CN101991688A - 药物组合物在制备治疗糖尿病溃疡药物中的用途 - Google Patents
药物组合物在制备治疗糖尿病溃疡药物中的用途 Download PDFInfo
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Abstract
本发明涉及药物组合物在制备治疗糖尿病肢体或体表溃疡药物或者医用辅料中用途，该药物组合物由以下组分组成，按照药物组合物总重量计，(A)3-15％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。本发明还涉及治疗糖尿病溃疡用的医用辅料及含有它们的药盒。
Description
技术领域
本发明涉及药物组合物在制备治疗糖尿病肢体或体表溃疡药物或者医用辅料中用途。本发明还涉及一种治疗糖尿病肢体或体表溃疡用的医用辅料及含有它们的药盒。
背景技术
中国专利ZL 93 1 00276 1披露一种治疗热损伤的药物组合物，该药物组合物由以下组分组成，按照药物组合物总重量计，(A)3-5％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。
此外，这一治疗热损伤的药物组合物主要用于治疗动物或者人的热损伤，包括烧伤，特别是大面积烧伤、烫伤、化学灼伤等等。它还可以被用来治疗人类的疮疡，包括创面溃疡，感染创面、阴道炎、子宫颈糜烂、痔疮、褥疮、创伤创面、冻伤、冻疮等。
术语：
一、“本发明所述的药物组合物”或者“本发明的药物组合物”。它是指一种药物组合物由以下组分组成，按照药物组合物总重量计，(A)3-5％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。
二、溃疡。本领域技术人员认为溃疡是常见病之一，作为临床医师经常遇到溃疡的治疗。溃疡的定义似乎不言而喻，然而，很多人对创面(wound)和溃疡(ulcer-)的区别并不十分清楚。一般认为“深达真皮或皮下组织缺损称为溃疡，其中圆孔形深在形的化脓性溃疡称为脓疮，位置很深的小孔性溃疡称为瘘孔。”Lever氏将溃疡定义为“治愈后遗留疤痕的表皮和真皮的部分缺损。”另一方面，Anderson病理学认为“组织或器官的表面附近发生炎症，强列的炎症刺激引起组织坏死，脱落后成为溃疡。”以上可见皮肤学在组织形态，将上皮和真皮的部分缺损称为溃疡，不一定有炎症症状作为条件。病理学上脏器表面先有炎症，坏死组织脱落后形成溃疡。即皮肽学中将创面(wound)划为溃疡的范畴，而病理学中则不将其划为溃疡的范畴。
创面和溃疡的关系，Siemens认为“一次性不能治愈的创面(wound)，通常发生二次感染，肉芽组织生长，覆盖于伤口底部，此时创面称为溃疡”。值得注意的是国内将这部分创面有时称为开放性伤口(open wound)，将这部分创面归为外伤性溃疡。
三、皮肤溃疡。本领域技术人员认为皮肤溃疡是皮肤破损累及真皮或更深层组织所形成的局限性缺损，愈合后遗留瘢痕。
四、糖尿病溃疡。本发明人认为糖尿病溃疡并非是上述意义的疮疡、创面溃疡或者溃疡，它是一种因为患糖尿病而引起的下肢和体表组织发生溃疡体征的特殊溃疡，主要发病在下肢，与因创伤等原因引起的创疡或者发病有着根本的区别，是目前世界上还没有理想治疗药物的疾病。
本发明所述的糖尿病溃疡包括糖尿病病人的肢体或体表溃疡。
糖尿病溃疡的发病机理非常复杂，目前还没有统一的明确认识，总结起来包括三个相互作用的过程：血管病变、神经病变和免疫病变。
血管病变：
血管病变分为两大类，一大类是大血管内膜的病变、一大类是微血管病变，由于血管病变导致下肢和体表软组织缺血导致溃疡。
神经病变：
神经病变参与了糖尿病足部病变的早期发病机制，也是糖尿病足部溃疡最重要的危险因素。在此过程中，所有的神经功能都受到了损害，但通常是最长、最细的神经纤维首先受损，包括支配足部肌肉的运动神经。蚓状肌功能的丧失导致足部畸形，使跖趾关节下、足趾背部或趾尖等部位压力或摩擦增加，容易发生溃疡。植物神经功能受损也在神经病变的早期出现，导致动静脉血管短路，组织灌注率降低。出现脱发、皮脂腺和汗腺功能丧失，导致皮肤干燥、鳞屑和容易皲裂。
免疫病变：
