CN113993561A - 注射装置 - Google Patents
注射装置 Download PDFInfo
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- CN113993561A CN113993561A CN202080044090.8A CN202080044090A CN113993561A CN 113993561 A CN113993561 A CN 113993561A CN 202080044090 A CN202080044090 A CN 202080044090A CN 113993561 A CN113993561 A CN 113993561A
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- injection device
- housing
- cartridge holder
- shrink label
- heat shrink
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Abstract
本发明涉及一种注射装置(1),所述注射装置包括:包含剂量设定机构的壳体(2);药筒保持器(3),所述药筒保持器包含具有药剂的药筒;以及热收缩标签(8),所述热收缩标签包括关于所述药剂的信息(9)和/或符号。所述注射装置(1)是一次性注射装置(1),其中所述药筒保持器(3)被不可分离地锁定到所述壳体(2)。所述热收缩标签(8)被热收缩在所述壳体(2)和所述药筒保持器(3)上,使得它至少部分地覆盖所述壳体(2)和所述药筒保持器(3)。
Description
本发明总体上涉及一种药物递送装置(例如,一种用于选择和分配药剂的数个使用者可变剂量的注射装置),尤其是涉及一种一次性注射装置。
笔式药物递送装置适用于未经正式医疗培训的人员进行常规注射的情况。这在患有糖尿病的患者中可能越来越常见,对于这些患者而言,自我治疗使得这些患者能够对其疾病进行有效的管理。在实践中,此类药物递送装置允许使用者单独选择和分配药剂的数个使用者可变剂量。本发明进一步涉及自动注射器、注射筒以及所谓的固定剂量装置,其仅允许分配预定剂量,而不可以增加或减少设定的剂量。
基本上存在两种药物递送装置:可复位装置(即,可重复使用的)和不可复位装置(即,一次性的)。例如,一次性笔式递送装置作为自含式装置供应。此类独立装置不具有可移除的预填充药筒。而是,预填充药筒不可以在不破坏装置本身的情况下从这些装置移除和替换。因此,此类一次性装置不需要具有可复位剂量设定机构。本发明涉及一次性装置。
这些类型的笔式递送装置(之所以如此命名是因为它们通常类似于放大的自来水笔)总体上包括三个主要元件:药筒区段,其包括通常包含在壳体或保持器内的药筒;连接到药筒区段的一端的针组件;以及连接到药筒区段的另一端的给药区段。药筒(经常被称为安瓿)典型地包括填充有药剂(例如,胰岛素)的储器、位于药筒储器的一端处的可移动橡胶型塞子或阻塞件、以及位于另一端(通常为颈缩端)处的具有可刺穿的橡胶密封件的顶部。典型地使用卷曲的环形金属带来将橡胶密封件保持就位。药筒壳体可以典型地由塑料制成,而药筒储器历史上由玻璃制成。
针组件典型地是可替换的双头针组件。在注射前,将可替换的双头针组件附接到药筒组件的一端,设定剂量,并然后施用设定的剂量。此类可移除的针组件可以被拧到或推(即,卡扣)到药筒组件的可刺穿的密封端上。
给药区段或剂量设定机构典型地是笔式装置中用于设定(选择)剂量的部分。在注射过程中,剂量设定机构内包含的心轴或活塞杆压靠药筒的塞子或阻塞件。这个力致使包含在药筒内的药剂通过附接的针组件注射。在注射之后,如大多数药物递送装置和/或针组件制造商和供应商通常建议的那样,针组件被移除并丢弃。
药物递送装置类型的进一步区别涉及驱动机构:有手动驱动的装置,例如通过使用者对注射按钮施加力;有由弹簧等驱动的装置;以及结合这两种概念的装置,即,仍然需要使用者施加注射力的弹簧辅助装置。弹簧类型的装置包括预加载的弹簧和使用者在剂量选择期间加载的弹簧。例如在剂量设定期间,一些储能装置使用弹簧预加载和使用者提供的附加能量的组合。
