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第三章_口服固体制剂课件

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第三 口服 固体 制剂 课件
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Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 第三章 口服固体制剂 3 1 口服固体制剂生产工艺技术 3 1 1 片剂生产工艺技术 流程及洁净区域 划分 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 片剂的生产方法 粉末压片法 颗粒压片法 制粒 干法制粒 湿法制粒 一步制粒 包衣 糖衣 薄膜包衣 包装 瓶装 主要是塑料瓶 双铝 铝塑 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 1 2 硬胶囊剂生产工艺技术 流程及洁净 区域划分 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 1 3 颗粒生产工艺技术 流程及洁净区域划分 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 1 4 口服固体制剂生产工艺质量控制 一 片剂的质量要求 片重差异 含量均匀度 硬度和脆碎度 崩解时限 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 二 胶囊剂的质量要求 内容物的含水量 空胶囊的质量 装量差异 崩解时限 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 2 口服固体制剂生产工艺设备 3 2 1 片剂生产工艺设备 粉碎机 制粒机 烘干机压片机 高效包 衣机 铝塑 包装机 制粒工序压片工序包衣工序内包工序 塑瓶 包装机 筛粉机 称配工序 混合机 整粒机 总混机 糖衣锅 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 一 混合机 1 槽形混合机 图片显示 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 由混合槽 搅拌桨 蜗轮减速器 电机 及机座等构成 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 性能及特点 1 一 般用在称量后 制粒前的混合 与摇摆式颗粒机配 套使用 目的是使物料达到均匀的相互分布 以保证药物 剂量准确 在干粉混合过程中要加粘合剂或润湿剂 2 主电机带动搅拌桨旋转 由于桨叶具有一定的曲线形 状 在转动时对物料产生各方向的推力 使物料翻动 达 到均匀混合的目的 副电机可使混合槽倾斜1050 使物料倾出 3 一般装料约占混合槽容积的80 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 4 缺点 搅拌效率低 混合时间长 搅拌轴两端的密封件容易漏粉 搅拌时粉尘外溢 污染环境 对人体健康不利 5 优点 价格低 操作简便 易于维修 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 V型混合机 1 结构简图 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 常用于干颗粒或粉末的混合 一般 适用于总混 每混一次为一个批号 3 工作原理 容器围绕转轴旋转一周时 容器内的物料一合一分 容器不停转动时 物料经多次的分开 掺合而达到均匀 4 缺点 安装不方便 有高度要求 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 三维运动混合机 特点 主轴转动一周时混合容器在两空间交叉轴上 下颠例4次 容器在空间既有公转又有自转和翻转 物料在容器内除被抛 落 平移外还作翻倒运动 进行有效的对流混合 剪切混合和 扩散混合 使混合在没有离心力作用下进行 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 三维运动混合机优点 混合均匀度高 物料装载系数大 特别是对物 粒间密度 形状 粒径差异较大时 得到很好 的混合效果 占地面积和空间高度小 上料和出料方便 容器和 机身可用隔墙隔开 符合GMP要求 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 二 制粒设备 1 摇摆式颗粒机 制粒原理 强制挤出型 对物料性能的要求 物料必须粘松恰 当 太粘挤出的颗粒成条不易断开 太 松则不能成颗粒而变成粉末 工作原理 1 由七根梯形截面的刮刀组成一个滚轮 紧贴于滚轮的筛网 制成的颗粒要求 用手紧握能成团 而用手指轻压团 块能立即分散为宜 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 通过滚筒的正反运动 即 摇摆 将软材 向筛孔挤 压成颗粒 3 运动的传动 图示 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 快速混和制粒机 卧式 图片展示 