CN108404088B - 一种治疗ⅱ型糖尿病的中药及其制备方法 - Google Patents
一种治疗ⅱ型糖尿病的中药及其制备方法 Download PDFInfo
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Abstract
本发明涉及医药技术领域,具体涉及一种治疗Ⅱ型糖尿病的中药及其制备方法。该中药具有清热降浊、益气养阴的作用,用于治疗气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言等证,特别适用于Ⅱ型糖尿病见上述症候者。本发明所述的中药由以下重量份原料组成:干姜30‑80份、黄连150‑220份、黄芩150‑220份、西洋参20‑45份、天花粉150‑220份和五谷虫150‑220份,采用一定的制备方法制备成胶囊剂、片剂、颗粒剂。
Description
一、技术领域:
本发明涉及医药技术领域,具体涉及一种治疗Ⅱ型糖尿病的中药及其制备方法。
二、背景技术:
糖尿病患者人数在逐年增加,据统计全球20-79岁的人中有约4.15亿人患糖尿病,患病率为8.8%,另外有3.18亿人糖耐量受损,前期患病率为6.7%。世界卫生组织(WHO)将糖尿病分为Ⅰ糖尿病、Ⅱ糖尿病、妊娠糖尿病以及特殊类型糖尿病四种,Ⅰ糖尿病主要由自身免疫导致胰岛B细胞严重损毁所致,患者的胰岛素数量绝对缺乏,必须依赖外源性胰岛素维持生命,此型患者约占糖尿病患者总数的5%;Ⅱ糖尿病主要病理机制是胰岛素抵抗或同时伴有胰岛素分泌相对不足,此型患者占糖尿病患者总数的90%以上;上述Ⅰ糖尿病、Ⅱ糖尿病为糖尿病的主要类型,其中Ⅱ糖尿病所占比例最高。现有的治疗手段主要是药物治疗、胰岛素注射,饮食辅助治疗。
三、发明内容
有鉴于此,本发明的提供一种治疗Ⅱ型糖尿病的中药及其制备方法,该中药具有清热降浊、益气养阴的作用,用于治疗气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言等证,特别适用于Ⅱ型糖尿病见上述症候者。
为实现上述目的,本发明采用的技术方案为:一种治疗Ⅱ型糖尿病的中药,其特征在于:所述的中药由以下重量份原料组成:干姜30-80份、黄连150-220份、黄芩150-220份、西洋参20-45份、天花粉150-220份和五谷虫150-220份。
所述的中药优选以下重量份原料:干姜54份、黄连180份、黄芩180份、西洋参36份、天花粉180份和五谷虫180份。
所述的中药的剂型为胶囊剂、片剂、颗粒剂。
所述的胶囊剂的制备方法为:
首先取西洋参、五谷虫粉碎成细粉或采用超微粉碎技术粉碎成细粉;
然后取干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,用乙醇制粒,装胶囊,制成硬胶囊剂;或加入色拉油中,搅拌均匀,压丸,制成软胶囊。
所述的片剂的制备方法为:
首先取西洋参、五谷虫粉碎成细粉或采用超微粉碎技术粉碎成细粉;
然后取干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,乙醇制粒,加入硬脂酸镁,混匀,压片,制成片剂。
所述的颗粒剂的制备方法为:
首先取西洋参、五谷虫粉碎成细粉或采用超微粉碎技术粉碎成细粉;
然后取干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,加入蔗糖粉、麦芽糊精或甜菊糖苷,用乙醇制粒,制成颗粒剂。
所述的中药在制备治疗气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言的药物中的应用。
所述的中药用于制备治疗Ⅱ型糖尿病的药物。
与现有技术相比,本发明具有如下优点和效果:
(1)本发明提供了一种全新的中药组合物制剂,其制剂服用、携带方便,组合物配方亦简单,仅六味药材;
(2)本发明提供的中药组合物通过清热降浊、益气养阴的中医治病原理,用于治疗气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言等证,特别适用于治疗具有气阴两虚所致的口渴喜饮、倦怠乏力、少气懒言等症候的Ⅱ型糖尿病;
(3)本发明中药组合的制备方法简单,仅包括粉碎、提取,浓缩、干燥、制粒等过程,提取溶剂环保,用水提取;
