CN107362330A - 治疗高血压的口服液的制备方法 - Google Patents
治疗高血压的口服液的制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗高血压的口服液的制备方法,所述口服液由以下重量份的中药组合物制备得到:柴胡10‑20、白芍5‑15、陈皮3‑9、葛根5‑15、香附2‑8、郁金3‑9、泽泻18‑26、白术6‑12、石菖蒲10‑20、泽兰10‑20、山药10‑20、黄芪10‑20、云苓5‑15、当归8‑16、冬葵子5‑15、石韦5‑15、甘草5‑15、枣仁5‑15、红花3‑11、三七10‑30、决明子5‑15、罗布麻6‑12、绞股蓝5‑15、砂仁5‑15、鬼针草15‑25、淫羊藿10‑20、铁线草5‑15、金丝草5‑15、车前草5‑15、萹蓄5‑15、苦荞麦15‑25、独行菜5‑15以及盒子草5‑15。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种治疗高血压的口服液的制备方法。
背景技术
随着生活水平的不断提高,人们由于工作、生活压力的原因及饮食问题上的不节制,导致精神长期处于过度紧张、焦虑的状态下,以及脂肪、盐类的过分的摄入,导致高血压病发呈逐年上升的趋势,高血压可伴有心、脑、肾等器官的功能或器质性损害的临床综合征,很多患者需长期联合用药来控制血压,无法摆脱对药物的依赖,对患者来说不仅是生活的负担,同时也是精神上的负担,现有治疗高血压的药物,需配合用药,疗程长,见效慢,治标不治本,提供一种标本兼顾的药物,且易于人体吸收,治疗效果显著,疗程短的口服液是高血压患者所迫切需要的。
发明内容
本发明的一个目的是解决至少上述问题,并提供至少后面将说明的优点。
本发明还有一个目的是提供一种治疗高血压的口服液的制备方法,能够得到有效治疗高血压的口服液。
为了实现根据本发明的这些目的和其它优点,提供了一种治疗高血压的口服液的制备方法,包括以下步骤:
步骤1、将中药组合物煎煮2次,过滤加入等体积的质量浓度为60-75%乙醇搅拌、静置,回收乙醇,减压浓缩得第一提取液备用;所述中药组合物包括以下重量份的原料:柴胡10-20、白芍5-15、陈皮3-9、葛根5-15、香附2-8、郁金3-9、泽泻18-26、白术6-12、石菖蒲10-20、泽兰10-20、黄芪10-20、云苓5-15、当归8-16、冬葵子5-15、石韦5-15、甘草5-15、枣仁5-15、红花3-11、决明子5-15、罗布麻6-12、绞股蓝5-15、砂仁5-15、鬼针草15-25、淫羊藿10-20、铁线草5-15、金丝草5-15、车前草5-15、萹蓄5-15、苦荞麦15-25、独行菜5-15以及盒子草5-15。
步骤2、将三七、山药分别粉碎得到三七粉和山药粉,备用;所述山药的重量份为:10-20,所述三七的重量份为:10-30。
步骤3、将第一提取液、三七粉和山药粉混合,加入辅料、纯净水,混匀加热,灭菌后封装,得所述治疗高血压的口服液。
优选的是,步骤1所述中药组合物包括以下重量份的原料:柴胡15、白芍10、陈皮6、葛根10、香附5、郁金6、泽泻21、白术9、石菖蒲15、泽兰15、黄芪15、云苓10、当归12、冬葵子10、石韦10、甘草10、枣仁10、红花7、决明子10、罗布麻9、绞股蓝10、砂仁10、鬼针草20、淫羊藿15、铁线草10、金丝草10、车前草10、萹蓄10、苦荞麦20、独行菜10以及盒子草10。
