CN105943640A - 一种治疗心肌缺血的中药自微乳速释滴丸及制备方法 - Google Patents
一种治疗心肌缺血的中药自微乳速释滴丸及制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗心肌缺血的中药自微乳速释滴丸及制备方法，该速释滴丸是通过提取黄芪、赤芍、红景天、红花中的有效药物成分，制得中药提取物；然后将中药提取物与二乙二醇单乙基醚、单亚油酸甘油酯和聚氧乙烯蓖麻油EL混合搅拌均匀后与调配液混合制得自微乳液，最后均质而成，本发明具有便于携带、易于保存、使用方便、载药量高、快速释药、生物利用度高的显著优势。
Description
技术领域
本发明涉及一种药物及其制备方法，尤其涉及一种治疗心肌缺血的中药自微乳速释滴丸及制备方法，属医药技术领域。
背景技术
心肌缺血是指各种原因引起冠状动脉血流量降低，心肌供氧量减少，心肌能量代谢不正常，致使心脏不能正常工作的临床状态。目前用于治疗心肌缺血的西药主要为硝酸酯类化合物，β受体阻滞剂及钙拮抗剂等，但是，这些药物仅能用于缓解症状，难以彻底治愈；用于治疗心肌缺血的中成药则主要包括丹参片、速效救心丸、冠脉宁片、血栓心脉宁片、冠心胶囊、复方丹参片、复方丹参滴丸、麝香保心丸、地奥心血康、冠脉宁、通心络、诺迪康(红景天)和银杏叶制剂等。但是，由于缺血性心脑血管疾病的发病人数众多，发病机理多种多样，现有药物仍不能满足临床的需要，因而需要发明一种高效低毒治疗药物以满足临床医生和患者的需要。本发明对中医药的发展具有十分重要的临床意义。
药物的自微乳化是将药物成分(特别是难溶性药物成分)制成均一的液体，在胃肠道环境中可自发形成粒径在微米级以下的微乳，能够提高药物的吸收速度和生物利用度。但是，自微乳药物通常为液体，稳定性差，在临床使用时会带来不便。将自微乳药物固体化，是现今制药领域的研究热点。滴丸是一类临床常用的药物剂型，常以固体或液体药物与一定成分的基质熔融混匀后，滴入相反极性的液体中冷凝成丸。由于滴丸的制备过程，其本质是利用固体分散体原理将药物制成小丸的形式。因此，滴丸充分发挥了固体分散体增溶、速释的特点，常作为急救药物制剂的剂型选择之一。同时，滴丸具有承载药物含量高、便于携带、简单易用等特点，常被用作家庭急救药物的首选制剂，如复方丹参滴丸、银杏酮酯滴丸等。本发明具有便于携带、易于保存、使用方便、载药量高、快速释药、生物利用度高的显著优势。即便是在患者中毒较深无法口服药片、汤药的情况下，滴丸亦可通过舌下含服吸收起效。
发明内容
本发明的目的在于克服现有技术的不足，提供了一种治疗心肌缺血的中药自微乳速释滴丸及制备方法，以解决现有药物价格高昂、保存条件严苛、载药量低、难以随身携带备用的技术问题而提出的。
本发明是通过以下技术方案实现的：
本发明公开了一种治疗心肌缺血的中药自微乳速释滴丸及制备方法，包括以下制备步骤：
1、中药提取物的制备：
1)、称取中药黄芪150～250g、赤芍100～200g、红景天80～150g、红花80～150g，混合粉碎后，加入3～5倍药物重量的浓度为65～80％的乙醇溶液，并在常温下浸泡3～5天，过滤去渣得醇提液；
2)、将过滤饼放入容器中，加入2～4倍重量的纯净水，加热煮沸2～3小时，冷却后过滤去渣得水提液；
3)、将醇提液、水提液合并，减压旋转加热蒸发，浓缩至含水量在5～10％粘稠膏状物，得中药提取物；
2、中药自微乳制备：
1)、将制得的中药提取物加入50～200ml的二乙二醇单乙基醚中，超声分散溶解。
2)、称取单亚油酸甘油酯20～25g、聚氧乙烯蓖麻油EL15～20g与上述含药的二乙二醇单乙基醚溶液混合，超声分散后，以500～1000rpm的转速搅拌25～30min，得中药自微乳液。
3、中药自微乳滴丸制备：