WO 2012/020084 A2披露了一种具有药筒保持器的可重复使用的药物递送装置,所述药筒保持器包含填充有药剂的药筒或类似储器。如果药筒中的药剂用完,则可以替换药筒。为了更换空药筒,使用者需要从剂量设定机构移除药筒保持器。热收缩标签定位在药筒的一部分和连接器的一部分上,使得热收缩构件将连接器维持在储器上。连接器的尺寸被确定成与药物递送装置(药物递送装置的药筒保持器或剂量设定构件)配合,由此防止药筒组件的无意间交叉使用以及药剂的无意间交叉使用。
从WO 2014/033197 A1已知具有外部壳体的一次性注射装置的例子,所述外部壳体包含剂量设定机构。在此装置中,外部壳体是大致管状的元件,其具有形成用于接纳药筒的药筒保持器的远侧部分和形成外部主体的近侧部分。外部壳体是透明的,而外部主体设有不透明层。除了透明窗口外,不透明层覆盖了大部分外部主体。
在一次性药物递送装置中,剂量设定机构典型地适配于药筒和包含在其中的药剂,使得使用者能够利用药物递送装置精确地设定和分配一定量的药剂。因此,更换药筒可能对剂量准确性造成负面影响,并因此可能导致健康问题。需要防止使用者用不适合于相应剂量设定机构的药筒来替换一次性药物递送装置中的空药筒。还需要显示操纵药物递送装置的任何尝试。
因此,本发明的目的是提供一种改进的注射装置,其具有防止意外使用经操纵装置的机构。
此目的是通过如权利要求1所限定的注射装置来解决的。
所述注射装置优选地包括:包含剂量设定机构的壳体;药筒保持器,所述药筒保持器包含具有药剂的药筒;以及热收缩标签,所述热收缩标签包括关于药剂的信息和/或符号。在根据本发明的一个方面的一次性注射装置中,药筒保持器被不可分离地锁定到壳体。换言之,在此类一次性注射装置中,壳体和药筒保持器一体地形成、锁定或永久地彼此附接,使得药筒保持器不应被注射装置的使用者从壳体拆卸。如果热收缩标签被热收缩在壳体和药筒保持器上,使得它至少部分地覆盖壳体和药筒保持器,则所述标签可以用于示出装置是否处于其原始状态。破损的标签指示所述装置可能已被操纵。根据实施方案,至少部分地覆盖壳体和药筒保持器的标签可以是至少覆盖药筒保持器与壳体之间的接口或药筒保持器与壳体之间的桥接区或过渡区的标签。
在一次性注射装置中,壳体和药筒保持器可以形成为整体零部件。作为替代方案,药筒保持器可以例如借助于卡扣特征、焊接、胶合等永久地附接到壳体。除了指示装置是否可能已被操纵之外,提供热收缩标签提供了额外的强度,以防止药筒保持器从壳体的拆卸。
在常规的注射装置中,关于药剂的信息和/或符号通常借助于粘附标签或通过印刷在装置的外表面上来提供。将粘附标签放置在装置上的正确位置有时很困难,并且取决于用于壳体或药筒保持器的材料,可能难以通过印刷永久地提供信息和/或符号。与此相反,热收缩标签具有促进永久提供信息和/或符号的额外益处。信息和/或符号不仅可以包括关于药剂的信息,如药剂和/或制造商和/或经销商的名称、活性成分的名称、浓度和/或数量、生产和/或有效期,而且还可以包括至少一个颜色代码、至少一个刻度、至少一个框架、至少一个指示符等。信息和/或符号可以是可见的和/或可触的(例如呈盲文)。进一步地,可以提供允许触觉区分的信息和/或符号。
根据本发明的一方面,热收缩标签具有至少部分地包覆壳体和药筒保持器的护套的形式。通过标签的这种套筒状构造,容易将装置插入护套中,由此将标签放置在预定位置。套筒状形式的护套适合于完全包覆装置的其中药筒保持器附接到壳体或药筒保持器延续到壳体中的区。因此,呈护套形式的标签适合于遮蔽装置的最有可能发生任何操纵的区。
热收缩标签可以至少包括透明或半透明部分,所述透明或半透明部分被定位在壳体上与设置在壳体中的窗口重叠。另外或作为替代方案,热收缩标签可以形成覆盖壳体中的孔口的窗口。此类窗口典型地与剂量设定机构结合使用,以用于显示装置的当前设定剂量。例如,数字套筒或显示套筒可以在装置的剂量设定过程中相对于壳体移动,使得对应于设定剂量的数字或符号通过壳体的窗口或窥口可见。
信息和/或符号优选地被印刷在热收缩标签的内表面上。与常规的粘附标签相比,这可以防止标签上的信息由于磨损或撕裂而丢失。例如,信息和/或符号包括定位在药筒保持器上的刻度以及定位在壳体上的关于药剂的信息。这促进药筒保持器和壳体的生产,因为不需要在药筒保持器和壳体上单独提供信息和/或符号以及对齐。进一步地,热收缩标签的外表面可以全部或部分地涂漆以给出所述装置。
