CN86102388A - 水合粘性凝胶及其制备方法 - Google Patents
水合粘性凝胶及其制备方法 Download PDFInfo
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- CN86102388A CN86102388A CN86102388.9A CN86102388A CN86102388A CN 86102388 A CN86102388 A CN 86102388A CN 86102388 A CN86102388 A CN 86102388A CN 86102388 A CN86102388 A CN 86102388A
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Abstract
本发明涉及一种由主要含有侧链上带氨基的蛋白质的水溶液、一种胶凝阻制剂和一种亲水增粘剂与某种N-羟基亚氨酸酯化合物的反应产物制得的水合粘性凝胶。
Description
本发明涉及水合粘性凝胶,具体地说,涉及用作片形自粘性泥敷剂和裹敷剂的水合粘性凝胶。
迄今为止,为了消除挫伤、扭伤等引起的肌肉炎症和消肿、退热以及缓解肌肉的疼痛等,均采用冷敷或热敷法对患处进行处理。
在这种情况下,要求所用的泥敷剂保持稳定的含湿量和粘弹性,使之不因体温作用而降低水合粘性凝胶(如软膏剂或硬膏剂)中的水含量,不因变干而失去粘性,不因水份被吸收而产生垂涎现象及表面发粘,也不因汗湿作用而***。
为了防止泥敷剂的敷贴部因弯曲和拉伸导致泥敷剂的滑动,要求水合粘性凝胶本身具有足够大的粘着力,而对固定的方式(如采用粘贴片)则没有要求。
这种一种泥敷剂已有公开报导,例如日本专利公开说明书No.58-21613中报导了其制备方法,即将丙烯酸酯共聚物乳液与一种含聚乙烯吡咯烷酮的底料混合,后者用甲基乙烯基醚/马来酸酐的共聚物进行交联以提供自粘性。
又如,根据日本专利公开说明书No.59-13718中所公布的发明,一种具有良好自粘性的泥敷剂是这样制备的:将双醛淀粉加入到含明胶和聚丙烯酸的酸性水溶液中,再加入一种金属盐或一种金属氧化物。
再如,为了增加美容处理的效果,需要清除皮肤中的污物和角蛋白,并使美容成份(如维生素或激素等)渗入皮肤,可以从市场上购
得某种裹敷剂,它们系含水溶性的高分子量化合物(如聚乙烯醇)或能形成明胶膜的成份的水色油型乳液。在使用前从容器(如软管等)中挤出所需量的裹敷剂,将其涂于颜面等部位的皮肤上使之成膜。待变干后,将薄膜揭去或洗去,这样就增加美容处理的效果。
这类裹敷剂需要很长时间才能变干,而当宾客突然来访时则需立即揭去,以免自己奇异的面容被人看到。同时很难做到将水合粘性凝胶(如软膏剂或硬膏剂)均匀地涂于皮肤上,因而当揭去干膜时,皮肤有被撕伤的危险。这类裹敷剂还有其它一些缺点,如由于涂敷的厚度不均匀,美容皮肤的各种成分就不可能均匀地发挥作用。为了改进这些缺点,日本专利公开说明书No.58-180,408中公布了一种片形裹敷剂,其制备方法是:将诸如氯化钙等交联剂加入聚丙烯酸水溶液中制成含水片形凝胶,然后将其贴于颜面皮肤上。
而日本专利公开说明书No.58-21,613中的发明所涉及的自粘性泥敷剂,则只是将作为粘合剂的丙烯酸酯共聚物乳液与底料或交联的聚乙烯吡咯烷酮混合。其结果导致了以下缺点,即由于底料与粘合剂之间没有发生化学结合所以粘着强度受到限制,且粘着力随时间而下降。
其次,日本专利公开说明书No.59-13,718中所公布的自粘性泥敷剂早期具有良好的粘着性,但是随着水份的蒸发,粘着力下降。尤其存在这样的缺点,即一旦将该泥敷剂从皮肤上揭下再重新贴上时,其粘着力很小。
再则,制作一种片形裹敷剂的方法(日本专利公开说明书No.58-180,408)是使用交联的含水凝胶,而制备该凝胶时是将交联剂加入到聚丙烯酸和(或)聚丙烯酸酯的水溶液中。该发明中使用金属盐(如氯化钙、氯化镁等)及分子中至少含两个环氧基的化合物(如聚乙
二醇二环氧甘油醚、甘油二环氧甘油醚等)作为交联剂。
当将上述化合物用作交联剂时,所制得的泥敷剂的早期粘合性虽好,但是只要将该片形裹敷剂从皮肤上揭下然后重新贴上,其粘性即显著下降,此情形与日本专利公开说明书No.59-13,718中所说的自粘性泥敷剂的情形一样。
当使用上述化合物或分子中至少含两个环氧基的化合物时,该种交联剂与聚丙烯酸和(或)聚丙烯酸盐水溶液之间的反应非常之慢。因此又产生一些缺点,例如反应需要较高温度(如90℃),以致只有在制成凝胶后才能将美化皮肤的易分解成份(如维生素等)吸收到含水片形凝胶中。
