1、单击此处编辑母版标题样式单击此处编辑母版副标题样式* 1医疗机构制剂的现状与发展This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of
2、 the system are AT89C51 microcontroller and DS18B20 temperature sensor.医疗机构制剂医疗机构制剂 ： 指医疗机构根据本单位临床需要经批准而配制、自用的固定处方制剂。一、定义This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital
3、 temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.弥补市场药品不足临床科研需要培养药学人才 弥补医院财政不足 新药开发的摇篮 已上市的新中成药中有90以上的品种是在医院制剂基础上开发而来二二 、 医疗机构医疗机构制剂的优点制剂的优点（ 陈锋，何冰冰以态式分析法论医院制剂室的发展 J中国医院药学杂志， 2007， 27(4)l 498500 ）T
4、his paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller a
5、nd DS18B20 temperature sensor.1.发展初期发展初期 （ 1949 1979）2.自然发展自然发展 （ 1980 1999） 3.规范发展规范发展（ 2000 2009）三三 、制剂、制剂 的发展的发展This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital tempe
6、rature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.、发展初期市售药品少 。医院制剂：品种多，剂型多 ,门栏低 。医院制剂大发展的势态持续到上个世纪 70年代未。5This paper mainly introduces the design of an intelligent temperature control system which realize
7、s the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.2、 自然发展市售药品增多80年代以后，中国制药工业迅猛发展，市售药品品种多，数量多，规格全，剂型全，质量好。医院制剂 大输液、注射剂
8、、滴眼剂等退出医院制剂。6This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 mic
9、rocontroller and DS18B20 temperature sensor.、规范化发展2000年年 12月月 5号国家药品监督号国家药品监督管理局下发了第管理局下发了第 27号令，关于号令，关于医疗机构制剂配制质量管医疗机构制剂配制质量管理规范理规范 。2005年年 6月月 22号国家药品监督号国家药品监督管理局下发了医疗机构制剂管理局下发了医疗机构制剂注册管理办法（试行）注册管理办法（试行）（局令第（局令第 20号）号） 。整顿前：整顿前： 8398家家整顿后：整顿后： 4944家家减少44.7%经过经过 2000年年 3和和 2005年年4两次制剂室换证验收整顿两次制剂室换证
10、验收整顿全国全国 医疗机构医疗机构制剂室制剂室 数量数量减少为：减少为： 1182家家减少32.2%其中，其中， 配制大容量注配制大容量注射剂的制剂室射剂的制剂室 数量数量This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and sin
11、gle chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.20号令 引发的制剂品种整顿2006 2008年 ，全国 开展医院制剂注册整顿工作。北京 7000多个批准文号 ， 只保留 3400余个。2005年年 6月月 22号国家药品监督管理局下发了号国家药品监督管理局下发了 医疗机构制剂注册管理办法医疗机构制剂注册管理办法 （试行）（局令第（试行）（局令第 20号）。号）。This paper mainly introd
12、uces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature
13、sensor.四、 制剂发展的现状制剂室数量制剂室数量制剂品种数量制剂品种数量人员的素质人员的素质制剂硬件的投入制剂硬件的投入This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer.
14、 The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.1、 制剂室数量减少2003年年 12月月 ， 31279家家2008年底年底 ， 有有 171家家2009年年 2月月 ， 170家家1.1 南京全省持南京全省持许可证的许可证的医疗机构医疗机构This paper mainly introduces the design of an intelligent temperature control system which realizes the func
15、tion of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.1.2 北京北京 地地 区区医疗机构医疗机构制剂室情况制剂室情况This paper mainly introduces the design of an
16、 intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.2006年年 45家家201
17、0年年39家家1.3 上海市上海市This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51
18、 microcontroller and DS18B20 temperature sensor.2、品种 数量 在减少上海上海批准文号数量批准文号数量r2000年年 ，由，由 9712个大幅降至个大幅降至2581个个 (部队医疗机构的制剂批部队医疗机构的制剂批准文号未计入准文号未计入 ， 下同下同 )。r2007年初年初 ，经过，经过 医疗机构制剂医疗机构制剂再注册再注册 整顿整顿 ，又注销了，又注销了 926个个 。r目前目前 ， 已经减少到已经减少到 1655个，其个，其中属于医疗机构主动放弃的有中属于医疗机构主动放弃的有700个，占注销批准文号的个，占注销批准文号的 756。This p
19、aper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS
20、18B20 temperature sensor.北京北京This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system
21、 are AT89C51 microcontroller and DS18B20 temperature sensor.Contents医疗机构制剂许可证药品管理法医疗机构制剂注册管理办法 医疗机构制剂配制监督管理办法五、 原因分析1 加强管理加强管理 等，对医疗机构制剂提出了更高的要求 。如 ： 配制医疗机构制剂要有类似于制药企业 GMP的软、硬件条件； 不得使用非药用规格的原料和辅料；医疗机构制剂以自用为原则，在不同医疗机构之间调剂使用有更严格的规定等。 This paper mainly introduces the design of an intelligent temperatur
22、e control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.2 高成本高成本品种剂型多、批量小，有的制剂一次只生产几十毫升，无法形成批