免疫病变在糖尿病患者感染的发生中所起作用仍存在争议。大多数研究者相信血糖控制不满意使患者易于感染。但是糖尿病患者的体液免疫似乎是正常的，循环中免疫球蛋白水平正常或偏高，B淋巴细胞数目正常。在小鼠模型中，未发现抗体反应或补体结合的缺陷。
例如糖尿病足的主要症状表现为糖尿病人因下肢的血管病变、神经病变及感染等因素导致下肢的疼痛、麻木、足部的溃疡及肢端坏疽，临床上统称为糖尿病足(俗称烂脚)其表现为：
1、患者皮肤瘙痒，干而无汗，肢端凉、浮肿或干枯，皮肤颜色暗及色素斑，毳毛脱落。
2、肢端刺痛、灼痛、麻木、感觉迟钝或丧失，脚踩棉絮感。鸭步行走，间歇性跛行，休息痛。
3、肢端营养不良，肌肉萎缩张力差，关节韧带易损伤。
4、常见跖骨头下陷，跖趾关节弯曲形成弓形足、槌状趾.鸡爪趾、夏科关节。骨质破坏可发生病理性骨折等。
5、足背动脉搏动减弱或消失。深浅反射迟钝或消失。
6、肢端皮肤干裂或水疱、血疱、糜烂、溃疡、坏疽或坏死。
在现有技术中，糖尿病患者可伴有多种皮肤损害，长期代谢紊乱，微血管和周围神经发生病变，是导致皮肤溃疡的基础。因为长期血管病变使血管尤其是下肢血管硬化、狭窄，影响血供，导致皮肤营养障碍；微血管病变可使神经内膜血供下降，自主神经病变加重，神经病变还可使皮肤痛觉、压觉阈值上升，足底压力承受部位改变；因此，以足部尤其是 趾感染居多，在这种情况下，患者皮肤如出现损伤，则修复能力差，容易继发感染、溃疡、坏疽。大部分患者发病时有明显诱因，以外伤多见，足癣、甲癣和长期使用抗生素的糖尿病患者足部还容易发生真菌感染；老年糖尿病患者由于病程长，活动少，末梢循环差，更容易发生皮肤溃疡，老年患者因血糖升高使机体免疫力下降，溃疡形成后感染的概率很高，严重者导致蜂窝组织炎、骨髓炎和败血症等使截肢率大大增加。通常糖尿病皮肤溃疡应采取内科综合治疗，包括控制血糖，抗感染，改善微循环及创面局部处理。例如：使用头孢类抗生素、林可霉素、青霉素、克拉霉素、阿昔洛韦、阿莫西林双氯西林钠胶襄、复方磺胺甲恶唑等进行抗感染治疗；外用“百多邦”等等。但是糖尿病溃疡，一旦发生，临床上难以有理想治愈创面的有效方法，目前仍然时有采取截肢的外科方法。临床上十分需要一种非手术疗法治疗糖尿病溃疡的方法，也非常需要新的医疗技术或者药物。
发明内容
本发明要解决的技术问题是采用上述的公知的治疗热损伤的药物组合物治疗糖尿病肢体或体表溃疡(简称糖尿病溃疡)。
因此，本发明涉及药物组合物在制备治疗糖尿病肢体或体表溃疡药物或者医用辅料中的用途，该药物组合物由以下组分组成，按照药物组合物总重量计，(A)3-15％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。
本发明所述的药物是外用药物。现有技术中外用药物用可以包括许多种剂型，如溶液、酊剂、粉剂、洗剂、油剂、乳剂、软膏、糊膏、贴剂或凝胶剂等等。本发明的药物组合物优选为油剂、乳剂、软膏、糊膏、贴剂或者凝胶剂。
本发明所述的药物组合物进一步包括药学上可接受的载体。
本发明的用途仅仅涉及本发明所述的药物组合物在制备治疗糖尿病肢体或体表溃疡创面药物中的用途，换言之，本发明所述的药物组合物作为外用药用于治疗糖尿病溃疡创面。本发明不涉及所述的药物组合物在制备糖尿病内源性治疗药物中的用途。换言之，本发明不涉及所述的药物组合物作为内用药治疗糖尿病本身。
本发明还涉及一种治疗糖尿病肢体或体表溃疡用的医用辅料，该辅料含有由以下组分组成的药物组合物，按照药物组合物总重量计，(A)3-15％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。
所述的医用辅料优选为医用棉纱、医用绷带。
本发明还涉及一种药盒，其包括本发明所述的药物组合物或者所述的医用辅料和使用说明书。该药盒将所述的药物组合物或者含有该药物组合物的医用辅料组合在一起，同时还包括至少一份使用说明书，便于在临床上使用本发明的药盒。
本发明中采用本发明所述的药物组合物对糖尿病溃疡创面进行了治疗，获得了满意的效果，特别是对临床上十分棘手的大面积、严重的糖尿病溃疡具有显著效果；对糖尿病下肢截后截肢面再次溃疡的治疗也具有显著疗效，其临床实施方法如下：
一、包扎疗法