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 结构 示意图 由盛料器 搅拌桨 搅拌电 机 制粒 刀 制粒 电机 电 器控制器 和机架等 组成 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 工作原理 通过搅拌器混合及高速旋转制粒刀切制将快 速翻动和转动的物料制成湿颗粒 结构特点 1 具有混合与制粒的功能 上有加料口 出气口 水管接口 2 混合操作时处于密闭状态 粉尘飞扬极少 3 转轴的缝隙有气流进行气密封 粉尘无外溢 4 出料口由气动控制 气源压力 0 5MPa 5 符合GMP要求 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 操作程序 主辅料加入容器内 开动搅拌桨先干粉混合1 2min 由加料口加入粘合剂 湿搅拌4 5min 制成软材状 开启快速制粒刀 由于物料的快速翻动和转动 使之被制成大小均匀的颗粒 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 优点 1 混合制粒时间短 颗粒大小均匀 细 粉少 流动性好 2 压成片剂后硬度好 崩解 溶出性能 较好 3 所消耗的粘合剂少 4 易操作 设备密封性好 清洗方便 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 混合机的出料机构是一个气动活塞门 它 受气源的控制来实现活塞门的开启或关闭 图9 9 出料机构 1 电磁阀 2 节流阀 3 出料口 4 活塞 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 出料操作 当按下 关 的按键时 二位五通电磁阀实现左 半的气路 即压缩空气从A口进人 推动活塞 将门关闭 当按下 开 的按键时 压缩空气从B口进人 活塞向左推动 此时容器的门打开 物料可以 从圆门处排出容器之外 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 立式快速混合制粒机 其传动件放在上部 容器可以上 下移动 工 作原理和实际效果基本与卧式机一样 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 三 干燥设备 1 热风循环烘箱 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 基本结构 热源1按实际情况 选用蒸汽加热或电 加热 如有易燃气 体 则选蒸汽加热 烘车 烘盘及管道 选用耐腐蚀的不锈 钢材料 工作原理 热源1放出热量 风机7使热风循环 循环路线如图所示 热风携带热量与烘盘的湿物料交换带走水分 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 特点 适用于物料含水量较大 质地较重的产 品 干燥过程中要定时翻动物料以防表层物 料过分干燥发热变黄而内层还未干透 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 沸腾干燥机 沸腾干燥是将湿颗粒药物处于流化沸腾状态下与载热 气体进行热交换的干燥设备 容器内部设 有搅拌器和 空气分布板 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 结构示意图 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 工作程序 装入物料 沸腾器到位 与上下气室充气密封 开启风机 容器成负压 热空气由下部冲出 物料成沸腾状态 经交换带走水份 物料干燥后 容器脱离上下气室被移出 出料 温度分布 经加热器加热后的热空气可达110 左右 有物料的沸腾器内温度40 50 左右 顶部出口的温度30 35 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 沸腾制粒机 是以沸腾形式进行混合 造粒 干燥的一步制 粒设备 故又称一步制粒机 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 沸腾制粒机原理 图示9 13 顶喷装置 图a一顶喷 底喷装置 图 b一底喷 喷枪 粉末流 分布板 热空气流 喷枪的位置一般置于物料运动的 最高点上方 以免物料将喷枪堵 塞 喷液方向与物料方向相向 喷液方向与物料运动方向相同 适用于包衣如薄膜包衣 缓 释包衣 肠溶包衣等 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 切线喷装置 喷枪装在容器的壁上 底部有旋转 运动的转盘 物料除上 下运动外 还有周围的旋转运动 形成了螺 旋状运动 适用于制粒制微丸 转盘 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial FL120型一步制粒机 结构示意图 图9 14 需要的动力源 电力 主要供给引风机 输液泵 控制柜 压缩空气 用来雾化粘合剂 脉冲反吹装置 驱动气缸 蒸汽 用来加热空气 1 反冲装置 2 过滤袋3 喷嘴 4 喷雾室5 盛料器 6 台车7 顶 升气缸 8 排水口9 安 全盖 10 排气口 11 空气过滤器 12 加热器 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial FL120型一步制粒机结构说明 一 空气过滤加热部分 