CN108686059A - 一种用于治疗疼痛的中药组合物及其制备方法 - Google Patents
一种用于治疗疼痛的中药组合物及其制备方法 Download PDFInfo
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- CN108686059A CN108686059A CN201810826807.9A CN201810826807A CN108686059A CN 108686059 A CN108686059 A CN 108686059A CN 201810826807 A CN201810826807 A CN 201810826807A CN 108686059 A CN108686059 A CN 108686059A
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Abstract
本发明属于中药技术领域,公开了一种用于治疗疼痛的中药组合物,该中药组合物是由以下述重量配比的原料制备而成:五灵脂8‑80份、生蒲黄8‑80份、乳香5‑60份、没药5‑60份、罂粟壳5‑60份、白英5‑60份、露蜂房5‑60份、冰片0.3‑5份。本发明采取纯中药通过科学配方,严谨的制造工艺,药味浓缩,制作而成。本发明中药组合物具有较强的止痛作用,可以应用于关节、筋骨疼痛的治疗。同时,本发明中药组合物对癌性疼痛也具有较强的治疗作用。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗疼痛的中药组合物及其制备方法。
背景技术
目前,业内常用的现有技术是这样的:在传统上,贴敷为膏药,在临床上多用于止痛的功能。恶性肿瘤发展到一定成度所引发的癌症疼痛,西药往往难以奏效,效果不理想。中药口服受剂型影响,很难让病人接受。用麻醉治疗疼痛,短期内容易成瘾。持续用药物,最终导致疼痛频繁发生,止痛时间越来越短,药量越来越大,难以摆脱疼痛的困境。而西药膏对慢性、轻、中型疼痛,经临床应用止痛维持时间短、皮肤刺激明显、缓解疼痛效果差,成本高,仍不能从根本上解决癌性疼痛的问题。而现有中药止痛膏剂往往药味大,止痛效率低,短期显效率和维持止痛效果不理想,皮肤会产生刺激反应,病人难以继续使用。癌性疼痛是疼痛的一种,属于慢性疼痛,是严重影响恶性肿瘤患者的常见症状之一。
癌性疼痛的病理生理基础至今尚未完全清楚。西医对癌痛的控制主要在抗肿瘤的基础上,采用三阶梯疗法,同时结合生物治疗和神经阻滞等方法。长期使用镇痛药,对肝肾功能、胃肠道、骨髓、心脏等危害大;引起恶心、呕吐、便秘、排尿困难、尿潴留等副反应;且有药物依赖性,给患者的身体和心理带来沉重的不适。另外,由于病理、生理机制的复杂变化,和联合用药的增多,可能发生严重的不良反应,均限制其临床广泛使用。中医认为“不通则痛”和“不荣则痛”是疼痛的基本病机。癌性疼痛属中医学“痛证”范畴,《临证指南医案》曰:“积伤入络,气血皆瘀,则流行失司,所谓痛则不通也。”脏腑功能失调,气血阴阳失和,痰浊瘀血内生,积聚日久,变生癌毒,导致脉络闭阻,瘀塞不通,而发生疼痛。外治法治疗癌痛有独到之处。《医学源流论》:“用膏贴之,闭塞其气,使药性从毛孔而入其腠理,通经贯络,在皮肤筋骨之间,或提而出之,或攻而散之,较服药尤捷”。中医对癌痛的治疗以辨证论治为主,可满足癌痛治疗多靶点干预的需求,且患者有很好的耐受性,临床应用广泛;中医外治法具有止痛迅速、安全性高、毒性和不良反应小、无依赖性等优势,且价格低廉患者容易接受等特点。尽管中药外治癌性疼痛在临床上广泛应用,但还存在一些问题。比如:临床多选用走窜气味强烈的药物,成分复杂;有毒药物的大剂量使用,加之制作工艺简单粗糙,对皮肤刺激性大;透皮速率达不到治疗要求,吸收率低,专一性差的问题。因此,寻找癌痛缓解的新方法,寻求一种安全有效、经济方便的止痛方案是临床目前急需解决的重要课题。
综上所述,现有技术存在的问题是:
现有中药止痛膏剂往往药味大,止痛效率低,短期显效率和维持止痛效果不理想,皮肤会产生刺激反应,病人难以继续使用。
解决上述技术问题的难度和意义:
中医药治疗疼痛止痛起效时间略逊于西药,但止痛维持时间优于西药,显示其巨大优势。本发明药物组合物是在中医药理论指导下,将中药复方粉碎为细粉,经过提取,纯化等工艺得到有效成分与适宜的辅料混合后制成,使中药成分接近恒定速度通过腧穴、孔窍、皮肤或黏膜表面吸收药力直达病所,止痛迅速有效,具有简、便、廉、验的优点。
