CN87101814A - 采用非锁紧配合装填和密封容器的方法 - Google Patents

采用非锁紧配合装填和密封容器的方法 Download PDF

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CN87101814A
CN87101814A CN87101814.4A CN87101814A CN87101814A CN 87101814 A CN87101814 A CN 87101814A CN 87101814 A CN87101814 A CN 87101814A CN 87101814 A CN87101814 A CN 87101814A
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container
cover cap
seal cover
charge bottle
aforesaid right
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CN1013564B (zh
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弗里茨·威特沃
马克斯·托马
克里斯琴·梅尔
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Warner Lambert Co LLC
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Warner Lambert Co LLC
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/48—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • B29C65/52—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding characterised by the way of applying the adhesive
    • B29C65/54—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding characterised by the way of applying the adhesive between pre-assembled parts
    • B29C65/548—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding characterised by the way of applying the adhesive between pre-assembled parts by capillarity
    • 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
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • 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
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • 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
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/072—Sealing capsules, e.g. rendering them tamper-proof
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/48—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • B29C65/4895—Solvent bonding, i.e. the surfaces of the parts to be joined being treated with solvents, swelling or softening agents, without adhesives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/124—Tongue and groove joints
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    • B29C66/12443—Tongue and groove joints characterised by the male part, i.e. the part comprising the tongue having the tongue substantially in the middle
