11.120.10 药物 标准查询与下载

KS P ISO 19610-2018 红参工业生产工艺通用要求

General requirements for industrial manufacturing process of red ginseng

BS PD ISO/TR 23021:2018 传统中医 日语贡布药材对照词汇

Traditional Chinese medicine. Controlled vocabulary on Japanese Kampo crude drugs

ISO/TR 23021:2018 中药.日本贡布药材的对照词汇

Traditional Chinese medicine - Controlled vocabulary on Japanese Kampo crude drugs

BS ISO 20334:2018 传统中医 公式编码系统

Traditional Chinese medicine. Coding system of formulae

T/CATCM 002-2018 西红花质量等级

1）西红花药材的系统调研，为药材等级标准的制定提供充足的理论依据。包括历代文献、现有标准状况、产地及市场情况调查等。研究历代文献，对药材的基源、产地、炮制等进行总结；研究现有标准状况，主要是中国药典，各国药典，国际标准化组织标准（ISO），部颁标准，地方标准等，对西红花标准的现有状况做进一步分析汇总。对药材实际产地及市场情况进行调研，收集产地，加工过程，商品等级信息，市场价格等信息，整理药材市场价格分级规律。 2）收集国内外各主要产地多批次药材，使标准制定研究对象具有广泛的代表性。目前国内西红花主要的产地包括上海，江苏，浙江，安徽等地。国外西红花的主要产区为西班牙，伊朗，希腊，克什米尔，马其顿大区。 3）对西红花药材稳定性及贮存条件进行系统研究。研究不同产地，不同储存条件下主要成分西红花苷-Ⅰ和西红花苷-Ⅱ以及西红花总苷、苦番红花素等的含量及相应的变化规律。 4）制定质量标准，完成质量标准草案及起草说明，参照借鉴中国药典标准及其他现行标准，运用高效液相-高分辨质谱联用技术（LC-HRMS）、核磁共振（NMR）和超高效液相色谱（UPLC）等多种现代化分析技术，对特征/指纹图谱、化学成分、含量测定等主要项目进行研究，明确西红花质量等级标准的评价指标，建立以特征性化合物为基础的质量控制方法。 5）建立等级质量标准，应用建立的分析方法对不同产地，不同批次的西红花进行指标性成分含量测定，并依据指标性成分含量结果对西红花进行质量分级，结合产地与市场产品结果论证分析，建立划分市场西红花质量等级的技术指标。制定西红花质量等级标准，并形成草案，申报并讨论。

Quality Grades of Croci Stigma

T/ZZB 0393-2018 银杏叶提取物

本标准规定了银杏叶提取物的基本要求、技术要求、检测方法、检验规则及标签、包装、运输、贮存以及质量承诺等。 本标准适用于以银杏干燥叶经乙醇溶液提取分离制成的银杏叶提取物。 【中文名称】银杏叶提取物 【CAS NO.】90045-36-6 【英文名称】GINKGO LEAVES EXTRACT

Ginkgo leaves extract

T/CCCMHPIE 1.33-2018 植物提取物 芦丁

"本标准规定了植物提取物芦丁的技术要求、检验方法、检验规则和和包装、运输、贮存及保质期要求。 本标准适用于以豆科植物槐Sophora japonica L.的干燥花蕾，经碱提酸沉和纯化制成的提取物。"

Plant extract——Rutin

T/CCCMHPIE 1.30-2018 植物提取物 槲皮素

"本标准规定了植物提取物槲皮素的技术要求、检验方法、检验规则和和包装、运输、贮存及保质期要求。 本标准适用于以豆科植物槐Sophora japonica L.的干燥花蕾，由碱提酸沉、纯化后的芦丁经水解后制成的提取物槲皮素。"

