CN106728248A - 一种治疗闭合性骨折的中药膏剂及其制备方法 - Google Patents
一种治疗闭合性骨折的中药膏剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗闭合性骨折的中药膏剂及其制备方法，它是由中药原料水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香制备而得，本发明中水冬瓜根皮祛风除湿、活血接骨，山豆根舒筋活血，接骨草、大血藤、透骨香祛风、利湿、活血、散瘀、止血、通络，酸咪咪、四块瓦、地麦子解毒消肿、活血散瘀，散血飞、闹羊花舒筋、镇痛，黑骨藤活血通经，刺老苞接骨生骨，五加皮、木槿、五根香壮筋骨。以上诸药均遵照主、臣、辅的水族医药配伍原则，组方严谨，谨守病机，为外用攻邪之方，共奏化瘀通络、生骨壮骨之功效。
Description
技术领域
本发明涉及中药技术领域，特别是涉及一种治疗闭合性骨折的中药膏剂及其制备方法。
背景技术
水医认为骨折愈合的过程就是“活血化瘀、生骨续骨”的过程，整个过程是持续进行的，且与机体的气运流畅，血之充盛密切相关。气是流动的物质，是人体一切生理活动的原动力，具有温养形体的温煦作用。血是由脾胃运化而来的水谷精之气变化而生成。“气”和“血”的关系十分密切，气推动血沿着经脉而循行全身，以营养五脏、六腑、四肢、百骸。两者相互依附，周流不息。《血证论》概括为：“气为血之帅，血随之而运行；血为气之守，气得之而静谧。”血的循行，靠气的推动，气行则血运行，气滞则血瘀。骨折患者早期以“气滞血瘀”为病机之重点，经复位、固定、外敷活血化瘀、消肿止痛药之后，疼痛减轻、肿胀瘀阻渐趋消退；骨折后期的病人，肿胀逐渐消退，疼痛减轻，断骨开始接续，以“接骨续损”为病机重点。在外敷用药治疗上宜在选活血化瘀药的同时加入接骨生骨的药物，以促瘀去新生，加速受损骨的修复。本发明就是在此背景技术上提出的。
发明内容
本发明所要解决的技术问题是提供一种具有化瘀通络、生骨壮骨之功效，且疗效确切的用于治疗闭合性骨折的中药膏剂及其制备方法。
为了解决上述技术问题，本发明采用如下的技术方案：按照重量份计算，本发明治疗闭合性骨折的中药膏剂是由中药原料水冬瓜根皮420～480g、山豆根370～420g、接骨草370～420g、酸咪咪370～420g、四块瓦270～320g、地麦子270～320g、散血飞220～300g、大血藤270～320g、黑骨藤270～320g、刺老苞150～220g、五加皮230～280g、木槿230～280g、闹羊花200～300g、五根香200～300g、透骨香150～220g制备而成。
优选为：按照重量份计算，它是由中药原料水冬瓜根皮450g、山豆根400g、接骨草400g、酸咪咪400g、四块瓦300g、地麦子300g、散血飞250g、大血藤300g、黑骨藤300g、刺老苞200g、五加皮250g、木槿250g、闹羊花250g、五根香250g、透骨香200g制备而成。
前述治疗闭合性骨折的中药膏剂的制备方法：
将水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香等15味药，70℃干燥粉碎过120目筛得细粉，加8倍量75％乙醇回流提取三次，每次2.0小时，滤过，合并滤液，回收乙醇并减压浓缩至相对密度为1.35(60℃)的稠膏；取上述稠膏再依次加入由聚丙烯酸钠、明胶、甘油、甘羟铝、尼泊金乙酯制成的基质中，搅拌均匀后，涂布，盖衬，切片，制成1000贴即得。
本发明的这种中药膏剂主要成分为水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香等组成。水冬瓜根皮祛风除湿、活血接骨，山豆根舒筋活血，接骨草、大血藤、透骨香祛风、利湿、活血、散瘀、止血、通络，酸咪咪、四块瓦、地麦子解毒消肿、活血散瘀，散血飞、闹羊花舒筋、镇痛，黑骨藤活血通经，刺老苞接骨生骨，五加皮、木槿、五根香壮筋骨。以上诸药均遵照主、臣、辅的水族医药配伍原则，组方严谨，谨守病机，为外用攻邪之方，共奏化瘀通络、生骨壮骨之功效。
本发明的药材质量标准如下：
1.水冬瓜根皮 本品为水冬瓜根皮(学名：Toricellia angulata Olinv)为落叶灌木或小乔木全株。质量标准参见《贵州省中药材、民族药材质量标准》2003版“水冬瓜根皮”项下规定。
