CN107296836A - 一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法 - Google Patents
一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法 Download PDFInfo
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Abstract
本发明一种具有镇静、安神作用的刺五加酸枣仁口服液及其制备方法,是用具有镇静、安神作用的酸枣仁为君药,以补肾健脾、益智安神作用的刺五加为臣药,经科学方法加工制备而成。其制备方法简述为,取刺五加和酸枣仁,加水煎煮后,用醇沉的方法,除去醇不溶物,加入适量矫味剂、防腐剂,加水至一定量,搅拌均匀,过滤,灌装,灭菌,即得。
Description
技术领域
本发明属保健食品开发领域,具体涉及一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法。
背景技术
失眠症在现今社会普遍发生,失眠不仅影响人们夜间的休息状况,还会影响白天的工作和生活。长期失眠,还易使人产生焦虑、烦躁、抑郁等精神症状。许多失眠症患者会服用巴比妥类和苯二氮卓类药物,长期服用此类药物会产生许多副作用,如焦虑、恐惧、妄想、幻觉及惊厥等。中药治疗失眠的副作用小,无成瘾性,因此是现在研究镇静催眠药物的新方向。
酸枣仁,别名枣仁、酸枣核、山枣仁。由鼠李科乔木酸枣成熟果实去果肉、核壳,收集种子,晒干而成。主要产于河南、河北、陕西、辽宁、山西、山东、云南等地。秋季果实成熟时采收,去果肉及硬核,取种子,生用或微炒用。
中国最早的一部药书《神农本草经》中记载:“补中益肝,坚筋骨,助阴气,皆酸枣仁之功也。”明代李时珍《本草纲目》中记载,枣仁“熟用疗胆虚不得眠,烦渴虚汗之症;生用疗胆热好眠,皆足厥阴少阳药也”。功效养肝,宁心,安神,敛汗。
现代研究表明,酸枣仁主要成分为酸枣仁皂苷(jujuboside)、生物碱、多种氨基酸、金属元素、白桦脂酸、桦木素、阿魏酸、维生素C及植物甾醇,环磷酸腺苷等,其生理功能主要是改善睡眠。药理实验对小鼠、豚鼠、猫、兔、犬均有镇静催眠作用。对大鼠做脑电测试,灌胃后睡眠时间(TS)和深睡阶段(SWS2)持续时间分别增加51min(26.0%)和41.4min(116.3%),差异极显著(P<0.001)。6h内TS发作频率平均减少22.7次(-36.3%),每次发作持续时间增加3.5min(+89.0%),差异均极显著(P<0.001)。其安全性LD50>(14.3±2.0)g/kg(小鼠腹腔注射酸枣仁煎剂),小鼠150g/kg经口未出现毒性。f小鼠煎剂经口20g/kg,历时30d,给药后出现安静现象,平均体重增长比对照组快,食欲无明显差别。食疗价值食疗功效
近年来有人将酸枣仁与安定药比较,发现有许多相似之处。酸枣仁煎剂给大鼠腹腔注射后,所有动物表现安静和嗜睡。但外界刺激可使之惊醒。加大剂量到中毒剂量,小鼠亦未出现翻正反射消失和麻醉。煎剂给小鼠灌胃后可抑制条件反射,而不抑制非条件反射。对皮下注射盐酸吗啡使猫产生的狂躁现象,酸枣仁也有显著的对抗作用。
刺五加别名刺拐棒、坎拐棒子、一百针、老虎潦,为五加科植物刺五加的干燥根及根茎、树皮,叶、茎、果实亦可供药。该药性温,味辛、微苦,无毒,入脾肾经。能扶正固本、补肾健脾、益智安神。主治脾肾阳虚、腰膝酸软、体虚乏力、失眠多梦、食欲不振。
现代研究表明,刺五加有促性腺、抗疲劳和防止记忆衰退等活性,特别是所含的多种糖类及刺五加苷是理想的干扰素促诱生剂,可提高机体内IFN水平,增强肌体免疫力。近年来,国内外学者经过大量的研究和实验,证实刺五加含有多种活性成分。
刺五加在中国医药学中做为药物广泛应用已有悠久的历史,具有“补中益精、坚筋骨、强志意”的作用,久服“轻身耐老”,与它药配伍亦可“进饮食、健气力、不忘事”。另雷教著《炮炙论》记五加皮有“阳人使阴,阴人使阳”的作用。国外对人参及其近缘植物刺五加进行了较系统的研究,证明了刺五加和人参有相似的药理作用和临床疗效。
酸枣仁和刺五加都是药食同源的食物。
发明内容
