CN114392319A - 一种治疗糖尿病前期的中药组合物及其应用 - Google Patents
一种治疗糖尿病前期的中药组合物及其应用 Download PDFInfo
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Abstract
本发明提供了一种治疗糖尿病前期的中药组合物及其应用,中药组合物由以下原料药制成:黄连10‑20份,黄芪20‑35份,山药20‑30份,苍术12‑30份,佩兰10‑20份,炒白术15‑30份,茯苓15‑30份,麦冬10‑30份。本发明的中药组合物以中医经典为理论支持,组方合理,配伍得当,可以补脾益气、清热燥湿,从而治疗糖尿病前期,其疗效确切,作用显著,且无明显不良反应,具有很好的安全性。
Description
技术领域
本发明涉及中医药技术领域,具体而言,涉及一种治疗糖尿病前期的中药组合物及其应用。
背景技术
糖尿病前期是由血糖正常向2型糖尿病过渡的重要环节。糖尿病前期,指介于糖代谢正常和糖尿病之间阶段的异常状态,表现为糖调节受损(impaired glucoseregulation,IGR),包括空腹血糖受损(impaired fasting glucose,IFG)、糖耐量减低(impaired glucose tolerance,IGT),或两者兼而有之。近年来,糖尿病前期的发生率呈现迅速上升态势,大规模横断面调查研究显示,中国成年人糖尿病前期患病率超过50%,成为2型糖尿病的重要后备军。糖尿病前期的血糖异常不仅是2型糖尿病的危险因素,也与心血管疾病、代谢综合征、认知功能障碍等疾病密切相关。然而,糖尿病前期的糖代谢异常状态是一个可以逆转的过程,因此,及时发现并积极干预糖尿病前期对于延缓或阻断糖尿病的发生意义重大。
目前,西医对于糖尿病前期的控制方法主要是生活方式干预及降糖、改善胰岛素抵抗(IR)等,缺乏特异性。近年来中医药在治疗糖尿病前期方面也有所研究,我国学者通过多年的临床实践,在防止糖尿病前期发展为糖尿病以及减轻和延缓并发症等多方面均取得了一定成绩,如专利CN109223902A公开了一种用于干预糖尿病前期人群的中药组合物,由生山楂2-10份,枸杞子1-6份,决明子1-6份,野菊花1-6份,乌梅1-4份制备而成;专利CN102836358A公开了一种用于治疗糖尿病前期的中药组合物,由白术1-10份、百合干1-10份、生地黄2-10份、黄芪2-10份、黄连1-5份、薏苡仁2-6份、岷当归2-6份、槐米2-6份制备而成。与西医相比,中医药具有疗效确切、不良反应少等优点。
虽然上述专利申请记载所用中药方具有一定的疗效,但鉴于治疗糖尿病前期药物的市场需求很大,每个患者的体质不同,现有的中药方存在疗效不确切、效果不显著的问题,因此亟需开发出疗效确切、服用简便、安全无毒副作用的中药制剂,为临床医生和患者提供更多的用药选择。
发明内容
为了解决上述现有技术的不足,本发明的目的之一是提供一种组方合理,效果显著的治疗糖尿病前期的中药组合物。
本发明的上述目的可通过以下技术方案实现:
一种治疗糖尿病前期的中药组合物,由以下重量份的原料药制成:黄连10-20份,黄芪20-35份,山药20-30份,苍术12-30份,佩兰10-20份,炒白术15-30份,茯苓15-30份,麦冬10-30份。
优选地,上述治疗糖尿病前期的中药组合物由以下重量份的原料药制成:黄连10-15份,黄芪20-25份,山药20-25份,苍术12-20份,佩兰10-15份,炒白术15-20份,茯苓15-20份,麦冬10-20份。
优选地,上述治疗糖尿病前期的中药组合物由以下重量份的原料药制成:黄连10份,黄芪20份,山药20份,苍术12份,佩兰10份,炒白术15份,茯苓15份,麦冬10份。
