CN1012661B - 弹性材料制成的预防装置及其制造方法 - Google Patents

弹性材料制成的预防装置及其制造方法

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CN1012661B
CN1012661B CN88106110A CN88106110A CN1012661B CN 1012661 B CN1012661 B CN 1012661B CN 88106110 A CN88106110 A CN 88106110A CN 88106110 A CN88106110 A CN 88106110A CN 1012661 B CN1012661 B CN 1012661B
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CN1031648A (zh
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雷尼·盖一·布斯尼尔
格里斯·艾尔基
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Hutchinson SA
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Abstract

本发明涉及一弹性材料制成的预防装置。该装置包括至少两个弹性材料层(11、12)，一层置于另一层外面；包括至少一种对病菌(病毒、霉菌和其它致病因子)或精子有灭活作用的药品或物质，该有效物质被置于上述两层之间，并封存在微囊中，其微囊壁在摩擦力和剪切力的作用下破裂。本发明可应用于避孕套、指套、手套及同类制品。

Description

本发明涉及一弹性材料制成的预防装置及其制造方法。
它特别涉及一能使应用者在性交过程中防止细菌和病毒感染的避孕套，及在某些医疗检查过程中具有防护作用的产品，如指套;或在某些外科或口腔科操作过程中医生应用的保护手套。但不仅限于这些用途。
在诊查、操作和防止性传播疾病的致病因子的时候，避孕套、指套或手套的膜（通过为橡胶制品）的破裂，有时甚至仅为裂隙，也能造成该器具的使用者被污染。所以使用这些器具时不是不冒风险的。这种风险以AQL（Acceptable    Quality    level-可接受质量水平）系数值来衡量，对避孕套来说通常的要求为0.4%，就整个医疗专业来说，这不是令人满意的值。为降低这一风险的程度，已有人建议将一确实能有效地挡住艾滋病毒的制品与避孕套贴附，该制品做为一复盖层，蒙在制成避孕套的橡胶表面。虽然这一装置理论上是令人满意的，但是由于有效层制品和做成避孕套的聚合物之间可能发生的相互作用能够引起这种套的弹性性能改变和老化。或者相反地，由于吸附作用及在橡胶和其它聚合物表面形成复合物，可引起有效药物分子活性的丧失。这些都是该设想的不利之处。此外，以膜的形式涂于橡胶套的一面或双面的有效药物可以转移到性伴侣的皮肤和/或粘膜上，反复使用后，可引起粘膜侵袭和刺激症状，及过敏、变 态反应等。
包括有两个分离套层，并将药物学活性液体注入两层之间的装置，已经问世一段时间了（具体参看第2586674号美国专利）。且莫说实际上有效药物与乳胶直接接触，或作用于乳胶的衍生物，常常很快破坏乳胶的机械性能和不渗透性，而且还需注意到两层之间的液体在摩擦发生时容易集中到一处，这样一来本应得到保护的器官的全部表面得不到保护。