本发明的各位发明者已研究出克服上述缺点的办法,同时发现:将N-羟基亚氨酸酯化合物的水溶液加入到由明胶(它含有在侧链上带氨基的蛋白质)和一种胶凝阻滞剂(如氯化钙、尿素等)的水溶液中并使蛋白质产生部份桥联作用,这样制得的反应产物在湿态下具有很强的粘着力。
其次,本发明的各位发明者发现,用亲水增粘剂,如甘油、乙二醇或常温下为液体的聚丙二醇代替水合粘性凝胶(如软膏剂或硬膏剂)中的部份水,则即使在含水粘性凝胶使用期间其含水量降低,也可避免水合粘性凝胶粘着力的下降。
本发明的一个目的在于提供一种由主要含有在侧链上带氨基的蛋白质的明胶水溶液与一种用结构式(Ⅰ)表示的N-羟基亚氨酸酯化合物的反应产物制成的水合粘性凝胶:
该结构式中,X是具有2~6个碳原子和2~6个羟基的化合物的残基;A是一个或几个选自氧乙烯基、氧丙烯基及氧丁烯基的基团;Y是二元残基;Z是:
②结构式为(3)
的基团及其部分取代的基团,
⑥结构式为(7)
的基团及其部分取代的基团,
m是1~3000,n是2~6
本发明的另一目的在于提供一种使用如下反应产物配制的水合粘性凝胶,该反应产物是由一种主要含有侧链上带氨基的蛋白质的水溶液,一种胶凝阻滞剂和一种亲水增粘剂与具有如下结构式(Ⅰ)的N-羟基
亚氨酸酯化合物反应而成的:
该结构式中,X是具有2~6个碳和2~6个羟基的一种化合物的残基;A是1~3个选自氧乙烯基、氧丙烯基和氧丁烯基的基团;
Y是二元酸的残基;
Z是:
③结构式为(4)
的基团及其部分取代的基团,
⑦结构式为(8)
的基团及其部分取代的基团,
m是1~3000,n是2~6。
本发明中所用的具有如下结构式(1)的N-羟基亚氨酸酯化合物(简称为具有通式(Ⅰ)的化合物)描述如下:
式中X是由具有2~6碳和2~6个羟基的化合物(如乙二醇、丙二醇、甘油、双甘油,三羟甲基乙烷、三羟甲基丙烷、赤藓醇、季戊四醇、山梨糖醇、甘露糖醇、葡萄糖、甘露糖、木糖、脱水山梨糖醇等)生成的醇残基。
n的值为2~6,相当于羟基的数目。
A是聚合链节单元或共聚链节单元,这种链节单元选自一种或2~3种下列基团的任意组合:羟乙烯基、羟丙烯基和羟丁烯基;m是链节单元的平均加成摩尔数。
Y是二元酸残基,如草酸、丙二酸、丁二酸、戊二酸、己二酸、庚二酸、辛二酸、壬二酸、癸二酸、十一烷二酸、十二烷二酸、十三烷二酸、异丁二酸、甲基丁二酸、乙基丙二酸、二甲基丙二酸、苹果酸、5-十八碳炔酸、马来酸、富马酸、草酰乙酸、酒石酸、丙酮二酸、丙酮二羧酸、柠康酸、中康酸、衣康酸、邻苯二甲酸、间苯二甲酸、对苯二甲酸、高邻苯二酸、六氢邻苯二甲酸、四氢邻苯二甲酸、二氢邻苯二甲酸、邻苯二乙酸、间苯二乙酸、对苯二乙酸、邻苯乙酸-β-丙酸、萘-2,3-二羧酸、萘-1,2-二羧酸、萘-1,8-二羧酸、联苯甲酸、天冬氨酸、谷氨酸、α-酮基戊二酸、α-羟基戊二酸等。
Z包括不同于上述结构式(2)~(8)的酸的酰亚胺结构,它具有如下所示的部分取代的基团:
对于结构式(2)的取代:
对于结构式(4)的取代:
对于结构式(5)的取代:
对于结构式(6)的取代:
具有上述各种结构的、通式为(1)的化合物与氨基进行专一性反应,产生氨基与亚氨氧基释放物的一种加成产物,因此通式为(1)的化合物能够充当明胶侧链上具有氨基的蛋白质的交联剂,它在水溶液中和常温下通过如下所示的交联反应将蛋白质转化为大分子量的物质,从而形成良好的凝胶:
在此反应中,当X是由二元醇(如乙二醇、丙二醇等)生成的残基、n是2时,通式(Ⅰ)的化合物就成为一种双官能团的交联剂,于是能够制得相对软的凝胶(如软膏剂)。当X是由多元醇(如季戊四醇、山梨糖醇等)生成的醇残基、n是4或6时,通式(1)的化合物就成为一种多官能团的交联剂。用这种化合物制备凝胶时,得到的是一种高交联度的硬凝胶。当A大于7时,所制得的凝胶无粘性。鉴于所说的理由,A的取值范围最好为2~3。
其次,当A是氧乙烯基时,通式(Ⅰ)的化合物的亲水性比A为氧丙烯基时的大。当A是氧乙烯基与氧丙烯基的共聚物时,通式(Ⅰ)的化合物的亲水性随该两种基团的比例而变,由此可以控制亲水性的程度。
m的取值范围可以是1~3000。当m值较小时,每单位重量的通式(Ⅰ)的化合物的交联密度增高。因此,容易制得硬凝胶,但通式(Ⅰ)的化合物的亲水性则太小。当m值超过3000时,通式(Ⅰ)的化合物的亚氨酸酯部分的比重显得太小,其作为交联剂的功能太弱,故该种化合物没有实用价值。因此,m的取值范围最好为5~200。
再则,二元羧酸(其中的Y是残基)可以任选,因为醇的氧烯基加成物与酸的酰亚胺之间的酯化反应很容易进行。
至于酸的酰亚胺,最好选用Z部分结构为通式(2)及其部分取代的结构式表示的邻苯二酰亚胺、Z部分为通式(5)及其部分取代的结构式表示的马来酰亚胺、Z部分为通式(6)及其部分取代的结构式表示的琥珀酰亚胺,因为这些化合物在工业上易于生产且很便宜。
