CN1466952A - 治疗皮肤炎之外用剂 - Google Patents
治疗皮肤炎之外用剂 Download PDFInfo
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- CN1466952A CN1466952A CNA031202403A CN03120240A CN1466952A CN 1466952 A CN1466952 A CN 1466952A CN A031202403 A CNA031202403 A CN A031202403A CN 03120240 A CN03120240 A CN 03120240A CN 1466952 A CN1466952 A CN 1466952A
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- dermatitis
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- cyclodextrin
- adrenocortical steroid
- krestin
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Abstract
一种治疗皮肤炎之外用剂，它以环糊精包覆肾上腺皮质类固醇，于含有多糖类的水溶液中，溶解0.025～0.5重量％的肾上腺皮质类固醇、0.2～30重量％的环糊精、0.5～55重量％的葡聚糖或支链淀粉，并掺入0.5～55重量％的木葡聚糖、海藻糖、昆布多醣、多醣K、果胶。作为水溶液的成分，还添加葡萄糖、水不溶性聚(α－1，3－葡萄糖)、香菇糖、氯化钠、氯化钾。它提高了对特应性皮肤炎、寻常性牛皮癣症的治疗效果。
Description
技术领域
本发明系关于一种治疗皮肤炎之外用剂，其特别对特应性皮肤炎、脂溢性皮肤炎有效，且具有极高的安全性。
背景技术
以往，在特应性皮肤炎等皮肤炎之治疗上，主要使用具有高抗炎症作用之肾上腺皮质激素等类固醇制剂。该类固醇制剂可添加凡士林、甲基纤维素、表面活性剂、合成树脂乳液、粉体等，根据其使用目的，多以乳膏状物形式使用。也有以含有表面活性剂的液状形式使用的。
另一方面，作为其它外用剂，有以①皮肤的杀菌、消毒作用、②皮膜作用、③防止皮肤水分蒸发以促进保湿作用等为目的之高安全性外用剂。作为这类外用剂的添加材料，这类外用剂中可添加，作为外用剂的添加材料，有使用氯化钠等无机盐的(U.S.P.3574854)、使用葡萄糖等天然糖的(U.S.P.3859436)、或使用血浆等的(U.S.P.3777597)。
本发明者已发明了对特应性皮肤炎、脂溢性皮肤炎、湿疹等有效且具有极高安全性之治疗皮肤炎之外用剂(日本专利公报第2920611号)。该外用剂用环糊精包覆肾上腺皮质类固醇，且添加了葡聚糖或支链淀粉等多醣，不会阻碍皮肤的生理功能，可使机体自身所具备的自然痊愈力与肾上腺皮质类固醇产生协同增强作用。
发明内容
然而，肾上腺皮质类固醇虽具有抑制纤维芽细胞增殖、抗炎症作用等，具有很强的药理效果，但对于特应性皮肤炎等治疗，不知为何，无显著效果。该原因迄今未知，有一种说法是，原因在用于形成软膏或乳膏的油成分上，该油成分将皮肤角质层溶解，阻止健康皮肤再生。又，多用肾上腺皮质类固醇制剂，有抑制脑下垂体、肾上腺皮质功能、引起其它脏器、眼等之功能障碍等副作用之虞。为解决上述副作用，希望能在减少现今使用的类固醇制剂的用量的同时，保留作为消炎剂之高药理效果。
又，使用氯化钠等的安全性高的外用剂，虽然能达到使肌肤柔和、润滑、保持肌肤清洁等皮肤杀菌及皮肤保养之目的，但未发现对特应性皮肤炎等皮肤炎之治疗有效果。
另一方面，本发明者先前发明的治疗皮肤炎之外用剂，可防止粒线体膜之障碍所引起的细胞内呼吸之阻断、作为细胞能量源之ATP(腺苷三磷酸)生成的减少，保持电解质平衡、渗透压平衡，有效发挥肾上腺皮质类固醇的药理效果。其结果，对特应性皮肤炎、脂溢性皮肤炎、寻常性牛皮癣症、湿疹、青春痘等许多症状有广泛的治疗效果。然而，在上述被治愈的症状中，脂溢性皮肤炎、湿疹、青春痘等的有效率平均在96％以上，而特应性皮肤炎的有效率为平均在95％左右，寻常性牛皮癣的有效率仅为90％。
