CN105381154A - 一种含辣木的药物组合物及其制剂的制备方法 - Google Patents
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Abstract
本发明公开了一种含辣木的药物组合物,包括以下重量份数的原料:辣木籽50~300份,鬼针草50~150份,桑寄生20~200份,制何首乌50~200份,山楂10~100份,五味子10~100份,葛根20~100份,熟地50~100,山药20~100份。所述含辣木的药物组合物可以平稳降压,改善血管,具有化痰活血,清热平肝,使过盛的气血下降,达到平衡血压的功能,适合高血压患者长期服用。
Description
技术领域
本发明涉及保健食品技术领域,尤其涉及一种含辣木的药物组合物及其制剂的制备方法。
背景技术
辣木又称鼓槌树,原产印度北部和非洲地区,为辣木科辣木属植物,共14个种,属小乔木植物,现在我国也有大量种植,辣木营养全面而丰富,在很多发展中国家,辣木常被用来为儿童补充钙、铁、维生素等一些营养成分,辣木作为一种功能性的植物,不仅含有多种营养物质,而且还具有很大的药用价值,可以有效治疗高血压、糖尿病、溃疡、皮肤感染等疾病,还可以缓解疼痛、保肝、改善维生素A缺乏症和癌症,此外辣木还具有增强SOD酶活性和抗氧化特性。辣木树所含的钙质是牛奶的四倍,钾是香蕉的三倍,铁是菠菜的三倍,维他命C是柑桔的七倍,维他命A是胡萝卜的四倍,可用于食疗保健的功能,也可用于医药、工业等方面,被誉为“神奇之树”、“生命之树”,辣木籽是今年来在欧美新兴的一种保健植物,具有降低血压、增强体力、治疗贫血、抑制病菌、驱除寄生虫等功效。
高血压是以体循环动脉压升高为主要表现的临床综合症,分为原发性高血压和继发性高血压,我国是高血压大国,严重危害着人类的健康,因此提高对高血压病的认识,对早期预防、及时治疗有及其重要的意义。高血压病的主要危害是心脏、脑、肾脏、血管的损害,以及由此引发的心脏、脑、肾脏、血管并发症,要能有效地防治高血压,就能降低由高血压引起的并发症的发生率和死亡率。采用中药治本病,具有简、便、廉、效之特点,无毒副反应,中药药材中有许多味药具有活血化瘀、调节血脂,软化血管,恢复调控血压的机制的功能,通过中医治疗高血压病达到标本兼职的效果。
由于辣木含有丰富的营养成分,作为药物原料有增进营养、食疗保健的功效,可以活化细胞增强免疫力,有助于调节高血压、降高血脂、降高血糖,还可以预防癌症、防治肿瘤、增强免疫力。
发明内容
有鉴于此,本发明提供了一种含辣木的药物组合物,具有降血压保健、降血脂、降血糖,防治心、脑、血管疾病的功效。
本发明采用的技术手段如下:一种含辣木的药物组合物,包括以下重量份数的原料:辣木籽50~300份,鬼针草50~150份,桑寄生20~200份,制何首乌50~200份,山楂10~100份,五味子10~100份,葛根20~100份,熟地50~100,山药20~100份。
优选地,所述辣木籽60~200份,所述鬼针草60~100份,所述桑寄生20~150份,所述制何首乌50~100份,所述山楂20~80份,所述五味子60~120份,所述葛根30~80份,所述熟地60~80份,所述山药30~80份。
优选地,还包括以下重量份数的原料的一种或多种:金樱子20~100份,甘草50~100份,辣木叶20~100份,枸杞子50~100份。
优选地,所述含辣木的药物组合物的制剂为口服液、颗粒剂、丸剂、片剂的一种。
本发明还提供了一种含辣木的药物组合物制剂的制备方法,包括如下步骤:
1)称取原料,加入原料总重量的20~30倍的水,浸泡1~2h,先用武火煎煮1~2h再转文火煎煮2~3h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入10~20倍的水,用文火煎煮2~3h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用乙醇溶液回流提取2~3次,提取温度为60~80℃,每次提取时间为1~2h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩,制得所述含辣木的药物组合物的制剂。
优选地,所述药物原液浓缩的相对密度为1.1~1.3。
优选地,所述乙醇溶液的浓度为45%~50%。
采用本发明所提供的一种含辣木的药物组合物,由于辣木含有丰富的营养成分,作为药物组合物有增进营养,活化细胞增强免疫力,有助于分泌胰岛素和调节血糖,有效地抗氧化、抗自由基、消除人体活性氧,有丰富的保健养生功效,长期服用对于降高血压、降高血脂、降高血糖有明显效果,由于辣木具有以上功效,以辣木为主药,各原料相互组合制得药物组合物,用于降血压方面具有好的效果,且操作简便。
