CN1094801C - 活性物质的回收方法 - Google Patents
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Abstract
在再处理用于活性物质经皮给药的装置或其工艺废弃物的方法中,将含活性物质的成分带进溶液,从中回收活性物质。
Description
发明领域
本发明涉及从未用过的或废弃的活性物质经皮施用装置和/或其工艺废弃物回收活性物质的方法,其中所述装置中所含的活性物质通常与聚合物膜和聚合物片一起存在。
背景技术
经皮施用装置可再分成两类:
a.经被动扩散释放活性物质到皮肤或器官的系统,和
b.在电流作用下或借助电流释放活性物质到皮肤或器官的系统。
基于被动扩散的系统即所谓经皮治疗系统(TTS)。
它们可分成所谓骨架系统和贮库系统。
在骨架系统中,活性物质溶于聚合物膜,或再有一部分以结晶形式或以微囊形式悬浮。因而在最简单的例子中,这些系统由活性物质基本上不能渗透的背衬层、含活性物质且最好具自粘性的骨架和在使用前除去的保护层所组成。
贮库系统在液体贮库中包含活性物质。活性物质可以完全或仅部分溶解的形式存在。在最简单的例子中,这些系统由贮库中所含物质不能渗透的背衬层和至少可透过活性物质的膜组成,为了将该系统敷贴于皮肤,较佳的还有粘性膜。
在施加电流时释放活性物质到皮肤或器官的系统可能有各种结构。它们特别适用于由于其理化性质、借助被动扩散不能有足够量透过皮肤的活性物质。
由于公知的原因,每个用过的TTS中存留着未用尽的活性物质部分。这样的含活性物质的废弃品代表一种毒理学和生态学的危险,因此必须以很大的经费作为有害的废弃物来处置。另一方面,这些废弃品仍然含有来自药物制剂的非常昂贵和有价值的成分或活性物质,有时回收这些成分似乎经济上是合适的。为何在这方面所作经济上的考虑支持活性物质的回收,一个原因是,此时基本上无活性物质的载体不再被认为是有害废弃物,可以最低限度的费用加以处置。
这同样适用于未用过的TTS及其工艺废弃物,它必然存在于某些生产方法,或并不是始终能避免的不完善的批号。
在本技术领域已知有一些再循环方法,特别是含有涂布有粘合剂的片材的废弃品的再循环。例如,DE 42 09 676描述了具有模压条纹膜的压敏自粘材料(特别是层压乙烯-对苯二酸-间苯二酸共聚酯的PET片材)的再循环方法。
DE 42 21 681描述了标签废弃品上的聚乙烯、聚丙烯或聚苯乙烯粘合剂的再循环方法。
DE 40 37 562描述了反复在溶剂中捏合、在螺旋输送机中排放和使剩余材料反复通过同样的工序而使涂布有粘合剂的塑料膜再循环。
DE 40 37 562描述了通过分离塑料材料和粘合剂,而使涂覆了粘合剂、以小片状存在的塑料片再循环的方法。在第一阶段,将塑料片的小片放在粘合剂的溶剂中以分散附着于小片的粘合剂,在机械作用下,与溶剂一起搅拌预定的时间。接着,在机械作用下,将分散于溶剂中的粘合剂与碎片分离出来。在类似的第二阶段,供应新鲜溶剂到第一阶段的碎片中,将第二阶段的溶剂-粘合剂分散体返回第一阶段。
发明内容
本发明的目的是提供一种方法,用此方法可经济有效地再处理药物制剂的废弃品,特别是未用过的活性物质经皮施用装置或经使用后丢弃的那些装置,即所谓TTS,以回收其中所含的活性物质,同时在回收其活性物质内容物后经济有效地进行载体材料的处置。
此目的是借助本发明的下述种类的方法来达到的,事实上是用溶剂将含活性物质的材料带到溶液中,再从中回收活性物质。
从未用过的或废弃的活性物质经皮给药装置(TTS)和/或其工艺废弃物回收活性物质的处置方法,未用过的装置或废弃品具有作为含活性物质材料的骨架,它可任选地为压敏粘合剂,或贮库,其中,小量活性物质作为均匀的混合物,以微囊形式或结晶形式或以液体溶液的形式含有,或与聚合物膜或聚合物片一起存在,该方法的特点是活性物质和进一步任选的成分被带入选出的溶剂的溶液,并从中回收活性物质,而活性物质已被充分除去的剩余材料供废物处置或再循环处理,特别是常规的处理。
一方面,所提议的方法在生态学上是安全的,在经济上是可行的,可回收各种有价值的粗活性物质;另一方面,得到基本上无活性成分、对环境呈中性的、因而易于处置的固体或载体材料。该载体或其它工艺残渣可按照本领域已知的方法进一步再循环。
具体实施方式