优选地,上述治疗糖尿病前期的中药组合物包括医学能够接受的药物载体。
本发明的另一个目的在于公开上述中药组合物在制备治疗糖尿病前期的药物中的应用。
优选地,上述药物的剂型为颗粒剂、口服液、片剂、胶囊、散剂、丸剂或膏方。
本发明的有益效果如下:
本发明的中药组合物以中医经典为理论支持,组方合理,配伍得当,可以补脾益气、清热燥湿,从而治疗糖尿病前期,其疗效确切,作用显著,且无明显不良反应,具有很好的安全性。
本发明的中药组合物可用于制备治疗糖尿病前期的药物,药物可选择多种剂型,在保证疗效的同时,具有了治疗方便,药效长久,药物可随身携带,疗效稳定,药物经济性强等优点。
具体实施方式
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。
本发明一种实施方式为治疗糖尿病前期的中药组合物,中药组合物由以下原料药制成:黄连、黄芪、山药、苍术、佩兰、炒白术、茯苓、麦冬。
中医学没有糖尿病前期这一病名,通常按患者症状可归为“脾瘅”范畴。“脾瘅”之名首见于《黄帝内经》。《素问·奇病论》曰:“有病口甘者,病名为何?何以得之?岐伯曰:此五气之溢也,名为脾瘅……此肥美之所发也,此人必数食甘美而多肥也,肥者令人热,甘者令人中满,故其气上溢,转为消渴”,指出“脾瘅”的一大重要病因是过食肥美,而中满内热由生,蕴结于脾,并且得不到及时干预就有可能进展为消渴。此外,《黄帝内经》还提出“脾瘅”的治疗原则:“治之以兰,除陈气也”,即采用芳香醒脾之药,化浊除湿。后世医家在《黄帝内经》的基础上对“脾瘅”的理论认识多有发挥,但多认为其病位在脾,发病原因不外先天禀赋、过食甘美、安逸少动、情志失调等。病机多以气虚为本,气滞、燥热、痰结为标。因此,本发明的药方旨在补脾益气、清热燥湿,从而治疗糖尿病前期临床症状。本发明方义如下:
君药:黄芪、山药。黄芪:甘,归脾肺经。补气固表,托毒排脓,利尿,生肌。《神农本草经》:“黄耆,味甘,微温。主痈疽久败创,排脓止痛,大风癞疾,五痔,鼠瘘,补虚,小儿百病。”山药:甘、平,归脾肺肾经。补脾养胃,生津益肺,补肾涩精。《本草正》:“山药,能健脾补虚,滋精固肾,治诸虚百损,疗五劳七伤。”《本草经读》:“山药,能补肾填精,精足则阴强、目明、耳聪。”二者共为君药,达健脾益气、助脾散精之效。
臣药:黄连、麦冬。黄连:苦,寒,归心、脾、胃、肝、胆、大肠经。清热燥湿,泻火解毒。《本草纲目》:“泻肝火,去心窍恶血,止惊悸。”《名医别录》:“微寒,无毒。主治五藏冷热,久下泄澼、脓血,止消渴、大惊,除水,利骨,调胃,厚肠,益胆,治口疮。”麦冬:甘,微苦,微寒。归心、肺、胃经。养阴生津,润肺止咳。《名医别录》:“身重目黄,心下支满,虚劳,客热,口干,燥渴,止呕吐,愈痿蹶,强阴益精,消谷调中,保神,定肺气,安五脏,令人肥健,美颜色,有子”《本草拾遗》:“止烦热,消渴,身重,目黄,寒热,体劳,止呕,开胃,下痰。”二者共为臣药,达清热燥湿、养阴生津之效。
佐药:白术、茯苓、苍术、佩兰。白术:苦、甘,温,归脾胃经。健脾益气,燥湿利水,止汗,安胎。《本草通玄》:“补脾胃之药,更无出其右者。土旺则能健运,故不能食者,食停滞者,有痞积者,皆用之也。土旺则能胜湿,故患痰饮者,肿满者,湿痹者,皆赖之也”。《本草汇言》:“白术,乃扶植脾胃,散湿除痹,消食除痞之要药也。”《本草求真》:“白术味苦而甘,既能燥湿实脾,复能缓脾生津。且其性最温,服则能以健食消谷,为脾脏补气第一要药也。”茯苓:甘、淡,归心、肺、脾、肾经。利水渗湿,健脾,宁心。《本草纲目》:“茯苓气味淡而渗,其性上行,生津液,开腠理,滋水源而下降,利小便,故张洁古谓其属阳,浮而升,言其性也;东垣谓其为阳中之阴,降而下,言其功也。”