CN111281971A - 一种具有降低血粘度的药物组合物 - Google Patents
一种具有降低血粘度的药物组合物 Download PDFInfo
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- CN111281971A CN111281971A CN202010176270.3A CN202010176270A CN111281971A CN 111281971 A CN111281971 A CN 111281971A CN 202010176270 A CN202010176270 A CN 202010176270A CN 111281971 A CN111281971 A CN 111281971A
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Abstract
本发明公开的是一种具有降低血粘度的药物组合物，由子仁激酶、红曲和中药提取物制备：取子仁激酶和红曲混合均匀，再加入中药提取物混合均匀，先制备成颗料剂，再将颗料剂压片，或将颗粒剂分装入胶囊，每片或每粒胶囊含子仁激酶的量是0.126‑0.128克。本发明具有治疗心血管疾病的作用，尤其是对于降低高粘血症、消除动脉回声斑的调整，效果确切，经广西壮族自治区陆川县茶花山医院进行了临床验证，对高粘血症经过两个疗程的服用观察，保健防治作用有效率100%，恢复正常率在80%左右，以上数据分析统计P≤0.01，有医学临床价值。服用子仁激酶片3个疗程，回声斑全部消失，说明坚持较长时间服用子仁激酶片，具有消除动脉回声斑作用，具有临床意义。
Description
技术领域
本发明涉及的是一种具有降低血粘度的药物组合物，属于中药制备技术领域。
背景技术
众所周知，人体的许多涉及心血管病和脑血管病，引起的病因或多或少都与血粘度有关，血粘度高容易诱发血小板聚集，直接或间接带来一系列疾病，如高血压病、冠心病、血管栓塞、中风等。因此，治疗这类涉及心脑血管疾病采取的主要措施之一就是降低血粘度。可见，维持正常的血粘度对人体而言是多么的重要。而随着生活节奏的加快，饮食习惯的改变，环境的影响，高粘血症成了常见病和多发病，治疗高粘血症较为有效的药物就是阿司匹林，需要长期服用，长期服用的药物带来的不良反应对人体也是一种侵害，其次是具有活血化瘀作用的中药，目前，有这方面作用的中药虽然具有一定的效果，但显效慢，也需要长期服用，适用于调理。中药是一个巨大的宝库，里面蕴藏着丰富的资源，通过科学合理的筛选，是能够筛选出具有更好效果的治疗药物的，但中药的不足是显效慢，效果不明显，需要长期服用才能显效，如何克服这一不足，而又不失中药的不良反应小，用药安全的特点，这就是我们要努力的方向。据报道，蛋白激酶是一类磷酸转移酶，其作用是将ATP的γ磷酸基转移到底物特定的氨基酸残基上，使蛋白质磷酸化。通过蛋白质磷酸化从而调节蛋白质的活性，或者通过蛋白质的逐级磷酸化，使信号逐级放大，引起细胞反应，得蛋白质具有不同的活性。许多具有活血化瘀作用的中药，含有的主要成份是蛋白质，通过对这些含有蛋白质的中药进行微生物发酵，使这些中药中的蛋白质转化为蛋白质激酶，赋予中药新的生物活性，或活性作用更强。从这一原理出发通过科学合理的配伍，并经临床验证，制备出具有迅速、有效和安全地降低血粘度的药物，就是本发明的意义所在。
发明内容
本发明的目的就是提供一种具有降低血粘度的药物组合物，制备出具有迅速、有效和安全地降低血粘度的药物。克服传统的中药治疗高血粘症时作用弱，起效慢，需长期服用的不足。
为实现上述目的，本发明采用了下述技术措施，一种具有降低血粘度的药物组合物，由下述重量份原料制备而成：
配方：
子仁激酶 3-5份 红曲 2-4份 中药提取物 1-2份；
通过下述制备方法将上述原料制备成片剂或胶囊剂：
