CN1259075C - 一种用于益气健脾、宁心安神的中药复方制剂 - Google Patents
一种用于益气健脾、宁心安神的中药复方制剂 Download PDFInfo
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Abstract
本发明涉及一种滋补强壮,用于益气健脾、宁心安神的中药复方制剂,成分的组方为:以1000g为一个重量单位,人参40~120g、山楂200~400g、维生素B10.2~3.0g、维生素B20.2~3.0g、维生素B60.1~4.2g、维生素E0.9~3.9g、泛酸钙1.0~3.2g、烟酰胺0.8~3.0g、余量为辅料,蔗糖或糊精、蜂蜜、乙醇制成药物组合物。可以直接制备成药,及对组合物中药物组份分别进行提取制成剂型为颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂或膏剂。本发明对气虚症有较好疗效,对心气虚、脾气虚患者的治疗总有效率为95%。适用于心脾气虚所致神疲乏力,心悸气短、自汗、大便溏薄、食欲不振、食后或下午腹胀等症,适用范围广、且无毒副作用,使用安全。
Description
技术领域
本发明为药品技术领域,涉及一种滋补强壮,用于益气健脾、宁心安神的中药复方制剂,也称为维他参。
背景技术
目前,随着生活节奏的加快、市场竞争日趋激烈,人们的大脑皮层高度紧张,精神压力的增大,心脑血管系统、胃、肝脏、神经衰弱等疾病的发病率有所增加,且发病有年青化的趋势。尽管西药的不断研制和开发,但西药的治疗方法均有一定的毒副作用和不良反应。我国著名中草药人参为五加科植物Panax ginseng C.A.Mey的根,历代本草记载,本品入脾、胃、肺三经,无毒,可治“男妇一切虚症”,近年来,我们对人参的临床作用作了大量的研究,结果表明:人参对心脑血管系统、胃、肝脏、神经衰弱等疾病均有可靠的治疗作用。特别引人注目的是近年来在适应原样作用、抗疲劳作用和提高脑力劳动和体力劳动工作效率方面的单肓和双盲对照临床实验,结果表明人参明显增加了患者的白细胞数目、血清总蛋白、防止血糖降低和胆固醇升高。在双盲试验中人参还可以明显的缩短反应时间和改善肺功能,对思维能力有不同程度的改善。山楂为蔷薇科植物山楂Cratageuspinnatifida Bge.va.major.N.E.Br的果实。性味酸、甘,微温,入脾、胃、肝经,具有消积食、散瘀血的功能,主治内积、痰饮、痞满等。B族维生素是人体重要的辅酶,为人体必要的营养成分,维持人体摄入丰富的B族维生素,对提高人体的免疫功能具有十分重要的意义。
发明内容
本发明的目的是根据中医理论,针对人体阴阳平衡失调所致气虚症等症状,如:心脑血管系统、胃、肝脏、神经衰弱等疾病,提供一种滋补强壮,用于益气健脾、宁心安神的中药复方制剂。
本发明一种用于益气健脾、宁心安神的中药复方制剂内容简述:
本发明一种用于益气健脾、宁心安神的中药复方制剂,其特征在于:其成分的组方为:以1000g为一个重量单位,人参40~120g、山楂200~400g、维生素B10.2~3.0g、维生素B20.2~3.0g、维生素B60.1~4.2g、维生素E0.9~3.9g、泛酸钙1.0~3.2g、烟酰胺0.8~3.0g、余量为辅料,蔗糖或糊精、蜂蜜、乙醇,制成的药物组合物为颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂或膏剂。
它是通过下列步骤完成的:
(1)、精选人参、山楂炮制处理为饮片;
(2)、人参、山楂为提取物,其提取方法为:A水提法或B醇提法;
