CN1226981C - 根除性治疗的药品包装 - Google Patents
根除性治疗的药品包装 Download PDFInfo
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Abstract
本发明的目的是提供一种适用于微生物根除性治疗的药品包装，使用该包装，患者的顺应性提高了，由此改善了治疗效果。
Description
技术领域
本发明涉及一种收藏用于根除性治疗的泡罩板的新的药品包装。使用该包装，患者的顺应性明显提高。
现有技术
为治疗幽门螺旋杆菌疾病，BDA(德国普通从业者职业协会(Professional association of general practitioners in Germany)：Künzel D.；BDA-Leitfaden：Unklare Oberbauchbeschwerden；由Kybermed GmbH出版，Emsdetten，第1版，Emsdetten 1999)和ESPCG(European Society for Primary Care Gastroenterology：RubinG.P.；European Journal of General Practice，Vol.5，1999)推荐了一种联合疗法，其中将两种不同的抗生素与质子泵抑制剂同时给药。使用这类三联疗法有可能获得令人印象深刻的根除性结果(Huang J.Q.，Hunt R.H.；GUT Vol.45，Suppl.1，1999，i40)。
这类三联疗法的缺点是，如果要达到所需的治疗结果，患者须吞服数片通常是较大的药片，且每天服用数次，一般是两至三次。通常还需服用约七天至两周的较长时间。为成功进行治疗，患者须表现出很高的顺应性(坚持治疗，即遵从治疗用法说明的顺应性)，因此患者须坚持服用现有的片剂组合物和服用时间。经验表明，在没有鼓励措施时，患者的耐心通常较预期的低。经常在不该服药的时间服用药片，或者完全和部分忘记服用，或者患者在没有服用完包装提供的所有的药片之前中止治疗。对于幽门螺旋杆菌的治疗，过早中断治疗尤其具有危险，因为患者的感觉在开始治疗后得到迅速改善。但过早中断治疗的后果是，微生物没有完全被根除，并且此外，微生物可发展为对使用的抗生素耐药。因此，可以预期，在没有鼓励顺应性的措施时，治疗结果显然较差。
EP-391459 B1描述了一种提高顺应性的具有基底的药品包装，其中多个泡罩板以确定的顺序水平地层叠于另一个泡罩板的顶部，并且具有一个覆盖基底的盖。该盖可移动至打开位置，由此可使用最上层的泡罩板。在复杂的治疗中，这种包装可以避免患者取用错误的泡罩板以及由此在确定的时间服用错误的药品。
发明描述
本发明的目的是提供一种药品包装，该包装适用于根除性治疗，使用该包装，患者的顺应性提高了，因此改善了治疗结果。
本发明的目的通过一种药品包装来实现，其中该包装包括：(a)通常具有统一水平方向的多个泡罩板，其中它们的主要方位是水平的并且以泡罩板的使用顺序层叠排放，其中取用的第一个泡罩板排放于底部；和(b)收藏所述层叠的泡罩板的容器，其中该容器具有取出排放在底物的泡罩板的通道，并且其中该容器具有指示与取出的泡罩板有关的剩余的治疗天数的部件。
在微生物根除性治疗中，本发明药品包装的使用明显提高了患者的顺应性，并且据证明该包装特别适用于联合使用泮托拉唑或其他质子泵抑制剂，例如奥美拉唑与抗生素的幽门螺旋杆菌的根除性治疗。
该药品包装包括其形状和尺寸适于收藏通常尺寸的泡罩板的容器。该容器优选具有二元药品包装的常见形状，例如立方形。该容器优选由常用于制造二元药品包装的材料，例如纸版制造。多个泡罩板层叠于容器中的其他水平方向的泡罩板的顶部。在各种情形下，该容器还具有建立取出排放于层叠的泡罩板底部的泡罩板的通道的部件。因此，容器可具有第一区域，该区域可与容器的其余部分分开。这些第一区域优选具有这样的尺寸，以使其与容器的其余部分的分开产生一个通道，当容器方向适合时，通过该通道仅可取出排放在底部的泡罩板。当容器由适合的纸版制造时，这些第一区域可包括穿孔的边际线，这些边际线使第一区域与容器的其余部分易于分开。该容器还具有根据取出的泡罩板数量的指示剩余治疗天数的部件。为此，容器可具有，例如第二区域，该区域可以使观察者确定与包装中存在的泡罩板数量有关的剩余的治疗天数的部件。例如，第二区域可以是垂直方向的；在容器侧壁中的一个延长的透明区域。该透明区域可以是，例如开口。作为层叠的泡罩板高度的函数的治疗天数的标尺水平地印制于该透明区域或者邻近延长的透明区域的容器上。如果包装中仍存在所有的泡罩板，则排放于容器最上面的泡罩板水平位于印制数量线处，该数量对应于总的治疗天数。取出第一个泡罩板后，层叠的泡罩板的高度降低，最顶层的泡罩板水平位于对应于总治疗天数减一的印制数量线处。取出第二个泡罩板后，层叠的泡罩板的高度降低，最顶层的泡罩板水平位于对应于总治疗天数减二的印制数量线处，等等。如果需要，可在层叠的泡罩板下面的容器中放一本小资料册给患者，但适宜地是，须在取出排放于底部的泡罩板之前取出该小册子。该容器以本领域技术人员熟悉的常规方式制造。
