CN1124143A - 医治受损皮肤的粉末制剂 - Google Patents

医治受损皮肤的粉末制剂 Download PDF

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CN1124143A
CN1124143A CN95107095A CN95107095A CN1124143A CN 1124143 A CN1124143 A CN 1124143A CN 95107095 A CN95107095 A CN 95107095A CN 95107095 A CN95107095 A CN 95107095A CN 1124143 A CN1124143 A CN 1124143A
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sucrose
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稻木敏南
末广才备
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Abstract

公开了用于医治受损皮肤的粉末制剂,它包括50-90wt.%蔗糖,0.5-10wt.%聚乙烯基吡咯烷酮—碘,和水溶性聚合物,该聚合物选自聚乙烯醇,聚乙烯基吡咯烷酮,聚丙烯酸及其盐类,粗芽短梗孢糖,羧基乙烯基聚合物类,甲基纤维素,羟甲基纤维素,羟丙基甲基纤维素,和羧甲基纤维素及其盐类。该粉末制剂的特征在于,甚至当在运输过程中或者类似情况下振动时或贮存很长时间不会结块,在其使用时不会散落并对伤口表面具有良好的粘合力。

Description

医治受损皮肤的粉末制剂
本发明涉及用于医治受损皮肤,如烧伤或烫伤、褥疮和创伤的外用药剂,更具体地说,涉及用于医治受损的皮肤的粉末制剂,该制剂含有糖和聚乙烯基吡咯烷酮(Povidone)一碘配合物作为活性成份。
糖类如蜂密和糖蜜作为民间传统医药常常用来治疗烧伤或烫伤和创伤。还已知这些糖类具有抑菌作用和粒状组织增生效果。除此之外,聚乙烯基吡咯烷酮—碘在全世界范围内极其广泛地被用作杀菌的药。
最近已有报道,当粒化糖与聚乙烯基吡咯烷酮—碘制剂如聚乙烯吡咯碘酮膏,聚乙烯吡咯碘酮药液或聚烯吡酮碘凝胶(Meiji SeikaKaisha,Ltd.的产品)混合,所得混合物被用于各种受损皮肤时,获得了极好的医治受损皮肤的效果[R.A.Knutson等,“Southern MedicalJournal”,Vol.74,NO.11,1329—1335(1981);和Kiyokazu Sone等,“Byoin Yakugaku(医院药物学)”,Vol.10,NO.5,315—322(1984)]。
然而,上述组合物存在有关问题:当在室温下贮存时,它们分为两层或者变成淀粉糖浆状,尤其是它们的活性成份分解降低了组合物的药效。因此,它们必须贮存在阴凉避光处。然而,即使以这种方式贮存,活性成份在几个月内会发生分解。刚好在使用它们之前制备该组合物是重要的。
因此,为了克服此类缺点曾经进行了许多研究。结果近年来,已开发出含有蔗糖和聚乙烯基吡咯烷酮—碘作为活性成份以及具有良好的长期贮存稳定性的膏状制剂。此类膏状制剂受到病人的好评和提高了医院的药房效益。但是,具有剧痛或类似症状的病人,则需要开发易于使用的制剂,施用在渗出物很多的伤口表面或很深的伤口,或者施用在易出血的粒状组织的表面。
鉴于以上情况,进行了临床试验,使用了其中将3%的聚乙烯基吡咯烷酮—碘粉末引入蔗糖的粉末制剂[“Nichiidai—shi(Journal ofNippon Medical.College)”,Vol.57,NO.2,94(1990)]。但是,这种粉末制剂存在缺点,在长时间的贮存过程中,它会出现结块现象,或者由于占粉末制剂97%的蔗糖的固有性质的缘故,由其运输过程中的振动而发生结块现象,因此,它既不能从容器中取出也不能散开使用。
因此,本发明的目的是提供一种粉末制剂,该制剂含有蔗糖和聚乙聚基吡咯烷酮—碘并且甚至贮存很长时间时,不会结块。
鉴于以上情况,本发明人已进行了深入的研究。结果,已经发现,当一种特定的水溶性聚合物引入蔗糖和聚乙烯基吡咯烷酮—碘中时,可以获得一种粉末制剂,该制剂甚至贮存长时间也不会结块的,表现出对伤口表面极好的粘合性,因为通过把它散布在纱布上或者类似物上并加压而被结合成块的缘故在使用时不会散落,尤其可以通过水洗方便地除去,因此而完成了本发明。
在本发明的一个方面,提供了一种用于医治受损皮肤的粉末制剂,它包括(a)50—90wt.%蔗糖,(b)0.5—10wt%聚乙烯基吡咯烷酮—碘,和(c)一种水溶性聚合物,该聚合物选自聚乙烯醇,聚乙烯基吡咯烷酮,聚丙烯酸及其盐类,出芽短梗孢糖,羧基乙烯基聚合物类,甲基纤维素,羟甲基纤维素,羟丙基甲基纤维素,和羧甲基纤维素及其盐类。
根据本发明的用于医治受损皮肤的粉末制剂,甚至当在运输过程中或者在类似情况下振动时或者贮存很长时间都不会发生结块,尤其是,它被装在振荡器中使用时具有良好的效果,在其使用过程中不会散落和对伤口表面具有良好的粘附力。
本发明的以上和其它目的、特征和优点从以下叙述和所附的权利要求中来看,将会变得很清楚。
在本发明中,为了获得均匀质量的组合物,在日本药典或者类似书籍上说明的蔗糖或者纯化蔗糖被用作蔗糖(a)则是特别优选的。另一方面,在日本药典或者类似书籍上描述的聚乙烯基吡咯烷酮—碘配合物被用作聚乙烯基吡咯烷酮—碘(b)。
被引入的蔗糖(a)的量是整个组合物的50—90wt.%(下文仅仅由“%”表示),优选60—80%。被引入的聚乙烯基吡咯烷酮—碘(b)的量落在0.5%(表现出杀菌作用所需要的最低比例)至10%的范围内。
在本发明中,水溶性聚合物(c)使由蔗糖和聚乙烯基吡咯烷酮—碘组成的制剂具有特定的效果,如粘合性,防止散落和防止结块。此类水溶性聚合物既可以单个使用又可以以两种或多种聚合物的结合物的形式使用,并以整个组合物的1—40%的比例引入,优选4—20%。
特别优选的水溶性聚合物的例子包括羧基乙烯基聚合物类和羧甲基纤维素钠。
除了这些必要的成份之外,根据需要,可以向根据本发明的制剂中引入常用的赋形剂,例如,糖醇(d)如甘露糖醇,麦芽糖醇,木糖醇或山梨糖醇。
如果被引入的话,糖醇(d)的量优选占整个组合物的10—30%,尤其是15—25%。
对根据本发明制剂的制备方法没有特别的限制。例如,通过由高速粉磨机或类似设备将蔗糖和赋形剂如糖醇一起磨成细粉,向这细粉中添加聚乙烯基吡咯烷酮—碘和水溶性聚合物,及由双缸混合机或类似的设备均匀混合所得混合物面制备该制剂。如果需要,由此制得的粉末制剂可以进行定级。
通过以下实例,将在下文中更详细地描述本发明。
实施例一
                             (重量份数)(1)聚乙烯基吡咯烷酮—碘           3(2)纯化蔗糖                       70(3)羧甲基纤维素钠                 20(4)羧基乙烯基聚合物               7
在成份(2)的粒径由高速粉磨机调节好后,成份(1),(3)和(4)被加入到其中,在混合器中将所得混合物均匀地混合成粉末制剂。
这种粉末制剂甚至在50℃下贮存一个月后仍然表现出均匀的粉末状态。
实施例二
按照与实施例一中同样的方式配制具有表1所示相应组成的粉末制剂,在50℃下一个月以后观察它们的性能。结果示于表1。
表1
成分(%) 发明产物1 发明产物2 发明产物3 发明产物4 发明产物5 发明产物6 对比产物1 对比产物2
聚乙烯基吡咯烷酮—碘蔗糖甘露糖醇CMC-MaCVPPVPPVA     77018---5     390--7--     1.55033.515---    560305---     37020.551.5--     3807--10-    397-----    37027----
性质  粉末状  粉末状  粉末状  粉末状   粉末状  粉末状   结块   结块
注:CMC-Na:羧甲基纤维素钠
    CVP:   羧基乙烯基聚合物
    PVP:   聚乙烯基吡咯烷酮
    PVA:   聚乙烯醇
实施例三
按照与实施例一中同样的方式配制具有表2所示相应组成的粉末制剂,在50℃下贮存一个月之后观察其性质和外观。结果示于表2。
表2
     成分(%) 发明产物1 发明产物2 对比产物3 对比产物4 对比产物5
聚乙烯基吡咯烷酮—碘蔗糖甘露糖醇PVACVPPluronic F68脂肪酸蔗糖酯聚乙二醇6000     770185----     390--7---     387---10--     387----10-     387-----10
性质外观   粉末状未变化   粉末状未变化    结块变黑  结块末变化 结块变黄
注:PVA:聚乙烯醇
    CVP:羧基乙烯基聚合物
    Pluronic F68:聚氧乙烯〔160〕聚氧丙烯〔30〕二醇

