CN117338870A - 一种辅助降血脂的软胶囊及其制备方法 - Google Patents
一种辅助降血脂的软胶囊及其制备方法 Download PDFInfo
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- CN117338870A CN117338870A CN202311254223.6A CN202311254223A CN117338870A CN 117338870 A CN117338870 A CN 117338870A CN 202311254223 A CN202311254223 A CN 202311254223A CN 117338870 A CN117338870 A CN 117338870A
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Abstract
本发明属于保健食品及药品技术领域,具体涉及一种辅助降血脂的软胶囊及其制备方法。本发明提供的辅助降血脂的软胶囊由内容物与囊壳组成,所述的内容物的包括如下组分:牡丹籽油、大蒜油和辅助保护剂;所述囊壳由如下组分制备而成:明胶、甘油、水、二氧化钛、抗老化剂和柠檬黄。本发明提供的辅助降血脂的软胶囊通过大蒜油、牡丹籽油及辅助保护剂的合理配比,能够共同维持人体内血脂、血压、血糖水平,预防血栓的发生发展,同时采用软胶囊作为载体,避免了大蒜油的刺激性味道对人体的刺激,长期服用安全、无毒、副作用,也避免了内容物容易渗出的问题,有效提高其储存稳定性。
Description
技术领域
本发明属于保健食品及药品技术领域,具体涉及一种辅助降血脂的软胶囊及其制备方法。
背景技术
近年来,随着经济水平的提高,人们的生活方式也发生改变,心脑血管疾病是世界范围内第一位致死、致残原因,已经成为危害人类健康的第一杀手。在我国,随着人口老龄化及城镇化进程的加速,心脑血管疾病患病率处于持续上升阶段。
高血脂是指由于脂肪代谢或运转异常使血浆一种或多种脂质高于正常值的情况。脂质不溶或微溶于水必须与蛋白质结合以脂蛋白形式存在,因此,高脂血又称为高脂蛋白血症,其表现为高胆固醇血症、高甘油三酯血症或两者兼有。高脂血症可分为原发性和继发性两类。现代临床医学研究认为,血脂高不仅会导致血压增高,还会增加脑血管病如脑动脉硬化、脑血栓等发病的危险性。
其中,动脉粥样硬化是以大量脂质(主要是胆固醇及胆固醇脂)在动脉壁内膜聚集,形成粥样状斑块为特征的系统性病变,它是心血管疾病的重要病理基础。引起动脉粥样硬化的病因很多,其中血脂异常是主要危险因素,主要表现为血液中总胆固醇(TC)、甘油三脂(TG)、低密度脂蛋白胆固醇(LDL-C)中的一种或几种水平升高,或者高密度脂蛋白胆固醇(HDL-C)水平降低。因此,有效降低血脂对治疗心血管疾病具有重要作用。
降血脂在临床上应用最广泛的最主要是他汀类的药物,他汀类药物最关键的一个副作用就是肝功能损害,第二个危害就是肌肉的损害。随着现代营养学的发展,功能食品应运而生,将功能性食品作为膳食补充、干预作为代谢性疾病的基础治疗,在可以促进人体健康的同时,不会对人体产生副作用,具有重要意义。
因此,非常有必要研制一种具有辅助降血脂,可以有效预防和治疗心血管疾病的保健品。
发明内容
为了解决现有技术中存在的问题,本发明的目的在于提供一种辅助降血脂的软胶囊及其制备方法。本发明提供的辅助降血脂的软胶囊通过大蒜油、牡丹籽油及辅助保护剂的合理配比,能够共同维持人体内血脂、血压、血糖水平,预防血栓的发生发展,有效降低人体血清中的胆固醇和甘油三酯。同时采用软胶囊作为载体,避免了大蒜油的刺激性味道对人体的刺激,长期服用安全、无毒、副作用,也避免了内容物容易渗出的问题,有效提高其储存稳定性。