同样，泡罩板可以以本领域技术人员熟知的常规方式制造。因此，可嵌入到由适宜材料，例如塑料和纸版制成的两层基础板之间，两层其他的材料，其中一层形成泡罩室，另一层形成易于穿通的泡罩基底，或者可选择两层结构的泡罩，其中泡罩室是于上层合成一体的，然后从下面将其用另一层易于穿通的材料包覆，该层密封其中放有药物的通道。
使用本领域技术人员已知常用于制造市售泡罩的材料，例如层压的铝片、PVC(聚氯乙稀)和PVdC(聚偏二氯乙烯)片或其组合体，或者PP(聚丙烯)片或者所述材料的组合体或层压体。
每个泡罩板优选包含一天治疗服用的药物。如果药物在一天的不同时间服用，按照一天服用药物的不同时间(例如清晨和傍晚或者清晨、正午和傍晚)，可将药物排放在泡罩板的不同区域。使每天特定时间一起服用的药物泡罩室排列在对应于在每天各个服用时间的区域。当然，每天的不同时间也应以清楚可见的方式标示于泡罩上。当然，也可标示服用药物的一段时间，例如规定的时间。
每日区域可呈泡罩板的一排，然后在该栏中以时间顺序识别时间。
将必须在每日特定时间一起服用的药物一起排放与泡罩板的特定时间处，优选分开很窄的距离，使其易于推出泡罩，并且具有不会忘记从泡罩中取出剂型的作用。
通过穿孔，使不同日的区域，并且如果需要，还有每天的时间区域彼此分开。因此取出药物后，患者能区分相应的区域并获得更易于检查的泡罩板。这降低了忘记服用的药物随后被服用的可能性，这种可能性可导致，例如有害的高药物浓度。
本发明药品包装中容纳的泡罩板数量取决于治疗的时间和服用的药物数量。泡罩板的数量一般为4-24，优选7-14个。
在幽门螺旋杆菌疾病的治疗中，可有益的使用本发明的药品包装。在这些情形下，优选联合使用质子泵抑制剂，例如泮托拉唑、奥美拉唑和本领域技术人员已知的其他质子泵抑制剂和抗生素，例如阿莫西林、克拉霉素、阿奇霉素、四环素、灭滴灵和替硝唑作为活性成分。更优选将质子泵抑制剂与两种不同的抗生素(三联疗法)联合给药。可提及的实例是联合给药质子泵抑制剂与阿莫西林和克拉霉素，联合给药质子泵抑制剂与克拉霉素和灭滴灵，以及联合给药质子泵抑制剂与阿莫西林和灭滴灵。在这些情形下，活性成分以治疗常用的需要的量使用。治疗一般进行7-14天。
因此可有益的使用本发明的药品包装，用于联合使用泮托拉唑与阿莫西林、克拉霉素、灭滴灵、替硝唑，或者常用于幽门螺旋杆菌根除性治疗的铋产品以控制幽门螺旋杆菌。优选用于联合使用泮托拉唑、阿莫西林和克拉霉素以控制幽门螺旋杆菌。
现在通过附图解释本发明，附图显示了用于幽门螺旋杆菌治疗的本发明药品包装的示例性实施方案。
附图1显示了由纸板制备的密封的本发明药品包装1，该包装用于7天的幽门螺旋杆菌的根除性治疗，其中联合使用泮托拉唑与阿莫西林和克拉霉素作为活性成分。包装1具有第一区域2，该区域用以分开并且被穿孔的线3包围。作为指示剩余治疗天数的部件，该包装具有垂直方向的延长的开口4。通过开口4，观察者可看见7个具有该包装1中使用的药物的每日剂量的泡罩板5。标尺6印刷于与延长的开口4相连的容器1上，并且标示有与泡罩板5的高度相关的剩余治疗天数。
附图2显示了沿穿孔的线3分开第一区域后2的药品包装1。在层叠的泡罩板5之下，有一给患者的小资料册7，通过已产生的取出口8可获得该小册子。
附图3显示了取出给患者的小册子7后以及取出两个泡罩板5后的药品包装1。层叠的泡罩板5仍包含用于剩余的5天治疗的五个泡罩板。现在，层叠排列的最顶部的泡罩板5与印有″5天”的线呈水平位置。
附图4显示了用于收藏每日剂量的使用药物的泡罩板5。泡罩板划分为每天两个时间区域9和10，各区域分别容纳在清晨和傍晚服用的药物。每天的各时间区域9和10包括三个泡罩室11，其中容纳泮托拉唑(40mg)、阿莫西林(1000mg)和克拉霉素(500mg)。
设计穿孔12来分开每天的时间区域9和10。
Claims (6)
1.一种用于提高微生物根除性治疗中的顺应性的药品包装，其中该包装包括：(a)通常具有统一的水平方向的多个泡罩板，其中它们的主要方位通常是水平的并且以泡罩板的使用顺序层叠排放，其中取用的第一个泡罩板排放于底部；和(b)容纳所述层叠的泡罩板的容器，其中该容器具有取出排放在底部的泡罩板的通道，并且其中该容器具有指示作为取出的泡罩板函数的剩余治疗天数的部件。
2.权利要求1的药品包装，其中取出排放在底部的泡罩板的通道是容器的第一区域，该区域包括穿孔的线并可与容器的剩余部分分开。