直接将本发明的药物组合物，涂在糖尿病患者的糖尿病溃疡创面上1-3毫米厚，而后用纱布(或相关透气性覆盖物)覆盖包扎(包扎不必太后)，每天早、晚各换药一次(条件差的可每天换药一次)，所述的换药是轻轻将糖尿病溃疡创面代谢产物和残留的药物组合物用面签粘净，而后再换新的相同的药物组合物，将其覆盖在创面上，再用纱布敷料包扎即可。如遇溃疡创面出现坏死肌腱组织，可用手术剪剪除；治疗期间禁止用消毒剂对创面消毒。
二：暴露疗法
直接将本发明药物组合物涂覆在糖尿病患者的糖尿病溃疡创面上，一般薄于2毫米厚，将药物组合物覆盖的溃疡创面暴露，而后见覆盖在溃疡创面上的药物组合物逐渐在创面被温化，创面的上一些白色的代谢产物也逐渐的排出在药层外，或者于药物组合物混合。一般6至8小时创面上的药物组合物全部变成了白色代谢产物的混合物，此刻可用棉签将混合的白色代谢产物粘净，而后在涂覆上新的相同的药物组合物，何时见涂上的药物组合物变成完全混合的白色代谢产物，何时更换新的药物组合物。这样循环使用，直至创面愈合。如遇溃疡创面出现坏死肌腱组织，可用手术剪剪除；治疗期间禁止用消毒剂对创面消毒。
三：制成油纱使用
将本发明药物组合物温化后浸在纱布中，像制作凡士林油纱的操作方法一样使用，将药物组合物油纱覆盖在溃疡创面上，而后采取包扎或半暴露疗法治疗。每天换药一次。
糖尿病是一种以慢性高血糖为特征的疾病，易发生下肢溃疡，且创面愈合延迟等诸多慢性并发症，现有技术中，大部分的糖尿病溃疡创面常可导致截肢，是糖尿病患者致残和死亡的主要原因之一。作为糖尿病最显著特征的高血糖状态与创面难愈间存在直接或间接的联系，严格的血糖控制可有效阻止糖尿病难愈创面的发生、发展。但是对许多患者而言，即使将血糖控制在正常水平范围内，创面愈合仍然十分缓慢。这种情况下，对糖尿病难愈创面的发病机制进行深入研究，找寻改善糖尿病创面愈合的新的防治方法显得十分有意义。糖尿病性溃疡以往多采用外科换药方法治疗，但效果多不理想。
本发明披露在血糖的有效控制的前提下，本发明药物组合物可显著促进糖尿病溃疡愈合。
本发明药物组合物中的有效成分亚油酸是必需的脂肪酸，是构成细胞生物膜不可缺少的组成部分，也是创面组织损伤后细胞修复的必需物质，它能增加炎性创面局部营养，为创面细胞修复提供了必要的营养基质。糖尿病属于神经营养和代谢性疾病。糖尿病溃疡创面大多发生在趾、踝、跟部，说明其发病因素与外周血管性病变和外周神经营养状况关系密切。
糖尿病溃疡创面局部治疗的关键措施是及时去除坏死组织，因为慢性溃疡表面常常变干枯而不易清除。手术去除坏死组织必定要损伤部分健康组织，尤其是采用含有肾上腺素类药物的麻醉制剂时，组织缺血加重。本发明的药物组合物优选为具有框架的软膏剂型，具有油性湿润的特性，创面留置时间长，并可保持创面的湿润，能使坏死组织发生酶解、酸败，通过“自动引流”作用排出创面分泌物，有利坏死组织的清除。同时也为干细胞原位分化建立了生理环境，使休眠状态的表皮干细胞被激活、再生，并可防止疲痕形成和粘连，坏死组织液化排除时间较一般溃疡偏长。在创面开始修复之前也可以实行短时间的包扎疗法。每次用药量相对地多些，厚度可超过1.5mm，待坏死组织开始液化排除时，改用湿润暴露疗法，同时减少每次药膏用量和增加用药次数。湿润暴露疗法治疗的糖尿病性皮肤溃疡创面变化特点是：坏死组织液化排除过程，伴有脂蛋白透明膜的形成。脂蛋白透明膜一旦形成，说明溃疡修复已经开始。要特别注意保护好透明膜的完整性，以保证溃疡的修复过程始终在脂蛋白透明膜下进行。当皮肤基底组织形成后，脂蛋白透明膜会自动消失，本发明中病例中溃疡多深达脂肪层，病史多偏长，能够实现溃疡治愈的机制：一是靠着溃疡创面基底部细胞的再生；二是溃疡创面周围新生皮肤向心生长。
本发明药物组合物的表面活性物质是由亲水性基团和亲油性非极性基团构成，本发明药物组合物表面活性高具有增溶作用[徐荣祥″再生医学的研究创立与展望″中国烧伤创疡杂志，2002，14(2)：122-130]。本发明药物组合物的两态变化有效隔离创面，从而起到了抗感染的作用：减少细菌感染机会，使细菌失去嗜活组织的能力，从而有效降低细菌量和抑制细菌生长，具有阻菌、抑菌、排菌的作用。药膏的有效隔离创面还能维持酶的活性，减少和阻止不饱和脂肪酸及维生素C的氧化，以及防止过氧化物的形成，从而保护了细胞膜及脂肪不受氧化破坏，对维持组织的正常新陈代谢具有一定的作用。
