CN1308524A - 生产平面的单独给药的活性成分制剂的干燥复制方法 - Google Patents
生产平面的单独给药的活性成分制剂的干燥复制方法 Download PDFInfo
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- G—PHYSICS
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Abstract
本发明涉及一种在特定的表层上定量配给粉末状活性药剂的方法。该方法的特征在于活性药剂以带电粉末的形式被转移到滚筒上,所述的滚筒带有相反的电荷,其中被转移到滚筒上的活性药剂又被转移到带有与其相反的电荷的平面感光胶层上,且其中被转移到感光胶层上的活性药剂通过热处理而被固定。
Description
单一剂量的活性成分制剂意指在能够被单独处理的独立制剂单位中,含有定量活性物质的制剂。
用于本发明目的的活性成分可以被理解为,例如,药用物质、杀虫剂、农药、试剂等。
如果活性成分是指,例如医用活性成分,那么这种单一剂量的制剂形式即是,如片剂、胶囊、栓剂或透皮治疗系统(TTS)。
非单一剂量制剂形式,可以是,如喷雾剂、糖浆、软膏和滴剂,其实际的给药剂量只在使用前立即产生。
在单一剂量的活性成分制剂中,将适量的活性成分是与必需的任意赋形剂一起被加工以得到能够使用的活性成分制剂。可以认为此技术对于片剂和胶囊的生产是成熟的。现代的压片和胶囊填充机械确保了高生产速度和规格在95-105%的非常准确的定量供给。
透皮治疗系统仍然是一相对较新的药剂形式,它是以硬膏剂的形式施用于皮肤,并通过皮肤将活性成分传递到身体。特殊的定量供给技术被用于生产这些TTS,有关新的定量供给技术的进一步革新是可能的。
在这些TTS的其中一个实施例中,活性成分直接包含在胶粘剂中且,在生产过程中,与胶粘剂一起在薄片上平面地定量供给。
这意味着TTS是仅有的药剂形式,对于这种药剂形式,在预定的范围和数量下,定量供给药用活性成分是很重要的。就非药用活性成分而论,例如,杀虫剂、农药或试剂、浸渍纸、薄片或板形式的平面制剂,很长时间以来早是已知的。然而,对这些应用在一定范围内定量供给的准确性的需求还不是很大。
本发明的目的在于提供一种在预定的范围内定量供给粉末状活性成分的方法。
该目的是通过使用根据独立权利要求1特征部分的干燥复制方法的技术来实现的。
已经发现,这一技术对于药用产品,可以在预定的范围以足够的准确性定量供给粉末状活性成分。这一点可以用彩色复制直接看出,其中每一种色彩被独立地定量供给,且大的误差会导致错误的颜色。
该干燥复制方法或静电复印功能在下文描述。
包覆有光电导材料的滚筒带有正电荷,且通过合适的光学系统被曝光在要复制的底片上。通过这一过程,电荷至少被部分除去,而光电导材料的传导性由于曝光而增加。
下一步,将带负电荷的彩色颗粒(调色剂)用于滚筒上,但是这些彩色颗粒只粘附在仍带电的滚筒,其数量依据电荷的大小而定,并在那里产生一可见的图像。
然后,将彩色的颗粒(调色剂)转移到一带正电的纸或薄片上,并通过热处理在该处被固定。
本方法的新的不同之处在于应用了一种所谓的激光打印剂。在这种情况中,滚筒不需要底片而被直接曝光在激光束中,因此图像在计算机的控制下被直接印在滚筒上。另外,相同的技术被用于激光打印机,例如干燥复制机。
本发明应用这些方法,是为了将活性成分颗粒转移到纸或薄片,而不是转移彩色颜料。
使用标准的黑/白复制机进行了试验,以便找到可被转移到纸张上的调色剂的量,及其可复制性。
市售DIN A4格式的大型聚酯纸被作为薄片使用。所使用的底片是一张灰黑纸,选择变黑程度最强的用于复制。结果记录在下表中。
试验编号 | 调色剂的施用(mg/cm2) |
1 | 0.609 |
2 | 0.601 |
3 | 0.640 |
4 | 0.603 |
5 | 0.603 |
6 | 0.604 |
平均 | 0.610 |
相对误差 | 2.4 |
表1
结果表明虽然只有比较小量的调色剂被转移,但是它对于医疗应用也是准确的。
在另一个试验中则要找出是否通过多次定量供给,无论多少量都可以增加转移。
该结果如图1中所述,表明所转移的调色剂的量与复制过程的次数成正比。
结果表明虽然一个复制过程中所转移的量小,但是这一缺点可以通过多次的复制被克服,而无损定量供给的准确性。
所转移的调色剂或活性成分的量取决于复制滚筒的带电状态,且可以通过施加比复制机带有的通常电荷更强的电荷来增加。
如果活性成分以非特殊形式被定量供给,则在曝光步骤中有可能完全分配。在这种情况下,复制滚筒不需要必须由光电导材料组成。
如果定量供给是在一定的形式下进行的,所述曝光步骤和包覆有光电导材料,如硒,的复制滚筒的使用是必需的。在这种情况中的曝光可以通过底片或计算机控制的激光来实现。当然由计算机控制的激光曝光的可变性是最大的。
假定大部分活性成分是无色的。从这一点看,应当将指示剂染料混合于粉末状的活性成分和赋形剂混合物中。所述的染色在适当校准后,可以允许用光学方法直接测量所转移的活性成分的量,以及自动校正任何标准偏差。
活性成分被转移在其上的平面感光胶层而且原则上可以由任意材料组成,只要它是可弯曲的,并适于承受固定过程。可以想象,在此连接处,该材料可以以薄片的形式而被运用或从滚筒供给。在更进一步的过程中,这一材料被切成更小的部分,然后被转换为单一剂量的活性成分制剂。这种材料也可以是被穿孔,在这种情况下通过穿孔预定剂量。
Claims (7)
1.在预定的范围内定量供给粉末状活性成分的方法,其特征在于