发明内容
针对现有技术存在的问题,本发明提供了一种用于治疗疼痛的中药组合物及其制备方法。
该药物组合物是由以下原料及重量比组成:五灵脂8-80份、生蒲黄8-80份、乳香5-60份、没药5-60份、罂粟壳5-60份、白英5-60份、露蜂房5-60份、冰片0.3-5份。
优选地,五灵脂15-60份、生蒲黄15-60份、乳香10-50份、没药10-50份、罂粟壳10-50份、白英10-50份、露蜂房10-50份、冰片0.5-4份。
优选地,五灵脂20-50份、生蒲黄20-50份、乳香15-30份、没药15-30份、罂粟壳15-30份、白英15-30份、露蜂房15-30份、冰片1-3份。
优选地,五灵脂30份、生蒲黄30份、乳香20份、没药20份、罂粟壳15份、白英15份、露蜂房15份、冰片1份。
本发明的另一目的在于提供一种用于治疗疼痛的中药组合物的制备方法,该方法包括如下步骤:
步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;
步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;
步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;
步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;
步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。其中,所述疼痛为关节疼痛、肩颈疼痛或癌性疼痛。
为使上述剂型能够实现,需在制备这些剂型时加入药学可接受的辅料,例如:填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括:淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等;崩解剂包括:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等;润滑剂包括:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂包括:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;粘合剂包括,淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂包括:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等;矫味剂包括:甜味剂及各种香精;防腐剂包括:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质包括:PEG6000,PEG4000,虫蜡等。
本发明的有益效果是:本发明药物组合物经过临床长期实践,反复筛选,最终确定的配伍药物及用量比例。该配方经过药效学验证表明具有明显的镇痛、抗炎、消肿的作用。另外,在实验过程中发现,本发明药物组合物与现有上市品种相比,本发明药物组合物的作用持续时间更长,而且对癌性疼痛的疗效更好。另外,本发明药物组合物在外用时对皮肤的刺激性更小,对外伤导致的疼痛也有明显的止痛效果,而且可以快速促进伤口创面的愈合。
附图说明
图1是本发明实施例提供的治疗疼痛的中药组合物的制备方法的流程图。
具体实施方式
下面结合具体实施例进一步详细描述本发明的技术方案,但本发明的保护范围不局限于以下所述。
实施例1
称取五灵脂8g、生蒲黄8g、乳香5g、没药5g、罂粟壳5g、白英5g、露蜂房5g、冰片0.3g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例2
称取五灵脂80g、生蒲黄80g、乳香60g、没药60g、罂粟壳60g、白英60g、露蜂房60g、冰片0.3g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例3