辣木籽
纯天然绿色食品,含有很多人体所需的营养物质,可取代符合维生素、钙片、鱼肝油等,特别对高血压、高血脂、糖尿病等有很好的效果,具有多重保健效果。
鬼针草
又名一把针、粘身草、刺针草、盲肠草等,现代药理证明,鬼针草含黄酮甙、皂甙、鞣质、多元酚、香豆素、碘、胆碱、氨基酸、维生素等成份,对调节人体血压具有良好的功效。
桑寄生
有降压的作用,近年来临床上常用于高血压。
制何首乌
味苦、甘、涩,微温,具有补肝、益肾、养血、祛风等功效,适用于肝肾阴亏、须发早白、血虚头晕、腰膝酸软、筋骨酸痛、遗精、崩带慢性肝炎等病症。
山楂
含有多种维生素、山楂酸、酒石酸、柠檬酸、苹果酸等,还含有黄酮类、类脂、糖类、蛋白质、脂肪和钙、磷铁等矿物质,常食山楂能扩张血管、降低血糖、降低血压、防治心血管疾病和老年性心脏病。
五味子
(玄及、会及、五梅子)具有敛肺、滋肾、生津、收汗的功效,具有调节人体五脏功能的作用。
葛根
味甘、性平、入脾,有解肌退热,生津止渴,透疹,升阳止泻,通经活络,解酒毒的功效。现代大量的实验和临床证明,葛根具有降血脂的作用。
熟地
又名熟地黄或伏地,属玄参科植物,是一种上号的中药材,具有补血滋阴功效,可用于血虚萎黄,眩晕,心悸失眠,月经不调,崩漏等症。本品质润入肾,善滋补肾阴,为补肾阴之要药。
山药
健脾、除湿、补气、益肺、固肾、益精的功效,山药含有可溶性纤维,能推迟胃内食物的排空,控制饭后血糖升高。
金樱子
酸涩平、益肾、涩精、止泻。治小便频数、遗尿、久泻、遗精、崩漏、带下。治肾阳虚。含苹果酸、柠檬酸。鞣酸、糖分、树脂及维生素C等。
甘草
又名国老、甜草、乌拉尔甘草、甜根子,外皮松紧不一,表面红棕色或灰棕色。根茎呈圆柱形,表面有芽痕,断面中部有髓。气微,味甜而特殊。功能清热解毒、祛痰止咳、脘腹等。喜阴暗潮湿,日照长气温低的干燥气候。甘草多生长在干旱、半干旱的荒漠草原、沙漠边缘和黄土丘陵地带。
辣木叶
为乔木辣木树的树叶,具有全面补充营养,提高免疫力,排毒养颜,通肠利便,减肥,降脂,降压、抗氧化等功效。
枸杞子
补肾益精、养肝明目、补血安神、生津止渴、润肺止咳。
具体实施方式
以下对本发明的原理和特征进行描述,所举实施例只用于解释本发明,并非用于限定本发明的范围。
实施例1
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽50,鬼针草50,桑寄生20,制何首乌50,山楂10,五味子10,葛根20,熟地50,山药20。
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的20倍的水,浸泡1h,先用武火煎煮1h再转文火煎煮2h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入10倍的水,用文火煎煮2h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为45%乙醇溶液回流提取2次,提取温度为60℃,每次提取时间为1h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.1。
实施例2
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽300,鬼针草150,桑寄生200,制何首乌200,山楂100,五味子100,葛根100,熟地100,山药100。
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的30倍的水,浸泡2h,先用武火煎煮2h再转文火煎煮3h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入20倍的水,用文火煎煮3h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为50%乙醇溶液回流提取3次,提取温度为80℃,每次提取时间为2h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.3。
实施例3
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽200,鬼针草100,桑寄生150份,制何首乌100份,山楂80,五味子120,葛根80,熟地80,山药80
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的25倍的水,浸泡1.5h,先用武火煎煮1.5h再转文火煎煮2.5h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入15倍的水,用文火煎煮2.5h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为47%乙醇溶液回流提取2次,提取温度为70℃,每次提取时间为1.5h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.2。
