CN1155371C - 可精确分开的药片 - Google Patents

可精确分开的药片 Download PDF

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Publication number
CN1155371C
CN1155371C CNB998098167A CN99809816A CN1155371C CN 1155371 C CN1155371 C CN 1155371C CN B998098167 A CNB998098167 A CN B998098167A CN 99809816 A CN99809816 A CN 99809816A CN 1155371 C CN1155371 C CN 1155371C
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tablet
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degree
end faces
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CN1313761A (zh
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R
R·斯彭格勒
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Abbott Ltd By Share Ltd
Abbott GmbH and Co KG
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Knoll GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Jellies, Jams, And Syrups (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

带有两个端面和一个外壳表面的药片，药片彼此对置的端面a)整体不平直并且至少近似于平行设置并且b)在上面和下面均设置有破断槽，其中在药片中部的破断槽彼此平行设置。

Description

可精确分开的药片
技术领域
本发明涉及一种可精确分开的药片。
背景技术
几乎所有带有制药学的高效物质的药片可以通过选择大小和形状以及刻制一个或多个破断刻槽来人工分开。然而迄今所知的药片或者仅在一个方向上可分开，这对于较旧的专利通常会导致问题，或者药片不能够被足够精确地将药量分成两半片。根据欧洲药典委员会的建议(第96界会议的报告)在药片的半片内的药物的重量份额对于大于250mg的整片药片的药物含量来说，允许偏差最大超过10％并且对于小于250mg整片药片药物含量，允许偏差最大15％的数量。因为在一个药片中的药物含量，已经参照德国药典(第10版)要求力争达到的药物量，随药片的大小，可以有力争达到数值5％至10％的偏差，在应用分开的药片时由于给药量偏差可能会出现困难。
现在发现一种药片，其可以在两个方向分开并且在分开时分成两半，每半的药量很大程度上相一致。
发明内容
本发明的主题是一种带有两个端面和一个外壳表面的药片，其特征在于，药片的彼此对置的端面
a)整体不平直并且至少近似于彼此平行设置并且
b)在上面和下面均设置有破断槽，其中破断槽在药片中部彼此平行设置。
药片的彼此对置的端面优选平行设置或彼此近似平行设置。药片的两半应构成130度至177度的角。对于小药片此角度优选为近似于130度，对于较大的药片角度可以大到177度。角度在任何情况下必须大到，药片在上或下侧的压力下良好断开。优选形式为彼此对置的端面相互平行。对于较大的药片，构成下面端面(如图3)的角度，可以略小(即到25度，优选为到15度)，若人们想加大药片的体积，不会影响到破断性。
破断槽的深度一般有药片在破断槽处厚度的5％到10％。破断槽的形状没有特别之处。
有利的是，药片在上下侧的边缘，优选为在两侧，具有倒角(多角平面，斜边)，由此印痕的受载能力在药片压制时被增加。若药片在上或下侧具有一个倒角，则彼此成约90度。
药片的形状一般是圆形的。但它也可以是椭圆形的(例如矩形的)或者是多角形的(例如直角以及正方形)，其中角被倒圆。药片直径应具有至少4mm至14mm，如果它是用于口服的话。
新药片具有如下优点：
1.药片可以在一个底座上通过压力从上面(例如用手指)轻松分开。在哪一边将药片放在底座上是无关紧要的。这样尤其重要的是，若药片必须由人来破断，他很难分出哪一边。
2.药片药量在药片破断过程中的损失是很小的。
3.断块的标准误差相对其药量小于3％。
4.药片具有一个量值很高的破断强度，这对按处方配制的顺序操作过程是重要的，对此药片必须对于同时有利的较小的破断力具有一个固定的强度。
5.由此，药片接下来在其上表面有一个平面，可以轻松地刻蚀以用于药片的辨识，而不会损坏药片，在较高的药片生产速度条件下也可以没有标识。对于成拱形的上表面，只是要大得多的花费来达到。
6.在药片生产过程中，新药片基于其半月形的多角形平面特别容易由压力模中滑出，则即使在较高的压制速度下也不会出现摘下过程时药片的损坏。
图中显示本发明的具体实施例。
附图说明及具体实施方式
图1显示一个药片的横截面。1和2是破断槽，3是上端面4是下端面，6是药片的外表面。
图2显示一个根据图1的药片的横截面，在其上有一个附加的倒角5。
图3对应于图2，然而下端面成较大角度。
图4是图2的药片的俯视图，1是破断槽，3是带有倒角的上端面。

Claims (2)

