CN1090488C - 一种治疗糖尿病的药物及制备工艺 - Google Patents
一种治疗糖尿病的药物及制备工艺 Download PDFInfo
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- CN1090488C CN1090488C CN00109182A CN00109182A CN1090488C CN 1090488 C CN1090488 C CN 1090488C CN 00109182 A CN00109182 A CN 00109182A CN 00109182 A CN00109182 A CN 00109182A CN 1090488 C CN1090488 C CN 1090488C
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Abstract
本发明涉及一种治疗糖尿病的药物及制备工艺，它由黄连、苦瓜、僵蚕、珍珠粉、人参组成，经生药成分的提取，混合，熔融，冷却，粉碎，装囊而成。它的降糖效果准确，快速，持久，无反弹现象，无耐药现象，它同时对胰岛细胞具有修复作用，此药批量制备生产成本低，可以相对降低患者经济负担。
Description
本发明涉及一种治疗糖尿病的药物及制备工艺，具体的说是涉及一种由多种中药配制而成的，对糖尿病有明显治疗作用的中药药物及制备工艺。
目前，糖尿病作为一种内分泌障碍疾病。全世界有病患1.2亿人，占世界人口的2％强，美国发病率为4-6％，中国有2000万，北京发病率3％，随着人们生活水平的提高，糖尿病发病率呈递增趋势。研究表明糖尿病是由于遗传和环境因子的相互作用所造成的一个综合症。引起糖尿病的病因很复杂，肥胖，遗传，自身免疫病，内分泌病，病毒感染，药物(如皮质激素，甲状腺素，噻嗪类，利尿剂)等，都是可能引起糖尿病的病因。糖尿病的病理生理改变是由于胰岛素相对或绝对不足引起糖、脂肪、蛋白质和继发水、电代谢紊乱。临床上出现三多(多食，多饮，多尿)体重下降，高血糖，严重时可引发酮症酸中毒。并常伴有，急性感染，肾和视网膜血管病变，神经病变，动脉粥样硬化等并发症。目前糖尿病作为一种慢性疾病，给患者带来极大的痛苦，甚至导致生命危险。比较非糖尿病人，糖尿病患者下肢坏死为5倍，尿毒症17倍，双目失明2.5倍，心梗塞3.3倍。广大医学工作者对糖尿病坚持不懈的研究下，从猪牛胰岛素的提取，到胰岛素基因密码的破译，人工胰岛素的合成，对糖尿病的治疗诊断有了一定发展，另外，口服降糖药物目前临床主要使用有磺酰脲类，双胍类及糖苷酶抑制剂等三类降糖药物。但是，目前为止糖尿病作为一种慢性病还没有一种特效药可以根治。而且，这些药物不可避免的产生：耐药性，过敏反应，注射部位脂肪萎缩，组织氧化抑制，酮症，乳酸中毒，胃肠反应，等等副作用。至于，临床应用的方药大都加杂西药降糖药，疗效不确定，一些降糖类中药拘泥于古法，缺乏科学的对比实验及毒性、副作用的观察，而且，成本高，使患者经济负担过重。故，对于治疗糖尿病的更安全，更有效，更持久的药物的产生已经成为广大病患迫切的呼声。
本发明的目的在于提供一种由全中药配制而成的，对糖尿病有明显治疗作用且疗效快速，准确，持久的一种治疗糖尿病的药物及制备工艺，以弥补现有技术的不足。
