CN1939506A - 降糖降脂降压明目的制剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种降糖、降脂、降压、明目的中药制剂，配方包括人参、女贞子、枸杞子、五味子、丹参、葛根、决明子、黄精、大枣等。将上述药物混合粉碎浸水，用醇提法和多功能罐浸提，馏液与煎汤及醇提液合成制剂。再做成口服液或其它剂型。可用于防止糖尿病及并发症、高血脂、高血压、视网膜病变、心血管等疾病。本发明与现有技术相比，具有治疗保健养生综合功能；生物利用度高，达到速效、高效、稳效、安全、无毒副作用的目的。
Description
1.技术领域
本发明涉及一种降血糖、降血脂、降血压、明目的制剂，具体地说是以“药食同源”的中草药为原料制备的物品。本发明还涉及该物品的制备方法。
2.背景技术
高血糖、高血脂、高血压称“三高症”，常并发视网膜病变。研究表明，患者由于血液中胰岛素相对或绝对缺乏，引起糖、脂肪、蛋白质代谢紊乱，血压异常，导致动脉粥样硬化及微循环障碍，血流动力学改变，纤溶系统及血小板功能异常聚集，血瘀滞留。中医药保健理论认为主要由气虚、阴虚所致，属于“浊阴”、“痰湿”“湿热”等范畴，两虚所致的血瘀可阻滞气机，津液失于输布，络脉瘀阻(小血管、神经病变)，所以出现多种并发症。
目前国内外对本病药物治疗，遇到了以下技术难题：
①西药类(如他汀类、双肌类、碘脲类、胰岛素等)效果好，但副作用大，久用损害肝脏、肾脏及血细胞，对并发症无效。
②中成药类作用缓慢，效果不十分明显。
③视网膜病变目前缺乏有效的治疗药物。
3.发明内容：
本发明的目的是提供一种降血糖、降血脂、降血压、明目的制剂。
本发明的另一目的是提供该制剂的制备方法。
本发明是根据中医药学对“三高症”及其合并症发病机理的认识及治疗原则，参考现代药理研究成果及先进工艺，从“药食同源”的植物药中筛选出益气养阴、降血糖、降血脂、降血压，活血通脉、明目，能提高血液微循环流量和免疫力的药材，按中医养生保健理论组方，用现代先进工艺提取精华，使其发挥整体调节与活血通脉、提高血流量和免疫力等诸法配合，促进内源胰岛素的分泌，降低外源胰岛素外周抗力，有效调节血糖、血脂代谢紊乱的同时，改善微循环，降低血压、缓解视网膜病变。
本发明物品是由下列组分制成的(用量为重量)：
人参10-30份 女贞子15-25份 枸杞子10-25份
五味子10-20份 丹参10-20份 葛根20-30份
决明子20-35份 黄精10-30份 大枣10-25份
制备本发明物品的配方优选重量配比范围是：
人参3-10份 女贞子6-20份 枸杞子6-15份
五味子1.5-10份 丹参5-15份 葛根9-25份
决明子8-15份 黄精9-25份 大枣6-15份
本发明物品的最佳重量配比是：
人 参5份 女贞子10份 枸杞子8份
五味子3份 丹 参12份 葛 根10份
决明子15份 黄 精11份 大 枣6份
将上述各组分制成本发明物品的生产方法是：
①将人参、女贞子、丹参按上述配方药材混合粉碎，制成粗粉，使能通过1号筛或2号筛，用乙醇回流提取，滤过，醇提液用聚山梨脂80增溶备用，药渣分别保存。
②将枸杞子、五味子、决明子、葛根、黄精、大枣、按上述配方药材混合粉碎成最粗粉，加上述药渣(醇提后的)用多功能罐水煎，按常规方法提取挥发油和药液。
③将水煎药液用酶技术澄清，浓缩，滤过。
④将挥发油用β-CD包合处理；
⑤将醇提液、挥发油、包合物水煎药液配合后加辅料(增溶剂、防腐剂、抗氧剂)得到配液；
⑥按常规方法把配液再制成中成药剂型，如硬胶囊、软胶囊、片剂、颗粒剂、散剂、丸剂、袋泡茶、药酒、口服液、(保健品)、露剂、注射剂等；也可与营养物品混合制成保健食品。
本发明的一个重要特点是药剂中含有萜烯类和黄酮类成份，还含有总皂苷、粗多糖、齐墩果酸，萜烯类总含量0.5％-1.0％，黄酮类总含量0.9％-1.8％。其中萜烯类成份有很好的降血糖降胆固醇作用。所含黄酮类化合物具有很强的抗氧化能力，能软化血管、降低血管脆性，改善微循环，可以降低过高的血脂、血压、防治血管硬化。总皂苷黄酮类化合物具有显著降血糖效果，能增加胰岛血流灌注，有利于胰岛素的合成与分泌；对血小板聚集及血栓形成有很好的抑制作用，可以活血化瘀、清理血管、促进血液循环、提高血流量；粗多糖有很强的抗衰老、增强人体免疫力的作用。所含齐墩果酸能有效降低谷转氨酶。
