CN111821345A - 用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物及其制备方法 - Google Patents
用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物及其制备方法 Download PDFInfo
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- Medicinal Preparation (AREA)
Abstract
用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物及其制备方法。其中药组合物原料重量份包括大黄1000‑5000份、栀子400‑800份、乳香800‑1600份、土鳖虫400‑800份、木瓜800‑1500份、蒲公英800‑1500份。针对以上中药组合物所含有效成分采用现代提取、浓缩、减压干燥及粉碎等工艺制成粉末,加入一定比例的基质辅料如松香、石蜡等制成适宜的外用制剂。经临床验证,本发明具有行气活血、化瘀消肿、通络止痛之功效,患者易揭易贴,携带方便,具有皮肤刺激性小、致敏率低等优势,对跌打损伤初期、急性软组织损伤及骨折具有良好的镇痛效果,副作用少,上市后可实现有效成分均一、质量稳定可控。
Description
技术领域
本发明涉及中药外用膏剂领域,具体涉及一种用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物及其制备方法。
背景技术
随着生活水平提高,社会对运动保健活动的需求逐年增加,导致了人体踝膝肘腕等关节在原有常见的跌打损伤、骨折的基础上,运动后致关节周围软组织急性损伤的发病率逐年提高。中医药治疗跌打损伤初期、急性软组织损伤历史悠久,在长期实践中形成了动静结合、筋骨并重、内外兼治、分期用药的综合治疗体系,取得一定进展。发展至今,中医药已产生诸多用于缓解跌打损伤初期、急性软组织损伤症状的方法,诸如含有活血化瘀、行气通络止痛的中药汤剂、中成药,针刺、艾灸、推拿按摩等改善局部经气运行,调气和血,中医外治如膏药贴敷活血祛瘀、镇痛消肿,且疗效显著。
但是传统中药跌打损伤膏药有药味组分多、含毒性药材、含有国家保护动物药材,传统制备工艺导致重金属超标,药材经煎炸后有效成分损失严重、存在皮肤刺激性、使用不方便、传统制备工艺导致产品质量难以统一等等缺点。
发明内容
本发明为解决现有技术中存在的问题,提供一种高透皮吸收,少刺激,迅速消肿止痛、活血化瘀等的组合物。
完成上述发明任务的技术方案是:一种用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,按重量份包括大黄1000-5000份、栀子400-800份、乳香800-1600份、土鳖虫400-800份、木瓜800-1500份、蒲公英800-1500份。
优选的,包括以下重量份的基质辅料:石蜡1200-2000份、凡士林800-1600份、液状石蜡100-400份、松香10-300份。
优选的,按重量份包括大黄1500-4500份、栀子450-750份、乳香900-1500份、土鳖虫450-750份、木瓜900-1500份、蒲公英900-1500份、石蜡1300-1900份、凡士林900-1500份、液状石蜡150-350份、松香30-250份。
优选的,按重量份包括大黄1800-4000份、栀子500-700份、乳香1000-1400份、土鳖虫500-700份、木瓜1000-1400份、蒲公英1000-1400份、石蜡1500-1800份、凡士林1000-1400份、液状石蜡170-320份、松香50-220份。
优选的,按重量份包括大黄2000-3800份、栀子550-650份、乳香1100-1300份、土鳖虫550-650份、木瓜1100-1200份、蒲公英1100-1300份、石蜡1550-1750份、凡士林1100-1200份、液状石蜡180-320份、松香80-200份。
优选的,大黄、栀子、木瓜、乳香、土鳖虫、蒲公英可以为原药材也可以为饮片或炮制品,凡士林可以是白凡士林或黄凡士林。
优选的,包括以下基质辅料:由压敏胶、聚丙烯酸钠系列、PAA-聚乙烯基吡咯烷酮、聚乙二醇、硅橡胶、硅油、羊毛脂、明胶、卡波姆等本技术领域技术人员显而易见的外用辅料中一种或多种的组合。
