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Jingdong book

国家药包材标准(精)

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Content Description

《中华人民共和国药品管理法》(2015年修正)中规定直接接触药品的包装材料和容器,必须符合药用要求,符合保障人体健康、安全的标准,并由药品监督管理部门在审批药品时一并审批。
为了进一步规范和完善我国药包材的质量标准,统一各项检验方法及技术要求,加强对药包材的监管。从2009年开始,由中国食品药品检定研究院牵头,组织全国药包材检验检测机构对现行的139个国家药包材标准进行了整理、勘误和汇编,结合《中国药典》2015年版四部通则内容特成此书。
《国家药包材标准》适用于药包材生产企业、药品生产企业、相关药包材检验检测单位、医药研究机构、医药院校和协会等使用。
Catalogue

新标准与原标准名称、标准号、页码对照表
第一部分 玻璃类药包材标准
YBB00032005-2015 钠钙玻璃输液瓶
YBB00012004-2015 低硼硅玻璃输液瓶
YBB00022005-2-2015 中硼硅玻璃输液瓶
YBB00332002-2015 低硼硅玻璃安瓿
YBB00322005-2-2015 中硼硅玻璃安瓿
YBB00332003-2015 钠钙玻璃管制注射剂瓶
YBB00302002-2015 低硼硅玻璃管制注射剂瓶
YBB00292005-2-2015 中硼硅玻璃管制注射剂瓶
YBB00292005-1-2015 高硼硅玻璃管制注射剂瓶
YBB00312002-2015 钠钙玻璃模制注射剂瓶
YBB00322003-2015 低硼硅玻璃模制注射剂瓶
YBB00062005-2-2015 中硼硅玻璃模制注射剂瓶
YBB00032004-2015 钠钙玻璃管制口服液体瓶
YBB00282002-2015 低硼硅玻璃管制口服液体瓶
YBB00022004-2015 硼硅玻璃管制口服液体瓶
YBB00272002-2015 钠钙玻璃模制药瓶
YBB00302003-2015 低硼硅玻璃模制药瓶
YBB00052004-2015 硼硅玻璃模制药瓶
YBB00362003-2015 钠钙玻璃管制药瓶
YBB00352003-2015 低硼硅玻璃管制药瓶
YBB00042004-2015 硼硅玻璃管制药瓶
YBB00282003-2015 药用钠钙玻璃管
YBB00272003-2015 药用低硼硅玻璃管
YBB00012005-2-2015 药用中硼硅玻璃管
YBB00012005-1-2015 药用高硼硅玻璃管
YBB00162005-2015 口服固体药用陶瓷瓶

第二部分 金属类药包材标准
YBB00152002-2015 药用铝箔
YBB00162002-2015 铝质药用软膏管
YBB00082005-2015 注射剂瓶用铝盖
YBB00092005-2015 输液瓶用铝盖
YBB00382003-2015 口服液瓶用撕拉铝盖

第三部分 塑料类药包材标准
YBB00012002-2015 低密度聚乙烯输液瓶
YBB00022002-2015 聚丙烯输液瓶
YBB00242004-2015 塑料输液容器用聚丙烯组合盖(拉环式)
YBB00342002-2015 多层共挤输液用膜、袋通则
YBB00102005-2015 三层共挤输液用膜(I)、袋
YBB10112005-2015 五层共挤输液用膜(I)、袋
YBB00062002-2015 低密度聚乙烯药用滴眼剂瓶
YBB0131072002-2015 聚丙烯药用滴眼剂瓶
YBB00082002-2015 口服液体药用聚丙烯瓶
YBB00092002-2015 口服液体药用高密度聚乙烯瓶
YBBl310102002-2015 口服液体药用聚酯瓶
YBB00392003-2015 外用液体药用高密度聚乙烯瓶
YBB00112002-2015 口服固体药用聚丙烯瓶
YBB00122002-2015 口服固体药用高密度聚乙烯瓶
YBB00262002-2015 口服固体药用聚酯瓶
YBB00172004-2015 口服固体药用低密度聚乙烯防潮组合瓶盖
YBB00132002-2015 药用复合膜、袋通则
YBB00172002-2015 聚酯/铝/聚乙烯药用复合膜、袋
YBB00182002-2015 聚酯/低密度聚乙烯药用复合膜、袋
YBB00192002-2015 双向拉伸聚丙烯/低密度聚乙烯药用复合膜、袋
YBB00192004-2015 双向拉伸聚丙烯/真空镀铝流延聚丙烯药用复合膜、袋
YBB00202004-2015 玻璃纸/铝/聚乙烯药用复合膜、袋
YBB00212005-2015 聚氯乙烯固体药用硬片
YBB00232005-2015 聚氯乙烯/低密度聚乙烯固体药用复合硬片
YBB00222005-2015 聚氯乙烯/聚偏二氯乙烯固体药用复合硬片
YBB00182004-2015 铝/聚乙烯冷成型固体药用复合硬片
YBB00202005-2015 聚氯乙烯/聚乙烯/聚偏二氯乙烯固体药用复合硬片
YBB00242002-2015 聚酰胺/铝/聚氯乙烯冷冲压成型固体药用复合硬片
YBB00372003-2015 抗生素瓶用铝塑组合盖
YBB00402003-2015 输液瓶用铝塑组合盖
YBB00212004-2015 药用铝塑封口垫片通则
YBB00132005-2015 药用聚酯/铝/聚丙烯封口垫片
YBB00142005-2015 药用聚酯/铝/聚酯封口垫片
YBBOCll52005-2015 药用聚酯/铝/聚乙烯封口垫片
YBB00252005-2015 聚乙烯/铝/聚乙烯复合药用软膏管
YBB0007213105-2015 药用低密度聚乙烯膜、袋