本发明所用的胶凝阻滞剂是这样一种化合物,它能随着温度的降低对经加热溶解于凝胶中的侧链上带氨基的蛋白质(如明胶)水溶液的渐变速度起阻滞作用,而且它还具有降低胶凝温度的作用。在水溶液中显示稳定性的胶凝阻滞剂的例子包括:含氯的无机化合物,如氯化钾,氯化钠、氯化钙、氯化镁、氯化铵镁、氯化铵、氯化锌、氯化铵锌、氯化锰、氯化钡、氯化镍、氯化锂、氯化钴、氯化铝、五氯化锑、氯化锡、氯化亚锡、氯化亚钛、氯化钛、氯化铁、氯化亚铁、氯化铜等;含溴的无机化合物,如溴化钾、溴化钠、溴化钙、溴化镁、溴化铵、溴化锌、溴化锰、溴化钡、溴化镍、溴化锂、溴化铝、溴化亚锡、溴化亚铁、溴化铁、溴化铜等;含硝酸根的无机化合物,如硝酸钾、硝酸钠、硝酸钙、硝酸铵、硝酸锌、硝酸钡、硝酸镍、硝酸铝、硝酸钴、硝酸镁、硝酸锰、硝酸锂、硝酸亚铁、硝酸铁、硝酸银、硝酸铜等;含硫氰根的无机化合物,如硫***、硫***、硫氰化钙、硫氰化铵、硫氰化钡、硫氰化铁等;非电解质化合物,如间苯二酚、氢醌、邻苯二酚、均苯三酚、糠醛、尿素、乙醇、甲醇改性的乙醇、异丙醇、氯丁醇、赤藓醇等。
胶凝阻滞剂的配料重量为含氨基蛋白质的配料重量的0.05~5倍,最好为0.5~1.5倍。
如果将本发明所用的亲水增粘剂溶于水,而当水合粘性凝胶(如软膏剂或硬膏剂)使用期间水份蒸发掉时,该增粘剂仍留在水合粘性凝胶(如软膏剂或硬膏剂)中,并赋于凝胶以粘性。亲水增粘剂包括甘油、乙二醇、丙二醇及在常温下为液体的聚乙二醇和聚丙二醇等。这些增粘剂本身各具有增粘剂的作用,而将它们混合使用也具有增粘作用。
用于配制水合粘性凝胶的亲水增粘剂的配料量为1~80%(重量),最好为3~50%(重量)。
当本发明之水合粘性凝胶用作外用药时,可以加入有效成份如水杨酸甲酯、水杨酸乙二醇酯、薄荷醇、龙脑、百里酚、冰片、联苯羟胺、消炎痛、酮洛芬、布洛芬、***油、薄荷油、激素类、维生素类等;润滑剂,如山梨糖醇、苄醇等;粉状底料,如高岭土、膨润土、锌白、二氧化钛等;如需要还可加入增粘剂,如松香、松香甘油酯、聚丁烯等,阳离子、阴离子和非离子型表面活性剂,其它水溶性或亲水性的合成高分子化合物或天然高分子化合物,如聚乙烯醇、羧甲基纤维素、***树胶、聚乙烯吡咯烷酮、聚丙烯酸、果胶等等。
再则,当本发明之水合粘性凝胶(如软膏剂或硬膏剂)用作片形化妆裹敷剂时,可以加入皮肤营养剂,如维生素类、激素类、氨基酸、从动物或植物组织中提取或分泌出的物质等;常见裹敷剂所用的皮肤美容成分,如皮肤改良剂(如漂白剂、脱毛剂等);着色剂,如二氧化钛、食品红2;若需要,还可加入亲水性的合成高分子化合物或天然高分子化合物,如聚丙烯酸、聚乙烯吡咯烷酮、果胶等。
本发明之水合粘性凝胶是基质中含有交联蛋白的含水凝胶。若将此水合粘性凝胶粘贴于皮肤上,其对皮肤的粘着力很强,因此这种凝胶在揭去后如需要还可再贴上,很少发现其粘性下降的情况。其次,它的初始粘性不随时间而下降,同时随着水份的蒸发其粘性反有增加的趋势。根据配方的要求,可以提高该种粘性凝胶中水份的含量,最高可达70%(重量)。当将本发明之具有良好性能的水合粘性凝胶用作泥敷剂时,该胶不易变形、不易失水,对皮肤有良好的粘着性,且能长时间维持清凉感。尤其是,因这种泥敷剂对皮肤具有良好的粘着性,故敷贴部位不因身体的活动而导致泥敷剂的偏移或脱落。再则,当该粘性凝胶揭去又重新敷上时,粘性依然良好。汗湿对粘性的下降影响很小。即使长期使用该软膏剂,若要揭去这种泥敷剂也很困难,因为其粘性不因水份的蒸发而下降。若用毕要揭下该泥敷剂时,不会有痛感。对比之下,常见的泥敷剂因使用胶布揭下时则有痛感。同时由于不用胶布、故本发明之泥敷剂对皮肤也无毒害作用。
当本发明之软膏剂以片形裹敷剂的形式用于皮肤的美容、尤其是用于面部皮肤的美容时,克服了常见的凝胶裹敷剂的若干缺点,这些缺点包括需要较长的干燥时间。用过的胶膜不能重复使用,成膜不均匀等等。据本发明,在水溶液中使用交联的聚丙烯酸酯制备片形裹敷剂,与使用氯化钙之类的交联剂制备裹敷剂相比,前一种软膏剂具有良好的粘性且重复敷贴的粘性也明显优越。
图1表示实施例1~7及对比例1和2中的泥敷剂的粘着力随时间变化的情况。
图2表示实施例1~7及对比例1和2中的泥敷剂的重复粘着力。
图3表示实施例8~10及对比例3和4中的泥敷剂的粘着力随时间变化的情况。
图4表示实施例8~10及对比例3和4中的泥敷剂的重复粘着力。
从以下实施例可以更清楚地看到本发明之其它目的和优越性。
(实施例与对比例)
通式(Ⅰ)的化合物(简称为交联剂)的制备。
制备例1:
取加成摩尔数为141摩尔的聚乙二醇与2摩尔的马来酸酐反应制成半酯;再将该半酯与2摩尔的N-羟基琥珀酰亚胺反应制成交联剂1。
制备例2:
取1摩尔甘油与1050摩尔环氧丙烷进行加成聚合;将制得的聚丙二醇甘油醚与3摩尔邻苯二甲酸酐反应制成半酯;再将该半酯与3摩尔N-羟基邻苯二甲酰亚胺反应制成交联剂2。