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    • B29C66/124—Tongue and groove joints
    • B29C66/1246—Tongue and groove joints characterised by the female part, i.e. the part comprising the groove
    • B29C66/12463—Tongue and groove joints characterised by the female part, i.e. the part comprising the groove being tapered
    • B29C66/12464—Tongue and groove joints characterised by the female part, i.e. the part comprising the groove being tapered being V-shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/128—Stepped joint cross-sections
    • B29C66/1282—Stepped joint cross-sections comprising at least one overlap joint-segment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/128—Stepped joint cross-sections
    • B29C66/1282—Stepped joint cross-sections comprising at least one overlap joint-segment
    • B29C66/12821—Stepped joint cross-sections comprising at least one overlap joint-segment comprising at least two overlap joint-segments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
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    • B29C66/128—Stepped joint cross-sections
    • B29C66/1284—Stepped joint cross-sections comprising at least one butt joint-segment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/78—Means for handling the parts to be joined, e.g. for making containers or hollow articles, e.g. means for handling sheets, plates, web-like materials, tubular articles, hollow articles or elements to be joined therewith; Means for discharging the joined articles from the joining apparatus
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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
  • Closures For Containers (AREA)
  • Injection Moulding Of Plastics Or The Like (AREA)
  • Sealing Material Composition (AREA)

Abstract

采用非锁紧配合装填和密封容器的方法及其所用设备。该容器是由天然淀粉或其它亲水物料或其混合物，采用压塑法，最好是用注塑法制成，包括盛料瓶和密封盖，特别是医用胶囊形容器。方法包括：a)把物料填入上述容器中，容器不用卡紧锁紧，b)容器密封时，把密封液涂在与盛料瓶配合部位相接触的密封盖的整个或局部配合面上和/或把密封液涂在与密封盖接触的盛料瓶的整个或局部配合面上，c)盛料瓶与密封盖随即结合在一起成为一个不可拆开的密封容器。

Description

