CN1267086C - 一种能调节血糖、治疗糖尿病的制剂的制备方法 - Google Patents
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Abstract
一种能调节血糖、治疗糖尿病的制剂的制备方法,涉及一种治疗糖尿病的制剂及制备方法。制剂由人参、黄连、天花粉、杜仲、黄芪、丹参、枸杞子、沙苑子、白芍、知母、格列本脲等配制而成。制备工艺是先将天花粉等9味药经煎煮、提取、浓缩、乙醇沉淀、过滤得上清液,上清液蒸馏去醇、浓缩、干燥为干浸膏,干浸膏粉碎得干浸膏粉。人参、黄连粉碎,过筛与于浸膏粉、格列本脲混合,加成型助剂得产品。本制剂将中、西药有效结合,中、西药协同作用,能显著降低患者血糖、尿糖及糖化血红蛋白,改善糖尿病患者的脂代谢紊乱,改善其气血两虚症状,用药安全、无明显毒副作用,是治疗II型糖尿病气阴两虚症的安全有效的药物。本发明制备方法可行,简单稳定。
Description
技术领域 本发明涉及一种治疗糖尿病的制剂及制备方法。
背景技术 糖尿病属中医消渴范畴,主要症状为多饮、多食、多尿、身体消瘦、俗称“三多一少”,尿有甜味等。糖尿病基本病理是由于胰岛素分泌绝对或相对不足,以及靶组织细胞对胰岛素敏感性降低,引起糖、蛋白质、脂肪、水及电解质等一系列代谢紊乱,表现为高血糖、高尿糖、葡萄糖耐受量减低,胰岛素分泌释放试验异常等。糖尿病由于糖代谢紊乱的同时伴有脂肪等物质代谢紊乱,使得全血、血浆比粘度,红细胞压积,红细胞变形能力以及胆固醇、甘油三酯均高于正常,血液呈凝、聚、浓、粘状态,其结果导致毛细血管壁增厚,血流动力学及血液成分的改变,出现微循环障碍,容易发生动脉粥样硬化及微血管病变,如冠心病(心肌梗塞),缺血性或出血性脑血管病,失明,肢端坏疽等严重并发症,这也是糖尿病诱发加重或死亡的重要原因。有资料表明,我国糖尿病的患病率为10.12‰,欧美国家更高,绝大多数表现为II型糖尿病。随着年龄和体重的增加而患病可能性越大,因此,糖尿病是一种常见病和多发病。目前,治疗糖尿病的化学药物有口服降糖药,如黄脲类、双胍类,以及各种胰岛素,其降糖效果肯定,但其中许多品种毒副作用较大,剂量及适应症不易掌握,容易出现低血糖反应;治疗糖尿病的中成药有很多,但疗效不肯定,重复性差,或虽可以改善症状,却降糖效果较差。
现已研制出一些新的治疗糖尿病的中成药,如《一种治疗糖尿病的药物》(专利申请号02106342),它由枸杞多糖、西洋参、天花粉、五味子、葛根及苍术联合组方。它减少用药量,增强了药物间的相互作用,克服了胰岛素的抵性,从而提高了有效治疗率;它对II类糖尿病、磺脲类药物的继发性失效及胰岛素抵抗综合症效果显著,无副作用。《一种治疗糖尿病的中药》(专利申请号02104040),其主要成份为知母、天花粉、西洋参、丹参、大黄、三七、山楂。该中药制剂疗效显著、作用稳定、持久、无依赖性、无毒副作用,对免疫系统有良好的调节作用。
发明内容 本发明的目的旨在提供能显著降低患者血糖、尿糖及糖化血红蛋白,改善糖尿病患者的脂代谢紊乱,改善其气血两虚症状,用药安全,无明显毒副作用的一种能调节血糖、治疗糖尿病的制剂及制备方法。
本发明目的的实现方式为,一种能调节血糖、治疗糖尿病的制剂,
