CN102973800A - 马勃复方涂膜剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种马勃复方涂膜剂，每1000g涂膜剂主要由下述配比的原料制成：马勃180～220g、黄连90～110g、连翘90～110g、冰片45～55g、白及胶浆18～22g、甘油110～140g、PVA-12415～20g、吐温-808～10g，余量为乙醇。该涂膜剂具有消肿解毒、止痒、止血的功效，用于痈疮、肿痛及外伤出血等的治疗，能有效隔离创面，避免创面污染及局部感染。
Description
技术领域
本发明属于涂膜剂技术领域，具体涉及一种马勃复方涂膜剂及其制备方法。该涂膜剂具有消肿解毒、止痒、止血的功效，可用于痈疮、肿痛及外伤出血等。
背景技术
目前，用于治疗痈疮、肿痛及外伤出血的外用药很多，但大部分都难以完全隔离创面，致使创面容易被污染，从而导致局部感染。
发明内容
本发明目的在于提供一种马勃复方涂膜剂及其制备方法。该涂膜剂具有消肿解毒、止痒、止血的功效，用于痈疮、肿痛及外伤出血等的治疗，能有效隔离创面，避免创面污染及局部感染。
为实现上述目的，本发明采用如下技术方案：
一种马勃复方涂膜剂，每1000g涂膜剂主要由下述配比的原料制成：马勃180～220g、黄连90～110g、连翘90～110g、冰片45～55g、白及胶浆18～22g、甘油110～140g、PVA-124 15～20g、吐温-80 8～10g，余量为乙醇。
具体的：所述乙醇体积浓度为70－80%。
本发明所用白及胶浆可选用普通市售产品，也可以按下述方法制得：将白及与其重量8－12倍的水混合，回流提取2－4次，每次1－2小时，合并提取液，减压浓缩至白及重量的3－4倍，添加乙醇至乙醇占溶液体积总量的70％，过滤，沉淀于60℃减压烘干后粉碎得白及胶半成品，备用；使用时加入白及胶半成品2－3重量倍的水溶解（可于90－95℃水浴中加热以促其溶解），即得。
所述马勃复方涂膜剂的制备方法，其包括如下步骤：按比例取各原料，将粉碎过的黄连、连翘同马勃子实体一起用85～90%（指体积浓度）乙醇浸渍36～48小时后渗漉，收集渗漉液并减压浓缩（优选50～60℃）至450－500g，然后加入白及胶浆、甘油、冰片及吐温-80，待溶解后，再加入PVA-124水溶液，待溶解完全后，用乙醇补至1000g，即得。分装于小瓶，密封。每瓶装量约10g。
具体的，所述PVA-124水溶液是由PVA-124与100ml水混合后，于80±5℃水浴中加热溶解制得。
本发明所述涂膜剂为外用药，用时涂于患处，一日2次。该涂膜剂具有消肿解毒、止痒、止血的功效，可用于痈疮、肿痛及外伤出血等。
马勃分布较广，世界上大部分地区均有记载。马勃在我国各地几乎都有分布，资源比较丰富。马勃含有多种氨基酸、无机盐，还含有麦角甾醇、类脂质、马勃素、马勃酸、抗环血酸、脱氢抗环血酸，以及铜、锌、铁、钙、镁等微量元素。马勃药性平、味辛，归肝、肺、肾、胃经。具有止血、抗菌、抗癌的作用。临床上多用于咳症，急性扁桃体炎、咽炎、喉炎、腮腺炎、颜面丹毒，胃病，吐血、衄血等。
黄连味苦、性寒、入心、肝、胃、大肠经, 功能清热燥湿、泻火解毒。是一种很好的清热解毒消炎药, 具有广谱抗生素的作用。常用于治疗湿热内蒸、痞满胀闷、烦躁呕逆、泄泻痢疾、消渴、暴发火眼、痈疽肿毒、中耳炎、急性扁桃体炎、百日咳、大叶性肺炎、流行性脑脊髓膜炎、胆囊炎等，且具有抗癌、抗放射及促进细胞代谢的作用。
连翘味苦，性微寒。入心、肺、小肠经。清热解毒，散结消肿、疏散风热，有“疮家圣药”之称。连翘果皮中含有木质素类、苯乙烷类、三萜类、香豆素类、甾醇类化合物及皂苷等，连翘酚为其抗菌成分。连翘具有抗菌、强心、利尿、镇吐等药理作用，常用于治疗急性风热感冒、咽喉肿痛、斑疹、丹毒、痈肿疮毒、淋巴结结核、尿路感染等症。
