CN115429815B - 一种长效饱腹组合物、制备方法及用途 - Google Patents
一种长效饱腹组合物、制备方法及用途 Download PDFInfo
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- CN115429815B CN115429815B CN202210614793.0A CN202210614793A CN115429815B CN 115429815 B CN115429815 B CN 115429815B CN 202210614793 A CN202210614793 A CN 202210614793A CN 115429815 B CN115429815 B CN 115429815B
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Abstract
本发明属于医药和食品技术领域,具体公开了一种长效饱腹组合物,同时还公开了该组合物的制备方法以及用途。本发明的长效饱腹组合物以重量份计,包括骨架材料300~1000份,崩解剂20~700份,凝胶剂10~200份,乳化稳定剂60~250份。本发明提供的长效饱腹组合物可增加饱腹感,降低食欲,因此可明显减少能量的摄入,有效控制使用者的体重,达到减肥的效果。
Description
技术领域
本发明涉及医药和食品技术领域,特别是涉及一种长效饱腹组合物,以及该组合物的制备方法和用途。
背景技术
肥胖不仅会影响形体美,还会给生活带来诸多不便。更为严重的是,肥胖会对身体产生多种危害,例如增加患心血管疾病的危险,影响消化系统及内分泌系统的功能,增加癌症的发生等。随着肥胖的影响越来越广泛地被人们认识和了解,减肥也越来越成为人们关注的健康问题。现有常见的减肥技术主要有以下四种:
第一种,食用减肥产品,在胃部膨胀增加饱腹感,以降低人对食物的需求。例如使用轻质漂浮以及膨胀性食用材料制备的片剂,可以实现在胃中膨胀,占有胃空间、增加饱腹感。但这类减肥产品通常容易排出体外,因此会造成服用量较大的问题,并且占据胃部空间的时间短,饱腹感的持续时间较短,需要多次服用。
第二种,食用能吸收水和油脂的产品,通过产品吸收人体内水、油脂等并排出体外,以降低胃肠道对油脂或营养成分的吸收。这类减肥产品在吸收脂肪时,还会将溶于脂肪的微量成分(如维生素A、D、E等)一并吸收并排出体外,长期使用可能会影响人体健康。
第三种,通过活性化学成分在人体吸收代谢系统的作用,降低脂肪的积蓄。该类产品会产生较为明显的副作用,如芬氟拉明能加快代谢,显著降低体重,但会引起血压上升、心率加快等副作用,目前已不再建议使用。
第四种,通过减肥手术人工干预直接降低体重。该技术成本高,风险大,并且需要后续持续跟进,导致该技术一般只少数人群中使用。
综上可知,现有的减肥技术都存在一定的缺陷,为了使减肥能够健康、科学地进行,有必要针对减肥产品进行研究,以提供一种更适合肥胖人群的减肥用产品。
发明内容
本发明主要解决的技术问题是提供一种长效饱腹组合物,可以增加饱腹感,降低食欲,减少使用者能量的摄入,有效控制使用者的体重,达到减肥效果。
本发明主要解决的另一个技术问题是提供一种长效饱腹组合物的制备方法。
本发明还提供了长效饱腹组合物的用途。
为解决上述技术问题,第一方面,本发明提供了一种长效饱腹组合物,以重量份计,所述组合物包括如下组分的原料:骨架材料300~1000份,崩解剂20~700份,凝胶剂10~200份,乳化稳定剂60~250份。
优选地,以重量份计,所述组合物还包括如下组分的原料:助流剂5~ 40份,润滑剂5~30份。