制剂由人参、黄连、天花粉、杜仲、黄芪、丹参、枸杞子、沙苑子、白芍、知母格刈本脲构成,各成分的重量配比如下:
人参45g 黄连45g 天花粉735g 杜仲135g
黄芪735g 丹参270g 枸杞子202.5g 沙苑子270g
白芍270g 知母202.5g 五味子90g 格列本脲1.05g。
一种能调节血糖、治疗糖尿病的制剂的制备方法,其具体步骤如下:
(1)取735g天花粉、135g杜仲、735g黄芪、270g丹参、202.5g枸杞子、270g沙苑子、270g白芍、202.5g知母、90g五味子加8倍量的水煎煮两次,每次2小时,放冷,过滤、合并滤液,滤液在55-65℃下浓缩至相对密度为1.08g/ml的浓缩液,浓缩液中加乙醇至含醇量为50%,混匀,静置24小时,过滤,得上清液,蒸馏乙醇,浓缩、在70℃以下减压干燥得相对密度为1.30g/ml的干浸膏,干浸膏粉碎,过80目筛,得干浸膏粉,
(2)将45g人参、45g黄连分别粉碎,过80目筛,得细粉,
(3)将干浸膏粉、人参、黄连细粉、过80目筛,加1.05g格列本脲混合均匀,混匀后,以95%乙醇作粘合剂,用14目筛制颗粒,将湿颗粒置于沸腾干燥床中,在50-60℃下恒温,干燥至颗粒含水量为4-5%,取出,颗粒中加入其重量1%的滑石粉及0.5%的硬脂酸镁,混合均匀,压片,将片置于高效包衣锅内,取薄膜包衣材料,用95%乙醇作为溶剂,溶胀均匀,过胶体磨研磨2次后,按4%比例喷入包衣液,干燥冷却1小时后,取出得产品。
本发明配方合理,方中人参(为生晒参)、黄芪、枸杞子、五味子、白芍益气养阴,既改善气阴两虚症状,又能降血糖,且能增加机体免疫功能;杜仲、沙苑子补益肝肾、消渴,治其本;佐以黄连、知母、天花粉、白芍清热泻火、滋阴生津;丹参活血化瘀、抑制血小板凝聚,改善微循环寓通于补,配小剂量优降糖,降低血糖,以加强降低血糖的疗效;知母主消渴热中,除邪气而降糖;黄芪益气,有直接改善红细胞变形性的功效;黄连具有促进糖酵解产生的降糖作用,还可以降血脂;枸杞养阴生津,止消渴,其有效成分胍类可导致血糖显著而持久性下降。再加上格列本脲,中西药融为一体,取长补短,最大限度发挥了中药的作用,以期获得近期和远期疗效,如此标本兼治、寓通于补,泻而不伤正,补而不滞。
本制剂将中、西药有效结合,中、西药协同作用,能显著降低患者血糖、尿糖及糖化血红蛋白,改善糖尿病患者的脂代谢紊乱,改善其气血两虚症状,用药安全,无明显毒副作用,是治疗II型糖尿病气阴两虚症的安全有效的药物。本发明制备工艺可行,简单稳定。
具体实施方式 本制剂由人参、黄连、天花粉、杜仲、黄芪、丹参、枸杞子、沙苑子、白芍、知母、格列本脲等配制而成。制备工艺是先将天花粉、杜仲、黄芪等9味药经煎煮、提取、浓缩、乙醇沉淀、过滤得上清液,上清液回收乙醇、浓缩、干燥为干浸膏,干浸膏粉碎得干浸膏粉。人参、黄连粉碎,过筛与干浸膏粉、格列本脲混合,加成型助剂得产品。
本发明按下述方法制备片剂:干浸膏粉、人参、黄连细粉、格列本脲混匀后,以95%乙醇作粘合剂,用14目筛制颗粒,将湿颗粒置于沸腾干燥床中,在50-60℃下恒温,干燥至颗粒含水量为4-5%,取出,颗粒中加入其重量1%的滑石粉及0.5%的硬脂酸镁,混合均匀,压片,片重0.6g/片,硬度8-10kg,将片置于高效包衣锅内,取薄膜包衣材料,用95%乙醇作为溶剂,溶胀均匀,过胶体磨研磨2次后,按4%比例喷入包衣液,干燥冷却1小时后,取出得产品。