所以本发明的总目的是提供一弥补上述缺陷的弹性材料制成的预防装置。
本发明的进一步目的是提供制造该预防装置的方法。
这些和其它一些目的在本发明装置中得以实现。这是一个弹性材料制成的预防装置，至少包括两弹性材料层，一层贴附于另一层外面，至少有一种对细菌、病毒、霉菌、精子等微生物有杀灭作用的物质被置于上述两层之间。这一种或数种有效物质被封存在微囊中，该囊壁在摩擦力和剪切力的作用下破裂。
微囊以凝聚方法制备，或以制药生产中的其它已知的常规方法制备，例如以生产无碳拷贝纸或类似柔韧物质的方法制备。
具有这样结构的装置，当弹性体的某一层破裂时，才释放有效药物与其使用者和/或性伴侣的皮肤/或粘膜相接触。所以，一方面没有必要担心习惯的副作用;另一方面，任何橡胶或者形成套膜的其它弹性材料与有效药物之间的相互作用现象被避免。所以有效药物的选择可以为一种分子，或是符合药理学作用要求的几种化学上相容的分子的混合物，例如，作用于艾滋病毒、疱疹病毒等抗病毒剂，或杀精子剂，抗霉菌剂，抗毛滴虫剂，抗菌素或广普作用的药物。
根据本发明，上述预防装置的制造方法包括：应用适当的常规制造技术，将第一层弹性材料做成需要的预防装置的形状;对所述第一弹性材料层进行第一次前硫化处理，然后将装有一种或多种有效药物的微囊形成的膜复盖于第一层上，再在这层膜上复盖符合装置形状的第二弹性体层;最后将制品整体硫化后从模具上取下。
在一个最佳实施例中，采用流化床或类似方法将微囊贴附于第一弹性体层上。将置于模具上的，处于前硫化状态的第一层浸入流化床。在前硫化状态的第一层只要和微囊一接触，立刻就由粘附效应贴在一起。
在另一实施例中，将第一弹性体层置于一生产模具上，然后把经过前硫化处理的第一层浸入乳胶中，该乳胶内除含有分散状态的弹性体外，还有包裹着一种或多种有效药物的微囊。接下去是将第二弹性体层贴附于含有微囊的中间层上。最后将整个制品硫化处理。
本预防装置的制造方法如上所述，即一种具有双层弹性体的装置，两层之间有一形成微囊的膜或层，该微囊中包有一种或多种有效药物，其贴附方法如第一和第二实施例中所述。当然可以重复该装置的制造方法而形成多层，这种装置不但增加了不透水性和机械强度，而且具有大量有效药物。
通过弹性体“桥”机械地将第一层和第二层包膜连接在一起，而弹性体“桥”位于两层包膜之间。这种加工方法能改善装置的整体机械性能。将该装置套上阴茎，或者戴到检查者或外科手术者手指或手上的动作，产生足够的力导致微囊膜破裂或破碎，这就使有效药物释放到相邻弹性体层之间的空间。
在本发明的一个优良的实施例中，对包裹有效药物的微囊的平均 直径的要求为5到50微米;用做避孕套时，弹性材料层的厚度为10到50微米或稍微再厚一些，用做指套或手套时，其厚度可达300到500微米。
选择这些尺寸使得小幅度的动力（包括使用避孕套的男性的2-3次动作;在作为手套使用时，则为300到500克压力，该压力与摩擦动作中产生的力相等）一方面造成微囊破裂，药物弥散;另一方面，由于同时撕裂薄薄的内层乳胶，使套着本装置的器官（性器官、手指等）被包围。
下面的描述将使本发明进一步的特征和优点更为突出。以下就参照附图对一个实施例予以说明。在附图中：
图1为局部放大剖面简图，示出本发明的结构和第一实施例的制造方法。
图2所示同图1，但示出的是第二实施例。
图3为本发明预防装置的局部简图。
