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    AIR-COOLING DROP PILL PRODUCTION LINE
    1.
    发明公开
    AIR-COOLING DROP PILL PRODUCTION LINE 审中-公开

    公开(公告)号：EP3020387A4

    公开(公告)日：2018-01-10

    申请号：EP14822215

    申请日：2014-07-11

    申请人： TASLY PHARMACEUTICAL GROUP CO

    发明人： YAN XIJUN ,  SUN XIAOBING ,  ZHENG YONGFENG ,  FAN LIJUN ,  FU YAN

    IPC分类号： A61J3/06 ,  A61K9/20 ,  A61K9/48 ,  A61K36/537 ,  A61P9/00 ,  A61P9/02 ,  A61P9/10 ,  B01J2/04 ,  B01J2/18 ,  B01J3/00 ,  B01J13/04

    CPC分类号： A61J3/005 ,  A61J3/06 ,  A61J2200/42 ,  A61J2200/44

    摘要： An air-cooling drop pill production line comprises a drop pill system, an air-cooling circulation system and a control system. The drop pill system comprises a molten material tank and a dripper. A vibration apparatus is arranged between the molten material tank and the dripper, and drives the dripper to vibrate up and down. A vibration shear force cuts liquor flowing out from the dripper into drops, and drop pills are formed after the drops fall into the air-cooling circulation system and are cooled. An online monitoring apparatus is arranged on the dripper, and comprises a pulse signal emission mechanism with an emission frequency which is the same as a vibration frequency of the vibration apparatus. The control system controls and regulates a dropping parameter according to a monitoring result of the online monitoring apparatus. The present invention combines vibration dropping, online monitoring and controlling, air cooling, and fluidized drying and coating together, which satisfies the requirement of high-speed dropping, micro pill preparation and improving a drug-loading capacity. Thus, the drug-loading capacity of drop pills can be multiply improved, the usage of auxiliary materials and the dosage can be greatly reduced, organic solvent residual can be completely avoided, and requirements of different processes including slow-release coating, film coating and sugar coating can be satisfied.

    PRODUCT QUALITY CONTROL METHOD
    3.
    发明授权
    PRODUCT QUALITY CONTROL METHOD 有权
    产品质量控制方法

    公开(公告)号：EP2730269B1

    公开(公告)日：2017-08-23

    申请号：EP12811023.6

    申请日：2012-07-06

    申请人： Daiichi Sankyo Company, Limited

    发明人： NAKAGAWA, Hiroshi ,  KAMADA, Makoto ,  MAEDA, Jin

    IPC分类号： A61J3/06 ,  A61J3/07 ,  G01N33/15 ,  G05B15/02 ,  G05B17/02

    CPC分类号： G06F17/5009 ,  A61J3/005 ,  A61K9/2853 ,  A61K31/444 ,  G01N33/15 ,  G05B15/02 ,  G05B17/02

    摘要： An object of the present invention is to provide real-time release testing capable of constantly ensuring quality and a method for quality testing of a product using real-time release testing. The present invention provides a method for quality testing of an in-process product and/or an end product by real-time release testing, comprising the step of assessing the quality from design space established with only material attributes as inputs. The present invention provides a manufacturing parameter-independent method for quality testing of a product using real-time release testing.

    摘要翻译： 本发明的一个目的是提供能够持续确保质量的实时释放测试和使用实时释放测试来对产品进行质量测试的方法。 本发明提供了一种通过实时释放测试对过程中产品和/或最终产品进行质量测试的方法，该方法包括从仅以材料属性作为输入建立的设计空间评估质量的步骤。 本发明提供了一种使用实时释放测试的产品质量测试的制造参数无关方法。

    USING THERMAL IMAGING FOR CONTROL OF A MANUFACTURING PROCESS
    4.
    发明公开
    USING THERMAL IMAGING FOR CONTROL OF A MANUFACTURING PROCESS 审中-公开
    THERMISCHE BILDGEBUNGFÜRDIE KONTROLLE EINES HERSTELLUNGSPROZESSSES

    公开(公告)号：EP2429402A4

    公开(公告)日：2017-03-15

    申请号：EP10775515

    申请日：2010-05-13

    申请人： GLAXOSMITHKLINE LLC

    发明人： ARP ZANE A

    IPC分类号： A61B6/00 ,  B01J2/22

    CPC分类号： G01J5/0022 ,  A61J3/005 ,  A61J3/10 ,  A61K9/2893 ,  B01J2/006 ,  B01J2/02 ,  B01J2/16 ,  B01J2/20 ,  B01J2/22 ,  B05D1/02 ,  B30B11/006 ,  F26B5/06 ,  G01J5/041 ,  G01J5/08 ,  G01J5/0893 ,  G01J2005/0085 ,  H04N5/33

    摘要： A thermal imaging camera monitors the temperature different zones in a pharmaceutical process such as ribbon compaction, coating, spray drying, fluid bed drying, high shear wet granulation, crystallization, lyophilization, precipitation, fermentation, and low dosage dispensing of a pharmaceutically active liquid. The thermal imaging camera can be used to produce a visual display of a temperature profile, or a spray pattern. In addition, feedback from the thermal imaging camera is used to control one or more processing parameters.