本申请人在制备方法上作了大量工作,片剂处方中九味药材所含成分大多数都溶于水和稀醇中,因而对方中九味药材均可以采用水提,对水提中的杂质采用乙醇沉降减少杂质含量,从而达到减少服用剂量的目的。水提取时,将天花粉等九味加水煎煮由一次改为二次,每次2小时,所得提取液,浓缩后醇沉,提取醇溶物,以期精制浸膏;干燥、制粒后压片;包薄膜衣,以提高药物稳定性。
本申请人作了正丁醇醇沉工艺试验,最终确定滤液浓缩至相对密度约1.08,醇沉程度为50%,沉降时间为12小时。
作了干燥过程试验,最终选择60℃-70℃下减压干燥,既周期短,又对正丁醇提取物无影响,效果较为理想。
本发明生产的片剂与胶囊比较有以下优点:
1、有效成份增加,片剂正丁醇提取物为0.048g/片,而胶囊为0.03g/粒,片剂有效成分含量比胶囊剂更高;
2、服用剂量小,一片相当于胶囊1.5粒,可以减少服用量;
3、稳定性好,片剂采用防潮薄膜包衣,能有效提高药物稳定性,将片剂与胶囊剂未包装,放置于75%湿度,37℃温度条件下一周后,片剂未见吸潮,胶囊剂内容物已明显吸潮。
4、质量提高:片剂增加了完善人参、黄连的药疗鉴别,增加了黄芪的药疗鉴别,增加芍药和格列本脲的含量和限量测定,质量标准大幅度提高;
5、疗效提高:通过国家指定的临床机构的临床研究,增加新工艺制剂,较原制剂疗效提高。
急毒:小鼠一日口服给药85g/kg(以中药生药计),对小鼠行为、体重无明显影响,连续观察七天,无一例死亡,表明本制剂LD50在85g/kg以上。
长毒:SD大鼠80只,随机分成高、中、低和生理盐水对照组,分别按9.6g/kg(以中药生药计,以下同)、4.8g/kg、2.4g/kg灌胃给药,观察大鼠实验期的一般表现,观察结果表明:
1、对大鼠行为、饮食、大小便、毛发、生长、体重均无明显影响,
2、对血常规无不良影响,用药组RBC、Hb、WBC+DC等指标与对照组无差异,
3、对血液生化无不良影响,用药组ALT、AST、T-BIL、TP、ALB、AKP、GLU、BUN、Grea、CH等指标与对照组之间无差异,
4、对大鼠心、肝、脾、肺、肾、肾上腺、睾丸、卵巢等组织器官脏器系数无影响,但用药组胸腺脏器系数明显提高,说明能提高机体免疫功能;
5、对大鼠各内脏形态结构,显微组织无不良影响。
结果证实本药剂在9.6g/kg范围内安全无毒,可供临床使用。
二、作了药效学证实,本片剂各剂量均有明显降低化学性糖尿病模型(四氧嘧啶造膜)大鼠血糖和血清胆固醇的作用,在0.69-2.47g/kg(以所含中药生药计)剂量范围内,对正常大鼠的血糖无明显影响。用药组血糖是下降趋势,但在正常范围内,与对照组比较差异不显著(P>0.05);本片剂对环磷酰胺导致小鼠免疫抑制有拮抗作用,使免疫功能抑制小鼠对绵羊红细胞致特异性抗体生成有一定促进作用,并能显著增加免疫功能抑制小鼠的E玫瑰花结的形成。
三、由湖北中医学院附属医院负责,湖北省中医药研究院附属医院、武汉市大学同仁医院参与,采用单盲随机对照,用片剂共治疗II型糖尿病气阴两虚症患者160例,其中用本制剂试验组60例,用已有的本药剂的胶囊对照组60例,用本片剂剂实验组60例,开放组40例。