冰片亦称龙脑、龙脑香、梅花脑、梅花冰片等，具有开窍醒神、清热止痛之功效，用于热病神昏、痉厥、中风痰厥、惊痫痰迷、喉痹齿痛、口疮痈疡、目赤。冰片较少单独应用，常用作“引药及佐药”，中成药有较多的冰片配伍应用，在心脑血管病治疗中应用尤其广泛。
白及胶浆主要成分为白及胶质，即白及甘露聚糖，具有一定的粘稠性，起到一定的辅助成膜作用，另外它还有止血、消肿、敛疮、生肌止痛之效。PVA-124为优选的成膜材料；吐温-80用作增溶剂、稳定剂；甘油起到溶解药物，滋润皮肤的作用；乙醇为溶剂，起到溶解主药，防腐的作用。
本发明涂膜剂采用复方药物及优化的涂膜基质，疗效显著，能够有效地隔离创面，避免创面污染及局部感染，促进疤痕消失，优于一般的涂膜制剂。成膜材料及马勃复方涂膜剂成膜好、无毒，对皮肤无刺激性。此外，本发明涂膜剂是一种外用制剂，制备工艺简单，不用裱背材料，无需特殊设备，使用方便，可要用于治疗痈疮、肿痛及外伤出血等。
与常规的外用制剂相比，本发明所述马勃复方涂膜剂在治疗痈疮、肿痛及外伤出血方面具有突出的优点：1）、药物直接涂擦或喷洒于患处，不需要包扎，形成一层均匀的药膜，不但可以防止药物脱落，而且能够防止皮肤表面水分的蒸发和组织液的渗出，有利于药物的吸收，起到了保护创面的作用。2）、对创面有促进残存上皮生长的作用，利于疤痕消失。3）、该涂膜剂使用方便，既不污染衣物，又能够使创面免受外界污染，且无毒副作用，患者容易接受。
具体实施方式
以下通过具体实施例对本发明做进一步详细说明，但本发明的保护范围不限于此。
实施例1和2所用白及胶浆按下述方法制得：将白及与其重量10倍的水混合，回流提取3次，每次1.2小时，合并提取液，减压浓缩至白及重量的3.5倍，添加乙醇至乙醇占溶液体积总量的70％，过滤，沉淀于60℃减压烘干后粉碎得白及胶半成品，备用；使用时加入白及胶半成品2重量倍的水溶解，即得。
实施例1：
一种马勃复方涂膜剂，每1000g涂膜剂主要由下述配比的原料制成：马勃220g、黄连90g、连翘100g、冰片55g、白及胶浆18g、甘油125g、PVA-124 16g、吐温-80 8.5g，余量为体积浓度80%的乙醇。
所述马勃复方涂膜剂的制备方法，其包括如下步骤：按比例取各原料，将粉碎过的黄连、连翘同马勃子实体一起用85%乙醇浸渍36小时后渗漉，收集渗漉液并减压浓缩至500g，然后加入白及胶浆、甘油、冰片及吐温-80，待溶解后，再加入PVA-124水溶液，待溶解完全后，用体积浓度80%的乙醇补至1000g，即得。分装于小瓶，密封。所述PVA-124水溶液是由PVA-124与100ml水混合后，于80℃水浴中加热溶解制得。
实施例2
一种马勃复方涂膜剂，每1000g涂膜剂主要由下述配比的原料制成：马勃200g、黄连100g、连翘100g、冰片50g、白及胶浆20g、甘油125g、PVA-124 15g、吐温-80 10g，余量为体积浓度70%的乙醇。
所述马勃复方涂膜剂的制备方法，其包括如下步骤：按比例取各原料，将粉碎过的黄连、连翘同马勃子实体一起用90%乙醇浸渍48小时后渗漉，收集渗漉液并减压浓缩至480g，然后加入白及胶浆、甘油、冰片及吐温-80，待溶解后，再加入PVA-124水溶液，待溶解完全后，用体积浓度70%的乙醇补至1000g，即得。分装于小瓶，密封。所述PVA-124水溶液是由PVA-124与100ml水混合后，于80±5℃水浴中加热溶解制得。
实施例3
一种马勃复方涂膜剂，每1000g涂膜剂主要由下述配比的原料制成：马勃180g、黄连90g、连翘110g、冰片55g、白及胶浆22g、甘油140g、PVA-124 20g、吐温-80 8g，余量为体积浓度70%的乙醇。
所述马勃复方涂膜剂的制备方法，参照实施例2。
为验证本发明所述马勃复方涂膜剂的药效，特进行如下试验。
