CN105833020A - 一种促进术后创面愈合的外用护理药物组合物 - Google Patents
一种促进术后创面愈合的外用护理药物组合物 Download PDFInfo
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Abstract
本发明公开了一种促进术后创面愈合的外用护理药物组合物，属于中药技术领域。本发明药物组合物由以下中药材制备而成：拳参、牡丹皮、土白芨、炉甘石、白花蛇舌草。本发明药物组合物组方精简，具有清热解毒，活血化瘀，消肿止痛，敛疮生肌之效，可有效促进术后创面愈合，减轻患者痛苦。经临床应用验证，其疗效确切，疗程短，药性平和，未出现毒副作用及不良反应，安全系数高，临床观察总有效率达到97.5％，可作为临床有效药物推广应用。
Description
技术领域
本发明属于中药技术领域，特别涉及一种促进术后创面愈合的外用护理药物组合物及其制备方法。
背景技术
创面愈合是指机体遭受外力作用，皮肤等组织出现离断或缺损后的愈复过程，为包括各种组织的再生和肉芽组织增生、瘢痕组织形成的复杂组合，表现出各种过程的协同作用。伤口处理正确，能使其迅速愈合；反之，可能化脓感染，经久不愈，甚至因并发全身感染、气性坏疽、破伤风等危及生命。外科手术创面属于典型的开放性创伤，特别是女性会阴侧切缝合术，肛肠手术，腹部手术等，手术切口开放污染，伤口不易愈合，病程长，渗出多，换药困难，患者痛苦，严重的影响了患者的生活质量。因此，促进术后伤口及早愈合、减少并发症的发生引起临床护理人员高度重视。
手术切口在中医学上属于金刀创伤。中医治疗创伤有悠久的历史经验，治疗上主要以清热解毒，活血化瘀，消肿止痛为主，通过改善局部血液、淋巴循环，减轻组织水肿，改善上皮，肉芽的生长环境，获得较好疗效，并被广泛应用。
发明内容
为了弥补现有技术的不足，本发明在祖方的基础上，经过改良、验证，为患者提供了一种疗效显著、疗程短、安全性高的促进术后创面愈合的药物组合物。
为实现本发明的目的，本发明采用的技术方案如下：
一种促进术后创面愈合的外用护理药物组合物，由以下五味中药材制备而成：拳参、牡丹皮、土白芨、炉甘石、白花蛇舌草。
优选地，本发明促进术后创面愈合的药物组合物，由以下重量份的中药材制备而成：拳参8-12份、牡丹皮10-14份、土白芨6-10份、炉甘石1-3份、白花蛇舌草8-12份。
进一步优选地，本发明促进术后创面愈合的药物组合物，由以下重量份的中药材制备而成：拳参10份、牡丹皮12份、土白芨8份、炉甘石2份、白花蛇舌草10份。
本发明组方中各味药材的性状及功能主治如下，
拳参：【性味】苦、涩，微寒。【归经】归肺、肝、大肠经。【功能主治】清热解毒，消肿，止血。用于赤痢，热泻，肺热咳嗽，痈肿，瘰疬，口舌生疮，吐血，衄血，痔疮出血，毒蛇咬伤。
牡丹皮：【性味】苦、辛，微寒。【归经】归心、肝、肾经。【功能主治】清热凉血，活血化瘀。用于温毒发斑，吐血衄血，夜热早凉，无汗骨蒸，经闭痛经，痈肿疮毒，跌扑伤痛。
土白芨：【性味】苦；平。【归经】肺；脾经。【功能主治】补肺止肌；化瘀止血。主肺痨咳血；吐血；衄血；创伤；烫火伤；痈肿。
