CN115212182A - 一种大豆磷脂软胶囊及其制备方法和应用 - Google Patents
一种大豆磷脂软胶囊及其制备方法和应用 Download PDFInfo
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- CN115212182A CN115212182A CN202210765848.8A CN202210765848A CN115212182A CN 115212182 A CN115212182 A CN 115212182A CN 202210765848 A CN202210765848 A CN 202210765848A CN 115212182 A CN115212182 A CN 115212182A
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- soft capsule
- berberine
- lecithin
- soybean lecithin
- chitosan
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Abstract
本发明公开了一种大豆磷脂软胶囊及其制备方法和应用,大豆磷脂软胶囊由芦荟提取物和椰枣籽提取物制备获得,重量比为1:0.6到1:1;通过乙醇萃取芦荟花获得第一芦荟提取物并浓缩;通过乙醇萃取芦荟叶获得第二芦荟提取物并浓缩;通过甲醇萃取椰枣籽得到第一椰枣籽提取物;通过己烷萃取椰枣籽得到第二椰枣籽提取物,混合后蒸发浓缩获得椰枣籽浓缩液;利用第一、第二芦荟提取物和椰枣籽浓缩液制备获得大豆磷脂软胶囊。本发明,通过芦荟提取物和椰枣籽提取物的配伍,利用芦荟抗炎、抗病毒活性的作用,配合椰枣籽抗病毒、抗氧化、抗菌的作用,对治疗消化性溃疡有一定的良好疗效,并且价格低、使用安全。
Description
技术领域
本发明涉及糖尿病药物技术领域,具体涉及一种大豆磷脂软胶囊及其制备方法和应用。
背景技术
大豆磷脂具有降低胆固醇和甘油三脂含量、降低血液粘稠度,防止血液凝固,促进血液循环、促进新陈代谢,减少肝细胞内脂肪的沉积等多种功能。另外,有研究表明,大豆磷脂还可以增强胰脏细胞的功能,降低血糖。因此,配合中药材用于治疗糖尿病。
例如,中国发明专利CN 102599495 B公开了一种牡丹籽油软胶囊及其制备方法,通过以下原料经调和、化胶、胶囊压制成型、硬化定型、洗擦干燥而成,所述份数均为重量份:牡丹籽油80-95份;岩藻甾醇1~3份;角鲨烯1~3份;没食子酸丙酯1~3份;生育酚0.05~0.25份;大豆卵磷脂0.05~0.25份;维生素C0.15~0.25份;明胶5~10份;水5~10份;山梨醇1.3~2.5份;甘油2.5~5份。该方案的主要原料是牡丹籽油,成本高。
有鉴于此,需要研发一种具有治疗糖尿病的大豆磷脂软胶囊,降低原料成本。
发明内容
针对上述缺陷,本发明所要解决的技术问题在于提供一种大豆磷脂软胶囊及其制备方法和应用,以解决现有产品原料成本高的问题。
为此,本发明提供的一种大豆磷脂软胶囊,包括以下重量份数的组分:
氯化小檗碱,10-40;
大豆卵磷脂:100-200;
豆蔻酸异丙酯,40-100;
壳聚糖,10-40。
本发明还提供了一种大豆磷脂软胶囊的制备方法,包括以下步骤:
利用氯化小檗碱、大豆卵磷脂,肉豆蔻酸异丙酯和壳聚糖制备获得小檗碱-卵磷脂纳米颗粒,其中各组分的重量份数据如下:氯化小檗碱,10-40;大豆卵磷脂:100-200;豆蔻酸异丙酯,40-100;壳聚糖,10-40;
配制胶液,具体方法是将300g大豆油和25g蜂蜡加入配料罐中,加热至65-75℃,搅拌30分钟,使蜂蜡完全熔融,降温至40℃±5℃,得油蜡液;再加入小檗碱-卵磷脂纳米颗粒200-300g,搅拌60分钟,置胶体磨中研磨得到料液;
配制胶液,具体方法是取357.9纯化水和150g甘油置化胶罐中,加热至65~75℃后,再加入375g明胶,保温75℃,使明胶溶胶,搅拌约60分钟,直至明胶全部溶解;将化胶罐抽真空,至胶液无气泡;
