CN103463364A - 一种治疗糖尿病神经病变的药物 - Google Patents
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Abstract
本发明涉及一种治疗糖尿病神经病变的药物，其由以下一定重量份数的中药为原料药制备获得：红花、丹参、鸡血藤、水蛭、黄芪、茯苓、焦白术、山药、山茱萸、补骨脂、五味子、仙灵脾、元胡，本发明药物在临床上取得了很好的疗效，无不良反应，治疗有效率达85.5%。
Description
技术领域
本发明涉及生物医药领域，具体的涉及一种治疗糖尿病神经病变的中药制剂。
背景技术
目前，糖尿病的发病机制尚未完全明确，现在认为主要与糖尿病引起的糖，脂肪，磷脂等代谢障碍及由于周围神经等的滋养血管的动脉硬化，中外膜肥厚，玻璃样变性甚至闭塞等血管性障碍有关，致使神经纤维节段性脱髓鞘性变化，轴索膨胀变性，纤维化及运动终板肿瘤等，病变主要见于周围神经，后根，亦可见于兴奋髓后索及肌肉。
糖尿病患者的微血管病变几乎可发生于所有的脏器，微血管病变与血糖控制水平相关，提示血糖控制不良是糖尿病神经病变发生的病理基础，而微血管病变则可能是糖尿病神经病变恶化的重要原因。在这些病人中毛细血管基膜增厚，动脉硬化，细动脉硬化，毛细血管基膜增厚伴缺血性因素存在。这些病变可引起毛细血管的通透性异常和某些物质中渗漏至血管周围。渗漏的物质中，毒性化学物进入神经内膜间隙，使神经元和雪旺细胞与毒性化学的接触，损害了后者的结构与机能的完整性，导致脱髓鞘与神经元中止，Gasser指出由于缺血可能出现蚁走感觉等。
糖尿病神经病变的表现；
一)、肌肉损害：可表现为骨盆带、肩胛带及四肢近端肌肉萎缩。糖尿病伴有低血钾时可有低钾性麻痹；
二)、脑损害症状：糖尿病时引起脑病的原因甚多，可因血糖过高，表现头痛、无力、体力和脑力易疲劳、兴奋、情绪不稳等症状，长期未经适当治疗可致记忆力减退、精神衰退；
三)、脊髓损害症状：可表现为类似慢性脊髓灰质炎的脊髓前角细胞损害，脊髓痨样(称假性脊髓痨)后根、后柱损害，及与亚急性脊髓联合变性相似的后索及侧索变性。这些改变多认为系糖尿病性血管引起的持续性脊髓供血不足所致；
四)、周围神经病变：以多发性神经炎最多见，为两侧对称性感觉障碍，运动障碍及共济失调表现。颅神经受累者较为少见，可有一侧或两侧外展神经、动眼神经麻痹，视网膜炎及视神经萎缩等。植物神经常可受累，表现为胃肠功能紊乱、腹泻、膀胱障碍、阳痿萎、***性低血压、泌汗异常及血管舒缩功能不稳定等改变。肌电图呈神经原性改变，神经传导速度减慢。
目前多使用西药进行治疗或预防，但副作用大或效果不明显，有许多中药复方也声称治疗糖尿病神经病变，但大多起效慢或没有经过验证。
发明内容
本发明的目的是提供一种治疗糖尿病神经病变的药物，在临床上取得了很好的疗效，无不良反应。
本发明治疗糖尿病神经病变的药物，是由以下重量份数的中药为原料药制备获得：
红花8－15 丹参7－12 鸡血藤25－35
水蛭10－15 黄芪28－35 茯苓8－18
焦白术8－15 山药5－18 山茱萸9－18
补骨脂5－15 五味子8－13 仙灵脾8－15
元胡5－10。
优选的，本发明的药物是由以下重量份数的中药为原料药制备获得：
红花10 丹参10 鸡血藤30
水蛭10 黄芪30 茯苓10
焦白术10 山药10 山茱萸10
补骨脂10 五味子10 仙灵脾10
元胡10。
上述药物可以制作药剂学上的任何一种口服剂型如片剂、丸剂、汤剂、胶囊剂等，本发明优选汤剂。
本发明药物汤剂的制备方法是：取所述药物洗净去杂，晾干，粉碎成颗粒，加水浸泡1 小时，加水淹没药物煎煮二次，每次煎煮1-1.5小时，取两次煎液，滤过，热封袋中，每袋200ml，120℃高温灭菌，包装即得。
本发明组方中红花活血通经、散瘀止痛；丹参活血祛瘀，通经止痛，清心除烦，凉血消痈；鸡血藤活血补血，调经止痛，舒筋活络；水蛭破血通经，逐瘀消癥；黄芪补气固表，利尿托毒，排脓，敛疮生肌；茯苓渗湿利水、健脾和胃、宁心安神；焦白术补气固表，利尿托毒，排脓，敛疮生肌；山药助消化，止泻，祛痰、滋补；山茱萸补益肝肾、涩精固脱、收敛止汗；补骨脂为温补脾肾的要药，补肾壮阳，固精缩尿，温脾止泻；五味子收敛固涩，益气生津，补肾宁心；仙灵脾补肾阳，强筋骨，祛风湿；元胡；活血，散瘀，理气，止痛；川芎归肝胆经，活血行气，诸药合用可以活血散瘀、通经止痛、敛疮生肌、补肾阳、强筋骨。