—活性成分作为带电荷的粉末,被转移到带有相反电荷的滚筒上,
—转移到滚筒上的活性成分被转移到带有与活性成分相反电荷的平面感光胶层上,
—转移到平面感光胶层上的活性成分通过热处理而被固定。
2.根据权利要求1的方法,其特征在于粉末状的赋形剂连同活性成分一起被定量供给。
3.根据权利要求2的方法,其特征在于至少一种赋形剂作为固定剂。
4.根据权利要求2的方法,其特征在于一种赋形剂是着色的,且被用于活性成分量的光学测定。
5.根据权利要求1-4的方法,其特征在于滚筒包覆有光电导材料。
6.根据权利要求1的方法,其特征在于滚筒上的电荷、所转移的活性成分的数量和/或形式受负荷滚筒的曝光影响。
7.根据权利要求6的方法,其特征在于滚筒的曝光通过计算机控制的激光或通常通过底片的光学成像而实现。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19830650.4 | 1998-07-09 | ||
DE19830650A DE19830650C1 (de) | 1998-07-09 | 1998-07-09 | Trockenkopierprozeß zur Herstellung flächiger, einzeldosierter Wirkstoffzubereitungen |
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CN1308524A true CN1308524A (zh) | 2001-08-15 |
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CN99808409A Pending CN1308524A (zh) | 1998-07-09 | 1999-07-02 | 生产平面的单独给药的活性成分制剂的干燥复制方法 |
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Country | Link |
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EP (1) | EP1094794B1 (zh) |
JP (1) | JP4252215B2 (zh) |
KR (1) | KR100517819B1 (zh) |
CN (1) | CN1308524A (zh) |
AT (1) | ATE256459T1 (zh) |
AU (1) | AU750142B2 (zh) |
BR (1) | BR9911961A (zh) |
CA (1) | CA2336713A1 (zh) |
DE (2) | DE19830650C1 (zh) |
DK (1) | DK1094794T3 (zh) |
ES (1) | ES2214035T3 (zh) |
HU (1) | HUP0104919A2 (zh) |
IL (2) | IL140745A0 (zh) |
WO (1) | WO2000002533A2 (zh) |
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FI121936B (fi) * | 2002-03-14 | 2011-06-15 | Metso Paper Inc | Jauhemaisten partikkelien siirto |
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FR2672800B1 (fr) * | 1991-02-15 | 1995-03-10 | Dolisos Lab | Nouvelle utilisation en therapeutique de pycnogenols pour la preparation de medicaments a activite anti-inflammatoire. |
GB2253164B (en) * | 1991-02-22 | 1994-10-05 | Hoechst Uk Ltd | Improvements in or relating to electrostatic coating of substrates of medicinal products |
EP0560990B1 (en) * | 1991-10-03 | 1997-05-28 | Sony Corporation | Image recording method |
US5681255A (en) * | 1993-05-21 | 1997-10-28 | Ranpak Corp. | Dispensing table and guide system for a cushioning conversion machine |
DK0869847T3 (da) * | 1995-05-09 | 2003-06-30 | Phoqus Ltd | Elektrostatisk belægning |
US5714007A (en) * | 1995-06-06 | 1998-02-03 | David Sarnoff Research Center, Inc. | Apparatus for electrostatically depositing a medicament powder upon predefined regions of a substrate |