本发明药物组合物有效隔离溃疡创面，避免外在因素对外露神经末梢的刺激，从而产生止痛效果。其减轻疼痛的机理除了与药层隔绝了异物对创面的刺激有关，还与：①本发明药物组合物所含β-谷甾醇等成份可有效减轻炎症反应；②药物本身无刺激性；③药物改善了局部微循环功能，增加局部血流量，促进局部的新陈代谢，减轻了溃疡面组织缺血、缺氧、水肿对末梢神经造成的刺激有关。干细胞原位分化建立了生理环境，使休眠状态的表皮干细胞被激活、再生有利于创面愈合。
本发明的药物组合物的临床应用价值在于
1、改善了糖尿病溃疡创面，尤其是大面积、严重的糖尿病溃疡创面、组织的供养状态，由明显的缺氧无生机，变为不缺氧有生机；
2、较快的产生有生机的肉芽组织；
3、逐步在肉芽组织上再生出新的皮肤组织愈合创面。
本发明弥补了现临床医学治愈糖尿病溃疡创面药物的空白。
附图说明
图1为实施例7糖尿病患者左侧外踝处的溃疡照片。
图2为实施例7中涉及的医用纱布贴涂溃疡表面的照片。
图3为实施例7中涉及的糖尿病患者左侧外踝溃疡治疗进展照片。
图4为实施例7中涉及的糖尿病患者左侧外踝溃疡治疗进展照片。
图5为实施例7中涉及的糖尿病患者左侧外踝溃疡治疗进展照片。
图6为实施例8中涉及的糖尿病患者左侧外踝处的溃疡照片。
图7为实施例8中涉及的糖尿病患者医用纱布贴涂溃疡表面的照片。
图8为实施例8中涉及的糖尿病患者贴涂溃疡表面愈合照片。
图9为实施例9中涉及的糖尿病患者治疗前糖尿病溃疡照片。
图10为实施例9中涉及的糖尿病患者治疗中糖尿病溃疡照片。
图11为实施例9中涉及的糖尿病患者治疗后糖尿病溃疡照片。
图12为实施例10中涉及的糖尿病患者治疗前糖尿病溃疡照片。
图13为实施例10中涉及的糖尿病患者治疗后糖尿病溃疡照片。
图14为实施例10中涉及的糖尿病患者治疗后糖尿病溃疡照片。
图15为实施例10中涉及的糖尿病患者治疗后糖尿病溃疡照片。
图16为实施例11中涉及的糖尿病患者采用贴剂治疗照片。
图17为实施例11中涉及的糖尿病患者治疗第31天时的照片。
图18为实施例11中涉及的糖尿病患者治疗第60天时的照片。
图19为实施例11中涉及的糖尿病患者治疗第90天时的照片。
图20为实施例11中涉及的糖尿病患者治疗第110天时的照片。
具体实施方式
下面将结合附图通过下述非限制性实施例进一步说明本发明，本领域技术人员公知，在不背离本发明精神的情况下，可以对本发明做出许多修改，但即使这样的修改也落入本发明的范围。
实施例1
采用中国专利ZL 93 10 0276 1中实施例1披露的方法，按照其披露的具体的相同原料得到含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，将所述的混合物与蜂蜡混合得到本发明所述的药物组合物1。
实施例2
采用中国专利ZL 93 1 00276 1中所述的方法生产本发明所述的药物组合物，不同的是黄连、黄芩、黄柏饮片各10公斤，蚯蚓或者罂粟壳各2公斤，芝麻油100公斤，蜂蜡10公斤，将得到的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物与蜂蜡混合得到药物组合物2。
实施例3
采用本发明实施例1所述的方法生产本发明所述的药物组合物，不同的是黄连、黄芩、黄柏饮片各8公斤，蚯蚓或者罂粟壳各3公斤，芝麻油100公斤，蜂蜡8公斤，将得到的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物与蜂蜡混合得到药物组合物3。
实施例4
采用中国专利ZL 93 1 00276 1中所述的方法生产本发明所述的药物组合物，不同的是黄连、黄芩、黄柏饮片各3公斤，蚯蚓或者罂粟壳各4公斤，芝麻油100公斤，蜂蜡15公斤，将得到的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物与蜂蜡混合得到药物组合物4。
实施例5
采用本发明实施例3所述的方法生产本发明所述的药物组合物，不同的是黄连、黄芩、黄柏饮片各10公斤，蚯蚓或者罂粟壳各10公斤，芝麻油100公斤，蜂蜡3公斤，将得到的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物与蜂蜡混合得到药物组合物5。
实施例6
将实施例1-5得到的本发明药物组合物温化后，采用本领域技术人员公知的方法分别直接浸在医用纱布中，至纱布完全浸透为止，形成含有本发明物组合物的医用辅料，将该辅料包装成可供市售的医用产品。
