CN103877084A - 一种治疗肛周溃疡的外用药物 - Google Patents
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Abstract
本发明公开了一种治疗肛周溃疡的外用药物，属于医药技术领域。该外用药物含有四氢巴马汀和吲哚美辛，优选四氢巴马汀与吲哚美辛的重量比为0.2-1：1。本发明涉及的外用药物可消除溃疡渗液，加快溃疡创面的愈合，从而达到治愈肛周溃疡的目的。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗肛周溃疡的外用药物。
背景技术
肛周溃疡是肛门腔末端的粘膜或衬里组织的溃疡。患有肛周溃疡的人通常肛门疼痛或肛门流血，在大便过程中及便后疼痛尤为明显。
延胡索乙素，是中药延胡索有效生物碱成分之一，化学结构为消旋四氢巴马汀(dl-tetrahydropalmatine，THP)，属于四氢原小藕碱同类物(tetrahydroprotoberberines，THPBs)。THP经化学分旋后可分为左旋体(1-THP)和右旋体(d-THP)。多年来的研究结果表明，仅l-THP具有中枢性镇痛、镇静、安定作用，d-THP则无明显镇痛作用，是脑内多巴胺(DA)排空剂。l-THP临床用药称为颅痛定(rotundine)，有长达40年的临床使用时间，镇痛疗效可靠，对慢性、持续性钝痛有良好的治疗作用，且其镇痛作用并不属于麻醉性镇痛和消炎解热镇痛的范畴。
吲哚美辛具有抗炎、解热及镇痛作用，用于类风湿性关节炎、风湿性关节炎，强直性脊椎炎、骨关节炎及急性痛风发作期等。其作用机理为通过对环氧化酶的抑制而减少前列腺素的合成。制止炎症组织痛觉神经冲动的形成，抑制炎性反应，包括抑制白细胞的趋化性及溶酶体酶的释放等。至于退热作用，由于作用于下视丘体温调节中枢，引起外周血管扩张及出汗，使散热增加。这种中枢性退热作用也可能与在下视丘的前列腺素合成受到抑制有关。
目前，在治疗肛肠疾病方面，尚未见有以四氢巴马汀或将四氢巴马汀与吲哚美辛联用作为主要活性成分的治疗药物。
发明内容
本发明的目的之一在于提供一种治疗肛周溃疡的外用药物。为了实现本发明的目的，发明人通过大量试验研究，最终获得了如下技术方案：
一种治疗肛周溃疡的外用药物，该外用药物含有四氢巴马汀和吲哚美辛。
优选地，如上所述的治疗肛周溃疡的外用药物，其中四氢巴马汀与吲哚美辛的重量比为0.2-1：1。
进一步优选地，如上所述的治疗肛周溃疡的外用药物，其中四氢巴马汀与吲哚美辛的重量比为0.5-1：1。
再进一步优选地，如上所述治疗肛周溃疡的外用药物，其中所述的四氢巴马汀为四氢巴马汀的消旋体或左旋体。
本发明所述的外用药物为软膏剂、擦剂、凝胶剂、栓剂。优选地，所述的外用药物为凝胶剂。进一步优选地，所述的凝胶剂中四氢巴马汀的浓度为0.5%（w/w），吲哚美辛的浓度为1.0%（w/w）。
通过动物实验研究，我们发现本发明所提供的组合物能够显著改善醋酸所致肛周溃疡的症状，从而加快溃疡面愈合。因此，本发明的目的之二是提供一种新的外用药物用于制备治疗肛周溃疡的药物中的用途；即：四氢巴马汀与吲哚美辛组成的组合物作为活性成分在制备治疗肛周溃疡的药物中的应用。优选地，左旋四氢巴马汀与吲哚美辛组成的组合物作为活性成分在制备治疗肛周溃疡的药物中的应用。
本发明涉及的外用药物可消除溃疡渗液，加快溃疡创面的愈合，从而达到治愈肛周溃疡的目的。
具体实施方式
以下是本发明的具体实施例，对本发明的技术方案做进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1凝胶剂的制备
处方：左旋四氢巴马汀5g、吲哚美辛10g、卡波姆10g、丙二醇60ml、甘油50ml、乙醇150ml、三乙醇胺适量，纯化水加至 1000g。
制备工艺：将卡波姆缓慢加入到处方量50%左右的水中，边加边搅拌直至形成透明的凝胶基质，将左旋四氢巴马汀、吲哚美辛溶于乙醇中，再加入基质中，搅拌均匀，加入甘油、纯化水至全量，三乙醇胺调节pH值至中性，即得。
实施例2 凝胶剂的制备
处方：四氢巴马汀10g、吲哚美辛10g、卡波姆10g、丙二醇60ml、甘油50ml、乙醇200ml、三乙醇胺适量，纯化水加至1000g。
制备工艺：将卡波姆缓慢加入到处方量50%左右的水中，边加边搅拌直至形成透明的凝胶基质，将左旋四氢巴马汀、吲哚美辛溶于乙醇中，再加入基质中，搅拌均匀，加入丙二醇、甘油、纯化水至全量，三乙醇胺调节pH值至中性，即得。
实施例3 四氢巴马汀联用吲哚美辛治疗大鼠肛周溃疡的试验研究
SD大鼠40只，雌雄各半，体重200-220 g。适应性饲养一周后，按如下方法制造大鼠肛周溃疡模型：取滤纸用内径为6mm的打孔器制成大小相等的滤纸片，放入99.0％醋酸溶液中充分浸泡，将浸泡后的滤纸片放到麻醉后的大鼠肛门周围，使滤纸片紧密接触肛周皮肤及黏膜，每次用一片滤纸，每只大鼠l min后换一次滤纸片，贴三次后取下滤纸片。
造模后第2日，将所有大鼠随机分为如下四组：模型对照组、四氢巴马汀组、吲哚美辛组和联合用药组，每组分别10只。联合用药组给予四氢巴马汀和吲哚美辛的甘油溶液，按质量份数计含0.5%左旋四氢巴马汀+1.0%吲哚美辛；吲哚美辛组给予2.0%吲哚美辛的甘油溶液，四氢巴马汀组给1.0%左旋四氢巴马汀的甘油溶液，模型对照组给等体积甘油。