A水提法提取人参、山楂提取物:精选人参加水煎煮两次,第一次加水8倍量,煎煮2小时,第二次加水6倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至相对密度为1.29~1.31,温度为60℃清膏,备用;取山楂加水煎煮两次,第一次加水8倍量,煎煮2小时,第二二次加水6倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至相对密度为1.29~1.31,温度为60℃清膏,备用;合并人参与山楂提取物;
B醇提法提取人参、山楂提取物:取人参准确称重后粉成粗粉,用60%乙醇润湿,放置约6小时后,装入渗滤罐浸泡48小时,然后开始渗滤,以每分钟3~5ml的速度渗滤至渗滤液无色,收集渗滤液、残渣挤压,榨出液与渗滤液合并浓缩,浓缩液备用;取山楂准确称重后用75%乙醇加热,回流提取三次,时间为3小时、2小时、1小时,加醇量分别为8倍量、6倍量、4倍量,合并提取液、过滤、减压浓缩,浓缩液备用;
(3)、将提取物与维生素B1、维生素B2、维生素B6、维生素E、泛酸钙、烟酰胺、辅料混合,加工制成颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂或膏剂的药物组合物。
本发明一种用于益气健脾、宁心安神的中药复方制剂,根据现代药理研究表明:
给小鼠ig、0.625g、1.25g、2.5g/kg本发明冲剂,每日两次,连续一周或iPl,2、4g/kg,每日一次,连续一周,可显著增强小鼠的耐缺氧能力。在1.25g/kg剂量下,可增强小鼠的自发活动,而在2.5g/kg的剂量下,可减少小鼠的自发活动,对小鼠中枢神经系统产生双向调节作用,在上述相同剂量下,尚可延长小鼠戍巴比妥钠睡眠时间和促进胃肠蠕动,开胃健脾。本发明冲剂0.05、0.15g/0.2ml/只,可显著增加家兔离体心脏冠脉输出量,改善心肌供血;给小鼠ig 1.25g、5.0g/kg本发明冲剂一周,可明显增强小鼠的免疫功能,连给4周,可产生抗自由基作用,延缓小鼠的衰老过程。
本发明冲剂的急性毒性试验表明:本品未测出LD50,小鼠最大耐受剂量为240g/kg/日连续观察七天,20只小鼠全部存活,未出现异常反应。本发明冲剂给小鼠灌胃给药的最大耐受倍数为成人每日口服量的3100倍。
本发明冲剂的长期毒性试验结果表明:给大鼠ig本发明冲剂5、10g/kg,分别相当于临床成人每日用量的25和50倍,每日一次,连续8周,对大鼠生长发育、活动行为、血象、肝、肾功能及病理检查等均无明显毒性反应。
本发明一种用于益气健脾、宁心安神的中药复方制剂的临床研究参照卫生部(87)卫药字32号有关中药治疗脾虚症的临床研究指导原则中有关规定进行。临床结果表明:
1、本发明对气虚症有较好疗效,对心气虚、脾气虚患者的四周总有效率为95%,其中显效率75%,无效5%;对照组人参蜂王浆的总有效率为85%。
2、本发明对心悸、乏力、便溏食欲不振等症状均有不同程度的改善,对乏力症状作用尤为证实本发明具有滋补强壮、益气健脾、宁心安神的功效,适用于心脾气虚所致的神疲乏力,心悸气短、自汗、大便溏薄、食欲不振、食后或下午腹胀等症。
3、临床观察表明,本发明的疗效与年龄、性别、疗程无明显关系,其适用范围广、且无毒副作用,使用安全。
具体实施方式
实施例1
用水提法制备本发明一种用于益气健脾、宁心安神的中药复方制剂,是以1000g为一个重量单位,人参120g、山楂300g、维生素B10.6g、维生素B20.6g、维生素B60.8g、维生素E2.9g、泛酸钙1.0g、烟酰胺2.0g、余量为辅料,蔗糖∶糊精=3∶1制成药物组合物。
通过下列步骤完成:
(1)、精选人参、山楂炮制处理为饮片;
(2)、水提法提取人参、山楂提取物,精选人参加水煎煮两次,第一次加水8倍量,煎煮2小时,第二次加水6倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至相对密度为1.29~1.31,温度为60℃清膏,备用;取山楂加水煎煮两次,第一次加水8倍量,煎煮2小时,第二次加水6倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至相对密度为1.29~1.31,温度为60℃清膏,备用;合并人参与山楂提取物;