即，虽对脂溢性皮肤炎、湿疹、青春痘等显示稳定的很好效果，但对于特应性皮肤炎，其效果有差异，而对寻常性牛皮癣症的治疗效果劣于对其它症状的治疗结果。
因此，本发明的目的是，进一步改良先前的治疗皮肤炎之外用剂，提供一种特别对特应性皮肤炎、寻常性牛皮癣症具有更高治疗效果之治疗皮肤炎之外用剂。
为达成上述目的，本发明的第1个方案是，提供这样一种治疗皮肤炎的外用剂，它是一种以环糊精包覆肾上腺皮质类固醇、含有多醣的水溶液，在该溶液中，溶解了0.025～0.5重量％的肾上腺皮质类固醇、0.2～30重量％的环糊精、0.5～55重量％的葡聚糖或支链淀粉，其特征在于，掺入0.5～55重量％的木葡聚糖、海藻糖、昆布多醣、多醣K、果胶。此时，将肾上腺皮质类固醇于室温下用均质机溶解、包覆后，边搅拌边均匀地添加于水溶液中。
第2个方案是，在上述水溶液中，还添加葡萄糖、水不溶性聚(α-1，3-葡萄糖)(mutan)、香菇糖、氯化钠、氯化钾。由于这样的水溶液可在细胞中产生与细胞间质液相同的环境，促进细胞之正常活动，故机体本身所具备的自然痊愈力会与肾上腺皮质类固醇制剂产生协同增强作用。
本发明的基本配制为，将肾上腺皮质类固醇溶解在含有多醣的水溶液中。为使难溶于水的肾上腺皮质类固醇溶解于水溶液中，预先将肾上腺皮质类固醇用环糊精包覆。
作为肾上腺皮质类固醇，主要使用二氟拉松类、氢化可的松类、甲泼尼龙类、地塞米松类、倍他米松类等。其含量占总重量的0.025～5％。又，包覆肾上腺皮质类固醇的环糊精占总重量的0.2～40％。
再掺入0.5～55重量％的木葡聚糖、海藻糖、昆布多醣、多醣K、果胶。
木葡聚糖是广泛存在于长形、肥大之植物细胞的壁(一次壁)中的结构糖链。植物种的特异性系通过半乳糖或岩藻糖基-半乳糖与木糖残基的结合而产生。该半乳糖残基及岩藻糖残基上可分别结合外源凝集素，但这些分支糖链的功能尚不清楚。植物细胞的成长通过由细胞具有的渗透压而产生的吸水现象引起，而吸水力由细胞壁的松弛所导致的壁压下降而产生。细胞壁松弛的机制尚不清楚，但细胞的伸长总是伴随着木葡聚糖之分解与可溶化而产生，故木葡聚糖作为主宰细胞生理活性的多糖之一而受到注目。
昆布多醣是一种碳氢化合物，属于β-葡聚糖。存在以香菇等蕈类，昆布等海藻类中，具有提高免疫力的效果。已知其难以单独被吸收，宜与蛋白质一起摄取。
多醣K被用作增强人类癌细胞HLA I级抗原的表达的免疫治疗药品，由河原菇的菌丝体提取。多醣K被发现对胃癌、结肠癌、直肠癌、小细胞肺癌等肿瘤疾病有免疫治疗作用。
海藻糖为一种糖质，存在于菇类、海草、面包酵母等中，最近已研究出其人工合成方法。被用作保湿剂、甜味剂替代品等，但在本发明中，通过与其它糖成分组合，用作皮肤炎外用剂成分。
果胶作为植物细胞壁的结构成分而为人们熟悉，是与纤维素等成分结合、将细胞膜连接的天然多醣。果胶被用作胶化剂、增粘剂、安定剂。
本发明者在众多的多醣中，研究适合外用剂的成分，其结果，通过将这些木葡聚糖、海藻糖、昆布多醣、多醣K、果胶组合，配制出对特应性皮肤炎、脂溢性皮肤炎有效的外用剂。
且于溶解肾上腺皮质类固醇的水溶液中添加多醣。所用的多醣为葡聚糖或支链淀粉等，占总重量的0.5～60％。除此之外，在溶解肾上腺皮质类固醇的水溶液中还添加葡萄糖、水不溶性聚(α-1，3-葡萄糖)、香菇糖、氯化钠、氯化钾。
具体实施方式
下面列举处方例及药理试验例，对本发明的外用剂做具体说明。处方例1
葡聚糖 3(g)
葡萄糖 5
麦芽糖 5
甘露糖醇 15
氯化钠 0.2
倍他米松 0.06
环糊精 15
木葡聚糖 2
海藻糖 3
昆布多醣 2.5
多醣K 3
果胶 1.24
纯水 45
总量 100.0g
上述处方例中，预先用所需的纯水的一部份制作10％环糊精溶液，往该溶液中边搅拌边添加倍他米松，其后将木葡聚糖、海藻糖、昆布多醣、多醣K、果胶与剩下的纯水、盐一起加入。
以下所示为处方例1的效果。
表 1
| 病 态 | 对象人数 | 有效性 | 有效率 | 与前次相比 |
| 特应性皮肤炎(1) | 50 | 98 | 98 | +2 |
| 特应性皮肤炎(2) | 24 | 46 | 96 | +1 |
| 特应性皮肤炎(3) | 56 | 110 | 98 | +6 |
| 特应性皮肤炎(4) | 25 | 49 | 98 | 0 |