优选地,热收缩标签由PET(聚对苯二甲酸乙二醇酯)或OPP(定向聚丙烯)组成。另外或作为替代方案,热收缩标签由抑制光化光透射的层组成和/或设有所述层。这具有保护包含在药筒中的药剂的益处。进一步地,热收缩标签可以具有光致变色功能,例如,提供由于暴露于太阳光的颜色变化。更进一步地,热收缩标签可以由生物可降解材料组成。
进一步地,热收缩标签可以包括电子部件和/或将电子部件维持在壳体上和/或药筒保持器上。例如,热收缩标签可以包括温度测量条。在另外的例子中,热收缩标签可以将附加装置或零部件定位并维持在一次性注射装置中或其上,优选地在其壳体上。此类附加装置或零部件可以包括用于发送和/或接收数据的通信单元、用于指示目标剂量值和/或实际剂量值的显示单元、用于记录值的读出单元、用于检测注射装置的至少一个零部件的位置、状态、运动、运动方向和/或加速度的至少一个传感器或等等。热收缩标签可以用作用于此类部件的唯一紧固件,或者可以除另外的附接器件之外使用。
根据本发明的另外的方面,热收缩标签可以包括至少一条弱化线,所述至少一条弱化线允许断开和移除热收缩标签的一部分。弱化线可以是穿孔线、切割线、间断线和/或较薄或由较弱的材料制成的线。至少一条弱化线可以设有促进沿预定线断开热收缩标签的撕开条或抽头。至少一条弱化线可以例如轴向地、周向地和/或径向地延伸。
例如,药筒保持器包括用于在药筒保持器上附接针的接口,其中热收缩标签包括覆盖用于附接针的接口的第一帽盖部分,并且其中至少一条弱化线被定位成允许断开和移除第一帽盖部分。另外或作为替代方案,剂量设定机构可以包括从壳体突出的剂量设定构件,其中热收缩标签包括覆盖剂量设定构件的第二帽盖部分,并且其中至少一条弱化线被定位成允许断开和移除第二帽盖部分。更进一步地,一次性注射装置可以包括必须被激活和/或操纵以开始剂量设定程序和/或剂量分配程序的零部件。此零部件可以是单独的零部件或可以与剂量设定构件相同。在此零部件是单独的部分的情况下,热收缩标签的设有弱化线的部分可以覆盖此零部件。换言之,热收缩标签的一部分可以用作用于装置或其一部分的防篡改封闭件。
根据本发明,标签被热收缩到注射装置上。另外,热收缩标签可以被胶合或焊接到壳体上和/或药筒保持器上。
在本发明的实施方案中,注射装置的剂量设定机构总体上如WO2014/033197A1中描述的那样设计和起作用。
注射装置典型地包括包含药剂的药筒。如本文所使用的,术语“药剂”意指包含至少一种药学活性化合物的药学制剂,
其中在一个实施方案中,药学活性化合物具有高达1500Da的分子量,和/或是肽、蛋白质、多糖、疫苗、DNA、RNA、酶、抗体或抗体片段、激素或寡核苷酸、或上述药学活性化合物的混合物,
其中在另外的实施方案中,药学活性化合物可用于治疗和/或预防糖尿病或与糖尿病相关的并发症(如糖尿病视网膜病变)、血栓栓塞症(如深静脉或肺血栓栓塞症)、急性冠状动脉综合征(ACS)、心绞痛、心肌梗死、癌症、黄斑变性、炎症、枯草热、动脉粥样硬化和/或类风湿性关节炎,
其中在另外的实施方案中,药学活性化合物包括至少一种用于治疗和/或预防糖尿病或与糖尿病相关的并发症(如糖尿病视网膜病变)的肽,
其中在另外的实施方案中,药学活性化合物包括至少一种人胰岛素或人胰岛素类似物或衍生物、胰高血糖素样肽(GLP-1)或其类似物或衍生物、或毒蜥外泌肽(exendin)-3或毒蜥外泌肽-4、或毒蜥外泌肽-3或毒蜥外泌肽-4的类似物或衍生物。
胰岛素类似物是例如Gly(A21)、Arg(B31)、Arg(B32)人胰岛素;Lys(B3)、Glu(B29)人胰岛素;Lys(B28)、Pro(B29)人胰岛素;Asp(B28)人胰岛素;人胰岛素,其中B28位的脯氨酸被Asp、Lys、Leu、Val或Ala替代,并且其中B29位Lys可以被Pro替代;Ala(B26)人胰岛素;Des(B28-B30)人胰岛素;Des(B27)人胰岛素和Des(B30)人胰岛素。
