CN1732973A - 含有硫酸软骨素锌的组合物及其应用 - Google Patents
含有硫酸软骨素锌的组合物及其应用 Download PDFInfo
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- CN1732973A CN1732973A CN 200510044384 CN200510044384A CN1732973A CN 1732973 A CN1732973 A CN 1732973A CN 200510044384 CN200510044384 CN 200510044384 CN 200510044384 A CN200510044384 A CN 200510044384A CN 1732973 A CN1732973 A CN 1732973A
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Abstract
本发明涉及含有硫酸软骨素锌的组合物及其治疗烧烫伤的应用。本发明组合物含有(按重量计)：a)1％到90％的硫酸软骨素锌作为活性成分；b)其余量是药物制剂常用的辅料。本发明组合物可以制备乳膏、油膏、凝胶、散剂、膜剂和涂膜剂，用于治疗烧烫伤具有加快伤口愈合和减少瘢痕形成的优点。
Description
技术领域：
本发明属于医疗技术领域，涉及含有硫酸软骨素锌的组合物及其治疗烧烫伤的用途。使用本发明组合物可以制备乳膏、油膏、凝胶、散剂、膜剂和涂膜剂，用于治疗烧烫伤具有加快伤口愈合和减少瘢痕形成的优点。
背景技术：
硫酸软骨素来源于动物组织，是一类硫酸糖胺聚糖，由糖醛酸和葡萄糖胺以糖苷键连接起来的重复二糖单位组成的多糖链的混合物，由D-葡萄糖醛酸和N-乙酰-D-氨基半乳糖组成二糖单位的多糖，其中由于硫酸基团位置不同，构成硫酸软骨素A、C、D、E、F和N等多种异构体，由艾杜糖醛酸和N-乙酰-D-氨基半乳糖硫酸酯组成二糖单位的多糖称为硫酸软骨素B，又称为硫酸皮肤素。硫酸软骨素分子量在2000～50000道尔顿之间，目前上市的产品为硫酸软骨素钠或硫酸软骨素钙的注射液、口服制剂和滴眼剂，临床主要用于治疗高血脂症、某些神经性头痛、神经痛、关节痛、冠心病、偏头痛、动脉粥样硬化等症及链霉素引起的听觉障碍及慢性肾炎、慢性肝炎、角膜炎以及角膜溃疡等的辅助治疗，此外还应用于化妆品、外伤创面的愈合剂和保健品，鲨鱼软骨中的软骨素还有抗肿瘤的作用。分子量低于10000道尔顿的硫酸软骨素组分具有生物利用度高、抗炎效果好的优点。试验表明，皮肤创面使用硫酸软骨素可以改善血液循环，加速新陈代谢，促进渗出液的吸收及炎症的消除，鲜见不良反应发生。锌盐应用于皮肤创面又具有收敛作用，可使创面干燥、结痂和早期愈合，硫酸软骨素锌应用于烧烫伤创面，集硫酸软骨素和锌盐的作用于一体，可明显加快愈合速度，减少感染和炎症发生，改善创面愈合质量。
发明内容：
本发明的目的是提供一系列含有硫酸软骨素锌的组合物，所述组合物用于烧烫伤的治疗，与现有产品相比，具有明显加快愈合速度、减少感染和炎症发生、改善创面愈合质量等优点。
本发明含有硫酸软骨素锌的组合物，按重量计含有：
a)1％到90％的硫酸软骨素锌作为活性成分；
b)余量是药物制剂常用的辅料。
本发明组合物中含有的硫酸软骨素锌优选平均分子量范围在2000～10000道尔顿的组分。
本发明组合物中含有的辅料选自聚乙烯醇、聚乙烯醇缩丁醛、羟丙甲纤维素、卡波姆、透明质酸钠、丙二醇、甘油、凡士林、单甘酯，十八醇、石蜡油、吐温、十二烷基硫酸钠、十六烷基二甲基苄基溴化铵、2，4，4’-三氯-2’-羟基二苯醚、醋酸氯己定、三乙醇胺、氮酮、对羟基苯甲酸乙酯、薄荷脑、芝麻油、蓖麻油、桐油、獾油、乙醇和蒸馏水及其混合物。
本发明组合物用于制备治疗烧烫伤用途的药物，可以制成适合临床使用的乳膏、油膏、凝胶、散剂、膜剂或涂膜剂等剂型。
具体实施方式：
1.本发明组合物，处方以100g计，含硫酸软骨素锌90g和透明质酸钠10g。硫酸软骨素锌和透明质酸钠先粉碎，过200目筛，按常法分散、混匀制成散剂，环氧乙烷灭菌，无菌分装入铝塑袋，封口，即得。
2.本发明组合物，处方以100g计，含硫酸软骨素锌90g，透明质酸钠9g和醋酸氯己定1g。硫酸软骨素锌和透明质酸钠先粉碎，过200目筛，加入醋酸氯己定，按常法分散、混匀制成散剂，分装入铝塑袋，封口，即得。