各组均为直肠给药0.6ml，于给药第3，5，7，9 d观察大鼠溃疡愈合情况，评定溃疡愈合程度。评分标准：有较多溃疡渗液计1分；有少许溃疡渗液计2分；有焦痂，基本愈合计3分；完全愈合计4分。各组大鼠肛周溃疡及治疗效果比较见表1。
表1 各组大鼠肛周溃疡程度比较
与模型对照组比较，★ P＜0.05，与模型对照组比较，★★ P＜0.01；
与吲哚美辛组比较， ● P＜0.05，与吲哚美辛组比较， ●● P＜0.01；
与四氢巴马汀组比较，△ P＜0.05，与四氢巴马汀组比较，△△ P＜0.01。
根据表1的试验结果可以看出，与模型对照组比较，单药组（四氢巴马汀组、吲哚美辛组）对醋酸所致的大鼠肛周溃疡没有明显的治疗作用（P＞0.05），而联合用药组在治疗5日后可发挥非常显著的治疗效果（P＜0.01）。另外，在治疗5日后联合用药组与各单药组相比具有显著性（P＜0.05）或极显著性差异（P＜0.01），这预示着四氢巴马汀联合吲哚美辛具有治疗肛周溃疡的协同作用。
Claims (8)
1.一种治疗肛周溃疡的外用药物，其特征在于：所述的外用药物含有四氢巴马汀和吲哚美辛。
2.根据权利要求1所述的治疗肛周溃疡的外用药物，其特征在于：四氢巴马汀与吲哚美辛的重量比为0.2-1：1。
3.根据权利要求2所述的治疗肛周溃疡的外用药物，其特征在于：四氢巴马汀与吲哚美辛的重量比为0.5-1：1。
4.根据权利要求1-3任一项所述治疗肛周溃疡的外用药物，其特征在于：所述的四氢巴马汀为四氢巴马汀的消旋体或左旋体。
5.根据权利要求1-3任一项所述治疗肛周溃疡的外用药物，其特征在于：所述的外用药物为软膏剂、擦剂、凝胶剂、栓剂。
6.根据权利要求5所述治疗肛周溃疡的外用药物，其特征在于：所述的的外用药物为凝胶剂。
7.根据权利要求6所述治疗肛周溃疡的外用药物，其特征在于：所述的凝胶剂中四氢巴马汀的浓度为0.5%w/w，吲哚美辛的浓度为1.0%w/w。
8.四氢巴马汀与吲哚美辛组成的组合物作为活性成分在制备治疗肛周溃疡的药物中的应用。
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| CN109364076B (zh) * | 2018-12-10 | 2021-02-26 | 西藏中孚医药科技有限公司 | 一种预防高原反应的千金藤提取物及基于该提取物的凝胶 |
| CN109431973B (zh) * | 2018-12-10 | 2021-08-03 | 西藏中孚医药科技有限公司 | 一种预防高原反应凝胶的制备方法 |
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| CN1483407A (zh) * | 2002-09-18 | 2004-03-24 | 中国人民解放军军事医学科学院毒物药 | 用于镇痛和戒毒的含罗通定的药物组合物 |
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| CN1562019A (zh) * | 2004-04-05 | 2005-01-12 | 孟繁浩 | 延胡索乙素长效制剂及其制备方法 |
| CN101152166B (zh) * | 2007-09-06 | 2010-12-08 | 武汉大学 | 一种治疗痔病的异甘草素凝胶剂及制备方法 |
| CN102125559B (zh) * | 2010-01-17 | 2013-05-29 | 鲁南制药集团股份有限公司 | 一种含有己酮可可碱和卡络磺钠的药物组合物及其制药用途 |
| CN102100694A (zh) * | 2011-02-18 | 2011-06-22 | 浙江大学 | 四氢巴马汀对映体在制备p-糖蛋白抑制剂中的应用 |
| CN103655459A (zh) * | 2013-12-19 | 2014-03-26 | 中国药科大学 | 一种多功能微乳凝胶制剂及其制备工艺 |
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| PEI LUO, ET AL.: "Anti-inflammatory and analgesic effect of plumbagin through inhibition of nuclear factor-κb activation. Pei Luo, et al. The Journal Of Pharmacology And Experimental Therapeutics.2010年第335卷，第735-742页", 《THE JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS》, vol. 335, 31 December 2010 (2010-12-31), pages 735 - 742 * |
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