CN105497637B - 一种治疗代谢综合征的中药制剂 - Google Patents
一种治疗代谢综合征的中药制剂 Download PDFInfo
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Abstract
本发明提供了一种治疗代谢综合征的中药制剂,按重量计,包括以下成分:党参15~25份、黄芪25~35份、煅石膏10~20份、半夏5~15份、麦冬10~20份、白芍10~20份、川芎5~15份、当归5~15份、黄芩5~15份、生地10~20份、甘草10~20份、竹叶10~20份、知母5~15份、柴胡5~15份;该中药制剂具有治疗效果好,成本低,无副作用等优点。
Description
技术领域
本发明涉及重要领域,特别提供了一种治疗代谢综合征的中药制剂。
背景技术
代谢综合征是一类以高血糖、肥胖、血脂异常和高血压等集簇存在为标志的临床综合征,是一组复杂的代谢紊乱症候群,是导致糖尿病心脑血管疾病的危险因素。其具有以下特点:①多种代谢紊乱集于一身,包括肥胖、高血糖、高血压、血脂异常、高血黏、高尿酸、高脂肪肝发生率和高胰岛素血症,这些代谢紊乱是心、脑血管病变以及糖尿病的病理基础。可见糖尿病不是一个孤立的病,而是代谢综合征的组成部分之一。②有共同的病理基础,目前多认为它们的共同原因就是肥胖尤其是中心性肥胖所造成的胰岛素抵抗和高胰岛素血症。③可造成多种疾病增加,如高血压、冠心病、脑卒中、甚至某些癌症,包括与性激素有关的乳腺癌、子宫内膜癌、前列腺癌,以及消化系统的胰腺癌、肝胆癌、结肠癌等。④有共同的预防及治疗措施,防治住一种代谢紊乱,也就有利于其他代谢紊乱的防治。其中,肥胖和胰岛素抵抗是被公认的重要的致病因素。
目前,代谢综合征尚缺少行业公认的中医辨证诊疗标准,临床上针对代谢综合征治疗的中医辨证施治方案所拟定的中药组方品类繁杂,临床疗效不好。
因此,如何研发一种新的治疗代谢综合征的药物,成为人们亟待解决的问题。
发明内容
鉴于此,本发明的目的在于提供一种治疗代谢综合征的中药制剂,以至少解决以往治疗代谢综合征的药物,存在治疗效果差等问题。
本发明提供的技术方案,具体为,一种治疗代谢综合征的中药制剂,其特征在于,按重量计,包括以下成分:
党参15~25份、黄芪25~35份、煅石膏10~20份、半夏5~15份、麦冬10~20份、白芍10~20份、川芎5~15份、当归5~15份、黄芩5~15份、生地10~20份、甘草10~20份、竹叶10~20份、知母5~15份、柴胡5~15份。
优选,所述治疗代谢综合征的中药制剂,按重量计,包括以下成分:
党参18~22份、黄芪28~32份、煅石膏12~18份、半夏8~12份、麦冬12~18份、白芍12~18份、川芎8~12份、当归8~12份、黄芩8~12份、生地12~18份、甘草12~18份、竹叶12~18份、知母8~12份、柴胡8~12份。
进一步优选,所述治疗代谢综合征的中药制剂,按重量计,包括以下成分:
党参20份、黄芪30份、煅石膏15份、半夏10份、麦冬15份、白芍15份、川芎10份、当归10份、黄芩10份、生地15份、甘草15份、竹叶15份、知母10份、柴胡10份。
进一步优选,所述中药制剂为汤剂、颗粒剂或片剂中的一种。
本发明提供的治疗代谢综合征的中药制剂,其依据代谢综合征前期的患者多有“虚”和“热”的病机特点,结合实际,将“滋阴生津清热”的治法应用于代谢综合征,针对“血糖、血脂、血压”多靶点进行治疗,并通过动物实验和临床试验均显示该中药制剂能有效降低血糖,调节血脂,改善胰岛素抵抗,保护胰岛细胞功能,可有效治疗代谢综合征。
本发明提供的治疗代谢综合征的中药制剂,具有治疗效果好,成本低,无副作用等优点。
具体实施方式