| 脂溢性皮肤炎(1) | 43 | 80 | 93 | -3 |
| 脂溢性皮肤炎(2) | 78 | 149 | 96 | -3 |
| 脂溢性皮肤炎(3) | 10 | 18 | 90 | -5 |
| 寻常性牛皮癣症 | 10 | 19 | 95 | +5 |
| 湿疹 | 15 | 28 | 93 | -3 |
| 青春痘 | 50 | 96 | 96 | -3 |
表1表示处方例1的药理试验结果。根据该结果，本发明中最受注目的对特应性皮肤炎的有效率为96～98％，平均为97.5％。即，有效率高且没有偏差。
另一方面，对寻常性牛皮癣症的有效率为95％，虽不及对特应性皮肤炎的有效率，但已显示相当好的治疗效果。值得一提的是，300个病例中，无1例副作用。此特点在先前的外用剂上已经证明，在此次改良后的外用剂中，其安全性亦得到确认。
此时的有效性按以下基准和下述公式算出：使用本发明的外用剂后，无变化者为0分，有向治愈方向变化者为1分，有效者为2分，得出各人之总得分。
又，对于特应性皮肤炎，列出在流山、仙台、大宫、吉祥寺之各诊所中进行的药理试验的结果，其它项目则是于流山诊所进行的药理试验的数据。
在处方例1的药理试验结果中，皆显示有效率在90％以上的治愈改善效果，最快者，约7天至30天后就无须本发明的外用剂。再涂布除去肾上腺皮质类固醇而含有多醣类的水溶液(日本特许第1597430号)，就完全痊愈。又，本次于使用中，皮肤的湿润感以「良好、普通、差」作三种评价，结果如下。
表2
该结果中，无一人评为差，有96％以上的人评价说，使用时触感良好。处方例2
| 良 好 | 普 通 | 差 | |
| 人数(人) | 356 | 14 | 0 |
| 比率(％) | 96.2 | 3.8 | 0.0 |
葡聚糖 10(g)
葡萄糖 5
麦芽糖 10
甘露糖醇 5
氯化钠 0.1
氯化钾 0.2
磷酸倍他米松钠 0.12
环糊精 10
木葡聚糖 2
海藻糖 8
昆布多醣 6
多醣K 4
果胶 12
纯水 27.58
总量 100.0g处方例3
支链淀粉 10(g)
甜菜碱 15
麦芽糖 10
氯化钠 0.1
地塞米松 0.06
环糊精 15
木葡聚糖 6
海藻糖 3
昆布多醣 2
多醣K 6
果胶 3
纯水 29.84
总量 100.0g处方例4
葡聚糖 5(g)
甜菜碱 20
麦芽糖 5
氯化钠 0.1
磷酸地塞米松钠 0.05
环糊精 6
木葡聚糖 2
海藻糖 5
昆布多醣 7
多醣K 2
果胶 8
纯水 39.75
总量 100.0g处方例5
葡聚糖 10(g)
羟乙基纤维素 2
甜菜碱 10
甘露糖醇 10
氯化钠 0.1
氯化钙 0.1
磷酸地塞米松钠 0.1
环糊精 10
木葡聚糖 10
海藻糖 7
昆布多醣 10
多醣K 2
果胶 8
纯水 20.7
总量 100.0g处方例6
支链淀粉 10(g)
羟乙基纤维素 6
甜菜碱 10
甘露糖醇 5
氯化钙 0.1
氯化钠 0.1
糊精 7
地塞米松 0.05
环糊精 5
木葡聚糖 6
海藻糖 9
昆布多醣 6
多醣K 9
果胶 8.5
纯水 18.25
总量 100.0g
可以看出，上述处方例2至6的结果顺应处方例1的效果。这些处方可根据各皮肤炎的症状而适当加以选择。
下面就以往的处方及其药理效果作比较说明。处方例7(以往的处方)
葡聚糖 10(g)
葡萄糖 10
麦芽糖 5
甘露糖醇 15
氯化钠 0.2
倍他米松 0.06
环糊精 15
纯水 44.74
全量 100.0g
表3
| 病 态 | 对象人数 | 有效性 | 有效率 |
| 特应性皮肤炎(1) | 25 | 48 | 96 |
| 特应性皮肤炎(2) | 10 | 19 | 95 |
| 特应性皮肤炎(3) | 25 | 46 | 92 |
| 特应性皮肤炎(4) | 25 | 49 | 98 |
| 脂溢性皮肤炎(1) | 25 | 48 | 96 |
| 脂溢性皮肤炎(2) | 100 | 198 | 99 |
| 脂溢性皮肤炎(3) | 10 | 19 | 95 |
| 寻常性牛皮癣症 | 5 | 9 | 90 |
| 湿疹 | 25 | 48 | 96 |
| 青春痘 | 50 | 99 | 99 |