制备3:
取1摩尔季戊四醇与12000摩尔环氧乙烷进行加成聚合;将制得的聚乙二醇季戊四醇醚与4摩尔宁康酸酐反应制成半酯;再将该半酯与4摩尔N-羟基马来酰亚胺反应制成交联剂3。
制备例4:
取加成摩尔数为1701摩尔的聚丙二醇与2摩尔琥珀酸酐反应,制成半酯;再将此半酯与2摩尔N-羟基戊烯二酰亚胺反应,制成交联剂4。
制备例5:
取1摩尔葡萄糖与25摩尔环氧乙烷及25摩尔环氧丙烷进行加成聚合;将制得的葡萄糖-聚氧乙烯二醇醚化合物与5摩尔酒石酸酐反应,制成半酯;再将此半酯与5摩尔N-羟基戊二酰亚胺反应,制成交联剂5。
制备例6:
取1摩尔甘油与24摩尔环氧乙烷和6摩尔环氧丁烷的混合物起加成反应;将制得的甘油-聚氧乙烯二醇醚化合物与3摩尔琥珀酸酐反应,制成半酯;再将此半酯与3摩尔N-羟基琥珀酰亚胺反应,制成交联剂6。
实施例1:
按表1所示的配方将1号原料加到9/10份的36号原料中去,在60~70℃下加热使之溶解。然后将3号原料加入该溶液,搅拌使之溶解。再将18号原料和26号原料加入,用搅拌器搅拌使之分散。将28号、29号、30号和33号原料加到此分散液中,搅拌器以2000转/分的速度搅拌5分钟使之分散,制得液体A1。另取1/10份的36号原料加到12号原料中,搅拌使之溶解,制得液体B1。
将液体A1加到液体B1中,搅拌使之混合,再将该溶液涂于一块无纺布上。然后用聚乙烯薄膜复盖于药面上,便制得实施例1的泥敷剂。
按下述方法测量该泥敷剂随时间的变化,结果示于表1。
(测量粘着力的方法)
将泥敷剂片裁成2厘米见方的块,贴于臂上平坦处。过一定时间后,取1毫米厚、2厘米见方的丙烯酸树脂板(该板中心处有一倒U型的拉鼻),用胶粘剂将该板粘合于臂上的泥敷剂片上。10分钟后,用一带勾的500克弹簧秤将拉鼻沿竖直方向向上拉起,测得泥敷剂的粘着力。
同时也对渗透性、形状稳定性、粘着力和清凉感持续时间进行测试,结果示于图1和表2。
(测量重复粘着力的方法)
按照上述测量粘着力的方法测量泥敷剂的初始粘着力。然后,将其敷于臂上,过10分钟后,再测其粘着力。这样的操作重复进行4次。
结果示于图2。
实施例2:
按照表1所示的配方,将1号原料加到9/10份的36号原料中,在60~70℃下加热使之溶解。然后,将4号原料加到该溶液中,搅拌使其溶解。再将21号和26号原料加入其中并用搅拌器搅拌使之分散。将27、29、30、31和33号原料加到该分散液中,令搅拌器以2000转/分的速度搅拌5分钟,使之分散,制得液体A2。另取1/10份的36号原料加到13号原料中,搅拌使之溶解,得液体B2。
将液体A2加到液体B2中后,搅拌使之混合,再将该溶液涂于一块无纺布上。然后用聚乙烯薄膜复盖于药面上,即制得实施例2的泥敷剂。
按实施例1中测试泥敷剂的相同方法进行测试,其结果示于图1和2及表2中。
实施例3:
按照表1所示的配方,将1号原料加到1/2份的36号原料中,在70~80℃下加热使之溶解。然后,将5号原料加到该溶液中,搅拌使之溶解。再将20、28、29、30和33号原料加入其中,搅拌器以1500转/分的速度搅拌10分钟使其分散,制得液体A3。另取1/2份的36号原料加到14号原料中,搅拌使其溶解,制得液体B3。
将液体A3加到液体B3中,然后搅拌使之混合,将该溶液涂于一块无纺布上。然后,用聚丙烯薄膜复盖于药面上,制得实施例3的泥敷剂。
按实施例1中测试泥敷剂的相同方法进行测试,其结果列于图1和2及表2中。
实施例4:
按照表1所示的配方,将1号原料加到3/4份的36号原料中,在90~100℃下加热使之溶解。然后将6号原料加到该溶液中,搅拌使其溶解。再将10、22、24和26号原料加入,用搅拌器搅拌使之分散。又将27、29、30和33号原料加到该分散液中,搅拌器以2500转/分的速度搅拌10分钟使其分散,制得液体A4。另取1/4份的36号原料加到15号原料中,搅拌使其溶解,制得液体B4。
将液体A4加到液体B4中,然后搅拌使之混合。将该溶液涂于一块无纺布上。然后,用聚丙烯薄膜复盖于药面上,即制得实施例4的泥敷剂。
按实施例1中测试泥敷剂的相同方法进行测试,其结果示于图1和2及表2中。
实施例5:
按照表1的配方,将1号原料加到9/10份的36号原料中,在90~100℃下加热使之溶解。然后,将7号原料加到该溶液中,搅拌使之溶解。再将18、19、23和25号原料加入其中,用搅拌器搅拌使分散。将原料28、29、31和33号加到该分散液中,搅拌器以2500转/分的速度搅拌10分钟使其分散,制得液体A5。另取1/10份的36号原料加到16号原料中,搅拌使其溶解,制得液体B5。
将液体A5加到液体B5中,然后搅拌使其混合,将该溶液涂于一块无纺布上。然后用聚丙烯薄膜复盖于药面上即制得实施例5的泥敷剂。
