CN108079271A - 一种治疗高血脂的药物组合物、制剂及其制备方法 - Google Patents
一种治疗高血脂的药物组合物、制剂及其制备方法 Download PDFInfo
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Abstract
一种治疗高血脂的药物组合物、制剂及其制备方法,涉及药物技术领域。一种治疗高血脂的药物组合物,药物组合物按重量份数计包括:决明子9~15份、槐花10~15份、槐米4.5~9份、乌梅4~7份、木瓜6~9份、杏仁5~10份、生牡蛎9~30份、玉米须30~60份、生姜3~10份、沙棘3~9份、桂圆6~9份、桑葚9~15份、菊花10~15份、茯苓10~15份以及生山楂9~12份。该药物组合物对高血脂及高血脂引起的肝硬化、脂肪肝、高血压具有良好的治疗效果。
Description
技术领域
本发明涉及药物技术领域,且特别涉及一种治疗高血脂的药物组合物、制剂及其制备方法。
背景技术
高脂血症是指由于脂肪代谢或运转异常使血浆或多种脂质高于正常水平的病症,高脂血症可直接引起一些严重危害人体健康的疾病。高脂血症可分为原发性和继发性两类。原发性与先天性和遗传有关,是由于单基因缺陷或多基因缺陷,使参与脂蛋白转运和代谢的受体、酶或载脂蛋白异常所致,或由于环境因素(饮食、营养、药物)和通过未知的机制而致。继发性多发生于代谢性紊乱疾病(糖尿病、高血压、黏液性水肿、甲状腺功能低下、肥胖、肝肾疾病、肾上腺皮质功能亢进),或与其他因素年龄、性别、季节、饮酒、吸烟、饮食、体力活动、精神紧张、情绪活动等有关。
发明内容
本发明的第一目的在于提供一种治疗高血脂的药物组合物,该药物组合物对高血脂及高血脂引起的肝硬化、脂肪肝、高血压具有良好的治疗效果。
本发明的第二目的在于提供一种治疗高血脂的药物制剂。
本发明的第三目的在于提供一种治疗高血脂的药物制剂的制备方法,该制备方法简单,所制得的药物制剂质量高、药效好。
本发明解决其技术问题是采用以下技术方案来实现的。
本发明提出一种治疗高血脂的药物组合物,药物组合物按重量份数计包括:
决明子9~15份、槐花10~15份、槐米4.5~9份、乌梅4~7份、木瓜6~9份、杏仁5~10份、生牡蛎9~30份、玉米须30~60份、生姜3~10份、沙棘3~9份、桂圆6~9份、桑葚9~15份、菊花10~15份、茯苓10~15份以及生山楂9~12份。
一种治疗高血脂的药物制剂,其主要由上述的治疗高血脂的药物组合物制成。
一种如上述的治疗高血脂的药物制剂的制备方法,包括:
按重量份数计,将生牡蛎与水按照料液比1:5~8混合煎煮10~20min后,加入决明子、槐花、槐米、乌梅、木瓜、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合煎煮10~20min后,加入杏仁煎煮5~10min,过滤得到第一滤液和滤渣,将滤渣与水混合煎煮得到第二滤液,将第一滤液和第二滤液混合得到药液,将药液进行浓缩得到浸膏。
本发明实施例的有益效果是:本发明公开的资料高血脂的药物组合物,由决明子、槐花、槐米、乌梅、木瓜、杏仁、生牡蛎、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂按合适的配比组成,该药物组合物按照中医理论拟定,配伍合理,功效互补,能产生较好地系统作用,各组分合用具有清肝泻火、健脾益气、活血散瘀、凉血止血、化浊降脂、消食健胃通便的功效,可以减轻体内脂肪堆积,血液流通顺畅,促进脂肪排出,从而有效治疗高血脂及高血脂引起的肝硬化、脂肪肝和高血压。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将对本发明实施例中的技术方案进行清楚、完整地描述。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
下面对本发明实施例的一种治疗高血脂的药物组合物、制剂及其制备方法进行具体说明。
一种治疗高血脂的药物组合物,药物组合物按重量份数计包括:
决明子9~15份、槐花10~15份、槐米4.5~9份、乌梅4~7份、木瓜6~9份、杏仁5~10份、生牡蛎9~30份、玉米须30~60份、生姜3~10份、沙棘3~9份、桂圆6~9份、桑葚9~15份、菊花10~15份、茯苓10~15份以及生山楂9~12份。