实施例7 对糖尿病人踝部软组织溃疡的治疗
糖尿病患者，男，59岁，左侧外踝溃烂已两年，面积约为4X4厘米(图1)，该溃疡确诊为糖尿病溃疡。入院后进行降糖对症治疗。使用实施例1方法得到药物组合物制成的如实施例6所述的医用纱布，贴覆溃疡表面(图2、图3、)。每天换药一次。治疗1个月后痊愈出院(图4、图5)。
实施例8 对糖尿病人踝部软组织溃疡的治疗
糖尿病患者，男，58岁，左侧内踝溃烂已两年，面积约为3.5X4厘米(图6)，该溃疡确诊为糖尿病溃疡。入院后进行降糖对症治疗。使用实施例2方法得到药物组合物制成的如实施例6所述的医用纱布，贴覆溃疡表面(图7、)。每天换药一次。治疗1个月后痊愈出院(图8)。
实施例9 对糖尿病足溃疡的治疗
患者女，42岁，以“左足溃烂”22天病情加重就诊。曾有医生建议截肢遭该患者拒绝。该患者入院时，晨空腹血糖22.67mmol/L，经临床诊断确诊为糖尿病，并可见左足内下侧处出现严重糖尿病溃疡。左足高度肿胀，足背外侧至足底中后部广泛溃烂；形成篓道，篓道之间相互贯通，指骨外露；筋膜肌肉出现坏死、溃烂，恶臭(图9)。经抗炎和营养支持治疗后，使用本发明实施例3所述的药物组合物涂覆治疗，涂覆厚度约2毫米，将药物组合物覆盖的溃疡创面完全暴露，每日换药一次(图10)。治疗45天后，溃疡基本痊愈出院(图11)。
实施例10 对糖尿病足溃疡的治疗
患者男，患糖尿病多年，平日血糖控制不好。临床发现左踝部患有糖尿病溃疡。左足远端内侧红肿明显，拇指及趾关节为开放创面。关节囊已经被破坏，可见骨关节面。骨远端内侧有坏死组织附着，肌腱肿胀变性。足底有一个8X6cm的创面，创面处可见分泌物，有恶臭(图12)。经使用实施例4所述的药物组合物涂覆治疗，涂覆厚度约1.5毫米，将药物组合物覆盖的溃疡创面完全暴露，每日换药一次。治疗35天后所述溃疡痊愈(图13、图14、图15)，出院。
实施例11
患者徐某，男，59岁，患糖尿病已20年。因糖尿病足坏疽在某中国某省级医院就诊，医生建议截肢治疗。患者不同意截肢，后转哈尔滨医科大学第一临床医院就诊。入院诊断：该患者患有：1)I型糖尿病；2)右下肢动脉闭塞性右糖尿病足坏疽半年。经创面处理后，使用本发明实施例2所述的药物组合物膏剂、实施例6(含实施例3的药物组合物)贴剂(图16)治疗，每日一次换药，暴露后再继续交替使用膏剂和贴剂，创面逐渐愈合(图17(第31天)、图18(第60天))，第90天，溃疡创面基本愈合(图19)，110天后溃疡创面愈合良好(图20)。
实施例12 60例糖尿病下肢溃疡患者疗效观察
60例糖尿病下肢溃疡患者，其中男性36例，女性24例，年龄60岁～80岁，，都具有多饮、多尿、多食、乏力等症状，多次空腹血糖浓度检查均大于7.8mmol/L，符合II型糖尿病诊断。下肢溃疡病史1个月～26个月。其中急性溃疡15个，慢性溃疡45个，后者均在其他院接受过治疗。病变在足趾部位者36例，足跟与足跖部各9例，胫前6例。足部溃疡均为慢性病变深度已达脂肪层，创面缺乏肉芽组织，干燥、渗液少。溃疡面积最小2.0cm×1cm，最大2.2cm×5.0cm，足部溃疡四周有厚而硬的胼胝样组织环绕，6例胫前溃疡有5例为外伤引起，其面积均小于2.0cm×3.5cm，周围皮肤红肿痒痛明显。用随机分组方法分成了观察组和对照组(各30例)，两组病人年龄、性别、糖尿病分期及溃疡面积经统计学处理，差别无显著性意义(p＞0.05)。对于原发病的治疗中，除加强饮食治疗外，都采用药物降糖治疗。为避免老年患者发生低血糖或乳酸血症，在饮食控制治疗的同时给予阿卡波糖治疗。定时测定血糖浓度，根据血糖浓度调整治疗方案。原发病的理想治疗效果为血糖浓度不超过8.3mmol/L。
观察组中，用1％碘伏消毒创面及周围皮肤，以无菌生理盐水清洗创面，坏死组织用无菌镊子或剪刀清除，再用无菌生理盐水或3％过氧化氢液清洗。观察组创伤局部均匀外涂碘伏，1分钟～2分钟后使碘伏浸入组织，再用无菌棉棒将实施例1的本发明药物组合物涂于溃疡面，拭平，保持1.5毫米～2.0毫米厚，药膏表面覆盖无菌纱布包扎，抬高患肢，每日换药一次。待坏死组织开始液化时改为湿润暴露疗法，用药厚度1.0毫米，每日换药2次，每次换药时及时清除液化坏死组织。