炉甘石：【性味】甘，平。【归经】归胃经。【功能主治】解毒明目退翳，收湿止痒敛疮。用于目赤肿痛，眼缘赤烂，翳膜胬肉，溃疡不敛，脓水淋漓，湿疮，皮肤瘙痒。
白花蛇舌草：【性味】甘、淡，凉。【归经】入胃、大肠、小肠经。【功能主治】清热解毒，利尿消肿，活血止痛。用于肠痈(阑尾炎)，疮疖肿毒，湿热黄疸，小便不利等症；外用治疮疖痈肿，毒蛇咬伤。
本发明药物组合物组方精简，配伍合理，对症给药，疗效独到，诸药合用，能够起到清热解毒，活血化瘀，消肿止痛，敛疮生肌之效，可有效促进术后创面愈合，减轻患者痛苦。经临床应用验证，其疗效确切，疗程短，药性平和，未出现毒副作用及不良反应，安全系数高，，临床观察总有效率达到97.5％，可作为临床有效药物推广应用。
本发明还提供了所述药物组合物的制备方法，其特征在于包含以下步骤：
(1)称取处方量的拳参、牡丹皮、土白芨、白花蛇舌草，分别放入中药粉碎机中粉碎成粗粉，混合均匀；加入煎煮锅，加水煎煮两次，第一次加水6-8倍量，温浸4小时，煎煮2.5h，第二次加水量为4-6倍量，煎煮时间为1.5h，合并煎煮液，过滤，得滤液；减压浓缩滤液，干燥，放入中药粉碎机中进行粉碎，粉碎后过80目筛；
(2)称取处方量的炉甘石粉碎成超细粉；
(3)混合步骤(1)和步骤(2)制备的细粉，加入药学上可接受的辅料载体制备成乳膏剂或凝胶剂。
本发明药物组合物与现有技术相比，具有如下优势：
1)与常规治疗药物相比，本发明药物组合物显著缩短了治疗时间。本发明药物组合物治疗效果十分显著，10天治愈率最高可达75％，有效率达到97.5％。
2)本发明药物组合物中5味中药配伍使用起到了协同增强作用。随意改变组方，不能达到本发明显著的治疗效果。
3)本发明方法制得的药物组合物有效活性成分高，并且安全、无毒副作用，极大地提高了患者接受治疗的依从性。
本发明药物组合物的特征和优点将在随后的具体实施方式部分予以详细说明。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实施例l 乳膏剂的制备
按以下重量份称取本发明各原料：拳参10份、牡丹皮12份、土白芨8份、炉甘石2份、白花蛇舌草10份。
制备方法：
(1)称取处方量的拳参、牡丹皮、土白芨、白花蛇舌草，分别放入中药粉碎机中粉碎成粗粉，混合均匀；加入煎煮锅，加水煎煮两次，第一次加水6-8倍量，温浸4小时，煎煮2.5h，第二次加水量为4-6倍量，煎煮时间为1.5h，合并煎煮液，过滤，得滤液；减压浓缩滤液，干燥，放入中药粉碎机中进行粉碎，粉碎后过80目筛；
(2)称取处方量的炉甘石粉碎成超细粉；
(3)混合步骤(1)和步骤(2)制备的细粉。
(4)取适量单硬脂酸甘油酯、硬脂酸、白凡士林、三乙醇胺水浴加热至熔化，混匀，作为油相；取适量的纯化水，将步骤(3)制备的细粉溶解到水中；取甘油、十二烷基硫酸钠、纯化水、尼泊金乙脂混合加热至80℃左右，作为水相；待油相温度为80℃时，搅拌下将细粉溶液加入其中，并使温度保持在80℃；将搅拌均匀后的油相，在慢速搅拌下，缓缓加入水相中，后加速搅拌20min，停止搅拌，即得乳膏剂。