在一些实施方式中,按重量份数计,决明子为10~14份、槐花为11~14份、槐米为5~8份、乌梅为5~7份、木瓜为7~9份、杏仁为6~9份、生牡蛎为15~28份、玉米须为40~55份、生姜为4~8份、沙棘为4~8份、桂圆为7~9份、桑葚为10~14份、菊花为11~14份、茯苓为11~14份、生山楂为10~12份。
在一些实施方式中,按重量份数计,决明子为11~13份、槐花为12~13份、槐米为6~7份、乌梅为5~6份、木瓜为7~8份、杏仁为7~8份、生牡蛎为20~25份、玉米须为45~50份、生姜为5~7份、沙棘为5~6份、桂圆为7~8份、桑葚为11~13份、菊花为12~13份、茯苓为12~13份、生山楂为10~11份。
决明子,味甘、苦、咸,性微寒。归肝、大肠经。其具有清热明目,润肠通便的功效。可用于治疗目赤涩痛,羞明多泪,头痛眩晕,目暗不明,大便秘结。
槐花,味苦、性微寒。归肝、肺、心、大肠经。其具有凉血止血,清肝泻火的功效。可用于治疗便血,痔血,血痢,崩漏,吐血,衄血,肝热目赤,头痛眩晕。
槐米,味甘平,性寒凉。入肝、大肠经。其具有凉血止血、清肝泻火、降低血压的功效。可用于治疗便血、痔血、血痢、崩漏、吐血、衄血、肝热目赤、头痛眩晕。
乌梅,味酸、涩,性平。归肝、脾、肺、大肠经。其具有收敛生津,安蛔驱虫的功效。可用于治疗久咳,虚热烦渴,久疟,久泻,痢疾,便血,尿血,血崩,蛔厥腹痛、呕吐,钩虫病,牛皮癣,胬肉。
木瓜,味酸,性温。归肝、脾经。其具有舒筋活络、胃化湿的功效。可用于治疗湿痹拘挛,腰膝关节酸重疼痛,暑湿吐泻,转筋挛痛,脚气水肿。
杏仁,味苦,性微温。归肺、大肠经。其具有降气止咳平喘,润肠通便的功效。可用于治疗咳嗽气喘,胸满痰多,肠燥便秘。
生牡蛎,味咸,性微寒。归肝、胆、肾经。其具有重镇安神,潜阳补阴,软坚散结的功效。可用于治疗惊悸失眠,眩晕耳呜,瘰疬痰核,瘕瘕痞块。
玉米须,味甘,性平。归膀胱、肝、胆经。其具有利尿,泄热,平肝,利胆的功效。可用于治疗肾炎水肿,脚气,黄疸肝炎,高血压,胆囊炎,胆结石,糖尿病,吐血衄血,鼻渊,乳痈。且可用于急、慢性肾炎,水肿,急、慢性肝炎,高血压,糖尿病,慢性鼻窦炎,尿路结石,胆道结石,小便不利、湿热黄胆等症。并可预防习惯性流产。
生姜,味辛,性微温。归肺、脾、胃、经。其具有解表散寒,温中止呕,化痰止咳的功效。可用于治疗风寒感冒,胃寒呕吐,寒痰咳嗽。
沙棘,性温,味酸、涩。归脾经、胃经、肺经、心经。其具有止咳祛痰,消食化滞,活血散瘀的功效。可用于治疗咳嗽痰多、消化不良、食积腹痛、跌扑瘀肿、瘀血经闭。
桂圆,味甘、酸,性寒。归肝、肾经。其具有益心脾,补气血,安神志的功效。可用于治疗虚劳羸弱,心悸任忡,失眠健忘,脾虚腹泻,产后浮肿,精神不振,自汗盗汗等病症。
桑葚,味甘,酸、性寒。肝、肾经。其具有滋阴补血、补肝益肾、生津止渴、乌发明目的功效。可用于治疗肝肾不足和血虚精亏的头晕目眩;腰酸耳鸣;须发早白;失眠多梦;津伤口渴;消渴;肠燥便秘。
菊花,味苦、甘,性微寒。归肺、肝经。其具有疏风,清热,明目,解毒的功效。可用于治疗头痛,眩晕,目赤,心胸烦热,疔疮,肿毒。
茯苓,味甘、淡,性平。归心、肺、脾、肾经。其具有利水渗湿,健脾,宁心的功效。可用于治疗水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
生山楂,味酸、甘,性微温。归脾、胃、肝经。其具有消食健胃,行气散瘀,化浊降脂的作用。可用于治疗肉食积滞,胃脘胀满,泻痢腹痛,瘀血经闭,产后瘀阻,心腹刺痛,胸痹。
本发明公开的资料高血脂的药物组合物,由决明子、槐花、槐米、乌梅、木瓜、杏仁、生牡蛎、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂按合适的配比组成,该药物组合物按照中医理论拟定,配伍合理,功效互补,能产生较好地系统作用,各组分合用具有清肝泻火、健脾益气、活血散瘀、凉血止血、化浊降脂、消食健胃通便的功效,可以减轻体内脂肪堆积,血液流通顺畅,促进脂肪排出,从而有效治疗高血脂及高血脂引起的肝硬化、脂肪肝和高血压。
一种治疗高血脂的药物制剂,其主要由上述的治疗高血脂的药物组合物制成。
在一些实施方式中,药物制剂由治疗高血脂的药物组合物和药剂学可接受的辅料组成。