本发明药物临床使用结果表明，有下述优点：
(1)本发明选用天然食用植物为原料，各组分符合药品食品法规定。利用组方药物的综合作用防治糖尿病、高血脂、高血压及并发症，对人体无毒、无害，也可以作为保健食品使用。
(2)选用醇提法和使用多功能提取灌提取有效成份，生物利用度高，达到速效、高效的目的。
(3)含有齐墩果酸，对肝有保护作用，这是本处方的特点。
为表明本发明对降脂、降血糖作用效果，经100例系统临床观察，并选择病史、病情、年龄、性别及原治疗方法相当的糖尿病及高血脂患者50例为对照组。从住院及内分泌专科门诊选择病例，按WHO1980年制定的糖尿病诊断标准，确诊的成年糖尿病患者，在饮食治疗法及药物(口服降糖药及胰岛素)治疗的基础上，空腹血糖7.2mmol/L者为观察对象，其中男48例，女52例，年龄27-50岁，病程半年至20年。试验组，在原治疗基础上，停用降脂药，服本发明药物。对照组：按常规降糖、降脂治疗，其中降糖药物、品种服法用量与试验组相匹配，降脂药采用进口利平脂。采用相同方法定期检查空腹血糖及血脂，观察期二个月，30天为一疗程。
服用方法：本发明口服液20ml/一次，日服3次，饭前开水冲服。临床试验结果如附表1-2。
附表1服用本发明药物前后胰岛素，达美康用呈及血糖变化
| 病例数 | 胰岛素用量(U/d) | 达美康用量(mg/d) | 空腹血糖下降(mmol/L) | |||
| 前 | 后 | 前 | 后 | 前 | 后 | |
| 试验组100对照组50TP | 46.245.890.28＞0.05 | 20.5949.1810.87＜0.01 | 2602400.26＞0.05 | 602808.75＜0.01 | 11.7±3.6911.37±3.180.54＞0.05 | 7.55±2.329.78±3.012.46＜0.01 |
附表2服用本发明药物前后降脂药用量及血脂平均浓度变化
| 病例数 | 利平脂用量(U/d) | 血清胆固醇平均值(mg/d) | 血清甘油平均值(mmol/L) | |||
| 前 | 后 | 前 | 后 | 前 | 后 | |
| 试验组100 | 0 | 0 | 5.77±1.10 | 4.52±0.82 | 2.12±1.07 | 1.34±0.53 |
| 对照组50TP | 300 | 300 | 5.87±1.060.84＞0.05 | 5.13±0.974.32＞0.01 | 2.08±0.930.76＞0.05 | 2.51±0.323.55＞0.05 |
从附表1可以看出，两组试验前空腹血糖浓度和降糖药物用量基本相似，P＜0.05，试验组服用本发明后血糖下降，降糖药用量却比原来减少1/3-1/2。
附表2数据表明，两组试验前血清胆固醇及甘油三脂平均浓度无显著差异；但试验组用本发明物品后，未使用任何其他降脂药，即可达到降脂目的。试验统计表明：用本发明的制剂对100名糖尿病及高血脂患者作治疗试验，取得显著疗效的占53％，基本有效的占42％，无效的占5％，总有效率达95％。为表明本发明对降血压功能的作用效果，经100人血压偏高者试用观察，按国家食品药品监管局保健食品功能评价方法进行。服用方法：用本发明口服液20ml/次，日服3次，饭前开水冲服。试验结果如附表3。
附表3
| 病例数 | 收缩压平均值(mmHg) | 舒张压平均值(mmHg) | ||
| 前 | 后 | 前 | 后 | |
| 试验组100 | 140±20 | 120±20 | 90±10 | 80±10 |
从附表3可以看出，收缩压平均下降≥20mmHg，舒张压平均下降≥10mmHg，或降至正常。总有效率为93％。
4.具体实施方式
实施例：按下述配比称取原料
人 参5g 女贞子10g 枸杞子8g