Plant extract——Quercetin

ASTM F2602-18 用多角度光散射检测（SEC-MALS）通过尺寸排阻色谱法测定壳聚糖和壳聚糖盐的摩尔质量的标准测试方法

1.1 This test method covers the determination of the molar mass of chitosan and chitosan salts intended for use in biomedical and pharmaceutical applications as well as in tissue engineered medical products (TEMPs) by size exclusion chromatography with multi-angle laser light scattering detection (SEC-MALS). A guide for the characterization of chitosan salts has been published as Guide F2103. 1.2 Chitosan and chitosan salts used in TEMPs should be well characterized, including the molar mass and polydispersity (molar mass distribution) in order to ensure uniformity and correct functionality in the final product. This test method will assist end users in choosing the correct chitosan for their particular application. Chitosan may have utility as a scaffold or matrix material for TEMPs, in cell and tissue encapsulation applications, and in drug delivery formulations. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

ISO 20334:2018 中药.方剂编码系统

This document specifies rules to encode formulae, and gives specific codes for 1233 frequently‐used formulae. Chinese patent medicines (CPM) are outside the scope of this document. Kampo formulae are outside of the scope of this document. This document is applicable to formula‐relating databases in fields of clinical medication, scientific research and teaching, electronic medical records and prescription of traditional Chinese medicine (TCM).

Traditional Chinese medicine - Coding system of formulae

DB35/T 1775-2018 泽泻生产技术规程

本标准规定了泽泻的术语和定义、产地环境条件、种子繁育技术、育苗技术、大田生产、采收及采后处理方法。 本标准适用于福建省泽泻药材生产。

Alisma production technical regulations

BS ISO 19617:2018 中药 天然产物生产工艺通用要求

1   Scope This document specifies the general requirements for manufacturing processes to ensure the quality of finished products used in traditional Chinese medicine (TCM). This document covers premises, documentation, personnel, training, manufacturing control and quality control. This document applies to the manufacturing of natural products used in and as TCM. This document does not conflict with general pharmaceutical good manufacturing practices (GMPs). This document applies to all materials of natural origin: medicinal plants , medicinal animals , medicinal minerals , crude drugs or crude drug preparations.

Traditional Chinese medicine. General requirements for the manufacturing process of natural products

ISO/TR 23022:2018 日本神道方剂的中药对照词汇及产品的适应症代码

Traditional Chinese medicine — Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products

ISO 19617:2018 中药天然产物生产工艺的一般要求

This document specifies the general requirements for manufacturing processes to ensure the quality of finished products used in traditional Chinese medicine (TCM). This document covers premises, documentation, personnel, training, manufacturing control and quality control. This document applies to the manufacturing of natural products used in and as TCM. This document does not conflict with general pharmaceutical good manufacturing practices (GMPs). This document applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.

Traditional Chinese medicine — General requirements for the manufacturing process of natural products

DB13/T 2707-2018 中药材种子质量标准 土木香

Seed Quality Standards of Chinese Medicinal Herbs Tumuxiang

DB13/T 2706-2018 中药材种子质量标准 大蓟

Seed Quality Standard of Chinese Medicinal Materials Daji

DB13/T 2704-2018 中药材种子质量标准 薄荷

Chinese herbal medicine seed quality standard mint

DB13/T 2692-2018 中药材种子种苗质量标准 北苍术

Seed seedling quality standard of Chinese herbal medicine Atractylodes argylae

DB13/T 2696-2018 热河黄苓良种选育技术规程

Breeding technical rules for fine varieties of Rehe Huangling

BS ISO 21371:2018 中药 口服或局部使用产品的标签要求

1   Scope This document specifies general requirements for the labelling of products intended for oral or topical use in and as traditional Chinese medicine (TCM). It is applicable to all finished manufactured products including packaged herbs used in and as TCM. This document includes the essential and informative elements for labelling of products to assist in the choice and safe use of these products by consumers and practitioners. NOTE A list of TCM labelling requirements of the WHO and various regions and countries is given in Annex A.

Traditional Chinese medicine. Labelling requirements of products intended for oral or topical use