水凝胶贴膏基质在未来中国贴剂加工行业的发展态势. 天津瑞康

水凝胶贴膏基质在未来中国贴剂加工行业的发展态势. 天津瑞康 浅谈水凝胶贴膏基质在未来中国贴剂加工行业的发展态势 水凝胶主要成份是以亲水性树脂，纯化水，保湿剂，交联剂遇水膨胀的交联聚合物。主要用于外用凝胶贴剂。如水凝胶小儿退热贴，水凝胶护眼贴，水凝胶眼袋贴，水凝胶面膜贴，该剂型最早起源于日本，主要是将化学药物与适宜的亲水性水凝胶基质混合后，涂布在背衬 材料 关于××同志的政审材料调查表环保先进个人材料国家普通话测试材料农民专业合作社注销四查四问剖析材料 上制成的水凝胶贴膏剂。由背衬(常用无纺布、水刺布)，膏体，防粘膜(膏体表面的菱形压花隔离膜)组成。 水凝胶贴膏基质载药量大，保湿性强，与皮肤的相容性好，耐老化，可以反复揭贴，随时终止给药，剂量准确，血药浓度平衡无峰谷现象，可减少毒副作用，在工业生产中无有机溶剂污染，符合医药GMP标准和国家环保要求。 水凝胶贴膏基质特点如下: 1、 水凝胶膏贴基质成份不同 一般的橡皮膏基质都采用橡胶或高聚化学材料，而这些材 料是由酒精提取的化合物，且对皮肤有较大的刺激，虽然目前 国内有些企业和研究所已对贴剂剂型进行研究和开发，但是大 多选用热熔胶，而热熔胶熔点在135?以上，其主要成份为石 油副产品，只不过是对橡皮膏进行改良加工，没有从根本上解 决问题。水凝胶主要成份是以亲水性树脂，纯化水，保湿剂， 交联剂遇水膨胀的交联聚合物，很好的避免了橡胶和高聚化 学材料基质带来的缺点。 implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future 2、 水凝胶膏贴基质药物包容量大 一般的橡皮膏贴剂，其基质经加药后涂布厚度在0.1毫米左右，且含药量低，只是靠添加一些类似于辣椒素，冬青油等发热体来从表面上蒙骗顾客，本产品经试验结果证明，添加中药(浸膏、药泥、干药粉体)，浸膏在其厚度1毫米到1.3毫米，面积60×90毫米或者70×100毫米时，大约3克;药泥在2.5-3克;干药粉体在1克左右。且药物与基质的比例进一步提高。一般的透皮药贴其基质与药物的比例在90:10，而水凝胶贴剂产品实验证明可将比例上升至65:35,相比之下药物比例的增加和含药层的增厚能够完全满足单位给药和药效持久。进一步保证和加强了药物治疗的效果。该剂型经多年试验表明基质与药物的可调可控以及高浓度载药非常适合中国中药多组方大剂量给药的特点。 3、 水凝胶基质强渗透、控缓释效果好 水凝胶基质采用亲水性高分子材料，使药物始终处于活性状态，提高了药物活性成分的皮肤渗透，使药物迅速直达病灶且在药物的控缓释方面有明显的效果，药物可在24小时至120小时以至更长时间内均匀释放药效，避免了药物的峰谷现象，这样可以提高药物成分的有效利用率，而且做到长效恒定。经北京中医药大学和西安交大研究生实验室TTS经皮给药检测试验，水凝胶基质添加药物后，其释放度可以达到32%.透皮率 implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future 61%。目前国内市场有厂家用热熔胶和化工胶制作贴剂，完全 将药物包裹在胶体内，试想怎能达到药物透皮吸收的效果, 4、 水凝胶膏贴基质与药物亲和力强 水凝胶基质采用了特殊的中性配方，其ph值在7左右，可以 添加中药、西药;水溶性、非水溶性;酸性、碱性等各种药物， 均具有较好的亲和力，且对药物无任何改性和影响，是理想的 添加多种治疗药物的医药载体。 5、 水凝胶膏贴基质无毒、无刺激、不过敏 由于水凝胶基质采用了天然及合成材料，经科学配制，无毒、无刺激，对人体皮肤无任何过敏现象，2011年---2012年水凝胶基质多次在苏州医学院环境与卫生检测中心检测，无毒、无刺激、不过敏。水凝胶基质制成药贴后，在人体使用，不会出现皮肤泛白、刺痒或红斑等现象，不污染皮肤，避免了传统膏贴汞、铅等有害物质对人体带来的损害。目前水凝胶已经成熟的用于小儿退热贴，小儿护眼贴，面膜贴，眼袋贴，减肥贴，烧伤辅料贴。 6、 水凝胶膏贴基质粘度可控且适中，可以反复揭贴 水凝胶基质制成药贴后不同于一般的橡皮膏和传统黑膏药， 包括热熔胶。热熔胶对皮肤粘贴力过大，会导致体毛受损，剥 离困难，造成患者痛苦，且为一次性使用，黑膏药使用时必须 加热，粘带体毛和污染皮肤，本剂型由于可调节粘度和亲和力， 可以做到对人体粘贴力适中，剥离容易，而且可以反复揭贴。 