胰岛素衍生物是例如B29-N-肉豆蔻酰-des(B30)人胰岛素;B29-N-棕榈酰-des(B30)人胰岛素;B29-N-肉豆蔻酰人胰岛素;B29-N-棕榈酰人胰岛素;B28-N-肉豆蔻酰LysB28ProB29人胰岛素;B28-N-棕榈酰-LysB28ProB29人胰岛素;B30-N-肉豆蔻酰-ThrB29LysB30人胰岛素;B30-N-棕榈酰-ThrB29LysB30人胰岛素;B29-N-(N-棕榈酰-Υ-谷氨酰)-des(B30)人胰岛素;B29-N-(N-石胆酰-Υ-谷氨酰)-des(B30)人胰岛素;B29-N-(ω-羧基十七烷酰)-des(B30)人胰岛素和B29-N-(ω-羧基十七烷酰)人胰岛素。
毒蜥外泌肽-4例如意指毒蜥外泌肽-4(1-39),一种具有以下序列的肽:H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2。
毒蜥外泌肽-4衍生物例如选自以下化合物列表:
H-(Lys)4-des Pro36,des Pro37毒蜥外泌肽-4(1-39)-NH2、
H-(Lys)5-des Pro36,des Pro37毒蜥外泌肽-4(1-39)-NH2、
des Pro36毒蜥外泌肽-4(1-39)、
des Pro36[Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[IsoAsp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14,IsoAsp28]毒蜥外泌肽-4(1-39)、
des Pro36[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[Trp(O2)25,IsoAsp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14Trp(O2)25,IsoAsp28]毒蜥外泌肽-4(1-39);或
des Pro36[Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[IsoAsp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14,IsoAsp28]毒蜥外泌肽-4(1-39)、
des Pro36[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[Trp(O2)25,IsoAsp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)、
des Pro36[Met(O)14Trp(O2)25,IsoAsp28]毒蜥外泌肽-4(1-39)、
其中基团-Lys6-NH2可以与毒蜥外泌肽-4衍生物的C-端结合;
或具有以下序列的毒蜥外泌肽-4衍生物:
des Pro36毒蜥外泌肽-4(1-39)-Lys6-NH2(AVE0010)、
H-(Lys)6-des Pro36[Asp28]毒蜥外泌肽-4(1-39)-Lys6-NH2、
des Asp28 Pro36,Pro37,Pro38毒蜥外泌肽-4(1-39)-NH2、
H-(Lys)6-des Pro36,Pro38[Asp28]毒蜥外泌肽-4(1-39)-NH2、
H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]毒蜥外泌肽-4(1-39)-NH2、
des Pro36,Pro37,Pro38[Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-(Lys)6-des Pro36[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-Lys6-NH2、
H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]毒蜥外泌肽-4(1-39)-NH2、
H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-NH2、
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-NH2、