按照本方法的一个实施方案,将准备再处理的材料预处理,其中以活性物质为准将其分拣成最好是纯的级别的几部分,活性物质已与外来物质(如载体和/或保护膜、包装材料等)分开,并将含活性物质的材料浓集。按照本发明的另一个实施方案,将准备进行再处理的材料(也称作“废弃品”)放在包装或包装装置中传送到再循环工段,包装或包装装置有与其内容物有关的明显识别标记,例如,适用于自动分拣的颜色图案或编码区。这样的编码区可使编码的包装完全自动分拣为纯的级别的各成分,例如,象邮件分捡一样。这避免了成本高的人工操作,可以完善地进行分捡。这对于诸如从TTS碎片回收活性物质的方法是极其重要的。为了有助于含活性物质的材料溶解于溶剂中,缩小废弃品的体积是有利的,如果需要,可在低温下脆化。除了其它优点,用液氮深度冷冻具有外加的优点,这样冷却的废弃材料当其粉碎时不向环境释放有害物质。可以这样达到体积缩小,例如缩小至粒径小于2mm,因有效表面增大,而导致粉碎的材料更容易、甚至更完全溶于溶剂浴;或因而可用浸渍、渗滤或流化床提取法回收活性物质。
为了溶解含活性物质的材料,本发明基本的方法是使用溶剂或溶剂混合物,它对粘合剂具有较低的溶解力,对活性物质具有较好的溶解力。然后,可用诸如液-液萃取、逆流萃取或其它合适的方法从溶液中进一步分离活性物质。
为了从溶液中回收活性物质,可进一步通过沉淀或暂时化学结合,或通过外来化合物沉积、蒸发、蒸馏或其它合适的分离方法,进行进一步回收。
用溶剂或溶剂混合物提取活性物质时,对于碱性活性物质,可取的是使用酸性pH的水或酸化的水/醇混合物;对于酸性活性物质,可取的是调节碱性的pH值。对于没有酸性或碱性官能团的活性物质,很明显是用中性水/醇混合物。然后可通过改变pH值或加水或借助液-液萃取而从这些混合物中取出活性物质。使用基本上水性的溶剂还有一个优点是进行共萃取的亲脂性辅助剂只用小量。
超临界气体也可用作提取活性物质的溶剂。它们的特殊优点在于溶解力、温度和压力、以及其它溶剂的混合可在一定的限度内受到影响,而且很容易从溶剂中分离所提取的成分。超临界气体粘度很低,因此能很快地扩散到被的提取的产品中,它们特别适用于从聚合材料中提取活性物质。超临界二氧化碳因其环境适应性好、价格低和易于处理而特别适合于此目的。固体在回收活性物质后基本无毒理学或生态学上的危险,这样分离的固体作为对环境呈中性的废弃品可经诸如焚烧或倾倒而易于处置。与倾倒有害废弃物的费用相比,它所省下的费用超过了按本发明回收方法所需的费用。
活性物质回收方法可能具有成本效益。溶于溶剂的活性或成分物质可借助诸如蒸馏或精馏等已知的热提纯方法,以已知的及本身证明其资本和动力消耗相当低的方式,从溶液或溶剂混合物中加以回收。
此外,在最后的操作中,将从溶液中回收的粗活性物质再处理成药学纯的活性物质。
适合于此目的的方法是熟练技术人员公知的,其例子包括重结晶或制备性高压或中压色谱法。
本方法是合适的和经济上有益的,它以最适方式达到开头所述的目的。
通过选择工艺参数,特别可以回收具有激素作用的活性物质雌二醇、雌二醇衍生物、孕激素类、孕激素衍生物及其混合物,吗啡或吗啡衍生物,丁丙诺啡,毒扁豆碱,东莨菪碱,加兰他敏。然后可按药理作用使用所回收的物质,如作为镇痛剂,以及治疗老年性痴呆、高血压、心律失常、血管疾病、成瘾、高血脂症、精神紊乱、影响血液凝固、饮食习惯上的疾病或血糖代谢障碍。
Claims (14)
1.从未用过的或废弃的活性物质经皮给药装置(TTS)和/或其工艺废弃物回收活性物质的处置方法,未用过的装置或废弃品具有作为含活性物质材料的骨架,它可任选地为压敏粘合剂,或贮库,其中,小量活性物质作为均匀的混合物,以微囊形式或结晶形式或以液体溶液的形式含有,或与聚合物膜或聚合物片一起存在,该方法的特征在于活性物质和进一步任选的成分被带入选出的溶剂的溶液,并从中回收活性物质,而活性物质已被充分除去的剩余材料供废物处置或再循环处理,特别是常规的处理。
2.如权利要求1所述的方法,其特征还在于将未用过的或废弃的TTS或废弃品经预处理,将其分拣成纯的级别的几部分,它们已与外来物质如载体和/或保护片材、包装材料等分开,并将含活性物质的材料浓集。
3.如权利要求1或2所述的方法,其特征还在于将放在包装或包装装置中的未用过的或废弃的TTS或废弃品传送到再循环工段,包装或包装装置有识别其内容物的明显标记,例如,适用于自动分拣的颜色图案或编码区。
4.如权利要求1所述的方法,其特征还在于任选地在低温脆化状态使未用过的或废弃的TTS或废弃品体积缩小。
5.如权利要求1所述的方法,其特征还在于使用溶剂或溶剂混合物溶解活性物质,它对粘合剂和TTS的其它成分具有较低的溶解力,对活性物质具有较好的溶解力。
6.如权利要求1所述的方法,其特征还在于活性物质的溶解在强烈搅拌及任选地在升高的温度下进行。