取子仁激酶和红曲提取物混合均匀，再加入中药提取物混合均匀，根据制备片剂的常规工艺要求加入辅料，先制备成颗料剂，再将颗料剂压片即得到片剂，或将颗粒剂分装入胶囊即得到胶囊剂，所述片剂中每片含子仁激酶的量是0.126-0.128克，所述胶囊剂中每粒含子仁激酶的量是0.126-0.128克。
所述子仁激酶的制备方法：取等量炒决明子和炒桃仁，烘干，粉碎为40-80目细粉，以1:1.2-1.7的重量比用水调成浆状,浸润20-30分钟后，隔水蒸30-40分钟，使蛋白变性得到子仁浆，于35公斤子仁浆中加入30-50毫升枯草芽胞杆菌培养液,搅拌均匀, 在35℃-40℃的条件下发酵18-24小时，期间每4小时搅拌 一次，让子仁浆均匀发酵,取发酵好的子仁浆置于5℃8℃的条件下稳定后熟24-30小时，取出于35℃-40℃以下的温度干燥至含水量为7％以下即得。
所述中药提取物的制备方法：
配方：丹参3-4重量份 山楂2-3重量份 红花1-2重量份
三七1-2重量份 天麻1-2重量份 红景天2-3重量份
远志2-3重量份 瓜蒌壳2-3重量份 回心草2-3重量份 花旗参1-2重量份；
制备方法：取丹参、山楂、红花、红景天、远志、瓜蒌壳和回心草洗净、晾干，加入5-8倍量的水浸泡1小时，加热提取2小时，过滤得滤液备用，残渣按上述方法重复提取1次，收集2次提取的滤液，减压浓缩，浓缩至80℃时检测相对密度为1.12-1.15，得到药物提取液备用；
另取三七、天麻和花旗参，冼净，干燥，粉碎为200目细粉，得到药物细粉备用；
将上述药物细粉加入上述药物提取液中混合均匀，按常规方法加入适量辅料制备成颗粒，干燥，使得每克颗粒剂含生药量为2.5-3克，即得中药提取物。
采取上述措施的本发明，取枯草芽孢杆菌对炒决明子和炒桃仁进行发酵，从而使炒决明子和炒桃仁产生了生物反应，反应产物之一就是子仁激酶，由此而产生了一系列的活性作用。经广西壮族自治区分析测试中心对五批子仁激酶进行检验，活性单位2839U/g-4230U/g，由此提示子仁激酶具有较强的生理活性。产生子仁激酶的两种中药，其中决明子的功效是清肝，明目，利水，通便, 现代研究表明，决明子除含有糖类、蛋白质、脂肪外，还含有人体必需的微量元素铁、锌、锰、铜、镍、钴、钼等。所含大黄素、大黄酸对人体有平喘、利胆、保肝、降压功效，并有一定抗菌、消炎作用。其中大黄素葡萄糖甙、大黄素蒽酮、大黄素甲醚，具有降低血清胆固醇和强心作用。现代临床用决明子治疗高脂血症收效满意。
桃仁含苦杏仁苷、野樱桃苷、2,4-次甲基珂阿尔廷醇、多花蔷薇苷、尿囊素、维生素B1、苦杏仁酶、脂肪油、脂肪酸、蛋白质等另含24-亚甲基环木菠萝烷醇、柠檬甾二烯醇、7-去氢燕麦固醇等成分。
现代研究表明桃仁提取液能明显增加脑血流量，增加犬股动脉的血流量，降低血管阻力，改善血流动力学状况。本发明就是根据决明子和桃仁所含有成份及具有的功效，通过采用枯草芽胞杆菌的发酵，得到的激酶强化了治疗心血管疾病的作用。
本发明所述的中药提取物的配方，是申请人长期实践中总结出来的组方，对心血管疾病的治疗行之有效，其中药物的君、臣、佐、使分工分确，各司其职，君药为丹参、三七、红花，臣药为花旗参、天麻，佐药为山楂、红景天、回心草，使药为瓜蒌壳、远志。将上述药物提取物与子仁激酶配合后，强化了治疗心血管疾病的作用，起到了增效的目的。
本发明所用红曲中，含有洛伐它汀成份，洛伐它汀是已被证明了功效的治疗心血管疾病药物。
将上述子仁激酶、中药提取物和红曲配合制备成中药组合物后，具有治疗心血管疾病的作用，尤其是对于降低高粘血症、消除动脉回声斑的调整，效果确切，经广西壮族自治区陆川县茶花山医院进行了临床验证，结果如下：
于2018年3月-2019年10月对9名志愿者进行高粘血症临床验证，经北海市人民医院和玉林市茶花山医院做了“血液流变学”测试，9人志愿者中有7人在服用子仁激酶前全血粘度：低切、中切、高切均高于正常值，诊断为高粘血症。经每天早、晚两次，饭后服用子仁激酶片18片，连服两个疗程，每个疗程30天，再经原医院复查“血液流变学”测试，将两次测试结果进行前后对比：