《本草衍义》:“茯苓、茯神,行水之功多,益心脾不可阙也。”《本草正》:“能利窍去湿,利窍则开心益智,导浊生津;去湿则逐水燥脾,补中健胃;袪惊痫,厚肠脏,治痰之本,助药之降。以其味有微甘,故曰补阳。但补少利多。”苍术:辛、苦,温。归脾、胃、肝经。燥湿健脾,祛风散寒,明目。《本草纲目》:“大风痹,筋骨软弱,散风除湿解郁。汁酿酒,治一切风湿筋骨痛。”。《本草从新》:“燥胃强脾。发汗除湿。能升发胃中阳气。止吐泻。逐痰水。”佩兰:味辛,性平。脾、胃、肺经。芳香化湿,醒脾开胃,发表解暑。《素问·奇病论》:“津液在脾,故令人口干也,此肥美之所发也。......其气上溢,转为消渴,治之以兰,除陈气也。”《本草经疏》:“肺主气,肺气郁结,则上窍闭而下窍不通,胃主纳水谷,胃气郁滞,则水唋不以时化而为痰癖,兰草辛平能散结滞,芬芳能除秽恶,则上来诸症自疗,大多开胃除恶,清肺消痰,散郁结之圣药也。”四者共为佐药,达健脾益气,燥湿利水之效。
全方合用,共奏补脾益气、清热燥湿之功。
中药组合物中原料药的重量份及药理作用如下:
黄连10-20份,黄芪20-35份,山药20-30份,苍术12-30份,佩兰10-20份,炒白术15-30份,茯苓15-30份,麦冬10-30份。
黄连:苦,寒,归心、脾、胃、肝、胆、大肠经。清热燥湿,泻火解毒。湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,心悸不宁,血热吐衄,目赤,牙痛,消渴,痈肿疗疮;外治湿疹,湿疮,耳道流脓等病症。黄连典型但非限制性的含量为:10份、11份、12份、13份、14份、15份、16份、17份、18份、19份、20份。
黄芪:甘,微温。归脾肺经。补气固表,托毒排脓,利尿,生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,内热消渴,血虚萎黄,半身不遂,痹痛麻木,痈疽难溃,久溃不敛等病症。黄芪典型但非限制性的含量为:20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份、31份、32份、33份、34份、35份。
山药:甘、平。归脾、肺、肾经。补脾养胃,生津益肺,补肾涩精。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴等病症。山药典型但非限制性的含量为:20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份。
苍术:辛、苦,温。归脾、胃、肝经。燥湿健脾,祛风散寒,明目。用于湿阻中焦,脘腹胀满,泄泻,水肿,脚气痿蹙,风湿痹痛,风寒感冒,夜盲,眼目昏涩等病症。苍术典型但非限制性的含量为:12份、13份、14份、15份、16份、17份、18份、19份、20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份。
佩兰:味辛,性平。脾、胃、肺经。芳香化湿,醒脾开胃,发表解暑。用于湿浊中阻,脘痞呕恶,口中甜腻,口臭,多涎,暑湿表证,湿温初起,发热倦怠,胸闷不舒等病症。佩兰典型但非限制性的含量为:10份、11份、12份、13份、14份、15份、16份、17份、18份、19份、20份。
炒白术:苦、甘,温。归脾、胃经。健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安等病症。炒白术典型但非限制性的含量为:15份、16份、17份、18份、19份、20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份。
