CN1293993A - 金疮止血消炎药及其制备方法 - Google Patents
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Abstract
本发明公开了一种止血、消炎、止痛、用于各种内外出血症治疗的药物及其制备方法,其主要组成:卷柏、松萝、白及胶、艾叶、冰片等,经过多步提取、分离最终制备成粉剂或胶囊剂;本发明生产工艺先进,其制剂经药效学及临床试验证明,有良好的止血、消炎、止痛、促进组织愈合等一效多能的功效,填补了中成药止血剂领域中该类药品的空白。
Description
本发明涉及一种止血、消炎、止痛的药物。具体地说是以中草药为主要原料制备的适用于各种内外出血症治疗的药物,本发明还涉及该药物的制备方法。
创伤出血是临床上经常遇到的急疹之一。处理此类急诊通常所使用的药物为云南白药;虽然云南白药有止血作用,但是重在活血去瘀、治跌打损伤。临床上迫切需要一种既能迅速止血,又能消炎、消肿止痛、促进破损组织愈合,具备一效多能的药物。
本发明的目的就是根据临床需要,提供一种使用方便,有显著止血作用,能预防和治疗创伤沾染(感染)引起的局部炎症、肿痛,并具有促进组织愈合,并能使瘕痕减少或无,又能被组织吸收、具备一效多能的中成药,以填补中成药止血剂领域中该类药品的空白。
本发明的另一目的是提供该药物的制备方法。
本发明的解决方案是根据祖国医学基础理论并结合现代医学研究成果而提出的。祖国医学基础理论以整体观念为指导,认识局部的病理变化与整体病理反应的统一性,即重视局部病变和与之相关的因素影响,更注重整体病理反应,并以辩证施治原则,按君、臣、佐、使的法则组方,用药,基于此,对创伤出血的治疗,既要重视局部病变快速止血,更要注重影响愈合的因素和愈合后的结果。以“急则治其标”、“虚则补之”、“务必先安未受邪之地”等法则为依据,按轻重缓急组方,主、辅、佐使三组中药相互为用,既能止血、消炎,又能止痛,促进组织愈合,而且愈合后瘕痕也相对减少,成为一效多能的止血方。
本发明药物主要含有下列组分(用量为重量份):
卷柏10-40 松萝10-30 白及胶10-40
艾叶5-30 冰片3-10
将上述各组分制备成本发明药物的制备方法如下:
①取卷柏、松萝、艾叶以水提醇沉法制备,得浓缩液,波美度控制在3.0-10.0,备用;②取明胶加水浸泡,溶解,加入固化剂,边打泡边加入上述步骤①所制备的浓缩液及配方量的白及胶,至体积发胀至3-4倍,固化后至-10-20℃下使其冰冻,取出切成小块,鼓风干燥,打碎,过20-60目筛;③加入配方量之冰片,混匀,灭菌,即得。
上述组方中所使用的白及胶,系从中药白及中以水提醇沉法提取制得的白色粘胶质,在方中与卷柏合用,具有明显的止血效果。
组方中使用松萝、艾叶,增强了抗菌消炎作用,再配以具有止痛作用的冰片,并辅以制备过程中所使用的明胶,更增加了全方止血、消炎、止痛及促进组织愈合的效果。
若将上述步骤所制得的粉末按制剂学上的常规方法制成胶囊剂或制成药剂学上所说的剂型作为内服药,对消化道出血等同样具有显著疗效。
本发明具有下述特点:
①利用方中药物的理化性质与新型工艺相结合的方法,在不增加制剂辅料条件下,使中药提出物能够均匀分散到制剂中,解决了浸膏提出物易吸潮、变质、不稳定的难点;
②充分利用部分药物和剂量的物理性能,制成一定的细度,使本药物用于创面易被迅速吸收,提高了该制剂生物利用度;
③资源丰富、价格低廉、适应症广,无毒副作用,使用方便安全,每克成本仅0.05元(云南白药每克2元左右)。
④经在显微镜下(5倍)观察,本工艺所制得的产品呈复粒网状结构,使药粉更易粘附创面,因而易于被组织吸收,修复被破坏的组织,促进组织愈合。
本发明的药效学动物试验研究结果如下:
经过对本发明创面局部止血试验(股动脉、肝组织、离断后肢等切口创面)、凝血机制的检测试验(血栓形成和血小板吸附率、凝血酶原时间、优球蛋白溶解时间等)、抗菌作用试验、抗炎作用试验、促进组织愈合试验、组织吸收试验等六个方面,十余项实验指标结果表明,对中等动脉切口、皮肤、皮下组织、肌肉、骨髓及肝组织等创面局部止血作用显著;经家兔口服吸收后检测,能促进兔血栓形成,提高血小板吸附率,对兔血浆凝血酶原时间具有缩短作用,使增加凝血酶原迅速转变为凝血酶,延长兔优球蛋白的溶解时间,显著增加优球蛋白与血浆中纤维蛋白和纤溶酶原的亲和力作用,从而加速和增强血浆凝固以达到迅速止血之功效;本品具有良好的和明显的抗炎、抗菌作用,对大肠杆菌、金黄色葡萄球菌及绿脓杆菌均有杀菌作用,尤其是对金黄色葡萄球菌的抗菌作用最强;经包埋肝组织、肌肉组织的本品均能被组织完全吸收,且血管越丰富的组织,吸收越迅速;对破损伤口创面有加速组织愈合作用。