表3为处方例7(以往的处方)的药理试验结果(有效性之计算方法及药理试验之诊所与表1相同)。由该结果可明了，使用以往的处方，对脂溢性皮肤炎、湿疹、青春痘等的平均有效率在96％以上，但对特应性皮肤炎的有效率平均在95％左右，对寻常性牛皮癣症的有效率仅为90％。
而处方例1中因添加木葡聚糖、海藻糖、昆布多醣、多醣K、果胶，特别是对特应性皮肤炎、寻常性牛皮癣症之治疗效果提高了。
本发明通过上述构成而达到当初的目的。
即，本发明是这样一种治疗皮肤炎的外用剂，以环糊精包覆肾上腺皮质类固醇，于含有多醣类的水溶液中，溶解0.025～0.5重量％的肾上腺皮质类固醇、0.2～30重量％的环糊精、0.5～55重量％的葡聚糖或支链淀粉，通过掺入0.5～55重量％的木葡聚糖、海藻糖、昆布多醣、多醣K、果胶，可得到稳定的很好的治疗特应性皮肤炎的效果，而用以往的外用治疗剂会有偏差。
此外，对于与其它症状相比、原先治疗效果较差的寻常性牛皮癣症，也能将其有效率提高至与其它病例同等的水平。
这样，与至今的外用剂相比，本发明大大提高了有效率，特别是对特应性皮肤炎、脂溢性皮肤炎等治疗改善较难之疾病极为有效且治愈率高、副作用极少，从安全性来看，亦可取代过去的外用剂。有望被世界上众多难治性皮肤炎之患者等使用。本发明的意义极大，对人类有重要的贡献。
Claims (2)
1.一种治疗皮肤炎之外用剂，它以环糊精包覆肾上腺皮质类固醇，于含有多醣类的水溶液中，溶解0.025～0.5重量％的肾上腺皮质类固醇、0.2～30重量％的环糊精、0.5～55重量％的葡聚糖或支链淀粉，其特征在于，掺入0.5～55重量％的木葡聚糖、海藻糖、昆布多醣、多醣K、果胶。
2.如权利要求1所述的治疗皮肤炎之外用剂，其特征在于，所添加的水溶液成分为葡萄糖、水不溶性聚(α-1，3-葡萄糖)、香菇糖、氯化钠、氯化钾。
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| TW (1) | TWI278318B (zh) |
| WO (1) | WO2003101460A1 (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106413759A (zh) * | 2014-03-28 | 2017-02-15 | 列日大学 | 用于治疗和预防肺部炎症的包含环糊精和布地奈德衍生物的组合物 |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005053841A (ja) * | 2003-08-05 | 2005-03-03 | Kyouto Biomedical Science:Kk | 皮膚外用剤 |
| SI1698630T1 (sl) | 2005-03-03 | 2015-01-30 | Alfa Wassermann S.P.A. | Nove polimorfne oblike rifaksimina, postopki za njihovo pripravo in njihova uporaba v medicinskih pripravkih |
| MY142987A (en) | 2005-06-08 | 2011-02-14 | Hayashibara Biochem Lab | Solution for tissue adhesion prevention and method for tissue adhesion prevention |
| US7919250B2 (en) * | 2007-07-31 | 2011-04-05 | New York University | Diagnostic and treatment methods for characterizing bacterial microbiota in skin conditions |
| US7854936B2 (en) * | 2008-01-14 | 2010-12-21 | Active Organics, Inc. | Anti-inflammatory hydrolysate of C. versicolor |
| JP5456802B2 (ja) * | 2012-01-23 | 2014-04-02 | 株式会社Ｃａｃ | 細胞遊走促進剤及び創傷治療用の経皮吸収剤 |