按实施例1中测试泥敷剂的相同方法进行测试,其结果示于图1和2及表2中。
实施例6:
按照表1所示的配方,将1号原料加到9/10份的36号原料中,在25~35℃下搅拌使之溶解。然后,将18和26号原料加到该溶液中,搅拌使之溶解。再将32和33号原料加入,搅拌器以2000转/分速度搅拌15分钟使其分散,制得液体A6。另取1/10份的36号原料加到17号原料中,搅拌使之溶解,制得液体B6。
将液体A6加到液体B6中,然后搅拌使之混合,将该溶液涂于一块无纺布上。然后,用聚丙烯薄膜复盖于药面上,即制得实施例6的泥敷剂。
按实施例1测试泥敷剂的相同方法进行测试,其结果示于图1和2及表2中。
实施例7:
按照表1所示的配方,将1号原料加到9/10份的36号原料中,在60~70℃下加热使之溶解。然后,将18号及26号原料加入此溶液中,用搅拌器搅拌使之分散。再将28、29、30和33号原料加入,搅拌器以2000转/分速度搅拌5分钟使其分散,制得液体A(1)。另取1/10份的36号原料加到12号原料中,搅拌使其溶解,制得液体B(1)。
将液体A(1)加到液体B(1)中,然后搅拌使之混合,将该溶液涂于一块无纺布上。然后,用聚乙烯薄膜复盖于药面上,即制得实施例7的泥敷剂。
按实施例1测试泥敷剂的相同方法进行测试,其结果示于图1和2及表2中。
对比例1:
按表1所示的配方,将1号原料加到9/10份的36号原料中,加热使之溶解。然后,将8、10、18、23、27和29号原料加入其中,搅拌器以2500转/分速度搅拌10分钟使其分散,将所制得的软膏剂或硬膏剂涂于一块无纺布上。然后,用聚乙烯薄膜复盖在药面上,即制得对比例1的泥敷剂。
按实施例1测试泥敷剂的相同方式进行测试,其结果示于图1和2及表2中。
对比例2:
按表1所示的配方将34号原料加到9号原料中,再将28、29和30号原料加入并均匀搅拌。然后,将1/2份36号原料溶于11号原料的溶液加入其中并均匀混合,然后将1/2份的36号原料加入,再加入35号原料并充分搅拌。将所得软膏剂或硬膏剂涂于一块无纺布上。用聚乙烯薄膜复盖在药面上,即制得对比例2的泥敷剂。
按实施例1测试泥敷剂的相同方法进行测试,其结果示于图1和2及表2中。
从图1的测试结果可以看出,实施例1~7显于高的初始粘着力。随着时间的推移,粘着力与水份的蒸发量同步增长,最终保持很高的粘着力。但对比例1的初始粘着力很低,而随着时间的推移,这种粘着力却不随水份蒸发量的增加而同步增长。120分钟之后,该粘着力值还达不到实施例1~7的初始粘着力值。在对比例2中,60分钟以前其粘着力值维持在实施例1~7的粘着力值水平。然而此后其粘着力则逐渐下降。
其次,从图2的测试结果看出,实施例1~7表现出具有重复的粘着力。当泥敷剂样品敷用后,将其剥下重新敷用,然后再剥下,这样操作重复4次。其结果粘着力没有降低,重复粘着力在45克/厘米2以上。然而,在对比例1中,初始粘着力低,只有8克/厘米2,重着粘着力也只有10克/厘米2。在对比例2中,初始粘着力为60克/厘米2,此值相当高。尽管如此,第一次重复粘着力却仅有26克/厘米2,此值是低的,而第4次重复粘着力则非常之低,仅为18克/厘米2。
注1:渗透试验
用下述评价模式评价泥敷剂渗透至无纺布背面的能力
○无渗透
△部分渗透
×明显渗透
注2:形状稳定性
用下述评价模式评价泥敷剂的形状稳定性
○基本辨别不出因体温或汗湿所致的垂涎现象。
△部分软化和垂涎
×垂涎
注3:粘着力
○皮肤感知的粘性良好,皮肤与膏剂之间的粘贴不因敷处的弯曲或拉伸而脱离。
△皮肤感知的粘性良好,但有时经过一段时间后粘贴处产生脱离。
×皮肤感知粘性差。
注4:保持清凉感的时间
在使用泥敷剂12小时后评价清凉感
○使用12小时后仍有清凉感。
△使用6小时后仍有清凉感。
×使用6小时后没有清凉感。
如表2的结果所示,实施例1~7的泥敷剂有优良的耐渗透性、外形稳定性、粘着力以及能保持长时间的清凉感。特别是粘着力和保持清凉感的时间明显优于对比例1和2。
实施例8:
按照表3所示的配方,将1号原料加到9/10份的19号原料中,在60~70℃下加热使之溶解。然后,将5号原料加到该溶液中,搅拌使其溶解。再将11、13和15号原料加入,搅拌器以1000转/分的转速搅拌5分钟使其分散制得液体A8。另取1/10份的19号原料加到7号原料中,搅拌使其溶解,制得液体B8。
将液体A8加到液体B8中,然后在室温下搅拌混合10分钟,将该溶液倾至200×250×2毫米的聚丙烯容器中,胶层厚为0.6毫米,在50℃下温热2分钟。用轻推法将一块无纺布铺于制得的凝胶上。冷却至室温后将胶体从容器中剥出。取一聚丙烯薄片贴于胶片的另一面,即制得实施例8的泥敷剂片。
按实施例1测试泥敷剂的相同方法,测试粘着力和重复粘着力,结果示于图3和4。