同时,经黄石市中医院多年临床应用,对开放性损伤、肛肠术后创面、宫颈光疗创面出血、鼻衄等症治疗,取得显著疗效,临床疗效观察结果总结如下:
金疮止血消炎药临床疗效观察总结
类型 | 例数 | 止血作用(%) | 抗感染作用(%) | 促进伤口愈合作用(%) | 与对照组比较P值 | |||
显效率 | 总有效率 | 显效率 | 总有效率 | 显效率 | 总有效率 | |||
开放性损伤肛肠术后宫颈光疗后小针刀术后鼻衄拔牙出血上消化道出血 | 1000100403240102 | 93.6659578.1显效显效显效 | 99.9100100100 | 7810095100 | 94100100100 | 8510095100 | 100100100100 | <0.05<0.05<0.05<0.01 |
上述临床应用结果,表明本品止血、抗炎、促进伤口愈合等作用均优于对照组,对开放性损伤、肛肠术后创面、宫颈光疗后创面、小针刀术后、鼻衄等止血疗效显著,无一例伤口感染,能被组织吸收,促进破损组织愈合,愈合后瘕痕少或无,也未发现任何毒副作用和不良反应。在临床应用病例中,有2例用于内服治疗血症的初步探讨,取得非常满意疗效,表明该制剂极有临床开发研究价值。
综上所述,本发明经药效学的系统研究,临床治疗的广泛应用,证实止血疗效显著,抗感染作用强,能促进创伤愈合,而被组织吸收,无毒副作用,使用方便,安全可靠,药源丰富,价格便宜,可广泛应用于各种内外出血症的治疗。
功能与主治:护膜生肌止血、清热解毒、止痛等。具有止血快速、消炎、止痛、补益生肌、促进组织愈合并使创面瘕痕减少等功效。用于各种创面出血及不易缝合的大面积创伤出血,对鼻衄、肛肠出血、子宫靡烂引起出血,拔牙出血等的治疗。
用法与用量:
粉剂:使用时布撒于各种创面出血处,严重者稍加压,或倒于纱布垫上,压在创面,鼻腔可喷入,用量:0.3-0.5g/cm2。
胶囊剂:每粒0.4克,每日四次,一次3粒。
贮存:密闭,置于阴凉入保存。
下面详述本发明的实施例:
实施例1:①取白及300g,粉碎成粗粉,加二倍水提取2-3次,每次4小时,过滤,得水提取液,加95%乙醇至含醇量为70-80%,静置过夜,过滤,将所得白及胶80℃干燥,称重为100g,备用;②卷柏100g、松萝100g、艾叶50g,加入4倍量的水浸泡60分钟,后煎煮二次,每次30分钟,合并二次滤液,浓缩至400-500ml放冷,加乙醇至含醇量65-70%左右,静置过夜,过滤,回收乙醇后浓缩至150-250ml,测波美度3.0,备用;③取冰片30g,备用;④取明胶300g,加蒸馏水2000ml,浸泡发胀,加温溶解,加固化剂250ml(取30ml 37%(g/g)甲醛加水至250ml),稍打泡,然后边打泡边加入上述步骤①②制得提取物,至体积发胀至3-4倍,固化后置-10~20℃下使其冰冻30分钟左右,取出切成小块,置烤箱中60-80℃鼓风干燥,粉碎,过60目筛;⑤加入步骤③之冰片,混匀,灭菌,冷却后捣匀分装小瓶或铝塑袋,每瓶3g即成。
实施例2:①取白及1200g,粉碎成粗粉,加二倍水提取2-3次,每次4小时,过滤,得水提液,加95%乙醇至含醇量为70%-80%,静置过夜,过滤,将所得白及胶80℃干燥,称重为400g,备用;②取卷柏400g、艾叶300g、松萝300g,加入8倍量的水浸泡60分钟,后煎煮二次,每次60分钟,合并二次滤液,浓缩至400-500ml放冷,加乙醇至含醇量65-70%左右,静置过夜,过滤,回收乙醇后浓缩至250-300ml,测波美度10.0,备用;③取冰片100g,备用;④取明胶1000g,加蒸馏水6000ml,浸泡发胀,加温溶解,加固化剂800ml(取60ml 37%(g/g)甲醛加水至800ml),稍打泡,然后边打泡边加入上述步骤①②所制得的提取物,至体积发胀至3-4倍,固化后置-10~20℃下使其冰冻30分钟左右,取出切成小块,置烤箱中60-80℃鼓风干燥,粉碎,过60目筛;⑤加入步骤③之冰片,混匀,灭菌,冷却后捣匀分装小瓶或铝塑袋,每瓶3g即成。