    摘要翻译： 热成像照相机监测制药过程中的温度不同区域，例如带状压实，涂布，喷雾干燥，流化床干燥，高剪切湿法制粒，结晶，冻干，沉淀，发酵和药物活性液体的低剂量分配。 热成像相机可用于产生温度曲线或喷射图案的视觉显示。 此外，来自热成像相机的反馈被用于控制一个或多个处理参数。

    TABLET SAMPLER ASSEMBLY
    5.
    发明公开
    TABLET SAMPLER ASSEMBLY 有权
    TABLETTENPROBENAHMEANORDNUNG

    公开(公告)号：EP3062758A1

    公开(公告)日：2016-09-07

    申请号：EP14796854.9

    申请日：2014-11-03

    申请人： Bosch Packaging Technology Limited

    发明人： MIKEDIS, Simos

    IPC分类号： A61J3/00 ,  G01N1/02

    CPC分类号： G01N1/04 ,  A61J3/005 ,  G01N1/2035

    摘要： M&C PM337215WOA 32 66605925-2-TWARNER ABSTRACT: Tablet Sampler Assembly A tablet sampler assembly is provided for a tablet coating machine which comprises a rotatable drum for containing a bed of tablets being coated. The tablet sampler assembly comprises a housing configured for attachment to said tablet coating machine, and a receptacle for receiving a sample of said tablets. At least a portion of the receptacle is movable between a collecting position in which the receptacle is configured to be in communication with the interior of the drum, thereby enabling collection of a sample by the receptacle from the drum, and a non-collecting position in which the receptacle is configured to be substantially out of communication with the interior of the drum.

    AIR-COOLING DROP PILL PRODUCTION LINE
    6.
    发明公开
    AIR-COOLING DROP PILL PRODUCTION LINE 审中-公开
    PILLENFERTIGUNGSLINIE MITLUFTKÜHLUNGSTROPFEN

    公开(公告)号：EP3020387A1

    公开(公告)日：2016-05-18

    申请号：EP14822215.1

    申请日：2014-07-11

    申请人： Tasly Pharmaceutical Group Co., Ltd.

    发明人： YAN, Xijun ,  SUN, Xiaobing ,  ZHENG, Yongfeng ,  FAN, Lijun ,  FU, Yan

    IPC分类号： A61J3/06

    CPC分类号： A61J3/005 ,  A61J3/06 ,  A61J2200/42 ,  A61J2200/44 ,  B01J2/02 ,  B01J2/04 ,  B01J2/18

    摘要： An air-cooling drop pill production line comprises a drop pill system, an air-cooling circulation system and a control system. The drop pill system comprises a molten material tank and a dripper. A vibration apparatus is arranged between the molten material tank and the dripper, and drives the dripper to vibrate up and down. A vibration shear force cuts liquor flowing out from the dripper into drops, and drop pills are formed after the drops fall into the air-cooling circulation system and are cooled. An online monitoring apparatus is arranged on the dripper, and comprises a pulse signal emission mechanism with an emission frequency which is the same as a vibration frequency of the vibration apparatus. The control system controls and regulates a dropping parameter according to a monitoring result of the online monitoring apparatus. The present invention combines vibration dropping, online monitoring and controlling, air cooling, and fluidized drying and coating together, which satisfies the requirement of high-speed dropping, micro pill preparation and improving a drug-loading capacity. Thus, the drug-loading capacity of drop pills can be multiply improved, the usage of auxiliary materials and the dosage can be greatly reduced, organic solvent residual can be completely avoided, and requirements of different processes including slow-release coating, film coating and sugar coating can be satisfied.

    摘要翻译： 空气冷却滴丸生产线包括滴丸系统，空气冷却循环系统和控制系统。 滴丸系统包括熔融材料罐和滴液器。 在熔融材料罐和滴水器之间设置振动装置，驱动滴水器上下振动。 振动剪切力将从滴液器流出的液体切割成液滴，并且在液滴落入空气冷却循环系统中之后形成滴丸并冷却。 一种在线监测装置设置在滴液器上，包括具有与振动装置的振动频率相同的发射频率的脉冲信号发射机构。 控制系统根据在线监控设备的监控结果控制和调节丢弃参数。 本发明将振动降落，在线监测和控制，空气冷却，流化干燥和涂层结合在一起，满足高速滴下，微丸制备和提高载药能力的要求。 因此，滴丸的药物负载能力可以提高，辅料的用量和用量可以大大降低，有机溶剂残留可以完全避免，不同方法的要求包括缓释涂层，薄膜包衣和 糖衣可以满足。