如这最后一图所示，预防装置10，如避孕套、指套、外科手套等，实质上包括两弹性体层11和12，例如可用天然橡胶做成，一种或多种有效药物13以微囊或微球的形式被封于两弹性体层之间。在这方面，图3表示一特别简要的略图，所示出的不能看成该装置组成部分的尺寸。要求包裹一种或多种有效药物的胶囊的实际平均直径为5到50微米，而弹性材料层在做为避孕套时的厚度为10到30微米，做为指套或手套时可厚达300微米。
微囊或微球形成支持系统，其壳由已知材料制成。如乙酰邻苯二甲酸纤维素，聚乙烯醇，果胶，阿拉伯树胶、甲基纤维素，明胶、环氧树脂等，里面包有一种或多种具有特殊的或作用互补的所需特性的 药物，尤其是抗病毒，抗毛滴虫，抗霉菌、抗细菌或能杀灭精子的药物。具体地，可以采纳下面列出的药物组（但不限于此）：盐酸吗啉双胍、阿糖腺甙、9-（2-羟基乙氧基甲基）乌嘌呤、5-碘脱氧胞嘧啶核甙和碘脱氧尿嘧啶核甙（DCI）;四价氨基化合物，如盐酸烷基二甲苯氨或氯化苯甲烃氨、加苄基月桂酰溴的酸性己基雷琐辛或加十二烷基硫酸钠的中性己基雷琐辛、壬苯聚醇、对异丁基苯氧基乙氧基醇、氯化苯甲乙氧氨（DCI）和加甲基对羟基苯甲酸酯的硝酸苯汞;硝酸双氯苯咪唑、硝酸氯苯甲氧咪唑、制霉菌素、硝砆噁酮和游霉素;乙酰胂胺、二氯甲羟喹、噻吩硝噻唑（DCI）和tern    idazole（DCI）;碘化聚乙烯吡咯烷酮、洗必泰（DCI）、双葡萄糖酸盐、硫酸新霉素（DCI）和硫酸多粘菌素B（DCI）;次氯酸钠、高锰酸钾、硝酸银和汞衍生物;这些有效分子的作用互相补充，如果需要则可加入赋形剂和/或防腐剂。
按照本发明制造该装置时，先制备一种陶瓷、玻璃等类似材料制成的模具，以放置第一弹性体层12，确定需要制造的手套、指套和避孕套的形状;可将模具浸入乳胶中，在促凝剂作用下，借助表面张力固定，或更佳地以电泳作用制备第一弹性体层。套在模具上的前述第一弹性体层在一热气管道中进行前硫化处理，管道温度和经过时间应规定为使弹性体不被完全硫化并保持粘性。离开上述管道后，套着前硫化处理的弹性体层的模具浸入含有有效药物的微囊14的流化床中，这时弹性体的粘性可被利用。这些微囊与层12的外侧15相接触并附着于此，依靠粘性保持固定于该层。整个制品随后被复盖上层11，最好将其浸入乳胶浴中，复盖于微囊14和微囊之间的自由空 间的这一弹性体层构成了图1中标号16表示的桥。它同时保证层11和层12机械地联接在一起，以及将微囊14包埋于其间。
然后将以这种方法制备的整个制品通过一热气管道进行第二阶段硫化。在任何情况下，管道的温度要低于使包埋于两弹性体层之间的有效药物和/或微囊、微球破坏的温度。
一种或多种有效药物的溶媒的沸点应高于弹性体的正常硫化温度。优先选用的如，硅油、乙二醇或任何其它化学上和药理学上兼容的溶媒。如果是水溶性物质，最好在一定压力下的烘箱中使弹性体聚合，因为这将防止明胶微囊在蒸气压力作用下破裂。
图2中所示的第二实施例中，其制备过程直到前硫化阶段是与上述方法相同的。在这一阶段以后，制品不是被浸入微囊的流化床中，而是浸入到其中均匀地分散有微囊15′的乳胶中。这样，在层12上形成一中间层17，其中含有在弹性体基质18中的微囊15′，中间层17将层12和层11′机械地联接。上述层11′与层11相似，也是将制品浸入乳胶中，使得层11′与基质18及微囊15′相联接。最后对整个制品进行硫化以得到最终的预防装置。
虽然图1、图2中描述的装置为两弹性体层包埋一种或多种有效药物的微囊，但是不言而喻，所指明的操作可多次（或n次）重复，以形成多层装置，这样的装置增加了机械强度，如果需要，它还能释放较大量的有效药物。
本说明书中的缩写字母DCI所指示的是国际通用药品名称。