1、总有效率见下表:
表1
组别 | 例数n | 显效 | 有效 | 无效 | 总有效率 |
n (%) | n (%) | n (%) | n (%) | ||
试验组 | 60 | 24 40.0 | 28 46.7 | 8 13.3 | 52 86.7 |
对照组 | 60 | 24 40.0 | 25 41.7 | 11 18.3 | 49 81.7 |
开放组 | 40 | 16 40.0 | 16 40.0 | 8 20.0 | 32 80.0 |
2、中医证候比较:实验组、对照组、开放组自身治疗前比较有非常显著的差异(p>0.01),实验组对各中医证候的改善优于对照组,组间下降分值比较,口渴喜饮、倦怠乏力有显著差异(p>0.01);
3、实验组、对照组、开放组对改善空腹血糖、餐后2小时血糖、24小时血糖定量方面有非常显著的差异(p>0.01),治疗后的结果优于治疗前,实验组的下降幅度大于对照组,空腹血糖水平下降差值比较有显著差异(p>0.05);
4、实验组和对照组均有降低糖化血红蛋白含量得作用,治疗前后有显著差异(p>0.05),两组间比较无差异,下降的差值比较亦无差异,
5、实验组有降低胆固醇和甘油三脂的作用,但只有胆固醇有非常显著性差异(p>0.01),与对照组比较有显著差异(p>0.05),实验组优于对照组,开放组降低胆固醇和甘油三脂的作用治疗前后比较有显著差异(p>0.05);
6、实验组、对照组、开放组对患者血尿常规、肝肾功能及心电图无不良影象;
7、实验过程中,实验组用本片剂未发现不良反应。
证实:本片剂在目前的口服剂量范围、疗程范围内,用药安全、无明显毒副作用,是一种治疗II型糖尿病气阴两虚证安全有效的药物。
Claims (2)
1、一种能调节血糖、治疗糖尿病的制剂的制备方法,其特征在于其具体步骤如下:
(1)取735g天花粉、135g杜仲、735g黄芪、270g丹参、202.5g枸杞子、270g沙苑子、270g白芍、202.5g知母、90g五味子加8倍量的水煎煮两次,每次2小时,放冷,过滤、合并滤液,滤液在55-65℃下浓缩至相对密度为1.08g/ml的浓缩液,浓缩液中加乙醇至含醇量为50%,混匀,静置24小时,过滤,得上清液,蒸馏乙醇,浓缩、在70℃以下减压干燥得相对密度为1.30g/ml的干浸膏,干浸膏粉碎,过80目筛,得干浸膏粉,
(2)将45g人参、45g黄连分别粉碎,过80目筛,得细粉,
(3)将干浸膏粉、人参、黄连细粉、过80目筛,加1.05g格列本脲混合均匀,混匀后,以95%乙醇作粘合剂,用14目筛制颗粒,将湿颗粒置于沸腾干燥床中,在50-60℃下恒温,干燥至颗粒含水量为4-5%,取出,颗粒中加入其重量1%的滑石粉及0.5%的硬脂酸镁,混合均匀,压片,将片置于高效包衣锅内,取薄膜包衣材料,用95%乙醇作为溶剂,溶胀均匀,过胶体磨研磨2次后,按4%比例喷入包衣液,干燥冷却1小时后,取出得产品。
2、根据权利要求1所述的一种能调节血糖、治疗糖尿病的制剂的制备方法,其特征在于压片的片重0.6g/片,硬度8-10kg。
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