众所周知，注塑技术可用于将天然淀粉或食用胶一类的亲水物料制成压塑件。用这类天然物料做成的容器是因为它们可用来装填药物、消费品、化学药品和一些类似物，特别是可制成定量服药的药用胶囊。这类容器包括盛物瓶和密封盖两部份。至少是其中之一，而通常这两部分都有互相啮合的凸纹和沟槽以便卡紧，并能保证两者之间有良好的密封性。药用胶囊相对来说体积较小，在把药物注入容器时，这种卡紧作用特别重要，因为必须防止容器被打开，不论是无意的还是有意的。根据目前所知的方法，这种卡紧密封是在盛料瓶和/或密封盖上采用精密削槽的方法制成的，其深度约为0.03-0.15毫米。削槽过浅会使密封不严，而削槽过深则会导致裂纹，特别是在盛料瓶上。即使精确制造，这样的卡紧密封也还有一系列不足之处。药用胶囊的壁原应尽可能保持薄，因此，盛料瓶的壁厚将不同于密封的壁厚。由于它们的壁厚不同，在非稳定状态下，这两部份将出现不同的变形特性，因而引起两部分在几何尺寸上不一致，这将导致产生应力，特别是大气湿度发生变化的时候。在某些条件下，就会引起容器破裂。如果容器内已充填粉料或者液体，则充填物就会泄漏出来。甚至还会给装料机带来麻烦，尤其是在对容器两部分进行密封操作时。
此外，这种卡紧密封制造技术是很复杂的。具体地说，需要用滑架模具或组合式带顶杆的模具，运动着的模具在压制件表面上会留下划痕。这种模具需要滑架或顶杆，其结果是模具的滑动件越多，遭受磨损也越多。模具是在高压或大的锁紧力下工作的，易于产生缺陷，因而会延长停工时间而增加工厂的费用。此外，滑架对模具的稳定性多少有些影响，因而减少了每单位工作区域上的模穴数量，使产量降低。
已经发现，当采用非锁紧配合的压塑件并按照本发明后面公开的方法密封压塑成型的具有非锁紧配合面的部件时，上述的诸缺点均可克服，这些部件可以构成一个外表面基本上是连续的容器。
本发明涉及采用非锁紧配合装填和密封容器的方法。这些容器是采用压塑法或最好是用注塑法由淀粉或者是一种亲水物料或者是几种亲水性的化合物的混合物制成。它包括一个盛料瓶和一个密封盖，最好具有药用胶囊形状。其装料密封方法如下：
a）把物料装填到上述容器中，容器未卡紧锁紧，
b）容器密封时，把密封液涂在与盛料瓶配合部位相接触的密封盖的整个配合面上，或者只局部涂在上述配合面的一部分上;和/或把密封液涂在与密封盖接触的盛料瓶的整个配合面上，或者只局部涂在上述配合面的一部分上。
c）盛料瓶与密封盖随即结合在一起成为一个不可拆开的密封容器。
术语“淀粉”这里是指主要由直链淀粉和支链淀粉组成的天然植物的碳水化合物。它是从各种植物如土豆、大米、木薯、玉米和各种谷类如黑麦、燕麦和小麦中提取的。通过加压并同时升温，这种天然淀粉可形成高精度高密度的压制品。模压操作，特别是在加压和升温下的注塑操作的有关生产技术已在欧洲专利申请书№.84300    940.8（公布号118240）中叙述了，并且这一技术也适用于本发明。该专利具体说明了有关工艺条件包括有关所用的添加物如增充剂、润滑剂、增塑剂和/或着色剂的资料，在此引入作为参考（包括所推荐的温度、压力和含水量）。
“其它的亲水物料”是指那些适用于按本发明制造容器的亲水性物料，特别是适用于制造药用胶囊形容器的材料。
“其他的亲水物料”是这样的聚合物，如食用胶、植物蛋白质，如向日葵蛋白质、大豆蛋白质、棉子蛋白质、花生蛋白质、油菜子蛋白质、血蛋白质、鸡蛋蛋白质、丙烯酸类蛋白质;水溶性多醣类，如藻酸盐、鹿角胶、瓜耳胶、琼脂、阿拉伯胶以及有关的树胶（茄替胶（ghatti）、刺梧桐树胶、黄蓍树胶）、果胶;纤维素的水溶性衍生物：烷基纤维素、羟基烷基纤维素，以及羟基烷基烷基纤维素，如甲基纤维素、羟基甲基纤维素、羟基乙基纤维素、羟基丙基纤维素、羟基乙基甲基纤维素、羟基丙基甲基纤维素、羟基丁基甲基纤维素、纤维素酯以及羟基烷基纤维素酯，如纤维素乙酰基邻苯二酸酯（CAP）、羟基丙基甲基纤维素（HPMCP）;羧基烷基纤维素、羧基烷基烷基纤维素、羧基烷基纤维素酯，如羧基甲基纤维素和它们的碱金属盐类;水溶性合成的聚合物，如聚丙烯酸和聚丙烯酸酯、聚甲基丙烯酸和聚甲基丙烯酸酯、聚醋酸乙烯、聚乙烯醇、聚醋酸乙烯邻苯二甲酸酯（PVAP）、聚乙烯吡咯烷酮、聚巴豆油酸;邻苯二甲酸酯，丁二酸酯、交联食用胶、虫胶、水溶性的淀粉的化学衍生物、阳离子改性丙烯酸酯和甲基丙烯酸酯，例如三价和四价氨基，例如需要时可将二乙基氨乙基变成四价的;以及其它类似的聚合物。食用胶是优先选用的。
其它亲水物料的压塑制造技术及其它提到过的类型，特别是采用加压和升温的注塑技术，在欧洲专利申请书№83301643.9（公布号090600）已叙述了，在这个申请书中详细说明了工艺条件，并且包括了有关的添加物如增充剂、润滑剂、增塑剂和着色剂。这个申请也在此引入作为参考（包括最适宜的温度、压力和含湿量）。在ROBERT    L.DAVIDSON编的《Handbook    of    Water-Soluble    Gums    and    Resins》（水溶性树胶及树脂）（由McGraw-Hill    Book公司出版）中介绍了上述的亲水物料。
在上面提到的两个欧洲专利申请书84300    940.8和83301643.9提供了有关所述型式压塑容器的制造，特别是最好用注塑方法生产压塑药用胶囊的详情，也应用于本发明中，并且是本发明的一部分。