优选的,所述组合物中包括透皮促渗剂,如氮酮、冰片、水杨酸甲酯、薄荷脑、丙二醇及等中药挥发油或挥发性成分。
本发明还提出了一种用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)乳香低温粉碎成细粉,过60-90目筛,备用;土鳖虫粉碎成细粉在50-70℃烘箱中烘2.5-4.5小时后粉碎成细粉,过60-90目筛,备用;
(2)大黄、栀子分别粗粉碎过20-40目筛后,与木瓜、蒲公英合并采用60-80%乙醇回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩至相对密度1.20~1.30(45~65℃)的稠膏,减压干燥(70-80℃以下,真空度-0.05MPa以上),所得干膏粉粉碎处理,过60-90目筛,混合均匀。
(3)将松香、石蜡、凡士林、液状石蜡加热至(约90-100℃),熔融,待温度降至65-75℃时,依次加入土鳖虫粉、乳香粉、干膏粉搅拌均匀,制成涂料。
(4)进行涂膏、切断、盖衬、切片,即得。
优选的,所述组合物也可以制备成黑膏药、软膏剂、橡胶膏剂、贴膏剂、涂膜剂、糊剂、擦剂、洗剂、凝胶剂等外用制剂。
本发明的有益效果:
急性软组织损伤是指各种致伤因素作用于机体而引起软组织的一系列病理变化的疾病,其病理变化以局部急性炎症与修复为主要特征。临床主要表现为局部肿胀、疼痛、功能障碍、青紫瘀斑等,是骨伤科临床常见病、多发病。随着社会的进步,生活方式的改变,外伤疾病相对增多,再加交通工具的日益发达,该病更呈绝对增加趋势。现代医学长期以来对急性软组织损伤的主要治疗方法有包扎,局部封闭,理疗,消炎镇痛等,这些方法疗效欠佳,康复时间较长,并有遗留陈旧性损伤,长期遗留慢性疼痛和关节功能障碍,影响患者的身心健康。本发明组合物由活血化瘀的地鳖虫、大黄,通络的木瓜和清热解毒的蒲公英等组成,具有活血止痛散瘀之功效。本发明中药组合物处方中以大黄、栀子为君药,大黄活血祛瘀、消肿止痛,为伤科要药,栀子泻火清热、凉血利湿,可防瘀血化热,具散痛止痛之功。以乳香、地鳖虫为臣药,乳香散血祛瘀、消肿定痛,地鳖虫有下瘀血、疗折伤之功,共为祛瘀止痛消肿。以木瓜、蒲公英为佐药,木瓜散瘀活血、舒经络、活筋骨,蒲公英清热解毒、消肿散结,二药合为和营利水通络。诸药合用,共奏行气活血、化瘀消肿、通络止痛之功,符合“疏其气血,令其调达,而致和平”(《素问·至真要大论》)之治疗大法。
随着社会的发展,生活水平的提高,传统的黑膏药制剂存在贴敷面积大,微生物易超标、有效保存期短、生产困难等弊端,不能满足患者方便性、清洁性、低过敏性方面的需求,制约了传统药物的传承与发展。本发明药物组合物在临床有效经验方基础上改良而得,患者在使用后反馈贴敷不方便,舒适感较差,容易污染衣物。本发明组合物采用中药现代提取纯化技术,从原药材富集清热消肿镇痛的有效成分,并运用现代辅料结合透皮给药技术真正发挥药物的治疗作用。发明人分别采用传统工艺和本发明工艺进行了多批次中试样品试制,通过加速及3个月长期稳定性试验考察,发现对传统工艺进行改良后,产品外观、性状、贴敷舒适度、便捷性、临床疗效均有明显提高,并且质量稳定可靠,微生物检测指标均合格,确保了患者使用的安全性。作为外用制剂,相比市场上口服制剂,通过局部针对性治疗达到迅速起效的目的,同时避免了肝脏首过效应,降低了药物口服带来的毒副作用;相对于传统膏药,贴敷舒适方便,致敏性低,患者易于接受。
具体实施方式
实施例1:按以下重量份取各组分:
大黄1000份、栀子400份、乳香800份、土鳖虫400份、木瓜800份、蒲公英800份、石蜡1200份、白凡士林800份、液状石蜡100份、松香10份。
制备步骤:
A、乳香低温粉碎成细粉,过60目筛,备用;土鳖虫粉碎成细粉在50-70℃烘箱中烘2.5小时后粉碎成细粉,过60目筛,备用;
B、大黄、栀子分别粗粉碎过20目筛后,与木瓜、蒲公英合并采用60%乙醇回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩至相对密度1.20~1.30(45~65℃)的稠膏,减压干燥(70-80℃以下,真空度-0.05MPa以上),所得干膏粉粉碎处理,过60目筛,混合均匀。
C、将松香、石蜡、凡士林、液状石蜡加热至(约90℃),熔融,待温度降至65℃时,依次加入土鳖虫粉、乳香粉、干膏粉搅拌均匀,制成涂料。