使用本发明药物组合物促进术后创面愈合时，使用所制备的乳膏剂，每支15g，含生药量5g，每日2-3次均匀涂敷患处。
实施例2 凝胶剂的制备
按以下重量份称取本发明各原料：拳参10份、牡丹皮12份、土白芨8份、炉甘石2份、白花蛇舌草10份。
制备方法：
(1)称取处方量的拳参、牡丹皮、土白芨、白花蛇舌草，分别放入中药粉碎机中粉碎成粗粉，混合均匀；加入煎煮锅，加水煎煮两次，第一次加水6-8倍量，温浸4小时，煎煮2.5h，第二次加水量为4-6倍量，煎煮时间为1.5h，合并煎煮液，过滤，得滤液；减压浓缩滤液，干燥，放入中药粉碎机中进行粉碎，粉碎后过80目筛；
(2)称取处方量的炉甘石粉碎成超细粉；
(3)混合步骤(1)和步骤(2)制备的细粉。
(4)将适量卡波姆缓慢加入水中，边加边搅拌直至形成透明的凝胶基质，将步骤(3)制备的细粉溶于水中，再加入凝胶基质中，搅拌均匀，加入丙二醇、甘油、适量水，适量三乙醇胺调节pH值至中性，即得。
使用本发明药物组合物治疗体表溃疡时，使用所制备的凝胶剂，每支15g，含生药量5g，每日2-3次均匀涂敷患处。
实施例3 乳膏剂的制备
按以下重量份称取本发明各原料：拳参12份、牡丹皮14份、土白芨10份、炉甘石3份、白花蛇舌草12份。
制备方法同实施例1。
实施例4 乳膏剂的制备
按以下重量份称取本发明各原料：拳参8份、牡丹皮10份、土白芨6份、炉甘石1份、白花蛇舌草8份。
制备方法同实施例1。
对比实施例 乳膏剂的制备
按以下重量份称取本发明各原料：拳参6份、牡丹皮18份、土白芨8份、炉甘石2份、白花蛇舌草10份。
制备方法同实施例1。
实施例6 本发明中药制剂促进术后创面愈合的临床观察
1、临床资料
一般资料：选取2013年10月-2014年9月期间在我院接受手术治疗的患者共120例。采用平行对照的原则，分为治疗组，对照1组，和对照2组各40例。其中治疗组男24例，女16例，年龄15-65岁，平均年龄(34.2±11.4)岁，Ⅰ类切口22例，Ⅱ类切口14例，Ⅲ类切口4例，四肢手术20例，腹部手术8例，肛门手术8，头颅手术4例，切口长度(10.34±8.36)cm；对照1组男25例，女15例，年龄12-60岁，平均年龄(32.6±10.8)岁，Ⅰ类切口23例，Ⅱ类切口13例，Ⅲ类切口4例，四肢手术18例，腹部手术10例，肛门手术9，头颅手术3例，切口长度(11.62±7.05)cm；对照2组男23例，女17例，年龄15-62岁，平均年龄(31.8±10.9)岁，Ⅰ类切口20例，Ⅱ类切口14例，Ⅲ类切口6例，四肢手术19例，腹部手术8例，肛门手术9，头颅手术4例，切口长度(10.47±9.34)cm；三组患者的性别、年龄、切口、手术部位等无显著差异，具有可比性。
2、排除标准：
(1)术前检查肝肾功能、HGB及凝血功能不正常的患者；
(2)合并有心脑血管疾病、肺系疾病、糖尿病、尿毒症、高脂血症等的患者；
(3)合并有恶性肿瘤的患者；
(4)未完成治疗周期的患者。
3、治疗方法
治疗组：创口缝合后，用本发明药物组合物实施例1制备的乳膏剂以0.1～0.2cm的厚度均匀涂抹患处，每日上药2次。
对照1组：术后创口采用常规处理，用0.02％的高锰酸钾溶液擦洗，每次5min.
