CN107875181A - 一种治疗高脂血症和促进睡眠的组合物及其制备的方法 - Google Patents
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Abstract
本发明公开了一种治疗高脂血症和促进睡眠的组合物及其制备的方法。所述治疗高脂血症和促进睡眠的组合物是一种三七地上部分和牡蛎组合物,含有以下原料,并按下述重量份数配制:三七地上部分80份,牡蛎20份,经前处理、提取、精制、混合后得到组合物。药理实验表明该组合物能有效预防和治疗高脂血症,同时具有镇静安神、缓解焦虑紧张,能有效治疗由此导致的神经衰弱、失眠。本发明与现有同类产品相比具有如下优势:(1)二者协同增效,比单独使用效果好;(2)三七温热,牡蛎微寒,药性相互补益,适宜长期服用。
Description
技术领域
本发明属于食品、医药及保健技术领域,具体涉及一种以三七地上部分、牡蛎为原料治疗高脂血症和促进睡眠的中药组合物及其制备方法。
背景技术
现代社会食物极大丰富,饮食结构变化造成糖尿病、痛风、心脑血管疾病已成为危害人类疾病的主要原因。其中营养过剩是造成高脂血症及脂质代谢障碍从而引发动脉硬化的主要因素;同时,由于社会人口结构的深刻变化和社会快速发展,工作压力、生活压力及心理适应性骤然加大,广泛的心理焦虑、忧郁等导致神经衰弱、失眠等多发,据相关统计我国约20%人口受到心理压力导致的失眠、神经衰弱等困扰。以上是我国亚健康人群常见的体征指标和精神状态,药物治疗的不可持续性和毒副作用损害,使多数人放弃药物干预方式解决“非迫切性治疗需求”。天然功能性食品补充剂和适当运动成为解决此难题的最有效方案,尤其以天然功能食品补充剂开发具有巨大的商业前景。
三七为我国特有名贵药材,其是血症圣药,尤其是其地上部分,已经列为云南省地方特色食品,其富含达玛烷型人参二醇皂苷,不但对高脂血症具有显著的预防和治疗作用,还具有镇静安神、缓解焦虑紧张和改善睡眠等作用;牡蛎重镇安神,潜阳补阴,主治心悸失眠、烦躁不安,其性微寒,能合宜三七温热之性。二者均为药食两用原料,组方协同增效,且兼具安全、无毒、亲和、天然等优点,具有良好的开发应用价值。
发明内容
本发明的目的是提供一种三七地上部分和牡蛎为原料的组合物及其制备方法,该组合物能有效预防和治疗高脂血症,同时具有镇静安神、缓解焦虑紧张,能有效治疗由此导致的神经衰弱、失眠。
本发明所采取的技术方案提供一种三七地上部分和牡蛎组合物,含有以下原料,并按下述重量份数配制:三七地上部分80份,牡蛎20份。
本发明所采取的技术方案还提供一种三七地上部分和牡蛎组合物的制备方法,具体步骤和工艺如下:
A、前处理:取三七地上部分原料重量80份:三七花10份、三七茎叶70份,打碎成粗粉备用;取牡蛎原料重量20份,打碎成粗粉备用;
B、提取:(1)取三七地上部分前处理原料,加入10倍量75%乙醇(V/W),加热回流提取3次,每次提取2小时,合并三次提取液,浓缩成约0.4倍投料原料量的浸膏(三七粗浸膏);(2)取牡蛎前处理原料,加入10倍量水(V/W),加热回流8小时,浓缩至约0.2倍投料原料量的浸膏(牡蛎粗浸膏);
C、精制:(1)取三七粗浸膏,加入10倍量水,搅拌,加入5%量活性炭(按三七投料量计),搅拌,静置12小时,过滤,滤液用浸膏2倍量大孔吸附树脂吸附(按三七投料量),用2倍树脂量水洗脱除去糖类等杂质,再用85%乙醇洗脱下皂苷成分,收集乙醇洗脱液,浓缩成约0.2倍投料原料量的浸膏(三七皂苷);(2)取牡蛎粗浸膏,加入95%乙醇,使含醇量为60%,搅拌,静置5小时,过滤,滤液浓缩成约0.1倍投料原料量的浸膏(牡蛎肽浸膏);
D、混合:将三七皂苷与牡蛎肽混合,搅拌,干燥,粉碎,即得。
本发明所采取的技术方案包括所制备的组合物可以加入食品、保健品或药物领域可接受的辅料制备成口服液、片剂、胶囊剂、颗粒剂等便于服用和保存。
本发明与现有同类产品相比具有如下优势:(1)二者协同增效,比单独使用效果好;(2)三七温热,牡蛎微寒,药性相互补益,适宜长期服用。
具体实施方式