7、 水凝胶膏贴基质皮肤亲和力更密切 implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future 水凝胶基质采用新型配方，进一步增强了对人体皮肤的亲和力，药物成份受人体温度感应向人体内渗透，药物的效能可以受皮肤温度调节，揭下后药物便可停止挥发，而一般贴剂揭下后药物严重挥发以至短时间内容易失效。 8、 水凝胶膏贴基质低温加工、保护药物的有效成份 水凝胶基质选用高分子亲水性材料合成配制，尤其基质调配过程中，温度控制在常温，众所周知，目前国内某些厂家在贴剂加工过程中使用热熔胶，而热熔胶其熔点在135?以上，加工中药贴剂添加中药浸膏或中药粉体后，长时间药物在高温135?的胶体中搅拌会造成药物有效成分的挥发和破坏，薄荷，冰片，人工麝香，其他的一些药物提取油都是贴剂生产过程中必备的原料，恰恰这些原料容易易挥发，而相比之下水凝胶基质常温加工避免了这一弊端。 9、 水凝胶膏贴基质绿色环保，价格适宜，适合医药市场 水凝胶基质由于其保湿剂选用马来西亚和印尼进口材料，稀释剂采用医药级纯化水，透皮剂采用水性天然材料，基质完全可以口服，无明火加工，选用医药级备膜备布，没有环境污染，完全符合国家贴剂的生产要求。热熔胶本来属于石油的副产物，在加工过程中将会有大量的有害气体挥发，容易导致人体呼吸道感染，传统熬制黑膏药在熬制过程中以及添加铅丹过程中有大量的致癌气体挥发，试想医药GMP车间必须有洁净要求，盲目的选择一种加热后挥发有毒气体的热熔胶作为贴剂 implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future 基质，将是错误的选择，(笔者没有攻击热熔胶的工业用途，或许热熔胶在胶带加工业以及包装行业，包括加工粘鼠强粘蚊彩条有其广泛的用途)但是用于贴剂加工则有所不妥，何况目前国内热熔胶的价格在23-26元每公斤，且过敏率几乎是100%，而水凝胶基质的价格完全远远低于热熔胶价格将近1倍，无过敏，无毒，无刺激，未来几年。将在国内贴剂加工企业逐渐推广和普及。贴剂作为外用产品，如何在医药市场竞争激烈的今天取得患者的认可，无非是疗效验证，短时间的广告炒作和忽悠只是昙花一现，广大的厂家无非是通过招商的手段来寻找代理商和产品大包商，一个没有疗效的贴剂，代理商不可能会用大量的资金和精力去运作，或许找到代理商，在OTC和临床使用，患者的过敏和无效投诉终究会追究在厂家。本来目前国内医患关系非常紧张，作为贴剂生产厂家，或许通过手段有能力解决厂家所在地药监部门的责任追查，但是没有能力涉及异地药监纠察，因为所做产品本身就不合格。尤其国家食品药品监督管理局药以及环保部门，消防部门，对药厂环境卫生以及易燃易爆，和药物不良反应的规范，热熔胶及黑膏药的烟气，毒气污染以及易燃危险，包括人体使用的毒性，刺激性，过敏性，将逐渐被贴剂行业淘汰，近几年有很多企业车间按照GMP标准装修，由于不懂得贴剂工艺流程和行业规范，盲目购置热熔胶涂布机(胶带加工设备改造加工贴剂)由于高污染和易燃危险，根本连生产许可证及消防批件无法通过，最后只有购置水 implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future 凝胶贴剂流水线来合法生产，医药和食品行业的第一宗旨是保 障人民的健康，三鹿事件，地沟油事件，毒胶囊事件，值得我 们去深思，我们的选择，直接影响着下一代的健康。 国家药典2010版，已经将水凝胶贴剂载入国家药典，目前 国内已经有很多制药企业选择使用水凝胶膏贴基质，包括正在 开发。如哈药集团人民同泰制药厂的骨友灵巴布膏，上海雷允 上制药的蟾乌巴布膏，河南羚锐，云南白药，广西花红药业， 武汉海格尔，青岛帝国，大连美罗，通化金马，长春精优药业。 北京中医药大学，南京中医药大学，西安交大医学院药学系， 湖南中医药大学，广州中医药大学，很多高校同时也对水凝胶 贴膏以及巴布剂基质进行研究，所以水凝胶贴膏基质的使用是 贴剂生产业的大势所需。 附: 透皮给药技术(TTS): 透皮给药技术(TTS)是一种新颖的很有发展潜力的具有革命性的外用医药方法。自20世纪80年代进入商品化之后，广泛被医药界及病员所接受。 特点如下: 保持平稳的血液浓度，避免了血液浓度的 峰谷现象，能平稳给药，长效治疗。 由于经皮给药，从而避免了胃、肠道及肝 脏等器官的副作用。克服了胃、肠道粘液的PH值的破坏implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future 与运作时间的影响，进而提高了药物的活性利用率，达到治疗的预见性。 