空气进气口 可调节流量以 控制物料运动状态和温度 过滤器11 定时清理或调换 加热器12 设定温度 机体 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 二 物料沸腾喷雾和加热部分 盛料容器5可移动 受气缸7进行密封 盛料容器底面是一个布满 1 2mm 小孔的不锈钢板 开孔率4 12 上面覆盖120目不锈钢丝制成的网 布 称为分布板 目的是均匀分布气 流 盛料容器装料量60 80 左右 一 般调节排风量 以进风量略大于排风 量为宜 起动排风机时风门要关闭 以减少起 动电源 风机运转正常后 可逐步加 大排风风门 形成理想的物料沸腾状 态 控制进风温度 过高 降低颗粒粒度 过低 结块 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 三 粉未捕集 反吹装置及排风结构 捕集装置是圆柱形滤袋 粉未留 在袋外 空气穿过袋网 布袋上方的 脉冲反吹装置 定时 由压缩空气向布袋反向吹风 使 细粉抖掉 保持气流畅通 容器顶部的安全盖起泄爆作用 容器内装有静电消除装置 粉末 产生的静电可及时消除 安全盖 吹 风 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 四 输液泵 喷枪管路 阀门和控制系统 喷枪的结构 图9 15 1 枪体 2 连接体 3 气缸4 活塞 5 调节螺丝 6 弹簧7 针 阀杆 8 阀座 9 调节帽 工作原理 压缩空气将活塞4右推 压缩空气从帽与阀座间 隙冲出 使液体雾化 一般压缩空气0 3 0 35Mpa 液体流量500 750ml min 带动针阀杆 喷枪口的 液体通道打开 喷液 压缩空气 液体 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 操作步骤 原辅料放入盛料器中 开启顶升气缸 将容器与机体联结 开启风机 容器内成负压 物料沸腾 同时加开蒸汽阀门加热空气 达到预定温度时 喷雾同时开动反冲装置 视物料温度切换开停喷雾 以防粘壁 喷完后进行干燥 当物料温度达到预定值 即可停止干燥 同时关闭风机 出料 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 四 压片机 单冲压片机 花篮式压片机 单向压片 仅上冲 加压 下冲不动 旋转式压片机 高速旋转式压片机 异形压片机 多冲双向压片 上冲 下冲 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 1 压片机基本结构 由冲模 加料 填充 压制 出片 等装置组成 1 冲模 结构图9 20 1 上冲 2 中模 3 颗粒 4 下冲 由上 下冲头和中模等组成 冲头端面可以刻有汉字 数字 字母 线条等 冲头和模孔形状可以是图形 也 可以是三角形等异形形状 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 加料 a 靴形加料器 图示9 21 1 上冲 2 加料器 3 中模 4 下冲 5 颗粒 6 拨杆 用于单冲或花篮式压片机 中 加料器作填充和刮料 运动 而模孔静止待料 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial b 月形栅式加料器 图示 9 22 1 中心轴 2 转 盘 3 中 模 4 药 片 5 加料器 6 刮 板 7 颗 粒 用于国产ZP 33 ZP 19型压片机的加料 特点 模孔绕轴中心周围运动 在特定位置自动受料 有 固定的刮板 靠颗粒的自由下落而充填于模孔内 因此对颗粒的质量要求较高 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial c 强迫式 加料器 料斗 主要起存 放物料的作用 其下 部与强迫加料器相连 加料电机 是 强迫加料器的动力源 变频调速 强 迫加料器 又可分为 齿轮箱和加料器两部 分 齿轮箱将加料电 机的动力传递到加料 器的两个拨料叶轮上 两叶轮逆向旋转 将物料强制充填到中 模孔中 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 强迫加料系统的 压片过程同月形 栅式加料系统基 本相同 也是分 为充填 刮平 压片 推片四个 步骤 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 填充 通过调节下冲头 的位置改变模孔 的容积来控制填 入颗粒的量 单冲压片机 直接调节螺母使 冲杆升上或降下 改变模孔的容积 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 图9 24 旋转式压片机 填充装置 1 手柄 2 调节杆 3 蜗杆 4 蜗 轮 5 填充 轨道 旋转式压片机 的充填通过调 节填充轨道的 高低来实现的 充填轨道 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 充填轨道 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 4 加压 a 单冲压片机加压机构 见图9 25 1 偏心轮 2 旋转轴 3 外套 4 连接销 5 调节螺杆 6 紧固螺母 7 上冲芯子 8 螺母 9 上冲 10 中模 11 下冲 利用上下冲相对位置机压于定量颗粒 使其受压成一定厚度和硬度的片状形态 分为曲柄冲击式和定位压轮式两种 