CN1301738C - 治疗糖尿病的中药口服制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种治疗糖尿病的中药口服制剂及其制备方法。其主要特征在于：以金线莲水提物为主要原料，可配以葛根、黄连素，经提取、浓缩、制粒、烘干、装胶囊或压片等工序而制成成品。本发明配方简单、便于制造、治疗多种糖尿病效果好，还有利于防治糖尿病并发症，而且治疗过程无不良反应，具有良好的开发前景。
Description
本发明涉及一种治疗糖尿病的中药口服制剂及其制备方法。其系兰科植物金线莲、毛莨科植物黄连或黄连素与豆科植物葛根，经冷、热提取水溶性、醇溶性浸膏或原生药粉制成口服制剂。
目前用于治疗糖尿病伴高血脂的药物是胰岛素系列及一些口服降血糖药。胰岛素的主要缺陷是必须注射、价贵、有过敏反应等缺点，此外，尚有耐受性发生等不足，对于必须终生给药的糖尿病患者而言，上述四点缺陷大大限制了胰岛素的应用。而目前所用的口服降血糖药的缺点是降血糖作用不显著及没有降血脂作用和抑制非酶糖基化作用对糖尿病的并发症往往往无特殊疗效且付作用较大，有的还可导致酸中毒等严重不良反应。
本发明的目的就是提供一种经济，无副作用，具有降糖，降血肢功用并对治疗多种糖尿病并发症有效的中药口服制剂及其制备方法。
本发明的特征在于：以金线莲水提物为主要原料，配以黄连素、葛根，经提取、制剂、分装等工艺而制成成品。
本发明的生产工艺有三种实施方案：(1)原料由金线莲水提物和黄连的生物碱提取物组成，原料各组分的重量配比为：金线莲30-40％，黄连60-70％；制备时，可先将原料置多能提取罐中，加入溶媒提取二次，每次1-3小时，过滤得提取液，真空浓缩得到浸膏；配制成口服液；或再用制粒机制粒，经烘干、填充胶囊或压片、包装得到成品；(2)原料由金线莲水提物和黄连素组成，原料各组分的重量配比为：金线莲80-90％，黄连素10-20％；制备时先将金线莲置多能提取罐中，加入水煮提取二次，每次1-3小时，过滤得水提取液，真空浓缩得到浸膏备用；再将黄连素加入到上述所得的浸膏中混匀，混匀后配制、分装成口服液或用制粒机制粒，经烘干、填充胶囊或压片、包装得到成品；(3)原料由金线莲水提物，黄连素和葛根的水提物、醇提物或原生药粉组成，原料各组分的重量配比为：金线莲45-46％，葛根45-46％，黄连素8-10％；制备时可先取配方中的部分葛根用乙醇提取，经回收乙醇后得浸膏备用，再将提取后的葛根渣与金线莲一起用水提取，经去渣浓缩后得浸膏备用，最后将上述所得的两种浸膏与其余葛根粉和黄连素一起制粒，经烘干、装胶囊或压片等工序后制成成品。
本发明所用原料中，金线莲又名金线兰、乌人参、金线石松，单用对高糖性糖尿病模型、肾上腺素糖尿病模型、四氧嘧啶性糖尿病模型以及链脲霉素性糖尿病模型等实验性糖尿病动物均有良好的降血糖作用，其机理可能与该药保护胰岛β细胞完整性及促进β细胞释放胰岛素等有关，它抗糖尿病的有效成份主要存在于多糖类水溶性部份。葛根具有解热、降血压等作用，其有效成份是以葛根素为指标的极性部份。黄连和黄连素有明显的解热、抗菌、抗病毒、抗原虫作用，黄连的成份小檗碱有降低血糖、抗炎等作用。经福建医科大学药理教研室、福建医科大学糖尿病研究室实验表明，将金线莲与葛根、黄连配制成的这种复方组合物对上述四种糖尿病模型动物具有降血糖、降血脂作用(降低甘油三酯的作用更显著)，和抑制蛋白非酶糖基化作用，有利于阻抑糖尿病时眼和神经等组织发生并发症，其作用机理与该组合物药具有改善机体代谢、抑制过氧化损伤、保护机体组织等作用有关。