des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-(Lys)6-des Pro36[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-Lys6-NH2、des Met(O)14Asp28 Pro36,Pro37,Pro38毒蜥外泌肽-4(1-39)-NH2、
H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-NH2、
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-NH2、
des Pro36,Pro37,Pro38[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-Asn-(Glu)5des Pro36,Pro37,Pro38[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-Lys6-NH2、
H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]毒蜥外泌肽-4(1-39)-NH2、
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]毒蜥外泌肽-4(1-39)-NH2、
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-NH2、
des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2、
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]毒蜥外泌肽-4(S1-39)-(Lys)6-NH2、
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]毒蜥外泌肽-4(1-39)-(Lys)6-NH2;
或上述任一毒蜥外泌肽-4衍生物的药学上可接受的盐或溶剂化物。
激素是例如如列于Rote Liste,2008年版第50章中的脑垂体激素或下丘脑激素或调节活性肽及其拮抗剂,如促性腺激素(Gonadotropine)(促卵泡激素(Follitropin)、促黄体素、绒毛膜促性腺激素(Choriongonadotropin)、促配子成熟激素)、生长激素(Somatropine)(促生长激素(Somatropin))、去氨加压素、特利加压素、戈那瑞林、曲普瑞林、亮丙瑞林、布舍瑞林、那法瑞林、戈舍瑞林。
多糖是例如糖胺聚糖、透明质酸、肝素、低分子量肝素或超低分子量肝素或其衍生物、或上述多糖的硫酸化形式(例如多硫酸化形式)、和/或其药学上可接受的盐。多硫酸化低分子量肝素的药学上可接受的盐的例子是依诺肝素钠。
抗体是球状血浆蛋白(约150kDa),也称为共享基本结构的免疫球蛋白。由于它们在氨基酸残基上添加了糖链,因此是糖蛋白。每种抗体的基本功能单元是免疫球蛋白(Ig)单体(仅包含一个Ig单元);分泌的抗体也可以是具有两个Ig单位的二聚体(如IgA)、具有四个Ig单位的四聚体(如硬骨鱼IgM)、或具有五个Ig单位的五聚体(如哺乳动物IgM)。
Ig单体是由四条多肽链组成的“Y”形分子;两条相同的重链和两条相同的轻链通过半胱氨酸残基之间的二硫键连接。每条重链长约440个氨基酸;每条轻链长约220个氨基酸。重链和轻链各自包含稳定其折叠的链内二硫键。每条链由名为Ig结构域的结构域构成。这些结构域包含约70-110个氨基酸,并根据其大小和功能分为不同类别(例如可变区或V区和恒定区或C区)。这些结构域具有特征免疫球蛋白折叠,其中两个β折叠成“三明治”状,通过保守半胱氨酸和其他带电氨基酸之间的相互作用保持在一起。
有五种类型的哺乳动物Ig重链,由α、δ、ε、γ和μ表示。存在的重链的类型定义了抗体的同种型;这些链分别在IgA、IgD、IgE、IgG和IgM抗体中发现。
