CN115444874B - 一种活血化瘀的三七中药膏及其制备方法 - Google Patents
一种活血化瘀的三七中药膏及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种活血化瘀的三七中药膏及其制备方法,涉及中药制剂技术领域。本发明的中药膏以质量比为1:0.3‑0.5的三七提取物和苜蓿提取物作为活性成分,仅采用两味中药原料,药味简单,在三七基础活血化瘀药物组分基础之上,协同苜蓿活性提取物,结合适宜的提取方法,实现了优异的活血化瘀效果,能够显著降低血液黏度、改善血液循环、提升机体免疫,实现了对血瘀证的显著治疗目的。
Description
技术领域
本发明涉及中药制剂技术领域,特别是涉及一种活血化瘀的三七中药膏及其制备方法。
背景技术
“瘀滞内结”是指血液在脉道中运行迟缓、阻滞、凝聚,“内结之血为血瘀”。中医理论认为,淤血是由于血液运行不畅而阻滞于脉中,或溢于脉外,凝聚于某一局部而形成的病理产物,而所产生的淤血又会影响血液的正常运行,进而成为一些疾病的致病因素,导致新的病症。活血化瘀是中医医学的一个重要理论和治疗原则,《内经》记载的“疏其血气、令其调达”,已成为活血化瘀治则的基础。在西医理论中,表现为血液流变学异常、血流动力学改变、血栓形成以及动脉管腔狭窄,上述这些表现容易引起心肌梗死、心力衰竭、心肌病、心绞痛、急性脑梗塞、血栓闭塞性脉管炎、深部静脉栓塞以及老年血管性痴呆等病症。
目前,活血化瘀主要采用按摩、热敷或采用西医膏药进行治疗,但存在治疗效果不理想的显著弊端,并且部分消炎药和活血类药物属于激素类药物,对机体存在刺激性,长期使用会产生耐受性以及副作用。中药具有安全、无毒副作用的显著优势,因此,提供一种治疗效果优异的活血化瘀中药膏极为必要。
发明内容
本发明的目的是提供一种活血化瘀的三七中药膏及其制备方法,以解决上述现有技术存在的问题,实现优异的活血化瘀疗效。
为实现上述目的,本发明提供了如下方案:
本发明提供一种活血化瘀的中药组合物,所述中药组合物由三七提取物和苜蓿提取物组成;所述三七提取物和苜蓿提取物的质量比为1:0.3-0.5。
进一步地,所述三七提取物的制备方法包括以下步骤:
将三七粉碎,加入水中,加入木瓜蛋白酶进行酶解,酶解结束后灭酶处理,过滤,收集滤液;将所述滤液依次利用乙酸乙酯和叔丁醇进行萃取,收集叔丁醇相,减压浓缩去除溶剂,得到三七提取物。
进一步地,所述木瓜蛋白酶的添加量为所述三七质量的0.6-0.8%。
进一步地,所述酶解的温度为室温,时间为20-25min。
进一步地,所述苜蓿提取物的制备方法包括以下步骤:
将苜蓿粉碎,然后在氢氧化钠溶液中浸泡,过滤,收集滤渣,将所述滤渣水洗至中性,然后加入乙醇回流提取,将所得回流液减压浓缩除去溶剂,得到苜蓿提取物。
进一步地,所述氢氧化钠溶液的质量浓度为5%。
进一步地,所述浸泡温度为55-65℃,时间为25-40min;所述乙醇回流提取的时间为0.5-2h。
本发明还提供一种活血化瘀的三七中药膏,含有上述中药组合物。
进一步地,所述中药组合物在所述三七中药膏中的质量含量为2%。
本发明进一步提供上述三七中药膏的制备方法,包括以下步骤:
将凡士林、十八醇、羊毛脂和硬脂酸混合加热溶解,加入所述中药组合物,搅拌均匀,即得所述三七中药膏。
所述凡士林、十八醇、羊毛脂和硬脂酸的质量比为15:15:18:20。
三七,为五加科人参属植物,味甘、微苦,性温,归肝、胃、心及小肠经,具有止血、散瘀、消肿、止痛、补虚等功效,主治咯血、衄血、外伤出血及跌打肿痛等,具有活血化瘀的功效。本发明首先利用木瓜蛋白酶对三七进行酶解,然后采用不同的有机相对酶解液进行萃取,有机相叔丁醇中的三七活性成分与苜蓿提取物共同作用,仅采用两味中药为原料进行活性成分提取即实现了优异的活血化瘀效果。
本发明公开了以下技术效果:
本发明的活血化瘀中药膏为中药制剂,仅采用两味中药原料,药味简单,药物配伍科学、合理,在三七基础活血化瘀药物组分基础之上,协同苜蓿活性提取物,结合适宜的提取方法,实现了优异的活血化瘀效果,能够显著降低血液黏度、改善血液循环、提升机体免疫,实现了对血瘀证的显著治疗目的。
具体实施方式
现详细说明本发明的多种示例性实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。