优选的是,步骤2所述山药和三七的重量份均为15。
优选的是,步骤1所述煎煮2次的具体方法为:第一次加入8-12倍的水,煎煮2-3小时;第二次加入6-8倍的水,煎煮1-2h。
优选的是,步骤2所述山药和三七分别粉碎至100-150目。
优选的是,步骤3所述的辅料主要包括以下重量份组分中的一种或几种:乳糖8-12份、D-木糖醇10-15份。
优选的是,步骤3中灭菌温度控制在80-95℃,灭菌时间为20-40min。
本发明至少包括以下有益效果:
本发明中,柴胡,苦、辛、微寒,和解退热、疏肝解郁、升举阳气;白芍,苦、酸、微寒,养血敛阴、柔肝止痛、平抑肝阳;陈皮,辛、苦、理气、调中、燥湿、化痰;葛根,甘、辛、凉,发表解肌、升阳透疹、解热生津、现代研究治疗高血压脑病能改善症状,效果不错;香附,辛、微苦、微甘、平、疏肝理气、调经止痛;郁金,辛、苦寒、活血止痛、行气解郁、凉血清心、利胆退黄;泽泻、白术、石菖蒲、泽兰;能增强利水渗湿,对高血压有显著疗效;黄芪、云苓,配伍能增强补气升阳、利水退肿、健脾;山药,甘、平,益气养阴、补脾肺肾;当归,甘、辛、温、补血、活血、止痛、润肠;冬葵子,甘、寒、利水通淋、下乳、润肠;石韦,利水通淋、止咳;甘草,补脾益气、缓和药性;枣仁,甘、平、养心安神、敛汗;红花,辛、温、活血祛瘀、通经;决明子,降低血脂胆固醇与降血压的功效,对防治血管硬化有一定疗效;罗布麻,本品有利尿作用降血压之功;绞股蓝,有保肝解毒、降血压、降血脂血糖、提高免疫力;砂仁,化湿、行气、温中;鬼针草,清热解毒、散瘀消肿、对降压效果增强;三七,散瘀止血、消肿定痛;淫羊藿,降压利尿、降血糖;铁线草,清热利尿、散瘀止血、舒筋活络;金丝草,清凉散热、解毒、利尿通淋;车前草,利尿、清热、明目、祛痰;萹蓄,利尿通淋;苦荞麦,降血压、降血脂、降血糖;独行菜,利尿、止咳、化痰;盒子草,利水消肿、清热解毒。本发明通过以上多种中药合理配伍,合用能起到相加的作用,达清热解毒,降血脂、降血糖之效。
本发明通过2次煎煮,并将山药、三七分开处理的制备方法,使得所述口服液的药效更易于人体吸收,从而有效治疗高血压。
本发明所述口服液无任何不良影响及毒副作用,根据临床统计,所述治疗高血压的口服液的治愈率达90%,总有效率达到96%,安全性高,疗程短,见效快。
本发明的其它优点、目标和特征将部分通过下面的说明体现,部分还将通过对本发明的研究和实践而为本领域的技术人员所理解。
附图说明
图1为本发明所述治疗高血压的口服液的制备方法的工艺流程图。
具体实施方式
下面结合附图对本发明做进一步的详细说明,以令本领域技术人员参照说明书文字能够据以实施。
应当理解,本文所使用的诸如“具有”、“包含”以及“包括”术语并不配出一个或多个其它元件或其组合的存在或添加。
本发明提供一种治疗高血压的口服液的制备方法,包括以下步骤:
步骤1、将中药组合物煎煮2次,过滤加入等体积的质量浓度为60-75%乙醇搅拌、静置,回收乙醇,减压浓缩得第一提取液备用;所述中药组合物包括以下重量份的原料:柴胡10-20、白芍5-15、陈皮3-9、葛根5-15、香附2-8、郁金3-9、泽泻18-26、白术6-12、石菖蒲10-20、泽兰10-20、黄芪10-20、云苓5-15、当归8-16、冬葵子5-15、石韦5-15、甘草5-15、枣仁5-15、红花3-11、决明子5-15、罗布麻6-12、绞股蓝5-15、砂仁5-15、鬼针草15-25、淫羊藿10-20、铁线草5-15、金丝草5-15、车前草5-15、萹蓄5-15、苦荞麦15-25、独行菜5-15以及盒子草5-15。