2.山豆根 本品为Ardisia crispa(Thunb.)A.DC.紫金牛科、紫金牛属植物的灌木。质量标准参见《贵州省中药材、民族药材质量标准》2003版“八爪金龙”项下规定。
3.接骨草 本品为接骨草(拉丁学名：Sambucus chinensis Lindl.)，高大草本或半灌木的全草。质量标准参见《贵州省中药材、民族药材质量标准》2003版“接骨草”项下规定。
4.酸咪咪 本品为野生醡浆草Oxanlis corniculata L..多年生草本植物全草。质量标准参见《水族医药宝典》2007版一部“酸咪咪”项下规定。
5.四块瓦 本品为金粟兰科植物(拉丁学名：Chloranthus holostegius(Hand.-Mazz.)Pei et Shan.)的全草。质量标准参见《贵州省中药材、民族药材质量标准》2003版“四块瓦”项下规定。
6.地麦子 为全草。质量标准参见《水族医药宝典》2007版一部“地麦子”项下规定。
7.散血飞 为Zanthoxylum dimorphophyllumHemsl.Var.spinifolium Rehd.EtWils.(原植物刺异叶花椒)。质量标准参见《贵州省中药材、民族药材质量标准》2003版“散血飞”项下规定。
8.大血藤 大血藤(拉丁学名:Sargentodoxa cuneata(Oliv.)Rehd.et Wils.)。质量标准参见《水族医药宝典》2007版一部“大血藤”项下规定。
9.黑骨藤 为萝摩科植物西南杠柳Periploca forrestii Schlechter的根或全株。质量标准参见《贵州省中药材、民族药材质量标准》2003版“黑骨藤”项下规定。
10.刺老苞 本品为五加科楤木属刺茎楤木(Aralia echinocaulis Hand.-Mazz.)之根皮。质量标准参见《水族医药宝典》2007版一部“刺老苞”项下规定。
11.五加皮 为五加科植物细柱五加Acanthopanar gracilistμlusW.W.Smith的干燥根皮。质量标准参见《贵州省中药材、民族药材质量标准》2003版“五加皮”项下规定。
12.木槿 为木槿(学名:Hibiscus syriacus Linn.):落叶灌木。花质量标准参见《水族医药宝典》2007版一部“木槿”项下规定。
13.闹羊花 本品为羊踯躅(学名:Rhododendron molle(Blume)G.Don):落叶灌木质量标准参见《水族医药宝典》2007版一部“闹羊花”项下规定。
14.五根香 质量标准参见《水族医药宝典》2007版一部“五根香”项下规定。
15.透骨香 拉丁植物名:Gaultheriayunnanensis(Franch.)Rehd.[G.
CrenulataKurzi；VacciniumyunnanenseFranch.」，质量标准参见《水族医药宝典》2007版一部“透骨香”项下规定。
本发明的产品名称：复方水冬瓜接骨膏。
本发明性状：巴布膏剂。
本发明功效：化瘀通络、生骨状骨。
本发明的临床试验：
1 临床资料
1.1一般资料 所有病例均为闭合性骨折患者。
1.2诊断标准 西医诊断标准参照高等医学院校教材《外科学》中关于骨折标准进行；中医辨证标准参照《中药新药临床研究指导原则》中有关血瘀证进行。
1.3纳入标准 (1)符合上述诊断标准者；(2)年龄18～65岁；(3)自愿作为受试对象，并能接受试验药物剂型，保证完成疗程者。(4)新鲜闭合骨折；(5)病程不超过3d；(6)未经内服、外敷药物及其他治疗者。
1.4排除标准 (1)不符合上述诊断标准者；(2)年龄在18岁以下和65岁以上者；(3)使用了其他治疗本病的药物者；(4)过敏体质或对组成本药物已知成分过敏者；(5)合并有心血管、脑血管、肝肾和造血系统或精神病严重原发性疾病者；(6)陈旧性或开放性骨折；(7)妊娠、哺乳期妇女。具备以上任何1项者排除。
1.5终止研究标准 (1)实验中未能坚持按医嘱用药或自行换用其他药物治疗者；(2)实验中出现局部皮肤不适不能继续治疗者；(3)出现严重不良事件；(4)临床试验过程中出现严重的其他并发疾病者。
2研究方法
2.1治疗方法
2.1.1 分组 本研究采用临床随机对照试验的方法，按照就诊的先后顺序，以随机数字表法随机分成复方水冬瓜接骨膏治疗组和对照组，进行临床疗效观察。实验组：120例，对照组：120例。