本发明一种具有镇静、安神作用的刺五加酸枣仁口服液体制剂及其制备方法,是用具有镇静、安神作用的酸枣仁为君药,以补肾健脾、益智安神作用的刺五加为臣药,经科学方法制备而成,本发明的技术方案如下:
处方:刺五加200-300g 酸枣仁100-200g 辅料 适量
制备方法:
取处方量的刺五加和酸枣仁,加水煎煮两次,第一次加水8~12倍量煎煮1~3小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水6~8倍量,煎煮1~2小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩至比重1.20~1.25的稠膏,备用;
1、口服液制备
取上述比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到60~80%,冷藏静止24~48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.05~1.10的清膏,加入适量矫味剂、防腐剂,加水至一定量,搅拌均匀,过滤,灌装,灭菌,即得。
所述矫味剂包括蔗糖、乳糖、果糖一种或多种,还包括甜菊素、阿斯巴甜、草莓香精、橘子香精、山楂香精中的一种或多种;
所述防腐剂包括苯甲酸、苯甲酸钠、山梨醇、山梨酸一种或几种以上混合物;
所述过滤,是用孔径为0.45um的滤器过滤;
所述灭菌,是100℃湿热灭菌30~60min,也可以是121℃灭菌15min;
所述灌装,是将滤液灌装与10ml~150ml密闭容器中。
2、糖浆剂的制备
取上述比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到60~80%,冷藏静止24~48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.20~1.25的稠膏,加入单糖浆,加水至一定量,搅拌均匀,过滤,灌装,灭菌,即得。
所述加水一定量,是指加水调整含糖量在45%以上。
3、煎膏剂的制备
取上述比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到60~80%,冷藏静止24~48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.20~1.25的稠膏,加练蜜、糖,加水至一定量,灌装,灭菌,包装,即得。
4、茶剂的制备
取上述比重1.20~1.25的稠膏,干燥,粉碎成细粉,加入事先准备好的茶叶粉末,混合均匀,包装,即得。
所述茶叶,可以是任何的绿茶或红茶。
5、果冻的制备
取上述比重1.20~1.25的稠膏,加至以加热融化的QQ糖中,在加热及搅拌状态下加入水果或矫味剂中,过滤,分装,放置冷库中冷却,即得。
所述水果,可以是苹果、梨、草莓、橘子等任何一种或多种;
所述矫味剂可以是蜂蜜、蔗糖、乳糖、果糖一种或多种,还可以是甜菊素、阿斯巴甜、草莓香精、橘子香精、山楂香精中的一种或多种;
所述放置冷库中冷却,是指冷却温度在-3~8℃。
6、软胶囊剂制备
取上述比重1.20~1.25的稠膏,将稠膏密封于胶囊壳中,包装,既得。
所述胶囊壳,是指用食用明胶制备的;
7、固体口服制剂制备
取上述比重1.20~1.25的稠膏,干燥,粉碎成细粉,加入一定量的辅料,制成颗粒剂或片剂或胶囊剂或水丸。
所述辅料,是指粘合剂、崩解剂、稀释剂和润滑剂。
所述粘合剂包括但不限于水、50-95%乙醇、羟丙基甲基纤维素、乙基纤维素、聚维酮k30、或淀粉的一种、二种或二种以上混合物,数量为适量;
所述崩解剂包括但不限于可溶性淀粉、交联羧甲基纤维素钠、羧甲淀粉钠、羧甲基纤维素钠、交联聚维酮中的一种、二种或二种以上的混合物;
所述稀释剂包括但不限于蔗糖、微晶纤维素、乳糖、预交化淀粉、甘露醇或糊精中的一种、二种或二种以上的组合物;
所述润滑剂包括但不限于微粉硅胶、滑石粉或硬脂酸镁。
具体实施例
实施例1刺五加与五味子合用后对小鼠的镇静催眠作用。