Claims (18)

1、一种预防装置，包括至少两弹性材料层，其中一层位于另一层上面，其特征是在所述两弹性材料层之间设置有微囊，所述微囊具有易破裂的囊壁且其中装有至少一种药物。
2、根据权利要求1的预防装置，其特征是所述微囊的平均直径为5到50微米。
3、根据权利要求1的预防装置，其特征是每一所述弹性材料层的厚度为10到50微米。
4、根据权利要求3的预防装置，其特征是所述预防装置为避孕套。
5、根据权利要求1的预防装置，其特征是每一所述弹性材料层的厚度为300到500微米。
6、根据权利要求5的预防装置，其特征是所述预防装置为指套或手套。
7、根据权利要求1的预防装置，其特征是所述药物至少是选自下组药物中的一种：抗病毒药物、杀毛滴虫药物、抗霉菌药物、抗菌药物、杀精子药物和杀菌药物。
8、根据权利要求1的预防装置，其特征是所述微囊还含有药用赋形剂和（或）防腐剂。
9、根据权利要求1的预防装置，其特征是所述药物是非水性的，并溶解在其沸点高于所述弹性材料的正常硫化温度的非水溶媒中。
10、根据权利要求9的预防装置，其特征是所述溶媒是乙二醇或硅油。
11、根据权利要求1的预防装置，其特征是所述两弹性材料层在所述微囊之间的间隙中彼此跨接。
12、根据权利要求1的预防装置，其特征是所述微囊分散在由所述弹性材料的胶乳形成的膜层中。
13、根据权利要求1的预防装置，其特征是所述微囊粘附在所述两弹性材料层之一上。
14、根据权利要求11或12的预防装置，其特征是还包括至少另一弹性材料层。
15、一种制造根据权利要求1到14中任何一项的预防装置的方法，其特征是包括：应用适当的常规制作技术把第一弹性材料层制成符合要求的预防装置的形状，对该层进行第一次前硫化处理，并把由含有药物的微囊形成的膜层贴附于该层的一面，然后再在这层膜上贴附具有所需装置形状的第二弹性材料层，将整个制品硫化后，再从模具上取下。
16、根据权利要求15的制造方法，其特征是用流化床及类似方法将微囊贴附于第一弹性材料层上，把附于模具上处于前硫化状态的第一弹性材料层浸入流化床中，这时处于前硫化状态的第一层和微囊接触后立刻由粘附效应贴附在一起。
17、根据权利要求15的制造方法，其特征是将带有经过前硫化处理的第一弹性材料层的模具浸入胶乳中，该胶乳中含有均匀分散的弹性材料和装有药物的微囊，接着将第二弹性材料层贴附于含有微囊的膜层上，然后硫化处理整个制品。
18、根据权利要求15到17中任何一项的制造方法，其特征是将该方法重复多次，制作一具有两层以上弹性材料的预防装置，以便使预防装置的强度增加并含有较大量的药物。
CN88106110A 1987-08-20 1988-08-19 弹性材料制成的预防装置及其制造方法 Expired CN1012661B (zh)

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EP0306389A1 (fr) 1989-03-08
ATE77931T1 (de) 1992-07-15
KR970001822B1 (ko) 1997-02-17
DE3872629D1 (de) 1992-08-13
US4930522A (en) 1990-06-05
GR890300107T1 (en) 1989-10-31
MA21355A1 (fr) 1989-04-01
EP0306389B1 (fr) 1992-07-08
CN1031648A (zh) 1989-03-15
DE3872629T2 (de) 1992-12-03
FR2619503A1 (fr) 1989-02-24
JPH0440023B2 (zh) 1992-07-01
ES2008647A4 (es) 1989-08-01
TNSN88086A1 (fr) 1990-07-10
BR8804229A (pt) 1989-03-14
MY103343A (en) 1993-05-29
NZ225775A (en) 1990-07-26
JPS6470044A (en) 1989-03-15
AU2046688A (en) 1989-02-23
DE306389T1 (de) 1989-09-14
CA1323266C (en) 1993-10-19
AU604952B2 (en) 1991-01-03
GR3005607T3 (zh) 1993-06-07
CA1332226C (en) 1994-10-04
US5024852A (en) 1991-06-18
ES2008647T3 (es) 1993-04-01
KR890003345A (ko) 1989-04-14

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