CN1142789C - 用于软组织增进的可注射组合物 - Google Patents

用于软组织增进的可注射组合物 Download PDF

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CN1142789C
CN1142789C CNB941938328A CN94193832A CN1142789C CN 1142789 C CN1142789 C CN 1142789C CN B941938328 A CNB941938328 A CN B941938328A CN 94193832 A CN94193832 A CN 94193832A CN 1142789 C CN1142789 C CN 1142789C
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E����ɭ
E·扬森
M·J·赫斯特拉
R·P·杜特里厄斯
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Datascope Investment Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/26—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

用于软组织增进的可注射植入物组合物，包括弹性蛋白、胶原和生物相容载体。用于软组织增进的可注射植入物组合物是由经处理除掉非胶原和非弹性蛋白的蛋白质的项韧带转化而来的。描述了用于软组织增进的可注射植入物组合物的制造方法。

Description

用于软组织增进的可注射组合物
                      发明背景
技术领域
本发明涉及主要用途在于软组织增进的可注射组合物。
相关背景技术
多年来，人们为开发用于软组织增进，尤其是隆乳的可注射组合物做了许多努力。虽然近年来，隆胸(乳)术的重点一直是手术植入胸部假体，但是可注射组合物由于可以避免手术故具有极大的优越性。
某些早期的制备隆胸用可注射组合物的努力涉及到硅氧烷凝胶的使用。可是，皮下注入的硅氧烷具有向周围组织迁移的倾向，其中包括导致肉芽瘤等问题。因此，人们便不再使用可注射液体凝胶了。
这样一来，悬浮体可注射胶原就成为人们选择的组合物。可是，天然胶原具有很大的再吸收倾向。因此，为了达到注射后不会很快逸散的软组织增进效果，据发现必须用戊二醛之类的试剂把胶原交联起来。交联能抑制再吸收。但是，近来戊二醛交联的胶原的应用本身又受到了责难。
                      发明概述
本发明通过使用含非交联胶原，再结合相当数量的弹性蛋白的可注射组合物来解决先有技术所碰到的问题。弹性蛋白比之胶原具有低得多的再吸收倾向。而且，据信，弹性蛋白能吸引纤维细胞，后者又生长出新的本地连接组织。于是，当按照本发明的组合物被皮下注射到软组织中时，随着被注入胶原的再吸收，新的本地连接组织也不断产生出来，直至达到一种稳定的状态为止。
使用弹性蛋白的另一个优点还在于，由于是悬浮状，其粘度比较低，因而比胶原远为容易流动。弹性蛋白的这一特点使得较容易注射比单独使用胶原时可能做到的高固体含量的组合物。
如上面所指出的，本发明组合物的一种应用是隆胸术。另一种美容术应用是作为皮下植入物以消除皱纹，主要围绕面部和颈部。此外，还有治疗上的应用。例如，本发明的组合物可以被应用于有关克服尿失禁等症状。当用于后一用途时，将按照本发明的组合物注射到尿道括约肌部位。
本发明组合物的其他可能的应用包括负载组织的增进，例如在鸡眼下方，以及一般或特定的外形改善，如用于鼻子轮廓的矫形和矫正病痘疱痕以及痤疮瘢痕等等。当用于负载组织增进时，可以把本发明组合物注射到负载组织(如鸡眼)和加载组织(如骨头)之间。为减轻皮肤外表缺陷，譬如病毒感染痘疱痕和痤疮瘢，可以把本发明组合物注射到紧贴缺陷的下方软组织。类似地，要改变一个人鼻子的外形，可以将本发明组合物注射到鼻子的软组织里。