步骤2、将三七、山药分别粉碎得到三七粉和山药粉,备用;所述山药的重量份为:10-20,所述三七的重量份为:10-30。
步骤3、将第一提取液、三七粉和山药粉混合,加入辅料、纯净水,混匀加热,灭菌后封装,得所述治疗高血压的口服液。
在上述方案中,柴胡,苦、辛、微寒,和解退热、疏肝解郁、升举阳气;白芍,苦、酸、微寒,养血敛阴、柔肝止痛、平抑肝阳;陈皮,辛、苦、理气、调中、燥湿、化痰;葛根,甘、辛、凉,发表解肌、升阳透疹、解热生津、现代研究治疗高血压脑病能改善症状,效果不错;香附,辛、微苦、微甘、平、疏肝理气、调经止痛;郁金,辛、苦寒、活血止痛、行气解郁、凉血清心、利胆退黄;泽泻、白术、石菖蒲、泽兰;能增强利水渗湿,对高血压有显著疗效;黄芪、云苓,配伍能增强补气升阳、利水退肿、健脾;山药,甘、平,益气养阴、补脾肺肾;当归,甘、辛、温、补血、活血、止痛、润肠;冬葵子,甘、寒、利水通淋、下乳、润肠;石韦,利水通淋、止咳;甘草,补脾益气、缓和药性;枣仁,甘、平、养心安神、敛汗;红花,辛、温、活血祛瘀、通经;决明子,降低血脂胆固醇与降血压的功效,对防治血管硬化有一定疗效;罗布麻,本品有利尿作用降血压之功;绞股蓝,有保肝解毒、降血压、降血脂血糖、提高免疫力;砂仁,化湿、行气、温中;鬼针草,清热解毒、散瘀消肿、对降压效果增强;三七,散瘀止血、消肿定痛;淫羊藿,降压利尿、降血糖;铁线草,清热利尿、散瘀止血、舒筋活络;金丝草,清凉散热、解毒、利尿通淋;车前草,利尿、清热、明目、祛痰;萹蓄,利尿通淋;苦荞麦,降血压、降血脂、降血糖;独行菜,利尿、止咳、化痰;盒子草,利水消肿、清热解毒。通过2次煎煮,并将山药、三七分开处理的制备方法,使得所述口服液的药效更易于人体吸收,从而有效治疗高血压。本发明还可作为泽泻汤加味方使用,有预防高血压,防止肾损伤的功效。
一个优选方案中,步骤1所述中药组合物包括以下重量份的原料:柴胡15、白芍10、陈皮6、葛根10、香附5、郁金6、泽泻21、白术9、石菖蒲15、泽兰15、黄芪15、云苓10、当归12、冬葵子10、石韦10、甘草10、枣仁10、红花7、决明子10、罗布麻9、绞股蓝10、砂仁10、鬼针草20、淫羊藿15、铁线草10、金丝草10、车前草10、萹蓄10、苦荞麦20、独行菜10以及盒子草10。
一个优选方案中,步骤2所述山药和三七的重量份均为15。
在上述方案中,本发明通过以上多种中药合理配伍,合用能起到相加的作用,易于人体吸收,达清热解毒,降血脂、降血糖之效。本发明所述口服液无任何不良影响及毒副作用,根据临床统计,所述治疗高血压的口服液的治愈率达90%,总有效率达到96%,安全性高,疗程短,见效快。
一个优选方案中,步骤1所述煎煮2次的具体方法为:第一次加入8-12倍的水,煎煮2-3小时;第二次加入6-8倍的水,煎煮1-2h。
一个优选方案中,步骤2所述山药和三七分别粉碎至100-150目。
一个优选方案中,步骤3所述的辅料主要包括以下重量份组分中的一种或几种:乳糖8-12份、D-木糖醇10-15份。