本发明的技术方案是:
一种辅助降血脂的软胶囊,由内容物与囊壳组成,所述的内容物包括如下组分及其重量份数:牡丹籽油405~475份,大蒜油10~70份,辅助保护剂15~25份;
所述囊壳由如下重量份数的组分制备而成:明胶20~70份,甘油10~40份、水20~70份,二氧化钛0.3~0.7份,抗老化剂0.8~2份,柠檬黄0.1~0.4份。
进一步地,所述的内容物包括如下组分及其重量份数:牡丹籽油438~472份,大蒜油10~40份,辅助保护剂18~22份;所述囊壳由如下重量份数的组分制备而成:明胶30~60份,甘油20~35份、水30~60份,二氧化钛0.4~0.6份,抗老化剂1.0~1.6份,柠檬黄0.2~0.3份。
进一步地,所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比10~16:3~5:2~4组成。
更进一步地,所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比14:4:3组成。
进一步地,所述囊壳中的抗老化剂为茶多酚、醋酸纤维素和橙黄决明子素的组合。
更进一步地,所述囊壳中的抗老化剂为茶多酚、醋酸纤维素和橙黄决明子素按照重量比5~9:1~4:1组成。
进一步地,所述囊壳中的二氧化钛为二氧化钛粉末,粒径为0.2~0.4μm。
进一步地,所述的内容物与囊壳的重量比为1~5:1。
另外,本发明还提供了一种所述的辅助降血脂的软胶囊的制备方法,包括如下步骤:
S1、将牡丹籽油、大蒜油和辅助保护剂在20~30℃下搅拌混合均匀,形成均一稳定的内容物;
S2、取5份明胶与二氧化钛加入10份水磨制成钛白粉糊,然后转移至化胶罐中,再加入甘油、柠檬黄、抗老化剂及剩余的水;加热至55~75℃,投入剩余的明胶,搅拌20~40min;开动真空泵抽真空除去泡沫,真空度0.06~0.08MPa,静置20~40min后放出液体并过滤,得胶液,于55~75℃保温备用;
S3、将步骤S1所得的内容物和步骤S2所得的胶液投入旋转模压型软胶囊机压制成软胶囊;
S4、将步骤S3所得定型后的软胶囊转移至干燥室中进行干燥,在温度为20~40℃,相对湿度为10~50%的条件下干燥10~30h,控制胶皮水分为5~30%,即得。
进一步地,所述步骤S1中的搅拌速度为40~60r/min,搅拌时间为30~40min。
更进一步地,所述步骤S1中的搅拌速度为50r/min,搅拌时间为30min。
进一步地,所述步骤S3中胶液投入旋转模压型软胶囊机在温度15~30℃,相对湿度30~65%条件下压制软胶囊。
本发明制得的用于辅助降血脂的软胶囊的内容物中,合理搭配了牡丹籽油和大蒜油:
大蒜是百合科植物大蒜Allium Sativuml.的地下鳞茎,被誉为天然的“药用植物黄金”,其作为调味食材和药物的使用历史已有愈四千年的历史。现代研究表明,大蒜具有抗菌消炎、降血压、降血脂、延长凝血时间等诸多功能,对冠心病、高血压、动脉粥样硬化等疾病具有显著的防治作用。
大蒜油是从大蒜中提取的浅黄色液体,有天然抗生素之称,其主要成分为大蒜素及多种烯丙基、丙基、甲基组成的硫醚化合物,它们是大蒜多种药理活性的物质基础。
牡丹籽油,又称牡丹油,是以牡丹籽仁为原料,经压榨、脱色、除臭等工艺制成的木本坚果植物油。牡丹籽油中富含有多种不饱和脂肪酸,不饱和脂肪酸占其总油量的比例为82.81%~93.23%,其中油酸24%,亚油酸27%,α-亚麻酸43%。牡丹籽油中的α-亚麻酸含量是“液体黄金”-橄榄油中α-亚麻酸含量的54倍多。