2.1.2 治疗方法 (1)实验组：待骨折手法复位后，将复方水冬瓜接骨膏外贴于患处，小夹板外固定,每3日患药1次，4周为1疗程；(2)对照组：待骨折手法复位后小夹板外固定，每日口服伤科接骨片，每日3次，每次4片，4周为1疗程。治疗期间停用其他与本病有关的治疗药物或疗法，禁用辛辣寒凉之品。观察并记录治疗前、治疗后的临床症状变化情况，若出现局部不良反应，立即予相应处理或停止用药，并予记录。治疗疗程为1个疗程。
2.2 观察指标及评定标准
2.2.1.安全性观测
在用药前及疗程结束时各检测一次，如试验过程中出现试验指标的异常，应复查至正常。
(1)一般体格检查；
(2)三大常规；
(3)肾功能(尿素氮、肌酐)、肝功能(谷丙转氨酶、谷草转氨酶)、血压、心电图；
(4)可能出现的不良反应。
2.2.2观察指标
(1)临床症状体征：治疗前及治疗后1、2、3、4周疼痛、肿胀、压痛及关节活动等改善情况。
(2)X线骨痂质量观察：分别于治疗后2、4周摄X线片判断骨痂的生长情况。
(3)血清碱性磷酸酶(AKP)活性测定：治疗前及治疗后2、4周活性变化情况。
(4)骨折愈合时间。
2.2.3 评定标准 参照《中药新药临床研究指导原则》[2]制定。(1)显效：骨折临床愈合时间缩短≥1/3；(2)有效:骨折临床愈合时间缩短≥1/5但<1/3；(3)无效：未达到以上标准者。
2.2.4症状评分标准 参照《中药新药临床研究指导原则》[2]制定标准进行。(1)疼痛计分法：①骨折断端完全无疼痛，计0分；②持续或间断隐痛但可耐受，并能正常生活，睡眠不受干扰，计2分；③疼痛明显不能忍受，要求服用镇痛药物，睡眠受干扰，计4分；④疼痛剧烈不能忍受，需要镇痛药物，睡眠严重受干扰，可伴有植物神经功能紊乱表现或被动体位，计6分。(2)肿胀计分法：以骨折处为中心测量伤肢的周径与健侧同一部位周径差来计分，①周径差0cm，计0分；②周径差0～1cm，计2分；③周径差1～2cm，计4分；④周径差2～3cm，计6分；⑤周径差3～4cm，计8分；⑥周径差≥4cm以上，计10分。(3)压痛情况：①无压痛,计0分；②轻度压痛，计2分；③明显压痛，计4分；④剧烈压痛,计6分。
2.2.5 X线骨痂质量评分标准 X线骨痂质量评分法：①骨折断端无骨痂，计0分；②骨折断端模糊无明显骨痂者，计2分；③骨折断端明显模糊有较淡骨痂者，计4分；④骨折断端骨折线消失，有大量骨痂者，计6分。
2.3统计分析 所有资料均在计算机上由SPSS 15.0版本软件包进行分析处理，计量资料数据以X±S表示，组间比较用t检验，分类变量资料的统计分析用χ2检验。P＜0.05有统计学意义。
3 结果
3.1 两组临床疗效比较 治疗组120例，显效89例，有效27例，无效4例，总有效率96.67％；对照组120例，显效58例，有效46例，无效16例，总有效率86.67％；两组临床总有效率比较差异有统计学意义(χ2＝7.86，P＜0.05)。表1。
表1 两组临床疗效比较
3.2 两组患者治疗前后中医症状改善情况比较 治疗前，两组患者比较,差异均无统计学意义(P＞0.05)；治疗后疼痛、肿胀、压痛与对照组比较，差异有统计学意义(P＜0.05)。治疗组在积分改善方面优于对照组。见表2-4。
表2 两组患者治疗前后疼痛改善情况比较(分,x±s)
表3 两组患者治疗前后肿胀改善情况比较(分,x±s)
表4 两组患者治疗前后压痛改善情况比较(分,x±s)
3.3 两组血清AKP活性比较 治疗前，两组患者组血清AKP活性比较，差异无统计学意义(P＞0.05)；治疗第2、4周，治疗组血清AKP活性与对照组和差异也有统计学意义(P＜0.05)。见表5。
表5 3组患者治疗前后血清AKP活性比较(U/L,x±s)
3.4 两组X线骨痂质量积分比较 治疗后第2、4周治疗组的X线骨痂质量积分与对照组比较有统计学意义(P＜0.05)。见表6。
表6 两组患者治疗后X线骨痂质量积分比较(分,x±s)
3.5 两组骨折临床愈合时间比较 治疗组临床愈合平均时间为(32.7±3.9)d,对照组为(49.9±5.4)d,治疗组临床愈合平均时间与对照组比较,差异均有统计学意义(P＜0.05)。通过随访两组均到达临床愈合。
3.6 不良反应 整个治疗过程未出现不良事件,治疗后生化检查及心电图检查未出现异常结果。
结论：由本发明的技术方案制成的产品复方水冬瓜接骨膏治疗闭合性骨折具有良好的化瘀通络、生骨状骨之功效。临床上治疗闭合性骨折疗效确切,且安全性好。