实施例9:
按照表3所示的配方,将2号原料加到8/10份的19号原料中,在室温下搅拌10分钟使之溶解。然后,将11、14和17号原料加入其中,搅拌器以1500转/分的转速搅拌10分钟使其分散,制得液体A9。另取2/10份的19号原料加到6号原料中,搅拌使之溶解,制得液体B9。
将液体A9加到液体B9中,然后在室温下搅拌10分钟使其混合,将该溶液倾至200×250×2毫米的聚丙烯容器中,胶层厚为0.6毫米,在40℃下温热5分钟。用轻推法将一块200×250×1毫米无纺布铺于制得的凝胶上。冷至室温后,将凝胶片从容器中剥出,取一片聚丙烯片贴于胶片的另一面,即制得实施例9的片型裹敷剂。
按实施例1测试泥敷剂的相同方法测试粘着力和重复粘着力,结果示于图3和4。
实施例10:
按照表3所示的配方,将18号原料加到8/10份的19号原料中。然后,将3号原料加入其中,在室温下搅拌10分钟使之溶解。然后将6号原料加入该溶液,搅拌使之溶解。再将12、13和16号原料加入其中,搅拌器以1500转/分的转速搅拌5分钟使之溶解并分散,制得液体A10,另取2/10份的19号原料加到8号原料中,搅拌使之溶解,制得液体B10。
将液体A10加到液体B10中,然后在室温下搅拌5分钟使之混合,将该溶液倾至200×250×2毫米的聚丙烯容器中,胶层厚为0.6毫米,在60℃下温热1分钟。用轻推法将一块200×250×1毫米的无纺布铺于制得的凝胶上。冷却至室温后,将凝胶从容器中剥出,取一片聚丙烯片粘在凝胶片的另一面,即制得实施例10的片型裹敷剂。
按实施例1测试泥敷剂的相同方法,测试此片型裹敷剂的粘着力和重复粘着力,结果示于图3和4。
对比例3
按照表3所示的配方,将18号原料加到4号原料中,并在室温下搅拌10分钟使其溶解。然后,将11和13号原料加入其中,搅拌器以1000转/分的转速搅拌5分钟使之溶解。接着加入5和19号原料,在室温下均匀搅拌。将所得的凝胶溶液涂于无纺布上,胶层厚为0.6毫米。取一聚酯薄膜贴于凝胶面上,然后将其封入口袋中,在60℃下加热5分钟,制得对比例3的片型裹敷剂。
按实施例1测试泥敷剂的相同方法测试此裹敷剂的粘着力和重复粘着力,其结果示于图3和4中。
对比例4:
按照表3所示的配方,将18号原料加到4号原料中,在室温下搅拌10分钟使之溶解。然后加入11和15号原料,搅拌器以1500转/分的转速搅拌5分钟使其溶解。接着,将10和19号原料加入并在室温下均匀搅拌。将制得的凝胶溶液涂于无纺布的一面,胶层厚为0.6毫米。取一块聚酯薄膜粘贴于凝胶面上,然后将其封入口袋并在60℃下加热5分钟,制得对比例4的片型裹敷剂。
按实施例1测试泥敷剂的相同方法,测试该裹敷剂的粘着力和重复粘着力,结果示于图3及图4中。
如图3中的结果所示,实施例8~10显示高的初始粘着力,随着时间推移,粘着力与水份蒸发量同步增长,并且最终保持很高的粘着力。然而,在对比例3中,其初始粘着力虽在实施例8~10的数值范围内,但自此以后粘着力即下降。在对比例4中,其初始粘着力就很低,粘着力随时间的增长也很小。
由于实施例8~10的片型裹敷剂显示很高的粘着力,故能牢固地粘着皮肤上的污物和老化的角蛋白。将该片型裹敷剂贴于皮肤上5~20分钟,然后再揭去,则对于清除那些抑制皮肤新陈代谢的物质显示出良好的效果。
其次,如实施例8~10所示,由于粘着力随时间而增长,因此皮肤被绷紧并受到刺激,从而对美容效果有利。
如图4的结果所示,在实施例8~10中,4次重复粘着力并没有降低。但是,对比例3的第一次重复粘着力却明显下降,而且以后粘着力也不恢复。在对比例4中,初始粘着力就很低,其重复粘着力的增加也不明显。
正如实施例8~10所示,由于本发明的片型裹敷剂的特点在于具有高的重复粘着力,故当宾客突然来访时,可将贴于脸上的裹敷剂揭下,事后再重新贴上,而其净化面容的效果并不降低。
斑疹试验:
用实施例1和9、对比例1和3的裹敷剂对20个20~61岁的健康成年人进行了斑疹试验。
(斑疹试验法)
将上述各样品切成25×25毫米的方块,贴于被测者臂膀内侧。
测试时间分别为1小时和24小时,在每一测试时间完结之后,均对被测者的皮肤观察5分钟,其结果用以下标准评价。
评价标准
-:没有红斑
± 很轻的红斑
+ 红斑明显
++ 中度至重度红斑
+++ 重度红斑至生成轻微的焦茄
试验结果列于表4和5中。
表4 1小时斑疹试验结果
编 姓名 性别 年龄 实施 实施 对比实 对比实
号 例1 例9 施例1 施例3
1 A.A. 女 25 - - - -
2 H.H. ″ 35 - - ± -
3 H.O. 男 26 - - - -
4 M.I. ″ 26 - - - -
5 S.O. ″ 44 - - - -