称取五灵脂15g、生蒲黄15g、乳香10g、没药10g、罂粟壳10g、白英10g、露蜂房10g、冰片0.5g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例4
称取五灵脂60g、生蒲黄60g、乳香50g、没药50g、罂粟壳50g、白英50g、露蜂房50g、冰片4g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例5
称取五灵脂20g、生蒲黄20g、乳香15g、没药15g、罂粟壳15g、白英15g、露蜂房15g、冰片1g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例6
称取五灵脂50g、生蒲黄50g、乳香30g、没药30g、罂粟壳30g、白英30g、露蜂房30g、冰片3g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例7
称取五灵脂30g、生蒲黄30g、乳香20g、没药20g、罂粟壳15g、白英15g、露蜂房15g、冰片1g。将上述药材研磨成粉,按常规工艺制成药膏。
实施例8
称取五灵脂8g、生蒲黄8g、乳香5g、没药5g、罂粟壳5g、白英5g、露蜂房5g、冰片0.3g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
实施例9
称取五灵脂80g、生蒲黄80g、乳香60g、没药60g、罂粟壳60g、白英60g、露蜂房60g、冰片0.3g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
实施例10
称取五灵脂15g、生蒲黄15g、乳香10g、没药10g、罂粟壳10g、白英10g、露蜂房10g、冰片0.5g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
实施例11
称取五灵脂60g、生蒲黄60g、乳香50g、没药50g、罂粟壳50g、白英50g、露蜂房50g、冰片4g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
实施例12
称取五灵脂20g、生蒲黄20g、乳香15g、没药15g、罂粟壳15g、白英15g、露蜂房15g、冰片1g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
实施例13
称取五灵脂50g、生蒲黄50g、乳香30g、没药30g、罂粟壳30g、白英30g、露蜂房30g、冰片3g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
实施例14
称取五灵脂30g、生蒲黄30g、乳香20g、没药20g、罂粟壳15g、白英15g、露蜂房15g、冰片1g。具体制备方法如下:步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
下面通过具体的药学试验来证明本发明的有益效果:
一、本发明组合物的扭体镇痛试验
1、试验材料
选用健康成年昆明小鼠50只,雌雄各半,体重20±2g。试验前将动物称重,编号,随机分成空白对照组、阿司匹林阳性对照组,本发明组合物高剂量组,中剂量组,低剂量组,一共5组,每组10只。实验药物及剂量参见实施例7进行制备。
2、试验方法及步骤
空白对照组采用蒸馏水灌胃给药,阳性对照组采用阿司匹林按照20mg/kg/天剂量灌胃,本发明药物高剂量组按照300mg/kg/天剂量灌胃,中剂量组按照150mg/kg/天剂量灌胃,小剂量组按照75mg/kg/天剂量灌胃给药。连续灌胃5天后进行热板法镇痛实验,用秒表记录每只小鼠放入热板至小鼠出现舔足的时间(S)作为该小鼠的痛阀值。连续灌胃7天后进行扭体法镇痛实验,各组实验动物按1ml/10g体重灌服药液,给药30分钟后,每只小鼠腹腔内注射0.2ml的0.6%醋酸溶液,观察记录注射醋酸溶液后30分钟扭体次数。
3、实验结果
各组经治疗后镇痛效果情况。结果见下表1。
表1各组治疗后镇痛效果
与空白组比较,★P<0.05。
结果表明,经灌胃给药,本发明组合物均对由醋酸引起的腹痛有抑制作用,其中组合物高剂量组与空白对照组相比有明显的抑制作用。
二、本发明组合物对大鼠佐剂性关节炎的影响
1、试验材料