本发明采用按这种方法制成的注塑容器或者压塑容器，这些容器最好制成药用胶囊形状。
将上述各种亲水物料混合使用也属本发明的范围。在上述亲水物料中可加入无机填料如镁、铝、硅、钛等的氧化物。增充剂浓度可达50%，但是最适宜的范围为3-10%（按形成容器壁的全部组成的重量为基础计）。
所添加的增塑剂的例子包括聚烯化氧，如聚乙二醇、聚丙二醇、聚乙烯-丙烯醇;低分子量的有机增塑剂如甘油、甘油醋酸酯、甘油二醋酸酯或甘油三醋酸酯、丙二醇、山梨醇、二乙基磺基丁二酸钠、柠檬酸三乙酯、柠檬酸三丁酯等，加入浓度为0.5-15%，最适宜的范围为0.5-5%（按全部组成的重量为基础计）。
着色剂的例子包括众所周知的偶氮染料，有机或无机的颜料，或天然的着色剂。最好选择无机颜料，如铁或钛的氧化物，这些氧化物加入的浓度范围为0.001-10%，最好是0.5-3%（按形成容器壁的全部组成的重量为基础计）。
由淀粉和或其它亲水物料制成的容器，其含水量为10-20%，但最好为12-19%，特别是14-18%（按形成容器壁的全部组成的重量为基础计）。
增塑剂和所含水分的总和以不超过25%为好，最好不超过20%（按形成容器壁的全部组成的重量为基础计）。
虽然本发明叙述了有关胶囊的形式，但是应当理解本发明包括一切可采用上述亲水物质制成的基本上是空心的容器，并组成可使用的密封容器。这种容器还以具有基本连续的外表面，为其特点。
与欧洲专利资料84300940.8（118240）和83301643.9（090600）相比，根据本发明制造的容器的特点是密封盖和盛物瓶不带锁紧用的凸纹和沟槽，因此它不具有任何锁紧机构。最好的容器型式是盛料瓶和密封盖连接时没有任何变形的那一种。这种型式的容器是新颖的，也是本发明的要点。按照本发明制造的容器，容器密封后，壁厚处处相同，因此避免了在不稳定状态下由于变形特性不同而引起的应力。
本发明的容器，制造简单，此外也很容易充填和密封。然而，因为不带卡口密封，所以很容易打开，或者它们在下述操作期间可以自行打开，特别是由于盛料瓶和密封盖是在没有任何变形的情况下配合在一起，即使这种配合操作是以很精确的方式进行时也如此。但可自行结合在一起的区域，是指一端伸入另一端的部分，通常只有0.5-2毫米高，2毫米是最大值。因此惊人地发现：若使盛料瓶和/或密封盖的接触部位与一种密封液接触，容器就不会再打开了，因此允许高速装料。与密封液接触的操作是在胶囊最后密封以前就完成的。
这种密封液最好含有水，而且最好是水和一种醇类的混合物。醇类采用1-4个碳原子的醇类，如乙醇、丙醇或丁醇，特别是乙醇或异丙醇，乙醇更好。水和醇的比例范围为95∶5至40∶60，但希望在约80∶20至60∶40的范围内，最好是70∶30左右。
其它含水密封剂尚有蔗醣、淀粉、单醣、低聚醣和多（聚）醣、甘油和其它多羟基化合物、乙二醇、聚乙二醇和/或聚丙二醇，阴离子、阳离子或阴阳离子的表面活性剂，食用胶、聚乙烯醇、水溶性丙烯酸聚合物（它可以是阴离子或阳离子型）等的水溶液，其浓度为0.5-10%（重量），最佳浓度为1-4%（重量），都是以密封液总重量为基础计。
上述水-乙二醇混合物是最可取的。
例如，水会导致过分潮湿或润湿不均匀，因而会引起胶囊的损坏，或者使它的组分降解。由于胶囊的外壁对水是敏感的，因此密封液必须能精确控制其润湿过程，包括润湿的部位和它的用量。
当然，密封作用开始以前必须经过一定时间。惊人的发现是，本发明的密封容器能在进一步包装和加工时不发生任何容器打开和损坏的现象。
对于密封液的涂敷包括涂敷的位置和用量，加以精确的控制，其结果是在获得一个精密的密封容器后，它就不渗透液体，一旦密封住了，要打开容器就非破坏它不可。
为了加速密封过程，可以适当地加热密封容器，或只在它们的配合部位加热也可。可利用不会损坏容器和其中的物质的任何热源，包括对流热空气、适当频率的电磁辐射（如微波或红外辐射）和超声波能。由此所产生的温度低于临界温度，不会对胶囊和其中物品带来损坏。然而，通常情况不需凭借这类辅助的方法促进密封过程。一般来说，加热到30-50℃就已足够。加热可以全部或部分地利用温度为30-100℃的密封液体来达到。
装入物料可以是固体、浆液或液体。这些配制到药用容器中的物质，本身是已知的，而这里，该物质与容器壁是相容的。往常，这些物质被配制在硬食用胶药用胶囊中。
除了能避免本申请开头提到的诸缺点外，采用按照本发明制造的容器，并按本发明之方法进行密封，还可以带来一些原先未预料到的优点。由于消除了卡口密封引起的机械应力，容器壁厚可以大为减少。这使容器在胃液和肠液中的溶解时间明显减少，同时还可节约材料和提高容器容积的利用率。
参阅下列附图就可更容易了解本发明。
图1表示本发明的容器侧视图。
图2表示本发明的容器在图1中Ⅱ-Ⅱ纵向剖面图。
图3a-3u表示相当于图2上标有18处的放大图，它是盛料瓶和密封盖二部份的无应力连接点的各种实例的剖面图。
图4表示本发明的容器装料和密封机的平面图。
图5表示与装料和密封机相联系的润湿和密封装置，该装置是描述图4中的沿Ⅴ-Ⅴ线的部份。