茯苓:甘、淡,归心、肺、脾、肾经。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。茯苓典型但非限制性的含量为:15份、16份、17份、18份、19份、20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份。
麦冬:甘,微苦,微寒,归心、肺、胃经。养阴生津,润肺止咳。用于渴、短气、肺痿、肺干咳嗽、虚劳、虚热等病症。麦冬典型但非限制性的含量为:10份、11份、12份、13份、14份、15份、16份、17份、18份、19份、20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份。
本发明的另一种实施方式为治疗糖尿病前期的药物,将上述治疗糖尿病前期的中药组合物和药学上可接受的辅料加工成为药物。药物的剂型为颗粒剂、口服液、片剂、胶囊、散剂、丸剂、膏方中的任意一种。
下面将结合具体实施例对本发明的技术方案进行进一步地说明。
实施例1
一种治疗糖尿病前期的中药组合物,包括如下重量组分的原料药:黄连10份,黄芪20份,山药20份,苍术12份,佩兰10份,炒白术15份,茯苓15份,麦冬10份。
制备及服用方法:药材用清水浸泡半小时,大火煮沸后,再文火煎煮30分钟,取头煎,再加水煎煮20分钟,取二煎,两煎和匀,分早晚两次服用。
实施例2
一种治疗糖尿病前期的中药组合物,包括如下重量组分的原料药:黄连10份,黄芪30份,山药30份,苍术15份,佩兰15份,炒白术15份,茯苓10份,麦冬10份。
制备方法:将上述药材按用量称取后,加水使浸没药材,浸泡3小时后,加热至沸,煎煮0.5小时,取煎液。药渣依法煎煮2-3次,合并各煎液。过滤后,蒸发浓缩(1:1),冷却后加入1.5倍量的乙醇,充分混匀,放置过夜,取上清,沉淀物用少量50%乙醇洗净,洗液与滤液合并,减压回收乙醇后,浓缩冷却静置,滤过后,真空低温浓缩至稠膏,稠膏比重为1.33,喷雾干燥后过300目筛,加入适量辅料后制成颗粒即可。
实施例3
一种治疗糖尿病前期的中药组合物,包括如下重量组分的原料药:黄连10份,黄芪25份,山药25份,苍术12份,佩兰10份,炒白术15份,茯苓30份,麦冬15份。
制备方法:将上述药材按用量称取后,取其药量的五分之三粉碎过50目筛后,加水使浸没药材,浸泡3小时后,加热至沸,煎煮0.5小时,取煎液。药渣依法煎煮2-3次,合并各煎液。过滤后,蒸发浓缩(1:1),冷却后加入1.5倍量的乙醇,充分混匀,放置过夜,取上清,沉淀物用少量50%乙醇洗净,洗液与滤液合并,减压回收乙醇后,浓缩冷却静置,滤过后,真空低温浓缩至稠膏,稠膏比重为1.33喷雾干燥研细过300目筛,得提取物粉末,填充制成胶囊剂。
实施例4
一种治疗糖尿病前期的中药组合物,包括如下重量组分的原料药:黄连15份,黄芪30份,山药30份,苍术12份,佩兰20份,炒白术30份,茯苓30份,麦冬10份。
制备方法:按照上述重量称取原料药后干燥,超微粉碎至800目以上的微粒,加入适量糊精搅拌均匀后制成片剂。
实施例5
一种治疗糖尿病前期的中药组合物,包括如下重量组分的原料药:黄连15份,黄芪30份,山药30份,苍术20份,佩兰20份,炒白术25份,茯苓25份,麦冬25份。
制备方法:将上述药材按用量称取后,加水使浸没药材,浸泡3小时后,加热至沸,煎煮0.5小时,取煎液。药渣依法煎煮2-3次,合并各煎液。过滤后,蒸发浓缩(1:1),冷却后加入1.5倍量的乙醇,充分混匀,放置过夜,取上清,沉淀物用少量50%乙醇洗净,洗液与滤液合并,减压回收乙醇后,浓缩冷却静置,滤过后,真空低温浓缩至比重为1.20-1.35流浸膏;将第二次药渣干燥后,粉碎成药渣细粉作为填加剂,将药渣细粉与上述比重1.20-1.35的流浸膏搅拌混合均匀,形成混合物,以水蒸汽气体或氮气为雾化气体,进行喷雾干燥,生成药粉颗粒。