低切：（mp.s ）10(1/s)正常值是6.80-9.85，服用子仁激酶片前的数值分别在10.07-14.10之间，7人都是超正常值，服用子仁激酶片后检测，数值分别在9.06-9.86之间，7人服用，全部都有降低，占比100%，其中5人都恢复正常，恢复正常率71.14%。
中切：（mp.s ）60(1/s)正常值是4.51-5.85，服用子仁激酶片前的数值分别在5.78-7.04之间，7人中有6人超正常值，服用子仁激酶片后检测，数值分别在4.61-5.57之间，7人服用，全部都有降低，占比100%，6人都恢复正常，恢复正常率85.7%。
高切：（mp.s ）150(1/s)正常值是3.73-4.60，服用子仁激酶片前的数值分别在4.88-5.57之间，7人都超正常值，服用子仁激酶片后检测，数值分别在3.99-5.15之间，7人服用，全部都有降低，占比100%，其中6人都恢复正常，恢复正常率85.7%。
通过以上7人服用子仁激酶片的统计，院方认为子仁激酶不良反应不明显，安全性较好，对高粘血症经过两个疗程的服用观察，保健防治作用有效率100%，恢复正常率在80%左右，以上数据分析统计
P≤0.01，可信，有医学临床价值。
于2018年3月至2019年11月，对14例志愿者进行了临床观察，服用子仁激酶片前先后在北海市中医院、玉林市第二人民医院、玉林市福绵区人民医院进行了B超检查。其国8例服用前B超检查回声斑在2-25.6mm之间，对这8例回声斑患者，经每天早、晚两次，饭后服用子仁激酶片18-20片，连服2-3个疗程，每个疗程30天，在服用前同一医院进行B超复查，复查结果是8例中有7例回声斑都有缩小，缩小率点人数的87.5%，8例中有一例，回声斑数据没有缩小，但血管壁光洁，血流量增加，说明对清理血管壁，增加血流量具有一定治疗作用。7例回声斑中有缩小，其中一例服用前B超检查，腹主动脉壁上见多个强回声斑光团，其中一个16.1х3.1mm,服用子仁激酶片3个疗程后复查，没有发现回声斑，全部消失，说明随着服用时间，坚持较长时间服用子仁激酶片，具有消除动脉回声斑作用，具有临床意义。
具体实施方式
实施例1
（一）制备子仁激酶
(1)先进行菌种培养，取从中国科学院微生物研究所购进的枯草芽孢杆菌1支，接种于营养肉汁琼脂培养基上，营养肉汁琼脂培养基主要由下述原料组成：蛋白胨10克，牛肉膏 3克，琼脂5克，氯化钠5克加无菌水至1000毫升，并调PH至7，上述原料配制成的培养基分为七支，按常规菌种培养方法在30-38℃条件下培养24-48 小时，然后合并所培养的菌种得到菌种培养液；
(2)取上述菌种培养液25毫升、28毫升、32毫升、36毫升50毫升分别加入35公斤子仁浆中搅拌均匀，在37℃的条件下发酵18-24小时，期间每4小时搅拌 一次，让子仁浆均匀发酵；
(3)上述发酵好的子仁浆置于5℃-8℃的条件下稳定后熟24-30小时，取出于32-38℃以下的温度干燥至含水量为7％以下即可。
经上述方法制备得到5批子仁激酶，经广西壮族自治区分析测试中心对五批子仁激酶进行检验，活性单位为2839U/g-4230U/g。
实施例2
（二）制备中药提取物
（1）配方：丹参3000克 山楂2000克 红花600克
三七1000克 天麻1000克 红景天2000克
远志2000克 瓜蒌壳2000克 回心草2000克 花旗参1000克；
（2）制备方法：取丹参、山楂、红花、红景天、远志、瓜蒌壳和回心草洗净、晾干，加入100千克的水浸泡1小时，加热提取2小时，过滤得滤液备用，残渣再加入100千克水，加热提取2小时，过滤取滤液，收集2次提取的滤液合并，减压浓缩，浓缩至80℃时检测相对密度为1.15，得到药物提取液10千克备用；
另取三七、天麻和花旗参，冼净，干燥，粉碎为200目细粉，得到3000克药物细粉备用；
将上述药物细粉加入上述药物提取液中混合均匀，按常规方法加入适量糊精制备成颗粒，干燥，使得每克颗粒剂含生药量为2.5克，即得中药提取物。