进一步优选地,以重量份计,所述组合物还包括如下组分的原料:助流剂20~30份,润滑剂10~15份。
进一步优选地,所述组合物中骨架材料和崩解剂的质量百分含量之和为70%~92%。
所述组合物中骨架材料的质量百分含量为30%~80%。
作为本发明一种优选的实施方案,所述骨架材料为羟丙甲纤维素、羟丙纤维素、丙烯酸树脂或丙烯酸树脂衍生物中的任意一种或几种的混合。
优选地,所述骨架材料的松密度为0.30~0.50g/cm3,进一步优选所述骨架材料的松密度为0.30~0.40g/cm3。
优选地,所述骨架材料的卡尔系数为20%~30%。
优选地,所述骨架材料的分子量为20万~120万,进一步优选为40 万~100万。
作为本发明一种进一步优选的实施方案,所述骨架材料为羟丙甲纤维素和/或羟丙纤维素。
所述羟丙甲纤维素选自以下型号中的至少一种:E4M、K100LV、K250、 K750、K1500、K4M、K15M、K35M、K100M和K200M;更优选K4M、K15M和K100M型号中的一种或几种的混合。
在一些具体实施方案中,骨架材料为羟丙甲纤维素K4M或者羟丙甲纤维素K15M或者羟丙甲纤维素K100M,或者,所述骨架材料为羟丙甲纤维素K4M、羟丙甲纤维素K15M、羟丙甲纤维素K100M中的任意两种或者三种的混合。
所述羟丙纤维素优选型号为HF。
本发明提供的长效饱腹组合物中通过对骨架材料的选择,得到的粉末混合物可压性好,并且漂浮性好;并且制成的片剂有足够的强度,在胃部蠕动下可长时间保持原有形态,饱腹感持续久。
作为本发明一种优选的实施方案,所述崩解剂为交联羧甲基纤维素钠、交联聚维酮、羧甲淀粉钠和低取代羟丙纤维素中的至少一种。其中,低取代羟丙纤维素(L-HPC)为一种市售的药用辅料,为纤维素碱化后与环氧丙烷在高温条件下发生醚化反应,然后经中和、重结晶、洗涤、干燥、粉碎和筛分制得,按干燥品计算,含羟丙氧基(-OCH2CHOHCH3)应为5.0%~16.0%。
在一些具体实施方案中,所述崩解剂可以为交联羧甲基纤维素钠、交联聚维酮、羧甲淀粉钠中的任意一种,或者是其中的任意两种或者其中的三种的混合。
作为本发明一种优选的实施方案,所述凝胶剂为羧甲基纤维素钠、卡波姆、分子量低于10万的羟丙纤维素和分子量低于10万的羟丙甲纤维素中的至少一种。
优选地,所述分子量低于10万的羟丙纤维素选自以下型号中的至少一种:SSL、SL、ELF、EF和LF。
所述分子量低于10万的羟丙甲纤维素选自以下型号中的至少一种: E5、E6、E15、K250、K750和K1500。
进一步优选地,所述凝胶剂为羧甲基纤维素钠。
作为本发明一种优选的实施方案,所述乳化稳定剂为黄原胶、魔芋胶和阿拉伯胶中的至少一种。
在一些具体实施方案中,所述乳化稳定剂可以为黄原胶、魔芋胶和阿拉伯胶中的任意一种,或者是其中的任意两种的混合,或者是其中三种的混合。进一步优选地,所述乳化稳定剂为黄原胶、魔芋胶和阿拉伯胶中的任意一种。
作为本发明一种优选的实施方案,所述助流剂为微粉硅胶、滑石粉、十二烷基硫酸镁、十二烷基硫酸钠中的至少一种。进一步优选为微粉硅胶和/或滑石粉。
作为本发明一种优选的实施方案,所述润滑剂为硬脂富马酸钠和/或硬脂酸镁。进一步优选为硬脂酸镁。
本发明还提供了一种包括以上所述长效饱腹组合物的素片。素片是指在片剂的制备过程中只加入填充淀粉等基础辅料,没有加入矫色、矫味、分散剂等其他辅料。
在其中一些实施例中,按每片的重量计,所述素片主要由下述重量的辅料制备而成:
骨架材料:375~1000mg,
崩解剂:25~650mg,
凝胶剂:10~200mg,