(4)采用本发明提供的配方制得的活性物质可以单独制备成临床上可以接受的剂型,也可以根据应用的方式或使用人群的特殊要求添加辅料制备成临床上可以接受的剂型。
四、具体实施方式
下面结合具体的实施方式来对本发明的技术方案做进一步的限定:
实施例一:
一种治疗Ⅱ型糖尿病的中药由以下重量份原料组成:干姜30份、黄连150份、黄芩150份、西洋参20份、天花粉150份和五谷虫150份。
所述的中药制备成胶囊剂的制备方法为:
首先取西洋参、五谷虫粉碎成细粉或采用超微粉碎技术粉碎成细粉;
然后取干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,用乙醇制粒,装胶囊,制成硬胶囊剂;或加入色拉油中,搅拌均匀,压丸,制成软胶囊。
实施例二:
一种治疗Ⅱ型糖尿病的中药由以下重量份原料组成:干姜80份、黄连220份、黄芩220份、西洋参45份、天花粉220份和五谷虫220份。
所述的中药制备成片剂的制备方法为:
首先取西洋参、五谷虫粉碎成细粉或采用超微粉碎技术粉碎成细粉;
然后取干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,乙醇制粒,加入硬脂酸镁,混匀,压片,制成片剂。
实施例三:
一种治疗Ⅱ型糖尿病的中药由以下重量份原料组成:干姜54份、黄连180份、黄芩180份、西洋参36份、天花粉180份和五谷虫180份。
所述的中药制备成颗粒剂的制备方法为:
首先取西洋参、五谷虫粉碎成细粉或采用超微粉碎技术粉碎成细粉;
然后取干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,加入蔗糖粉、麦芽糊精或甜菊糖苷,用乙醇制粒,制成颗粒剂。
主要药效学试验
一、试验药物的制备
1.试验药物
A组:本发明实施例1制备的制剂A;
B组:本发明实施例2制备的制剂B;
C组:本发明实施例3制备的制剂C;
二、药学试验方法及结果
(一)对Ⅱ型糖尿病模型大鼠糖代谢的影响
实验材料
1.动物:大白鼠,雌雄各半,体重73~103g。
2.药物:本发明提供的制剂A、B、C药物在实验前用蒸馏水配置,灌胃给药。
实验方法
健康大白鼠70只,雌雄各半,用高热量饲料喂养(10公斤基础饲料加生米2kg、鸡蛋1.5kg、猪油2kg、麻油0.5kg)。持续喂养8周后,禁食不禁水48小时,每只大鼠腹腔注射STZ30mg/kg,2周后,禁食8小时,测空腹血糖后,灌胃给葡萄糖2g/kg,测定120分钟时的糖耐量。选空腹血糖≥7.0及糖耐量≥11.0mmol/L的大鼠用于实验,分成4组,每组10只,雌雄各半,其中一组为对照组,另外三组为药物组,各组继续高脂肪饲养,自饲养之日起,药物组灌胃给药0.4g/kg,对照组灌胃等体积蒸馏水,连续给药7周时,禁食12小时,测空腹测血糖、糖耐量。结果见表l、2。
与照组比较#P<0.05##P<0.01
分组 | 动物数(n) | 服用剂量(g/kg) | 给药前(mmol/L) | 给药后(mmol/L) |
对照组 | 10 | - | 13.42±1.74 | 16.29±4.8 |
A组 | 10 | 0.4 | 14.37±3.81 | 10.27±2.84## |
B组 | 10 | 0.4 | 13.85±2.17 | 10.39±2.97## |
C组 | 10 | 0.4 | 14.1±3.24 | 10.12±2.51## |
与照组比较#P<0.05##P<0.01
结果显示:分别依据本发明1-3实施例制备的制剂A、B、C组与对照组比较,血糖值明显低于对照组,其中A、B组对空腹血糖的影响具有显著的统计学意义(P<0.05),尤其C组具有极显著的统计学意义(P<0.01),对空腹糖耐量的影响各药物组均具有极显著的统计学意义(P<0.01),结果表明本发明提供的组合物能够有效降低Ⅱ型糖尿病大鼠的血糖值和改善糖耐量。
(二)对Ⅱ型糖尿病模型家兔糖代谢的影响
实验材料
1.动物:大耳白家兔,雌雄各半,体重1.2~2.6kg。
2、药物:本发明提供的制剂A、B、C药物在实验前用蒸馏水配置,灌胃给药。
实验方法