不同重链的大小和组成不同;α和γ包含大约450个氨基酸,且δ包含大约500个氨基酸,而μ和ε包含大约550个氨基酸。每个重链具有恒定区(CH)和可变区(VH)两个区域。在一个物种中,恒定区在相同同种型的所有抗体中基本相同,但在不同同种型的抗体中不同。重链γ、α和δ具有由三个串联Ig结构域构成的恒定区,和用于增加柔性的铰链区;重链μ和ε具有由四个免疫球蛋白结构域构成的恒定区。所述重链的可变区在由不同B细胞产生的抗体中不同,但对于由单个B细胞或B细胞克隆产生的所有抗体来说是相同的。每条重链的可变区长约110个氨基酸,且由单个Ig结构域构成。
在哺乳动物中,有两种类型的免疫球蛋白轻链,由λ和κ表示。轻链具有两个连续的结构域:一个恒定结构域(CL)和一个可变结构域(VL)。轻链的近似长度为211至217个氨基酸。每种抗体包含两条总是相同的轻链;在哺乳动物中每种抗体仅存在一种类型的轻链κ或λ。
尽管所有抗体的一般结构非常相似,但给定抗体的独特性质是由如上文详述的可变(V)区确定的。更具体地,可变环(每条轻链(VL)三个,重链(VH)上三个)负责结合抗原,即负责其抗原特异性。这些环称为互补决定区(CDR)。因为来自VH结构域和VL结构域的CDR构成了抗原结合位点,所以是重链和轻链的组合(而不是各自单独)决定了最终的抗原特异性。
“抗体片段”包含至少一个如上文定义的抗原结合片段,并且展现出与完整抗体具有本质上相同的功能和特异性,所述抗体片段来自所述完整抗体。用木瓜蛋白酶进行的限制性蛋白水解将Ig原型裂解成三个片段。两个相同的氨基末端片段是抗原结合片段(Fab),每个片段包含一条完整的L链和约半条的H链。第三个片段是可结晶片段(Fc),所述片段大小相似但包含两条重链的羧基末端的一半及其链间二硫键。Fc包含碳水化合物、补体结合位点和FcR结合位点。有限的胃蛋白酶消化产生单个F(ab')2片段,所述片段包含Fab段和铰链区二者,包括H-H链间二硫键。F(ab')2对于抗原结合是二价的。F(ab')2的二硫键可以被裂解以便获得Fab'。此外,重链和轻链的可变区可以融合在一起以形成单链可变片段(scFv)。
药学上可接受的盐是例如酸加成盐和碱性盐。酸加成盐是例如HCl盐或HBr盐。碱性盐是例如具有如下阳离子的盐,所述阳离子选自:碱或碱性的,例如,Na+、或K+、或Ca2+,或铵离子N+(R1)(R2)(R3)(R4),其中R1至R4彼此独立地表示:氢、可选地经取代的C1-C6-烷基基团、可选地经取代的C2-C6-烯基基团、可选地经取代的C6-C10-芳基基团、或可选地经取代的C6-C10-杂芳基基团。药学上可接受的盐的另外例子描述于以下文献中:“Remington's Pharmaceutical Sciences”第17版Alfonso R.Gennaro(编),MarkPublishing Company,Easton,Pa.,U.S.A.,1985以及Encyclopedia of PharmaceuticalTechnology。
药学上可接受的溶剂化物是例如水合物。
现在将参照附图描述本发明的非限制示例性实施方案,在附图中:
图1示意性地示出了根据现有技术的注射装置;
图2示意性地示出了根据现有技术的注射装置,其中帽盖被移除并且剂量被设定;以及
图3示意性地示出了热收缩到根据图1的注射装置上的标签。
参考图1和图2,示出了如WO 2014/033197 A1中披露的一次性注射装置。所述装置具有远端(图1中的上端)和近端(图1中的下端)。注射装置1包括壳体2和药筒保持器3,所述药筒保持器牢固地连接到壳体2或是壳体2的整体部分。包含药剂的药筒(未示出)被接纳在药筒保持器3中。在图1中,可拆卸的帽盖4覆盖药筒保持器3。在图2中,帽盖4被移除。
一次性注射装置1进一步包括设置在壳体2中的剂量设定机构。剂量设定机构的剂量设定构件5从壳体2突出,使得使用者可以在剂量设定过程中抓握剂量设定构件5并相对于壳体2移动所述剂量设定构件。图1描绘了剂量设定为零的状态(即,装置的静止状态),所述剂量通过壳体2中的窗口或孔口6可见。与此相反,在图2中已经通过相对于壳体2移动(例如旋转)剂量设定构件5设定了更大的剂量。
药筒保持器3的远端设有螺纹接口7,用于将针组件(未示出)附接到药筒保持器。