本发明组成衍化自古代著名中医朱丹溪的“消渴方”。它以黄连为君，取其“大苦大寒，苦燥湿，寒胜热”之意，清热燥湿，去心火，解热毒。黄连的有效成分为黄连素(小檗碱)，实验证明小檗碱不影响胰岛素的分泌和释放，也未影响肝细胞膜胰岛素受体的数目和亲合力，故认为小檗碱的作用可能为受体后效应。实验观察到，小檗碱可以对抗注射葡萄糖引起的血糖升高，可以抑制以丙氨酸为底物的糖原异生，以及小檗碱的作用与血乳酸的升高密切相关，因而可以认为，小檗碱可能通过糖原异生促进糖酵解产生降血糖作用，临床已证明黄连的降糖效果。以人参为臣，取其大补元气，生津止渴，调和阴阳之功效，且能弥补它药的弊端，现在医学表明人参含有人参烯、人参素、人参甙、脂肪酸、维生素等。对糖尿病，主要有促进性腺激素样作用，促进性腺机能，降低血糖，与胰岛素有协同作用，影响代谢，抑制高血糖发生。实验证明，人参对实验性糖尿病有降血糖作用，抑制胰高血糖素的分泌，并使症状得到改善，对肾上腺素或高渗葡糖引起的高血糖有抑制作用，既能降低饮食性高血糖，又能升高胰岛素引起的低血糖。其降糖机理，是其促进糖原分解，抑制乳酸合成肝糖原并刺激琥珀酸脱氢酶和细胞色素氧化酶的活性，使糖的氧化作用增强。苦瓜为佐，取其苦寒之性。苦瓜有对胰脏和非胰脏两种降糖作用尤其临床上和黄连诸药合用能够相互促进功效。白僵蚕为使，其性味咸辣，有清肃降火之力，有报导，白僵蚕对胰岛素有修复功能，临床上治疗糖尿病效果良好。珍珠粉与君臣佐使相伍，取其清滑滋润，镇心安神，养阴息风，以辅诸药。珍珠粉含有碳酸钙，无机元素，有机角壳蛋白和多种氨基酸，有利诸药调和。
本发明的目的是这样实现的：它由黄连、苦瓜、僵蚕、珍珠粉、人参组成，经生药成分的提取，混合，熔融，冷却，粉碎，装囊而成，其特征在于它是由下述重量份的中药提取制备而成的一种治疗糖尿病的药物及制备工艺；黄连 100-280份 苦瓜 300-720份僵蚕 100-280份 珍珠粉 1-2.8份人参 100-280份。
将选出的生药，黄连、苦瓜、人参、僵蚕分别提取得到黄连素(盐酸小檗碱)、苦瓜素、人参皂甙及白僵蚕总有机酸几种有效成分，连同珍珠粉一起混匀后，即可制备出一种治疗糖尿病的药物(又名“龙公降糖胶囊”)。一种治疗糖尿病的药物的制备工艺，其特征在于按下列方法制备：
①黄连素即盐酸小檗碱的制备；将黄连根粉碎，过20目筛，称取适量，用二倍体积的乙醇液60℃浸泡一小时，取乙醇浸出液浓缩至原体积的1/5放置过滤，滤液加浓盐酸适量，沉淀，放置过夜，取黄色沉淀，用水重结晶三次，得盐酸小檗碱，
②苦瓜素的制备；将苦瓜适量洗净，用破碎机破碎，打成匀浆，在-20℃放置过夜，再自然融化，重复三次，离心取上清夜，超滤，取滤液减压浓缩，真空干燥，得苦瓜素，
③人参皂甙的制备：将人参粉碎，过20目筛，称取适量，用二倍体积的甲醇液水浴80℃提取，将提取液浓缩至原体积的1/5，放置，加入浓缩液体积1/5的乙醚，沉淀，将析出物溶于10-15倍体积的95％乙醇中，加入1/3量乙醚，析出沉淀，过滤，重复三次，得人参皂甙，
④白僵蚕总有机酸的制备；将白僵蚕粉碎，过20目筛，称取适量，用一倍体积的1％稀盐酸，混合搅拌均匀，放置一小时后，用一倍量体积乙醚回流提取，将提取液，用一倍量的80％NaHCO3萃取，用盐酸调萃取液约至pH＝4，析出沉淀，将沉淀干燥后，到入乙醚中充分搅拌，震摇，静置，到出上清夜，加新乙醚洗2-3次，回收乙醚液，即得白僵蚕总有机酸，
⑤取市售珍珠粉适量，
⑥将上述诸药混合均匀后，用1.5-2倍适量95％乙醇溶解，加入19倍聚乙二醇6000搅匀，水浴加热约60℃使其熔融，并蒸去乙醇，将熔融物倾入冰浴中的不锈钢盘中，使成薄层，并吹以冷气使其迅速冷却固化，置干燥器中干燥，粉碎，过100目筛，装入胶囊即得一种治疗糖尿病的药物。
本发明与现有技术相比，它处方合理、科学，有效成分纯中药提取，它的降糖效果准确，快速，持久，平均服药5-10天血糖即开始下降，到28天达稳定水平，无反弹现象，无耐药现象，它同时对胰岛细胞具有修复作用，此药采用胶囊为剂型，生物利用度高，溶解度好，利于吸收，在研制过程中的对比实验，毒性实验，副作用观察实验进行完善，另外，此药批量制备生产成本低，可以相对降低患者经济负担。