改善病人对药物适应程度，避免了口服药物对人体胃、肠道及肝脏等器官的副作用。TTS吸收率易控制，释药平稳，持续恒定，极大的增加了安全性，无副作用，避免了口服或注射治疗的危险性，从而深受患者欢迎。 透皮给药技术(TTS)的基础是透皮贴剂、各种治疗药物。我国古代早已有“透皮给药技术”即俗称“狗皮膏药”二者原理是一样的，“狗皮膏药”所存在的缺点是，贴剂达不到当今世界经皮给药技术的要求:透皮性、粘贴性差、反复粘贴次数少、不亲水、尤其严重的是透皮给药的药物利用率低并且对人体过敏。而新型水凝胶贴膏，巴布剂基质平台，避免了这些缺点，从而将成为未来医药界贴剂制作广泛使用的载体。 我国自1997年以来，已有企业和研究所在着手研发和生产水凝胶贴膏以及巴布剂，但是缺乏对水凝胶贴膏以及巴布剂这一新剂型真正意义上的认识，和对水凝胶贴膏及巴布剂基质和生产设备深层次的研究，将药物混合在热熔胶和万能胶中，涂布加厚就称其“巴布剂”，而衡量水凝胶贴膏和巴布剂最基本的指标是，是否亲水，如果不亲水就称不上是水凝胶贴膏和巴布剂 implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future implementation Shang combined buildings actual status and this times transformation achieved of integrated function, main achieved digital, network of unified concentrated management. achieved advanced of, stable of, structure reasonable of, extended sex strong, economic practical of high standards integrated management. reached medical integrated floor, rehabilitation floor overall supporting using, meet full hospital has network operation management integration. Medical complex layers of security, fire management office will serve as the weak electricity construction project monitoring and control system, access control system, parking management systems, fire alarm and fire protection and public broadcasting systems, intelligent building control system, information guides and release system, weak electricity intellectualization management system management control center. Medical information integrated floor room as this weak electricity construction project of computer network systems, voice communications systems Center and hospital-wide medical information management system (HIS,PACS,LIS) operations control center. Construction target with hospital trend Yu to set medical, teaching, research Yu one of modern business management mode development, and China promotion created "peace hospital" development requirements, while consider to domestic hospital adapted healthcare future