6 M.K. ″ 23 - - - -
7 H.K. ″ 34 - - - -
8 T.K. ″ 24 - - - -
9 Y.K. ″ 41 - - - -
10 M.S. ″ 23 - - - -
11 I.T. ″ 50 - - - -
12 H.D. ″ 49 - - - -
13 M.T. ″ 25 - - - -
14 K.N. ″ 40 - - - -
15 S.M. ″ 42 - - - -
16 T.M. ″ 38 - - - -
17 S.M. ″ 33 - - - -
18 S.Y. ″ 42 - - - -
19 T.Y. ″ 61 - - - -
20 T.Y. ″ 41 - - - -
表5 24小时斑疹试验结果
编 姓名 性别 年龄 实施例 实施例 对比例 对比例
号 1 9 1 3
1 A.A. 女 25 - - - -
2 M.I. 男 26 - - - -
3 H.O. ″ 26 - - - -
4 S.O. ″ 44 - - - -
5 H.O. ″ 49 - - - -
6 M.K. ″ 23 - - - -
7 H.K. ″ 34 - - - -
8 T.K. ″ 24 - - - -
9 Y.K. ″ 41 - - - -
10 M.S. ″ 23 - - + +
11 K.T. ″ 34 - - - -
12 H.D. ″ 49 - - ± -
13 M.T. ″ 25 - - - -
14 T.N. ″ 47 - - - -
15 N.F. ″ 45 - - - -
16 S.M. ″ 42 - - - -
17 T.M. ″ 38 - - - -
18 S.M. ″ 33 - - - -
19 S.Y. ″ 42 - - - -
20 T.Y. ″ 41 - - - -
从以上各表看出,对比例1中,1小时斑疹试验结果表明20个人中有一人产生轻微红斑,而24小时斑疹试验结果表明20个人中有2人产生红斑。在对比例3中,24小时斑疹试验表明,每20人中有1人产生红斑。
相比之下,在实施例1和9中,无论是1小时斑疹试验还是24小时斑疹试验都没有人产生红斑。从这些结果可以看出,本发明的泥敷剂和裹敷剂对皮肤的刺激性很小。
勘误表
CPCH866122
文件名称 页 行 补正前 补正后
说明书 29 13 交联剂3 交联剂6
12 15 均苯三酚 焦棓酚
权利要求书 7 4 联苯三酚 焦棓酚
Claims (5)
1、一种由主要含有侧链上带氨基的蛋白质的水溶液与如下结构式(1)所代表的N-羟基亚氨酸酯化合物的反应产物制得的水合粘性凝胶:
其中X是含2~6个碳及2~6羟基的一种化合物的残基,A是一个或几个选自氧乙烯基、氧丙烯基和氧丁烯基的基团,Y是一种二元酸的残基,Z为:
m是1~3000,n是2~6。
2、一种由主要含有侧链带氨基的蛋白质的水溶液、胶凝阻滞剂及亲水增粘剂与如下结构式(1)所示的N-羟基亚氨酸酯化合物的反应产物制得的水合粘性凝胶。
其中X为含有2~6个碳和2~6个羟基的一种化合物的残基,A是一个或几个选自氧乙烯基、氧丙烯基和氧丁烯基的基团,Y是一种二元酸的残基,Z是:
⑤结构式为(6)
的基团及其部份取代的基团,
⑥结构式为(7)
的基团及其部份取代的基团,
m是1~3000,n是2~6。
3、按照权利要求1或2所述的一种水合粘性凝胶,其中的胶凝阻滞剂是一种选自含氯、溴、硝基的无机化合物和如间苯二酚、对苯二酚、邻苯二酚、联苯三酚、醇类、脲和糠醛的有机化合物。
4、按照权利要求1或2所述的水合粘性凝胶,其中的亲水增粘剂选自丙三醇、乙二醇、丙二醇、在室温下为液体的聚乙二醇和聚丙二醇。
5、按照权利要求1所述的水合粘性凝胶,其中的水合粘性凝胶制成软膏剂或硬膏剂。
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JP60045765A JPS61205209A (ja) | 1985-03-09 | 1985-03-09 | パツプ剤用膏体 |
JP45,765/85 | 1985-03-09 | ||
JP124,740/85 | 1985-06-08 | ||
JP60124740A JPS61282314A (ja) | 1985-06-08 | 1985-06-08 | パツプ剤用膏体 |
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Publication Number | Publication Date |
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CN86102388A true CN86102388A (zh) | 1986-09-17 |