D、进行涂膏、切断、盖衬、切片,即得。
实施例2:按以下重量份取各组分:
大黄5000份、栀子800份、乳香1600份、土鳖虫800份、木瓜1500份、蒲公英1500份、
石蜡2000份、白凡士林1600份、液状石蜡400份、松香300份。
制备步骤:
A、乳香低温粉碎成细粉,过90目筛,备用;土鳖虫粉碎成细粉在50-70℃烘箱中烘4.5小时后粉碎成细粉,过90目筛,备用;
B、大黄、栀子分别粗粉碎过40目筛后,与木瓜、蒲公英合并采用80%乙醇回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩至相对密度1.20~1.30(45~65℃)的稠膏,减压干燥(70-80℃以下,真空度-0.05MPa以上),所得干膏粉粉碎处理,过90目筛,混合均匀。
C、将松香、石蜡、凡士林、液状石蜡加热至(约100℃),熔融,待温度降至75℃时,依次加入土鳖虫粉、乳香粉、干膏粉搅拌均匀,制成涂料。
D、进行涂膏、切断、盖衬、切片,即得。
实施例3:按以下重量份取各组分:
大黄1500份、栀子450份、乳香900份、土鳖虫450份、木瓜900份、蒲公英900份、石蜡1300份、白凡士林900份、液状石蜡150份、松香30份。
制备步骤:
大黄5000份、栀子800份、乳香1600份、土鳖虫800份、木瓜1500份、蒲公英1500份、
石蜡2000份、白凡士林1600份、液状石蜡400份、松香300份。
制备步骤:
A、乳香低温粉碎成细粉,过80目筛,备用;土鳖虫粉碎成细粉在50-70℃烘箱中烘4.5小时后粉碎成细粉,过80目筛,备用;
B、大黄、栀子分别粗粉碎过24目筛后,与木瓜、蒲公英合并采用70%乙醇回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩至相对密度1.20~1.30(45~65℃)的稠膏,减压干燥(70-80℃以下,真空度-0.05MPa以上),所得干膏粉粉碎过80目筛,混合均匀。
C、将松香、石蜡、凡士林、液状石蜡加热至(约100℃),熔融,待温度降至70℃时,依次加入土鳖虫粉、乳香粉、干膏粉搅拌均匀,制成涂料。
D、进行涂膏、切断、盖衬、切片,即得。
实施例4:按以下重量份取各组分:
大黄4500份、栀子750份、乳香1500份、土鳖虫750份、木瓜1500份、蒲公英1500份、石蜡1900份、黄凡士林1500份、液状石蜡350份、松香250份。
制备步骤:基本同实施例3。
实施例5:按以下重量份取各组分:
大黄1800份、栀子500份、乳香1000份、土鳖虫500份、木瓜1000份、蒲公英1000份、石蜡1500份、白凡士林1000份、液状石蜡170份、松香50份
制备步骤:基本同实施例3。
实施例6:按以下重量份取各组分:
大黄4000份、栀子700份、乳香(制)1400份、土鳖虫(炒)700份、木瓜1400份、蒲公英1400份、石蜡1800份、黄凡士林1400份、液状石蜡320份、松香220份
制备步骤:基本同实施例3。
实施例7:按以下重量份取各组分:
大黄3000份、栀子600份、乳香(制)1200份、土鳖虫(炒)600份、木瓜1150份、蒲公英1150份、石蜡1600份、白凡士林1200份、液状石蜡250份、松香150份。
制备步骤:基本同实施例3。
实施例8:按以下重量份取各组分:
大黄3000份、栀子600份、乳香(制)1200份、土鳖虫(炒)600份、木瓜1200份、蒲公英1200份、石蜡1600份、白凡士林1200份、液状石蜡250份、松香150份、氮酮100份。
制备步骤:
A-B步骤基本同实施例3。
C、将松香、石蜡、凡士林、液状石蜡加热至(约95℃),熔融,待温度降至70℃时,依次加入土鳖虫粉、乳香粉、干膏粉、氮酮搅拌均匀,制成涂料。
D、进行涂膏、切断、盖衬、切片,即得。
实施例9:按以下重量份取各组分:
在实施例7组合物基础上加入促渗剂丙二醇500份
制备步骤:
A-B步骤基本同实施例3。
C、将松香、石蜡、凡士林、液状石蜡加热至(约95℃),熔融,待温度降至70℃时,依次加入土鳖虫粉、乳香粉、干膏粉、丙二醇搅拌均匀,制成涂料。
D、进行涂膏、切断、盖衬、切片,即得。
实施例10:
按以下重量份取各组分:
在实施例7组合物基础上加入促渗剂冰片400份
制备步骤:
A-B步骤基本同实施例3。