乳化稳定剂:62.5~250mg,
助流剂:5~40mg,
润滑剂:5~30mg。
在其中一些实施例中,骨架材料的松密度在0.30~0.40g/cm3之间,卡尔系数在20.0~30.0%之间。
在其中一些实施例中,按每片的重量计,所述素片包括骨架材料 375~1000mg,所述骨架材料为羟丙甲纤维素、羟丙纤维素和丙烯酸树脂及其衍生物中的一种或多种。
在其中一些实施例中,按每片的重量计,所述素片包括骨架材料 375~1000mg,所述骨架材料为羟丙甲纤维素,羟丙甲纤维素型号包括但不限于E4M、K100LV、K250、K750、K1500、K4M、K15M、K35M、K100M 和K200M的任意一种或多种。
在其中一些实施例中,羟丙甲纤维素为进口辅料。
在其中一些实施例中,所述骨架材料为羟丙纤维素,优选型号为HF。
在其中一些实施例中,按每片的重量计,所述素片包括崩解剂 25~650mg,所述崩解剂为交联羧甲基纤维素钠、交联聚维酮、羧甲淀粉钠和低取代羟丙纤维素的一种或多种。
在其中一些实施例中,按每片的重量计,所述素片包括凝胶剂 10~200mg,所述凝胶剂为羧甲纤维素钠、卡波姆、分子量低于10万的羟丙纤维素和分子量低于10万的羟丙甲纤维素中的一种或多种。
在其中一些实施例中,按每片的重量计,所述素片包括乳化稳定剂62.5~250mg,所述乳化稳定剂为黄原胶、魔芋胶和阿拉伯胶中至少一种。
在其中一些实施例中,按每片的重量计,所述素片包括助流剂5~40mg,所述助流剂为微粉硅胶和/或滑石粉。
在其中一些实施例中,按每片的重量计,所述素片包括润滑剂5~30mg,所述润滑剂为硬脂酸镁。
第二方面,本发明提供了一种所述长效饱腹组合物的制备方法,所述制备方法包括:将所述骨架材料、崩解剂、凝胶剂、乳化稳定剂和助流剂共混;之后再加入润滑剂共混;将共混物压片制成素片,即得到长效饱腹组合物。
优选地,所述素片的硬度为13~22kg,进一步优选13~20kg。经研究发现,片剂的硬度与起漂时间有关。硬度过大时,所需压片机压力大,片厚减少,片剂体积小,会导致起漂时间延长。
第三方面,本发明提供了一种所述长效饱腹组合物的用途,所述组合物作为减肥食品或者减肥药物的用途。
第四方面,本发明还提供了一种所述长效饱腹组合物的用途,所述组合物作为缓释药物载体的用途。
本发明提供了一种长效饱腹组合物,该组合物主要由骨架材料、崩解剂、凝胶剂、乳化稳定剂等制备而成。该组合物具有明显的溶胀效果,因此在胃中的饱腹感更强。该组合物还具有在水中或胃液中快速起漂的特点,在胃液中所需的起漂时间短,因此在胃部可以快速吸水膨胀,这样就保证了该组合物在充分膨胀前能持续在胃中停留,不容易排出胃部。该组合物能长时间保持相对稳定的结构,饱腹感持续时间长。
经试验表明,本发明的长效饱腹组合物具有以下技术效果:
(1)能在胃部膨胀并在胃部长时间停留,因此可以提高服用者的饱腹感;
(2)该组合物在水中能快速起漂,起漂时间在15min之内(胃排空最快时间约为15min),甚至可以立即起漂,保证了在充分膨胀前能持续在胃中停留而不被排出,可以减少服用量;
(3)遇水膨胀效果好,4h后膨胀体积达到2~5倍,24h的膨胀体积甚至达到9倍以上,在服用后一段时间内不容易通过幽门,饱腹感持续久;
(4)在水中24h的溶蚀率不超过10%,具有较强的机械强度,能在胃部的蠕动下保持原有形态,持续起到饱腹效果;
(5)该组合物无副作用,不会在胃肠道积累,之后可以正常排出体外,不会对胃造成阻塞,不会引起不良反应;