本发明的优点在于：配方简单，能治疗多种糖尿病，既能降血糖，又能降血脂，还能抑制蛋白非酶糖基化作用，有利于防治糖尿病并发症。经临床试验，有效率超过80％，而且治疗过程无不良反应。
本发明的实施例如下：
实施例一：原料的重量配比为：金线莲30-40％，黄连60-70％。制备方法：将金线莲和黄连一起加入到多能提取罐中，加溶媒提取二次，每次1-3小时，过滤得提取液，用真空浓缩锅浓缩得到浸膏；配制、分装成口服液或用制粒机制粒，经烘干、填充胶囊或压片、包装得到成品。
实施例二：原料的重量配比为：金线莲80-90％，黄连素10-20％。制备方法：将金线莲加入到多能提取罐中，加水煮提取二次，每次1-3小时，过滤得水提取液，用真空浓缩锅浓缩得到浸膏备用；将黄连素加入到上述所得的浸膏中混匀，混匀后配制、分装成口服液或用制粒机制粒；经烘干、填充胶囊或压片、包装得到成品。
实施例三：原料的重量配比为：金线莲45-46％，葛根45-46％，黄连素8-10％。制备方法：先取22-46％的葛根置多能提取罐中，用几种不同浓度的乙醇(重量百分比为5-95％)加热回流提取1-2小时，或浸渍渗滤，经过滤得到乙醇提取液，回收乙醇后得到浸膏备用；再将金线莲加入多能提取罐与葛根渣一起用水煮提取二次，每次1-3小时，过滤得水提取液，用真空浓缩锅浓缩得到浸膏备用；最后将所剩0-23％葛根磨成粉，与黄连素一起加入到上述所得的两种浸膏中混匀，混匀后用制粒机制粒，经烘干、填充胶囊或压片、包装得到成品。经福建中医药研究院临床研究基地实验表明，本产品治疗糖尿病患者既有降低血糖作用，又有降低血脂作用，有效率达50-90％，而且降血脂作用优于降血糖作用，而在降血脂作用中，降低血清甘油三酯的作用优于降胆固醇作用；试验用药期未见不良反应。
本发明配方简单、便于制造、治疗多种糖尿病效果好，还有利于防治糖尿病并发症，而且治疗过程无不良反应，具有良好的开发前景。
Claims (4)
1.一种治疗糖尿病的中药口服制剂的制备方法，其特征在于：按重量配比计，制成有效成分的原料为：金线莲80-90％、黄连素10-20％，将金线莲加入多能提取罐中，加水煮提取两次，每次1-3小时，过滤得水提取液，真空浓缩得浸膏，备用，再将黄连素加入到上述浸膏中，混匀后配置、分装成口服液或用制粒机制粒，经烘干、填充胶囊或压片、包装后得到成品。
2.一种治疗糖尿病的中药口服制剂的制备方法，其特征在于：按重量配比计，制成有效成分的原料为：葛根45-46％，金线莲45-46％，黄连素8-10％，将22-46％的葛根用乙醇提取，过滤得到乙醇的提取液，回收乙醇后得浸膏备用，再将提取后的葛根渣与金线莲一起用水提取，经去渣浓缩后得浸膏备用，最后将上述所得的两种浸膏与其余0-23％的葛根粉和黄连素一起制粒，经烘干、填充胶囊或压片、包装后得到成品。
3.根据权利要求2所述的治疗糖尿病的中药口服制剂的制备方法，其特征在于：其中乙醇提取为加热回流提取1-2小时或浸渍渗滤。
4.根据权利要求2或3所述的治疗糖尿病的中药口服制剂的制备方法，其特征在于：其中用水提取为水煮提取两次，每次1-3小时。
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| CN1108952A (zh) * | 1994-12-23 | 1995-09-27 | 李强 | 消渴灵胶囊 |
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