对照2组：创口缝合后，用本发明药物组合物对比实施例制备的乳膏剂以0.1～0.2cm的厚度均匀涂抹患处，每日上药2次。
治疗期间所有患者均忌辛辣、酒类、鱼虾等食品。疗程均为10天。
4.疗效判断标准：
参照《中医临床病证诊断疗效标准》结合临床制订疗效评定标准。
痊愈：创面全部愈合，无痴下积脓等假性愈合现象；
显效：创面面积缩小范围＞75％，无脓性分泌物，肉芽组织新鲜、颜色鲜红；
有效：创面面积缩小范围缩小＞25％，无脓性分泌物或脓性分泌物明显减少，肉芽组织色红；
无效：创面面积缩小范围＜25％，创面脓性分泌物无明显减少，肉芽组织色暗，创面无明显缩小趋势。
总有效率＝(痊愈例数+显效例数+有效例数)/总例数×％。
4.治疗结果：
1)统计学分析
所得数据应用SPSS14.0软件进行统计学分析，计量资料以均数±标准差表示，采用t检验，计数资料采用x2检验，P＞0.05为差异无统计学意义，P＜0.05为差异有统计学意义。
2)临床观察具体结果如下：
经过1个疗程的治疗，120例患者均完成临床观察。治疗组疗效结果如下：
临床痊愈30例，显效6例，有效3例，无效1例，总有效率97.5％；对照1组临床痊愈14例，显效10例，有效8例，无效8例，总有效率80％；对照2组临床痊愈20例，显效7例，有效6例，无效7例，总有效率82.5％。
治疗组治疗效果明显优于对照1组和对照2组，且差异有统计学意义(P＜0.05)。
伤口愈合时间见下表1：
| 组别 | 例数 | 伤口长度(cm) | 愈合时间(d) |
| 治疗组 | 40 | 10.34±8.36 | 5.2±1.5 |
| 对照1组 | 40 | 11.62±7.05 | 8.6±1.7 |
| 对照2组 | 40 | 10.47±9.34 | 8.4±1.6 |
治疗组治疗过程中生命体征平稳且无过敏等严重不良反应，治疗结束后对40例患者的血常规、尿常规等指标进行统计学处理，未见明显异常。结果表明本方的临床运用是安全有效的。同时，通过治疗组和对照2组的临床效果对比表明，改变组方不能达到本发明药物组合物同样优异的治疗效果。
实验结果表明：本发明促进术后创面愈合的药物组合物具有治愈率高，疗程短，安全性高的优点，其疗效确切，药性平和，未出现毒副作用及不良反应，可作为临床有效药物，值得进一步研究并推广应用。
Claims (5)
1.一种促进术后创面愈合的外用护理药物组合物，其特征在于，由以下中药材制备而成：拳参、牡丹皮、土白芨、炉甘石、白花蛇舌草。
2.如权利要求1所述的药物组合物，其特征在于，由以下重量份的中药材制备而成：拳参8-12份、牡丹皮10-14份、土白芨6-10份、炉甘石1-3份、白花蛇舌草8-12份。
3.如权利要求2所述的药物组合物，其特征在于，由以下重量份的中药材制备而成：拳参10份、牡丹皮12份、土白芨8份、炉甘石2份、白花蛇舌草10份。
4.如权利要求1-3所述的药物组合物的制备方法，其特征在于，包含以下步骤：
(1)称取处方量的拳参、牡丹皮、土白芨、白花蛇舌草，分别放入中药粉碎机中粉碎成粗粉，混合均匀；加入煎煮锅，加水煎煮两次，第一次加水6-8倍量，温浸4小时，煎煮2.5h，第二次加水量为4-6倍量，煎煮时间为1.5h，合并煎煮液，过滤，得滤液；减压浓缩滤液，干燥，放入中药粉碎机中进行粉碎，粉碎后过80目筛；
(2)称取处方量的炉甘石粉碎成超细粉；
(3)混合步骤(1)和步骤(2)制备的细粉，加入药学上可接受的辅料载体制备成乳膏剂或凝胶剂。
5.如权利要求1或2所述的药物组合物在制备治疗促进术后创面愈合的药物中的用途。
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