門大型方剤全書,方剤と理論

Synoptic formulae books:

1、傷寒雑病論shang-han-za-bing-lun

113方 漢代の張仲景zhang-zhong-jing

AD2-3 弁証に分類 11類 初めての弁証論治

2、肘後備急方zhou-hou-bei-ji-fang

晋代の葛洪ge-hong

101方 分科より病症に分類 8卷

便利で応用できる

3、太平惠民和済局方tai-ping-hui-min-he-ji-ju-fang

• 788方

• 宋代の和済局

• 1131-1161年

• 弁証論治に疾病のよって分類する

• 10卷14門

• 実用性が高い

• 第一部政府編方剤書

• 方剤と理論

4、普済本事方pi-ji-ben-shi-fang

• 366方

• 宋代の許叔微xu-shu-wei

• 1132年

• 病症に分類する

• 23類

• 実用性が高い

• 方剤と使い方

Specialized formulae books:

卫济宝书

wei-ji-bao-shu

宋代东轩居士著

dong-xuan-ji-shu

1卷

1170 年

外科专用方剂39首

妇人良方大全

fu-ren-da-quan-liang-fang

宋代 陈自明che-zi-ming著

24卷 1237年

妇科专用方剂

傅青主女科fu-qing-zhu-nv-ke

清代 傅山 fu-shan 著

妇科方剂83首

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12

The formulae classification method involves

1. Classification according to the symptom

(the early stage, represented by

傷寒論, Han Dynasty)

(the maturation stage, represented by

千金要方 Tang Dynasty)

2. Classification according to the source of the formulae 主方来源 ;

3. Classification according to the treatment methods 治法(功效)

17

Classification according to the source of the formulae

主方来源

祖剂 Zu Ji

By Shi Pei,施沛Ming Dynasty

Traced back the original and the regulation of the formulae.

Recorded over 800 formulae.

张氏医通 Zhang Shi Yi Tong

By Zhang lu,Qing Dynasty.

Recorded over 400 formulae.

There are several such books published after 1949.

The classification method can help to understand the source of the

formulae but not convenient for clinical practice.

《景岳全书jing Yue Quan Shu》(Ming Dynasty AD1642)

补 和 攻 散 寒 热 固 因

古方

八阵

165 378 113 114 184 193 66 330

新方

八阵19

29 20 6 17 20 25 10 59

22Formulae-- 医方集解 Yi –Fang- Ji -JIe

by Qing Dynasty 汪昂 Wang Ang

• First classifies the formulae according to the

clinical efficacy.

• This classification method corresponds with the

principle of treatment based on syndrome

differentiation and very convenient for clinical

practice. So the classification method gets

popular.

22剂--清代汪昂《医方集解》

首次按照临床功效分类的方法,将方剂分为

“补养”、“发表”、“涌吐”、“攻里”、

“表里”、“和解”、“理气”、“理血”、

“祛风”、“祛寒”、“清暑”、“利湿”、

“润燥”、“泻火”、“除痰”、“消导”、

“收涩”、“杀虫”、“明目”、“痈疡”、

“经产”、“急救良方”。

Classification in the first text book of formulae in China (1960)

方剤学 南京中医学院方剤教研室

人民衛生出版社

1960年

効能に分類

20種類

解表剤

湧吐剤

瀉下剤

和解剤

表裏双解剤

清熱剤

去暑剤

治風剤

芳香開竅剤

去寒剤

去湿剤

潤燥剤

理気剤

理血剤

補益剤

消導剤

去痰剤

固澁劑

駆虫剤

癰瘍剤

中薬学 南京中医学院,江苏省中医研究所

人民衛生出版社

1959年

効能に分類

19種類

解表薬

催吐薬

止吐薬

瀉下薬

利尿渗水薬

祛風湿薬

祛暑薬

祛寒薬

清熱薬

理気薬

理血薬

止咳化痰薬

芳香開竅薬

安神镇静薬

補養薬

固澁薬

消化薬

駆虫薬

外科薬

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13

出版時間 版順 著作者 同類教材1960年 第1版 南京中医学院 惟一1964年 第2版 南京中医学院 惟一1972年 第3版 江蘇新医学院 惟一1982年 第5版 許済群 惟一1995年 第6版 段冨津 惟一2000年 新世紀版 謝鳴,他 5種類以上

28

History of text book of formulae in China

方剤学

74

75 76

77 78

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14

The sixth version of text book of formulae in China (1995)

方剂学 (段冨津)

上海科学技術出版社 1995年

功能に分類

18種類

解表剤

瀉下剤

和解剤

清熱剤

温里剤

補益剤

固澁劑

安神剤

開竅剤

理気剤

理血剤

治風剤

治燥剤

去湿剤

去痰剤

消食剤

駆虫剤

湧吐剤

中薬学(雷載権)

上海科学技術出版社 1995年

効能に分類

22種類

解表薬

清熱薬瀉下薬祛風湿薬

化湿薬利水渗湿薬

温裏薬理気薬

消食薬駆虫薬止血薬

活血祛瘀薬化痰止咳平喘薬

安神薬平肝熄風薬開竅薬

補虚薬収澁薬

外用及び其の他薬湧吐薬解毒殺虫燥湿止痒薬

抜毒化腐生肌薬

New version of text book of formulae

21世紀教材方剤学(謝鳴)