在上述方案中,选用所述辅料的特点是无糖、低热量,不仅保证了所述口服液的口感,同时不会导致血糖上升。
一个优选方案中,步骤3中灭菌温度控制在80-95℃,灭菌时间为20-40min。
实施例1
一种治疗高血压的口服液的制备方法,包含以下步骤:
步骤1、将中药组合物煎煮2次,过滤加入等体积的质量浓度为60%乙醇搅拌、静置,回收乙醇,减压浓缩得第一提取液备用;所述中药组合物包括以下重量份的原料:柴胡10g、白芍5g、陈皮3g、葛根5g、香附2g、郁金3g、泽泻18g、白术6g、石菖蒲10g、泽兰10g、黄芪10g、云苓5g、当归8g、冬葵子5g、石韦5g、甘草5g、枣仁5g、红花3g、决明子5g、罗布麻6g、绞股蓝5g、砂仁5g、鬼针草15g、淫羊藿10g、铁线草5g、金丝草5g、车前草5g、萹蓄5g、苦荞麦15g、独行菜5g以及盒子草5g。
其中,所述煎煮2次的具体方法为:第一次加入8倍的水,煎煮2小时;第二次加入6倍的水,煎煮1h。
步骤2、将三七10g、山药10g分别粉碎至100目得到三七粉和山药粉,备用;
步骤3、将第一提取液、三七粉和山药粉混合,加入辅料、纯净水,混匀加热,灭菌后封装,得所述治疗高血压的口服液。
其中,所述的辅料为:乳糖8g、D-木糖醇10g。
其中,步骤3中灭菌温度控制在80℃,灭菌时间为40min。
实施例2
一种治疗高血压的口服液的制备方法,包含以下步骤:
步骤1、将中药组合物煎煮2次,过滤加入等体积的质量浓度为70%乙醇搅拌、静置,回收乙醇,减压浓缩得第一提取液备用;所述中药组合物包括以下重量份的原料:柴胡15g、白芍10g、陈皮6g、葛根10g、香附5g、郁金6g、泽泻21g、白术9g、石菖蒲15g、泽兰15g、黄芪15g、云苓10g、当归12g、冬葵子10g、石韦10g、甘草10g、枣仁10g、红花7g、决明子10g、罗布麻9g、绞股蓝10g、砂仁10g、鬼针草20g、淫羊藿15g、铁线草10g、金丝草10g、车前草10g、萹蓄10g、苦荞麦20g、独行菜10g以及盒子草10g。
其中,所述煎煮2次的具体方法为:第一次加入10倍的水,煎煮2.5小时;第二次加入7倍的水,煎煮1.5h。
步骤2、将三七15g、山药15g分别粉碎至120目得到三七粉和山药粉,备用;
步骤3、将第一提取液、三七粉和山药粉混合,加入辅料、纯净水,混匀加热,灭菌后封装,得所述治疗高血压的口服液。
其中,所述的辅料为:乳糖10g、D-木糖醇12g。
其中,步骤3中灭菌温度控制在85℃,灭菌时间为30min。
实施例3
一种治疗高血压的口服液的制备方法,包含以下步骤:
步骤1、将中药组合物煎煮2次,过滤加入等体积的质量浓度为75%乙醇搅拌、静置,回收乙醇,减压浓缩得第一提取液备用;所述中药组合物包括以下重量份的原料:柴胡20g、白芍15g、陈皮9g、葛根15g、香附8g、郁金9g、泽泻26g、白术12g、石菖蒲20g、泽兰20g、黄芪20g、云苓15g、当归16g、冬葵子15g、石韦15g、甘草15g、枣仁15g、红花11g、决明子15g、罗布麻12g、绞股蓝15g、砂仁15g、鬼针草25g、淫羊藿20g、铁线草15g、金丝草15g、车前草15g、萹蓄15g、苦荞麦25g、独行菜15g以及盒子草15g。
其中,所述煎煮2次的具体方法为:第一次加入12倍的水,煎煮3小时;第二次加入8倍的水,煎煮2h。
步骤2、将三七20g、山药30g分别粉碎至150目得到三七粉和山药粉,备用;
