11.120.10 药物 标准查询与下载

T/SDAS 540-2022 阿胶制作技艺规程

本文件规定了阿胶制作的原料炮制、提取胶汁、澄清过滤、浓缩出胶、凝胶切胶、胶块晾制、擦胶印字、胶块灭菌、包装入库等技艺流程。 本文件适用于阿胶的生产制作技艺。

Ejiao production technical regulations

T/SHZX 0004-2022 定制膏方加工质量管理规范

6　工艺要求 6.1　饮片浸泡 浸泡（煎煮）用水应符合GB 5749要求(以使用40℃以下温水浸泡为宜)，按药料6—8倍量水将药料完全浸没，一般以超出药面10-20cm为度。浸泡时间：常压煎汁（传统铜锅等敞口煎煮）浸泡时间应≥6h；使用密闭式加压煎药机煎汁的浸泡时间应≥8h 。 6.2　辅料、胶料处理 对处方要求使用的辅料、胶料等，用黄酒或合适的溶媒浸泡、搅拌至充分烊化后，用80-100目筛网过滤后备用。 6.3　煎制 6.3.1药料应煎煮两次（汁）。使用常压煎汁（用传统铜锅等敞口煎煮），头汁煎煮时间≥1h，二汁煎煮时间≥0.5h（以上时间指煮沸后开始计时），最后压榨取汁；使用密闭式加压煎药机煎汁，煎煮时间煮沸后≥1h。对处方药量较大，设备容积无法实现同时煎煮的，药料调配后应充分拌匀均分，分锅（机）煎煮，合并煎液。 6.3.2贵细料投料前应双人复核，确认无误后由双人投料，并按照处方要求分别处理〔或打细粉后混入膏滋中，或单独用小锅煎煮等〕。贵细药料应煎煮2-3次，分别取汁，汁水合并过滤备用。贵细料药渣（粉碎入药除外）顾客要求返还的，应妥善包装和保存，交还顾客。 6.4　沉淀 药液用筛网粗滤（根据不同的药物使用24-40目筛网），静置6h以上；或将滤液冷却至常温，静置2h以上，使之充分沉淀；也可将药汁过滤，趁热适当浓缩成半清膏（为方便沉淀、再过滤，半清膏不宜浓缩得过于稠密），静置沉淀。取经沉淀后的上清液，用80-100目的筛网过滤。 6.5　浓缩 滤液置洁净的锅内浓缩，在浓缩过程中，不断撇除浮起的泡沫；药汁经浓缩去除大部分水分后，兑入贵细料的煎汁，继续加热浓缩至稠厚状，即得“清膏”。浓缩过程中，注意掌握火候，适度搅拌，防止浓缩液暴沸溢出及药液粘锅底烧糊结焦，影响成膏质量。 6.6　收膏 在清膏中加入处方中规定的糖和胶类（制备后趁热加入），继续加热，充分搅拌以免粘底起焦。在收膏即将完成时，兑入细粉药及其他备用物料，边加边搅直至成膏。成膏的判断：药汁在竹片（铲）上“挂旗”或在加水的容器中滴水成珠。 6.7　灌装 趁热将膏体倒入洁净容器（不可马上加盖）或膏体包装机料斗内分装，每料膏滋的外包装上应贴有消费者的信息标签。 6.8　凉膏 分装后的膏滋应置于凉膏间冷却并储存。凉膏间温度应保持在20℃以下，相对湿度应保持在35～75%。每天进行不少于两次，每次0.5h以上的紫外线消毒，并做好记录。 6.9　质量控制 应对包装好的定制膏方进行质量控制，满足以下要求方可发出： a)　膏滋外观：应无焦臭、异味、无糖的结晶析出。 b)　装量差异：每袋分装均匀，装量差异控制在±5%以内； c)　包装质量：包装袋封口平整完好，无渗漏，无污染。 d)　不溶物检查：取膏滋5ml，加热水200ml，搅拌使其溶解，放置3min后观察，不应有焦屑、药渣等异物。

Quality Management Specification of customized herbal paste processing

DB43/T 2484-2022 枳壳林套种黄精生产技术规程

Technical Regulations for Interplanting Polygonatum Aurantii Fructus

T/SDCMIA DD16-2022 山东道地药材蟾酥

山东道地药材蟾酥标准

Shandong authentic medicinal materials toad cake

DB3710/T 182-2022 远程处方审方一体化服务规范

Remote prescription review integrated service specification

ISO 19609-4:2022 中药.原料和用原料制成的成品的质量和安全.第4部分:防腐剂和有害化合物的试验

This document specifies the testing of preservatives and unwanted compounds within a quality control framework for starting materials and finished products used in and as traditional Chinese medicine.

Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 4: Testing for preservatives and unwanted compounds

DB45/T 2611-2022 老鼠簕质量控制技术规程

Rat bovine quality control technical regulations

DB45/T 2610-2022 厚藤质量控制技术规程

Houteng Quality Control Technical Regulations

DB45/T 2612-2022 木榄质量控制技术规程

Mulan quality control technical regulations

T/SHDSGY 118-2022 女性内分泌失调调理药丸生产技术规范

本文件规定了女性内分泌失调调理药丸生产技术规范的概述、药物成分及剂量、工艺生产、规范性技术要素、检验规则、标志、包装及运输。 本文件适用于女性内分泌失调调理药丸生产技术规范。

Technical specification for production of women's endocrine disorder regulating pills

T/ZRTZS 06-2022 柘荣太子参质量等级

1 范围 2 规范性引用文件 3 术语和定义 4 质量要求 5 试验方法 6 检验规则 7 标签、标志、包装、运输、贮藏

Zherong Pseudostellariae Radix Ginseng Quality Grade

ISO 4754:2022 中药-发酵虫草粉

Traditional Chinese medicine — Fermented Cordyceps powder

T/AHN 012-2022 桔梗产地加工技术规程

本文件规定了桔梗产地加工的基本要求、加工和贮存。 本文件适用于桔梗产地加工的生产、加工。

Technical specification for place of origin processing of Platycodon grandiflorum

T/QGCML 467-2022 凝胶类退热贴

本文件规定了凝胶类退热贴的术语和定义、产品分类、要求、试验方法、检验规则、标志、包装、运输和贮存。 本文件适用于用于人体物理退热、体表面特定部位降温，用于临床辅助退热、对患者局部降温或作为闭合性软组织损伤降温冷敷的凝胶类医用退热贴（以下简称“退热贴”），不适用于非凝胶类退热贴。

gel cooling patch

ISO 19609-3:2022 中药.原材料和用原材料制成的成品的质量和安全.第3部分:污染物试验

This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pes ticides, aflatoxins and microorganisms . It is applicable to raw materials and finished products used in traditional Chinese medicine.

Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 3: Testing for contaminants

DB2327/T 038-2022 防风种子繁育技术规程

本文件适用于黑龙江省大兴安岭地区防风的种子繁育

Technical Regulations for Propagation of Parsnip Seeds

T/MXNHZL 6.2-2022 地理标志产品 岷江百合 第2部分：药用百合

保护范围、要求、检验方法、检验规则和标志、包装、运输和贮存

Geographical Indication Products Minjiang Lily Part 2: Medicinal Lily

T/FPHA 02-2022 中药饮片代煎服务管理规范

规定了中药饮片代煎服务管理的设施和设备要求、人员要求、中药处方调配、煎药操作要求、质量管理要求

Standards for management of decoction service of traditional Chinese medicine decoction pieces

ASTM E2476-22 影响药品生产PAT工艺设计、开发和操作的风险评估和风险控制标准指南

1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Guide E2500 and ICH Q8. 1.2 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 This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice. Current edition approved Nov. 1, 2022. Published December 2022. Originally approved in 2009. Last previous edition approved in 2016 as E2476 – 16. DOI: 10.1520/E2476-22. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 Note that safety in this context refers to operational and operator safety, not to patient safety. 1.3 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 Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

T/QCSA 1-2022 青海天然冬虫夏草保存技术规程

1、范围。 2、规范性文件。 3、术语与定义。 4、采收要求。 5、保存要求。 6、活性检测。

Qinghai Natural Cordyceps Preservation Technical Regulations