3.权利要求1的药品包装，其中指示作为取出的泡罩板函数的剩余治疗天数的部件是一个在容器侧壁上的垂直方向的、延长的透明区域，并且指示作为层叠的泡罩板高度函数的治疗天数的标尺水平地印刷于该透明区域或者与该延长透明区域相邻的容器上。
4.权利要求1-3任一项的药品包装，其中泡罩板包含每日剂量的药物，并且药物按照每天必须服用的时间排放于泡罩板上的区域。
5.权利要求1-4任一项的药品包装的应用，用于联合使用泮托拉唑与阿莫西林、克拉霉素、灭滴灵、替硝唑，或者常用于幽门螺旋杆菌根除性治疗的铋产品以控制幽门螺旋杆菌。
6.权利要求5的应用，用于联合使用泮托拉唑、阿莫西林和克拉霉素以控制幽门螺旋杆菌。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| DE10030318A DE10030318C1 (de) | 2000-06-27 | 2000-06-27 | Arzneimittelverpackung für die Eradikationstherapie |
| DE10030318.8 | 2000-06-27 |
Publications (2)
| Publication Number | Publication Date |
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| CN1438866A CN1438866A (zh) | 2003-08-27 |
| CN1226981C true CN1226981C (zh) | 2005-11-16 |
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| EP (1) | EP1296633B1 (zh) |
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| CN (1) | CN1226981C (zh) |
| AT (1) | ATE410131T1 (zh) |
| AU (2) | AU8187901A (zh) |
| BR (1) | BRPI0112044B8 (zh) |
| CA (1) | CA2412205C (zh) |
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| MX (1) | MXPA02012824A (zh) |
| PL (1) | PL204431B1 (zh) |
| PT (1) | PT1296633E (zh) |
| SI (1) | SI1296633T1 (zh) |
| WO (1) | WO2002000161A1 (zh) |
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2000
- 2000-06-27 DE DE10030318A patent/DE10030318C1/de not_active Expired - Lifetime
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2001
- 2001-06-23 AU AU8187901A patent/AU8187901A/xx active Pending
- 2001-06-23 JP JP2002504944A patent/JP4955893B2/ja not_active Expired - Fee Related
- 2001-06-23 DK DK01960370T patent/DK1296633T3/da active
- 2001-06-23 WO PCT/EP2001/007148 patent/WO2002000161A1/en active Search and Examination
- 2001-06-23 AT AT01960370T patent/ATE410131T1/de active
- 2001-06-23 KR KR1020027017810A patent/KR100801941B1/ko not_active IP Right Cessation
- 2001-06-23 EP EP01960370A patent/EP1296633B1/en not_active Expired - Lifetime
- 2001-06-23 DE DE60136068T patent/DE60136068D1/de not_active Expired - Lifetime
- 2001-06-23 PT PT01960370T patent/PT1296633E/pt unknown