实施例4
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽60,鬼针草60,桑寄生20,制何首乌50,山楂20,五味子50,葛根30,熟地60,山药30
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的20倍的水,浸泡1.6h,先用武火煎煮1.4h再转文火煎煮2.7h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入16倍的水,用文火煎煮2.7h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为48%乙醇溶液回流提取3次,提取温度为72℃,每次提取时间为1.6h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.2。
实施例5
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽60,鬼针草60,桑寄生20,制何首乌50,山楂20,五味子60,葛根30,熟地60,山药30,金樱子60,金樱子20,辣木叶20。
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的20倍的水,浸泡1h,先用武火煎煮1h再转文火煎煮2h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入10倍的水,用文火煎煮2h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为45%乙醇溶液回流提取2次,提取温度为60℃,每次提取时间为1h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.1。
实施例6
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽200,鬼针草100,桑寄生150,制何首乌100,山楂80,五味子120,葛根80,熟地80,山药80,金樱子100,甘草100,辣木叶100,枸杞子100。
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的20倍的水,浸泡1h,先用武火煎煮1h再转文火煎煮2h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入10倍的水,用文火煎煮2h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为45%乙醇溶液回流提取2次,提取温度为60℃,每次提取时间为1h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.1。
实施例7
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽300,鬼针草150,桑寄生200,制何首乌200,山楂100,五味子100,葛根100,熟地100,山药100,金樱子100,甘草50,辣木叶100,枸杞子50。
其制剂为口服液,口服液的制备方法包括如下步骤:
1)称取原料,加入原料总重量的30倍的水,浸泡2h,先用武火煎煮2h再转文火煎煮3h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入20倍的水,用文火煎煮3h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用浓度为50%乙醇溶液回流提取3次,提取温度为80℃,每次提取时间为2h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩至相对密度为1.3。
实施例8
一种含辣木的药物组合物,按以下重量份数称取原料(单位:g):
辣木籽160,鬼针草100,桑寄生100份,制何首乌160份,山楂50,五味子50,葛根60,熟地60,山药60,金樱子70,甘草70,辣木叶70。
上述原料按常规方法水煎煮。
实施例9
按以下重量份数称取原料(单位:g):
辣木籽50,鬼针草50,桑寄生20,制何首乌50,山楂10,五味子10,葛根20,熟地50,山药20。
上述原料按常规方法制成颗粒剂制剂。