五味子3g 葛 根10g 决明子15g
丹 参12g 黄 精11g 大 枣6g
生产方法如说明书附图所示：
先将人参、丹参、女贞子按上述配方混合粉碎，制成能通过1号或2号筛的粗粉，用75％乙醇(8倍量)回流提取2次，滤过，醇提液用0.2的聚山梨脂80增溶备用，药渣分别保存；再将枸杞子、五味子、决明子、葛根、黄精、大枣按上述配方混合粉碎成粗粉；将粗粉加2倍水浸泡1小时，再加入醇提后的药渣，用“多功能提取罐”水煎2次，每次8倍水，按常规方法提取挥发油和药液，将药液用酶技术澄清后，用高速离心法使煎汤纯化；将药液浓缩达到每次每人服用量20ml浓度；配液：将浓缩液、挥发油(β-CD包合)、增溶后的醇提液混合添加适宜的防腐剂、抗氧剂、矫味剂和增溶剂；把配制好的药液及时灌装于无菌的洁净干燥易拉盖瓶中(10ml/支)，加盖闭塞，100℃流通蒸汽灭菌30min。制得口服液。
Claims (6)
1.一种降血糖、降血脂、降血压、明目的制剂，其特征在于它是由下述重量配比的原料制成的。
人参10-30份 女贞子15-25份 枸杞子10-25份
五味子10-20份 丹参10-20份 葛根20-30份
决明子20-35份 黄精10-30份 大枣10-25份。
2.根据权利要求1.所述的制剂，其中各原料的重量配比是：
人参3-10份 女贞子6-20份 枸杞子6-15份
五味子1.5-10份 丹参5-15份 葛根9-25份
决明子8-15份 黄精9-25份 大枣6-15份。
3.根据权利要求1.所述的制剂，其中各原料的重量配比是：
人参5份 女贞子10份 枸杞子8份
五味子3份 丹参12份 葛根10份
决明子15份 黄精11份 大枣6份。
4.根据权利要求1.、2.或3.所述的制剂，其特征在于所说的制剂是任何一种药剂学上所述说的剂型。
5.根据权利要求4.所述的制剂，其特征在于所说的制剂可加工成保健食品。
6.权利要求4.或5.，所述的药物的制备方法，其特征在于取人参、女贞子、丹参按配方比例混合粉碎制成粗粉，用乙醇回流提取、滤过，醇提液与药渣分别保存；取枸杞子、五味子、葛根、决明子、黄精、大枣混合粉碎至粗粉，加入醇提后的药渣，再用“多功能提取罐”水煎，按常规方法提取挥发油和药液(浓缩)并把药液用酶技术澄清；再把醇提液(增溶)、挥发油(包合)、水煎药液混合滤过后加辅料，按常规制剂方法制备成所需的剂型。
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| CN104277958A (zh) * | 2014-10-30 | 2015-01-14 | 范鹏琳 | 一种降血糖的保健酒 |
| CN104524138A (zh) * | 2014-12-19 | 2015-04-22 | 刘鹏捷 | 一种治疗高血压的中药组合物 |
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| CN104277958A (zh) * | 2014-10-30 | 2015-01-14 | 范鹏琳 | 一种降血糖的保健酒 |
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| CN104720044A (zh) * | 2015-04-13 | 2015-06-24 | 高德龙 | 一种益眼保健梨汁饮料 |
| CN105250494A (zh) * | 2015-10-30 | 2016-01-20 | 华北理工大学 | 一种改善糖代谢中药配方及制备工艺 |
| CN105876550A (zh) * | 2016-05-13 | 2016-08-24 | 何家英 | 一种糖尿病患者饮用固体饮料 |
| CN112057549A (zh) * | 2020-04-04 | 2020-12-11 | 杨京润 | 降糖降脂抗病毒的制剂及其制备方法 |
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