试验方法:采用阈上和阈下剂量戊巴比妥钠致小鼠睡眠法,对酸枣仁和刺五加单用及合用的镇静催眠作用进行比较研究。应用戊巴比妥钠所致小鼠睡眠的方法,研究酸枣仁和刺五加改善睡眠作用的量效关系。结果:酸枣仁可以延长睡眠时间(P<0.01),起效剂量为16g/kg,起效范围为16~128g/kg,其中剂量为64g/kg时效果最为显著。刺五加可以缩短睡眠潜伏期(P<0.05),起效剂量为3g/kg,起效范围为3~12g/kg,其中剂量为12g/kg时效果最为显著。与空白组相比,酸枣仁和刺五加合用组可显著缩短戊巴比妥钠小鼠的入睡潜伏期(P<0.01)并能延长其睡眠时间(P<0.01),能明显增加阈下剂量戊巴比妥钠小鼠的入睡率(P<0.05)。其作用优于单用酸枣仁组和单用刺五加组。结论:酸枣仁和刺五加合用具有镇静催眠的作用。
1、酸枣仁镇静催眠作用的量效关系研究实验结果表明,酸枣仁水煎液对小鼠的睡眠潜伏期无影响,但可延长睡眠时间,起效剂量为16g/kg,在16~64g/kg剂量范围内,随剂量增大,睡眠时间延长,到64g/kg效果不再增加,存在一定剂量依赖关系。其中,酸枣仁水煎液剂量为64g/kg时效果最为显著。结果见表1。
表1酸枣仁镇静催眠作用的量效关系剂量(g/kg)
与空白组相比*P<0.05,**P<0.01
2、刺五加镇静催眠作用的量效关系研究实验结果表明,刺五加水煎液对小鼠的睡眠时间无影响,但可缩短睡眠潜伏期,起效剂量为3g/kg,在3~12g/kg剂量范围内,随剂量增大,睡眠潜伏期缩短,存在一定剂量依赖关系,其中,五味子水煎液剂量为12g/kg时效果最为显著,结果见表2。
表2五味子镇静催眠作用的量效关系
组别 | 剂量(g/kg) | 鼠数(只) | 睡眠潜伏期(min) | 睡眠潜伏期(min) |
空白 | 12 | 3.23±0.71 | 40.28±15.91 | |
地西洋 | 2.5mg/kg | 12 | 1.93±0.37** | 134.65±38.33** |
酸枣仁 | 0.095 | 12 | 3.11±0.29 | 42.00±16.63 |
酸枣仁 | 0.19 | 12 | 3.19±0.53 | 45.59±16.07 |
酸枣仁 | 0.375 | 12 | 2.94±0.82 | 46.10±19.00 |
酸枣仁 | 0.75 | 12 | 2.80±0.64 | 50.07±21.28 |
酸枣仁 | 1.5 | 12 | 2.82±0.66 | 58.39±22.04 |
酸枣仁 | 3 | 12 | 2.66±0.52* | 56.25±20.66 |
酸枣仁 | 6 | 12 | 2.42±0.67* | 53.97±23.93 |
酸枣仁 | 12 | 12 | 2.42±0.89 | 49.21±17.54 |
刺五加与五味子合用对阈上剂量戊巴比妥钠的小鼠催眠作用的影响实验结果表明,和空白组比较,单用刺五加时,能显著延长小鼠的睡眠时间,但对睡眠潜伏期没有影响;单用五味子时,能显著缩短小鼠的睡眠潜伏期,但睡眠时间没有影响;刺五加与五味子合用各剂量组既可以显著地缩短小鼠的睡眠潜伏期,也可以延长睡眠时间,结果见表3。
表3对阈上剂量戊巴比妥钠的小鼠催眠作用的影响
实验结果表明,和空白组比较,酸枣仁和刺五加合用高剂量组,能明显增加小鼠入睡只数,提高入睡率,结果见表4。
表4对阈下剂量戊巴比妥钠的小鼠催眠作用的影响(x珋±s)
组别 | 剂量(g/kg) | 鼠数(只) | 入睡数 | 入睡率(%) |
空白 | 10 | 1 | 10 | |
地西泮 | 2.5mg/kg | 10 | 10 | 100 |
酸枣仁 | 64 | 10 | 5 | 50 |
刺五加 | 12 | 10 | 4 | 40 |
酸枣仁+刺五加 | 19(16+3) | 10 | 4 | 40 |
酸枣仁+刺五加 | 38(32+6) | 10 | 6 | 60 |
酸枣仁+刺五加 | 76(64+12) | 10 | 7 | 70 |
实施例二(口服液制备)
按发明内容的制备方法进行制备:
1、取刺五加250g和酸枣仁175g,加水煎煮两次,第一次加水8倍量煎煮2小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水6倍量,煎煮1小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩,浓缩至比重1.20~1.25的稠膏,备用;