(6)通过控制骨架材料的松密度在0.30~0.40g/cm3之间,卡尔系数在 20~30%之间,使得粉末有很好可压性;通过选择凝胶剂及用量,保证了片剂的膨胀率;通过控制组合物中骨架材料的用量比例30~80%,且分子量在200000~1200000之间,使片剂有足够强度,确保在胃部蠕动下长时间保持原有形态。
本发明提供的长效饱腹组合物的制备方法,采用成熟的粉末直接压片工艺制成,工艺简单。
本发明提供的长效饱腹组合物可增加饱腹感,降低食欲,因此可明显减少能量的摄入,有效控制使用者的体重,达到减肥的效果。
此外,由于本发明的组合物可以在胃部长时间停留,因此本发明的组合物还可以作为药物的载体,使药物在胃部长时间停留并以相对稳定的速率释放药物,达到缓释效果。
具体实施方式
下面通过具体实施例对本发明的技术方案进行详细说明。
实施例1~10
以下实施例提供了十组组合物,具体组成如下表1。
表1
注:表1中的“/”表示未添加该组分,表中的数值单位均为mg。
上述组合物的制备方法:将骨架材料、崩解剂、凝胶剂、乳化稳定剂和助流剂共混20min;之后再加入润滑剂共混3min;将共混物压片制成素片,即得到组合物。
实施例1-10中骨架材料的检测数据见表2。
表2
对实施例1-10中制成的片剂进行了相关性能检测,检测结果见表3。
表3
注:实施例9中未加入二氧化硅,颗粒无流动性,不能压片。
结合上表2和表3数据可知,实施例3骨架材料选用聚氧化乙烯 N-12K,制成的片剂不起漂。实施例2、4、6、7、8、10制得的素片硬度在13kg~20kg之间,素片均能立刻起漂。实施例1和实施例5制得的片剂硬度较大,大于20kg,片厚较小,片剂体积小,片剂的起漂时间较长,分别为7分钟和9分钟,但均小于15分钟。因此,片剂硬度优选控制在13~22kg 范围内,更优选控制为13~20kg。
在膨胀效果方面,实施例1、2、4、5、7、8、10的片剂在4h后膨胀体积为2~4倍,24h的膨胀体积达到7倍以上,在服用后一段时间内不容易通过幽门,饱腹感持续久。实施例3片剂在4h后膨胀率为139.17%,24h 膨胀率为467.88%;实施例6片剂在24h膨胀率为422.67%。
在溶蚀率方面,实施例1、2、4、5、7、8、10的片剂在水中24h的溶蚀率不超过10%,具有较强的机械强度,能在胃部的蠕动下保持原有形态,持续起到饱腹效果。实施例3和实施例6在4h时的溶蚀率已超过10%, 24h溶蚀率超过40%。
由以上效果可见,实施例1、2、4、5、7、8、10的片剂在水中能快速漂浮,可在胃中吸水膨胀并在胃部长时间停留(4-24h),以提高服用者的饱腹感,从而达到减肥效果。
本发明中涉及起漂时间、膨胀率和溶蚀率时,测定方法均参照以下方法进行。
起漂时间:取1000ml烧杯,向烧杯中加入500ml水,水温为25±1℃,取供试样品,将供试样品投入烧杯中,记录供试品漂浮到水面的时间。每组进行3次试验,记录平均值。
膨胀率测定:对供试样品的长度、宽度和厚度进行测定,之后将供试样品放入装有900ml水的烧杯中,供试样品在水中分别放置4h、8h和24h 后取出,分别测定水中浸泡4h、8h和24h后供试样品的长度、宽度和厚度,之后计算出4h、8h和24h的膨胀率;膨胀率计算公式为:
其中,
S--膨胀率,%;
L0--吸水前样品长度,单位为mm;
K0--吸水前样品宽度,单位为mm;
T0--吸水前样品厚度,单位为mm;
L1--吸水后样品长度,单位为mm;
K1--吸水后样品宽度,单位为mm;
T1--吸水后样品厚度,单位为mm。
每组进行3次试验,取平均值。
溶蚀率测定:将供试样品置于装有900ml水的烧杯中,在样品放置4h、 8h和24h,分别在这3个时间点取样,之后将取得的样品置于60±2℃烘箱中干燥24h,称量干燥后的片重。溶蚀率计算公式为:
D=(W0-W1)/W0*100%,
其中,D--溶蚀率,%;
W0--吸水前样品重,单位为g;
W1--吸水干燥后样品重,单位为g。
每组进行3次试验,取平均值。
实施例11~14
实施例11~14分别提供了四种组合物,具体组成如下表4。
表4
组成成分 | 实施例4 | 实施例11 | 实施例12 | 实施例13 | 实施例14 |
羟丙甲纤维素K100M | 875.00 | 875.00 | 875.00 | 875.00 | 875.00 |
交联聚维酮 | 150.00 | 150.00 | 150.00 | 150.00 | 150.00 |
黄原胶 | 125.00 | 125.00 | 125.00 | 125.00 | 125.00 |
羧甲基纤维素钠 | 62.50 | 62.50 | 62.50 | 62.50 | 62.50 |
微粉硅胶(二氧化硅) | 25.00 | 25.00 | 25.00 | 25.00 | 25.00 |
硬脂酸镁 | 12.50 | 12.50 | 12.50 | 12.50 | 12.50 |
总计 | 1250.00 | 1250.00 | 1250.00 | 1250.00 | 1250.00 |
注:表4中数值单位均为mg。
以上组合物均制成片剂,制备方法同实施例1~10。
实施例11~14中骨架材料的检测数据见表5。
表5
骨架材料 | 实施例4 | 实施例11 | 实施例12 | 实施例13 | 实施例14 |
松密度g/cm3 | 0.34 | 0.40 | 0.42 | 0.46 | 0.53 |
卡尔系数% | 27.7 | 22.9 | 28.8 | 29.3 | 31.7 |
分子量 | 1000000 | 1000000 | 1000000 | 1000000 | 1000000 |
对实施例11~14制成的片剂进行了相关性能检测,检测结果见表6。
表6
结合表5和表6数据可知,实施例14骨架材料松密度为0.53g/cm3,起漂时间为2小时12分钟,大于15分钟;实施例12和实施例13中骨架材料松密度分别为0.42g/cm3和0.46g/cm3,起漂时间稍长,分别为8分钟和10分钟,但均小于15分钟。实施例4和实施例11中骨架材料松密度分别为0.34g/cm3和0.40g/cm3,片剂能立刻起漂。
实施例11~14制备的片剂膨胀率4h为2~4倍,24h膨胀率均在7倍以上;溶蚀率24h均小于10%。
实施例15~17
以下实施例提供了三种组合物,具体组成如下表7。
表7
组成成分 | 实施例15 | 实施例16 | 实施例11 | 实施例17 |
羟丙甲纤维素K100M | 375.00 | 625.00 | 875.00 | 1000.00 |
交联聚维酮 | 650.00 | 400.00 | 150.00 | 25.00 |
黄原胶 | 125.00 | 125.00 | 125.00 | 125.00 |
羧甲基纤维素钠 | 62.50 | 62.50 | 62.50 | 62.50 |
微粉硅胶(二氧化硅) | 25.00 | 25.00 | 25.00 | 25.00 |
硬脂酸镁 | 12.50 | 12.50 | 12.50 | 12.50 |
总计 | 1250.00 | 1250.00 | 1250.00 | 1250.00 |
注:表7中数值单位均为mg。
以上组合物均制成片剂,制备方法同实施例1~10。
实施例15-17中骨架材料的检测数据见表8。
表8