进一步地,该药物制剂包括片剂或丸剂。需要说明的是,本实施方式的药物制剂不限于片剂或丸剂,也可以是现有技术中的其他剂型,如口服液、胶囊剂等。
一种如上述的治疗高血脂的药物制剂的制备方法,包括:
按重量份数计,将生牡蛎与水按照料液比1:5~8混合煎煮10~20min后,加入决明子、槐花、槐米、乌梅、木瓜、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合煎煮10~20min后,加入杏仁煎煮5~10min,过滤得到第一滤液和滤渣,将滤渣与水混合煎煮得到第二滤液,将第一滤液和第二滤液混合得到药液,将药液进行浓缩得到浸膏。需要说明的是,料液比中的料指的是药物组合物各组分总和的量,液指的是水的量。
进一步地,浸膏在60℃温度下的相对密度为1.1~1.3g/cm3。
进一步地,浸膏与药剂学可接受的辅料混合、干燥、压片可得丸剂或片剂。其中,药剂学可接受的辅料可为木糖醇或葡萄糖。需要说明的是,药剂学可接受的辅料并不限定于为木糖醇或葡萄糖。
这种药物制剂的制备方法,简单易行,可操作性强,能够较大程度地避免药效被破坏,保留了药物制剂中有效物质的含量,从而保证药效。
本实施方式还提供一种治疗高血脂的药物制剂的制备方法,包括:
按重量份数计,将生牡蛎、决明子、槐花、槐米、乌梅、木瓜、杏仁、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合得到混合物,将混合物与水及益生菌混合后在80-100℃的温度下发酵后,过滤后得到药物液剂。
该药物制剂的制备方法,药物组合物的有效成分经过益生菌转化,由大分子变成小分子,能够人体更好地吸收,药效更好,疗效更快。发酵过程中,药物经过转化,减弱了药物的有害毒性,改善中药的苦味。
以下结合实施例对本发明的特征和性能作进一步的详细描述。
实施例1
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物和木糖醇制成。该药物组合物包括:决明子12g、槐花10g、槐米7g、乌梅6g、木瓜7g、杏仁8g、生牡蛎20g、玉米须60g、生姜5g、沙棘6g、桂圆6g、桑葚12g、菊花13g、茯苓10g以及生山楂9g。
该药物制剂的制备方法,包括:
按重量份数计,将生牡蛎与水按照料液比1:7混合煎煮10min后,加入决明子、槐花、槐米、乌梅、木瓜、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合煎煮15min后,加入杏仁煎煮5min,过滤得到第一滤液和滤渣,将滤渣与水混合煎煮得到第二滤液,将第一滤液和第二滤液混合得到药液,将药液进行浓缩60℃温度下的相对密度为1.1g/cm3的浸膏,将浸膏与木糖醇按照重量比5:1混合后、干燥、压片。
实施例2
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物和木糖醇制成。该药物组合物包括:决明子10g、槐花11g、槐米9g、乌梅5g、木瓜8g、杏仁7g、生牡蛎30g、玉米须35g、生姜10g、沙棘8g、桂圆6g、桑葚14g、菊花14g、茯苓11g以及生山楂10g。
该药物制剂的制备方法,包括:
按重量份数计,将生牡蛎与水按照料液比1:5混合煎煮20min后,加入决明子、槐花、槐米、乌梅、木瓜、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合煎煮10min后,加入杏仁煎煮10min,过滤得到第一滤液和滤渣,将滤渣与水混合煎煮得到第二滤液,将第一滤液和第二滤液混合得到药液,将药液进行浓缩60℃温度下的相对密度为1.2g/cm3的浸膏,将浸膏与木糖醇按照重量比6:1混合后、干燥、压片。
实施例3
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物和木糖醇制成。该药物组合物包括:决明子9g、槐花12g、槐米7g、乌梅6g、木瓜6g、杏仁10g、生牡蛎12g、玉米须30g、生姜9g、沙棘7g、桂圆7g、桑葚15g、菊花15g、茯苓12g以及生山楂12g。
该药物制剂的制备方法,包括:
按重量份数计,将生牡蛎与水按照料液比1:8混合煎煮15min后,加入决明子、槐花、槐米、乌梅、木瓜、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合煎煮20min后,加入杏仁煎煮8min,过滤得到第一滤液和滤渣,将滤渣与水混合煎煮得到第二滤液,将第一滤液和第二滤液混合得到药液,将药液进行浓缩60℃温度下的相对密度为1.1g/cm3的浸膏,将浸膏与木糖醇按照重量比6:1混合后、干燥、压片。
实施例4
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物和葡萄糖制成。该药物组合物包括:决明子13g、槐花15g、槐米8g、乌梅4g、木瓜7g、杏仁6g、生牡蛎28g、玉米须40g、生姜8g、沙棘3g、桂圆9g、桑葚13g、菊花10g、茯苓15g以及生山楂11g。
该药物制剂的制备方法,包括:
按重量份数计,将生牡蛎与水按照料液比1:6混合煎煮18min后,加入决明子、槐花、槐米、乌梅、木瓜、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合煎煮14min后,加入杏仁煎煮6min,过滤得到第一滤液和滤渣,将滤渣与水混合煎煮得到第二滤液,将第一滤液和第二滤液混合得到药液,将药液进行浓缩60℃温度下的相对密度为1.3g/cm3的浸膏,将浸膏与葡萄糖按照重量比7:1混合后、干燥、压片。
实施例5
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物发酵制成。该药物组合物包括:决明子15g、槐花13g、槐米6g、乌梅5g、木瓜9g、杏仁5g、生牡蛎9g、玉米须50g、生姜3g、沙棘9g、桂圆8g、桑葚9g、菊花11g、茯苓13g以及生山楂12g。
该治疗高血脂的药物制剂的制备方法,包括:
将生牡蛎、决明子、槐花、槐米、乌梅、木瓜、杏仁、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合得到混合物,将混合物与水及益生菌混合后在100℃的温度下发酵后,过滤后得到药物液剂。其中,混合物与水及益生菌的重量比为3:1:1。
实施例6
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物发酵制成。该药物组合物包括:决明子11g、槐花14g、槐米4.5g、乌梅4g、木瓜8g、杏仁9g、生牡蛎25g、玉米须45g、生姜7g、沙棘4g、桂圆8g、桑葚10g、菊花14g、茯苓13g以及生山楂10g。
该治疗高血脂的药物制剂的制备方法,包括:
将生牡蛎、决明子、槐花、槐米、乌梅、木瓜、杏仁、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合得到混合物,将混合物与水及益生菌混合后在90℃的温度下发酵后,过滤后得到药物液剂。其中,混合物与水及益生菌的重量比为10:3:3。
实施例7
本实施例提供一种治疗高血脂的药物制剂,其由治疗高血脂的药物组合物发酵制成。该药物组合物包括:决明子14g、槐花13g、槐米5g、乌梅7g、木瓜6g、杏仁8g、生牡蛎15g、玉米须55g、生姜4g、沙棘5g、桂圆8g、桑葚11g、菊花12g、茯苓14g以及生山楂9g。
该治疗高血脂的药物制剂的制备方法,包括:
将生牡蛎、决明子、槐花、槐米、乌梅、木瓜、杏仁、玉米须、生姜、沙棘、桂圆、桑葚、菊花、茯苓以及生山楂混合得到混合物,将混合物与水及益生菌混合后在80℃的温度下发酵后,过滤后得到药物液剂。其中,混合物与水及益生菌的重量比为14:5:5。
试验例
1.病例选择:
本组病例均为病程为0.5~10年的失眠患者。年龄为35~65岁,平均50岁。随机分成7组,每组各20例。这7组患者的年龄、病情等资料无显著性差异,具有可比性。
2.治疗方案:
第1-4组的患者口服实施例1~4提供的药物制剂,每日服药三次,每次服药的药量为100mg。第5-7组的患者口服实施例5~7提供的药物制剂,每日服药三次,每次服药的药量为150mL。连续治疗3个月,治疗期间不使用其他药物。其治疗结果请参照表1。
3.临床评价标准:
显效:
(1)空腹血糖<7.22mmol/L,餐后2h血糖≤10.08mmol/L;
(2)血脂:TC<5.96mmol/L,TG<1.47mmol/L,糖基化血红蛋白<8%;
(3)24小时尿糖<10g;