实施例3:①取白及800g,粉碎成粗粉,加二倍水提取2-3次,每次4小时,过滤,得水提液,加乙醇至含醇量为70%-80%,静置过夜,过滤,将所得白及胶80℃干燥,称重为240g,备用;②取卷柏150g、艾叶150g、松萝150g,加入6倍量的水浸泡60分钟,后煎煮二次,每次30分钟,合并二次滤液,浓缩至400-500ml放冷,加乙醇至含醇量65-70%左右,静置过夜,过滤,回收乙醇后浓缩至120-130ml,测波美度6.5,备用;③取冰片80g,备用;④取明胶600g,加蒸馏水3600ml,浸泡发胀,加温溶解,加固化剂400ml(取60ml 37%(g/g)甲醛加水至400ml),稍打泡,然后边打泡边加入上述步骤①②所制得提取物,至体积发胀至3-4倍,固化后置-10~20℃下使其冰冻30分钟左右,取出切成小块,置烤箱中60-80℃鼓风干燥,粉碎,过20目筛;⑤加入步骤③中的备用冰片,混匀,灭菌,冷却后捣匀分装小瓶或铝塑袋,每瓶3g即成。
实施例4:①取白及300g,粉碎成粗粉,加二倍水提取2-3次,每次4小时,过滤,得水提液,加95%乙醇至含醇量为70%-80%,静置过夜,过滤,将所得白及胶80℃干燥,称重为100g,备用;②取艾叶50g、松萝100g、卷柏80g,加入4倍量的水浸泡60分钟,后煎煮二次,每次30分钟,合并二次滤液,浓缩至400-500ml放冷,加乙醇至含醇量65-70%左右,静置过夜,过滤,回收乙醇后浓缩至150-250ml,测波美度3.0,备用;③取冰片30g,备用;④取明胶770g,加蒸馏水4000ml,浸泡发胀,加温溶解,加固化剂600ml(取80ml 37%(g/g)甲醛加水至600ml),稍打泡,然后边打泡边加入上述步骤①②所制得的提取物至体积发胀至3-4倍,固化后置-10~20℃下使其冰冻30分钟左右,取出切成小块,置烤箱中60-80℃鼓风干燥,粉碎,过20目筛;⑤加入步骤③之冰片,混匀,灭菌,冷却后捣匀,按药剂学胶囊剂制剂通则装胶囊,每粒0.4g,治疗消化道出血,一天四次,每次3粒。
Claims (5)
1. 一种具有止血消炎作用的药物,其特征在于它主要含有下述组分及用量(用量为重量份):
卷柏10-40 松萝10-30 白及胶10-40
艾叶5-30 冰片3-10
2.根据权利要求1所述的一种具有止血消炎作用的药物,其特征在于它在制备过程中还加入了30-100重量份的明胶。
3.根据权利要求1或2所述的一种具有止血消炎作用的药物,其特征是在于所说的药剂是任何一种药剂学上所能接受的剂型。
4.根据权利要求3所述的一种具有止血消炎作用的药物,其特征在于所说的药剂是散剂或胶囊剂。
5.根据权利要求1所述的一种具有止血消炎作用的药物的制备方法,其特征是在于由以下步骤制得:
①取卷柏、松萝、艾叶以水提醇沉法制备,得浓缩液至波美度3.0-10.0,备用;②取明胶加水浸泡,溶解,加入固化剂,边打泡边加入上述步骤①所制备的提取液及配方量的白及胶,至体积发胀至3-4倍,固化后至-10~20℃下使其冰冻,取出切成小块,鼓风干燥,打碎,过20-60目筛;③加入配方量之冰片,混匀,灭菌,即得。
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CN104173747A (zh) * | 2014-09-02 | 2014-12-03 | 王永红 | 一种止血消炎护理剂及其制备方法 |
CN106729645A (zh) * | 2016-12-09 | 2017-05-31 | 苏州艾博迈尔新材料有限公司 | 一种轻微外伤止血消炎喷剂及其制备方法 |
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CN1060380C (zh) * | 1997-02-19 | 2001-01-10 | 杨家骥 | 治疗伤口愈合的药 |
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CN106729645A (zh) * | 2016-12-09 | 2017-05-31 | 苏州艾博迈尔新材料有限公司 | 一种轻微外伤止血消炎喷剂及其制备方法 |
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