2、在搅拌状态下,将上述稠膏加至事先准备好的乙醇中,使乙醇含量达到75%,冷藏静止48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.05~1.10的清膏,加入蔗糖133g、苯甲酸钠2g,加水至1000ml,搅拌均匀,过滤,灌装,灭菌,即得。
实施例三(煎膏剂的制备)
取刺五加300g和酸枣仁150g,加水煎煮两次,第一次加水10倍量煎煮1.5小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水8倍量,煎煮1小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩,浓缩至比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到80%,冷藏静止24小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.20~1.25的稠膏,加练蜜250g、糖200g,加水至1000ml,灌装,灭菌,包装,即得。
实施例四(果冻的制备)
1、取刺五加200g和酸枣仁200g,加水煎煮两次,第一次加水10倍量煎煮1小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水8倍量,煎煮1小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩,浓缩至比重1.20~1.25的稠膏,备用;
2、取QQ糖10枚加热至融化,在搅拌状态下加入上述稠膏和苹果汁,过滤,分装,放置冷库中冷却,即得。
实施例五(颗粒剂的制备)
取刺五加250g和酸枣仁175g,加水煎煮两次,第一次加水10倍量煎煮2小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水8倍量,煎煮1小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩,浓缩至比重1.20~1.25的稠膏,干燥,粉碎成细粉,加至880g蔗糖粉中,混合均匀,制粒,干燥,颗粒筛分,加入150g硬脂酸镁,混合均匀后包装,即得。
实施例六(软胶囊的制备)
取刺五加250g和酸枣仁175g,加水煎煮两次,第一次加水10倍量煎煮3小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水8倍量,煎煮1小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩,浓缩至比重1.20~1.25的稠膏,用明胶壳包裹,包装,即得。
上述所有实施例所得刺五加酸枣仁制剂,都具有镇静、安神、提高免疫力作用,对于长期失眠,焦虑、烦躁、抑郁等精神症状患者具有很好的调节作用。
Claims (15)
1.一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,是由刺五加200-300g、酸枣仁100-200g及适量的辅料经科学方法加工而成,其制备方法如下:
1.1取上述处方量的刺五加和酸枣仁,加水煎煮两次,第一次加水8~12倍量煎煮1~3小时,煎煮液滤过,滤液放置洁净容器中,备用;滤渣加水6~8倍量,煎煮1~2小时,煎煮液滤过,滤液与第一次煎煮滤液合并后浓缩,浓缩至比重1.20~1.25的稠膏,备用;
(1)口服液制备
取上述比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到60~80%,冷藏静止24~48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.05~1.10的清膏,加入适量矫味剂、防腐剂,加水至一定量,搅拌均匀,过滤,灌装,灭菌,即得;
(2)糖浆剂的制备
取上述比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到60~80%,冷藏静止24~48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.20~1.25的稠膏,加入单糖浆,加水至一定量,搅拌均匀,过滤,灌装,灭菌,即得;