选用健康成年Wistar大鼠60只,雌雄各半,体重200±2g。试验前将动物称重,编号,随机分成空白对照组、模型对照组,尪痹颗粒剂阳性对照组,本发明组合物高剂量组,本发明组合物中剂量组,本发明组合物低剂量组,一共五组,每组10只。
2、试验方法及步骤
本试验采用大鼠佐剂性关节炎动物模型:在大鼠右后足跖皮下进针至踝关节,注射弗氏完全佐剂0.1mL致炎。各给药组组均于造模前1d开始灌胃给药,1次/d,连续3d;再于造模后第8d继续灌胃,连续16d。本发明组合物高、中、低剂量组给药剂量分别为300mg/kg/天、150mg/kg/天、75mg/kg/天,阳性对照组给予尪痹颗粒剂360mg/kg/天;空白对照组和模型组给予蒸馏水。关节肿胀度于注射佐剂前与注射佐剂后第6、12、24、48h,8、12、16、20、24d用特制软尺测量每只大鼠右后足跖定点处周长。每只大鼠同侧足跖注射前后周长之差为肿胀值。肿胀值=致炎后大鼠足跖周长(mm)-致炎前同足跖周长(mm)。
3、实验结果
3.1本发明组合物对大鼠佐剂性关节炎大鼠右后足踝关节肿胀的影响。
与模型组比较,本发明药物组合物高中剂量组,阿司匹林阳性对照组对大鼠佐剂性关节炎大鼠右后足踝关节肿胀有显著抑制作用。本发明高剂量与阳性对照组疗效相近,但无统计学意义。
表2对大鼠佐剂性关节炎大鼠右后足踝关节肿胀的影响
注:与模型组比较,★P<0.05。
3.2本发明组合物对佐剂性关节炎大鼠继发性足跖肿胀的影响
与模型组比较,本发明药物组合物高、中剂量组,阳性对照组对佐剂性关节炎大鼠继发性肿胀有显著抑制作用(p<0.05);与阳性对照组相比,本发明药物组合物高剂量组对佐剂性关节炎大鼠继发性足跖肿胀疗效与阳性对照药相近。结果表明本发明药物组合物高剂量组对佐剂性关节炎大鼠原发行足跖肿胀有显著抑制作用。结果见表3。
表3对大鼠佐剂性关节炎大鼠右后足踝关节肿胀的影响
注:与模型组比较,★P<0.05。
综上所述,本发明药物对佐剂性关节炎大鼠原发和继发性肿胀均有明显的抑制作用。
另外,在实验过程中发现,本发明药物组合物与现有上市品种相比,本发明药物组合物的作用持续时间更长,而且对癌性疼痛的疗效更好。另外,本发明药物组合物在外用时对皮肤的刺激性更小,对外伤导致的疼痛也有明显的止痛效果,而且可以快速促进伤口创面的愈合。以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (5)
1.一种用于治疗疼痛的中药组合物,其特征在于:所述用于治疗疼痛的中药组合物按重量比由五灵脂8-80份、生蒲黄8-80份、乳香5-60份、没药5-60份、罂粟壳5-60份、白英5-60份、露蜂房5-60份和冰片0.3-5份组成。
2.如权利要求1所述的用于治疗疼痛的中药组合物,其特征在于:所述用于治疗疼痛的中药组合物按重量比由五灵脂15-60份、生蒲黄15-60份、乳香10-50份、没药10-50份、罂粟壳10-50份、白英10-50份、露蜂房10-50份、冰片0.5-4份组成。
3.如权利要求1所述的用于治疗疼痛的中药组合物,其特征在于:所述用于治疗疼痛的中药组合物按重量比由五灵脂20-50份、生蒲黄20-50份、乳香15-30份、没药15-30份、罂粟壳15-30份、白英15-30份、露蜂房15-30份、冰片1-3份组成。
4.如权利要求1所述的用于治疗疼痛的中药组合物,其特征在于:所述用于治疗疼痛的中药组合物按重量比由五灵脂30份、生蒲黄30份、乳香20份、没药20份、罂粟壳15份、白英15份、露蜂房15份、冰片1份组成。
5.一种制备权利要求1-4任意一项所述中药组合物的方法,其特征在于:它包括如下步骤:
步骤一:按重量比称取五灵脂、生蒲黄、乳香、没药、罂粟壳、白英、露蜂房和冰片,备用;
步骤二:将五灵脂、生蒲黄、罂粟壳、白英、露蜂房混合,加入5~8倍药材重量的水浸泡0.5~1小时,煎煮2次,1~1.5小时,过滤两次水煎液,药渣弃去,药液备用;
步骤三:将步骤二步骤的药液加热浓缩成浸膏,然后将浸膏真空干燥得到干膏,将干膏粉碎得到干膏粉末;
步骤四:将乳香、没药和冰片混合粉碎后过40-60目筛,得到复合物,备用;
步骤五:将步骤三步骤得到的干膏粉末和步骤四步骤得到的复合物混合均匀,加入药学上可接受的辅料制备成药学上常用的药物制剂。
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