CN102430021B - 一种预防或治疗儿童麻风溃疡的中药组合物及其应用 - Google Patents
一种预防或治疗儿童麻风溃疡的中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种预防或治疗儿童麻风溃疡的中药组合物及其应用，涉及中药技术领域。其由如下重量份的活性成分组成：地骨皮15-20份、仙人掌10-15份、荆芥20-25份、细辛10-15份、槟榔15-20份、艾叶15-20份、苍耳子15-20份、防风10-15份、草乌20-25份。本发明的中药组合物在创面修复增值期具有促进创面收缩、肉芽生长及创面微循环再生作用，可显著促进麻风溃疡愈合。
Description
技术领域
本发明涉及中药技术领域，特别是涉及一种预防或治疗儿童麻风溃疡的中药组合物及其应用。
背景技术
麻风病是一种毁容残肢的疾病，历史上在世界范围内曾经到处可见，甚至《圣经》里也曾提到过麻风病。患者身上可多处发生溃疡，由于损害不能恢复可导致残疾。儿童最容易患这种病，感染这种病后要过2-7年才会发病。麻风病有如下主要症状：（1）肌肉溃疡；（2）脚底穿洞；（3）不能合眼（兔眼）；（4）鹰爪指；（5）鞍鼻；（6）手断脚断；（7）眉毛脱失；（8）神经粗大；（9）皮肤颗颗；（10）狮子脸。
中医认为：由于体虚感受山岚瘴疠之风邪，或经常接触患者及其污染之厕所、床、被、衣服、用具等，感染疠气，袭人血脉，客于经络，留而不去，与血气相干，致营卫不和，淫邪散溢而发。
发明内容
本发明的目的在于通过对传统中药药理进行研究后重新组方，提供了一种疗效更好、见效快，毒副作用小的预防或治疗儿童麻风溃疡的中药组合物及医药用途。该中药组合物在创面修复增值期具有促进创面收缩、肉芽生长及创面微循环再生作用，能增加创面碱性成纤维生长因子水平，促进创面胶原的合成和上皮的生长，可显著促进麻风溃疡愈合。
本发明的目的是这样实现的：
一种预防或治疗儿童麻风溃疡的中药组合物，由如下重量份的活性成分制备而成：地骨皮15-20份、仙人掌10-15份、荆芥20-25份、细辛10-15份、槟榔15-20份、艾叶15-20份、苍耳子15-20份、防风10-15份、草乌20-25份。
在本发明一个最优选的实施例中，所述的预防或治疗儿童麻风溃疡的中药组合物，由如下重量份的活性成分制备而成：地骨皮18份、仙人掌12份、荆芥20份、细辛12份、槟榔18份、艾叶20份、苍耳子18份、防风12份、草乌20份。
所述预防或治疗儿童麻风溃疡的中药组合物为外用制剂。
优选地，所述预防或治疗儿童麻风溃疡的中药组合物为洗剂、擦剂、软膏剂、熏蒸剂。
通过动物试验研究发现，由上述活性成分组成的药物组合物在预防或治疗儿童麻风溃疡方面具有显著的疗效。因此，本发明的第二个目的在于提供一种医药新用途，即上述的中药组合物在制备预防或治疗儿童麻风溃疡的药物中的应用。
根据中医药史料记载，上述中药具有如下药理活性和功能主治：
地骨皮：凉血除蒸，清肺降火。用于阴虚潮热、骨蒸盗汗、肺热咳嗽、咯血、衄血。选用茄科植物枸杞Lycium chinense Mill.的根皮。
仙人掌：清热解毒，散瘀消肿，健胃止痛，镇咳。用于胃、十二指肠溃疡，急性痢疾，咳嗽；外用治流行性腮腺炎，乳腺炎，痈疖肿毒，蛇咬伤，烧烫伤。选用全株入药。
荆芥：解表散风，透疹，消疮，止血。用于感冒，麻疹透发不畅，便血、崩漏、鼻衄。选用唇形科植物荆芥 (Nepeta cataria Linn Sp.) 的干燥地上部分。
细辛：解表散寒；祛风止痛；温肺化饮；通窍。风寒表证；头痛，牙痛；风湿痹痛；痰饮咳喘；鼻塞；鼻渊；口疮。选用马兜铃科植物辽细辛、细辛及汉城细辛的带根全草。
槟榔：驱虫；消积；下气；行水；截疟。虫积；食滞；脘腹胀痛；泻痢后重；脚气；水肿；疟疾。选用棕榈科植物槟榔Areca catechu Linn.的种子。
艾叶：散寒止痛，温经止血。用于少腹冷痛，经寒不调，宫冷不孕，吐血， 衄血，崩漏经多，妊娠下血；外治皮肤瘙痒，脱皮。选用菊科植物艾Artemisia argyi Levl. et Vant. 的干燥叶。
苍耳子：散风寒；通鼻窍；祛风湿；止痒。主治鼻渊；风寒头痛；风湿痹痛；风疹；湿疹；疥癣。选用菊科植物苍耳Xanthium sibiricum Patr.的带总苞的果实。
防风：祛风解表，胜湿止痛，止痉定搐。主治外感表证，风疹瘙痒，风湿痹痛，破伤风。选用伞形科多年生草本植物防风的根。
草乌：搜风胜湿，散寒止痛，开痰，消肿。治风寒湿痹，中风瘫痪，破伤风，头风，脘腹冷痛，痰癖，气块，冷痢，喉痹，痈疽，疔疮，瘰疬。秋季茎叶枯萎时采挖，除去残茎及泥土，晒干或烘干。
将上述各中药材制备成本发明的复方制剂的制备方法，包括如下步骤：
（1）取上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材10-12倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8-10倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至每毫升含0.25-0.3g生药量，得洗剂，低温保存。
用法用量：患者每日用约400 毫升温汤溃疡处浸泡清洁1次, 每次20-30min, 洗后无菌敷料包扎，疗程为4个月。