- 2001-06-23 US US10/297,257 patent/US6988619B2/en not_active Expired - Lifetime
- 2001-06-23 CA CA2412205A patent/CA2412205C/en not_active Expired - Fee Related
- 2001-06-23 SI SI200130890T patent/SI1296633T1/sl unknown
- 2001-06-23 MX MXPA02012824A patent/MXPA02012824A/es active IP Right Grant
- 2001-06-23 CN CNB018119808A patent/CN1226981C/zh not_active Expired - Fee Related
- 2001-06-23 AU AU2001281879A patent/AU2001281879B2/en not_active Ceased
- 2001-06-23 BR BRPI0112044A patent/BRPI0112044B8/pt not_active IP Right Cessation
- 2001-06-23 ES ES01960370T patent/ES2315299T3/es not_active Expired - Lifetime
- 2001-06-23 PL PL358291A patent/PL204431B1/pl unknown
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2004
- 2004-02-26 HK HK04101388A patent/HK1058617A1/xx not_active IP Right Cessation
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- 2008-12-17 CY CY20081101457T patent/CY1108672T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PL358291A1 (en) | 2004-08-09 |
| BR0112044B1 (pt) | 2013-11-12 |
| CA2412205A1 (en) | 2002-01-03 |
| CA2412205C (en) | 2010-03-30 |
| JP2004500967A (ja) | 2004-01-15 |
| ES2315299T3 (es) | 2009-04-01 |
| MXPA02012824A (es) | 2003-05-14 |
| BRPI0112044B8 (pt) | 2017-04-25 |
| DE60136068D1 (de) | 2008-11-20 |
| CY1108672T1 (el) | 2014-04-09 |
| HK1058617A1 (en) | 2004-05-28 |
| EP1296633B1 (en) | 2008-10-08 |
| JP4955893B2 (ja) | 2012-06-20 |
| SI1296633T1 (sl) | 2009-04-30 |
| AU8187901A (en) | 2002-01-08 |
| PT1296633E (pt) | 2009-01-08 |
| ATE410131T1 (de) | 2008-10-15 |
| WO2002000161A1 (en) | 2002-01-03 |
| US20030136698A1 (en) | 2003-07-24 |
| CN1438866A (zh) | 2003-08-27 |
| DK1296633T3 (da) | 2009-02-09 |
| KR20030018010A (ko) | 2003-03-04 |
| BR0112044A (pt) | 2003-06-10 |
| DE10030318C1 (de) | 2002-02-28 |
| AU2001281879B2 (en) | 2006-04-06 |
| EP1296633A1 (en) | 2003-04-02 |
| US6988619B2 (en) | 2006-01-24 |
| KR100801941B1 (ko) | 2008-02-12 |
| PL204431B1 (pl) | 2010-01-29 |
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