实施例10
按以下重量份数称取原料(单位:g):
辣木籽60,鬼针草60,桑寄生20,制何首乌50,山楂20,五味子60,葛根30,熟地60,山药30,金樱子60,金樱子20,辣木叶20。
以上原料按常规方法压制成丸剂制剂或填充为胶囊剂制剂。
为了验证本发明的有益效果,采用本发明的一种含辣木的药物组合物的实验组1(实施例3)、实验组2(实施例8)和对照组(卡托普利片)进行试验,试验方法及结果如下:
1、试验方法
1.1、病例选择
1.11诊断标准:
早期表现:早期多无症状,偶尔体检时发现血压增高,或在精神紧张,情绪激动或劳累后感头晕,头痛,眼花,耳鸣,失眠,乏力,注意力不集中等症状,可能系高级精神功能失调所致,早期血压仅暂时升高,随病程进展血压持续升高,脏器受累。脑部表现:头痛,头晕常见,多由于情绪激动,过度疲劳,气候变化或停用降压药而诱发,血压急骤升高,剧烈头痛,视力障碍,恶心,呕吐,抽搐,昏迷,一过性偏瘫,失语等。心脏表现:早期,心功能代偿,症状不明显,后期,心功能失代偿,发生心力衰竭。肾脏表现:长期高血压致肾小动脉硬化,肾功能减退时,可引起夜尿,多尿,尿中含蛋白,管型及红细胞,尿浓缩功能低下,酚红排泄及尿素廓清障碍。
按照世界卫生组织(Who)建议使用的血压标准是:凡正常成人收缩压应小于或等于140mmHg(18.6kPa),舒张压小于或等于90mmHg(12kPa)。亦即收缩压在141-159mmHg(18.9-21.2kPa)之间,舒张压在91-94mmHg(12.1-12.5kPa)之间,为临界高血压。诊断高血压时,必须多次测量血压,至少有连续两次舒张压的平均值在90mmHg(12.0kPa)或以上才能确诊为高血压。
根据血压升高的不同,高血压分为3级:
1级高血压(轻度):收缩压140~159mmHg;舒张压90~99mmHg。
2级高血压(中度):收缩压160~179mmHg;舒张压100~109mmHg。
3级高血压(重度):收缩压≥180mmHg;舒张压≥110mmHg。
单纯收缩期高血压:收缩压≥140mmHg;舒张压<900mmHg。
1.12病例选择标准:
将150例患有高血压的病人,随机分为三组,即实验组1、实验组2和对照组。其中实验组1:共50例,男30例,占60%;女20例,占40%;年龄最小为35岁,最大为70岁,病程最短为半年,最长为10年,病例选择符合高血压诊断标准;高血压1级26例,高血压2级为16例,高血压3级为8例。
实验组2:共50例,男32例,占64%;女18例,占36%;年龄最小为40岁,最大为80岁,病程最短为1年,最长为15年,病例选择符合高血压诊断标准;高血压1级28例,高血压2级为16例,高血压3级为6例。
对照组:共50例,男32例,占64%;女18例,占36%;年龄最小为38岁,最大为80岁,病程最短为半年,最长为12年,病例选择符合高血压诊断标准;高血压1级28例,高血压2级为16例,高血压3级为6例。
1.2治疗方法
实验组1:本发明的一种含辣木的药物组合物(实施例3),20ml/每次,每日2次。
实验组2:本发明的一种含辣木的药物组合物(实施例8),日1剂,水煎分2次温服用。
对照组:12.5mg/每次,每日2~3次,按需要1~2周内增至50mg/每次,每日2~3次。
其中实验组1、实验组2和对照组均为35天为1个疗程,一般为2-3个疗程,每月检查血压1次,3个月后统计结果。治疗期间均嘱咐患者合理膳食,适当运动,戒烟戒酒。
2、结果
对照结果病例例数如下表1所示:
痊愈:症状消失,血压检查恢复正常,且复查3次未在增高。显效:症状消失,血压检查恢复正常,复查可再度升高。有效:症状明显减轻,血压检查在1个月以内恢复正常,复查常再度升高。
表1分析结果表明试验组的疗效率大于对照组的疗效率,表明实验组治疗效果优于对照组的疗效效果。
为进一步说明本发明的有益效果,本发明提供了如下典型病例:
病例1
陈某某(男)54岁,伴有头晕、胸闷、胸痛,治疗前医院检查血压数值170/100mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用62天后血压检测数值变为145/90mmHg,常回访检测没发现血压升高。
病例2
彭某某(女)63岁,伴有汗多、失眠、头痛,治疗前医院检查血压数值160/95mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用65天后血压检测数值变为125/85mmHg,回访检测没发现血压升高。
病例3
黎某某(女)31岁,眩晕、头重、胸闷,治疗前医院检查血压数值150/95mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用90天后血压检测数值为120/80mmHg,常回访检测没发现血压值升高。