图3描绘了呈透明护套形式的透明热收缩标签8,壳体2和药筒保持器3可以插入所述透明热收缩标签中。通过将标签8热收缩到壳体2和药筒保持器3上,可以将热收缩标签8牢固地附接到注射装置1。当对标签8施加热量时,标签收缩并适配于壳体2和药筒保持器3的外轮廓。因此,标签8牢固地装配在壳体2和药筒保持器3上。另外,标签8可以进一步通过粘合剂来固定在壳体2和药筒保持器3上。由于标签8至少部分地覆盖壳体2和药筒保持器3,因此在将药筒保持器3从壳体2强行拆卸或将其破坏之前将需要移除标签8。
热收缩标签8由足够强和耐用的材料制成以将标签8维持在一次性注射装置1上以用于装置的预期使用。合适的材料包括但不限于PET或OPP。热收缩标签8可以由抑制光化光透射的材料组成和/或可以设有抑制光化光透射的层。优选地,热收缩标签8由可以印刷和/或涂漆的单层材料组成。作为替代方案,热收缩标签8可以包括若干层材料。
在图3所描绘的示例性实施方案中,刻度9印刷在标签8的内侧上,使得刻度9通过透明标签8可见。进一步地,透明标签8允许使用者读取通过壳体2的窗口或孔口6可见的剂量数字。另外或作为替代方案,另外的信息和/或符号(例如关于药剂)可以印刷在标签8的内侧。更进一步地,标签8的外侧可以至少部分地被涂漆。呈穿孔形式的弱化线10相应地设置在标签8的远端附近和近端附近。
在图3所描绘的示例性实施方案中,标签8所具有的长度不仅适合于覆盖壳体2和药筒保持器3,而且在被热收缩到注射装置1上时进一步适合于覆盖剂量设定构件5和螺纹接口7。因此,标签8形成覆盖螺纹接口7的第一帽盖部分11和覆盖剂量设定构件5的第二帽盖部分12。相应的弱化线10被设计成允许从标签8的其余部分断开和移除帽盖部分11、12。换言之,标签8进一步形成用于注射装置1的防篡改封闭件。
虽然图3的实施方案已经用形成到标签8的相应帽盖部分的两条弱化线10进行了解释,但是替代实施方案可以仅包括单条弱化线10或者可以没有弱化线10。
尽管未在图3中描绘,热收缩标签8可以用于定位、固定和/或维护一次性注射装置1中和/或上的零部件。特别地,热收缩标签8可以用于将电子零部件(例如,温度感测条)维持在壳体2或药筒保持器3上。
附图标记
1 注射装置
2 壳体
3 药筒保持器
4 帽
5 剂量设定构件
6 窗口
7 接口
8 热收缩标签
9 刻度
10 弱化线
11 第一帽盖部分
12 第二帽盖部分
Claims (15)
1.一种注射装置,其包括
-包含剂量设定机构的壳体(2),
-药筒保持器(3),所述药筒保持器包含具有药剂的药筒,以及
-热收缩标签(8),所述热收缩标签包括关于所述药剂的信息(9)和/或符号,
其特征在于,所述药筒保持器(3)被不可分离地锁定到所述壳体(2),并且所述热收缩标签(8)被热收缩在所述壳体(2)和所述药筒保持器(3)上,使得它至少部分地覆盖所述壳体(2)和所述药筒保持器(3)。
2.根据权利要求1所述的注射装置,其特征在于,所述热收缩标签(8)具有至少部分地包覆所述壳体(2)和所述药筒保持器(3)的护套的形式。
3.根据权利要求1或2所述的注射装置,其特征在于,所述热收缩标签(8)至少包括透明或半透明部分,所述透明或半透明部分被定位在所述壳体(2)上与设置在所述壳体(2)中的窗口(6)重叠。
4.根据前述权利要求之一所述的注射装置,其特征在于,所述信息(9)和/或符号被印刷在所述热收缩标签(8)的内表面上。
5.根据前述权利要求之一所述的注射装置,其特征在于,所述信息和/或符号包括定位在所述药筒保持器(3)上的刻度(9)以及定位在所述壳体(2)上的关于所述药剂的信息。
6.根据前述权利要求之一所述的注射装置,其特征在于,所述热收缩标签(8)的外表面被部分地涂漆。
7.根据前述权利要求之一所述的注射装置,其特征在于,所述热收缩标签(8)由PET或OPP组成。
8.根据前述权利要求之一所述的注射装置,其特征在于,所述热收缩标签(8)由抑制光化光透射的层组成和/或设有所述层。
9.根据前述权利要求之一所述的注射装置,其特征在于,所述热收缩标签(8)包括电子部件和/或将电子部件维持在所述壳体(2)上和/或所述药筒保持器(3)上。
10.根据权利要求9所述的注射装置,其特征在于,所述热收缩标签(8)包括温度测量条。
