CN116392530A - 一种治疗风湿的中药组合物及制备方法 - Google Patents
一种治疗风湿的中药组合物及制备方法 Download PDFInfo
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Abstract
本发明涉及中药技术领域,尤其是涉及一种治疗风湿的中药组合物及制备方法。该中药组合物包括以下重量份的原料:威灵仙10‑12份、肉桂10‑12份、六月雪10‑12份、巴戟天12‑15份、桂枝8‑10份、云实15‑20份、附子8‑13份、当归9‑14份、黄芪25‑28份、党参15‑17份、六神曲15‑17份。该组合物治疗风湿性疾病效果显著,不易复发。本发明还提供了该中药组合物的制备方法,能够充分提取药物的有效成分,保护药物中的有效成分和活性不被破坏,提高人体吸收率,增强治疗效果。
Description
技术领域
本发明涉及中药技术领域,尤其是涉及一种治疗风湿的中药组合物及制备方法。
背景技术
风湿病是一组侵犯关节、骨骼、肌肉、血管及有关软组织或结缔组织为主的疾病,其中多数为自身免疫性疾病。发病多较隐蔽而缓慢,患病因素包括感染、免系统缺陷、遗传,病程较长,需要长期接受治疗,且大多具有遗传倾向。
现有的许多抗风湿药物,比如非甾体抗炎药(如阿司匹林、布洛芬、双氯芬酸)、免疫抑制剂(如甲氨蝶呤、来氟米特、柳氮磺胺吡啶)及部分生物制剂等都可以引起药物性肝损,同时服药时间长,有的患者可能需要终身服药,治疗效果并不理想。
中药是以中国传统医药理论指导采集、炮制、制剂,说明作用机理,指导临床应用的药物,用于预防、治疗、诊断疾病并具有康复与保健作用的物质。中药主要来源于天然药及其加工品,包括植物药、动物药、矿物药类药物,长期食用对身体无损害,但是现有的中药配方治疗风湿的效果并不显著,易复发,而且其制备方法过程中不能很好的保留药物的有效成分,不能发挥药物的最大作用。
鉴于此,需要一种不易复发的中药组合物用于治疗风湿,同时也需要一种能够最大程度地保留药物中有效成分的制备方法。
发明内容
本发明的第一目的在于提供一种治疗风湿的中药组合物,该组合物治疗风湿性疾病效果显著,不易复发。本发明的第二目的在于提供一种治疗风湿的中药组合物的制备方法,该方法能够充分提取药物的有效成分。
本发明提供的一种治疗风湿的中药组合物,包括以下重量份的原料:威灵仙10-12份、肉桂10-12份、六月雪10-12份、巴戟天12-15份、桂枝8-10份、云实15-20份、附子8-13份、当归9-14份、黄芪25-28份、党参15-17份、六神曲15-17份。
优选地,包括以下重量份的原料:威灵仙10份、肉桂10份、六月雪10份、巴戟天12份、桂枝8份、云实15份、附子8份、当归10份、黄芪25份、党参15份、六神曲17份。
本发明提供的上述中药组合物的制备方法,将上述所有原料加工制成中药制剂。
优选地,所述中药制剂为散剂、丸剂、膏剂、口服液或药酒。
优选地,所述中药制剂为散剂。
优选地,包括以下步骤:
(1)将云实、附子、当归、黄芪、党参、六神曲粉碎后,加入纯净水浸泡后煎煮,煎煮后获得第一提取液;
(2)将威灵仙、肉桂、六月雪、巴戟天、桂枝粉碎后加入超声逆流提取设备中,加入提取溶剂乙醇,提取后,过滤,滤液减压浓缩,得到第二提取液;
(3)将第一提取液和第二提取液混合,减压浓缩,真空冷冻干燥,粉碎,过筛,灭菌,得到中药散剂。
优选地,所述步骤(1)中浸泡时间为20-24小时,加水煎煮两次,每次煎煮加入药材重量2-3倍的水,在95-100℃的条件下煎煮3-4小时;更优选地,所述步骤(1)中浸泡时间为24小时,加水煎煮两次,每次煎煮加入药材重量3倍的水,在100℃的条件下煎煮3.5小时。采用煎煮的方法相比较采用回流法更能充分地提取出上述药物中的有效成分,重复两次煎煮能够保证各有效成分被富集,增强治疗效果。
优选地,所述步骤(2)中加入乙醇的重量为药材重量的8-10倍,超声频率设置为30-50kHz,温度为45-50℃,提取时间为4-5小时。更优选地,所述步骤(2)中加入乙醇的重量为药材重量的10倍,超声频率设置为50kHz,温度为50℃,提取时间为5小时。采用超声波提取比水煎煮法提取的药物的要有效成分更全面,治疗效果更好。