图6表示装有润湿装置的装料机的透视图，也就是代表图4所示的机器。
容器20由盛料瓶22和密封盖21组成并充填有粉料19。图1与图2表示容器经过密封后的外形，这种外形使容器不再具有应力。可以看到，盛料瓶的配合部份24和密封盖配合部份23贴合后，胶囊外表面基本上是连续无突变的。图3a-3u表示配合部份18的不同形状，在每个图中可以看到容器20的配合部份18的外表面是连续和光滑的。图4表示装料机水平剖面的设计，该部份机器装备有密封装置。在这台机器上，贮存库1与连续振动输送道2相连接，通过输送道2把空的盛料瓶送到供瓶装置3去。
在供瓶装置3，盛料瓶的开口部分应向上，然后由顶杆3a推向盛料瓶托架5上。盛料瓶的托架5是固定在旋转台4上的，盛料瓶按一定的时间间隔输送到装料装置6去，时间间隔是由旋转台的间歇转动控制的。在装料装置，每一个盛料瓶装入经计量后的一定量的粉料19，也可以装入浆液或液体，这些物料都是从大贮槽6a供给的。
盛料瓶装料后被送到密封装置7，同样是依次地按一定的时间间隔进行。在密封装置7，密封盖是从贮存库10通过输送道9靠振动送来，送到一块毡布12a上将其润湿，然后再把它们放到盛料瓶上，这些操作是通过星形转子8和密封盖托架8a完成的。此后进一步输送，同样是依次地按时间间隔进行，已密封好的容器-在举例中其形状如同药物胶囊，当到达推出装置11时就从盛料瓶托架5上推出来。图5是表示密封装置的剖面图。密封盖21是置于输送通道9内，由托架8a藉真空作用吸上，接着被输送到定位和润湿装置12，这个动作是由旋转和垂直运动相结合完成的。密封盖托架8a的垂直运动使密封盖21被压紧到毡布12a上，毡布12a上浸润着密封液13。
同时，将密封盖21对齐，其搭接部份用密封液润湿。密封液是由贮存器14供给的，由毛细作用汲入毡布12a内，贮存器内的液面靠滴管15和溢流管16使其保持一定。随后，密封盖托架8a同时进行垂直方向的运动和旋转运动，使密封盖21送到密封装置7，在密封装置中由于密封盖托架8a垂直运动的结果，使其压向盛料瓶22上。当然，其它合适的润湿技术也是可以采用的。
同时，撤除真空，原先真空的作用是使密封盖21与密封盖托架8a相贴紧。这时密封盖托架8a作旋转和垂直运动，其目的是使其推进到振动通道9，以便重新再取得密封盖21。
如上所述的密封机及密封装置二者都是新颖的，都是本发明的组成部份。往常的食用胶制药用胶囊通常的做法是在送到密封机以前就闭合上，而本发明使得密封盖21和盛料瓶22可以分别放在单独的贮存库10和1内，彼此独立地被送到密封装置7。此外，本发明也使得在密封操作以前可以对盖和瓶独立进行润湿。
本项发明可用下列实例来阐明：
例1
容器密封盖21的唇边（即图3a的配合部份），其形状如图1所示，被压入到一块精制的毡布上，其深度为1.5毫米，毡布浸润着成份为70%体积的水和30%体积乙醇的密封液，这样，使密封盖薄薄的唇边全部被润湿。该容器是由天然小麦制淀粉按EP文件84300940.8（118240）的例8（含水量为12.7%）中规定的条件进行注塑成型的。此后密封盖就与盛料瓶紧密相结合，这种密封操作是不会产生应力的。
10分钟后，容器就不能再打开了。当容器如前面所述充填有医药用的固体、浆液或液体时，效果是一样的，已密封好的容器不会泄漏。
例2
重复上文例1所述的操作步骤，但是附加了一个操作，就是把容器立刻放到下列任一热源中处理：
（ⅰ）已被加热到35℃的热空气中：3分钟，
（ⅱ）红外线辐射：2 1/2 分钟，
（ⅲ）超声波能：2秒钟。
此后，该容器也不能再打开了，并且液体不会渗透出来。
例3
食用胶胶囊的密封盖21的唇边（如图31）具有与本发明有关的示于图1的形状，把它放在板上，板上有一层深度为1.0毫米的液膜，这种液体是80∶20的水与乙醇的混合物。胶囊本身是按EP    83301643.9（090600）文件例B-2（含水量为14.6%）的规定条件制成的。此后，密封盖就与盛液瓶相结合，这种密封操作不产生变形。
在室温下保持15分钟后，容器就不能再打开了。若采用例2中的任一热源，其粘接时间可以比上例所述时间缩短。
经过完整的密封过程后在任何情况下除非破坏容器就不能再打开了。
例4
重复例1、2、3所介绍的步骤，只不过所用的密封液的成份为：
№    水%    乙醇%    其它加入物
1    95    5    -
2    85    15    -
3    60    40    -
4    50    50    -
5 98 - SLS＊2%
6    98    -    葡萄糖1%，SLS    1%
7    89    10    SLS    1%
8    60    38    SLS    2%
9    70    20    葡萄糖5%，SLS    5%
10    80    16    甘油4%
＊SLS＝十二烷基硫酸钠

Claims (15)

1、采用非锁紧配合装填和密封容器的方法，这些容器是用压塑法，最好是用注塑法由淀粉或者是一些亲水物料或者是这些亲水性的化合物的混合物制成的，容器包括盛料瓶和密封盖二部分，该容器最好具有药用胶囊形状，该装料及密封方法为：