其中,油酸是一种单不饱和Omega-9脂肪酸,它能够调节血脂水平,降低胆固醇,有效减少高胆固醇血症以及心血管疾病的发生,降低冠心病发病几率。亚油酸是人体必需的脂肪酸之一,能够降低血胆固醇及血脂水平、软化血管、降低血压、预防动脉粥样硬化、促进微循环,有着“血管清道夫”的美誉,具有防治动脉粥样硬化及心血管疾病的保健效果。
α-亚麻酸是人体必需的多不饱和脂肪酸,是构成人体脑细胞和组织细胞发重要组成部分;α-亚麻酸可在人体代谢酶的作用下,分解成人体所需的DHA、DPA和EPA。亚麻酸具有增强中智力、免疫力,保护视力,降低血脂、血糖、血压,抑制出血性脑疾病和血栓性疾病,预防炎症以及延缓衰老等功能。α-亚麻酸不仅能增加胆固醇排泄,还能抑制HMG-CoA活性而减少内源性胆固醇的合成,更能抑制脂肪合成酶系、加强线粒体中的β-氧化而减少甘油三酯的合成、增加其消耗,从而发挥其降血脂的作用。
富含油酸、亚油酸、α-亚麻酸等不饱和脂肪酸的牡丹籽油,具有降低血清总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白和极低密度蛋白,升高血清高密度脂蛋白的作用,能显著降低血脂、血糖水平,预防出血性脑疾病和血栓性疾病的发生。
本发明提供的软胶囊内容物中采用富含油酸、亚油酸、α-亚麻酸等不饱和脂肪酸的牡丹籽油代替现有技术中的大豆油,作为大蒜油软胶囊的填充物,在发挥大蒜油杀菌抑菌、调理肠胃、降脂血脂血糖水平、提高免疫力的同时,又能补充体内油酸、亚油酸、α-亚麻酸等不饱和脂肪酸,二者协同增效,能够更好的维持体内血脂和血糖水平,抑制血小板聚集,预防血栓。
更进一步地,本发明所采用的大蒜油和牡丹籽油均是采用现有技术中常规的提取工艺所得,其中,所采用的牡丹籽油购自菏泽中禾健元生物科技有限公司,为低温压榨法生产所得;所采用的大蒜油江西亿森源植物香料有限公司,为水蒸气蒸馏法提取所得。
进一步地,本发明提供的胶囊内容物中,还添加了辅助保护剂,经试验证明,当添加了由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按一定比例组成的辅助保护剂时,不但能够与牡丹籽油和大蒜油共同起到降血脂的作用,还能够使形成的内容物更加均一稳定,减少软胶囊漏油情况的发生。
更进一步地,为了保证软胶囊具有良好的储存性能,本申请发明人还在囊壳的组分中创造性的添加了由茶多酚、醋酸纤维素和橙黄决明子素组成的抗老化剂,可以有效提高囊壳的抗老化性能,防止软胶囊在储存过程中由于环境等因素造成的胶皮老化、开裂、漏油及崩解时间延长等情况的产生,有效的延长了软胶囊的保质期。
与现有技术相比,本发明提供的辅助降血脂的软胶囊及其制备方法具有以下优势:
(1)本发明提供的辅助降血脂的软胶囊通过大蒜油和牡丹籽油的合理配比,在发挥大蒜油维持血脂水平、消炎杀菌、增强免疫力、降低血压、血糖、预防血栓功效作用的同时,利用牡丹籽油补充体内油酸、亚油酸、α-亚麻酸等不饱和脂肪酸,同时结合辅助保护剂协同作用,共同维持人体内血脂、血压、血糖水平,预防血栓的发生发展。
(2)本发明采用软胶囊作为载体,避免了大蒜油的刺激性味道对人体的刺激,长期服用安全、无毒、副作用,同时避免了内容物容易渗出的问题,有效提高其储存稳定性。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明,但这并非是对本发明的限制,本领域技术人员根据本发明的基本思想,可以做出各种修改或改进,但是只要不脱离本发明的基本思想,均在本发明的保护范围之内。