对照组以16万单位庆大霉素浸湿的无菌纱布敷于创面，用敷料包扎1次/天。换药时，两组均应将创面的液化物或坏死组织清除干净，直至肉芽生长最终达到完全上皮化为止。
溃疡创面愈合率的测算，用透明方格纸画创面形状的方法，采用Adobephotoshop 7.0和Osiris软件进行面积计算。以伤治疗前创面面积为初始面积，以研究结束时面积为时相点创面面积。创面愈合率计算公式：愈合面积＝初始面积-时相点创面面积；创面愈合率＝(愈合面积/烫伤面积)×100％。治愈+显效+有效＝总有效。治愈：创面完全上皮化，无渗液；显效：创面愈合率大于80％，无分泌物，肉芽组织生长明显，新鲜易出血；有效：创面缩小但未达到80％，渗出液减少，肉芽组织增生，不新鲜或苍白；无效：创面无变化或扩大，创面不新鲜。
经统计学处理，数据均以±s表示，采用spssl1.0统计软件进行t检验和卡方检验以及计数资料的相关性分析，p＜0.05，差异有统计学意义。
在上述的病例中，6例胫前溃疡均于4周内愈合，其愈合过程与深II度烧伤创面相似，愈合后的局部皮肤平复。足趾与足跟部的慢性溃疡愈合时间最短35天，最长2个月。根据临床观察将这类创面的愈合过程分为坏死组织液化排除、脂蛋白透明膜形成和再生愈合三个阶段。坏死组织液化排除阶段时间长短与原发病和溃疡创面坏死程度有关，但都能在治疗3天～4天开始液化，2周～4周内液化排除完成脂蛋白透明膜形成阶段与坏死组织液化排除阶段为相互街接的两个阶段，即脂蛋白透明膜是在坏死组织液化排除过程中逐渐形成的，坏死组织液化排除结束之时脂蛋白透明膜完全形成。脂蛋白透明膜一旦形成，创面再生修复速度加快，肉眼下能见到点片状皮钉或皮岛扩展生长；随着用药治疗，环绕于创面周围的胼胝样组织逐渐脱落，出现新生皮肤并向心生长，最终修复创面，均为自行愈合。
两组治疗效果比较
| 组别 | 例数 | 治愈 | 显效 | 有效 | 无效 | 总有效数 | 平均愈合时间(d) |
| 对照组 | 30 | 9 | 12 | 6 | 3 | 27 | 47.30±20.40 |
| 实验组 | 30 | 27 | 2 | 1 | 0 | 30 | 25.00±10.50 |
注：率的比较采用行×列表资料X2检验，有效率和治愈率的X2值分别为22.71与20.07，均大于X20.05＝12.84，故p＜0.05；平均愈合时间比较采用t检验，t＝5.32，p＜0.01
实施例13
将实施例1得到的药物组合物，或者实施例6得到的所属的医用辅料，采用现有技术公知的方法制备一种药盒，最后将印制的使用说明书与该分别包装的药物组合物(例如药膏)或者所述的医用辅料(例如贴剂)包装，成为可供市售的药盒。
Claims (10)
1.药物组合物在制备治疗糖尿病肢体或体表溃疡药物或者医用辅料中的用途，该药物组合物由以下组分组成，按照药物组合物总重量计，(A)3-15％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。
2.根据权利要求1所述的用途，其特征在于所述的药物是外用药物。
3.根据权利要求2所述的用途，其特征在于所述的外用药物为油剂、乳剂、软膏、糊膏、贴剂或凝胶剂型。
4.根据权利要求1或2所述的用途，其特征在于所述的药物组合物进一步包括药学上可接受的载体。
5.根据权利要求1所述的用途，其特征在于所述的医用辅料为医用棉纱、医用绷带。
6.一种治疗糖尿病肢体或体表溃疡用的医用辅料，该辅料含有由以下组分组成的药物组合物，按照药物组合物总重量计，(A)3-15％的蜂蜡，(B)85-97％的含有黄芩、黄连、黄柏、蚯蚓和罂粟壳的芝麻油的提取物，其中黄芩、黄连、黄柏、蚯蚓和罂粟壳按照其干药重量计分别占芝麻油总重量的2-10％。
7.根据权利要求6所述的医用辅料，其特征在于所述的医用辅料为医用棉纱、医用绷带。
8.根据权利要求6或7所述的医用辅料，其特征在于所述的药物组合物为油剂、乳剂、软膏、糊膏、贴剂或凝胶剂型。
9.根据权利要求6或7所述的医用辅料，其特征在于所述的药物组合物进一步包括药学上可接受的载体。
10.一种药盒，其包括如权利要求1所述的药物组合物或者如权利要求6所述的医用辅料和使用说明书。