健康家兔30只,雌雄各半,用高热量饲料喂养(10公斤基础饲料加鸡蛋1.5kg、猪油2kg)。持续喂养9周后,禁食不禁水48小时,每只家兔静脉注射四氧嘧啶88mg/kg,检测血糖值,选血糖值≥10mmol/L的家兔用于实验,分成4组,每组6只,雌雄各半,其中一组为对照组,另外三组为药物组,各组继续高脂肪饲养,自饲养之日起,药物组灌胃给药0.2g/kg,对照组灌胃等体积蒸馏水,连续给药8周,分别在给药4周、6周、8周后,测空腹测血糖。结果见表3、4、5。
与照组比较#P<0.05##P<0.01
与照组比较#P<0.05##P<0.01
与照组比较#P<0.05##P<0.01
结果显示:分别依据本发明1-3实施例制备的制剂A、B、C组与对照组比较,在给药第4周后,A、B组血糖值降低,C组明显降低并具有具有显著的统计学意义(P<0.05),给药6周后,A、B、C三组血糖均明显降低,具有显著的统计学意义(P<0.05),给药第8周后,A、B、C三组血糖均明显降低,尤其C组具有极显著的统计学意义(P<0.01),结果表明本发明提供的组合物能够有效降低Ⅱ型糖尿病家兔的血糖值。
毒理实验:
急性毒性实验结果表明:将按本发明制备的制剂A、B、C最大浓度、最大容积灌胃给药,在24h内连续给药3次,每次间隔4h,累积药物总量达48g/kg,相当于人临床拟用量的约827.6倍。给药后7d内,小鼠活动、进食、***均正常,生长良好,毛色光亮,其平均体重均随试验时间的延长而增加。第8d处死后解剖每只小鼠肉眼观察心、肝、脾、肺、肾、脑、胸腺、胃、肠等均未发现颜色及形态异常,未能测出LD50。表明本发明所提供的组合物无急性毒性反应。
长期毒性实验结果表明:按本发明制备的制剂A、B、C分别低、中、高剂量,分别为8、4、2g/kg,相当于临床剂量的137.9、69、34.5倍,灌胃给药12周后,中药制剂A、B、C对动物的一般状况、血液学指标、血液生化指标均无明显的影响,***解剖、脏器系数及组织病理学检查也未发现异常病理改变。停药2周也未见明显改变。在长期毒性试验中,未发现明显毒性反应和延迟毒性反应,可见,本发明所提供的组合物无毒性反应,长期用药安全可靠。
本发明所提供的中药组合物的药效学试验结果良好,按照三个实施例制备的中药制剂与对照组比较,本发明所提供的中药组合物在对采用小剂量链脲霉素配合喂饲高脂饲料造成大鼠2-型糖尿病模型和四氧嘧啶配合喂饲高脂饲料造成家兔2-型糖尿病模型改善糖代谢作用方面效果明显,且急毒、长毒试验结果显示该组合物无毒副作用,可以安全服用。
Claims (6)
1.一种治疗Ⅱ型糖尿病的中药,其特征在于:所述的中药由以下重量份原料制成:
干姜30-80份、黄连150-220份、黄芩150-220份、西洋参20-45份、天花粉150-220份和五谷虫150-220份。
2.根据权利要求1所述的一种治疗Ⅱ型糖尿病的中药,其特征在于:所述的中药优选以下重量份原料:干姜54份、黄连180份、黄芩180份、西洋参36份、天花粉180份和五谷虫180份。
3.根据权利要求2所述的一种治疗Ⅱ型糖尿病的中药,其特征在于:所述的中药的剂型为胶囊剂、片剂或颗粒剂。
4.根据权利要求3所述的一种治疗Ⅱ型糖尿病的中药的制备方法,其特征在于:所述胶囊剂的制备方法为:取西洋参、五谷虫粉碎成细粉;干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,用乙醇制粒,装胶囊,制成硬胶囊剂;或加入色拉油中,搅拌均匀,压丸,制成软胶囊。
5.根据权利要求3所述的一种治疗Ⅱ型糖尿病的中药的制备方法,其特征在于:所述的片剂的制备方法为:取西洋参、五谷虫粉碎成细粉;干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,乙醇制粒,加入硬脂酸镁,混匀,压片,制成片剂。
6.根据权利要求3所述的一种治疗Ⅱ型糖尿病的中药的制备方法,其特征在于:所述的颗粒剂的制备方法为:取西洋参、五谷虫粉碎成细粉;干姜、黄连、黄芩、天花粉四味药材加水煎煮2次,第一次加入10-12倍量水,煎煮1-2小时,第二次加入8-10倍量水,煎煮1-1.5小时,合并两次水煎液,沉淀12-24小时,滤过,滤液浓缩成稠膏,加入西洋参、五谷虫细粉,干燥,粉碎成细粉,加入蔗糖粉、麦芽糊精或甜菊糖苷,用乙醇制粒,制成颗粒剂。
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