以下实施例和对比例中,未作特别说明的试剂为常规试剂,均可在常规试剂生产销售公司购买,所用方法,如无特殊说明,均为现有技术,部分原料生产厂家等信息如下:
鼠尾草酸,CAS号:3650-09-7,货号:B21175;橙黄决明素,CAS号:67979-25-3,货号:B20180,亚麻籽油,CAS号:8001-26-1,货号:S25937;聚甘油蓖麻醇酸酯,CAS号:114355-43-0,货号T24778;茶多酚,CAS号:84650-60-2,货号:S18152,均购自上海源叶生物科技有限公司。
实施例1一种辅助降血脂的软胶囊及其制备方法
一种辅助降血脂的软胶囊,由内容物与囊壳组成,所述的内容物由如下组分及其重量份数组成:牡丹籽油438份,大蒜油10份,辅助保护剂18份;
所述囊壳由如下重量份数的组分制备而成:明胶30份,甘油20份、水30份,二氧化钛0.4份,抗老化剂1.0份,柠檬黄0.2份。
所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比10:3:2组成。
所述囊壳中的抗老化剂由茶多酚、醋酸纤维素和橙黄决明子素按照重量比5:1:1组成。
所述的内容物与囊壳的重量比为2:1。
所述的辅助降血脂的软胶囊的制备方法,包括如下步骤:
S1、将牡丹籽油、大蒜油和辅助保护剂在20℃下搅拌40min,搅拌速度为40r/min,形成均一稳定的内容物;
S2、取5份明胶与粒径为0.2~0.4μm的二氧化钛加入10份水磨制成的钛白粉糊,然后加入化胶罐中,再加入甘油、柠檬黄、抗老化剂及剩余的水;加热至55℃,投入剩余的明胶,搅拌40min;开动真空泵抽真空除去泡沫,真空度为0.06~0.08MPa,静置20min后放出液体并过滤,得胶液,于55℃保温备用;
S3、将步骤S1所得的内容物和步骤S2所得的胶液投入旋转模压型软胶囊机在温度15℃,相对湿度30%条件下压制软胶囊;
S4、将步骤S3所得定型后的软胶囊转移至干燥室中进行干燥,在温度为20℃,相对湿度为10%的条件下干燥30h,控制胶皮水分为10%,即得。
实施例2一种辅助降血脂的软胶囊及其制备方法
一种辅助降血脂的软胶囊,由内容物与囊壳组成,所述的内容物由如下组分及其重量份数组成:牡丹籽油460份,大蒜油20份,辅助保护剂20份;
所述囊壳由如下重量份数的组分制备而成:明胶50份,甘油30份、水50份,二氧化钛0.35份,抗老化剂1.3份,柠檬黄0.3份。
所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比14:4:3组成。
所述囊壳中的抗老化剂由茶多酚、醋酸纤维素和橙黄决明子素按照重量比7:3:1组成。
所述的内容物与囊壳的重量比为3:1。
所述的辅助降血脂的软胶囊的制备方法,包括如下步骤:
S1、将牡丹籽油、大蒜油和辅助保护剂在28℃下搅拌30min,搅拌速度为50r/min,形成均一稳定的内容物;
S2、取5份明胶与粒径为0.2~0.4μm的二氧化钛加入10份水磨制成的极细的钛白粉糊,然后加入化胶罐中,然后加入甘油、柠檬黄、抗老化剂及剩余的水;加热至60℃,投入剩余的明胶,搅拌30min;开动真空泵抽真空除去泡沫,真空度0.06~0.08MPa,静置30min后放出液体并过滤,得胶液,于60℃保温备用;
S3、将步骤S1所得的内容物和步骤S2所得的胶液投入旋转模压型软胶囊机在温度20℃,相对湿度50%条件下压制软胶囊;
S4、将步骤S3所得定型后的软胶囊转移至干燥室中进行干燥,在温度为30℃,相对湿度为30%的条件下干燥20h,控制胶皮水分为20%,即得。
