CN116549541B - 一种减重的复方组合物及其制剂 - Google Patents
一种减重的复方组合物及其制剂 Download PDFInfo
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- CN116549541B CN116549541B CN202310707137.XA CN202310707137A CN116549541B CN 116549541 B CN116549541 B CN 116549541B CN 202310707137 A CN202310707137 A CN 202310707137A CN 116549541 B CN116549541 B CN 116549541B
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Classifications
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Abstract
本发明公开了一种减重的复方组合物及其制剂,属于植物活性物质提取技术领域。其减重的复方组合物包括组分番泻叶、绿茶、决明子、荷叶、泽泻。其制备方法包括步骤:油分提取、厌氧发酵、离子液体提取、冻干。本发明通过三段提取方法,尽可能保留多不同类型的活性有效成分。本发明最后得到的组合物,经试验证明对减重有统计学意义上的治疗作用。
Description
技术领域
本发明属于植物活性物质提取技术领域,具体涉及一种减重的复方组合物及其制剂。
背景技术
肥胖是指身体储存了过多的脂肪,导致体重超出正常范围而引起的健康问题。它在世界范围内都是一种持续增长的公共卫生问题,并且会增加很多慢性疾病的风险,例如高血压、心脏病、糖尿病、骨关节疾病等。此外,肥胖还可能对个体产生不良心理和社会后果,会增加医疗成本。因此,亟需提供一款安全性好的减脂减肥产品来满足消费者需求。
目前奥利司他是国内唯一批准的口服减重药,但也具有一定的副作用,例如肠胃不适,脂肪泻、大便失禁等。
碧生源牌纤纤茶(国食健注G20110711)是以番泻叶、绿茶、决明子、荷叶、泽泻作为原料,具有减少脂肪吸收效果从而辅助减肥的产品。然而此产品问世已经十余年,其生产工艺较为原始,对温度敏感和易氧化的有效成分容易流失,具有一定的改进空间。
发明内容
本发明提供了一种减重的复方组合物及其制剂,基于碧生源牌纤纤茶进行改进,通过制备方法的改进从而提高其中有效成分的效果。
为了实现上述目的,本发明采用以下技术方案:
一种减重的复方组合物,其制备方法包括以下步骤:
(1)油分提取:将决明子粉碎,低温冷榨;得决明子油和决明子粕;
(2)厌氧发酵:将番泻叶、绿茶、荷叶粉碎后与决明子粕混合,在厌氧环境下发酵一段时间,发酵后高温超声处理,过滤发酵液与发酵底物;
(3)离子液体提取:发酵底物利用离子液体萃取,然后通过有机溶剂反萃取分离并回收离子溶液,去除有机溶剂,得萃取液;
(4)冻干:将萃取液、过滤发酵液混合浓缩,再与决明子油混合均匀,通过低温冻干技术得到减重的复方组合物。
特别地,在步骤(1)油分提取中,将决明子粉碎至≤3mm,压榨温度为40-60℃。
特别地,在步骤(2)厌氧发酵中,发酵的菌种为丁酸梭菌、枯草芽孢杆菌、嗜酸乳酸杆菌的组合,其质量比为1∶0.5-1∶0.2-0.3,初始浓度为106-108CFU/ml,添加量为番泻叶、绿茶、荷叶、决明子粕总质量的0.8-1.25wt%。
特别地,在步骤(2)厌氧发酵中,发酵的温度为28-32℃,发酵时间为16-24h。
特别地,在步骤(2)厌氧发酵中,在发酵后将发酵液加热至65-75℃并超声5-10min灭菌。
特别地,在步骤(3)离子液体提取中,使用胆碱类离子液体,添加量为发酵底物的120-160wt%。
特别地,在步骤(3)离子液体提取中,反萃取的有机溶剂为乙醇,乙醇的用量为离子液体的100-120wt%。
特别地,在步骤(4)冻干中,将萃取液、过滤发酵液混合浓缩至浓度≥1.1g/ml。
一种制剂,包含前述的减重的复方组合物。
