11.120.10 药物 标准查询与下载

T/ZZB 1643-2020 银杏叶片

本标准规定了银杏叶片基本要求、技术要求、检测方法、检验规则及说明书、标签、包装、运输、贮存以及质量承诺等。 本标准适用于以银杏叶提取物为主要原料，加入适量辅料，经加工制成的片剂。 【中文名称】银杏叶片 【英文名称】 Ginkgo Tablets

Ginkgo tablets

ASTM E3219-20 基于健康的接触限值（HBEL）推导的标准指南

1.1 This guide describes the scientific procedures underlying the integrative interpretation of all data concerning an active pharmaceutical ingredient (API) taking into account study adequacy, relevance, reliability, validity, and compoundspecific characteristics (for example, potency, toxicological profile, and pharmacokinetics) leading to a numerical value for the API, which is used further in the quality risk management (ICH Q9) of cross contamination during the manufacture of different products in the same manufacturing facilities. 1.2 This guide describes general guidance for calculating and documenting a health-based exposure limit (HBEL). It should serve the involved qualified experts as a reference for HBEL derivations and should harmonize the different approaches and nomenclature to the greatest extent possible. 1.3 This guide should be used for calculating and documenting an HBEL, when required or necessary, for APIs (including biologics), intermediates, cleaning agents, excipients, and other chemicals (that is, reagents, manufacturing residues, and so forth) used for cleaning validation and verification (Guides F3127 and E3106). In scope is the cleaning and cross contamination of surfaces of manufacturing equipment and medical devices but does not include leachables/extractables (21 CFR 211.67, 21 CFR 610.11, 21 CFR 820.70, and 21 CFR 111.27). 1.4 The principles in this guide may also be used as a basis for setting occupational exposure limits. 1.5 The principles in this guide may be applied during the development and commercial manufacturing of small or large molecular weight medicines as well as isolated pharmaceutical intermediates. 1.6 Subsequent-product HBEL values may be set for specific routes of exposure (for example, oral, inhalation, and parenteral) when necessary (for example, because of differences in bioavailability) and for specific patient populations (for example, children) if formulations are manufactured in which one daily dose is not for the 50 kg standard adult but the dosage form is adjusted to a target population with a lower body weight. 1.7 The primary scope of this guide is to ensure the safety of human patients exposed to residual active substances and intermediates via medicinal products. The general principles of this guide can also be applied to the manufacture of veterinary medicinal products. However, there may be certain unique toxicological and pharmacological species-specific differences, such as metabolism and sensitivity, as well as assumptions such as body weight for veterinary medicines that are not addressed in this guide. 1.8 This guide may be used independently or in conjunction with other proposed E55 standards published by ASTM International. 1.9 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.10 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. 1.11 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 Guide for Derivation of Health-Based Exposure Limits (HBELs)

20/30345971 DC BS ISO 19609-1 中药 原材料和用原材料制成的产品的质量和安全第1部分：一般要求

BS ISO 19609-1. Traditional Chinese medicine. Quality and safety of raw materials and manufacturing products made with raw materials - Part 1. General requirements

20/30345979 DC BS ISO 19609-2 中药 原材料和用原材料制成的产品的质量和安全 第 2 部分：草药来源成分的身份测试

BS ISO 19609-2. Traditional Chinese medicine. Quality and safety of raw materials and manufacturing products made with raw materials - Part 2. Identity testing of constituents of herbal origin

ISO 22988:2020 中药黄芪

This document specifies the quality and safety requirements of Astragalus mongholicus root [root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao]. This document applies to Astragalus mongholicus root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Traditional Chinese medicine — Astragalus mongholicus root

DB51/T 2669-2019 川产道地药材种子种苗分级 川芎

本标准规定了川产道地药材川芎苓种的术语和定义、分级要求、检验方法、检验规则。 本标准适用于川芎苓种生产者、经营者和使用者。

Chuanxiong Rhizoma Ligusticum Ligusticum Chuanxiong

T/NTZX 004-2019 胞嘧啶核苷

1、性状：白色或类白色结晶状粉末； 2、干燥失重，% ：≤0.5； 3、炽灼残渣，%：≤0.1； 4、熔点，℃：210～220； 5、含量（HPLC），% ：≥99.0； 6、UV含量 ，%：≥98.0； 7、重金属（以Pb计），mg/kg：≤10。