实施例3一种辅助降血脂的软胶囊及其制备方法
一种辅助降血脂的软胶囊,由内容物与囊壳组成,所述的内容物由如下组分及其重量份数组成:牡丹籽油472份,大蒜油40份,辅助保护剂22份;
所述囊壳由如下重量份数的组分制备而成:明胶60份,甘油35份、水60份,二氧化钛0.6份,抗老化剂1.6份,柠檬黄0.4份。
所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比16:5:4组成。
所述囊壳中的抗老化剂由茶多酚、醋酸纤维素和橙黄决明子素按照重量比9:4:1组成。
所述的内容物与囊壳的重量比为5:1。
所述的辅助降血脂的软胶囊的制备方法,包括如下步骤:
S1、将牡丹籽油、大蒜油和辅助保护剂在30℃下搅拌35min,搅拌速度为60r/min,形成均一稳定的内容物;
S2、取5份明胶与粒径为0.2~0.4μm的二氧化钛加入10份水磨制成的极细的钛白粉糊,然后加入化胶罐中,然后加入甘油、柠檬黄、抗老化剂及剩余的水;加热至75℃,投入剩余的明胶,搅拌20min;开动真空泵抽真空除去泡沫,真空度0.06~0.08MPa,静置40min后放出液体并过滤,得胶液,于75℃保温备用;
S3、将步骤S1所得的内容物和步骤S2所得的胶液投入旋转模压型软胶囊机在温度30℃,相对湿度65%条件下压制软胶囊;
S4、将步骤S3所得定型后的软胶囊转移至干燥室中进行干燥,在温度为40℃,相对湿度为50%的条件下干燥10h,控制胶皮水分为30%,即得。
对比例1一种辅助降血脂的软胶囊及其制备方法
与实施例2相比,对比例1的区别在于,将所述软胶囊内容物中的大蒜油替换为亚麻籽油,其他组分和操作与实施例2相同。
对比例2一种辅助降血脂的软胶囊及其制备方法
与实施例2相比,对比例2的区别在于,将内容物的辅助保护剂中的聚甘油蓖麻醇酸酯替换为单硬脂酸甘油酯,其他组分和操作与实施例2相同。
对比例3一种辅助降血脂的软胶囊及其制备方法
与实施例2相比,对比例3的区别在于,所述内容物的辅助保护中不添加鼠尾草酸,相应的增加维生素E的用量,即所述辅助保护剂为由维生素E和聚甘油蓖麻醇酸酯按照重量比18:3组成,其他组分和操作与实施例2相同。
对比例4一种辅助降血脂的软胶囊及其制备方法
与实施例2相比,对比例1的区别在于,将囊壳的抗老化剂中的茶多酚替换为抗坏血酸钠,其他组分和操作与实施例2相同。
对比例5一种辅助降血脂的软胶囊及其制备方法
与实施例2相比,对比例1的区别在于,将囊壳的抗老化剂中的醋酸纤维素替换为乙基纤维素,其他组分和操作与实施例2相同。
试验例一、本发明制得的辅助降血脂的软胶囊内容物维持血脂水平作用的研究
1.材料与方法
1.1试验样品:实施例1~3、对比例1~3中制备的辅助降血脂的软胶囊内容物。
1.2动物:SD雄性大鼠,80只,体重180~220g,由济南朋悦实验动物公司单位提供,合格证号:SCXK(鲁)20220006。
1.3高脂饲料:在基础维持饲料中添加20.0%蔗糖、15.0%猪油、1.2%胆固醇、0.2%胆酸钠,适量酪蛋白、磷酸氢钙、石粉等。除粗脂肪外,模型饲料的水分、粗蛋白、粗脂肪、粗纤维、粗灰分、钙、磷、钙、磷均要达到维持饲料的国家标准。基础维持饲料与高脂饲料购自济南朋悦实验动物公司。
1.4试剂与仪器:TC(总胆固醇)、TG(甘油三酯)、LDL-C(低密度脂蛋白)、HDL-C(高密度脂蛋白)试剂盒由索莱宝生物科技有限公司提供。
1.5人体推荐量及计量设计:成人推荐量为2粒/d(1g/d),即0.0167g/(d·kg)。则大鼠的灌胃剂量为104mg/(d·kg)。