3.本发明组合物，处方以100g计，含硫酸软骨素锌5g，透明质钠0.5g，丙二醇3.5g，凡士林7g，单甘酯5g，十八醇8g，石蜡油5g，十二烷基硫酸钠0.8g，氮酮2g，对羟基苯甲酸乙酯0.3g，其余为蒸馏水。按常法乳化制成乳膏，分装入铝管，封口，即得。
4.本发明组合物，处方以100g计，含硫酸软骨素锌10g，丙二醇4g，凡士林7g，单甘酯6g，十八醇9g，石蜡油5g，十二烷基硫酸钠0.8g，氮酮3g，对羟基苯甲酸乙酯0.3g，其余为蒸馏水。按常法乳化制成乳膏，分装入铝管，封口，即得。
5.本发明组合物，处方以100g计，含硫酸软骨素锌20g，凡士林72g和石蜡油8g。硫酸软骨素锌先粉碎，过200目筛，按常法分散、混匀制成油膏，分装入铝管，封口，即得。
6.本发明组合物，处方以100g计，含硫酸软骨素锌10g，凡士林60g和芝麻油30g。硫酸软骨素锌先粉碎，过200目筛，按常法分散、混匀制成油膏，分装入铝管，封口，即得。
7.本发明组合物，处方以100g计，含硫酸软骨素锌10g，凡士林60g和桐油30g。硫酸软骨素锌先粉碎，过200目筛，按常法分散、混匀制成油膏，分装入铝管，封口，即得。
8.本发明组合物，处方以100g计，含硫酸软骨素锌8g、獾油91.8g和薄荷脑0.2。硫酸软骨素锌先粉碎，过200目筛，按常法分散、混匀制成油膏，分装入塑料瓶，封口，即得。
9.本发明组合物，处方以100g计，含硫酸软骨素锌10g，羟丙甲纤维素3g，透明质酸钠1g，吐温80 0.1g，十六烷基二甲基苄基溴化铵0.1g，其余为蒸馏水。按常法制成凝胶，分装入铝管，封口，即得。
10.本发明凝胶，处方以100g计，含硫酸软骨素锌5g，卡波姆1g，三乙醇胺1.2g，丙二醇5g，乙醇10g，薄荷脑0.01g，吐温80 0.15g，十六烷基二甲基苄基溴化铵0.1g，其余为蒸馏水。按常法制成凝胶，分装入铝管，封口，即得。
11.本发明组合物，处方以100g计，含硫酸软骨素锌10g，聚乙烯醇10g，三乙醇胺3g，乙醇40g，醋酸氯己定0.02g，其余为蒸馏水。按常法制成涂膜剂，分装入塑料瓶，封口，即得。
12.本发明组合物，处方以100g计，含硫酸软骨素锌5g，聚乙烯醇缩丁醛4g，薄荷脑0.02g，乙醇50g，其余为蒸馏水。按常法制成涂膜剂，分装入塑料瓶，封口，即得。
13.本发明组合物，处方以100g计，含硫酸软骨素锌10g，透明质酸钠0.5g，2，4，4’-三氯-2’-羟基二苯醚0.05g，乙醇40g，其余为蒸馏水。按常法制成涂膜剂，分装入塑料瓶，封口，即得。
14.本发明组合物，处方以100g计，含硫酸软骨素锌15g，透明质酸钠5g，聚乙烯醇68g，蓖麻油12g。聚乙烯醇先溶解于100mL 20％的乙醇溶液，再投入硫酸软骨素锌和透明质酸钠，搅拌溶解，最后投入蓖麻油搅拌混匀，按常法涂膜、烘干制成厚度为0.2mm膜剂，裁成小块，分装入透气纸袋，封口，环氧乙烷灭菌，即得。
15.本发明组合物，处方以100g计，含硫酸软骨素锌20g，醋酸氯己定lg，聚乙烯醇67g，甘油12g。聚乙烯醇和醋酸氯己定先溶解于100mL 25％的乙醇溶液，再投入硫酸软骨素锌、甘油和肝素钠，搅拌溶解，按常法涂膜、烘干制成厚度约为0.2mm的膜剂，裁成小块，分装入透气纸袋，封口，环氧乙烷灭菌，即得。
本发明组合物治疗烧烫伤的动物实验：
1.增生性瘢痕动物模型
在新西兰白兔兔耳腹面手术切除2cm×5cm全层皮肤缺损创面，作长期瘢痕模型〔具体操作方法参考Morris(1997)Acute and chronic animal models for excessive dermalscarring：quantitative studies〕。对照组创面用1％磺胺嘧啶银乳膏外敷包扎至痊愈，换药1次/周，试验组创面用5％硫酸软骨素锌乳膏(本发明实施例1)外敷包扎至痊愈，亦换药1次/周。术后12个月内观察创面愈合情况，愈合标准为痂壳小于创面的5％。取瘢痕组织作Masson染色，光学显微镜下观察并测定创面上皮化后的真皮厚度(Da)及邻近正常组织中的真皮厚度(Db)，计算瘢痕指数＝(Da-Db)D/b。结果见下表。
| 组别 | 对照组 | 试验组 |