11.根据前述权利要求之一所述的注射装置,其特征在于,所述热收缩标签(8)包括至少一条弱化线(10),所述至少一条弱化线允许断开和移除所述热收缩标签(8)的部分(11,12)。
12.根据权利要求11所述的注射装置,其特征在于,所述药筒保持器(3)包括用于在所述药筒保持器(3)上附接针的接口(7),其中所述热收缩标签(8)包括覆盖用于附接针的所述接口(7)的第一帽盖部分(11),并且其中所述至少一条弱化线(10)被定位成允许断开和移除所述第一帽盖部分(11)。
13.根据权利要求11或12所述的注射装置,其特征在于,所述剂量设定机构包括从所述壳体(2)突出的剂量设定构件(5),其中所述热收缩标签(8)包括覆盖所述剂量设定构件(5)的第二帽盖部分(12),并且其中所述至少一条弱化线(10)被定位成允许断开和移除所述第二帽盖部分(12)。
14.根据前述权利要求之一所述的注射装置,其特征在于,所述热收缩标签(8)被胶合或焊接到所述壳体(2)上和/或所述药筒保持器(3)上。
15.根据前述权利要求之一所述的注射装置,其特征在于,所述药剂是胰岛素或生长激素。
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- 2020-06-23 EP EP20735104.0A patent/EP3990064A1/en active Pending
- 2020-06-23 BR BR112021026240A patent/BR112021026240A2/pt unknown
- 2020-06-23 MX MX2021015715A patent/MX2021015715A/es unknown
- 2020-06-23 WO PCT/EP2020/067392 patent/WO2020260220A1/en unknown
- 2020-06-23 JP JP2021576852A patent/JP2022538257A/ja active Pending
- 2020-06-23 US US17/620,415 patent/US20220313916A1/en active Pending
- 2020-06-23 AU AU2020306580A patent/AU2020306580A1/en active Pending
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2021
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JP2010268883A (ja) * | 2009-05-20 | 2010-12-02 | Dainippon Printing Co Ltd | プレフィルドシリンジ用注射器およびプレフィルドシリンジ |
CN103826678A (zh) * | 2011-09-26 | 2014-05-28 | 泰尔茂株式会社 | 给药装置、穿刺装置、药液填充装置、药液填充方法及药液填充系统 |
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Also Published As
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KR20220029684A (ko) | 2022-03-08 |
MX2021015715A (es) | 2022-02-03 |
AU2020306580A1 (en) | 2022-02-24 |
IL289260A (en) | 2022-02-01 |
EP3990064A1 (en) | 2022-05-04 |
US20220313916A1 (en) | 2022-10-06 |
JP2022538257A (ja) | 2022-09-01 |
BR112021026240A2 (pt) | 2022-06-07 |
WO2020260220A1 (en) | 2020-12-30 |
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