1.6试验方法:基础维持饲料喂养3天后,将大鼠按体重随机分成2组,10只给予维持饲料作为空白对照组,70只给予模型饲料作为模型组。
模型组给予模型饲料1-2周后,空白对照组和模型组大鼠不禁食采血,采血后尽快分离血清,测定血清TC、TG、LDL-C、HDL-C水平。
根据TC水平将模型组随机分成两组(即模型对照组与模型给药组),两组间比较TC、TG、LDL-C、HDL-C差异均无显著性;模型对照组(10只)、模型给药组(60只)与空白对照组(10只)比较,TC、TG、LDL-C、HDL-C升高均有显著性,判定模型成立。
分组后,模型给药组分为6组,每组10只大鼠,每天分别灌胃给予实施例1~3、对比例1~3中制备的辅助降血脂的软胶囊内容物,空白对照组和模型对照组同时给予同体积的纯化水,空白对照组继续给予维持饲料,模型对照组及模型给药组继续给予模型饲料,并定期称量体重,于实验结束时(连续5周后)不禁食采血,采血后尽快分离血清,测定血清TC、TG、LDL-C、HDL-C水平。
2实验结果
2.1辅助降血脂的软胶囊对大鼠体重的影响,如表1所示。
表1辅助降血脂的软胶囊对大鼠体重的影响(x±s,g)
由表1可知,大蒜牡丹籽油软胶囊对大鼠体重的影响见表1。在整个实验过程中,各组大鼠的生长、活动无异常。实验前后各组大鼠体重及增重比较,模型对照组及模型给药组大鼠体重均高于空白对照组。与模型对照组比较实施例1~3组,大鼠体重有明显的下降,对比例1~3组中大鼠的体重有所下降,但是下降幅度小于实施例1~3组。
2.2大蒜牡丹籽油软胶囊对大鼠血脂水平的影响,如表2、表3、表4、表5所示。
表2辅助降血脂的软胶囊对大鼠总胆固醇TC的影响
由表2可知,给予受试物前,模型对照组和模型给药组的血清总胆固醇含量相对于空白对照组显著升高,表明模型建立成功。给予受试物后,相比于模型对照组和对比例1~3组,本发明实施例1~3组中的总胆固醇TC值显著降低,表明本发明提供的辅助降血脂的软胶囊内容物能显著降低血清中的总胆固醇含量。
表3辅助降血脂的软胶囊对大鼠甘油三酯TG的影响
由表3可知,给予受试物前,模型对照组和模型给药组的血清甘油三酯含量相对于空白对照组显著升高。给予受试物后,相比于模型对照组和对比例1~3组,本发明实施例1~3组的血清中甘油三酯TG显著降低,表明本发明制得的辅助降血脂的软胶囊内容物能显著降低血清甘油三酯含量。
表4辅助降血脂的软胶囊对大鼠高密度脂蛋白HDL-C的影响
由表4可知,给予受试物前,模型对照组和模型给药组的血清高密度脂蛋白含量相对于空白对照组无显著区别。给予受试物后,相比于模型对照组,实施例1~3组中血清高密度脂蛋白HDL-C显著升高。
表5辅助降血脂的软胶囊对大鼠低密度脂蛋白LDL-C的影响
由表5可见,给予受试物前,模型对照组和模型给药组的低密度脂蛋白含量相对于空白对照组显著升高。给予受试物后,实施例1~3组中的低密度脂蛋白的含量明显低于模型对照组中低密度脂蛋白的含量,但仍高于空白对照组水平,表明本品能显著降低血清中的低密度脂蛋白水平。
试验例二、本发明的辅助降血脂的软胶囊的稳定性试验检测
1.试验材料:本发明实施例1~3,对比例1~5制得的辅助降血脂的软胶囊。
2.试验方法:
参考2020年版《中国药典》第四部通则9001原料药物与制剂稳定性试验指导原则中的加速试验,在温度40±2℃,相对湿度75±5%的条件下将本发明实施例1~3,对比例1~5制得的辅助降血脂的软胶囊放置6个月,在试验期间的第0、3、6个月末分别取样1次,考察软胶囊的崩解时限和外观性状,崩解时限的检测方法参考2020年版《中国药典》第四部通则9021崩解时限检查法。检测结果如表6所示。