| 创面愈合时间(天)瘢痕指数60天180天 | 27.1±2.73(n＝8)2.58±0.57(n＝6)3.13±0.68(n＝6) | 23.6±2.04(n＝8)*2.49±0.70(n＝6)2.71±0.85(n＝6)* |
*与对照组比较，差异有显著性(p＜0.05)。
2.烧伤动物模型
大鼠5％水合氯醛腹腔麻醉后背部脱毛，90℃水蒸气烫10秒，造成20％面积的深二度烫伤(具体操作方法参考陆树良主编(2003)烧伤创面愈合机制与新技术)，伤后1小时腹腔注射生理盐水1mL补充血容量。对照组创面涂1％磺胺嘧啶银乳膏至痊愈，厚度0.5～1mm，换药1次/日，试验组创面涂5％硫酸软骨素锌乳膏(本发明实施例1)至痊愈，厚度0.5～1mm，亦换药1次/日。伤后间隔时间取样，用重量法测定创面组织湿重(Ga)和经80℃烘72小时的组织干重(Gb)，计算烧伤创面含水量W＝(Ga-Gb)/Ga×100％，W值表示水肿的程度；用氯胺T氧化法(参考许志勤(1990)组织羟脯氨酸测定方法的改进)测定创面羟脯氨酸含量，羟脯氨酸含量反映创面胶原的含量。结果见下表。
| 组别 | 正常组 | 试验组 | 对照组 | |
| 愈合时间 | (d) | -- | 21.1±1.7(n＝10)# | 23.3±1.9(n＝9) |
| 创面羟脯氨酸含量(ug/mL) | 1d2d3d5d7d10d14d21d | 18.37±1.27(n＝5)---------------- | --18.07±1.85(n＝5)19.89±1.44(n＝5)21.61±1.13(n＝5)22.03±2.91(n＝6)22.97±2.76(n＝6)26.87±3.75(n＝7)*#26.98±2.27(n＝7)*24.54±2.32(n＝8)* | --17.54±1.97(n＝5)17.69±2.08(n＝5)18.24±2.11(n＝5)21.58±2.87(n＝5)21.96±1.95(n＝5)22.35±3.07(n＝8)23.16±2.77(n＝8)26.79±3.12(n＝8) |
| 创面含水量W） | 8h24h48h72h5d | 67.28±1.86(n＝5)---------- | --83.45±1.17(n＝6)*72.10±1.67(n＝6)*#71.00±1.52(n＝6)69.28±1.91(n＝5)68.31±1.66(n＝5) | --83.28±2.37(n＝6)*76.42±2.10(n＝6)*72.76±1.85(n＝6)*69.07±2.29(n＝5)68.49±2.36(n＝5) |
| 7d | -- | 67.55±0.89(n＝5) | 67.87±1.84(n＝5) |
#与对照组比较，差异有显著性(p＜0.05)。
*与正常组比较，差异有显著性(p＜0.01)。
Claims (3)
1.含有硫酸软骨素锌的组合物，按重量计含有：
a)1％到90％的硫酸软骨素锌作为活性成分；
b)余量是药物制剂常用的辅料。
2.如权利要求1所述的组合物，其中含有的硫酸软骨素锌优选平均分子量范围在2000～10000道尔顿的组分。
3.如权利要求1所述的组合物，其中含有的辅料选自聚乙烯醇、聚乙烯醇缩丁醛、羟丙甲纤维素、卡波姆、透明质酸钠、丙二醇、甘油、凡士林、单甘酯，十八醇、石蜡油、吐温、十二烷基硫酸钠、十六烷基二甲基苄基溴化铵、2，4，4’-三氯-2’-羟基二苯醚、醋酸氯己定、三乙醇胺、氮酮、对羟基苯甲酸乙酯、薄荷脑、芝麻油、蓖麻油、桐油、獾油、乙醇和蒸馏水及其混合物。
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| CN106511661A (zh) * | 2016-12-06 | 2017-03-22 | 南京中医药大学 | 一种祛痘面膜及制备方法和应用 |
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| CN106511661A (zh) * | 2016-12-06 | 2017-03-22 | 南京中医药大学 | 一种祛痘面膜及制备方法和应用 |
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