Claims (4)

1.用于医治受损皮肤的粉末制剂,它包括:
(a)50—90wt.%蔗糖
(b)0.5—10wt.%聚乙烯基吡咯烷酮—碘;和
(c)水溶性聚合物,选自聚乙烯醇,聚乙烯基吡咯烷酮,聚丙烯酸及其盐类,出芽短梗孢糖,羧基乙烯基聚合物类,甲基纤维素,羟甲基纤维素,羟丙基甲基纤维素,和羧甲基纤维素及其盐类。
2.根据权利要求1的粉末制剂,其中含有占整个组合物的1—40wt.%的量的水溶性聚合物(c)。
3.根据权利要求1的粉末制剂,还包括(d)糖醇。
4.根据权利要求3的粉末制剂,其中含有占整个组合物的10—30%的量的糖醇。
CN95107095A 1994-06-27 1995-06-26 医治受损皮肤的粉末制剂 Expired - Fee Related CN1059088C (zh)

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ES2189811T3 (es) 2003-07-16
TW336173B (en) 1998-07-11
DE69529249T2 (de) 2003-08-07
JPH0812582A (ja) 1996-01-16
US5618799A (en) 1997-04-08
SI0689841T1 (en) 2003-04-30
KR960000214A (ko) 1996-01-25
KR100370313B1 (ko) 2003-03-19
CA2150888A1 (en) 1995-12-28
JP3583166B2 (ja) 2004-10-27
EP0689841B1 (en) 2003-01-02
CN1059088C (zh) 2000-12-06
DE69529249D1 (de) 2003-02-06
DK0689841T3 (da) 2003-02-24
EP0689841A1 (en) 1996-01-03

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