CN1739588A - 一种治疗心血管疾病的中药制剂及其制备方法 - Google Patents
一种治疗心血管疾病的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗心血管疾病的中药制剂及其制备方法，它是主要组成成分为川芎、冰片的速效救心微丸或分散片或舌下片。本发明的制备方法是：取川芎、冰片分别粉碎成细粉，川芎细粉，用乙醇回流提取，提取液经减压浓缩，再流经大孔吸附树脂柱，先用水洗，再用乙醇进行洗脱，洗脱液，减压浓缩，加入冰片细粉，混匀，加入适量的辅料制成微丸或分散片或舌下片。本发明的优点是制备工艺简单，服用、携带方便，产品质量稳定，有利于提高药效。
Description
技术领域：
本发明涉及一种中药制剂及其制备方法，尤其涉及一种治疗心血管疾病的中药制剂及其制备方法。
背景技术：
经检索速效救心现有剂型只有滴丸，已列入部颁中药成方制剂十八册。通过专利检索，天津市第六中药厂于98申请了速效救心丸制造工艺的专利，张晴龙于2001年申请了一种速效救心口腔崩解片及其制备方法的专利，天津大学于2004年申请了速效救心口崩片及制备方法的专利，无速效救心微丸或分散片或舌下片的相关专利。
中药制剂中的微丸或分散片或舌下片作为一种药物剂型，根据我国药品管理的相关法规，改变剂型或工艺作为新药研究管理。微丸具有在胃肠道分布面积大，生物利用度高，刺激性小，由于粒径小，受消化道输送食物节律影响小(如幽门关闭等)，流动性好，大小均匀，易于处理(如包衣、分剂量)；分散片具有分散状态佳，崩解时间短，药物溶出迅速，吸收快，生物利用度高，服用方便、可吞服、咀嚼含吮或用水分散后服用；舌下片可防止胃肠道不同pH值对药物的影响及消化酶对药物的破坏，也可避免药物的肝脏首过作用，起效快等优点。
现有的速效救心丸工艺技术特点是取处方中川芎，用乙醇加热回流提取，提取液减压回收乙醇，加入盐酸调节pH值，用氯仿萃取，氯仿层加入盐酸，静置，分离，水层用氨水调节pH，再用氯仿萃取，减压回收氯仿，溶液浓缩得川芎提取物；将聚乙二醇加热熔融，立即加入川芎提取物及冰片，搅拌均匀，滴入液体石蜡中，即得。
现有速效救心丸需特殊的设备，成本高，制备工艺复杂等。
发明内容：
本发明的目的是提供一种治疗心血管疾病的中药制剂及其制备方法，克服现有技术的上述弊端，提高了产品的质量、更好地满足医疗的需要。
本发明的目的是通过如下技术方案实现的。
一种治疗心血管疾病的中药制剂，它是主要组成成分为川芎、冰片的速效救心微丸或分散片或舌下片。
其制备方法是：
(1)药物组成成分及其重量百分比如下：
川芎65.3-88.4％、冰片11.6-34.7％；
药物组成成分最佳重量百分比为：
川芎76.9％、冰片23.1％；
(2)取川芎、冰片分别粉碎成细粉，备用；
(3)取(2)所得川芎细粉，用乙醇回流提取2-3次，合并提取液，减压浓缩，再流经大孔吸附树脂柱，先用水洗，再用20-50％乙醇进行洗脱，收集洗脱液，减压浓缩，得川芎提取物，备用；
(4)取(3)所得川芎提取物，加入(2)所得冰片细粉，混匀，得混合药物备用；
(5)取(4)所得混合药物，加入适当的辅料，混匀，制成微丸或分散片或舌下片；
其微丸的制备方法：取(4)所得混合药物，加入适量的辅料，混合均匀，制粒，包衣或不包衣，制成直径小于2.5mm的微丸，即得速效救心微丸；
微丸辅料为下列一种或多种组合或其它适宜的辅料，按任意比例混用：乙基纤维素(EC)、聚丙烯聚硅氧烷、蜡类、聚乙二醇(PEG)、硬脂酸、虫胶、丙烯酸树脂、聚乙烯醇、聚乙烯吡咯烷酮(PVP)、甲基纤维素、羟丙基纤维素、丙酸纤维素、丙烯酸树脂水分散体、乙基纤维素伪胶乳、邻苯二甲酸醋酸纤维素(CAP)胶乳、聚苯二甲酸醋酸乙烯脂(PVAP)水分散体、丙二醇、甘油、甘油三醋酸酯、乙酰单甘油酸酯、邻苯二甲酸酯、聚山梨酯80、十二烷基硫酸钠、乳糖、果糖、蔗糖；