本发明包括番泻叶、绿茶、决明子、荷叶、泽泻五种植物原料,其中绿茶富含咖啡因和多种生物活性物质,可以促进代谢、加速脂肪氧化分解,消耗体内脂肪,达到减肥的效果。
而番泻叶含有大量的蒽醌类成分,如番泻苷A、番泻苷B、芦荟大黄素等,这些成分能够刺激肠道神经末梢,加速肠道蠕动,促进排便。
决明子含有苷类物质、大黄素、油脂以及大量的纤维素,能够刺激肠道蠕动。
荷叶中含有荷叶碱、柠檬酸、苹果酸、葡萄糖酸、草酸、琥珀酸等。其中荷叶碱中含有多种有效的化脂生物碱,可以分解体内的脂肪并附着在人体肠壁上,形成脂肪隔离膜,阻止脂肪吸收。
泽泻中含有泽泻醇(A、B)、乙酸泽泻醇(A、B)酯、挥发油和生物碱等成分,能够刺激肠道壁运动,促进排便。
本发明中,决明子含有较高的油脂含量,而其他组分的油脂含量较低。决明子油含有丰富的黄酮类化合物,可以软化粪便并促进肠壁蠕动,从而加速排泄,改善便秘和肠道问题。
本发明的短时间厌氧发酵,增加有机酸的含量。有机酸能够调节肠道菌群平衡,且部分如草酸等有机酸可以促进肠道蠕动。有机酸还具有抗氧化的作用,保护本发明中如油脂等易氧化的成分防止变质,但如果发酵时间过长,会导致纤维素或者生物碱的损失导致反而无法增强肠道蠕动的效果,所以要严格控制发酵的时间。
本发明使用的丁酸梭菌(Clostridium butyricum)、枯草芽孢杆菌(Bacillussubtilis)、嗜酸乳酸杆菌(Lactobacillus acidophilus)均为已经证明可用在食品上的厌氧发酵菌种。本发明发现,采用三种菌种混合发酵,能够比单一菌种在相同发酵环境和菌种用量下能获得更多的有机酸。
本发明的厌氧发酵除了获得部分的有益次生代谢物外,还能溶解细胞壁释放出植物内部的物质有助于提取。
本发明采用离子液体法提取,常用胆碱丙氨酸离子液体提取,也可以使用其他的胆碱类离子液体。离子液体提取的温度较低,能够更好地保留植物成分的天然活性。本发明发现针对于本发明的五种原料,胆碱类离子液体相比其他类型的离子液体具有较高的极性和离子化程度,能够与植物原料中的多种生物活性物质发生强的疏水相互作用,最后离子液体还能回收再利用。
与现有技术相比,本发明的有益效果为:
(1)本发明通过三段提取方法,尽可能保留多不同类型的活性有效成分。
(2)本发明通过短时间厌氧发酵,增加有机酸等对减重有益的成分的含量。
(3)本发明提取过程全程使用的溶剂以及过程中使用的必要物质均为无毒或低毒物质,且挥发后无残留,保证了对人体的安全性。
(4)本发明最后得到的组合物,经试验证明对减重有统计学意义上的治疗作用。
具体实施方式
为了更好地理解本发明,下面结合具体实施例对本发明作进一步的描述,其中实施例中使用的术语是为了描述特定的具体实施方案,不构成对本发明保护范围的限制。
本发明中:
番泻叶为豆科植物狭叶番泻Cassia angustifolia Vah1或尖叶番泻Cassiaacutifolia Delile的干燥小叶。
绿茶为山茶科值误差Camellia sinensis(L.)O.Ktze.的干燥嫩叶。春至秋季采收,未经发酵,经杀青、揉拧、干燥等工艺的制成品。
决明子为豆科植物钝叶决明Cassia obtusifolia L.或决明(小决明)Cassiatora L.的干燥成熟种子。秋季采收成熟果实,晒干,打下种子,除去杂质。
荷叶为睡莲科植物莲Nelumbo nucifera Gaertn.的干燥叶。夏、秋二季采收,晒至七八成干时,除去叶柄,折成半圆形或折扇形,干燥。
泽泻为泽泻科植物东方泽泻Alisma orientale(Sam.)Juzep.或泽泻Alismaplantago-aquatica Linn.的干燥块茎。冬季茎叶开始枯萎时采挖,洗净,干燥,除去须根和粗皮。
实施例一减重的复方组合物的制备
一种减重的复方组合物,其制备方法包括以下步骤:
(1)称量:将绿茶、决明子、番泻叶、荷叶、泽泻按质量比为4∶3∶2∶2∶1的比例称取各原料分开备用。
(2)油分提取:将决明子粉碎,低温冷榨,得决明子油和决明子粕;
(3)厌氧发酵:将番泻叶、绿茶、荷叶粉碎后与决明子粕混合,在厌氧环境下发酵一段时间,发酵后高温超声处理,过滤发酵液与发酵底物;