以2～3倍质量(400～600g)的聚乙二醇-6000/聚乙二醇-4000(质量比1：1)与上述中药自微乳液混合，搅拌均匀并水浴加热至60～80℃保温，使用滴丸锅以每分钟30～60滴的速度，于10～20cm高度滴入2～8℃的液体石蜡中，收集冷凝筒底部的成型固体滴丸，整粒后即得治疗心肌缺血中药自微乳速释滴丸。
将上述配方以现代工艺提取并制得自微乳速释滴丸，是将复方中药提取有效成分，并将其制成自微乳，提高了单位药物的载药量和难溶性成分的含量，再通过滴丸的形式将中药自微乳固化，制成自微乳速释滴丸，本发明具有载药量高、快速释药等优势，为治疗心肌缺血提供了一种中药自微乳速释滴丸新中药剂型，是一种治疗心肌缺血的理想剂型。
具体实施方式
下面对本发明的实施例作详细说明，本实施例在以本发明技术方案为前提下进行实施，给出了详细的实施方式和具体的操作过程，但本发明的保护范围不限于下述的实施例。
实施例1
本发明公开了一种治疗心肌缺血的中药自微乳速释滴丸及制备方法，制备方法如下：
1)称取中药黄芪150g、赤芍100g、红景天80g和红花80g，混合粉碎后，加入1200g浓度为65％的乙醇溶液在常温下浸泡3天，过滤去渣得醇提液Ⅰ；
2)将步骤1)过滤中得到的滤饼，加入3倍滤饼重量的水，100℃下加热煮沸2h，冷却后，过滤，收集滤液得到水提取液Ⅱ；
3)将醇提取液Ⅰ和水提取液Ⅱ合并，真空旋干后得到中药提取物A；
4)将中药提取物A加入到50ml的二乙二醇单乙基醚中，进行超声分散溶解，得到溶解液B；
5)将单亚油酸甘油酯20g、聚氧乙烯蓖麻油EL15g和溶解液B三者混合后，进行超声分散溶解，搅拌均匀后得到中药自微乳液C；
6)将400g聚乙二醇-6000和聚乙二醇-4000的混合液按质量比1:1混合后形成的调配液D与上述中药自微乳液C混合，调配液D的重量是中药自微乳液C的2倍，搅拌均匀并水浴加热至60℃保温，得到目标混合药剂E；
7)将目标混合药剂E滴加到2℃的液体石蜡中，收集冷凝成型的固体滴丸，整粒后即得到治疗心肌缺血中药自微乳速释滴丸。
实施例2
本发明公开了一种治疗心肌缺血中药自微乳速释滴丸及制备方法，制备方法如下：
1)、称取中药黄芪250g、赤芍200g、红景天150g、红花150，混合粉碎后，加入4千克浓度为80％的乙醇溶液在常温浸泡5天，过滤去渣得醇提液Ⅰ；
2)将步骤1)过滤中得到的滤饼，加入1000g的水，100℃下加热煮沸3h，冷却后，过滤，收集滤液得到水提取液Ⅱ；
3)将醇提取液Ⅰ和水提取液Ⅱ合并，减压旋转加热蒸水分后得到中药提取物A；
4)将中药提取物A加入到200ml的二乙二醇单乙基醚中，进行超声分散溶解，得到溶解液B；
5)将单亚油酸甘油酯25g、聚氧乙烯蓖麻油EL20g和溶解液B三者混合后，进行超声分散溶解，搅拌均匀后得到中药自微乳液C；
6)将600g聚乙二醇-6000和聚乙二醇-4000按质量比1:1混合后形成的调配液D与上述中药自微乳液C混合，调配液D的重量是中药自微乳液C的3倍，搅拌均匀并水浴加热至80℃保温，得到目标混合药剂E；
7)将目标混合药剂E滴加到8℃的液体石蜡中，收集冷凝成型的固体滴丸，整粒后即得到治疗心肌缺血中药自微乳速释滴丸。
步骤7)中用到的设备为滴丸锅，滴加的速度为30滴/分钟。
本实施例中采用的除溶剂方式均在旋转蒸发仪上进行真空旋干。
实施例3
与实施例2中的各步骤相同，取样比例相同，区别在于实施例3中步骤7)中滴液滴加的速度为60滴/分钟；步骤5)中各组分用量为：二乙二醇单乙基醚200ml，单亚油酸甘油酯20g，聚氧乙烯蓖麻油EL20g；步骤1)中的有机溶剂是浓度为75％的乙醇溶液，室温下浸泡3天。
实施例4
本发明公开了一种治疗心肌缺血的中药自微乳速释滴丸及制备方法，制备方法如下：
1、中药提取物的制备：
1)称取中药黄芪150g、赤芍100g、红景天80g、红花170，混合粉碎后，加入5倍浓度为70％的乙醇在常温浸泡3天，过滤去渣得醇提液；
2)将过滤物(渣)放入容器中，加入4倍的水，温度控制在90～100℃，加热2～3小时，冷却后过滤去渣得水提液；