虽然胶原迄今一直被用于上述的用途，但是，一般都是以交联胶原的形式来使用的。然而即使使用交联胶原，其再吸收时间也常常是短得不能接受，尤其经反复注射之后。的确如此，交联胶原的注射常常必须在短时期内反复注射若干次才能达到足够的增进。另外，戊二醛交联胶原往往引起某些患者的组织反应，不仅如此，还出现人们对因使用戊二醛交联过的胶原而引起潜在免疫学问题的忧虑。象戊二醛这样的交联剂已知是有毒性的，于是人们担心反复注射含戊二醛的组合物可能进行性地产生较为严重的免疫反应和愈来愈快的再吸收。另一方面，本发明组合物据信具有长得多的再吸收时间，而且不产生明显的免疫学反应或组织反应问题。
                      发明详述
众所周知，项韧带主要由弹性蛋白组成，只带有较少数量的胶原。的确，此韧带干重70％以上是弹性蛋白。由于较高的弹性蛋白含量和较低的胶原含量，它是用来制备按照本发明的可注射组合物的理想原料。
为了制备按照本发明的较好可注射组合物，可以采用如U.S.专利号5,028,695所提出的方法(该公开收做本文参考文献)净化。通常，首先洗掉血和除去粘附的组织。然后，对其进行化学处理以除掉非弹性蛋白和非胶原成分。化学处理一般包括，先用强碱溶液，然后用酸，最后用中和剂处理韧带。希望的话，可以反复此碱顺序若干次。化学处理之后，进行机械加工以分离出弹性蛋白纤维。随后把分离出的纤维悬浮在合适的生物相容载体，例如水和甘油的混合物中。
尽管较好的原料是项韧带，但是也可以使用其他的韧带和腱。例如，可以使用腹膜、网膜和其他的动物膜，特别是那些含有相当数量弹性蛋白的膜。还可以把来自不同来源的弹性蛋白和胶原混在一起，生产出具有认为有利于某种特定用途的任何比例的混合物。然而，据信组合物应该具有尽可能少至约10％弹性蛋白(干重)的最低含量和尽可能多达90％或更高的弹性蛋白。
虽然如上所述，据信较好不使用任何交联剂，但是，也许有一些场合可以容许，甚至希望用交联剂。在此种情况下，此交联剂应该是能与胶原生成非常稳定结合的交联剂，以便交联剂不扩散出去，以及该交联的胶原不具有囊腺毒性和不激起免疫或者细胞反应。这类交联剂当中可以包括六亚甲基二异氰酸酯、某些聚环氧化合物。例如，聚乙二醇二缩水甘油醚，以及某些水溶性碳化二亚胺，如1-乙基-3-[3-二甲基氨基丙基]碳化二亚胺·HCl，在N-羟基琥珀酰亚胺的存在下。
实例
将重约10kg的部分牛项韧带泡在约40 l室温的自来水中过夜，以去除粘附的血和其他水溶性成分。在水中浸泡还保证了或多或少的天然水合程度，据信这将有利于以后的化学处理。
初始浸泡之后，还是用自来水，把韧带洗两遍，每遍约10分钟，继而放入50 l溶于自来水的4％(重量)氢氧化钠(NaOH)溶液中。令其在室温下的这种强碱性浸泡液中放置48小时。
碱性浸泡之后，接着是3遍10分钟的自来水洗涤，每次50 l水，然后对其进行第二次碱性浸泡，这次是在室温下，在2％(重量)NaOH的自来水溶液中浸泡72个时。然后，再进行3遍自来水洗涤以除掉溶解了的成分。
经第二次碱泡和随后的水洗之后，把韧带放到盐酸(HCl)溶液中浸泡约4小时。这次浸泡所用的HCl溶液是通过把4 l浓盐酸(37％)与36 l自来水混合配制的。经酸泡的韧带随后用自来水洗涤直至水的pH介于约2.5到3为止。
此时，把韧带放入碳酸氢钠(NaHCO3)中浸泡以中和残留的酸。碳酸氢钠浸泡液是通过在50 l自来水中加入350g NaHCO3制备的。让韧带在中和浴里过夜，然后再次用自来水洗涤以除去生成的盐。水洗进行到洗涤水与硝酸银(AgNO3)溶液混合时不产生沉淀为止。
继而，采用胶体磨将天然胶原/弹性蛋白基质磨碎，并分离出弹性蛋白纤维。接着采用丙酮萃取以除去水分，并随后将纤维放入约75℃的烘箱中进行空气干燥。
最后，取150g干燥纤维悬浮在由1 l水和1 l甘油组成的2 l水/甘油混合物中。此悬浮液便可供按照本发明之用了。
据信，按照本发明的组合物中的胶原在注射后的初期阶段起一种兴奋剂的作用。它易于引起某种温和的组织反应和增强的血管活动。自然，这会导致再吸收，但在此过程中，似乎对弹性蛋白有亲合性的纤维细胞会入侵到注射组合物中来，从而本身连结到弹性蛋白纤维上。这样，这些纤维细胞便铺成了一层新生本地连接组织构成的有组织的基体。最终，注入的胶原再被吸收，而所有留下的就是被包围在新生本地连结组织构造里的注入弹性蛋白。
对于本门技术的内行人来说将变得很清楚的是：可以对上面描述的种种细节进行修改和改变而仍不背离这里所述的富于创意的概念。所以，所有这些变换方案均应被视为属于下面权利要求划定的本发明范围之内。