(4)离子液体提取:发酵底物利用乙酰丙酸胆碱离子液体萃取,然后通过乙醇反萃取分离并回收离子溶液,去除有机溶剂,得萃取液;
(5)冻干:将萃取液、过滤发酵液混合浓缩至浓度≥1.1g/m,再与决明子油混合均匀,通过低温冻干技术得到减重的复方组合物。
步骤(2)-(5)中的技术参数如下表1所示。
表1技术参数
取碧生源牌纤纤茶(国食健字G20110711,北京澳特舒尔保健品开发有限公司,生产批号19190503,生产日期2019.05.24)作为对比例;分别测量其茶多酚含量、总蒽醌含量和有机酸的含量,结果如表2所示。
茶多酚含量的测试方法根据《GB/T 8313-2018茶叶中茶多酚和儿茶素类含量的检测方法》中茶叶中茶多酚的检测部分进行测量。
总蒽醌含量的测试方法参考《保健食品中总蒽醌的测定》(叶碧莎等,中国卫生检验杂志,DOI:10.3969/j.issn.1004-8685.2007.05.027)。
有机酸含量的测定方法根据《GB 5009.157-2016食品中有机酸的测定》
表2含量的测定结果
序号1 | 序号2 | 序号3 | 对比例 | |
茶多酚含量,wt% | 5.42 | 5.38 | 5.68 | 3.21 |
总蒽醌含量,wt% | 1.21 | 1.19 | 1.18 | 0.62 |
苹果酸含量,wt% | 1.03 | 1.01 | 1.02 | 0.59 |
柠檬酸含量,wt% | 1.22 | 1.18 | 1.21 | 0.82 |
草酸含量,wt% | 0.08 | 0.08 | 0.07 | 0.06 |
表2的数据表示,经过发酵和提取后,其中茶多酚和总蒽醌和总有机酸的含量都得到了提高,但其中有机酸中的含量提高存在差异,其中苹果酸提高比例最高、柠檬酸其次,而草酸含量发酵前后不存在统计学差异;分析其原因应为发酵菌种的选取所导致的。
实施例二动物毒理学安全性试验
1)材料与方法
1.受试物:表1序号1至3的样品;取前述材料加十倍水量,在常压、85℃浸泡30min,同样条件提取两次,将提取液合并,常压,85℃浓缩至每毫升浓缩液相当于1g样品。
2.急性毒性实验:选用体重为18-22g的昆明种小鼠60只,雌雄各半;环境:温度22-24℃,湿度52-58%。
取序号1-3样品浸泡浓缩液经口给小鼠灌胃1次,灌胃体积为0.2mi/10g·bw,折合剂量为20.0g/kg·bw。灌胃前禁食16小时,灌胃后连续观察两周,记录中毒表现及死亡情况,如表3所示。
表3小鼠急性毒性实验
组别 | 性别 | 途径 | 剂量(g/kg·bw) | 死亡数(只) | MTD(g/kg·bw) |
序号1 | 雄 | 经口 | 20.0 | 0 | >20.0 |
序号1 | 雌 | 经口 | 20.0 | 0 | >20.0 |
序号2 | 雄 | 经口 | 20.0 | 0 | >20.0 |
序号2 | 雌 | 经口 | 20.0 | 0 | >20.0 |
序号3 | 雄 | 经口 | 20.0 | 0 | >20.0 |
序号3 | 雌 | 经口 | 20.0 | 0 | >20.0 |
实施例三动物减重功能试验
1)材料与方法
1.受试物:表1序号1至3的样品,以及碧生源牌纤纤茶(生产批号19190503)作为对比例。取前述材料加十倍水量,在常压、85℃浸泡30min,同样条件提取两次,将提取液合并,常压,85℃浓缩至每毫升浓缩液相当于1g样品。
2.动物:SPF级雄性SD大鼠70只,随机分为7组,每组10只。
3.环境:温度22-24℃,湿度52-58%。
4.剂量选择及样品处理:设低、中、高剂量分别为0.42g/kg·bw、0.83g/kg·bw、2.50g/kg·bw(分别相当于人体推荐剂量的5、10、30倍)。低、中、高剂量受试液配制时,分别取样品浸泡浓缩液4.2ml、8.3ml、25.0m加蒸留水至100ml,另设模型对照组与空白对照组。受试物以灌胃方式给予动物,每天灌胃一次,灌胃量为1.0ml/100g.bw,连续30天。
5.主要仪器与营养饲料:
解剖器械,天平。营养饲料:基础饲料80%,猪油10%,蛋黄粉10%。
6.实验方法:
自试验开始,模型对照组、3个受试物组动物均给予营养饲料,空白对照组动物给予等量的基础饲料,各剂量组灌胃给予受试物,空白对照组、模型对照组给予等体积的蒸馏水,每天灌胃一次,连续30天。试验期间记录每只动物的加食量、剩食量,定期称量体重,试验结束时称体重,剖腹取体脂(睾丸及肾周脂肪垫)并称重,计算脂/体比。
7实验数据处理
用Spss11.0软件进行数据转化和统计分析。各剂量组与模型对照组比较采用方差分析,分析时,先对数据进行方差齐性检验,若方差齐,采用单因素方差分析进行总体比较,发现差异再用Dunnett法进行多个剂量组与一个对照组均数间的两两比较。若方差不齐,则对原始数据进行适当的变量转换,满足方差齐性检验后,用转换后的数据进行统计,若变量转换后仍未达到方差齐的目的,改用秩和检验进行统计,发现总体比较有差异,则采用不要求方差齐性的Tamhane’sT2检验进行两两比较。模型对照组与空白对照组比较采用T检验。
8结果判定
试验组体重和体内脂肪重量,或体重和脂/体比低于模型对照组,差异有显著性,进食量不显著低于模型对照组,可判定该受试物动物减肥功能试验结果阳性。结果如下表4、表5、表6、表7所示。
表4对动物体重的影响
表5对动物体重的影响
表6对动物增重、进食量及食物利用率的影响
表7对动物体内脂肪重量及脂/体比值的影响
由表4、5、6可知,模型对照组动物第三周末体重、试验术体重、体重增重均明显高于空白对照组,差异均有显著性(P<0.05或P<0.01)。各剂量组动物试验术体重体重增重明显低于模型对照组,差异均有显著性(P<0.05或P<0.01)。各剂量组动物进食量和食物利用率与模型对照组比较,无显著性差异(P>0.05)。
由表7可知,模型对照组动物试验后动物体内脂肪重量、脂/体比值均明显高于空白对照组,差异均有显著性(P<0.01)。各实验组动物试验后体内脂肪重量脂/体比值与模型对照组比较明显降低,差异有显著性(P<0.05或P<0.01)。
上述详细说明是针对本发明其中之一可行实施例的具体说明,该实施例并非用以限制本发明的专利范围,凡未脱离本发明所为的等效实施或变更,均应包含于本发明技术方案的范围内。
Claims (4)
1.一种减重的复方组合物,其特征在于,为以下组分:番泻叶、绿茶、决明子、荷叶、泽泻;
所述绿茶、决明子、番泻叶、荷叶、泽泻的质量比为4:3:2:2:1;
其制备方法包括以下步骤:
(1)油分提取:将决明子粉碎,低温冷榨,得决明子油和决明子粕;
(2)厌氧发酵:将番泻叶、绿茶、荷叶粉碎后与决明子粕混合,在厌氧环境下发酵一段时间,发酵后高温超声处理,过滤发酵液与发酵底物;
(3)离子液体提取:发酵底物利用离子液体萃取,然后通过有机溶剂反萃取分离并回收离子溶液,去除有机溶剂,得萃取液;
(4)冻干:将萃取液、过滤发酵液混合浓缩,再与决明子油混合均匀,通过低温冻干技术得到减重的复方组合物;
在步骤(2)厌氧发酵中,发酵的菌种为丁酸梭菌、枯草芽孢杆菌、嗜酸乳酸杆菌的组合,其质量比为1:0.5-1:0.2-0.3;初始浓度为106-108 CFU/ml;添加量为番泻叶、绿茶、荷叶、决明子粕总质量的0.8-1.25wt%;发酵的温度为28-32℃,发酵时间为16-24h;在发酵后将发酵液加热至65-75℃并超声5-10min灭菌;
在步骤(3)离子液体提取中,使用胆碱类离子液体,添加量为发酵底物的120-160wt%;反萃取的有机溶剂为乙醇,乙醇的用量为离子液体的100-120wt%。
2.根据权利要求1所述的减重的复方组合物,其特征在于,在步骤(1)油分提取中,将决明子粉碎至≤3mm,压榨温度为40-60℃。
3.根据权利要求1所述的减重的复方组合物,其特征在于,在步骤(4)冻干中,将萃取液、过滤发酵液混合浓缩至浓度≥1.1g/ml。
4.一种制剂,其特征在于,为权利要求1-3任一所述的减重的复方组合物。
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