临床试验
1.研究对象
选取就诊于宁波市第一医院中医内分泌科的糖尿病前期患者60例,按照是否采用清热益气方治疗分为中药组30例,西药组30例。两组患者平均年龄分别为(42.43±4.93)、(42.83±4.90),差异无统计学意义(P>0.05)。两组患者发现血糖异常时间、BMI、腰臀比均无统计学差异(P>0.05),具有可比性。
2.执行标准及方法
(1)诊断标准
①空腹血糖受损(IFG):空腹静脉血浆葡萄糖(FBG)≥6.1mmol/L且<7.0mmol/L;及75g口服糖耐量试验后(OGTT)血浆葡萄糖<7.8mmol/L。
②糖耐量异常(IGT):空腹静脉血浆葡萄糖<7.0mmol/L(126mg/d1);及75克口服糖耐量试验后2小时血浆葡萄糖(2hPG)≥7.8mmol/L且<11.1mmoL/L。
达到上述空腹血糖受损、糖耐量异常或空腹血糖受损合并糖耐量异常的标准,均为糖尿病前期。
(2)治疗方法:
中药组:黄连10份,黄芪20份,山药20份,苍术12份,佩兰10份,炒白术15份,茯苓15份,麦冬10份。水煎服,日一剂,早晚分服。每个***为1疗程,治疗3个疗程。
西药组:二甲双胍,一次250mg,一日2次,饭后服用。
(3)观察指标及方法
1)一般情况
①人口统计学资料:年龄,性别;
②既往病史、家族史及治疗史:糖尿病病程、糖尿病家族史、其他疾病及其对应治疗史;
③生活习惯:吸烟史及饮酒史;
④体格检查:BMI(BMI<24正常,24-28超重,>28肥胖)、腰围(女性腰围≤80、男性腰围≤90正常,女性腰围>80、男>90中心性肥胖)。
2)疗效指标
12周后中药组和西药组的糖耐量复常率。随访12周时,在末次随访时会进行口服葡萄糖耐量试验(OGTT),根据实验结果判断患者的糖耐量状态。
3)糖脂代谢相关指标
①空腹血糖(FastingPlasmaGlucose,FPG);
②餐后血糖(Post-PrandialGlucosese,PPG);
③糖化血红蛋白(HemoglobinA1C,HbA1C)(0、12周随访时);
④空腹胰岛素(0、12周随访时);
⑤血脂(总胆固醇(TotalCholesterol,TC)、甘油三酯(Triglyceride,TG)、低密度脂蛋白胆固醇(LowDensityLipoprotein-Cholesterol,LDL-C)、高密度脂蛋白胆固醇(HighDensityLipoprotein-Cholesterol,HDL-C))(0、12周随访时);
⑥胰岛素抵抗指数(HOMA-IR)。
患者空腹八小时以上测量空腹血糖(葡萄糖氧化酶法)、HbA1C(高压液相色谱法)及脂代谢相关指标(酶法),受试者服用75g无水葡萄粉后2小时测量餐后血糖(葡萄糖氧化酶法)。
(4)统计学方法
统计描述和分析采用SPSS25.0统计软件进行数据处理。计量资料符合正态分布采用率、构成比等描述患者的一般情况、BMI、腰围、臀围等,不符合正态分布采用M(P25,P75)表示,计量资料符合正态分布采用t检验,不符合正态分布采用秩和检验;计数资料采用频数和百分比描述,二分类资料采用χ2检验或确切概率的Fisher检验进行组间比较。P<0.05为差异有统计学意义。
3.研究结果
(1)监测指标观察比较
如表1所示,中药组和西药组分别组内用药前后的FPG、2hPG、HbA1c、HOMA-IR指标均有统计学意义,且空腹血糖、餐后血糖、糖化血红蛋白均降低,胰岛素抵抗程度减轻。中药组用药前后TC、LDL差异有统计学意义(P<0.05),TG、HDL差异无统计学意义(P>0.05)。西药组用药前后LDL差异有统计学意义(P<0.05),TC、TG、HDL差异无统计学意义(P>0.05)。