(4)患者高血脂的临床症状明显减轻。
有效:
(1)空腹血糖<8.3mmol/L,餐后2h血糖≤11.1mmol/L;
(2)血脂:TC<6.48mmol/L,TG<1.7mmol/L;
(3)24小时尿糖<15g;
(4)患者高血脂的临床症状有一定程度减轻。
无效:
患者在服用药物制剂的条件下没有发现病情的改观。
表1临床试验结果
从表1的结果可知,本发明提供的药物组合物对高血脂具有很好的治疗效果。主要表现在:用药之后,在没有使用任何其他药物的情况下,血糖、尿糖和血脂的情况均有改善。且实施例1~7提供的药物制剂在3个月内对患者的治疗有效率高,其中显效和有效的患者占总数的90%及以上。说明本发明的药物组合物及利用该药物组合物制成的药物制剂对高血脂的治疗效果好,具有起效快,疗效好的优点。
以上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。本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作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。
Claims (10)
1.一种治疗高血脂的药物组合物,其特征在于,所述药物组合物按重量份数计包括:
决明子9~15份、槐花10~15份、槐米4.5~9份、乌梅4~7份、木瓜6~9份、杏仁5~10份、生牡蛎9~30份、玉米须30~60份、生姜3~10份、沙棘3~9份、桂圆6~9份、桑葚9~15份、菊花10~15份、茯苓10~15份以及生山楂9~12份。
2.根据权利要求1所述的治疗高血脂的药物组合物,其特征在于,按重量份数计,所述决明子为10~14份、所述槐花为11~14份、所述槐米为5~8份、所述乌梅为5~7份、所述木瓜为7~9份、所述杏仁为6~9份、所述生牡蛎为15~28份、所述玉米须为40~55份、所述生姜为4~8份、所述沙棘为4~8份、所述桂圆为7~9份、所述桑葚为10~14份、所述菊花为11~14份、所述茯苓为11~14份、所述生山楂为10~12份。
3.根据权利要求1所述的治疗高血脂的药物组合物,其特征在于,按重量份数计,所述决明子为11~13份、所述槐花为12~13份、所述槐米为6~7份、所述乌梅为5~6份、所述木瓜为7~8份、所述杏仁为7~8份、所述生牡蛎为20~25份、所述玉米须为45~50份、所述生姜为5~7份、所述沙棘为5~6份、所述桂圆为7~8份、所述桑葚为11~13份、所述菊花为12~13份、所述茯苓为12~13份、所述生山楂为10~11份。
4.一种治疗高血脂的药物制剂,其特征在于,其主要由权利要求1-3任一项所述的治疗高血脂的药物组合物制成。
5.根据权利要求4所述的治疗高血脂的药物制剂,其特征在于,其由所述药物组合物和药剂学可接受的辅料组成。
6.根据权利要求5所述的治疗高血脂的药物制剂,其特征在于,所述药物制剂包括丸剂或片剂。
7.一种如权利要求4所述的治疗高血脂的药物制剂的制备方法,其特征在于,包括:
按重量份数计,将所述生牡蛎与水按照料液比1:5~8混合煎煮10~20min后,加入所述决明子、所述槐花、所述槐米、所述乌梅、所述木瓜、所述玉米须、所述生姜、所述沙棘、所述桂圆、所述桑葚、所述菊花、所述茯苓以及所述生山楂混合煎煮10~20min后,加入所述杏仁煎煮5~10min,过滤得到第一滤液和滤渣,将所述滤渣与水混合煎煮得到第二滤液,将所述第一滤液和所述第二滤液混合得到药液,将所述药液进行浓缩得到浸膏。
8.根据权利要求7所述治疗高血脂的药物制剂的制备方法,其特征在于,还包括将所述浸膏与药剂学可接受的辅料混合、干燥、压片。
9.根据权利要求8所述治疗高血脂的药物制剂的制备方法,其特征在于,所述药剂学可接受的辅料包括葡糖糖和木糖醇。
10.一种如权利要求4所述的治疗高血脂的药物制剂的制备方法,其特征在于,包括:
按重量份数计,将所述生牡蛎、所述决明子、所述槐花、所述槐米、所述乌梅、所述木瓜、所述杏仁、所述玉米须、所述生姜、所述沙棘、所述桂圆、所述桑葚、所述菊花、所述茯苓以及所述生山楂混合得到混合物,将所述混合物与水及益生菌混合后在80-100℃的温度下发酵后,过滤后得到药物液剂。
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