优选地,所述步骤(3)中的真空冷冻干燥具体过程为:在0.1Pa-0.3Pa真空度下,先在-25℃--30℃下冷冻7-8h,然后以每分钟1-2℃的速度缓慢升温,至0-5℃下干燥3-4h,再以每分钟1-2℃的速度继续缓慢升温,至25-30℃下干燥14-15h。更优选地,所述步骤(3)中的真空冷冻干燥具体过程为:在0.1Pa真空度下,先在-30℃下冷冻7h,然后以每分钟1℃的速度缓慢升温,至2℃下干燥3h,再以每分钟1℃的速度继续缓慢升温,至30℃下干燥14h。采用真空冷冻干燥比采用加热烘干能更好的保护中原料中的有效成分和活性物质,增强治疗效果。采用上述逐级升温干燥能够防止药物内部也充分干燥,粉碎后在水中易溶解,易于人体吸收。
优选地,所述步骤(3)中过筛采用80-100目筛;灭菌采用紫外线辐射处理40-50分钟。
综上所述,本发明与现有技术相比具有以下优点:
本发明提供的中药组合物采用威灵仙、肉桂、六月雪、巴戟天、桂枝为君药,散风祛湿,舒筋活络,温经通脉;云实、附子和当归为臣药,抗菌消炎;黄芪、党参和六神曲为佐药,补中益气,健脾益肺,增强免疫力,提高身体素质;君臣相辅,先消除患处的炎症,再进行温经通脉,治疗效果更明显,与传统治疗风湿的中药相比缩短了治疗时间,佐药配合二者增强身体免疫力,长期服用对身体无损害,不宜复发,适用于风湿痹痛、四肢酸麻、腰膝无力、风湿导致的关节变形等症。
本发明提供的上述中药组合物的制备方法,能够最大程度提取各个药物中的有效成分,使药性发挥到最大,保护药物中的有效成分和活性不被破坏,提高人体吸收率,增强治疗效果。
具体实施方式
应该指出,以下详细说明都是例示性的,旨在对本申请提供进一步的说明。除非另有指明,本文使用的所有技术和科学术语具有与本申请所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本申请的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也包括复数形式,此外,还应当理解的是,当在本说明中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
下面将结合实施例对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗风湿的中药组合物,由以下重量份的原料组成:威灵仙10份、肉桂10份、六月雪10份、巴戟天12份、桂枝8份、云实15份、附子8份、当归10份、黄芪25份、党参15份、六神曲17份。
将上述中药组合物加工制成中药散剂,具体步骤如下:
(1)将云实、附子、当归、黄芪、党参、六神曲粉碎后,加入纯净水浸泡24小时,加入云实、附子、当归、黄芪、党参、六神曲总重量3倍的水,在100℃的条件下煎煮3.5小时,重复煎煮2次,获得第一提取液;
(2)将威灵仙、肉桂、六月雪、巴戟天、桂枝粉碎后加入超声逆流提取设备中,加入提取溶剂乙醇,加入乙醇的重量为威灵仙、肉桂、六月雪、巴戟天、桂枝总重量的10倍,超声频率设置为50kHz,温度为50℃,提取5小时后过滤,滤液减压浓缩,得到第二提取液;
(3)将第一提取液和第二提取液混合,减压浓缩,真空冷冻干燥,在0.1Pa真空度下,先在-30℃下冷冻7h,然后以每分钟1℃的速度缓慢升温,至2℃下干燥3h,再以每分钟1℃的速度继续缓慢升温,至30℃下干燥14h,干燥后粉碎,过80目筛,紫外线辐射处理50分钟,分装,每袋10克,得到中药散剂。
上述中药散剂使用时直接取一包放入150mL温水中搅拌均匀,一日三次,每次一包,三天为一个疗程,连续服用3个疗程。
实施例2
一种治疗风湿的中药组合物,由以下重量份的原料组成:威灵仙12份、肉桂12份、六月雪12份、巴戟天15份、桂枝10份、云实20份、附子13份、当归14份、黄芪28份、党参17份、六神曲15份。
将上述中药组合物加工制成中药散剂,具体步骤如下:
(1)将云实、附子、当归、黄芪、党参、六神曲粉碎后,加入纯净水浸泡20小时,加入云实、附子、当归、黄芪、党参、六神曲总重量2倍的水,在95℃的条件下煎煮4小时,重复煎煮2次,获得第一提取液;
(2)将威灵仙、肉桂、六月雪、巴戟天、桂枝粉碎后加入超声逆流提取设备中,加入提取溶剂乙醇,加入乙醇的重量为威灵仙、肉桂、六月雪、巴戟天、桂枝总重量的8倍,超声频率设置为30kHz,温度为45℃,提取4小时后过滤,滤液减压浓缩,得到第二提取液;
(3)将第一提取液和第二提取液混合,减压浓缩,真空冷冻干燥,在0.3Pa真空度下,先在-25℃下冷冻8h,然后以每分钟1℃的速度缓慢升温,至5℃下干燥3h,再以每分钟1℃的速度继续缓慢升温,至25℃下干燥15h,干燥后粉碎,过80目筛,紫外线辐射处理45分钟,分装,每袋10克,得到中药散剂。
上述中药散剂使用时直接取一包放入150mL温水中搅拌均匀,一日三次,每次一包,3天为一个疗程,连续服用3个疗程。
实施例3
一种治疗风湿的中药组合物,由以下重量份的原料组成:威灵仙11份、肉桂11份、六月雪11份、巴戟天13份、桂枝9份、云实17份、附子11份、当归12份、黄芪27份、党参16份、六神曲16份。
将上述中药组合物加工制成中药散剂,具体步骤如下:
(1)将云实、附子、当归、黄芪、党参、六神曲粉碎后,加入纯净水浸泡22小时,加入云实、附子、当归、黄芪、党参、六神曲总重量2.5倍的水,在98℃的条件下煎煮3.5小时,重复煎煮2次,获得第一提取液;
(2)将威灵仙、肉桂、六月雪、巴戟天、桂枝粉碎后加入超声逆流提取设备中,加入提取溶剂乙醇,加入乙醇的重量为威灵仙、肉桂、六月雪、巴戟天、桂枝总重量的9倍,超声频率设置为40kHz,温度为47℃,提取4.5小时后过滤,滤液减压浓缩,得到第二提取液;
(3)将第一提取液和第二提取液混合,减压浓缩,真空冷冻干燥,在0.2Pa真空度下,先在-27℃下冷冻7.5h,然后以每分钟1.5℃的速度缓慢升温,至3℃下干燥3.5h,再以每分钟1.5℃的速度继续缓慢升温,至27℃下干燥14.5h,干燥后粉碎,过100目筛,紫外线辐射处理40分钟,分装,每袋10克,得到中药散剂。
上述中药散剂使用时直接取一包放入150mL温水中搅拌均匀,一日三次,每次一包,3天为一个疗程,连续服用3个疗程。
本发明实施例1-3中的制备方法步骤(2)中采用的提取溶剂为质量分数为95%的乙醇。本发明采用的原料均为市售中药药材。
对比例1
一种中药组合物,其技术方案与实施例1基本一致,不同之处在于:将其中的云实、附子和当归替换为金银花、肉桂和单参。
对比例2
一种中药组合物,其技术方案与实施例1基本一致,不同之处在于:将其中的黄芪、党参和六神曲替换为白术、人参和麦芽。
对比例3
一种中药组合物,其技术方案与实施例1基本一致,不同之处在于:将其中的六月雪替换为独活,肉桂替换为干姜,巴戟天替换为鹿茸。
对比例4
一种中药组合物,其技术方案与实施例1基本一致,不同之处在于:制备方法中步骤(1)为:将云实、附子、当归、黄芪、党参、六神曲粉碎后,加入纯净水浸泡24小时,加入云实、附子、当归、黄芪、党参、六神曲总重量3倍的95%的乙醇溶液加热回流3.5小时,获得第一提取液。
对比例5
一种中药组合物,其技术方案与实施例1基本一致,不同之处在于:制备方法中步骤(2)为:将威灵仙、肉桂、六月雪、巴戟天、桂枝粉碎后加入纯净水,加入水的重量为威灵仙、肉桂、六月雪、巴戟天、桂枝总重量的10倍,在100℃下煎煮4小时,重复煎煮两次后过滤,滤液减压浓缩,得到第二提取液。
对比例6
一种中药组合物,其技术方案与实施例1基本一致,不同之处在于:制备方法中步骤(3)为:将第一提取液和第二提取液混合,减压浓缩,放置在80℃的烘箱中烘干,粉碎,过筛,灭菌,得到中药散剂。
毒性试验
选择80只健康的实验用小白鼠,质量200±5g,随机分为四组,每组20只,其中雌鼠和雄鼠各10只。其中1-3组为实验组分别喂实施例1-3制备的中药组合物,一日一次,饭后服用,每只喂50毫克的药加2毫升水溶解,最后一组作为对照,饭后仅喂2毫升水。在同样的环境中喂普通饲料,实验周期为2个月。