(2)两组用药后监测指标观察比较
中药组用药后FBG、2hPG、HbA1c、HOMA-IR、TC、LDL改善程度较西药组明显,差异有统计学意义(P<0.05)。TG、HDL改善不明显。
(3)安全性评价指标
两组均未见明显不良反应。
研究结果表明:本发明中药复方可降低患者血糖情况、改善患者胰岛功能及临床症状,且无明显不良反应,具有较好的安全性。
典型案例
病例1:罗某,男,62岁,已婚。主诉:发现血糖偏高1年。现病史:2020年体检发现血糖偏高,FBG:6.4mmol/L,2hPG:7.6mmol/L,未予重视及治疗。2021年体检发现FBG:6.8mmol/L,2hPG:10.2mmol/L,患者于2021年9月1日就诊,刻下症见:一般情况可,形胖,无明显口渴喜饮,无体重减轻,无双目干涩,无腰膝酸软等症状,纳可,寐安,便溏。舌质淡红苔薄白脉濡。证属脾虚湿盛证,以健脾益气燥湿为主要治疗原则。方以:黄连10g,黄芪20g,山药20g,苍术12g,佩兰10g,炒白术15g,茯苓15g,麦冬10g,水煎服,日一剂,早晚分服。嘱患者调整生活方式,增强运动,不适随诊。治疗3月后复查血,FBG:5.4mmol/L,2hPG:5.9mmol/L,HbA1c:5.8%。
病例2:陈某,女,35岁,已婚。主诉:发现血糖偏高1年。现病史:患者1年前单位体检发现FBG:6.3mmol/l,未予重视及治疗。1月前后自觉口干口渴,就诊,行OGTT,FBG:6.9mmol/L,2hPG:9.8mmol/l,HbA1c:6.1%。刻下症见:形胖,口干口渴,脾气急躁,无体重下降,无腰膝酸软,纳可,晚睡,大便时干时稀,舌稍红苔白稍厚脉弦细。证属肝郁脾虚证,湿热内蕴,以疏肝健脾清热燥湿为主要治疗原则。方以:黄连10g,黄芪20g,山药20g,苍术12g,佩兰10g,炒白术15g,茯苓15g,麦冬10g,水煎服,日一剂,早晚分服。嘱患者调整生活方式,不适随诊。治疗6月后复查OGTT,FBG:4.9mmol/L,2hPG:6.5mmol/l,HbA1c:5.3%。
虽然本公开披露如上,但本公开的保护范围并非仅限于此。本领域技术人员,在不脱离本公开的精神和范围的前提下,可进行各种变更与修改,这些变更与修改均将落入本发明的保护范围。
Claims (6)
1.一种治疗糖尿病前期的中药组合物,其特征在于,由以下重量份的原料药制成:黄连10-20份,黄芪20-35份,山药20-30份,苍术12-30份,佩兰10-20份,炒白术15-30份,茯苓15-30份,麦冬10-30份。
2.根据权利要求1所述的治疗糖尿病前期的中药组合物,其特征在于,由以下重量份的原料药制成:黄连10-15份,黄芪20-25份,山药20-25份,苍术12-20份,佩兰10-15份,炒白术15-20份,茯苓15-20份,麦冬10-20份。
3.根据权利要求1所述的治疗糖尿病前期的中药组合物,其特征在于,由以下重量份的原料药制成:黄连10份,黄芪20份,山药20份,苍术12份,佩兰10份,炒白术15份,茯苓15份,麦冬10份。
4.根据权利要求1所述的治疗糖尿病前期的中药组合物,其特征在于,包括医学能够接受的药物载体。
5.根据权利要求1-4任一所述的中药组合物在制备治疗糖尿病前期的药物中的应用。
6.根据权利要求5所述的应用,其特征在于,所述药物的剂型为颗粒剂、口服液、片剂、胶囊、散剂、丸剂或膏方。
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