CN1022022C CN1022022C (zh) | 1993-09-08 |
Family
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CN86102388A Expired - Fee Related CN1022022C (zh) | 1985-03-09 | 1986-03-08 | 水合粘性凝胶的制备方法 |
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US (1) | US4839345A (zh) |
EP (1) | EP0194807B1 (zh) |
KR (1) | KR900004316B1 (zh) |
CN (1) | CN1022022C (zh) |
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CA (1) | CA1262092A (zh) |
DE (1) | DE3674815D1 (zh) |
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FR2551660B1 (fr) * | 1983-09-13 | 1986-11-14 | Centre Nat Rech Scient | Hemoglobine modifiee chimiquement, sa preparation, solutions aqueuses en contenant et leur utilisation |
US4692462A (en) * | 1985-03-18 | 1987-09-08 | Menley & James Laboratories, Ltd. | Compositions and method of controlling transdermal penetration of topical and systemic agents |
-
1986
- 1986-03-04 US US06/836,080 patent/US4839345A/en not_active Expired - Fee Related
- 1986-03-05 AU AU54291/86A patent/AU576946B2/en not_active Ceased
- 1986-03-06 EP EP86301575A patent/EP0194807B1/en not_active Expired - Lifetime
- 1986-03-06 DE DE8686301575T patent/DE3674815D1/de not_active Expired - Lifetime
- 1986-03-07 CA CA000503559A patent/CA1262092A/en not_active Expired
- 1986-03-08 CN CN86102388A patent/CN1022022C/zh not_active Expired - Fee Related
- 1986-03-08 KR KR1019860001655A patent/KR900004316B1/ko not_active IP Right Cessation
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1310628C (zh) * | 2002-10-31 | 2007-04-18 | 麦考尔制造株式会社 | 放热体 |
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AU5429186A (en) | 1986-09-11 |
CA1262092A (en) | 1989-10-03 |
DE3674815D1 (de) | 1990-11-15 |
EP0194807A2 (en) | 1986-09-17 |
KR860006986A (ko) | 1986-10-06 |
US4839345A (en) | 1989-06-13 |
AU576946B2 (en) | 1988-09-08 |
KR900004316B1 (ko) | 1990-06-22 |
EP0194807B1 (en) | 1990-10-10 |
EP0194807A3 (en) | 1987-09-02 |
CN1022022C (zh) | 1993-09-08 |
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