Cytidine

T/JGYX 01-2019 地理标志产品 金口河川牛膝生产技术规范

1 范围 2 规范性引用文件 3 术语和定义 4 产地环境　 5 加工环境 6 栽培管理　 7 产地初加工　 8 运输　 9 生产记录　 附录A（资料性附录）主要病虫害及推荐防治方法　

Product of geographical indication Producing technical specification of Jinkouhe Cyathula Radix

T/JGYX 02-2019 地理标志产品 金口河川牛膝

1范围  2规范性引用文件  3术语和定义  4地理标志保护范围  5质量要求  6试验方法  7检验规则  8贮藏、包装、标签、运输  附录A （规范性附录 金口河川牛膝地理标志产品保护范围 

Product of geographical indication Jinkouhe Cyathulae Radix

ISO 22584:2019 中药当归

This document specifies minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Traditional Chinese medicine — Angelica sinensis root

DB13/T 5109-2019 中药材种子质量 苦参

Chinese herbal medicine seed quality Sophora flavescens

T/CACM 1328-2019 何首乌安全用药指南

本标准适用于何首乌及相关制剂,首乌藤及相关制剂可参考使用。 本标准主要供医疗服务、药物研发、行政监管等机构及人员参考使用。

Guidelines for the safe use of Polygoni Multiflori Radix

DB13/T 5113-2019 紫花苜蓿高水分窖式青贮技术规程

Technical regulations for alfalfa high moisture pit silage

T/NTZX 003-2019 胞苷

1、性状：白色或类白色结晶状粉末；2、干燥失重，% ：≤0.5；3、炽灼残渣，%：≤0.1；4、熔点，℃：210～220；5、含量（HPLC），% ：≥99.0；6、UV含量 ，%：≥98.0；7、重金属（以Pb计），mg/kg：≤10。

Cytidine

DB5307/T 17-2019 云木香种植规范

本标准规定了云木香产地环境条件、良种繁育技术、栽培管理技术等相关要求。

Cinnabar planting specification

T/SDCMIA DD15-2019 中华大蟾蜍养殖技术规范

中华大蟾蜍养殖技术规范

Technical specification for the breeding of giant bufo

T/ZZB 1267-2019 莪术油

本标准规定了莪术油的基本要求、技术要求、试验方法、检验规则、标签、包装、运输和贮存、质量承诺与服务等。 本标准适用于以莪术为原料经水蒸气蒸馏法提取的挥发油(即莪术油)产品的生产与质量控制，本产品可供药用。 莪术油主要成分有：呋喃二烯、牻牛儿酮和莪术二酮等。 --化学名称：呋喃二烯 分子式：C15H20O； 相对分子量：216.31（按2016年国际相对原子质量计）； 结构式： CH3 O CH3 CH3 --化学名称：牻牛儿酮 分子式：C15H22O； 相对分子量：218.34（按2016年国际相对原子质量计）； 结构式： CH3 O CH3 CH3 CH3 --化学名称：莪术二酮 分子式：C15H24O2； 相对分子量：236.35（按2016年国际相对原子质量计）； 结构式： CH3 CH3 O CH3

Zedoary turmeric oil

DB65/T 4277-2019 医疗人才“组团式”援疆工作指南

Guidelines for the "group-style" assistance of medical talents to Xinjiang

T/CCCMHPIE 1.50-2019 植物提取物 莽草酸

"本标准规定了莽草酸的技术要求、检验方法、检验规则、包装、标签、运输、贮存和保质期要求。 本标准适用于八角、莽草等的干燥成熟果实，经乙醇水提取、浓缩、精制、干燥等工序制成的莽草酸。"

Plant extract——Shikimic acid

DB31/T 1197-2019 疫苗产品编码规则

Vaccine Product Coding Rules