7.如权利要求1所述的方法,其特征还在于活性物质从溶液中的提取是用以下方法进行的:
-液-液萃取
-浸渍或渗滤
-逆流萃取
-流化床萃取
或其它合适的方法。
8.如权利要求1所述的方法,其特征还在于活性物质从溶液中的回收是用沉淀、暂时化学键合、外来物质的沉积、蒸发、蒸馏或其它适当的分离方法进行的。
9.如权利要求5所述的方法,其特征还在于用酸性pH的水或酸化的水/醇混合物溶解碱性活性物质。
10.如权利要求5所述的方法,其特征还在于用中性或碱化的水/醇混合物溶解活性物质。
11.如权利要求1所述的方法,其特征还在于用超临界气体,较佳的为二氧化碳,溶解活性物质。
12.如权利要求1所述的方法,其特征还在于将从溶液中回收的活性物质在最后操作中再处理成药学纯的活性物质。
13.如权利要求1所述的方法,其特征还在于通过
-用蒸馏的分离方法或
-用超临界气体,较佳的为CO2,进行高压萃取
来达到粗活性物质的精制。
14.如权利要求1所述的方法,其特征还在于通过改变pH值或加水、或通过液-液萃取,从水/醇/活性物质混合物中取出活性物质。
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DE19524083A DE19524083C2 (de) | 1995-07-01 | 1995-07-01 | Verfahren zur Entsorgung von Transdermalapplikations-Sondermüll |
DE19524083.9 | 1995-07-01 |
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CN1189788A CN1189788A (zh) | 1998-08-05 |
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EP (1) | EP0836538B1 (zh) |
JP (1) | JP3213006B2 (zh) |
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CN (1) | CN1094801C (zh) |
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AU (1) | AU714549B2 (zh) |
CA (1) | CA2226153C (zh) |
CZ (1) | CZ289134B6 (zh) |
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DE19736520A1 (de) * | 1997-08-22 | 1999-02-25 | Lohmann Therapie Syst Lts | Kennzeichnung für klebende flächenförmige dermale und transdermale therapeutische Darreichungsformen unter Verwendung eines klebenden Plfasters als Informationsträger, sowie Verfahren zu seiner Herstellung |
DE19800277B4 (de) * | 1998-01-07 | 2004-09-02 | Lts Lohmann Therapie-Systeme Ag | Verfahren zur Rückgewinnung von Arzneistoffen aus Zubereitungen, deren Vorprodukten oder Abfällen |
FR2790851B1 (fr) | 1999-03-12 | 2001-06-08 | Ge Medical Syst Sa | Procede d'amelioration de la detection d'elements d'interet dans une image radiographique numerique |
DE10348046A1 (de) * | 2003-10-16 | 2005-05-19 | Beiersdorf Ag | Verfahren zur Herstellung von Matrizes für transdermale oder topicale Wirkstoffsysteme |