(3)、将提取物与维生素B1、维生素B2、维生素B6、维生素E、泛酸钙、烟酰胺、辅料混合,可以加工制成颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂、膏剂。
实施例2
用醇提法制备本发明一种用于益气健脾、宁心安神的中药复方制剂,是以1000g为一个重量单位,人参120g、山楂300g、维生素B10.6g、维生素B20.6g、维生素B60.8g、维生素E2.9g、泛酸钙1.0g、烟酰胺2.0g、余量为辅料,蔗糖∶糊精=3∶1制成药物组合物。
通过下列步骤完成:
(1)、精选人参、山楂炮制处理为饮片;
(2)、醇提法提取人参:取人参准确称重后粉成粗粉,用60%乙醇润湿,放置约6小时后,装入渗滤罐浸泡48小时,然后开始渗滤,以每分钟3~5ml的速度渗滤至渗滤液无色,收集渗滤液、残渣挤压,榨出液与渗滤液合并浓缩,浓缩液备用;
(3)、醇提法提取山楂:取山楂准确称重后用75%乙醇加热,回流提取三次,时间为3小时、2小时、1小时,加醇量分别为8倍量、6倍量、4倍量,合并提取液、过滤、减压浓缩,浓缩液备用。
(4)、将提取物与维生素B1、维生素B2、维生素B6、维生素E、泛酸钙、烟酰胺、辅料混合,加工制成颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂或膏剂。
Claims (2)
1、一种用于益气健脾、宁心安神的中药复方制剂,其特征在于:其成分的组方为:以1000g为一个重量单位,人参40~120g、山楂200~400g、维生素B10.2~3.0g、维生素B20.2~3.0g、维生素B60.1~4.2g、维生素E0.9~3.9g、泛酸钙1.0~3.2g、烟酰胺0.8~3.0g、余量为辅料,蔗糖、糊精、蜂蜜、乙醇,制成的药物组合物为颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂或膏剂。
2、根据权利要求1所述的用于益气健脾、宁心安神的中药复方制剂的制备方法,其特征在于:它是通过下列步骤完成的:
(1)、精选人参、山楂炮制处理为饮片;
(2)、人参、山楂为提取物,其提取方法为:A水提法或B醇提法;
A水提法提取人参、山楂提取物:精选人参加水煎煮两次,第一次加水8倍量,煎煮2小时,第二次加水6倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至相对密度为1.29~1.31,温度为60℃清膏,备用;取山楂加水煎煮两次,第一次加水8倍量,煎煮2小时,第二次加水6倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至相对密度为1.29~1.31,温度为60℃清膏,备用;合并人参与山楂提取物;
B醇提法提取人参、山楂提取物:取人参准确称重后粉成粗粉,用60%乙醇润湿,放置约6小时后,装入渗滤罐浸泡48小时,然后开始渗滤,以每分钟3~5ml的速度渗滤至渗滤液无色,收集渗滤液、残渣挤压,榨出液与渗滤液合并浓缩,浓缩液备用;取山楂准确称重后用75%乙醇加热,回流提取三次,时间为3小时、2小时、1小时,加醇量分别为8倍量、6倍量、4倍量,合并提取液、过滤、减压浓缩,浓缩液备用;
(3)、将提取物与维生素B1、维生素B2、维生素B6、维生素E、泛酸钙、烟酰胺、辅料混合,加工制成颗粒剂、片剂、丸剂、胶囊剂、口服液、散剂、酒剂或膏剂的药物组合物。
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