C、将松香、石蜡、凡士林、液状石蜡加热至(约95℃),熔融,待温度降至70℃时,依次加入土鳖虫粉、乳香粉、干膏粉、冰片搅拌均匀,制成涂料。
D、进行涂膏、切断、盖衬、切片,即得。
Claims (10)
1.一种用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,按重量份包括大黄1000-5000份、栀子400-800份、乳香800-1600份、土鳖虫400-800份、木瓜800-1500份、蒲公英800-1500份。
2.根据权利要求书1所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,包括以下重量份的基质辅料:石蜡1200-2000份、凡士林800-1600份、液状石蜡100-400份、松香10-300份。
3.根据权利要求书2所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,按重量份包括大黄1500-4500份、栀子450-750份、乳香900-1500份、土鳖虫450-750份、木瓜900-1500份、蒲公英900-1500份、石蜡1300-1900份、凡士林900-1500份、液状石蜡150-350份、松香30-250份。
4.根据权利要求书3所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,按重量份包括大黄1800-4000份、栀子500-700份、乳香1000-1400份、土鳖虫500-700份、木瓜1000-1400份、蒲公英1000-1400份、石蜡1500-1800份、凡士林1000-1400份、液状石蜡170-320份、松香50-220份。
5.根据权利要求书3所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,按重量份包括大黄2000-3800份、栀子550-650份、乳香1100-1300份、土鳖虫550-650份、木瓜1100-1200份、蒲公英1100-1300份、石蜡1550-1750份、凡士林1100-1200份、液状石蜡180-320份、松香80-200份。
6.根据权利要求书3、4或5任一项所述用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,大黄、栀子、木瓜、乳香、土鳖虫、蒲公英可以为原药材也可以为饮片或炮制品,凡士林可以是白凡士林或黄凡士林。
7.根据权利要求书1所述用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,包括以下基质辅料:由压敏胶、聚丙烯酸钠系列、PAA-聚乙烯基吡咯烷酮、聚乙二醇、硅橡胶、硅油、羊毛脂、明胶、卡波姆等本技术领域技术人员显而易见的外用辅料中一种或多种的组合。
8.根据权利要求书3-7任一项所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物,其特征在于,所述组合物中包括透皮促渗剂,如氮酮、冰片、水杨酸甲酯、薄荷脑、丙二醇及等本技术领域技术人员显而易见的中药挥发油或挥发性成分。
9.权利要求书6所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)乳香低温粉碎成细粉,过60-90目筛,备用;土鳖虫粉碎成细粉在50-70℃烘箱中烘2.5-4.5小时后粉碎成细粉,过60-90目筛,备用;
(2)大黄、栀子分别粗粉碎过20-40目筛后,与木瓜、蒲公英合并采用60-80%乙醇回流提取2次,每次2小时,合并提取液,回收乙醇,浓缩至相对密度1.20~1.30的稠膏,70-80℃以下,真空度-0.05MPa以上减压干燥,所得干膏粉粉碎处理,过60-90目筛,混合均匀;
(3)将松香、石蜡、凡士林、液状石蜡加热至90-100℃,熔融,待温度降至65-75℃时,依次加入土鳖虫粉、乳香粉、干膏粉搅拌均匀,制成涂料;
(4)进行涂膏、切断、盖衬、切片,即得。
10.根据权利要求书9所述的用于治疗跌打损伤初期、急性软组织损伤及骨折的中药组合物的制备方法,其特征在于,所述组合物也可以制备成黑膏药、软膏剂、橡胶膏剂、贴膏剂、涂膜剂、糊剂、擦剂、洗剂、凝胶剂等外用制剂。
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