将上述的胶液和料液投入软胶囊压丸机压制成丸,定型干燥获得大豆磷脂软胶囊;
其中,制备获得小檗碱-卵磷脂纳米颗粒的方法如下:
将肉豆蔻酸异丙酯溶于96%乙醇中,获得肉豆蔻酸异丙酯乙醇溶液,其中肉豆蔻酸异丙酯的含量为1%-3%w/v;
将大豆卵磷脂和氯化小檗碱溶于肉豆蔻酸异丙酯乙醇溶液中,通过10000rpm/min机械搅拌15分钟,超声分散15分钟,配制获得大豆卵磷脂-氯化小檗碱液;
将壳聚糖溶于1%的乙酸水溶液中,得到壳聚糖乙酸液,壳聚糖的含量为1%-3%w/v;
将壳聚糖乙酸液置于磁力搅拌器上,使用注射器将大豆卵磷脂-氯化小檗碱液注入到壳聚糖乙酸液液中,搅拌合成悬浮液;
将悬浮液通过0.45μm过滤膜过滤,在4℃温度下以19000rpm/min离心60分钟,除去上清液;
将沉淀重悬于去离子水中再次在4℃温度下以19000rpm/min离心60分钟离心,重复两次,获得小檗碱-卵磷脂纳米颗粒。
在上述方法中,注射器的注射速率为4mL/min,磁力搅拌器的转速为1000rpm,悬浮液的pH值调整为5.0-5.5。
在上述方法中,小檗碱-卵磷脂纳米颗粒用3%葡萄糖作为冷冻保护剂冻干48小时,并在-20℃下储存直至使用。
在上述方法中,小檗碱-卵磷脂纳米颗粒的粒径为120-230nm,表面电荷为27-36mV。
在上述方法中,软胶囊压丸机转速为2.5~3.0转/分钟,喷体温度为38~48℃,胶皮厚度为0.7mm~0.8mm,调节装量为0.5g/粒,压丸期间保持室温18~26℃,相对湿度45~65%。
在上述方法中,当软胶囊漏油时,将无法擦干净的部分软胶囊经洗丸机,用95%的食用乙醇洗涤,直至软胶囊表面干净。
本发明还提供了一种上述的大豆磷脂软胶囊在制备糖尿病治疗药物或保健品中的应用。
由上述技术方案可知,本发明提供的大豆磷脂软胶囊及其制备方法和应用,通过利用氯化小檗碱、大豆卵磷脂,肉豆蔻酸异丙酯和壳聚糖制备获得小檗碱-卵磷脂纳米颗粒,进而制成大豆磷脂软胶囊,原料成本较低,应用于治疗糖尿病,具有很好的效果。
附图说明
为了更清楚地说明本发明的实施例或现有技术中的技术方案,下面将对本发明实施例或现有技术描述中所需要使用的附图做出简单地介绍和说明。显而易见地,下面描述中的附图仅仅是本发明的部分实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1为本发明中大豆磷脂软胶囊制备方法的一种实施例流程图;
图2为大鼠糖尿病治疗实验伤口变化对比照片;
图3为大鼠糖尿病治疗实验伤口闭合百分比对比统计图。
具体实施方式
下面将结合本发明实施例附图,对本发明实施例的技术方案进行清楚、完整地描述,显然,以下所描述的实施例,仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明的实施例,本领域普通技术人员在没有做出创造性劳动的前提下,所获得的所有其他实施例,都属于本发明保护的范围。
为了对本发明的技术方案和实现方式做出更清楚地解释和说明,以下介绍实现本发明技术方案的几个优选的具体实施例。
需要说明的是,本文中“内、外”、“前、后”及“左、右”等方位词是以产品使用状态为基准对象进行的表述,显然,相应方位词的使用对本方案的保护范围并非构成限制。
本发明提供的一种大豆磷脂软胶囊,包括以下重量份数的组分:
氯化小檗碱,10-40;
大豆卵磷脂:100-200;
豆蔻酸异丙酯,40-100;
壳聚糖,10-40。
具体配方实施例请参照以下表1。
表1,大豆磷脂软胶囊有效成分典型配比实施例。
本发明还提供了一种利用上述小檗碱-大豆磷脂-壳聚糖纳米颗粒制备获得大豆磷脂软胶囊的方法,包括以下步骤:
步骤110,制备小檗碱-卵磷脂纳米颗粒。
利用上述配方的氯化小檗碱、大豆卵磷脂,肉豆蔻酸异丙酯和壳聚糖,制备获得小檗碱-卵磷脂纳米颗粒的具体步骤如下:
将肉豆蔻酸异丙酯溶于96%乙醇中,获得肉豆蔻酸异丙酯乙醇溶液,其中肉豆蔻酸异丙酯的含量为1%-3%w/v;
将大豆卵磷脂和氯化小檗碱溶于上述的肉豆蔻酸异丙酯乙醇溶液中,通过10000rpm/min机械搅拌15分钟,超声分散15分钟,配制获得大豆卵磷脂-氯化小檗碱溶液;
将壳聚糖溶于1%的乙酸水溶液中,得到壳聚糖乙酸液,壳聚糖的含量为1%-3%w/v;
将壳聚糖乙酸液溶液置于磁力搅拌器上,使用注射器将大豆卵磷脂-氯化小檗碱液,注入到壳聚糖乙酸液液中,搅拌合成悬浮液。其中,注射器的注射速率为4mL/min,磁力搅拌器的转速为1000rpm。该悬浮液的pH值调整为5.0-5.5。
将悬浮液通过0.45μm过滤膜过滤,在4℃温度下以19000rpm/min离心60分钟,除去上清液;
将沉淀重悬于去离子水中再次在4℃温度下以19000rpm/min离心60分钟离心,重复两次,获得小檗碱-卵磷脂纳米颗粒。小檗碱-卵磷脂纳米颗粒用3%葡萄糖作为冷冻保护剂冻干48小时,并在-20℃下储存直至使用。
经过优化试验,纳米颗粒最佳粒径为168.4nm,表面电荷为33.1mV,该条件下治疗糖尿病的效果最佳。
步骤120,配制料液。
将300g大豆油和25g蜂蜡加入配料罐中,加热至65-75℃,搅拌30分钟,使蜂蜡完全熔融,降温至40℃±5℃,得油蜡液。
加入小檗碱-卵磷脂纳米颗粒200-300g,搅拌60分钟,置胶体磨中研磨得到料液,过80目滤网,置于料液桶中静置4小时左右备用。
步骤130,配制胶液。
取357.9纯化水和150g甘油置化胶罐中,加热至65~75℃后,再加入375g明胶,保温75℃,使明胶溶胶,搅拌约60分钟,直至明胶全部溶解;将化胶罐抽真空,至胶液无气泡。
步骤140,压制成丸。
将上述的胶液和料液投入软胶囊压丸机压制成丸,软胶囊压丸机转速为2.5~3.0转/分钟,喷体温度为38~48℃,胶皮厚度为0.7mm~0.8mm,调节装量为0.5g/粒,压丸期间保持室温18~26℃,相对湿度45~65%。
步骤150,定型干燥。
通过转笼预干机定型,转笼中放上洁净的擦丸布,擦除软胶囊表面的残余石蜡油,第一节和最后一节转笼不放擦丸布;定型完毕的软胶囊送入干燥间干燥,定型时每一节转笼的定型时间不低于15分钟,室温18~26℃,相对湿度45~65%。定型后的软胶囊均匀撒布于洁净的晾丸盘中,每盘厚度以铺平晾丸盘为宜,在干燥间中干燥,干燥温度为21℃~25℃,相对湿度≤45%,干燥40小时左右,使软胶囊胶皮水分含量为9%-13%。
当软胶囊漏油时,需要将无法擦干净的部分软胶囊经洗丸机,用95%的食用乙醇洗涤,直至软胶囊表面干净,在洗丸过程中不得破坏软胶囊的形状。
本发明提供的大豆磷脂软胶囊,可应用于制备糖尿病治疗药物和保健品。
大鼠糖尿病治疗实验如下:
1、实验对象及实验方法。
取170-210克大鼠24只,通过给予链脲佐菌素诱导出糖尿病,随机分为3组,每组8只。
A组,对照组,不使用任何药物;
B组,口服盐酸小檗碱片,剂量0.1克/片;
C组,口服本发明提供的大豆磷脂软胶囊。
链脲佐菌素用后72小时检查糖尿病诱导结果,如果血糖水平超过200mg/dL,并且存在以下症状证实糖尿病诱导成功:多尿、多食和烦渴。每三天检查一次血糖,以确保血糖水平保持稳定。
在糖尿病确认后10天,麻醉大鼠,剃除动物肩胛骨之间的背侧区域,并用70%乙醇消毒,使用直径10mm的无菌活检冲头来形成圆形伤口。
治疗从伤口形成之日(第0天)开始,连续十四天,口服药早、中、晚一日三次,每次一片/粒。
2、结果与评估。
通过宏观观察和伤口闭合百分比对比进行评估。
宏观观察采用的方法是,在第0,3,6,9,12和14天分别拍摄伤口数字图像,在图像上描摹并计算出伤口面积。伤口闭合百分比是指测量天伤口面积与第0天伤口原始面积的比值。
宏观观察结果如图2所示,其中,图片为每组中最有代表性的大鼠伤口照片。
伤口闭合百分比的统计结果如图3所示。
