固零碎剂车间新非青非头破费地区复方磺胺甲噁唑片接着工艺确认文件编号：VR-GT-2016-3006上海新亚药业闵行目录1产物概述.........................................................................................................................................32破费工艺剖析.................................................................................................................................32.1要害工艺参数确实认.......................................................................................................................32.2要害工艺参数数据统计趋向剖析...................................................................................................43产物放行剖析.................................................................................................................................63.1要害品质属性确实认.......................................................................................................................63.2要害品质属性据统计趋向剖析.......................................................................................................64论断及倡议...................................................................................................................................101产物概述复方磺胺甲噁唑片是固零碎剂非青非头车间破费的口服片剂，其规格为磺胺甲噁唑0.40g、甲氧苄啶80mg，包装规格为100片/瓶*1瓶/盒*10盒/热缩*30热缩/纸箱，赞成文号为国药准字H31020387，储存前提为遮光,密封保存。无效期：36个月。复方磺胺甲噁唑片为磺胺类抗菌药，是磺胺甲恶唑〔SMZ〕与甲氧苄啶〔TMP〕的复方制剂，要紧习惯症为敏感菌株所致的以下沾染。〔1〕大年夜肠埃希杆菌、克雷伯菌属、肠杆菌属、共同变形杆菌、一般变形杆菌跟莫根菌属敏感菌株所致的尿路沾染。〔2〕肺炎链球菌或流感嗜血杆菌所致2岁以上小儿急性中耳炎。〔3〕肺炎链球菌或流感嗜血杆菌所致的成人慢性支气管炎急性发生。〔4〕由福氏或宋氏志贺菌敏感菌株所致的肠道沾染、志贺菌沾染。〔5〕医治卡氏肺孢子虫肺炎，本品系首选。〔6〕卡氏肺孢子虫肺炎的防备，可用已有卡氏肺孢子虫病至多一次发生史的患者，或HIV成人沾染者,其CD4≤淋巴细胞计数200/mm3或少于总淋巴细胞数的20%。〔7〕由产肠毒素大年夜肠埃希杆菌〔ETEC〕所致巡游者腹泻2破费工艺剖析2.1要害工艺参数确实认要害工序制粒要害装备要害工艺参数搅拌慢档转速搅拌快档转速制粒刀参数范畴高效湿法制粒机12-02-04-08110-150rpm150-190rpm1400-1600rpm10-30rpm150-300rpm1min搅拌桨整粒刀干混时刻进风温度冷却温度转速枯燥整粒总混压片沸腾枯燥机12-02-03-02整粒机120±5℃45±2℃300-1000rpm12-02-04-09混杂机混杂时刻混杂转速主压力转速1200s12-02-09-018rpm高速压片机12-02-05-153-30Kn20-60rpm内包数片机12-04-02-05运转速率20-100rpm2.2要害工艺参数数据统计趋向剖析2.2.1目标对要害工艺参数进展接着的工艺确认2.2.2次第“对要害工艺参数进展统计剖析汇总，填写附件1〞“对要害工序物料均衡及制品率进展统计汇总，填写附件对要害工序统计剖析2〞2.2.3.可承受规范要害工艺参数单值契合设定的规范央求要害工序工艺参数坚定可控，工序才能满意央求2.2.4论断要害工艺参数单值契合设定的规范央求，详见附件要害工序的物料均衡统计剖析如下：12.2.4.1压片工序压片物料均衡的I-MR操纵图101100UCL=100.601值独单_X=99.2159998LCL=97.829UCL=1.70312345678910批号1.61.2差极动0.8移__MR=0.5210.40.0LCL=012345678910批号后果剖析：一切批次的压片物料均衡呈随机散布，单值在操纵范畴内阐明该进程坚定可控。下限为100.6%，下限为97.8%，因而依照破费倾向状况压片工序的物料均衡限制为97.0-100.0%。2.2.4.2数片工序数片物料均衡的I-MR操纵图103102UCL=102.826值独单_X=100.73410110099LCL=98.642UCL=2.57012345678910批号2.41.81.20....