为进一步考察本发明药物的临床疗效和安全性，对本发明药物的汤剂进行了临床观察。
患者资料：入选病例62名患者，男34例，女28例，年龄42-65岁，入选病例均为确诊为糖尿病神经病变的患者。
诊断标准：（1）可诊断为Ⅱ型糖尿病，诊断符合1999年WHO制定的糖尿病诊断标准；有糖尿病临床症状并且随即静脉血浆血糖≥11.0mmol/L，或空腹静脉血浆血糖≥7.0mmol/L，或口服葡萄糖耐量试验2小时静脉血浆血糖≥11.0mmol/L；
（2）四肢（至少在双下肢）有持续性疼痛或感觉异常；双侧或一侧踝反射减弱；振动觉减弱（内踝弱于胫骨内侧踝）；或神经电生理检查主侧神经传导速度（NCV）减低者；并排除其他原因引起的神经病变患者。
治疗方法：服用本发明药物的汤剂，每次200ml，每日两次，6个月为一个疗程。
疗效判定标准：
显效：自觉症状消失，神经***检查无异常；
有效：自觉症状减轻或病变范围缩小，神经***检查好转；
无效：自觉症状无改善或加重。
治疗结果：62名患者中，显效32例，显效率51.6%；有效21例，有效33.9%率，总有效率为85.5%，无效9例，无效率为14.5%。
具体实施方式
实施例1
将各原料药物洗净去杂，晾干，粉碎成颗粒；
取红花10g、丹参12 g、鸡血藤30 g、水蛭12 g、黄芪35 g、茯苓15 g、焦白术8 g、山药10 g、山茱萸15 g、补骨脂15 g、五味子10 g、仙灵脾8 g、元胡8 g；
将所取药物加水浸泡1 小时，加水淹没药物煎煮二次，每次煎煮1-1.5小时，取两次煎液，滤过，热封袋中，每袋200ml，120℃高温灭菌，包装即得。
实施例2
将各原料药物洗净去杂，晾干，粉碎成颗粒；
取红花15g、丹参7g、鸡血藤25 g、水蛭10 g、黄芪30 g、茯苓18 g、焦白术10g、山药18g、山茱萸9 g、补骨脂10g、五味子13g、仙灵脾15g、元胡10g；
将所取药物加水浸泡1 小时，加水淹没药物煎煮二次，每次煎煮1-1.5小时，取两次煎液，滤过，热封袋中，每袋200ml，120℃高温灭菌，包装即得。
Claims (3)
1.一种治疗糖尿病神经病变的药物，其特征在于是由以下重量份数的中药为原料药制备获得：
红花8－15 丹参7－12 鸡血藤25－35
水蛭10－15 黄芪28－35 茯苓8－18
焦白术8－15 山药5－18 山茱萸9－18
补骨脂5－15 五味子8－13 仙灵脾8－15
元胡5－10。
2.根据权利要求1所述的治疗糖尿病神经病变的药物，其特征在于是由以下重量份数的中药为原料药制备获得：
红花10 丹参10 鸡血藤30
水蛭10 黄芪30 茯苓10
焦白术10 山药10 山茱萸10
补骨脂10 五味子10 仙灵脾10
元胡10。
3.根据权利要求1或2所述的治疗糖尿病神经病变的药物，其特征在于将所述药物制成汤剂。
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| CN102293895A (zh) * | 2011-08-17 | 2011-12-28 | 张子桂 | 一种用于治疗ⅱ型糖尿病的中药组合药物 |
| CN102614405A (zh) * | 2012-04-06 | 2012-08-01 | 刘英晓 | 一种治疗糖尿病性神经病变的肢体疼痛的中药汤剂 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102293895A (zh) * | 2011-08-17 | 2011-12-28 | 张子桂 | 一种用于治疗ⅱ型糖尿病的中药组合药物 |
| CN102614405A (zh) * | 2012-04-06 | 2012-08-01 | 刘英晓 | 一种治疗糖尿病性神经病变的肢体疼痛的中药汤剂 |
Non-Patent Citations (2)
| Title |
|---|
| 徐生生: "温阳化瘀法治疗老年糖尿病周围神经病变疗效观察", 《辽宁中医杂志》, vol. 31, no. 05, 18 May 2004 (2004-05-18), pages 376 * |
| 高志生等: "糖尿病周围神经病变中医药治疗进展", 《中西医结合心脑血管病杂志》, vol. 09, no. 03, 10 March 2011 (2011-03-10) * |
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