1.带有两个端面和一个外壳表面的药片，其特征在于，药片的彼此对置的端面
a)整体不平直并且至少近似于彼此平行设置并且
b)在上面和下面均设置有破断槽，其中破断槽在药片中部彼此平行设置，其特征在于，在上面和下面的边缘侧面均有两个半月形的倒角，并且上面和下面的半月形倒角彼此成90°。
2.如权利要求1所述的药片，其特征在于，由破断槽分开的药片的两半构成一个130度至177度的角。
CNB998098167A 1998-08-19 1999-08-11 可精确分开的药片 Expired - Lifetime CN1155371C (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19837684A DE19837684A1 (de) 1998-08-19 1998-08-19 Exakt teilbare Tablette
DE19837684.7 1999-08-19

Publications (2)

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CN1313761A CN1313761A (zh) 2001-09-19
CN1155371C true CN1155371C (zh) 2004-06-30

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US (1) US6692765B1 (zh)
EP (1) EP1105103B1 (zh)
CN (1) CN1155371C (zh)
AT (1) ATE243505T1 (zh)
AU (1) AU763894B2 (zh)
BR (1) BR9914610A (zh)
CA (1) CA2341005C (zh)
CZ (1) CZ302617B6 (zh)
DE (2) DE19837684A1 (zh)
DK (1) DK1105103T3 (zh)
ES (1) ES2203172T3 (zh)
HK (1) HK1040618B (zh)
HU (1) HU230457B1 (zh)
IL (2) IL141092A0 (zh)
NO (1) NO318249B1 (zh)
PT (1) PT1105103E (zh)
TW (1) TWI222366B (zh)
WO (1) WO2000010535A2 (zh)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19849434A1 (de) * 1998-10-27 2000-05-04 Isis Pharma Gmbh Teilbare Tablette
AU5551800A (en) * 1999-06-23 2001-01-31 Eu Pharma Ltd. Divisible tablets
JP5049517B2 (ja) * 2006-06-09 2012-10-17 高田製薬株式会社 分割錠剤
US7985419B1 (en) 2006-12-22 2011-07-26 Watson Laboratories, Inc. Divisible tablet and associated methods
USD669573S1 (en) * 2010-12-15 2012-10-23 Otsuka Pharmaceutical Co., Ltd. Tablet
DE102016119675A1 (de) 2016-10-14 2018-04-19 Ritter Pharma-Technik Gmbh Tablette mit Bruchwinkel und senkrecht zur Pressrichtung eingebrachter Teilungskerbe
USD941457S1 (en) * 2020-04-07 2022-01-18 Nutramax Laboratories, Inc. Dietary supplement

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1200790B (de) * 1961-12-06 1965-09-16 Thomas L Cooper Zerlegbare Tablette
BE632692A (zh) * 1963-05-28
US3336200A (en) 1963-05-28 1967-08-15 Warner Lambert Pharmaceutical Tablet structure
USD202467S (en) * 1963-10-07 1965-10-05 Jacques Guilmot Pharmaceutical tablets
USD201497S (en) * 1964-09-28 1965-06-29 Warner Lambert Co Tablet
US4258027A (en) * 1979-03-26 1981-03-24 Mead Johnson & Company Multi-fractionable tablet structure
GB8514089D0 (en) * 1985-06-04 1985-07-10 Sandoz Ltd Pharmaceutical tablet
JPH07179333A (ja) * 1993-12-21 1995-07-18 Kikusui Seisakusho:Kk 錠 剤
USD383535S (en) * 1996-04-24 1997-09-09 Schering Corporation Tablet

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Publication number Publication date
BR9914610A (pt) 2001-07-03
CA2341005C (en) 2008-09-23
NO20010785D0 (no) 2001-02-16
HK1040618A1 (en) 2002-06-21
TWI222366B (en) 2004-10-21
IL141092A (en) 2007-03-08
PT1105103E (pt) 2003-11-28
AU5515199A (en) 2000-03-14
EP1105103B1 (de) 2003-06-25
WO2000010535A2 (de) 2000-03-02
DE19837684A1 (de) 2000-02-24
DE59906114D1 (de) 2003-07-31
HU230457B1 (hu) 2016-07-28
WO2000010535A3 (de) 2000-06-02
CN1313761A (zh) 2001-09-19
NO20010785L (no) 2001-02-16
NO318249B1 (no) 2005-02-21
US6692765B1 (en) 2004-02-17
HK1040618B (zh) 2005-04-08
CA2341005A1 (en) 2000-03-02
HUP0103163A2 (hu) 2001-12-28
CZ302617B6 (cs) 2011-08-03
ES2203172T3 (es) 2004-04-01
ATE243505T1 (de) 2003-07-15
IL141092A0 (en) 2002-02-10
CZ2001632A3 (cs) 2001-08-15
HUP0103163A3 (en) 2006-07-28
DK1105103T3 (da) 2003-10-20
EP1105103A2 (de) 2001-06-13
AU763894B2 (en) 2003-07-31

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