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| US14/634,470 US20150174189A1 (en) | 2009-08-20 | 2015-02-27 | Use of pharmaceutical compositions in preparing pharmaceuticals for treating diabetic ulcer |
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| CN86108951A (zh) * | 1986-12-31 | 1988-08-24 | 徐荣祥 | 低熔点软膏剂型及湿润烧伤膏的制作工艺 |
| CN1045059C (zh) * | 1993-01-15 | 1999-09-15 | 徐荣祥 | 一种治疗温血动物或人类热损伤的药用组合物及其制法 |
| JP3126583B2 (ja) * | 1994-01-13 | 2001-01-22 | ロンシャン シュ | 熱傷治療剤、その製造方法及びそれを用いた治療方法 |
| GB9510226D0 (en) * | 1995-05-20 | 1995-07-19 | Smith & Nephew | Sterilisable cream or paste product for topical application |
| CN1062129C (zh) * | 1995-09-14 | 2001-02-21 | 徐荣祥 | 药物基质及其用途 |
| BRPI9908182C1 (pt) * | 1998-02-27 | 2021-05-25 | Biora Ab | composições de proteína de matriz para cura de feridas |
| US6555118B1 (en) * | 2001-02-22 | 2003-04-29 | Sarfaraz K Niazi | Pharmaceutical preparation for the treatment of topical wounds and ulcers |
| CN1827766B (zh) * | 2001-06-28 | 2010-08-25 | 徐荣祥 | 体外细胞的培养方法 |
| US6685971B2 (en) * | 2001-06-28 | 2004-02-03 | Rongxiang Xu | Method and composition for repairing and promoting regeneration of mucosal tissue in the gastrointestinal tract |
| RU2264798C2 (ru) * | 2002-11-04 | 2005-11-27 | Ардашев Вячеслав Николаевич | Аптечка неотложной самопомощи при приступе аритмии с частым пульсом |
| CN101069753A (zh) * | 2006-05-09 | 2007-11-14 | 上海美宝生命科技有限公司 | 一种创面速愈贴及其制造方法 |
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2009
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2010
- 2010-01-20 AU AU2010283917A patent/AU2010283917B2/en active Active
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- 2010-01-20 CA CA2746459A patent/CA2746459C/en active Active
- 2010-01-20 RU RU2011130248/15A patent/RU2523889C2/ru active
- 2010-01-20 JP JP2012525024A patent/JP5580896B2/ja active Active