旋松紧固螺旋调节上冲芯子 右旋压力减小 片子硬度减小 左旋压力加大 片子硬度增加 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial b 旋转式压片机的加压机构 图9 26 通过调节蜗杆 等控制下压轮 使下冲头上升 或下降 以此 调节颗粒的受 压及片厚等 1 蜗杆 2 蜗轮 3 下压轮轴 2 4 下压轮 5 下冲 下冲头上升颗粒的受压加大 下冲头下降颗粒的受压减小 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 下压轮 上压轮 充填轨道 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 5 出片 出片机构的主要作用是将中模孔内压制 成型的片剂推出 这一机构无论是何种压片机 其方法都 是使下冲升高并能将片剂顶出中模为止 在单冲压片机中 见图9 23 可调节螺母9 使下冲端口上升最高时与中模对平为至 而在旋转式压片中 常采用坡度导轨 使下冲渐渐上升 直至推出片剂 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 下压轮 上压轮 充填轨道出片轨道 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2 ZP33型旋转式压片机 图形展示 由传动机构 工作机 构及电器装置 机身 等部件组成 工作原理 图9 28 加料 填充 压片 出片 每旋转一周 冲模经过二次 压片过程 有两套加料装置 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 下压轮 上压轮 充填轨道出片轨道 上冲 下冲 压片 图9 28 33冲压片机工作原理 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 包衣设备 普通包衣机 流化包衣机 网孔式包衣机 五 包衣设备 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 图7 21 普通包衣机 1 鼓风机 2 角度调节器 3 电加热器 4 包衣锅 5 吸尘罩 6 煤气辅助加热器 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 图7 22 流化包衣机工作原理1 气体分布器 2 流化室 3 喷嘴 4 袋滤器 5 排气口 6 进气口 7 换热器 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 图7 23 网孔式包衣机工作原理示意图 1 排气管 2 进气管 3 喷嘴 4 网孔包衣锅 5 外壳 6 药片 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 3 2 2 胶囊剂生产工艺设备 图7 33 主工作盘及各区域功能示意图 1 排序与定向区 2 拔囊区 3 体帽错位区 4 药物填充区 5 废囊剔除区 6 胶囊闭合区 7 出囊区 8清洁区 9 主工作盘 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 1 空胶囊的排序与定向 2 空胶囊的体帽分离 3 填充药物 4 剔除装置 5 闭合胶囊装置 6 出囊装置 7 清洁装置 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 图7 34 排序装置结构 与工作原理 1 贮囊斗 2 落料器 3 压囊爪 4 弹簧 5 卡囊簧片 6 簧片架 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial I 帽在上 II 帽在下 图7 35 定向装置结构与工作原理 1 顺向推爪 2 定向滑槽 3 落料器 4 定向器座 5 压囊爪 a b c d分别表示定向过程中胶囊所处的空间状态 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial a 接通真空前 b 接通真空后 图7 36 拨囊装置结构与工作原理 1 上囊板 2 下囊板 3 真空气体分配板 4 顶杆 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial a 间歇式 b 连续式 图7 37 插管定量装置结构与工作原理 1 定量管 2 活塞 3 药粉斗 4 胶囊体 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 图7 38 模板定量装置结构与工作原理 1 底盘 2 定量盘 3 剂量冲头 4 粉盒圈 5 刮粉器 6 上囊板 7 下囊板 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial a 药物定量 b 药物填充 图7 39 活塞 滑块定量装置结构与工作原理 1 填料器 2 定量活塞 3 定量管 4 料斗 5 物料高度调节板 6 药物颗粒或微丸 7 滑块 8 支管 9 胶囊体 10 下囊板 Five weeks of practice ended in this way and my feelings can only be summed up
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