其分散片的制备方法：取(4)所得的混合药物，加入适量的辅料，混合均匀，制粒、干燥、整粒，压片，即得速效救心分散片；
辅料为下列物料中一种或多种的混合物或其它适宜的辅料按任意比例混用：低取代羟丙基纤维素、维澎淀5000、交联聚维酮1NF-10、聚乙二醇、聚乙烯吡咯酮类、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、邻苯二甲酸醋酸纤维素、苯二甲酸羟丙基甲基纤维素、羟甲基乙基纤维素、微晶纤维素、枸橼酸、胆酸、富马酸、琥珀酸、酒石酸、胶性二氧化硅，硬脂酸镁、滑石粉；
其舌下片的制备方法：取(4)所得的混合药物，加入适量的辅料，混合均匀，干燥，压制成舌下片；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料按任意比例混用：羧甲基淀粉钠、木糖醇、山梨醇、乳糖、蔗糖、二氧化硅、微粉硅胶、吐温-80、聚乙烯吡咯烷酮、甘露醇、硬脂酸镁。
具体实施方案：
本发明结合具体实施例进一步说明，可供参考，但并不限制本发明的范围：
一种治疗心血管疾病的中药制剂，它是主要组成成分为川芎、冰片的速效救心微丸或分散片或舌下片。
本发明一种治疗心血管疾病的中药制剂具有行气活血，祛瘀止痛，增加冠脉血流量，缓解心绞痛。主要用于气滞血瘀型冠心病，心绞痛。
本发明的一种治疗心血管疾病的中药制剂速效救心微丸或分散片或舌下片的制备方法是：
(1)药物组成成分及其重量用量如下：
川芎100g、冰片30g；
(2)取川芎、冰片分别粉碎成细粉，备用；
(3)取(2)所得川芎细粉，用乙醇回流提取2次，合并提取液，减压浓缩，再流经大孔吸附树脂柱，先用水洗，再用30％乙醇进行洗脱，收集洗脱液，减压浓缩，得川芎提取物，备用；
(4)取(3)所得川芎提取物，加入(2)所得冰片细粉，混匀，得混合药物备用；
(5)一种治疗心血管疾病的中药制剂速效救心微丸，其制备方法是取(4)所得混合药物，与30g糊精混合均匀，5％PVP醇液为粘合剂，首先制备60目的颗粒作母核，再以5％PVP醇液为粘合剂，加混合药粉放大制成40目的微丸，即得。
(6)一种治疗心血管疾病的中药制剂速效救心分散片，其制备方法是取(4)所得混合药物，加入交联聚乙烯基吡咯烷酮30g，低取代羟丙纤维素20g，微晶纤维素100g，混合均匀，过筛二次，加入0.5％的微粉硅胶，混合均匀，过80目筛二次，压片，即得分散片。
(7)一种治疗心血管疾病的中药制剂速效救心舌下片，其制备方法是取(4)所得的药物细粉，加乳糖1.5g，蔗糖5g、羧甲基淀粉钠1g、硬脂酸镁0.2g，充分混匀，过筛、制粒、整粒、压制成舌下片。
本发明的优点是：
制备工艺简单，服用、携带方便，产品质量稳定，有利于提高药效。
Claims (3)
1、一种治疗心血管疾病的中药制剂，其特征在于它是主要组成成分为川芎、冰片的速效救心微丸或分散片或舌下片。
2、一种治疗心血管疾病的中药制剂的制备方法，它是速效救心微丸或分散片或舌下片的制备方法，其特征在于：
(1)药物组成成分及其重量百分比如下：
川芎65.3-88.4％、冰片11.6-34.7％；
(2)取川芎、冰片分别粉碎成细粉，备用；
(3)取(2)所得川芎细粉，用乙醇回流提取2-3次，合并提取液，减压浓缩，再流经大孔吸附树脂柱，先用水洗，再用20-50％乙醇进行洗脱，收集洗脱液，减压浓缩，得川芎提取物，备用；
(4)取(3)所得川芎提取物，加入(2)所得冰片细粉，混匀，得混合药物备用；
(5)取(4)所得混合药物，加入适当的辅料，混匀，制成微丸或分散片或舌下片；
其微丸的制备方法：取(4)所得混合药物，加入适量的辅料，混合均匀，制粒，包衣或不包衣，制成直径小于2.5mm的微丸，即得速效救心微丸；