骨架材料 | 实施例15 | 实施例16 | 实施例11 | 实施例17 |
松密度g/cm3 | 0.34 | 0.34 | 0.40 | 0.34 |
卡尔系数% | 27.7 | 27.7 | 22.9 | 27.7 |
分子量 | 1000000 | 1000000 | 1000000 | 1000000 |
对实施例15-17制成的片剂进行了相关性能检测,检测结果见表9。
表9
结合表8和表9数据可知,实施例15~17中分别采用不同用量的羟丙甲纤维素K100M和交联聚维酮,但羟丙甲纤维素K100M和交联聚维酮的用量之和均为1025mg,制得的片剂起漂时间均为立刻起漂。膨胀率4h均在2~4倍,24h均在7倍以上;溶蚀率24h均小于10%。可见,骨架材料用量在300~1000mg范围内起漂时间、膨胀率和溶蚀率均能满足要求。
实施例18~20
以下实施例提供了三组组合物,具体组成如下表10。
表10
注:表10中的“/”表示未添加该组分,表中的数值单位均为mg。
以上组合物均制成片剂,制备方法同实施例1~10。
实施例18-20中各实施例骨架材料的检测数据见表11。
表11
骨架材料 | 实施例11 | 实施例18 | 实施例19 | 实施例20 |
羟丙甲纤维素K100M松密度g/cm3 | 0.40 | 0.34 | 0.34 | / |
羟丙甲纤维素K15M松密度g/cm3 | / | 0.36 | / | 0.36 |
羟丙甲纤维素K4M松密度g/cm3 | / | / | 0.32 | 0.32 |
羟丙甲纤维素K100M卡尔系数% | 22.9 | 27.7 | 27.7 | / |
羟丙甲纤维素K15M卡尔系数% | / | 26.9 | / | 26.9 |
羟丙甲纤维素K4M卡尔系数% | / | / | 25.3 | 25.3 |
羟丙甲纤维素K100M分子量 | 1000000 | 1000000 | 1000000 | / |
羟丙甲纤维素K15M分子量 | / | 575000 | / | 575000 |
羟丙甲纤维素K4M分子量 | / | / | 400000 | 400000 |
注:表11中的“/”表示未添加该组分。
对实施例18-20制成的片剂进行了相关性能检测,检测结果见表12。
表12
结合上表11和表12数据可知,实施例18~20中骨架材料为两种不同型号的羟丙甲纤维素的混合物,所得片剂起漂时间均为立刻起漂。膨胀率 4h为2~4倍,24h均在8倍以上;溶蚀率24h均小于10%。
实施例21-31
实施例21-31提供的组合物具体组成如下表13。
表13
注:表13中的数值单位均为mg。
以上组合物均制成片剂,制备方法同实施例1~10。
实施例21-31中各实施例骨架材料的检测数据见表14。
表14
对实施例21-31制成的片剂进行了相关性能检测,检测结果见表15。
表15
注:表15中实施例23和24的4h溶蚀率为-0.77%和-0.26,原因为片剂未干燥完全引起误差。
从上表14和15数据可知,实施例18、21、22和23采用了不同用量的崩解剂,所得片剂起漂时间均为立刻起漂;膨胀率4h均在2~4倍范围内,24h均在7倍以上;溶蚀率24h均小于10%。
实施例24、25、26和27采用了不同用量的乳化稳定剂,所得片剂起漂时间均为立刻起漂;膨胀率4h均在2~5倍范围内;实施例24、25和26 溶蚀率24h均小于10%;实施例27膨胀率24h为472.46%,膨胀率小于7 倍,溶蚀率24h为55.66%,大于10%,黄原胶用量过大时,片剂机械强度降低,溶蚀率变大。