本发明涉及的中药组合物在创面修复增值期具有促进创面收缩、肉芽生长及创面微循环再生作用，能增加创面碱性成纤维生长因子水平，促进创面胶原的合成和上皮的生长，具有使创面肉芽由苍白、紫暗变为红润、鲜活的作用，可显著促进麻风溃疡愈合。
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中药口服液的制备
生药处方：
地骨皮180g、仙人掌120g、荆芥200g、细辛120g、槟榔180g、艾叶200g、苍耳子180g、防风120g、草乌200g。
制备方法：
（1）称取上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材10倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至每毫升含0.25g生药量，得洗剂，低温保存。
实施例2中药口服液的制备
生药处方：
地骨皮150g、仙人掌150g、荆芥250g、细辛100g、槟榔150g、艾叶150g、苍耳子150g、防风150g、草乌250g。
制备方法：
（1）称取上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至每毫升含0.3g生药量，得洗剂，低温保存。
实施例3中药口服液的制备
生药处方：
地骨皮200g、仙人掌150g、荆芥220g、细辛150g、槟榔200g、艾叶200g、苍耳子200g、防风100g、草乌220g。
制备方法：
（1）称取上述9味中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材12倍量的水，煎煮2h，取煎液，滤过，第二次加总药材10倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至每毫升含0.25g生药量，得洗剂，低温保存。
实施例4 本发明的中药洗剂对麻风足底溃疡的治疗效果
将23例麻风足底溃疡患者随机分为如下2组：治疗组13 例，男性11 例，女性2例，年龄52-67岁，病程5-20年，平均9.7年，溃疡面积0.9cm×1cm～11cm×9cm；对照组10例，男性8例，女性2例，年龄53-63 岁，病程4-23年，平均10.2年，溃疡面积0.8cm×1.1cm～10cm×9cm。2组的年龄、病程、溃疡大小之间的差异无统计学意义(P ＞0.05)。
治疗组的患者每日用约400毫升本发明实施例1制备的中药洗剂，经加热后在溃疡处浸泡清洁1次, 每次20min, 洗后无菌敷料包扎，疗程为4个月。对照组清创消毒后以凡士林纱布换药，疗程为4个月。治疗同时嘱患者注意抬高患肢、禁止负重、穿麻风足专用防护鞋以避免溃疡部位受压。对每例患者详细记录溃疡大小、渗液、组织坏死及肉芽情况。
试验结束后，下肢慢性溃疡评分采用LUMT 评定并记录足底创面肉芽生长积分。评分标准: ( 1) 痊愈，溃疡完全愈合，0分；( 2) 红活，肉芽覆盖创面＞76%，1分； ( 3) 紫暗，肉芽覆盖创面51%～75%，2分；( 4) 苍白，肉芽覆盖创面26%～50%，3分；( 5) 无，肉芽覆盖创面＜25%，4分。
疗效标准参照《中华人民共和国中医药行业标准·中医病证诊断疗效标准》及国家统编教材《中医外科学》( 新世纪全国高等中医药院校教材) 疗效标准判定。
痊愈：为溃疡面完全愈合；
显效：为溃疡面积缩小1/2以上，表面干净，局部肉芽组织新鲜；
好转：为溃疡面积缩小1/3以上；
无效：为治疗后溃疡面无明显变化。
有效率=(痊愈+显效)/总例数×100%。
两组患者在治疗前创面肉芽积分均为2.5～2.6，具体表现为创面肉芽紫暗及苍白，覆盖创面约50%。治疗4个月后，治疗组患者平均肉芽积分较治疗前下降60%～70%，表现为肉芽红活新鲜，且有8例患者创面愈合；对照组治疗后患者肉芽积分仅下降25%左右。两组治疗后，治疗组2种积分均优于对照组(P＜0.05)。见表1。
创面愈合结果治疗组痊愈率和总有效率高于对照组，提示治疗组痊愈率、总有效率均有显著增高，见表2。
表1两组创面肉芽生长积分比较（分）
注：与对照组比较，* P＜0.05，** P＜0.01。
表2 两组创面愈合情况比较（例）
| 组别 | 例数 | 痊愈 | 显效 | 好转 | 无效 | 痊愈率（%） | 总有效率（%） |
| 对照组 | 10 | 1 | 1 | 4 | 4 | 10.0 | 20.0 |
| 治疗组 | 13 | 8 | 3 | 1 | 1 | 61.5 | 84.6 |
Claims (4)
1.一种预防或治疗儿童麻风溃疡的中药组合物，其特征在于：由如下重量份的活性成分制备而成：地骨皮18份、仙人掌12份、荆芥20份、细辛12份、槟榔18份、艾叶20份、苍耳子18份、防风12份、草乌20份。
2.根据权利要求1所述的一种预防或治疗儿童麻风溃疡的中药组合物，其特征在于：所述中药组合物为外用制剂。
3.根据权利要求1所述的一种预防或治疗儿童麻风溃疡的中药组合物，其特征在于：所述中药组合物为洗剂、擦剂、软膏剂或熏蒸剂。
4.权利要求1所述的中药组合物在制备预防或治疗儿童麻风溃疡的药物中的应用。
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