CN1200711C - 烟碱转运系统 - Google Patents

烟碱转运系统 Download PDF

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CN1200711C
CN1200711C CNB008074704A CN00807470A CN1200711C CN 1200711 C CN1200711 C CN 1200711C CN B008074704 A CNB008074704 A CN B008074704A CN 00807470 A CN00807470 A CN 00807470A CN 1200711 C CN1200711 C CN 1200711C
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戴维·勒西利·麦克内特
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    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine

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Abstract

本发明公开了烟碱转运系统，所述系统包含封装在微胶囊系统中的烟碱，所述微胶囊系统在与烟碱溶剂接触时释放所封装的烟碱。

Description

烟碱转运系统
本发明涉及烟碱转运系统。
烟碱通常在卷烟，主要是雪茄烟和烟丝(pipe tobacco)中，以吸烟的形式被吸收。在更小的范围内，烟草或其制品被咀嚼。如今，更少的是鼻吸入。吸烟已被宣布对健康有害，但是烟碱本身在适当的量，不象吸烟一样有害，吸烟的害处是因为卷烟的烟中烟碱以外的其它成分，烟碱本身在适当的量甚至可能是有益的-很多时候其被报道为辅助浓度(aiding concentration)。
虽然还有一些疑问，烟碱已被普遍认为确有成瘾性，提高对烟草的税、政府的健康警告、因吸烟而得绝症的人或其亲属对烟草公司的频繁诉讼，似乎都未减少其消费。
有几种商品化的帮助那些希望戒烟的人的产品。它们采用片剂、口香糖和药贴的形式，所有这些形式都试图避免烟及与之相关的致癌或其它有害成分的产生而转运烟碱。
配方这些产品的问题是烟碱本身是极易挥发的液体，其沸点在大气压下低至123℃-125℃，这将由于配方期间的蒸发损失以及为确保合理的保质期需要密封产品以防止烟碱蒸发而使将其混入产品中变得困难。与此同时，烟碱必须在使用时易于释放——在口香糖或锭剂的情况下在口中易于释放；或者在药贴的情况下易于通过皮肤释放。
烟碱注射的方式是通过溶解在脂肪组织中。烟碱不易在肠中被吸收，没有产品试图被用以吞服。
当然，药贴有一些临床价值，并且毫无疑问十分有效，然而药贴不美观。口香糖常常和抽烟一样被认为是反社会的-口香糖有许多其使用者忽略的处置问题，这导致其在新加坡是不合法的，很可能别的国家会效仿该措施。在所有的途径中，最美观的-不遗留任何需要处置的东西，可以吮吸而避免有时极令人反感的咀嚼运动的锭剂-可能是最难配方的，通常需要高温加工，导致通过蒸发的烟碱损失和锭剂中不确定的烟碱最终剂量，如果需要合理的保质期，还需要特殊保护以防终产物中的烟碱蒸发。
已有技术包括如GB2299756，其公开了含有烟碱的凝胶状锭剂。GB 2171906公开了用于治疗记忆损伤的控释配方，包括烟碱配方。DE 19856432公开了含有活性试剂如烟碱，用于口服或经皮施用的毫微粒。K.H.Bauer等在“PharmazeutischeTechnologie”，1991，Georg Thieme Verlag，Stuttgart，纽约中，在第341页讨论了各种微胶囊、毫微粒和脂质体。这些出版物既没有提示也没有公开酵母细胞作为烟碱储器(即含有烟碱的微胶囊)的用途。
本发明提供避免已有技术问题的烟碱转运系统，其可以在已有范围内产生改善的产品，尤其是对于锭剂。
本发明包括烟碱转运系统，所述系统包含封装在微胶囊系统中的烟碱，所述微胶囊系统包含酵母细胞，其在所述微胶囊与口腔脂肪组织接触时释放所封装的烟碱。
该系统可以包含负载有烟碱的细胞以及稀释剂、空细胞的混合物。
该系统可以存在于固体载体中，为了受控转运，微胶囊从该载体表面被逐步释放。
固体载体可以包含在唾液中可溶或可分散的物质，且可以包含锭剂，锭剂可以是糖基的。锭剂可以具有这样的大小、溶解性和烟碱的负载，它们使其在4至20分钟的使用时间里转运相当于一支卷烟所转运的剂量的烟碱。锭剂可以是长形的，长度在5至20厘米之间，且通过具有优先的折断位置，其可被折断成多个部分，各部分均能够舒适地被容纳在口中。
然而，该固体载体可以包括口香糖。
该系统可以包含矫味物质，其也可以被封装在微胶囊系统中，也可以包含维生素添加物，其也可以被封装入微胶囊系统中。
该系统可以被包含在药贴中。
根据本发明的烟碱转运系统和包含其的产品的实施方案将参照附图描述，其中：
图1是微胶囊化烟碱的制备方法的示意图；
图2是锭剂产品的一个实施方案的视图；
图3是锭剂产品的第二个实施方案的视图。
图1说明烟碱转运系统的制备方法，所述系统包含封装入微胶囊系统的烟碱，所述微胶囊系统在与烟碱溶剂接触时释放烟碱。
液态烟酸(nicotine acid)11形式的烟碱被倾入具有搅拌器13的混和容器12中。将定量的烟碱混入一定体积的酵母细胞14中，以给出烟碱进入各酵母细胞的合理浓度的吸收。合适的混和是25克烟碱、50克酵母细胞和100克水。将其在约40℃搅拌1-24小时。通过离心分离细胞并将细胞干燥。预期的负载是25-60％(重量)烟碱进入细胞，取决于所用的混和物。
在该方法的第二阶段，将这样的负载有烟碱的酵母细胞14从容器12中倾入大体积的酵母细胞中，此大体积的酵母细胞在第二个混和容器15中，容器15也具有搅拌器13，并搅拌混合物。
这样将得到封装在酵母细胞中的预期浓度的烟碱。
然后将该混和的负载酵母细胞和稀释剂酵母细胞混入具有适量酵母的产品中，以给出期望的产品中烟碱的剂量。
两个这种产品在图2和图3中说明。
图2说明锭形长条糖，它可能有9或10厘米长以适于装入如同卖香烟时所用的包装中。长条上具有横向的凹槽，使其能被折断成一口体积(bite-size)的片。
图3说明类似的产品，这次的形状更象卷烟，仍然有横向的凹槽以供折断。图2和图3的外观在GB 2 299 756 A中首次提出。
这些产品都很象卷烟，它们可以被用作戒烟的辅助剂，或者在不允许吸烟的地方用作卷烟替代品，通过它们的负载的酵母含量，它们含有吸一支烟所转运的等量烟碱。
也可以加入矫味剂例如薄荷、苏格兰威士忌、法国科涅克白兰地酒或薄荷醇，同样以类似的方式封装入酵母中，也可以加入其它有益物质如维生素添加物。