步骤3、将第一提取液、三七粉和山药粉混合,加入辅料、纯净水,混匀加热,灭菌后封装,得所述治疗高血压的口服液。
其中,所述的辅料为:乳糖12g、D-木糖醇15g。
其中,步骤3中灭菌温度控制在95℃,灭菌时间为20min。
一、病例选择标准
(一)诊断标准
1、西医诊断标准:收缩压等于或高于160mmHg(21.3kPa),舒张压等于或者高于95mmHg(12.7kPa),两者有1项经核实,即可确诊。
2、中医辨证:
肝火亢盛证:头晕胀痛,面红目赤,目胀耳鸣,急躁易怒,失眠多梦,尿黄便秘。舌红苔黄,脉弦数有力;
阴虚阳亢证:头晕目眩,双目干涩,五心烦热,腰腿酸软,口干欲饮,失眠或入睡易醒,尿黄,便干,舌红苔少,脉弦细数;
阴阳两虚证:头昏目花视糊,心悸气短,间有面部烘热,腰酸腿软,四肢清冷,便溏纳差,夜尿频数,遗精,阳痿,舌淡红或淡白,质胖,脉沉细或弦细。
痰湿中阻证:头晕头重,胸脘满闷,恶心欲呕,心悸时作,肢体麻木,胃纳不振,尿黄,便溏不爽,舌淡红,苔白腻,脉沉缓。
气虚血瘀证:头晕肢麻,倦怠乏力,活动欠灵,胃纳呆滞,动则气短,日轻夜重,甚至半身麻木,小便失禁,舌质暗红,边有瘀点,脉弦涩。
(二)试验病例
1、纳入病例标准
符合高血压病诊断及中医辨证标准的患者,可纳入试验病例,以I期高血压病(血压达到确诊高血压水平,临床无心、脑、肾并发症表现者)为主要观察对象。
2、排除病例标准
(1)年龄在18岁以下或70岁以上,妊娠及哺乳妇女、对本药过敏者:
(2)伴有严重心、脑、肝、肾疾病及精神病患者。
二、分组及用药方法
采用随机表随机分组、单盲对照试验方法,治疗组和对照组各100人。
治疗组:使用本发明实施例2制备的所述口服液,每次1瓶,早晚各1次,饭后服用,治疗疗程为4周。
对照组:用卡托普利,口服一次12.5mg,每日2-3次,饭后服用,治疗疗程为4周。
观测指标
(一)安全性指标
l、一般体检项目;
2、血、尿、便常规化验;
3、心电图、肝功能、肾功能检查。
(二)疗效性观测指标
l、相关症状及体征;
2、血压测量;
3、尿常规检查;
4、肾功能检查;
5、胸部X线检查;
6、心电图检查;
7、心电向量图检查;
8、眼底检查;
9、血脂含量检查;
10、血浆肾素活性,血管紧张素Ⅱ测定;
11、超声心动图检查。
临床资料:
1、疗效评价标准参照《中药新药临床研究指导原则》相关标准判定:
显效:1、舒张压下降10毫米汞柱或以上并达到正常范围;
2、舒张压虽未降至正常,但已下降20毫米汞柱或以上。
有效:1、舒张压下降不及10毫米汞柱,但已达到正常范围;
2、舒张压较治疗前下降10-19毫米汞柱,但未达到正常范围。
无效:未达到以上标准者。
总有效率=治愈率+显效率
两组间治愈率、总有效率有显著性差异,治疗组治愈率、总有效率显著高于对照组。
表1两组间疗效的比较
如表1所示,二组的治愈率及总有效率均有显著性差异,说明所述口服液疗效显著。治疗组100例患者治疗前后,疗效观测指标未见有所述口服液所致的不良反应,说明本品有较高的安全性,综上说明所述治疗高血压的口服液安全有效,值得推广。
具体病例:
张某,36岁,头晕胀痛,面红目赤,目胀耳鸣,急躁易怒,失眠多梦,尿黄便秘,收缩压180mmHg,高血压病史2年,使用本发明的实施例2制备的所述口服液,患者每次1瓶,早晚2次饭后服用,连续服用30天,期间无不良反应,上述不良症状消失,血压恢复正常收缩压120mmHg,舒张压85mmHg,随访一年无复发。