| ITMI20122002A1 (it) * | 2012-11-26 | 2014-05-27 | Farmacologico Milanese Srl Lab | Preparazioni farmaceutiche liquide stabilizzate |
| WO2015066819A1 (en) | 2013-11-08 | 2015-05-14 | Carlos Filipe | Method of stabilizing molecules without refrigeration using water soluble polymers and applications thereof in performing chemical reactions |
| KR102587444B1 (ko) * | 2015-09-29 | 2023-10-11 | 킴벌리-클라크 월드와이드, 인크. | 미생물총의 건강한 균형을 유지하기 위한 상승 조성물 |
| KR20190120235A (ko) | 2017-02-28 | 2019-10-23 | 킴벌리-클라크 월드와이드, 인크. | 미생물총의 건강한 균형을 유지하기 위한 상승적 조성물 |
| KR102071614B1 (ko) | 2019-04-30 | 2020-01-30 | 김민청 | 6-디아조-5-옥소-l-노르루신을 포함하는 염증성 피부 질환 치료용 약제학적 조성물 |
Family Cites Families (15)
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|---|---|---|---|---|
| FR5799M (zh) | 1966-03-22 | 1968-03-25 | ||
| US3859436A (en) | 1968-10-02 | 1975-01-07 | Kolmar Laboratories | Sugar composition for topical application |
| US3777597A (en) | 1970-04-29 | 1973-12-11 | Pharmachem Corp | Method of shaving employing an aqueous solution of dextran |
| US5547997A (en) * | 1991-10-01 | 1996-08-20 | Chemisches Laboratorium Dr. Kurt Richter Gmbh | Plant-derived cosmetic composition and method of treatment of skin |
| GB9211736D0 (en) * | 1992-06-03 | 1992-07-15 | Univ Cardiff | Allergic treatment |
| FR2719772B1 (fr) * | 1994-05-11 | 1996-08-02 | Goemar Lab Sa | Composition cosmétique ou pharmaceutique, notamment dermatologique contenant de la laminarine ou des oligosaccharides dérivés de laminarine. |
| JP2920611B2 (ja) | 1995-12-11 | 1999-07-19 | 株式会社シーエーシー | 皮膚炎の治療外用剤 |
| JPH1025240A (ja) * | 1996-04-09 | 1998-01-27 | Dokutaazu Kosumeteikusu:Kk | 浴用剤 |
| JPH09315987A (ja) | 1996-05-24 | 1997-12-09 | Kureha Chem Ind Co Ltd | 泡盛の抗アレルギー有効成分としての利用 |