Claims (13)

1.烟碱转运系统，所述系统包含封装在微胶囊系统中的烟碱，所述微胶囊系统由酵母细胞组成，其在所述微胶囊与口腔脂肪组织接触时释放所封装的烟碱。
2.根据权利要求1的烟碱转运系统，所述系统包含负载有烟碱的细胞和空稀释细胞的混合物。
3.根据前述权利要求1的烟碱转运系统，其存在于固体载体中，为了受控转运，微胶囊从该载体表面被逐步释放。
4.根据权利要求3的烟碱转运系统，其中固体载体包含在唾液中可溶或可分散的物质。
5.根据权利要求4的烟碱转运系统，其中固体载体是锭剂。
6.根据权利要求5的烟碱转运系统，其中锭剂是糖基的。
7.根据权利要求5或6的烟碱转运系统，其具有这样的大小、溶解性和烟碱的负载，它们使其在4至20分钟的使用时间里转运相当于一支卷烟所转运的量的烟碱。
8.根据权利要求7的烟碱转运系统，其中锭剂是长形的，长度在5至20厘米之间，且通过具有优先的折断位置，其可被折断成多个部分，各部分均能够舒适地被容纳在口中。
9.根据权利要求3的烟碱转运系统，其中固体载体包括口香糖。
10.根据前述权利要求1-6之任一项的烟碱转运系统，其包含矫味物质。
11.根据权利要求10的烟碱转运系统，其中矫味物质也被封装在微胶囊系统中。
12.根据前述权利要求1-6之任一项的烟碱转运系统，其包含维生素添加物。
13.根据权利要求12的烟碱转运系统，其中维生素也被封装在微胶囊系统中。
CNB008074704A 1999-05-13 2000-05-11 烟碱转运系统 Expired - Fee Related CN1200711C (zh)

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GBGB9911037.1A GB9911037D0 (en) 1999-05-13 1999-05-13 Nicotine delivery service
GB9911037.1 1999-05-13

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US20060120974A1 (en) 2006-06-08
DE60006376D1 (de) 2003-12-11
WO2000069440A2 (en) 2000-11-23
WO2000069440A3 (en) 2001-04-05
EP1176961B1 (en) 2003-11-05
DE60006376T2 (de) 2004-09-09
AU4769900A (en) 2000-12-05
GB9911037D0 (en) 1999-07-14
JP2002544230A (ja) 2002-12-24
EP1176961A2 (en) 2002-02-06
ATE253363T1 (de) 2003-11-15
DK1176961T3 (da) 2004-03-15
US20070269417A1 (en) 2007-11-22
ES2209882T3 (es) 2004-07-01
PT1176961E (pt) 2004-03-31

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