第四部分 橡胶类药包材标准
YBB00042005-2015 注射液用卤化丁基橡胶塞
YBB00052005-2015 注射用无菌粉末用卤化丁基橡胶塞
YBB00232004-2015 药用合成聚异戊二烯垫片
YBB00222004-2015 口服制剂用硅橡胶胶塞、垫片

第五部分 预灌封类药包材标准
YBB00112004-2015 预灌封注射器组合件(带注射针)
YBB00062004-2015 预灌封注射器用硼硅玻璃针管
YBB00092004-2015 预灌封注射器用不锈钢注射针
YBB00072004-2015 预灌封注射器用氯化丁基橡胶活塞
YBB00082004-2015 预灌封注射器用溴化丁基橡胶活塞
YBB00102004-2015 预灌封注射器用聚异戊二烯橡胶针头护帽
YBB00122004-2015 笔式注射器用硼硅玻璃珠
YBB00132004-2015 笔式注射器用硼硅玻璃套筒
YBB00142004-2015 笔式注射器用铝盖
YBB00152004-2015 笔式注射器用氯化丁基橡胶活塞和垫片
YBB00162004-2015 笔式注射器用溴化丁基橡胶活塞和垫片

第六部分 其他类药包材标准
YBB00122005-2015 固体药用纸袋装硅胶干燥剂

第七部分 方法类药包材标准
YBB00262004-2015 包装材料红外光谱测定法
YBB00272004-2015 包装材料不溶性微粒测定法
YBB00282004-2015 乙醛测定法
YBB00292004-2015 加热伸缩率测定法
YBB00302004-2015 挥发性硫化物测定法
YBB00312004-2015 包装材料溶剂残留量测定法
YBB00322004-2015 注射剂用胶塞、垫片穿刺力测定法
YBB00332004-2015 注射剂用胶塞、垫片穿刺落屑测定法
YBB00342004-2015 玻璃耐沸腾盐酸浸蚀性测定法
YBB00352004-2015 玻璃耐沸腾混合碱水溶液浸蚀性测定法
YBB00362004-2015 玻璃颗粒在98℃耐水性测定法和分级
YBB00372004-2015 砷、锑、铅、镉浸出量测定法
YBB00382004-2015 抗机械冲击测定法
YBB00392004-2015 直线度测定法
YBB00402004-2015 药用陶瓷吸水率测定法
YBB00412004-2015 药品包装材料生产厂房洁净室(区)的测试方法
YBB00172005-2015 药用玻璃砷、锑、铅、镉浸出量限度
YBB00182005-2015 药用陶瓷容器铅、镉浸出量限度
YBB00192005-2015 药用陶瓷容器铅、镉浸出量测定法
YBB00242005-2015 氧乙烷残留量测定法
YBB00262005-2015 橡胶灰分测定法
YBB00012003-2015 胞毒性检查法
YBB00022003-2015 热原检查法
YBB00032003-2015 溶血检查法
YBB000420032015 急性全身毒性检查法
YBB00052003-2015 皮肤致敏检查法
YBB00062003-2015 皮内刺激检查法
YBB000720032015 原发性皮肤刺激检查法
YBB00082003-2015 气体透过量测定法
YBB00092003-2015 水蒸气透过量测定法
YBB00102003-2015 剥离强度测定法
YBB00112003-2015 拉伸性能测定法
YBB00122003-2015 热合强度测定法
YBB00132003-2015 密度测定法
YBB00142003-2015 氯乙烯单体测定法
YBB00152003-2015 偏二氯乙烯单体测定法
YBB00162003-2015 内应力测定法
YBB00172003-2015 f内压力测定法
YBB00182003-2015 热冲击和热冲击强度测定法
YBB00192003-2015 垂直轴偏差测定法
YBB00202003-2015 平均线热膨胀系数测定法
YBB00212003-2015 线热膨胀系数测定法
YBB00232003-2015 三氧化二硼测定法
YBB002420032015 121℃内表面耐水性测定法和分级
YBB00252003-2015 玻璃颗粒在121℃耐水性测定法和分级
YBB00342003-2015 药用玻璃成分分类及理化参数
YBB00142002-2015 药品包装材料与药物相容性试验指导原则

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Brand Jingdong book
Brand Origin China

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Jingdong book