Claims (11)

1.一种用于软组织增进的可注射植入物组合物，它包含弹性蛋白和胶原以及生物相容载体。
2.按照权利要求1的组合物，其中所说弹性蛋白至少是弹性蛋白与胶原干重总和的10％(重量)。
3.按照权利要求1的组合物，其中所说弹性蛋白含量至少是所说总干重总和的50％。
4.按照权利要求1的组合物，其中所说弹性蛋白含量至少是所说总重量的70％。
5.按照权利要求1的组合物，其中所说弹性蛋白和所说胶原至少部分地是由不同的组织源转化而来的。
6.按照权利要求1的组合物，其中所说胶原和弹性蛋白曾经过处理而去除了非胶原及非弹性蛋白的蛋白质。
7.按照权利要求1的组合物，其中所说胶原未被交联。
8.按照权利要求1的组合物，其中所说胶原用一种选自由六亚甲基二异氰酸酯、聚环氧化物和水溶性碳化二亚胺构成的一组中的化合物交联。
9.一种由弹性蛋白和胶原组成的用于软组织增进的可注射植入物组合物，它是通过下述方法由项韧带得到的，所述方法包括下列步骤：
——用水洗涤项韧带，
——用强碱溶液处理洗过的项韧带，
——用酸处理项韧带，
——用碱处理项韧带以中和酸，
——机械处理项韧带以分离出弹性蛋白纤维，
——将至少一些胶原和弹性蛋白纤维悬浮在合适的载体中。
10.一种制备软组织增进用的可注射植入物组合物的方法，包括下列步骤，
——从动物的韧带、腱及膜中选择组织原料，
——把所说组织用水洗涤，
——用强碱溶液处理洗过的组织，
——用酸处理该组织，
——用碱处理该组织以中和酸，
——机械处理该组织以分出弹性蛋白纤维，
——将至少一些弹性蛋白纤维悬浮在合适的载体中。
11.按照权利要求10的方法，其中所选择的组织原料是项韧带。
CNB941938328A 1993-09-07 1994-09-07 用于软组织增进的可注射组合物 Expired - Fee Related CN1142789C (zh)

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US08/116,517 US5523291A (en) 1993-09-07 1993-09-07 Injectable compositions for soft tissue augmentation
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CN1133562A (zh) 1996-10-16
KR100333088B1 (ko) 2002-09-12
AU7685794A (en) 1995-03-27
JPH09502372A (ja) 1997-03-11
WO1995007095A1 (en) 1995-03-16
US5705488A (en) 1998-01-06
EP0717634A1 (en) 1996-06-26
KR960704562A (ko) 1996-10-09
BR9407420A (pt) 1996-11-12
US5523291A (en) 1996-06-04
DE69429522D1 (de) 2002-01-31
ATE210992T1 (de) 2002-01-15
AU675879B2 (en) 1997-02-20
CA2170754C (en) 2006-07-11
EP0717634A4 (en) 1999-03-17
EP0717634B1 (en) 2001-12-19
DK0717634T3 (da) 2002-04-15
ES2169085T3 (es) 2002-07-01
PT717634E (pt) 2002-06-28
CA2170754A1 (en) 1995-03-16
JP3596892B2 (ja) 2004-12-02
DE69429522T2 (de) 2002-08-01

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