a)把物料装填到上述的容器中，容器未卡紧锁紧，
b)容器密封时，把密封液涂在与盛料瓶配合部位相接触的密封盖的整个配合面上，或者只局部涂在上述配合面的一部分上，和/或把密封液涂在与密封盖接触的盛料瓶的整个配合面上，或者只局部涂在上述配合面的一部分上。
c)盛料瓶与密封盖随后结合在一起成为一个不可拆开的密封容器。
2、按照上述权利要求1的方法，其中的“天然淀粉”主要由直链和支链（淀粉）组成的天然植物中的碳水化合物，最好是从土豆、大米、食用木薯、玉米、黑麦、燕麦和/或小麦中提取出来的。
3、按照上述权利要求1中的方法，其中的“其他亲水物料”是从食用胶、植物蛋白质如向日葵蛋白质、大豆蛋白质、棉子蛋白质、花生蛋白质、油菜子蛋白质、血蛋白质、鸡蛋蛋白质、丙烯酸类蛋白质、水溶性多醣类如藻酸盐、鹿角胶、瓜耳胶、琼脂、阿拉伯树胶以及有关的树胶（茄替（ghatti）树胶、剌梧桐树胶、黄蓍树胶）、果胶中选取的。
4、按照上述权利要求1中的方法，其中的其他亲水性聚合物质是从下列纤维素的水溶性衍生物中选择出来的：烷基纤维素、羟基烷基纤维素和羟基烷基烷基纤维素如甲基纤维素、羟基甲基纤维素、羟基乙基纤维素、羟基丙基纤维素、羟基乙基甲基纤维素、羟基丙基甲基纤维素、羟基丁基甲基纤维素、纤维素酯和羟基烷基纤维素酯，如纤维素乙酰基邻苯二酸酯（CAP）、羟基丙基甲基纤维素（HPMCP）、羧基烷基纤维素、羧基烷基烷基纤维素、羧基烷基纤维素酯，如羧基甲基纤维素和它们的碱金属盐类  水溶性合成聚合物，如聚丙烯酸和聚丙烯酸酯、聚甲基丙烯酸和它的酯类、聚醋酸乙烯酯、聚乙烯醇、聚醋酸乙烯邻苯二甲酸酯（PVAP）、聚乙烯吡咯烷酮、聚巴豆油酸、邻苯二甲酸食用胶、食用胶琥珀酸酯、交联食用胶、虫胶、水溶性淀粉化学衍生物、阳离子改性丙烯酸盐和甲基丙烯酸盐。
5、按照上述权利要求1～4之一中的方法，除了天然淀粉和亲水物料外还有添加物如增充剂、增塑剂和/或着色剂存在。
6、按上述权利要求1～5之一中的方法，其容器是由淀粉和/或其他亲水物料模压成的，其含水量为按形成容器壁所有组成重量的10～20%，12～19%更好，14～18%最好。
7、按上述权利要求1～6之一中的方法，其盛料瓶和密封盖能连接起来而不发生任何变形。
8、按上述权利要求1～7之一中的方法，其中所使用的密封剂是蔗糖、淀粉、单醣、低聚醣、和多（聚）醣、甘油和其他多聚羟基化合物、乙二醇、聚乙二醇和/或聚丙二醇、阳离子、阴离子或阴阳离子的表面活性剂、食用胶、聚乙烯醇、水溶性丙烯酸聚合物（它可以是阳离子或阴离子）等的水溶液，按密封液总重量为基础计，其浓度为0.5～10%（重量），最佳浓度为1～4%（重量）。
9、按照上述权利要求1～7之一中的方法，其中所使用的密封液是由水与一种醇类混合液制成的，水/醇比的范围从95∶5到40∶60，比较好的范围为约80∶20到60∶40，最合适的范围为70∶30。
10、按照上述权利要求9中的方法，其中所使用的醇类含1-4个碳原子，比较好的是乙醇、丙醇或丁醇，特别合适的是乙醇和异丙醇，最合适的是乙醇。
11、按照上述权利要求1中的方法，其中的密封部位在密封操作后最好进行加热，可采用对流法或用一定频率下的电磁辐射法，最好是采用微波或红外辐射，或用超声波能的方法加热。
12、按照上述权利要求1-11之一中的方法，其中所充装的物料可以是固体、浆液或液体。
13、按权利要求1-12制成的密封好的容器。
14、非锁紧配合式的容器，是用天然淀粉或其它亲水物料或这些亲水性化合物的混合物通过注塑而制成的，特别是该容器呈药用胶囊形，它包括盛料瓶和密封盖，它们可按权利要求1-13中所述的一种方法连接起来，而不会产生任何变形。
15、一种为药用胶囊形压塑容器进行装料和密封的设备，该设备包括盛料瓶的贮存库1、连接贮存库1与盛料瓶的供瓶装置3的输送通道2，使盛料瓶和安装在旋转台4上的盛料瓶托架5贴紧的顶杆3a、装料装置6、密封装置7、密封盖贮存库10、将密封盖送到密封托架8a用的输送通道9和装在密封装置后面的推出装置11。
CN87101814A 1986-03-12 1987-03-11 采用非锁紧配合装填和密封容器的方法 Expired CN1013564B (zh)

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CA1295246C (en) 1992-02-04
IT1207335B (it) 1989-05-17
GB2187703B (en) 1990-10-24
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DE3704992A1 (de) 1987-09-24
BE1000456A3 (fr) 1988-12-13
KR870008675A (ko) 1987-10-20
IT8747715A0 (it) 1987-03-11

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