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014114045A1 (zh) * | 2013-01-24 | 2014-07-31 | Xu Rongxiang | 治疗热损伤、创疡合并骨损伤的药物组合物 |
| CN103961445A (zh) * | 2013-01-24 | 2014-08-06 | 徐荣祥 | 治疗热损伤、创疡合并骨损伤的药物组合物 |
| US9533020B2 (en) | 2013-01-24 | 2017-01-03 | Kevin Peng Xu | Pharmaceutical compositions for treating thermal injuries and wounds combined with bone injuries |
| RU2636227C2 (ru) * | 2013-01-24 | 2017-11-21 | СЮЙ Кевин Пэн | Фармацевтическая композиция для лечения термических травм и ран в сочетании с повреждением кости |
| CN103961445B (zh) * | 2013-01-24 | 2018-04-17 | 徐荣祥 | 治疗热损伤、创疡合并骨损伤的药物组合物 |
| CN104524002A (zh) * | 2014-12-12 | 2015-04-22 | 陈霞 | 一种治疗糖尿病足的消炎生皮油纱及其制备方法 |
| CN106075538A (zh) * | 2016-06-08 | 2016-11-09 | 成都森科制药有限公司 | 防粘油纱条及其制作工艺 |
| CN116327837A (zh) * | 2023-04-25 | 2023-06-27 | 北京荣祥再生医学研究所有限公司 | 一种组合物及其在制备抑制细胞周期蛋白d1的药物中的应用 |
Also Published As
| Publication number | Publication date |
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| EP2362777A1 (en) | 2011-09-07 |
| RU2523889C2 (ru) | 2014-07-27 |
| EP2362777B1 (en) | 2014-07-16 |
| EP2362777A4 (en) | 2012-08-22 |
| MX2011007707A (es) | 2011-10-19 |
| AU2010283917A1 (en) | 2011-07-07 |
| AU2010283917B2 (en) | 2014-07-17 |
| WO2011020311A1 (en) | 2011-02-24 |
| KR101534468B1 (ko) | 2015-07-09 |
| CA2746459C (en) | 2015-06-23 |
| KR20140129370A (ko) | 2014-11-06 |
| RU2011130248A (ru) | 2013-09-27 |
| US9814750B2 (en) | 2017-11-14 |
| KR20120041689A (ko) | 2012-05-02 |
| JP2013502382A (ja) | 2013-01-24 |
| US20120171298A1 (en) | 2012-07-05 |
| JP5580896B2 (ja) | 2014-08-27 |
| BRPI1006040A2 (pt) | 2016-05-10 |
| BRPI1006040B1 (pt) | 2019-10-08 |
| US20150174189A1 (en) | 2015-06-25 |
| US20150104522A1 (en) | 2015-04-16 |
| ES2500840T3 (es) | 2014-09-30 |
| CA2746459A1 (en) | 2011-02-24 |
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