实施例3
制备中药提取物
（1）配方：丹参4000克 山楂3000克 红花2000克
三七1000克 1麻2000克 红景天3000克
远志3000克 瓜蒌壳3000克 回心草3000克 花旗参1000克；
（2）制备方法：取丹参、山楂、红花、红景天、远志、瓜蒌壳和回心草洗净、晾干，加入200千克的水浸泡1小时，加热提取2小时，过滤得滤液备用，残渣再加入100千克水，加热提取2小时，过滤取滤液，收集2次提取的滤液合并，减压浓缩，浓缩至80℃时检测相对密度为1.12，得到药物提取液20千克备用；
另取三七、天麻和花旗参，冼净，干燥，粉碎为200目细粉，得到3000克药物细粉备用；
将上述药物细粉加入上述药物提取液中混合均匀，按常规方法加入适量糊精制备成颗粒，干燥，使得每克颗粒剂含生药量为3克，即得中药提取物。
实施例4
制备子仁激酶片
配方：
子仁激酶 300克 红曲 200克 中药提取物 100克；
通过下述制备方法将上述原料制备成片剂：
取子仁激酶和红曲混合均匀，再加入中药提取物混合均匀，加入100克糊精混合均匀，先制备成颗料剂，再将颗料剂压制为片重是0.3克的子仁激酶片2330 片，每片含子仁激酶的量是0.128克。所述红曲是市售商品，由西安市陕西天行健生物化工技术有限公司购进。
实施例5
制备子仁激酶胶囊
配方：
子仁激酶 500克 红曲 400克 中药提取物 200克；
通过下述制备方法将上述原料制备成胶囊剂：
取子仁激酶和红曲提取物混合均匀，再加入中药提取物混合均匀，加入辅料羟甲基纤维素钠70克，先制备成颗料剂，再将颗料剂分装入内容物重是0.3克的胶囊即得到4000粒胶囊剂，每粒胶囊含子仁激酶的量是0.128克。
Claims (3)
1.一种具有降低血粘度的药物组合物，其特征在于所述药物组合物由下述重量份原料制备而成：
配方：
子仁激酶 3-5份 红曲 2-4份 中药提取物 1-2份；
通过下述制备方法将上述原料制备成片剂或胶囊剂：
取子仁激酶和红曲提取物混合均匀，再加入中药提取物混合均匀，根据制备片剂的常规工艺要求加入辅料，先制备成颗料剂，再将颗料剂压片即得到片剂，或将颗粒剂分装入胶囊即得到胶囊剂，所述片剂中每片含子仁激酶的量是0.126-0.128克，所述胶囊剂中每粒含子仁激酶的量是0.126-0.128克。
2.根据权利要求1所述的一种具有降低血粘度的药物组合物，其特征在于所述子仁激酶的制备方法是：取等量炒决明子和炒桃仁，烘干，粉碎为40-80目细粉，以1:1.2-1.7的重量比用水调成浆状,浸润20-30分钟后，隔水蒸30-40分钟，使蛋白变性得到子仁浆，于35公斤子仁浆中加入30-50毫升枯草芽胞杆菌培养液,搅拌均匀, 在35℃-40℃的条件下发酵18-24小时，期间每4小时搅拌 一次，让子仁浆均匀发酵,取发酵好的子仁浆置于5℃8℃的条件下稳定后熟24-30小时，取出于35℃-40℃以下的温度干燥至含水量为7％以下即得。
3.根据权利要求1所述的一种具有降低血粘度的药物组合物，其特征在于所述中药提取物的制备方法是：
配方：丹参3-4重量份 山楂2-3重量份 红花1-2重量份
三七1-2重量份 天麻1-2重量份 红景天2-3重量份
远志2-3重量份 瓜蒌壳2-3重量份 回心草2-3重量份
花旗参1-2重量份；
制备方法：取丹参、山楂、红花、红景天、远志、瓜蒌壳和回心草洗净、晾干，加入5-8倍量的水浸泡1小时，加热提取2小时，过滤得滤液备用，残渣按上述方法重复提取1次，收集2次提取的滤液，减压浓缩，浓缩至80℃时检测相对密度为1.12-1.15，得到药物提取液备用；
另取三七、天麻和花旗参，冼净，干燥，粉碎为200目细粉，得到药物细粉备用；
将上述药物细粉加入上述药物提取液中混合均匀，按常规方法加入适量辅料制备成颗粒，干燥，使得每克颗粒剂含生药量为2.5-3克，即得中药提取物。
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