片剂包衣技术概况和发展(完成)(3).docxVIP

片剂包衣技术概况和发展 学生姓名 董丹丹 班 级 生工 1002 班 专业名称 生物化工工艺 系部名称 制药工程系 指导教师 崔润丽 提交日期 2012 年 10 月 答辩日期 2012 年 11 月 河北化工医药职业技术学院 2012 年 10 月 目录 摘要 § 1.绪 论 ··············································································································1 § 2. 片剂包衣技术概况 ························ ····· ·· ··· ····· ····· ····· ··· ·· ·· ··· ····· ··· ·· ··· ·· ····· ····· ··1 § 2.1 片剂包衣工艺 ······················· ····· ·· ··· ····· ····· ····· ··· ·· ·· ··· ····· ··· ·· ··· ·· ····· ····· ··2 § 2.2 包衣原理（包衣机） ··········· ····· ····· ····· ·· ··· ····· ··· ·· ·· ··· ····· ····· ····· ····· ··· ·· ··3 §2.3 包衣设备 ····························· ··· ····· ····· ····· ····· ·· ··· ·· ··· ··· ·· ··· ·· ····· ····· ····· ····· ··4 § 3. 质量控制和存在问题 ···················· ····· ·· ··· ····· ····· ····· ··· ·· ··· ·· ····· ····· ··· ·· ··· ·· ····· ··5 § 3.1 质量控制 ·························· ··· ····· ····· ····· ····· ····· ·· ··· ·· ··· ··· ·· ··· ·· ····· ····· ····· ··5 § 3.2 存在问题 ·························· ··· ····· ····· ····· ····· ····· ·· ··· ·· ··· ··· ·· ··· ·· ····· ····· ····· ··6 § 3.3 解决办法及个人建议 ··········· ····· ····· ····· ·· ··· ····· ··· ·· ·· ··· ····· ····· ····· ····· ··· ·· ··8 § 4. 结 论 ···········································································································9 参考文献 ············································· ····· ····· ····· ·· ··· ····· ··· ·· ··· ·· ··· ·· ····· ····· ··· ·· ····· ··9 致 谢 ·················································································································10 摘要 包衣片剂是指在片心（压制片）外包衣膜的片剂。包衣的目的是增加片剂中药物的 稳定性，改善片剂的外观，控制药品的溶出等等，本文以查阅大量资料和在包衣岗位的 轮岗实习的经验为前提，系统的介绍了片剂包衣技术的现状、发展、以及存在的问题； 主要从包衣工艺：片芯 包隔离层 包粉衣层 包分衣层 包有色 衣层 打光；包衣原理：片芯在包衣机洁净密闭的旋转滚筒内，不停地做复杂轨迹运 动，翻转流畅，交换频繁，由恒温搅拌桶搅拌的包衣介质，经过蠕动泵的作用，从进口 喷枪喷漉到片芯， 同时在排风和负压作用下， 由热风柜供给的 10万级洁净热风穿过片芯， 由底部筛孔从风门排出，使包衣介质在片芯表面快速干燥，形成坚固、致密、光滑的表 面薄膜。包衣设备：由主机 ( 原糖衣机) 、可控常温热风系统、自动供液供气的喷雾系统 等部分组成；质量控制包括：包衣片芯的质量要求外溶出、重量差异和含量均匀性、包 衣后达到的要求；包衣存在的问题：干裂，标识架桥，气泡，针孔，色泽差异，粘结， 花斑，皱皮，剥落；解