病例4
钱某某(男)48岁,咽喉炎、胸闷、常进行体力劳动,治疗前医院检查血压数值180/100mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用60天后血压检测数值为122/80mmHg,常回访检测没发现血压值升高。
病例5
王某某(男)60岁,高血压多年、头昏、头痛,治疗前医院检查血压数值178/110mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用60天后血压检测数值为120/80mmHg,常回访检测没发现血压值升高。
病例6
陈某某(女)55岁,伴有头晕、失眠、乏力、常恶心,治疗前医院检查血压数值160/96mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用90天后血压检测数值为130/90mmHg,常回访检测没发现血压值升高。
病例7
刘某某(男)54岁,经常眩晕、失眠、耳鸣,治疗前医院检查血压数值为196/98mmHg,服用本发明含辣木的药物组合物制得的片剂,一天两次,每次10g,连续服用62天后血压检测数值为120/80mmHg,长回访检测没发现血压值升高及反弹。
综上所述,采用本发明所提供的一种含辣木的药物组合物,目前高血压治疗采用西药较多,西药的副作用较大,需长期服用,一旦停药,血压容易反弹,由于辣木含有丰富的营养成分,作为药物组合物有增进营养,活化细胞增强免疫力,有助于分泌胰岛素和调节血糖,有效地抗氧化、抗自由基、消除人体活性氧,有丰富的保健养生功效,长期服用对于降高血压、降高血脂、降高血糖有明显效果,由于辣木具有以上功效,以辣木为主药,各原料相互组合制得药物组合物,用于降血压方面具有好的效果,且操作简便。
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,所做的任何修改、等同替换、改进等,均应包含在本发明保护的范围之内。
Claims (8)
1.一种含辣木的药物组合物,其特征在于,包括以下重量份数的原料:辣木籽50~300份,鬼针草50~150份,桑寄生20~200份,制何首乌50~200份,山楂10~100份,五味子10~100份,葛根20~100份,熟地50~100,山药20~100份。
2.如权利要求1所述的一种含辣木的药物组合物,其特征在于,所述辣木籽60~200份,所述鬼针草60~100份,所述桑寄生20~150份,所述制何首乌50~100份,所述山楂20~80份,所述五味子60~120份,所述葛根30~80份,所述熟地60~80份,所述山药30~80份。
3.如权利要求1所述的一种含辣木的药物组合物,其特征在于,还包括以下重量份数的原料的一种或多种:金樱子20~100份,甘草50~100份,辣木叶20~100份,枸杞子50~100份。
4.如权利要求1~3任一项所述的一种含辣木的药物组合物的制剂,其特征在于,所述制剂为口服液、颗粒剂、丸剂、胶囊剂、饮料的一种。
5.如权利要求4所述的一种含辣木的药物组合物,其特征在于,所述含辣木的药物组合物的制剂为口服液。
6.如权利要求5所述的一种含辣木的药物组合物的制剂的制备方法,其特征在于,包括如下步骤:
1)称取原料,加入原料总重量的20~30倍的水,浸泡1~2h,先用武火煎煮1~2h再转文火煎煮2~3h,过滤得到药液,剩余药渣。
2)再将步骤1)的药渣再加入10~20倍的水,用文火煎煮2~3h,过滤得到药液,将两次过滤得到的药液相互混合得到混合物。
3)将步骤2)得到的混合物过滤,用乙醇溶液回流提取2~3次,提取温度为60~80℃,每次提取时间为1~2h,得到药物原液。
4)挥去乙醇,将药物原液灭菌浓缩,制得所述含辣木的药物组合物的制剂。
7.如权利要求6所述的一种含辣木的药物组合物的制备方法,其特征在于,所述药物原液浓缩的相对密度为1.1~1.3。
8.如权利要求6所述的一种含辣木的药物组合物的制备方法,其特征在于,所述乙醇溶液的浓度为45%~50%。
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CN105833109A (zh) * | 2016-06-15 | 2016-08-10 | 谢晓亮 | 一种包含辣木的治疗高血糖、高血脂的组合物及其制备方法和用途 |
CN105833109B (zh) * | 2016-06-15 | 2020-01-17 | 河北省农林科学院经济作物研究所 | 一种包含辣木的治疗高血糖、高血脂的组合物及其制备方法和用途 |
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