为使本领域技术人员详细了解本发明的生产工艺和技术效果,下面以具体的生产实例来进一步介绍本发明的应用和技术效果。
实施例(一):中药组合物制备
A、前处理:取三七地上部分原料80公斤:三七花10公斤、三七茎叶70公斤,打碎成粗粉备用;取牡蛎原料20公斤,打碎成粗粉备用;
B、提取:(1)取三七地上部分前处理原料(80公斤),加入10倍量75%乙醇(800L),加热回流提取3次,每次提取2小时,合并三次提取液,浓缩成浸膏(三七粗浸膏:34.3公斤);(2)取牡蛎前处理原料(20公斤),加入10倍量水(200L),加热回流8小时,浓缩成浸膏(牡蛎粗浸膏:3.9公斤);
C、精制:(1)取三七粗浸膏(34.3公斤),加入10倍量水(343L),搅拌,加入4公斤活性炭(200目),搅拌,静置12小时,过滤,滤液用160公斤大孔吸附树脂吸附,用320L水洗脱除去糖类等杂质,再用85%乙醇洗脱下皂苷成分(薄层色谱检测),收集乙醇洗脱液;浓缩成浸膏(三七皂苷:16.3公斤);(2)取牡蛎粗浸膏,加入95%乙醇,使含醇量为60%,搅拌,静置5小时,过滤,滤液浓缩成浸膏(牡蛎肽:2.2公斤);
D、混合:将三七皂苷与牡蛎肽混合,搅拌,干燥,粉碎,得组合物6.76公斤。
实施例(二):组合物片剂的制备
取实施例(一)中的组合物2000g,加淀粉2000g,用75%乙醇制粒,干燥,整粒,加入硬脂酸镁50g,混匀,压片(每片0.4g),得9850片;
实施例(三):组合物口服液的制备
取实施例(一)中的组合物2000g、果糖1500g、柠檬酸200g,加蒸馏水200L,加热搅拌使溶解,加入食用香精(香蕉香)80g,搅拌均匀,灌封(每支20ml),90℃水浴灭菌2小时,得9923支口服液。
实施例(四):组合物治疗失眠疗效观察
1.病例选择
随机选择80例,男40例,女40例;年龄35~65岁,平均年龄44.5岁。病程3个月~6个月。入选者指标:A、入睡困难超过1h;B、睡眠时间每日不足4h;C、易醒、多梦或入睡时半睡半醒;D、轻重不等的头晕、乏力或易疲劳。具备以上三项者并停服其他药物24小时以上可入选为观察病例;患者随机分成两组:组合物片组、七叶神安片组。
2.试验方法
取实施例中的组合物,压制成片剂,每片含提取物200mg;连服10天,每天2次,中午11:30-12:00服用2片;晚上21:00-21:30点服用3片。
治疗期间患者作息规律、不服用含咖啡因饮料、不服用其他治疗睡眠药物;观察患者入睡所需时间、睡眠持续时间、自我感觉身体状态及不良反应;电话随访。
(1)入睡时间
由上表数据表明,组合物片组患者在30分钟内入睡为36例(占80%),七叶神安片组患者在30分钟内入睡为26例(占65%);1小时以内不能入睡患者,组合物片组2例(占5%),七叶神安片组5例(12.5%)。组合物疗效优于七叶神安片。
(2)睡眠时间
由上表数据表明,组合物片组患者在通过治疗睡眠时间达到6小时的有17例(占42.5%),七叶神安片组为12例(占30%)。组合物疗效优于七叶神安片。
(3)患者身体状态及不良反应
由上表数据表明,组合物片组患者感觉服药后睡眠质量明显改善的有19例(占47.5%),七叶神安片组为14例(占35%)。组合物疗效优于七叶神安片。
实施例(五):组合物治疗高脂血症疗效观察
1、病例选择
患者78例,其中男30例,女28例,年龄35~55岁,病程6个月~2年,继发性脂质异常18例,单纯血胆固醇(TC)增高11例、单纯血甘油三酯(TG)增高33例,两者都增高的混合型15例。所选患者排除其他疾病及药源性引起的血脂升高;无痛风、高血压、糖尿病等并发疾病。
2、诊断标准
2.1诊断标准参照《中国成人血脂异常防治指南》:正常饮食情况下,血标本(血清)检查符合以下其中1项或以上者即可确诊,血清总胆固醇(TC≥5.72mmol/L,血清甘油三脂(TG)≥1.70mmol/L,低密度脂蛋白胆固醇(LDL-C≥3.64mmol/L。