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US5461147A (en) * | 1993-09-27 | 1995-10-24 | Schering Corporation | Process for preparing benzazepine intermediates for the synthesis of D1 antagonists |
DE4340093A1 (de) * | 1993-11-24 | 1995-06-01 | Cognis Bio Umwelt | Verfahren zur vereinfachten Trennung von Mehrstoffgemischen wenigstens anteilig organischen Ursprungs |
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DE4221681A1 (de) * | 1992-07-02 | 1994-01-05 | Pago Etikettiersysteme | Verfahren und Recycling von Folienabfällen, Recyclingmaterial und seine Verwendung |
US5288408A (en) * | 1992-10-26 | 1994-02-22 | Chemical Industry Consultants, Inc. | Method of gelatin recovery and purification from encapsulation processes |
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JPH11508815A (ja) | 1999-08-03 |
KR19990028517A (ko) | 1999-04-15 |
WO1997002100A1 (de) | 1997-01-23 |
DE19524083A1 (de) | 1997-01-09 |
NO975923D0 (no) | 1997-12-16 |
AU714549B2 (en) | 2000-01-06 |
HUP9900336A2 (hu) | 1999-05-28 |
US5869652A (en) | 1999-02-09 |
EP0836538B1 (de) | 1999-09-15 |
GR3032071T3 (en) | 2000-03-31 |
NO309707B1 (no) | 2001-03-19 |
DE19524083C2 (de) | 2000-07-06 |
DE59603092D1 (de) | 1999-10-21 |
ZA965495B (en) | 1997-01-30 |
NO975923L (no) | 1997-12-16 |
CA2226153C (en) | 2004-05-11 |
EP0836538A1 (de) | 1998-04-22 |
ES2139365T3 (es) | 2000-02-01 |
CA2226153A1 (en) | 1997-01-23 |
HUP9900336A3 (en) | 2001-01-29 |
AU6304796A (en) | 1997-02-05 |
JP3213006B2 (ja) | 2001-09-25 |
DK0836538T3 (da) | 2000-04-03 |
SK798A3 (en) | 1998-09-09 |
PL324406A1 (en) | 1998-05-25 |
CZ289134B6 (cs) | 2001-11-14 |
CN1189788A (zh) | 1998-08-05 |
MX9800243A (es) | 1998-03-31 |
ATE184519T1 (de) | 1999-10-15 |
NZ311681A (en) | 1999-01-28 |
CZ420897A3 (cs) | 1998-06-17 |
SK282659B6 (sk) | 2002-11-06 |
MY132204A (en) | 2007-09-28 |
KR100411690B1 (ko) | 2004-03-30 |
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