痈疮临床诊断：感染局部呈紫红色肿胀，高出体表，边界不清，病灶表面可见多个“脓头”，有剧痛;局部区域淋巴结肿大;可有寒战、高热、乏力、头痛等全身症状。初起时，局部皮肤有一个红、肿、热、痛的炎性浸润的扁平硬块，颜色暗红，境界不清，逐渐向四周和深部组织发展。约在1～2周内患处化脓、坏死、破溃，表面有多个溃孔，坏死的组织与脓液自溃孔排出。严重时整个患部全坏死，表面皮肤完全脱落，形成一个深的巨大溃疡。由新生的肉芽组织来代替，痊愈后形成瘢痕。好发于颈部背侧，其次，背部。也可发生在全身任何部位。
疗效标准：
治愈：红肿消失，皮肤无硬块，按压无疼痛感，临床体征消失，愈后患处无明显疤痕。
好转：临床体征基本消失，红肿、疼痛明显减轻，局部皮肤硬块明显减小。
无效：临床体征无变化，皮肤红肿、疼痛、硬块消失不明显。
为表明本发明马勃复方涂膜剂的治疗效果，经52例（其中男36例，女16例，年龄18～52岁）痈疮患者临床观察，涂抹使用本发明涂膜剂，临床治愈39例，好转13例，总有效率100%。
以下通过典型病例来进一步阐述本发明涂膜剂的有益效果。
病例1：
李某，男，32岁。就诊时背部及臀部有多个痈疮，痈疮部位紫红色肿胀，用手触摸有灼热感，按压时疼痛并具有硬块感；其中臀部红肿疼痈，呈蜂窝状；臀部痈疮表面有溃孔，有脓液流出，疼痛难忍，坐立不安。就诊前用紫药水涂抹，效果不好，未用其他药物。采用局部常规消毒，清除脓液及清洁伤口，涂抹本发明实施例1马勃复方涂膜剂治疗1周，红肿逐渐消失，溃孔逐渐愈合，继续用药一周，硬块消失，触摸患处无疼痛感，后又加强巩固3天，治愈。愈后患处无明显瘢痕，无复发。
病例2：
吴某，男，21岁，学生。臀部痈疮如蜂窝状，多已溃烂，有脓液流出，瘙痒、疼痛难忍，坐立不安。并伴有发热症状，测体温37.8℃，昼夜不能睡眠。酒精消毒，涂抹皮康王效果不显。用双氧水清除患处脓液后，酒精清洁患处周围皮肤后，涂抹本发明实施例2马勃复方涂膜剂治疗3天，溃烂部位逐渐愈合，瘙痒、疼痛减轻，体温转为正常；继续涂抹用药一周，皮肤变平滑，触摸患处无疼痛感，遂治愈。愈后患处无明显斑痕，无复发。
本马勃复方涂膜剂用于外伤出血（主要用于轻微外出血，如皮肤轻微创伤，刀伤等）的治疗，经27例（其中男18例，女9例，年龄21～46岁）患者临床观察，涂抹使用本发明涂膜剂，临床治愈27例，有效率为100%。
典型病例：王某，男，37岁，工人。搬运东西时左胳膊手腕处被金属器具划伤，皮肤外伤，伤口长小于3cm，深小于3mm，碘酒消毒伤口后涂抹本发明实施例1马勃复方涂膜剂，3分钟后血止，连续涂抹7天，伤口愈合，无明显疤痕。
Claims (5)
1.一种马勃复方涂膜剂，其特征在于：每1000g涂膜剂主要由下述配比的原料制成：马勃180～220g、黄连90～110g、连翘90～110g、冰片45～55g、白及胶浆18～22g、甘油110～140g、PVA-124 15～20g、吐温-80 8～10g，余量为乙醇。
2.如权利要求1所述的马勃复方涂膜剂，其特征在于：所述乙醇体积浓度为70－80%。
3.如权利要求1所述的马勃复方涂膜剂，其特征在于：所述白及胶浆按下述方法制得：将白及与其重量8－12倍的水混合，回流提取2－4次，每次1－2小时，合并提取液，减压浓缩至白及重量的3－4倍，添加乙醇至乙醇占溶液体积总量的70％，过滤，沉淀减压烘干后粉碎得白及胶半成品，备用；使用时加入白及胶半成品2－3重量倍的水溶解，即得。
4.权利要求1至3任一所述马勃复方涂膜剂的制备方法，其特征在于，包括如下步骤：按比例取各原料，将粉碎过的黄连、连翘同马勃子实体一起用85～90%乙醇浸渍36～48小时后渗漉，收集渗漉液并减压浓缩至450－500g，然后加入白及胶浆、甘油、冰片及吐温-80，待溶解后，再加入PVA-124水溶液，待溶解完全后，用乙醇补至1000g，即得。
5.如权利要求4所述马勃复方涂膜剂的制备方法，其特征在于，所述PVA-124水溶液是由PVA-124与100ml水混合后，于80±5℃水浴中加热溶解制得。
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