微丸或微丸胶囊辅料为下列一种或多种组合或其它适宜的辅料，按任意比例混用：乙基纤维素(EC)、聚丙烯聚硅氧烷、蜡类、聚乙二醇(PEG)、硬脂酸、虫胶、丙烯酸树脂、聚乙烯醇、聚乙烯吡咯烷酮(PVP)、甲基纤维素、羟丙基纤维素、丙酸纤维素、丙烯酸树脂水分散体、乙基纤维素伪胶乳、邻苯二甲酸醋酸纤维素(CAP)胶乳、聚苯二甲酸醋酸乙烯脂(PVAP)水分散体、丙二醇、甘油、甘油三醋酸酯、乙酰单甘油酸酯、邻苯二甲酸酯、聚山梨酯80、十二烷基硫酸钠、乳糖、果糖、蔗糖；
其分散片的制备方法：取(4)所得的混合药物，加入适量的辅料，混合均匀，制粒、干燥、整粒，压片，即得速效救心分散片；
辅料为下列物料中一种或多种的混合物或其它适宜的辅料按任意比例混用：低取代羟丙基纤维素、维澎淀5000、交联聚维酮1NF-10、聚乙二醇、聚乙烯吡咯酮类、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、邻苯二甲酸醋酸纤维素、苯二甲酸羟丙基甲基纤维素、羟甲基乙基纤维素、微晶纤维素、枸橼酸、胆酸、富马酸、琥珀酸、酒石酸、胶性二氧化硅，硬脂酸镁、滑石粉；
其舌下片的制备方法：取(4)所得的混合药物，加入适量的辅料，混合均匀，干燥，压制成舌下片；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料按任意比例混用：羧甲基淀粉钠、木糖醇、山梨醇、乳糖、蔗糖、二氧化硅、微粉硅胶、吐温-80、聚乙烯吡咯烷酮、甘露醇、硬脂酸镁。
3、根据权利要求2所述的一种治疗心血管疾病的中药制剂的制备方法，其特征在于其主要组成成分的最佳重量百分比为：
川芎76.9％、冰片23.1％。
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| WO2018040989A1 (zh) * | 2016-08-29 | 2018-03-08 | 烟台益诺依生物医药科技有限公司 | 依达拉奉与(+)-2-莰醇的舌下用药物组合物 |
| CN109602710A (zh) * | 2019-01-20 | 2019-04-12 | 怀化梅片科技有限公司 | 一种龙脑丸（片）及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018040989A1 (zh) * | 2016-08-29 | 2018-03-08 | 烟台益诺依生物医药科技有限公司 | 依达拉奉与(+)-2-莰醇的舌下用药物组合物 |
| AU2017317950B2 (en) * | 2016-08-29 | 2019-09-19 | Neurodawn Pharmaceutical Co., Ltd. | Sublingual pharmaceutical composition of edaravone and (+)-2-borneol |
| RU2720204C1 (ru) * | 2016-08-29 | 2020-04-27 | Яньтай Енэфарма Ко., Лтд. | Сублингвальная фармацевтическая композиция эдаравона и (+)-2-борнеола |
| US11135199B2 (en) | 2016-08-29 | 2021-10-05 | Neurodawn Pharmaceutical Co., Ltd. | Sublingual pharmaceutical compositions of edaravone and (+)-2-borneol |
| CN109602710A (zh) * | 2019-01-20 | 2019-04-12 | 怀化梅片科技有限公司 | 一种龙脑丸（片）及其制备方法 |
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