通过图2、图3对比可见,口服盐酸小檗碱片的B组和口服本发明提供的大豆磷脂软胶囊的C组,伤口均得到改善。所有组的伤口一直开放到第九天,口服本发明提供的大豆磷脂软胶囊的C组的伤口在第九天几乎闭合,第14天伤口面积缩小方面表现显著。
综合以上具体实施例的描述,本发明提供的大豆磷脂软胶囊及其制备方法和应用,对糖尿病引起的创伤具有很好的愈合促进作用,并且,原料成本低,有效成分采用纳米颗粒,吸收快,效果好。
最后,还需要说明的是,在本文中使用的术语"包括"、"包含"或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下,由语句"包括一个…"限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
本发明并不局限于上述最佳实施方式,任何人应该得知在本发明的启示下做出的结构变化,凡是与本发明具有相同或相近的技术方案,均落入本发明的保护范围之内。
Claims (8)
1.一种大豆磷脂软胶囊,其特征在于,包括以下重量份数的组分:
氯化小檗碱,10-40;
大豆卵磷脂:100-200;
豆蔻酸异丙酯,40-100;
壳聚糖,10-40。
2.一种大豆磷脂软胶囊的制备方法,其特征在于,包括以下步骤:
利用氯化小檗碱、大豆卵磷脂,肉豆蔻酸异丙酯和壳聚糖制备获得小檗碱-卵磷脂纳米颗粒,其中各组分的重量份数据如下:氯化小檗碱,10-40;大豆卵磷脂:100-200;豆蔻酸异丙酯,40-100;壳聚糖,10-40;
配制胶液,具体方法是将300g大豆油和25g蜂蜡加入配料罐中,加热至65-75℃,搅拌30分钟,使蜂蜡完全熔融,降温至40℃±5℃,得油蜡液;再加入小檗碱-卵磷脂纳米颗粒200-300g,搅拌60分钟,置胶体磨中研磨得到料液;
配制胶液,具体方法是取357.9纯化水和150g甘油置化胶罐中,加热至65~75℃后,再加入375g明胶,保温75℃,使明胶溶胶,搅拌约60分钟,直至明胶全部溶解;将化胶罐抽真空,至胶液无气泡;
将上述的胶液和料液投入软胶囊压丸机压制成丸,定型干燥获得大豆磷脂软胶囊;
其中,制备获得小檗碱-卵磷脂纳米颗粒的方法如下:
将肉豆蔻酸异丙酯溶于96%乙醇中,获得肉豆蔻酸异丙酯乙醇溶液,其中肉豆蔻酸异丙酯的含量为1%-3%w/v;
将大豆卵磷脂和氯化小檗碱溶于肉豆蔻酸异丙酯乙醇溶液中,通过10000rpm/min机械搅拌15分钟,超声分散15分钟,配制获得大豆卵磷脂-氯化小檗碱液;
将壳聚糖溶于1%的乙酸水溶液中,得到壳聚糖乙酸液,其中,壳聚糖的含量为1%-3%w/v;
将壳聚糖乙酸液置于磁力搅拌器上,使用注射器将大豆卵磷脂-氯化小檗碱液注入到壳聚糖乙酸液液中,搅拌合成悬浮液;
将悬浮液通过0.45μm过滤膜过滤,在4℃温度下以19000rpm/min离心60分钟,除去上清液;
将沉淀重悬于去离子水中再次在4℃温度下以19000rpm/min离心60分钟离心,重复两次,获得小檗碱-卵磷脂纳米颗粒。
3.根据权利要求2所述的方法,其特征在于,注射器的注射速率为4mL/min,磁力搅拌器的转速为1000rpm,悬浮液的pH值调整为5.0-5.5。
4.根据权利要求2所述的方法,其特征在于,小檗碱-卵磷脂纳米颗粒用3%葡萄糖作为冷冻保护剂冻干48小时,并在-20℃下储存直至使用。
5.根据权利要求2所述的方法,其特征在于,小檗碱-卵磷脂纳米颗粒的粒径为120-230nm,表面电荷为27-36mV。
6.根据权利要求2所述的方法,其特征在于,软胶囊压丸机转速为2.5~3.0转/分钟,喷体温度为38~48℃,胶皮厚度为0.7mm~0.8mm,调节装量为0.5g/粒,压丸期间保持室温18~26℃,相对湿度45~65%。
7.根据权利要求2所述的方法,其特征在于,当软胶囊漏油时,将无法擦干净的部分软胶囊经洗丸机,用95%的食用乙醇洗涤,直至软胶囊表面干净。
8.如权利要求1所述的大豆磷脂软胶囊在制备糖尿病治疗药物或保健品中的应用。
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