(3)煎膏剂的制备
取上述比重1.20~1.25的稠膏,在搅拌状态下,将稠膏加至事先准备好的乙醇中,使乙醇含量达到60~80%,冷藏静止24~48小时,取上清液,回收乙醇至无醇味,并继续浓缩至比重为1.20~1.25的稠膏,加练蜜、糖,加水至一定量,灌装,灭菌,包装,即得;
(4)茶剂的制备
取上述比重1.20~1.25的稠膏,干燥,粉碎成细粉,加入事先准备好的茶叶粉末,混合均匀,包装,即得;
(5)果冻的制备
取上述比重1.20~1.25的稠膏,加至以加热融化的QQ糖中,在加热及搅拌状态下加入水果或矫味剂中,过滤,分装,放置冷库中冷却,即得。
(6)软胶囊剂制备
取上述比重1.20~1.25的稠膏,将稠膏密封于胶囊壳中,包装,既得;
(7)固体口服制剂制备
取上述比重1.20~1.25的稠膏,干燥,粉碎成细粉,加入一定量的辅料,制成颗粒剂或片剂或胶囊剂或水丸。
2.根据权利要求1(1)中所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述矫味剂包括蔗糖、乳糖、果糖一种或多种,还包括甜菊素、阿斯巴甜、草莓香精、橘子香精、山楂香精中的一种或多种。
3.根据权利要求1(1)中所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述防腐剂包括苯甲酸、苯甲酸钠、山梨醇、山梨酸一种或几种以上混合物。
4.根据权利要求1中(1)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述灭菌,是100℃湿热灭菌30~60min,也可以是121℃灭菌15min。
5.根据权利要求1中(1)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述灌装,是将滤液灌装与10ml~150ml密闭容器中。
6.根据权利要求1中(2)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述加水一定量,是指加水调整使含糖量在45%以上。
7.根据权利要求1中(4)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,所述茶叶,可以是任何的绿茶或红茶。
8.根据权利要求1中(5)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述水果,可以是苹果、梨、草莓、橘子等任何一种或多种。
9.根据权利要求1中(5)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述矫味剂可以是蜂蜜、蔗糖、乳糖、果糖一种或多种,还可以是甜菊素、阿斯巴甜、草莓香精、橘子香精、山楂香精中的一种或多种。
10.根据权利要求1中(5)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述放置冷库中冷却,是指冷却温度在-3~8℃。
11.根据权利要求1中(7)所述一种具有镇静、安神作用的刺五加酸枣仁口服制剂及其制备方法,其特征在于所述辅料,是指粘合剂、崩解剂、稀释剂和润滑剂。
12.根据权利要求10所述粘合剂,其特征在于所述粘合剂包括但不限于水、50-95%乙醇、羟丙基甲基纤维素、乙基纤维素、聚维酮k30、或淀粉的一种、二种或二种以上混合物,数量为适量。
13.根据权利要求10所述崩解剂,其特征在于所述崩解剂包括但不限于可溶性淀粉、交联羧甲基纤维素钠、羧甲淀粉钠、羧甲基纤维素钠、交联聚维酮中的一种、二种或二种以上的混合物。
14.根据权利要求10所述稀释剂,其特征在于所述稀释剂包括但不限于蔗糖、微晶纤维素、乳糖、预交化淀粉、甘露醇或糊精中的一种、二种或二种以上的组合物。
15.根据权利要求10所述润滑剂,其特征在于所述润滑剂包括但不限于微粉硅胶、滑石粉或硬脂酸镁。
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