为了解决以往治疗代谢综合征的药物品种繁杂,临床治疗效果差等问题,本实施方案依据代谢综合征早期以“虚”、“热”为病机特点,采用“滋阴生津清热”法治疗早期代谢综合征,并依此研发了一款中药制剂,该中药制剂按重量计,包括以下成分:
党参15~25份、黄芪25~35份、煅石膏10~20份、半夏5~15份、麦冬10~20份、白芍10~20份、川芎5~15份、当归5~15份、黄芩5~15份、生地10~20份、甘草10~20份、竹叶10~20份、知母5~15份、柴胡5~15份。
上述中药制剂由党参、黄芪、煅石膏、半夏、麦冬、白芍、川芎、当归、黄芩、生地、甘草、竹叶、知母、柴胡多味中药组成。党参:性甘,平,入脾、肺经,本方用之大补脾肺之气,补血生津;黄芪:性甘,微温,入肺、脾经,能补中气之不足;上两味药主要针对代谢综合征“虚”的病机特点发挥作用。方中又用半夏、生地、麦冬、当归、白芍养阴清热。柴胡、川芎调畅气机,使补而不滞。煅石膏:甘、辛,大寒,归肺、胃经,既清热泻火,与知母相须为用,又能生津润燥,黄芩又能助煅石膏清热,相伍为用,清热而不伤津。本方用煅石膏、生地、竹叶通补兼施,针对“虚”、“热”的病机,清热而不伤正,补虚而不留邪。不仅清热,而且补虚,真正做到了祛邪不伤正,寓通于补。
诸药配伍,滋阴生津,意在治本,清热养阴,意在治标。标本兼顾,攻守兼施。
优选,按重量计,包括以下成分:党参18~22份、黄芪28~32份、煅石膏12~18份、半夏8~12份、麦冬12~18份、白芍12~18份、川芎8~12份、当归8~12份、黄芩8~12份、生地12~18份、甘草12~18份、竹叶12~18份、知母8~12份、柴胡8~12份;更为优选,按重量计,包括以下成分:党参20份、黄芪30份、煅石膏15份、半夏10份、麦冬15份、白芍15份、川芎10份、当归10份、黄芩10份、生地15份、甘草15份、竹叶15份、知母10份、柴胡10份。
上述的中药制剂可制成汤剂、颗粒剂或片剂中的任何一种,不影响其药效。
上述中药制剂的制备方法是按照传统制备中药的方法进行制备的,如果汤剂就采用加热煎熬的方式即可。
下面以具体的实施例对本发明进行进一步解释,但是并不用于限制本发明的保护范围。
实施例1
一种治疗代谢综合征的中药制剂,由以下成分组成:党参15克、黄芪25克、煅石膏20克、半夏5克、麦冬20克、白芍10克、川芎15克、当归15克、黄芩5克、生地10克、甘草20克、竹叶10克、知母5克、柴胡15克,采用煎熬的方法制成汤剂。
实施例2
一种治疗代谢综合征的中药制剂,由以下成分组成:党参25克、黄芪35克、煅石膏10克、半夏15克、麦冬10克、白芍20克、川芎5克、当归5克、黄芩15克、生地20克、甘草10克、竹叶20克、知母15克、柴胡5克,采用中药造粒剂制成颗粒剂。
实施例3
一种治疗代谢综合征的中药制剂,由以下成分组成:党参18克、黄芪28克、煅石膏18克、半夏12克、麦冬12克、白芍12克、川芎12克、当归8克、黄芩8克、生地12克、甘草18克、竹叶18克、知母8克、柴胡8克,将其制成片剂。
实施例4
一种治疗代谢综合征的中药制剂,由以下成分组成:党参22克、黄芪32克、煅石膏12克、半夏8克、麦冬18克、白芍18克、川芎8克、当归12克、黄芩12克、生地18克、甘草12克、竹叶12克、知母12克、柴胡12克,将其采用煎煮的方法制成汤剂。
实施例5
一种治疗代谢综合征的中药制剂,由以下成分组成:党参20克、黄芪30克、煅石膏15克、半夏10克、麦冬15克、白芍15克、川芎10克、当归10克、黄芩10克、生地15克、甘草15克、竹叶15克、知母10克、柴胡10克,将其采用煎煮的方法制成汤剂。
实施例6
临床病例
1、一般资料,选取来医院治疗的患者167例,均为气阴两虚型并有糖调节异常(impaired glucose regulation,IGR)的代谢综合征(metabolic syndrome,MS)患者。
2、诊断标准,入选病人要同时符合IGR诊断和MS诊断,并同时符合中医气阴两虚辩证诊断。