US5858099A (en) * | 1996-04-09 | 1999-01-12 | Sarnoff Corporation | Electrostatic chucks and a particle deposition apparatus therefor |
GB9623634D0 (en) * | 1996-11-13 | 1997-01-08 | Bpsi Holdings Inc | Method and apparatus for the coating of substrates for pharmaceutical use |
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1998
- 1998-07-09 DE DE19830650A patent/DE19830650C1/de not_active Expired - Fee Related
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1999
- 1999-07-02 CA CA002336713A patent/CA2336713A1/en not_active Abandoned
- 1999-07-02 DK DK99932794T patent/DK1094794T3/da active
- 1999-07-02 BR BR9911961-7A patent/BR9911961A/pt not_active Application Discontinuation
- 1999-07-02 CN CN99808409A patent/CN1308524A/zh active Pending
- 1999-07-02 DE DE59908117T patent/DE59908117D1/de not_active Expired - Lifetime
- 1999-07-02 AU AU49055/99A patent/AU750142B2/en not_active Ceased
- 1999-07-02 ES ES99932794T patent/ES2214035T3/es not_active Expired - Lifetime
- 1999-07-02 IL IL14074599A patent/IL140745A0/xx active IP Right Grant
- 1999-07-02 WO PCT/EP1999/004612 patent/WO2000002533A2/de active IP Right Grant
- 1999-07-02 HU HU0104919A patent/HUP0104919A2/hu unknown
- 1999-07-02 JP JP2000558794A patent/JP4252215B2/ja not_active Expired - Fee Related
- 1999-07-02 KR KR10-2001-7000089A patent/KR100517819B1/ko not_active IP Right Cessation
- 1999-07-02 EP EP99932794A patent/EP1094794B1/de not_active Expired - Lifetime
- 1999-07-02 AT AT99932794T patent/ATE256459T1/de active
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Also Published As
Publication number | Publication date |
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EP1094794A2 (de) | 2001-05-02 |
IL140745A0 (en) | 2002-02-10 |
ES2214035T3 (es) | 2004-09-01 |
AU4905599A (en) | 2000-02-01 |
DE59908117D1 (de) | 2004-01-29 |
DE19830650C1 (de) | 1999-08-12 |
WO2000002533A3 (de) | 2000-02-17 |
JP4252215B2 (ja) | 2009-04-08 |
KR100517819B1 (ko) | 2005-09-30 |
DK1094794T3 (da) | 2004-03-29 |
WO2000002533A2 (de) | 2000-01-20 |
KR20010074643A (ko) | 2001-08-04 |
AU750142B2 (en) | 2002-07-11 |
EP1094794B1 (de) | 2003-12-17 |
IL140745A (en) | 2007-05-15 |
CA2336713A1 (en) | 2000-01-20 |
ATE256459T1 (de) | 2004-01-15 |
HUP0104919A2 (hu) | 2002-04-29 |
JP2002520266A (ja) | 2002-07-09 |
BR9911961A (pt) | 2001-03-27 |
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