以下结合实施例进一步说明本发明
本发明的原料可以由上述5种生药组成，从而发挥更安全，更有效，更持久的降糖作用。
实施例1
①黄连素(盐酸小檗碱)的制备；将黄连根粉碎，过20目筛，称取280克，用二倍体积的乙醇液60℃浸泡一小时，取乙醇浸出液浓缩至原体积的1/5放置过滤，滤液加浓盐酸适量，沉淀，放置过夜，取黄色沉淀。用水重结晶三次，得盐酸小檗碱。
②苦瓜素的制备；将苦瓜840克洗净，用破碎机破碎，打成匀浆。在-20℃放置过夜，再自然融化，重复三次。离心取上清夜，超滤，取滤液减压浓缩，真空干燥，得苦瓜素。
③人参皂甙的制备：将人参粉碎，过20目筛，称取280克，用二倍体积的甲醇液水浴80℃提取，将提取液浓缩至原体积的1/5，放置，加入浓缩液体积1/5的乙醚，沉淀。将析出物溶于10-15倍体积的95％乙醇中，加入1/3量乙醚，析出沉淀，过滤，重复三次，得人参皂甙。
④白僵蚕总有机酸的制备；将白僵蚕粉碎，过20目筛，称取280克，用一倍体积的1％稀盐酸，混合搅拌均匀，放置一小时后，用一倍量体积乙醚回流提取，将提取液，用一倍量的80％NaHCO3萃取，用盐酸调萃取液约至pH＝4，析出沉淀，将沉淀干燥后，到入乙醚中充分搅拌，震摇，静置，到出上清夜，加新乙醚洗2-3次，回收乙醚液，即得白僵蚕总有机酸。
⑤取市售珍珠粉1-2.8克。
⑥将上述诸药混合均匀后，用1.5-2倍适量95％乙醇溶解，加入19倍聚乙二醇6000搅匀，水浴加热约60℃使其熔融，并蒸去乙醇，将熔融物倾入冰浴中的不锈钢盘中，使成薄层，并吹以冷气使其迅速冷却固化，置干燥器中干燥，粉碎，过100目筛，装入胶囊即得一种治疗糖尿病的药物，又名“龙公降糖胶囊”。
Claims (2)
1、一种治疗糖尿病的药物，它由黄连、苦瓜、僵蚕、珍珠粉、人参组成，经生药成分的提取，混合，熔融，冷却，粉碎，装囊而成，其特征在于它是由下述重量份的中药提取制备而成的一种治疗糖尿病的药物黄连 100-280份 苦瓜 300-720份僵蚕 100-280份 珍珠粉 1-2.8份人参 100-280份。
2 、一种治疗糖尿病的药物的制备工艺，其特征在于按下列方法制备：
①黄连素即盐酸小檗碱的制备；将黄连根粉碎，过20目筛，称取适量，用二倍体积的乙醇液60℃浸泡一小时，取乙醇浸出液浓缩至原体积的1/5放置过滤，滤液加浓盐酸适量，沉淀，放置过夜，取黄色沉淀，用水重结晶三次，得盐酸小檗碱，
②苦瓜素的制备；将苦瓜适量洗净，用破碎机破碎，打成匀浆，在-20℃放置过夜，再自然融化，重复三次，离心取上清夜，超滤，取滤液减压浓缩，真空干燥，得苦瓜素，
③人参皂甙的制备：将人参粉碎，过20目筛，称取适量，用二倍体积的甲醇液水浴80℃提取，将提取液浓缩至原体积的1/5，放置，加入浓缩液体积1/5的乙醚，沉淀，将析出物溶于10-15倍体积的95％乙醇中，加入1/3量乙醚，析出沉淀，过滤，重复三次，得人参皂甙，
④白僵蚕总有机酸的制备；将白僵蚕粉碎，过20目筛，称取适量，用一倍体积的1％稀盐酸，混合搅拌均匀，放置一小时后，用一倍量体积乙醚回流提取，将提取液，用一倍量的80％NaHCO3萃取，用盐酸调萃取液约至pH＝4，析出沉淀，将沉淀干燥后，到入乙醚中充分搅拌，震摇，静置，到出上清夜，加新乙醚洗2-3次，回收乙醚液，即得白僵蚕总有机酸，
⑤取市售珍珠粉适量，
⑥将上述诸药混合均匀后，用1.5-2倍适量95％乙醇溶解，加入19倍聚乙二醇6000搅匀，水浴加热约60℃使其熔融，并蒸去乙醇，将熔融物倾入冰浴中的不锈钢盘中，使成薄层，并吹以冷气使其迅速冷却固化，置干燥器中干燥，粉碎，过100目筛，装入胶囊即得一种治疗糖尿病的药物。
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