实验结束后,检验实验组小白鼠的血液细胞学指标、血液生化学指标与对照组的无明显差异。将4组小白鼠处死后内脏进行病理切片染色检查,实验组小白鼠脏器组织结构排列有序,细胞形态正常,染色清晰,与对照组比较无明显差异。
毒性试验表明,本发明实施例1-3提供的中药组合物对小白鼠长期给药后未见毒性反应。
临床试验
选择年龄在45-60周岁的360名风湿性关节炎患者,分为9组,每组40人。每组患者分别使用实施例1-3和对比例1-6提供的中药组合物,一日三次,连续服用9天,治疗情况如表1所示。
疗效标准如下:
痊愈:症状消失,关节功能恢复;有效:症状减轻,关节活动障碍有所改善;无效:治疗前后无任何变化。
表1风湿性关节炎治疗效果
其中表1中的总有效率为有效率与痊愈率之和。
从表1中可以看出,本发明实施例1-3提供的中药组合物具有显著的治疗效果,痊愈率在67.5%以上,比对比例1-3提供的中药组合物至少高32.5%;实施例1-3总有效率在90%,比对比例1-3提供的中药组合物至少高20%。
通过实施例1与对比例4-6治疗效果可以看出,本发明实施例1的治疗效果最好,该中药组合物的制备方法能够充分的提取各个药物中的有效成分,使药性发挥到最大,保护药物中的有效成分和活性不被破坏,从而保证好的治疗效果。
上述痊愈的患者停药六个月后进行随访,统计风湿性关节炎复发情况,如表2所示。
表2停药后的复发结果
通过表2可以看出,本发明实施例1-3提供的中药组合物,复发率最高仅为22.2%,与对比例1-3相比,复发率至少低了27.8%,本发明提供的中药组合物治愈风湿后不易复发。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (10)
1.一种治疗风湿的中药组合物,其特征在于,包括以下重量份的原料:威灵仙10-12份、肉桂10-12份、六月雪10-12份、巴戟天12-15份、桂枝8-10份、云实15-20份、附子8-13份、当归9-14份、黄芪25-28份、党参15-17份、六神曲15-17份。
2.根据权利要求1所述的治疗风湿的中药组合物,其特征在于,包括以下重量份的原料:威灵仙10份、肉桂10份、六月雪10份、巴戟天12份、桂枝8份、云实15份、附子8份、当归10份、黄芪25份、党参15份、六神曲17份。
3.一种权利要求1-2任一所述的治疗风湿的中药组合物的制备方法,其特征在于,将上述所有原料加工制成中药制剂。
4.根据权利要求3所述的制备方法,其特征在于,所述中药制剂为散剂、丸剂、膏剂、口服液或药酒。
5.根据权利要求4所述的制备方法,其特征在于,所述中药制剂为散剂。
6.根据权利要求5所述的制备方法,其特征在于,包括以下步骤:
(1)将云实、附子、当归、黄芪、党参、六神曲粉碎后,加入纯净水浸泡后煎煮,煎煮后获得第一提取液;
(2)将威灵仙、肉桂、六月雪、巴戟天、桂枝粉碎后加入超声逆流提取设备中,加入提取溶剂乙醇,提取后,过滤,滤液减压浓缩,得到第二提取液;
(3)将第一提取液和第二提取液混合,减压浓缩,真空冷冻干燥,粉碎,过筛,灭菌,得到中药散剂。
7.根据权利要求6所述的制备方法,其特征在于,所述步骤(1)中浸泡时间为20-24小时,加水煎煮两次,每次煎煮加入药材重量2-3倍的水,在95-100℃的条件下煎煮3-4小时。
8.根据权利要求6所述的制备方法,其特征在于,所述步骤(2)中加入乙醇的重量为药材重量的8-10倍,超声频率设置为30-50kHz,温度为45-50℃,提取时间为4-5小时。
9.根据权利要求6所述的制备方法,其特征在于,所述步骤(3)中的真空冷冻干燥具体过程为:在0.1Pa-0.3Pa真空度下,先在-25℃--30℃下冷冻7-8h,然后以每分钟1-2℃的速度缓慢升温,至0-5℃下干燥3-4h,再以每分钟1-2℃的速度继续缓慢升温,至25-30℃下干燥14-15h。
10.根据权利要求6所述的制备方法,其特征在于,所述步骤(3)中过筛采用80-100目筛;灭菌采用紫外线辐射处理40-50分钟。
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