应理解本发明中所述的术语仅仅是为描述特别的实施方式,并非用于限制本发明。另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。本说明书中提到的所有文献通过引用并入,用以公开和描述与所述文献相关的方法和/或材料。在与任何并入的文献冲突时,以本说明书的内容为准。
在不背离本发明的范围或精神的情况下,可对本发明说明书的具体实施方式做多种改进和变化,这对本领域技术人员而言是显而易见的。由本发明的说明书得到的其他实施方式对技术人员而言是显而易见的。本发明说明书和实施例仅是示例性的。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。
本发明中所述的“份”如无特别说明,均按质量份计。
实施例1
一种活血化瘀中药组合物,组分为三七提取物和苜蓿提取物质量比1:0.3的混合物。
三七提取物的制备方法为:
将三七清洗、干燥,粉碎至60目,将得到的三七粉加入5倍的去离子水中,然后加入三七粉质量0.6%的木瓜蛋白酶酶解20min,酶解结束后升温至95℃灭酶,降至室温,过滤,收集滤液;然后将所得滤液依次利用乙酸乙酯和叔丁醇进行萃取,收集叔丁醇相,减压浓缩去除溶剂,得到三七提取物。
苜蓿提取物的制备方法为:
将苜蓿粉碎,将得到的苜蓿粉末置于质量浓度5%的氢氧化钠溶液中,在65℃条件下浸泡35min,过滤,收集滤渣,将所得滤渣水洗至中性,然后加入乙醇回流提取1h,将回流液减压浓缩除去溶剂,得到苜蓿提取物。
实施例2
一种活血化瘀中药组合物,组分为三七提取物和苜蓿提取物质量比1:0.5的混合物。
三七提取物的制备方法为:
将三七清洗、干燥,粉碎至50目,将得到的三七粉加入4倍的去离子水中,然后加入三七粉质量0.6%的木瓜蛋白酶酶解20min,酶解结束后升温至95℃灭酶,降至室温,过滤,收集滤液;然后将所得滤液依次利用乙酸乙酯和叔丁醇进行萃取,收集叔丁醇相,减压浓缩去除溶剂,得到三七提取物。
苜蓿提取物的制备方法为:
将苜蓿粉碎,将得到的苜蓿粉末置于质量浓度5%的氢氧化钠溶液中,在55℃条件下浸泡40min,过滤,收集滤渣,将所得滤渣水洗至中性,然后加入乙醇回流提取2h,将回流液减压浓缩除去溶剂,得到苜蓿提取物。
实施例3
一种活血化瘀中药组合物,组分为三七提取物和苜蓿提取物质量比1:0.4的混合物。
三七提取物的制备方法为:
将三七清洗、干燥,粉碎至50目,将得到的三七粉加入4倍的去离子水中,然后加入三七粉质量0.7%的木瓜蛋白酶酶解20min,酶解结束后升温至95℃灭酶,降至室温,过滤,收集滤液;然后将所得滤液依次利用乙酸乙酯和叔丁醇进行萃取,收集叔丁醇相,减压浓缩去除溶剂,得到三七提取物。
苜蓿提取物的制备方法为:
将苜蓿粉碎,将得到的苜蓿粉末置于质量浓度5%的氢氧化钠溶液中,在60℃条件下浸泡25min,过滤,收集滤渣,将所得滤渣水洗至中性,然后加入乙醇回流提取0.5h,将回流液减压浓缩除去溶剂,得到苜蓿提取物。
对比例1
与实施例1不同之处在于,调整三七提取物和苜蓿提取物质量比为1:0.7。
对比例2
与实施例1不同之处在于,三七提取物制备过程中,仅利用乙酸乙酯进行萃取,具体步骤如下:
将三七清洗、干燥,粉碎至50目,将得到的三七粉加入4倍的去离子水中,然后加入三七粉质量0.6%的木瓜蛋白酶酶解20min,酶解结束后升温至95℃灭酶,降至室温,过滤,收集滤液;然后将所得滤液利用乙酸乙酯进行萃取,收集乙酸乙酯相,减压浓缩去除溶剂,得到三七提取物。
实施例4
一种活血化瘀的三七中药膏,经以下步骤制备得到:
制备方法:
将凡士林、十八醇、羊毛脂和硬脂酸按照质量比15:15:18:20投入加热反应罐中并加热溶解,然后加入实施例1的中药组合物,使中药组合物质量浓度为2%,高速搅拌至混合均匀,即得活血化瘀的三七中药膏。
实施例5
以实施例2的中药组合物为活性成分,采用同实施例4的制备工艺和参数,制备得到活血化瘀的三七中药膏。
实施例6
以实施例3的中药组合物为活性成分,采用同实施例4的制备工艺和参数,制备得到活血化瘀的三七中药膏。
效果验证例1血液流变学效果验证:
1.实验对象:雄性SD种大鼠,240只,体重200-230g。
2.实验分组及给药:将SD大鼠240只随机分为12组,每组20只,灌胃给药:
空白组:蒸馏水(10mL/kg);
模型组:蒸馏水(10mL/kg);
阳性对照组:复方丹参片(0.625g/kg);
中药组合物低剂量组:(50mg/kg);中药组合物中剂量组(100mg/kg);中药组合物高剂量组(200mg/kg);
中药组合物低剂量对照组1:(50mg/kg);中药组合物中剂量对照组1(100mg/kg);中药组合物高剂量对照组1(200mg/kg);
中药组合物低剂量对照组2:(50mg/kg);中药组合物中剂量对照组2(100mg/kg);中药组合物高剂量对照组2(200mg/kg)。
中药组合物低/中/高剂量组为实施例1中的中药组合物;中药组合物低/中/高剂量对照组1为对比例1中的中药组合物;中药组合物低/中/高剂量对照组2为对比例2中的中药组合物。
每天一次,连续4天。
3.建立“肝气郁结和寒凝”型血瘀证模型:
在给药后的第4天,在给药1h后,除空白组外,各组大鼠均按照“肝气郁结和寒凝”型血瘀证模型法,以0.1%肾上腺素0.2ml/只进行皮下注射,一天注射2次,每次间隔6h,并在此期间,将大鼠四肢捆绑固定,利用冰水浸泡躯体,每次浸泡时间为5min。从而建立模型,使得血液粘稠、增浓、易凝。模型建立完成后,所有大鼠禁食处理,不禁水。
4.血液流变学测定
第5天,各组大鼠腹腔注射乌来糖溶液(质量分数为20%)5ml/kg麻醉、剖腹,待大鼠麻醉后腹主动脉取血5mL于含肝素钠的真空采血管中,混匀,送检。采用全自动血液流变分析仪检测全血粘度,结果如表1所示。
表1
效果验证例2
本发明活血化瘀三七中药膏临床应用实验如下:
1.病例纳入标准:血液淤滞、具有肢体麻木情况的患者。
2.病例情况:选取80例符合上述标准的患者,年龄在18-65岁,病程3月-2年;其中男性48例,女性32例。
3.治疗方法:将患处用清水洗净并擦干,于患处涂抹本发明实施例4的活血化瘀三七中药膏,并轻柔按摩至发热。每天2次,7天为一个疗程。
4.疗效标准:
治愈:肢体麻木症状消失,活动灵活;
显效:肢体麻木症状明显减轻;
有效:肢体麻木症状减轻程度不明显,但有所改善;
无效:肢体麻木症状无改善。
5.临床疗效:
两个疗程后,统计临床疗效数据,结果如表2所示。
表2
治愈 | 显效 | 有效 | 无效 |
47人 | 26人 | 5人 | 2人 |
本发明的活血化瘀三七中药膏疗效显著,使用疗程短,且对正常及破损皮肤均未见刺激性反应,未出现过敏等不良反应。
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (8)
1.一种活血化瘀的中药组合物,其特征在于,所述中药组合物由三七提取物和苜蓿提取物组成;所述三七提取物和苜蓿提取物的质量比为1:0.3-0.5;
所述三七提取物的制备方法包括以下步骤:
将三七粉碎,加入水中,加入木瓜蛋白酶进行酶解,酶解结束后灭酶处理,过滤,收集滤液;将所述滤液依次利用乙酸乙酯和叔丁醇进行萃取,收集叔丁醇相,减压浓缩去除溶剂,得到三七提取物;
所述苜蓿提取物的制备方法包括以下步骤:
将苜蓿粉碎,然后在氢氧化钠溶液中浸泡,过滤,收集滤渣,将所述滤渣水洗至中性,然后加入乙醇回流提取,将所得回流液减压浓缩除去溶剂,得到苜蓿提取物。
2.根据权利要求1所述的中药组合物,其特征在于,所述木瓜蛋白酶的添加量为所述三七质量的0.6-0.8%。
3.根据权利要求1所述的中药组合物,其特征在于,所述酶解的温度为室温,时间为20-25min。
4.根据权利要求1所述的中药组合物,其特征在于,所述氢氧化钠溶液的质量浓度为5%。
5.根据权利要求4所述的中药组合物,其特征在于,所述浸泡温度为55-65℃,时间为25-40min;所述乙醇回流提取的时间为0.5-2h。
6.一种活血化瘀的三七中药膏,其特征在于,含有权利要求1-5任一项所述的中药组合物。
7.根据权利要求6所述的三七中药膏,其特征在于,所述中药组合物在所述三七中药膏中的质量含量为2%。
8.如权利要求6-7任一项所述的三七中药膏的制备方法,其特征在于,包括以下步骤:
将凡士林、十八醇、羊毛脂和硬脂酸混合加热溶解,加入所述中药组合物,搅拌均匀,即得所述三七中药膏。
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