3)将醇提液、水提液合并减压旋转蒸发，浓缩至含水量在5～10％粘稠膏状物，得中药提取物；
2、中药自微乳制备：
1)、将制得的中药提取物加入二乙二醇单乙基醚50～200ml，超声分散溶解。
2)、取单亚油酸甘油酯20g、聚氧乙烯蓖麻油EL20g与上述含药的二乙二醇单乙基醚溶液混合，超声分散后，以1000rpm的转速搅拌25～30min，得中药自微乳液。
3、中药自微乳滴丸制备：
以500g的聚乙二醇-6000/聚乙二醇-4000(质量比1：1)与上述中药自微乳液混合，搅拌均匀并水浴加热至60～80℃保温，使用滴丸锅以每分钟30～60滴的速度，在10～20cm高度滴入5℃的液体石蜡中，收集冷凝筒底部的成型固体滴丸，整粒后即得治疗心肌缺血中药自微乳速释滴丸。
Claims (7)
1.一种治疗心肌缺血的中药自微乳速释滴丸的制备方法，其特征在于，包括以下制备步骤：
1)称取黄芪、赤芍、红景天和红花，混合后加入到有机溶剂中进行浸泡萃取，过滤，收集滤液并将所述滤液旋干后得到浓缩物Ⅰ；
2)将步骤1)中过滤所得到的滤饼与纯净水混合，加热煮沸2～3h，冷却后，过滤，收集滤液得到水提取液Ⅱ；
3)将所述浓缩物Ⅰ和所述水提取液Ⅱ合并，蒸发水分后，后得到中药提取物A；
4)将所述中药提取物A加入到二乙二醇单乙基醚中，进行超声分散溶解，得到溶解液B；
5)将单亚油酸甘油酯、聚氧乙烯蓖麻油EL和所述溶解液B三者混合后，进行超声分散溶解，搅拌均匀后得到中药自微乳液C；
6)将聚乙二醇-6000和聚乙二醇-4000混合后形成的调配液D与步骤5)中的所述中药自微乳液C混合，搅拌均匀并水浴加热至60～80℃保温，得到目标混合药剂E；
7)将目标混合药剂E滴加到2～8℃的液体石蜡中，收集冷凝成型的固体滴丸，整粒后即得到治疗心肌缺血的中药自微乳速释滴丸。
2.如权利要求1所述的一种治疗心肌缺血的中药自微乳速释滴丸的制备方法，其特征在于，所述黄芪、赤芍、红景天、红花、二乙二醇单乙基醚、单亚油酸甘油酯、聚氧乙烯蓖麻油EL、聚乙二醇-6000和聚乙二醇-4000的组份含量是：
黄芪 150～250g
赤芍 100～200g
红景天 80～150g
红花 80～150g
二乙二醇单乙基醚 50～200ml
单亚油酸甘油酯 20～25g
聚氧乙烯蓖麻油 EL15～20g
聚乙二醇-6000 200～300g
聚乙二醇-4000 200～300g。
3.如权利要求1所述的一种治疗心肌缺血的中药自微乳速释滴丸的制备方法，其特征在于，所述黄芪、赤芍、红景天、红花、二乙二醇单乙基醚、单亚油酸甘油酯、聚氧乙烯蓖麻油EL、聚乙二醇-6000和聚乙二醇-4000的组份含量是：
黄芪 150g
赤芍 100g
红景天 80g
红花 80g
二乙二醇单乙基醚 50ml
单亚油酸甘油酯 20g
聚氧乙烯蓖麻油EL 15g
聚乙二醇-6000 200g
聚乙二醇-4000 200g。
4.如权利要求1所述的一种治疗心肌缺血的中药自微乳速释滴丸的制备方法，其特征在于，步骤1)中所述有机溶剂是浓度为65～80％的乙醇溶液，所述浸泡的时间为3～5天，步骤2)中所述水的重量是所述滤饼重量的2～3倍。
5.如权利要求1所述的一种治疗心肌缺血的中药自微乳速释滴丸的制备方法，其特征在于，步骤3)中所述中药提取物A中的含水量为5～10％。
6.如权利要求1所述的一种治疗心肌缺血的中药自微乳速释滴丸的制备方法，其特征在于，步骤6)中所述聚乙二醇-6000和所述聚乙二醇-4000是按质量比1:1进行调配的，所述调配液D的质量是所述中药自微乳液C的质量的2～3倍。
7.一种治疗心肌缺血的中药自微乳速释滴丸，其特征在于，所述治疗心肌缺血的中药自微乳速释滴丸是通过权利要求1～6所述的一种治疗心肌缺血的中药自微乳速释滴丸的制备方法中任一方法制得的。
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