人民衛生出版社2002年効能に分類21種類

解表剤瀉下剤和解剤清熱剤去暑剤温裏剤表裏双解剤補益剤固澁劑安神剤開竅剤理気剤理血剤治風剤治燥剤去湿剤去痰剤消導化積剤駆虫剤湧吐剤治瘍剤

21世紀課程教材中薬学(黄兆勝)人民衛生出版社2002年効能に分類21種類

解表薬清熱薬瀉下薬祛風湿薬化湿薬利水渗湿薬温裏薬理気薬消食薬駆虫薬止血薬活血祛瘀薬化痰止咳平喘薬安神薬平肝熄風薬開竅薬補虚薬収澁薬湧吐薬殺虫止痒薬抜毒生肌薬

81

国家基本中成药 /二部

800 formulae of Chinese patent drug (2000)人民衛生出版社

分科によって効能に分類 2000年改正、薬品と保健品 付録保健薬品234種

内科17種類

解表剤

清熱剤

去風剤

去湿剤

健脾開胃剤

止瀉剤

去痰止咳平喘剤

温里剤

理気剤

理血剤

補益剤

開竅剤

安神剤

固澁劑

熄風剤

駆虫剤

婦人科3種類

月経剤

帯下剤

孕産剤

小児科6種類

時病清熱剤

化痰止咳剤

しん静治驚剤

消積治疳剤

健脾養胃剤

小児雑病剤

外科8種類

癕瘍剤

皮膚剤

湯傷剤

骨傷剤

肛腸剤

いん瘤剤

焼傷剤

蛇傷剤

五官科4種類

眼科剤

耳鼻剤

口腔剤

咽喉剤

83

Contents1. Background for the study

2. HATC project

3. Other standardization projects on characterization of herbal medicines

4. History of classification of herbs in China

5. History of classification of herbs in Japan

Guidelines for national examination for CM physician (2007)

方剤学 2007執業医師試験大綱

国家中医薬管理局

効能に分類

19種類

解表薬

清熱薬

瀉下薬

祛風湿薬

芳香化湿薬

利水渗湿薬

温裏薬

理気薬

消食薬

駆虫薬

止血薬

活血祛瘀薬

化痰止咳平喘薬

安神薬

平肝熄風薬

開竅薬

補虚薬

収澁薬

外用及び其の他薬

中薬学 2007執業中医師試験大綱

国家中医薬管理局

効能に分類

19種類

解表剤

瀉下剤

和解剤

清熱剤

去暑剤

温裏剤

補益剤

固澁劑

安神剤

開竅剤

理気剤

理血剤

治風剤

治燥剤

去湿剤

去痰剤

消食剤

湧吐剤

駆虫剤

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15

Classification of Kampo drugs in Japan (1930s-50s)

皇漢医学要方解説 東京春陽堂発行(157方)

奥田謙蔵 1934年

主方に分類 (21分類+兼用)

桂枝湯 49

麻黄湯 9

白虎湯 3

小半夏湯 3

第五柴胡湯 18

桔皮湯 5

瓜蔞薤白白酒湯 4

薏苡附子湯 3

瀉心湯 5

白頭翁湯 2

附子湯 9

大陷胸丸 3

大陷胸湯 3

承气丸 4

防己湯 4

抵当湯 3

膠艾湯 4

承气湯 10

赤石脂禹余粮湯 2

逆湯 9

類族不明方5 瓜蒂散;十枣湯;酸枣湯;三物黄芩湯;牡蛎澤瀉湯

兼用方一巴豆剤; 二軽粉剤;三大黄剤;四甘遂剤

漢方後世要方解説 医道の日本 (125方)

矢数道明 1959年

効能に分類と主方に分類 (11類・5類)

前編

補養剤 19

瀉火剤 18

解表剤 4

表里剤 3

和解剤 2

理气剤 2

理血剤 7

潤燥剤 6

除痰剤 8

消導剤 7

其他薬方:中和解毒13;心下脾胃9;雑方3

後編

香蘇散 5

平胃散 7

二陳湯 6

四君子湯類 11

四物湯類 6;

No classification of formula in Kampo books

published in association with the Ministry of Health,

Labor and Welfare of Japan一般用漢方処方の手引き

210方

厚生省薬務局監修

1975

五十音順 (in Hiragana order)

漢方治療の原則に基づいて、証に随っ

て使用すべきものであり、その運用

を誤れば、十分な効果ができなくな

る恐れもあります。

新一般用漢方処方の手引き案

210方

厚生労働科学研究費補助金

「一般用漢方処方の見直しを図るための調査研究班」

2006

五十音順 (in Hiragarna order)

証の概念に対応した、新「しばり」が導

入する、適応証に対して説明しよう。

87

Discussion and interim conclusion

1. Apparent needs for classification of herbal drugs in east

Asia.

2. Different classification system exists in east Asia

reflecting their own historical development.

3. While currently around 20 categories used in China,

around 10 is used by Japanese

4. Handbook widely used in Japan has certain similarity to

handbook used in China in 1960-70 during cultural

revolution.

5. Less use of classification of Kampo drugs in Japan

started in 1960-70, with revival of Kampo medicine

together with its industrialization.