| DE19710368A1 (de) | 1997-03-13 | 1998-09-17 | Henkel Kgaa | Verwendung von wasserlöslichen beta-Glucanen als Wirkstoffe zur Herstellung von therapeutischen Mitteln zur Hautbehandlung |
| JPH11180813A (ja) * | 1997-12-19 | 1999-07-06 | Ichimaru Pharcos Co Ltd | 海藻抽出物含有抗菌・防腐剤 |
| AU3657100A (en) * | 1999-03-12 | 2000-10-04 | Biotec Asa | Use of water-soluble beta-(1,3) glucans as agents for producing therapeutic skintreatment agents |
| US20030130248A1 (en) * | 2000-05-31 | 2003-07-10 | Mozzone Keith C. | Topical anti-inflammatory compositions |
| JP2002114670A (ja) * | 2000-10-02 | 2002-04-16 | Noevir Co Ltd | 抗菌性皮膚外用剤 |
| JP2002060314A (ja) | 2001-09-18 | 2002-02-26 | Hakuto Co Ltd | 皮膚外用剤 |
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- 2002-11-12 DK DK02788607T patent/DK1512404T3/da active
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106413759A (zh) * | 2014-03-28 | 2017-02-15 | 列日大学 | 用于治疗和预防肺部炎症的包含环糊精和布地奈德衍生物的组合物 |
Also Published As
| Publication number | Publication date |
|---|---|
| ES2356370T3 (es) | 2011-04-07 |
| JPWO2003101460A1 (ja) | 2005-09-29 |
| US20050175640A1 (en) | 2005-08-11 |
| AU2002355005A1 (en) | 2003-12-19 |
| KR100647857B1 (ko) | 2006-11-23 |
| EP1512404B1 (en) | 2009-10-21 |
| US7897161B2 (en) | 2011-03-01 |
| AU2002355005B2 (en) | 2006-04-13 |
| TW200307552A (en) | 2003-12-16 |
| EP1512404A1 (en) | 2005-03-09 |
| DE60234132D1 (de) | 2009-12-03 |
| CA2488011C (en) | 2008-02-12 |
| DK1512404T3 (da) | 2010-01-04 |
| EP1512404A4 (en) | 2006-04-12 |
| CN1219520C (zh) | 2005-09-21 |
| HK1060981A1 (en) | 2004-09-03 |
| WO2003101460A1 (fr) | 2003-12-11 |
| CA2488011A1 (en) | 2003-12-11 |
| JP3820577B2 (ja) | 2006-09-13 |
| ATE446096T1 (de) | 2009-11-15 |
| TWI278318B (en) | 2007-04-11 |
| KR20050016479A (ko) | 2005-02-21 |
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