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长治市三宝生化药业有限公司编号SBB2.8.5.6利巴韦林注射液生产工艺验证方案长治市三宝生化药业有限公司方案制订签名日期方案会签签名日期生产技术部签名日期验证小组签名日期方案批准质量保证部日期目录1.概述`````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````4` 1.1.产品简述``````````````````````````````````````````````````````````````````````````````````````````````````````````````4 1.2.处方及依据``````````````````````````````````````````````````````````````````````````````````````````````````````````41.3.生产工艺流``````````````````````````````````````````````````````````````````````````````````````````````````````````5`2.验证目的````````````````````````````````````````````````````````````````````````````````````````````````````````````````````53.验证的范围```````````````````````````````````````````````````````````````````````````````````````````````````````````````64.验证各部门职责及组织结构```````````````````````````````````````````````````````````````````````````````65.验证准备````````````````````````````````````````````````````````````````````````````````````````````````````````````````````76.验证内容及实施``````````````````````````````````````````````````````````````````````````````````````````````````````8` 6.1.洗瓶工序````````````````````````````````````````````````````````````````````````````````````````````````````````````8 6.2.配制工序```````````````````````````````````````````````````````````````````````````````````````````````````````````12 6.3.灌封工序```````````````````````````````````````````````````````````````````````````````````````````````````````````15 6.4.灭菌工序```````````````````````````````````````````````````````````````````````````````````````````````````````````20 6.5.灯检工序```````````````````````````````````````````````````````````````````````````````````````````````````````````24 6.6.包装工序```````````````````````````````````````````````````````````````````````````````````````````````````````````266.7.成品检验结果``````````````````````````````````````````````````````````````````````````````````````````````````287.偏差分析``````````````````````````````````````````````````````````````````````````````````````````````````````````````````298.验证结论``````````````````````````````````````````````````````````````````````````````````````````````````````````````````299.附表````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````29 9.1. 设备一览表及生产能力```````````````````````````````````````````````````````````````````````````````30 9.2.设备性能验证确认及检查情况表```````````````````````````````````````````````````````````````31 9.3参加验证人员培训情况检查表````````````````````````````````````````````````````````````````````32 9.4.厂房与公用设施验证的确认和检查情况表`````````````````````````````````````````````34 9.5.空气净化系统、工艺用水系统验证的确认和检查情况表`````````````````35 9.6.计量器具检查情况表```````````````````````````````````````````````````````````````````````````````````````36 9.7.三批（按四批准备）验证使用的原料、辅料和安瓿供应商确认及检查情况表`````````````````````````````````````````````````````````````````````````````37 9.8.质量检验系统验证和准备情况表```````````````````````````````````````````````````````````````38 9.9.检验仪器检查情况表``````````````````````````````````````````````````````````````````````````````````````39 9.10检验试剂检查情况表````````````````````````````````````````````````````````````````````````````````````40 9.11质量监控点、监控内容、监控方法、监控频次表`````````````````````````````411.概述1.1.利巴韦林注射液（1ml：100mg）常温状态下是无色的澄明液体，属抗病毒药，用于呼吸道合胞病毒引起的病毒性肺炎与支气管炎。
复方氯丙那林溴己新片【药品名称】通用名称：复方氯丙那林溴己新片英文名称：Compound Clorprenaline and Bromhexine T ablets【成份】盐酸氯丙那林5mg,盐酸溴己新10mg,盐酸去氯羟嗪25mg【适应症】用于支气管哮喘，喘息型支气管炎及慢性支气管炎等。
【用法用量】口服。
一次1片，一日1～3次。
【不良反应】1.个别患者服药后有心悸，手颤等。
2.对胃黏膜可有刺激反应。
3.偶有嗜睡、口干、失眠等反应，停药后可消失。
【禁忌】对本品成分过敏者禁用。
【注意事项】1 高血压和心、肾功能不全者慎用。
2 胃炎患者或胃溃疡病人慎用。
3 偶见血清氨基转移酶短暂升高，但能自行恢复。
【特殊人群用药】儿童注意事项：未进行该项实验，且无可靠的参考文献。
妊娠与哺乳期注意事项：孕妇及哺乳期妇女不宜应用。
老人注意事项：心、肾功能不全者和高血压患者慎用本药，使用时应根据年龄和病情酌减给药次数。
【药物相互作用】1.与其他支气管β2受体激动剂合用有叠加作用。
2.本品与其他β2受体激动剂同用，药效降低而不良反应如手颤、心悸等可更明显。
3.如配合以茶碱等磷酸二酯酶抑制剂或抗胆碱平喘药，其扩张支气管、缓解哮喘的效果增强。
4.盐酸溴己新可增加四环素族抗生素在支气管的浓度。
【药理作用】盐酸氯丙那林为β2受体激动剂，对支气管有明显的扩张作用，平喘效果较弱，但对心脏毒性明显降低。
盐酸溴己新有较强溶解黏痰作用，可使痰中的多糖纤维素裂解，稀化痰液。
抑制杯状细胞和黏液腺体合成糖蛋白，使痰液中的唾液酸减少，减低痰黏度，便于咳出。
盐酸去氯羟嗪有抗组胺作用，并有平喘及镇静效果。
【贮藏】遮光，密封，在干燥处保存。
【有效期】暂定24个月【批准文号】国药准字H33021989【说明书修订日期】核准日期：修改日期：【生产企业】企业名称：浙江安贝特药业有限公司生产地址：浙江省金华市十里铺。