孙某,54岁,头昏目花视糊,心悸气短,间有面部烘热,腰酸腿软,四肢清冷,便溏纳差,夜尿频数,舒张压为110mmHg,高血压病史5年,使用本发明的实施例3制备的所述口服液,患者每次1瓶,早晚2次饭后服用,连续服用30天,期间无不良反应,上述不良症状消失,血压恢复正常收缩压140mmHg,舒张压80mmHg,随访一年无复发。
尽管本发明的实施方案已公开如上,但其并不仅仅限于说明书和实施方式中所列运用,它完全可以被适用于各种适合本发明的领域,对于熟悉本领域的人员而言,可容易地实现另外的修改,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节和这里示出与描述的图例。
Claims (7)
1.一种治疗高血压的口服液的制备方法,其中,包括以下步骤:
步骤1、将中药组合物煎煮2次,过滤加入等体积的质量浓度为60-75%乙醇搅拌、静置,回收乙醇,减压浓缩得第一提取液备用;所述中药组合物包括以下重量份的原料:柴胡10-20、白芍5-15、陈皮3-9、葛根5-15、香附2-8、郁金3-9、泽泻18-26、白术6-12、石菖蒲10-20、泽兰10-20、黄芪10-20、云苓5-15、当归8-16、冬葵子5-15、石韦5-15、甘草5-15、枣仁5-15、红花3-11、决明子5-15、罗布麻6-12、绞股蓝5-15、砂仁5-15、鬼针草15-25、淫羊藿10-20、铁线草5-15、金丝草5-15、车前草5-15、萹蓄5-15、苦荞麦15-25、独行菜5-15以及盒子草5-15;
步骤2、将三七、山药分别粉碎得到三七粉和山药粉,备用;所述山药的重量份为:10-20,所述三七的重量份为:10-30;
步骤3、将第一提取液、三七粉和山药粉混合,加入辅料、纯净水,混匀加热,灭菌后封装,得所述治疗高血压的口服液。
2.如权利要求1所述的治疗高血压的口服液的制备方法,其中,步骤1所述中药组合物包括以下重量份的原料:柴胡15、白芍10、陈皮6、葛根10、香附5、郁金6、泽泻21、白术9、石菖蒲15、泽兰15、黄芪15、云苓10、当归12、冬葵子10、石韦10、甘草10、枣仁10、红花7、决明子10、罗布麻9、绞股蓝10、砂仁10、鬼针草20、淫羊藿15、铁线草10、金丝草10、车前草10、萹蓄10、苦荞麦20、独行菜10以及盒子草10。
3.如权利要求1所述的治疗高血压的口服液的制备方法,其中,步骤2所述山药和三七的重量份均为15。
4.如权利要求1所述的治疗高血压的口服液的制备方法,其中,步骤1所述煎煮2次的具体方法为:第一次加入8-12倍的水,煎煮2-3小时;第二次加入6-8倍的水,煎煮1-2h。
5.如权利要求1所述的治疗高血压的口服液的制备方法,其中,步骤2所述山药和三七分别粉碎至100-150目。
6.如权利要求1所述的治疗高血压的口服液的制备方法,其中,步骤3所述的辅料主要包括以下重量份组分中的一种或几种:乳糖8-12份、D-木糖醇10-15份。
7.如权利要求1所述的治疗高血压的口服液的制备方法,其中,步骤3中灭菌温度控制在80-95℃,灭菌时间为20-40min。
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