23、量规模化生产；制剂的效期短，损耗较大；制剂室占用房屋面积大，投入多，成本高，改造或新建制剂室都需投入几百万元至几千万元，维持费用高。 This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcompu
24、ter. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.长期以来，医疗机构制剂给人的感觉是价廉物美，而物价长期以来，医疗机构制剂给人的感觉是价廉物美，而物价部门在核定制剂价格时又仅将价廉作为其区别于市售药品的部门在核定制剂价格时又仅将价廉作为其区别于市售药品的根本特征。根本特征。现行的制剂价格仅计算了制剂原辅料、包材、工时费、检现行的制剂价格仅计算了制剂原辅料、包材、工时费、检测费，并且是建立在多年前物价基础之上的。而建设符合测费，并且是建立在多年前物价基
25、础之上的。而建设符合GPP标准制剂室的大量投入标准制剂室的大量投入 (包括房屋、净化系统、设备及包括房屋、净化系统、设备及维护费用等维护费用等 )、因物价上涨而大幅提升的制剂成本、因物价上涨而大幅提升的制剂成本 (包括研发包括研发投入、生产成本、检验成本及各项管理成本等投入、生产成本、检验成本及各项管理成本等 )、人员工资以、人员工资以及水电、能源等投入均未计入制剂价格的成本。使得现行制及水电、能源等投入均未计入制剂价格的成本。使得现行制剂价格与其实际价值偏离太远。剂价格与其实际价值偏离太远。零售价格由制造成本零售价格由制造成本加不超过加不超过 5的利润构的利润构成。成。3 低价格低价格Thi
26、s paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and
27、 DS18B20 temperature sensor.This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system
28、are AT89C51 microcontroller and DS18B20 temperature sensor.附件：关于加强医疗机构中药制剂管理的意见（二） 医疗机构制剂注册管理办法 （试行）中规定，根据中医药理论组方，利用传统工艺配制（即制剂配制过程没有使原组方中治疗疾病的物质基础发生变化的），且该处方在 本本医疗机构具有医疗机构具有 5年以上（含年以上（含 5年）使用年）使用历史历史 的中药制剂，可免报资料项 1317。本医疗机构具有本医疗机构具有 5年以上（含年以上（含 5年）使用历史年）使用历史 ： 指能够提供在本医疗机构连续使用 5年以上的文字证明资料（如医师处方，科研课题记
29、录，临床调剂记录等），并提供 100例以上相对完整的临床病历。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the syst
30、em are AT89C51 microcontroller and DS18B20 temperature sensor.（四）下列情况不纳入医疗机构中药制剂管理范围：1.中药加工成细粉，临用时加水、酒、醋、蜜、麻油等中药传统基质调配、外用，在医疗机构内由医务人员调配使用。2.鲜药榨汁。3.受患者委托，按医师处方（一人一方）应用中药传统工艺加工而成的制品。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temp
31、erature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.This paper mainly introduces the design of an intelligent temperature control system whic
32、h realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.This paper mainly introduces the design of an intelligent
33、temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.5 制药工业制药工业发展迅速发展迅速6 药学工作药学工
34、作重心的转移重心的转移4 社会与行业社会与行业关注度增加关注度增加随着社会各界对药品 (包括医疗机构制剂 )的安全性、有效性关注度越来越高，国家对药品的管理力度在不断加强 。制药工业的迅猛发展，削弱了制剂弥补市售药品供应不足的地位。对制剂的发展也造成了影响。从供应到药学服务This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using si
35、ngle bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.医疗机构制剂何去何从？消亡发展发展 消亡消亡This paper mainly introduces the design of an intelligent temperature control system which realizes the functi
36、on of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.应该发展的理由1 医院制剂能有效解决临床特殊医院制剂能有效解决临床特殊 需需要。仍然是正规制药企业产品的有益补充。要。仍然是正规制药企业产品的有益补充。2 医
37、院制剂成本低，价格也相对低廉能减轻医院制剂成本低，价格也相对低廉能减轻患者的经济负担。患者的经济负担。3 医院制剂曾经并继续推动着新药的开医院制剂曾经并继续推动着新药的开发发 和医药事业的发展。和医药事业的发展。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature se
38、nsor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.应该消亡的理由应该消亡的理由1 医院制剂已变为一些医医院制剂已变为一些医疗机构或企业牟取暴利的疗机构或企业牟取暴利的工具有可能加重百姓的工具有可能加重百姓的经济负担。经济负担。2 医院制剂水医院制剂水平与当下的药平与当下的药品监管要求相品监管要求相悖。悖。3 医院制剂自我改造能力医院制剂自我改造能力有限，身处药品工业化大有限
39、，身处药品工业化大生产的时代难以有发展生产的时代难以有发展的机会，消亡已成必然趋的机会，消亡已成必然趋势。势。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The cor
40、e components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.1 患者的需求，临床的需要2 重点专科发展的需要3 医院等级评审发展的需要六、 制剂发展的必要性4 形势发展的需要This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by us
41、ing single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.七、发展的方向七、发展的方向发展特色品种发展特色品种This paper mainly introduces the design of an intelligent temperature control system which realizes
42、the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.实行委托实行委托加工生产加工生产建立区域性建立区域性制剂生产加制剂生产加工中心，创工中心，创造规模经济造规模经济。This paper m
43、ainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.