表6辅助降血脂软胶囊加速稳定性测定试验结果
由表6可知,与对比例组相比,本发明实施例1~3制成的软胶囊,在进行0-6个月的加速实验时,在0、3、6个月时的崩解时限均在20min内,而对比例4、5中改变了抗老化剂的组分时,在3个月后其崩解时限明显延长,外光也存在胶皮发硬,漏油的情况,对比例2中也在第6个月时出现了漏油的情况。这说明本发明提供的软胶囊可以有效的提高胶囊的存储稳定性,有效解决其崩解时限随时间增加的问题,减少胶囊漏油情况的发生。
上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。
Claims (10)
1.一种辅助降血脂的软胶囊,由内容物与囊壳组成,其特征在于,所述的内容物包括如下组分及其重量份数:牡丹籽油405~475份,大蒜油10~70份,辅助保护剂15~25份;所述囊壳由如下重量份数的组分制备而成:明胶20~70份,甘油10~40份,水20~70份,二氧化钛0.3~0.7份,抗老化剂0.8~2份,柠檬黄0.1~0.4份。
2.根据权利要求1所述的辅助降血脂的软胶囊,其特征在于,所述的内容物包括如下组分及其重量份数:牡丹籽油438~472份,大蒜油10~40份,辅助保护剂18~22份;所述囊壳由如下重量份数的组分制备而成:明胶30~60份,甘油20~35份,水30~60份,二氧化钛0.4~0.6份,抗老化剂1.0~1.6份,柠檬黄0.2~0.3份。
3.根据权利要求1所述的辅助降血脂的软胶囊,其特征在于,所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比10~16:3~5:2~4组成。
4.根据权利要求3所述的辅助降血脂的软胶囊,其特征在于,所述内容物中的辅助保护剂由维生素E、鼠尾草酸和聚甘油蓖麻醇酸酯按重量比14:4:3组成。
5.根据权利要求1所述的辅助降血脂的软胶囊,其特征在于,所述囊壳中的抗老化剂为茶多酚、醋酸纤维素和橙黄决明子素的组合。
6.根据权利要求1所述的辅助降血脂的软胶囊,其特征在于,所述囊壳中的二氧化钛的粒径为0.2~0.4μm。
7.根据权利要求1所述的辅助降血脂的软胶囊,其特征在于,所述的内容物与囊壳的重量比为1~5:1。
8.一种根据权利要求1~7任一项所述的辅助降血脂的软胶囊的制备方法,其特征在于,包括如下步骤:
S1、将牡丹籽油、大蒜油和辅助保护剂在20~30℃下搅拌混合均匀,得内容物;
S2、取5份明胶与二氧化钛加入10份水磨制成钛白粉糊,然后加入化胶罐中,再加入甘油、柠檬黄、抗老化剂及剩余的水;加热至55~75℃,投入剩余的明胶,搅拌20~40min;开动真空泵抽真空除去泡沫,真空度0.06~0.08MPa,静置20~40min后放出液体并过滤,得胶液,于55~75℃保温备用;
S3、将步骤S1所得的内容物和步骤S2所得的胶液投入旋转模压型软胶囊机压制成软胶囊;
S4、将步骤S3所得定型后的软胶囊转移至干燥室中进行干燥,在温度为20~40℃,相对湿度为10~50%的条件下干燥10~30h,控制胶皮水分为5~30%,即得。
9.根据权利要求8所述的辅助降血脂的软胶囊的制备方法,其特征在于,所述步骤S1中的搅拌速度为40~60r/min,搅拌时间为30~40min。
10.根据权利要求8所述的辅助降血脂的软胶囊的制备方法,其特征在于,所述步骤S3中胶液投入旋转模压型软胶囊机在温度15~30℃,相对湿度30~65%条件下压制软胶囊。
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