2.2疗效判断标准参照《药物临床研究及指导原则》制定:(1)显效:TC、TG恢复正常或TC下降大于等于20%;TG下降大于等于40%。(2)有效:TC下降10%~20%,TG下降20%~40%。(3)无效:未达到“有效”标准。
3、治疗方法
取实施例(一)中的组合物,压制成片剂,每片含提取物200mg;每天2次,中午9:00-10:00服用3片;晚上20:00-21:00点服用3片,15天为1个疗程(两个疗程间隔3天)。
治疗期间停服其他降脂类药物、作息规律、正常饮食(戒酒);分别于治疗后1、2、3个疗程随访观察血脂情况。
4、治疗效果
由上表数据表明,组合物片具有显著的治疗高脂血症效果,但其疗效与七叶神安片没有统计学差异。
以上实施例仅用以说明而非限制本发明的技术方案,尽管参照上述实施例对本发明进行了详细说明,本领域技术人员应当理解,依然可以对本发明进行修改或者等同替换,而不脱离本发明的精神和范围的任何修改或局部替换,其均应涵盖在本发明的权利要求范围中。
Claims (13)
1.一种治疗高脂血症和促进睡眠的组合物,其特征在于:所述治疗高脂血症和促进睡眠的组合物包括原料重量份三七地上部分80份、牡蛎20份,经前处理、提取、精制、混合后制备得到的组合物。
2.一种权利要求1所述的治疗高脂血症和促进睡眠的组合物的制备方法,其特征在于包括前处理、提取、精制、混合步骤,具体包括:
A、前处理:取三七地上部分原料重量80份:三七花10份、三七茎叶70份,打碎成粗粉备用;取牡蛎原料重量20份,打碎成粗粉备用;
B、提取:(1)取三七地上部分前处理原料,加入10倍量75%乙醇(V/W),加热回流提取3次,每次提取2小时,合并三次提取液,浓缩成约0.4倍投料原料量的三七粗浸膏;(2)取牡蛎前处理原料,加入10倍量水(V/W),加热回流8小时,浓缩至约0.2倍投料原料量的牡蛎粗浸膏;
C、精制:(1)取三七粗浸膏,加入10倍量水,搅拌,加入5%量活性炭,搅拌,静置12小时,过滤,滤液用浸膏2倍量大孔吸附树脂吸附,用2倍树脂量水洗脱除去糖类等杂质,再用85%乙醇洗脱下皂苷成分,收集乙醇洗脱液,浓缩成约0.2倍投料原料量的三七皂苷;(2)取牡蛎粗浸膏,加入95%乙醇,使含醇量为60%,搅拌,静置5小时,过滤,滤液浓缩成约0.1倍投料原料量的牡蛎肽浸膏;
D、混合:将三七皂苷与牡蛎肽混合,搅拌,干燥,粉碎,即得目标物组合物。
3.根据权利要求2所述的制备方法,其特征在于A步骤中所述的三七地上部分与牡蛎的重量份数比例在5:5~9:1之间。
4.根据权利要求2所述的制备方法,其特征在于A步骤中所述的三七花与三七茎叶的重量份数比例在0:1~1:0之间。
5.根据权利要求2所述的制备方法,其特征在于B步骤中所述的乙醇溶液的质量百分比浓度为50%~85%。
6.根据权利要求2所述的制备方法,其特征在于B步骤中所述提取加液量为5~20倍。
7.根据权利要求2所述的制备方法,其特征在于B步骤中所述三七地上部分提取时间为0.5~4h。
8.根据权利要求2所述的制备方法,其特征在于B步骤中所述牡蛎提取时间为3~10h。
9.根据权利要求2所述的制备方法,其特征在于B步骤中所述的三七地上部分提取物浸膏为0.2~0.6倍投料原料量。
10.根据权利要求2所述的制备方法,其特征在于B步骤中所述的牡蛎提取物浸膏为0.1~0.3倍投料原料量。
11.根据权利要求2所述的制备方法,其特征在于C步骤中所述的三七粗浸膏加入5~15倍水搅拌,加入3%~10%量活性炭,搅拌,静置8~24h即可。
12.根据权利要求2所述的制备方法,其特征在于C步骤中所述的三七提取物滤液用浸膏1.5~5倍量大孔吸附树脂吸附,用1.5~5倍树脂量水洗脱除去糖类等杂质,再用70~90%乙醇洗脱下皂苷成分,收集乙醇洗脱液,浓缩成约0.1~0.3倍投料原料量的浸膏。
13.根据权利要求2所述的制备方法,其特征在于C步骤中所述的牡蛎粗浸膏,加入75~95%乙醇,使含醇量为45~75%,搅拌,静置4~8小时,过滤,滤液浓缩成为0.1~0.3倍投料原料量的浸膏。
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