具体实施方式：
实施例1：原料：水冬瓜根皮450g、山豆根400g、接骨草400g、酸咪咪400g、四块瓦300g、地麦子300g、散血飞250g、大血藤300g、黑骨藤300g、刺老苞200g、五加皮250g、木槿250g、闹羊花250g、五根香250g、透骨香200g。
制备方法：将水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香等15味药，70℃干燥粉碎过120目筛得细粉，加8倍量75％乙醇回流提取三次，每次2.0小时，滤过，合并滤液，回收乙醇并减压浓缩至相对密度为1.35(60℃)的稠膏；取上述稠膏及地龙细粉，分别加入到由聚丙烯酸钠(200g)、明胶(800g)、甘油(960g)、甘羟铝(20g)、尼泊金乙酯(20g)制成的基质中，搅拌均匀后，涂布，盖衬，切片，制成1000贴，即得复方水冬瓜接骨膏。
实施例2：原料：水冬瓜根皮420g、山豆根380g、接骨草380g、酸咪咪380g、四块瓦320g、地麦子320g、散血飞230g、大血藤280g、黑骨藤280g、刺老苞220g、五加皮250g、木槿250g、闹羊花250g、五根香250g、透骨香180g。
制备方法：将水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香等15味药，70℃干燥粉碎过120目筛得细粉，加8倍量75％乙醇回流提取三次，每次2.0小时，滤过，合并滤液，回收乙醇并减压浓缩至相对密度为1.35(60℃)的稠膏；取上述稠膏及地龙细粉，分别加入到由聚丙烯酸钠(220g)、明胶(800g)、甘油(880g)、甘羟铝(20g)、尼泊金乙酯(20g)制成的基质中，搅拌均匀后，涂布，盖衬，切片，制成贴剂，即得复方水冬瓜接骨膏。
实施例3：原料：水冬瓜根皮480g、山豆根420g、接骨草420g、酸咪咪420g、四块瓦350g、地麦子350g、散血飞220g、大血藤270g、黑骨藤270g、刺老苞170g、五加皮220g、木槿220g、闹羊花220g、五根香220g、透骨香180g。
制备方法：将水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香等15味药，70℃干燥粉碎过120目筛得细粉，加8倍量75％乙醇回流提取三次，每次2.0小时，滤过，合并滤液，回收乙醇并减压浓缩至相对密度为1.35(60℃)的稠膏；取上述稠膏及地龙细粉，分别加入到由聚丙烯酸钠(250g)、明胶(500g)、甘油(660g)、甘羟铝(25g)、尼泊金乙酯(25g)制成的基质中，搅拌均匀后，涂布，盖衬，切片，制成贴剂，即得复方水冬瓜接骨膏。
Claims (3)
1.一种治疗闭合性骨折的中药膏剂，其特征在于：它是由中药原料水冬瓜根皮420～480g、山豆根370～420g、接骨草370～420g、酸咪咪370～420g、四块瓦270～320g、地麦子270～320g、散血飞220～300g、大血藤270～320g、黑骨藤270～320g、刺老苞150～220g、五加皮230～280g、木槿230～280g、闹羊花200～300g、五根香200～300g、透骨香150～220g制备而成。
2.根据权利要求1所述治疗闭合性骨折的中药膏剂，其特征在于：它是由中药原料水冬瓜根皮450g、山豆根400g、接骨草400g、酸咪咪400g、四块瓦300g、地麦子300g、散血飞250g、大血藤300g、黑骨藤300g、刺老苞200g、五加皮250g、木槿250g、闹羊花250g、五根香250g、透骨香200g制备而成。
3.权利要求1或2所述治疗闭合性骨折的中药膏剂的制备方法，其特征在于：水冬瓜根皮、山豆根、接骨草、酸咪咪、四块瓦、地麦子、散血飞、大血藤、黑骨藤、刺老苞、五加皮、木槿、闹羊花、五根香、透骨香这15味药，70℃干燥粉碎过120目筛得细粉，加8倍量75％乙醇回流提取三次，每次2.0小时，滤过，合并滤液，回收乙醇并减压浓缩至相对密度为1.35的稠膏；取上述稠膏再依次加入由聚丙烯酸钠(200g)、明胶(800g)、甘油(960g)、甘羟铝(20g)、尼泊金乙酯(20g)制成的基质中，搅拌均匀后，涂布，盖衬，切片，制成1000贴即得。
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