3、纳入标准,1)符合MS诊断标准,且符合IGR诊断标准;2)符合中医辩证分型属于气阴两虚者;3)年龄18~70岁者;4)血压在收缩压<180mmHg;舒张压<100mmHg;5)知情同意,志愿受试。
4、排除标准,1)并有1型糖尿病者;2)患有心梗者;3)有药物过敏史或过敏体质者;4)准备妊娠、妊娠或哺乳期妇女;5)精神病患者及依从性差的患者;6)正在接受胰岛素治疗者;7)脑血管病。
5、实验药品,实施例5提供的中药汤剂,用法,口服,每日早饭前,晚饭后。
6、综合治疗,1)所用受试者均接收MS知识宣传及生活方式干预;2)并有IGR的MS患者均采用国际糖尿病联盟治疗建议进行综合治疗:并有高血压者,给予利尿剂、β-手提阻滞剂、血管扩张素转换酶抑制剂(AXEI)、血管紧张素受体阻断剂(ARB)、钙离子拮抗剂(CCB)等的一种或几种联合治疗;并有血脂异常、根据血脂升高水平、类型采用美国国家胆固醇教育计划(NCEP)指南推荐的MS临床治疗的双叉法治疗方案。
7、治疗方案,治疗组:综合治疗+实施例5提供的中药汤剂;安慰剂组:综合治疗+安慰剂组治疗。
8、观察指标,血糖、血脂、血压、糖化血红蛋白、体重指数、中医证形积分、疾病积分、生存质量积分。
9、结果见表1~表5。
表1 两组患者的基线比较
从表1中可以看出,两组年龄、性别构成、体质量、体重指数、病程均无统计学差异。
表2 两组患者治疗前后西医效应指标比较
注:与本组治疗前比较,*P<0.05,**P<0.01;与安慰剂组同期比较,△P<0.05,△△P<0.01,下表同。
从表2可以看出,实施例5提供的中药汤剂可以降低换证的BP、BMI、FPG和2hPG(O<0.01),基础治疗可以改善气阴两虚型患者的2hPG、TG和收缩压。
表3 两组患者治疗后西医效应指标总体达标率比较
从表3可以看出,实施例5提供的中药汤剂可以提高气阴两虚型患者的FPG、2hPG、BP和BMI的达标率(P<0.05)。
表4 两组患者治疗前后中医证型及症候积分的比较
从表4可以看出,实施例5提供的中药汤剂能够有效改善气阴两虚型患者的主要临床症状及全身状况,同时提高患者的生存质量。
表5 证型积分各时段总有效率比较
从表5可以看出,实施例5提供的中药汤剂其证型积分疗效的改善从治疗后10周开始明显,并且随着辽程的延长,疗效愈发的显著。
同时将实施例1~实施例4中的药物均作了类似上述的临床试验,结果证明均可以达到治疗代谢综合征的目的,但实施5中的中药制剂效果最佳。
Claims (4)
1.一种治疗代谢综合征的中药制剂,其特征在于,按重量计,由以下成分组成:
党参15~25份、黄芪25~35份、煅石膏10~20份、半夏5~15份、麦冬10~20份、白芍10~20份、川芎5~15份、当归5~15份、黄芩5~15份、生地10~20份、甘草10~20份、竹叶10~20份、知母5~15份、柴胡5~15份。
2.按照权利要求1所述治疗代谢综合征的中药制剂,其特征在于,按重量计,由以下成分组成:
党参18~22份、黄芪28~32份、煅石膏12~18份、半夏8~12份、麦冬12~18份、白芍12~18份、川芎8~12份、当归8~12份、黄芩8~12份、生地12~18份、甘草12~18份、竹叶12~18份、知母8~12份、柴胡8~12份。
3.按照权利要求1所述治疗代谢综合征的中药制剂,其特征在于,按重量计,由以下成分组成:
党参20份、黄芪30份、煅石膏15份、半夏10份、麦冬15份、白芍15份、川芎10份、当归10份、黄芩10份、生地15份、甘草15份、竹叶15份、知母10份、柴胡10份。
4.按照权利要求1~3任一所述治疗代谢综合征的中药制剂,其特征在于:所述中药制剂为汤剂、颗粒剂或片剂中的一种。
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