实施例28、29、30和31采用了不同用量的凝胶剂,所得片剂起漂时间均为立刻起漂;膨胀率4h均在2~5倍范围内;实施例28、29和30溶蚀率24h均小于10%;实施例31膨胀率24h为402.33%,膨胀率小于7 倍,溶蚀率24h为49.89%,大于10%,实施例31中凝胶剂用量增加,片剂凝胶增加,机械强度降低,溶蚀率变大。
由以上试验可知,本发明提供的组合物在水中能快速漂浮甚至立即漂浮,可在胃中吸水膨胀并在胃部长时间停留(4-24h),以提高服用者的饱腹感,从而达到减肥效果。
实施例32-36
实施例32-36提供的组合物具体组成如下表16。
表16
注:表16中的数值单位均为mg。
以上组合物均制成片剂,制备方法同实施例1~10。
实施例32-36中各实施例骨架材料的检测数据见表17。
表17
对实施例32-36制成的片剂进行了相关性能检测,检测结果见表18。
表18
从上表16、17和18数据可知,实施例22、32、33、34、35和36采用了不同用量的助流剂,所得片剂起漂时间均为立刻起漂;膨胀率4h均在2~4倍范围内,24h均在7倍以上;溶蚀率24h均小于10%。
由以上试验可知,本发明提供的组合物在水中能快速漂浮甚至立即漂浮,可在胃中吸水膨胀并在胃部长时间停留(4-24h),以提高服用者的饱腹感,从而达到减肥效果。
采用实施例18的产品进行了临床效果检测。选用10人一组,共四组受试者进行实验,其中两组为食量大组,两组为肥胖受试者组,试验组服用实施例18样品,对照组为空白对照,未服用任何减肥药食品,1个月后进行受试者体重变化检测。试验结果见表19。
表19
经结果分析,证明本发明实施例18的组合物具有明显的减重效果,平均体重减少3~5kg。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (13)
1.一种长效饱腹组合物,其特征在于,以重量份计,所述组合物包括如下组分的原料:骨架材料300~1000份,崩解剂20~700份,凝胶剂10~200份,乳化稳定剂60~250份;
所述骨架材料为羟丙甲纤维素和/或羟丙纤维素;所述崩解剂为交联羧甲基纤维素钠、交联聚维酮、羧甲淀粉钠中的至少一种;所述凝胶剂为羧甲基纤维素钠和/或卡波姆;所述乳化稳定剂为黄原胶、魔芋胶和阿拉伯胶中的至少一种;所述组合物的硬度为13~22kg;
所述组合物中骨架材料和崩解剂的质量百分含量之和为70%~92%;所述骨架材料的松密度为0.30~0.50g/cm3,所述骨架材料的卡尔系数为20%~30%,所述骨架材料的分子量为20万~120万。
2.根据权利要求1所述的组合物,其特征在于,以重量份计,所述组合物还包括如下组分的原料:助流剂5~40份,润滑剂5~30份。
3.根据权利要求1或2所述的组合物,其特征在于,所述羟丙甲纤维素选自以下型号中的至少一种:E4M、K100LV、K250、K750、K1500、K4M、K15M、K35M、K100M和K200M。
4.根据权利要求3所述的组合物,其特征在于,所述羟丙甲纤维素为K4M、K15M和K100M型号中的一种或几种的混合。
5.根据权利要求1或2所述的组合物,其特征在于,所述凝胶剂为羧甲基纤维素钠。
6.根据权利要求2所述的组合物,其特征在于,所述助流剂为微粉硅胶、滑石粉、十二烷基硫酸镁、十二烷基硫酸钠中的至少一种。
7.根据权利要求2所述的组合物,其特征在于,所述助流剂为微粉硅胶和/或滑石粉。
8.根据权利要求2所述的组合物,其特征在于,所述润滑剂为硬脂富马酸钠和/或硬脂酸镁。
9.根据权利要求2所述的组合物,其特征在于,所述润滑剂为硬脂酸镁。
10.如权利要求1~9任意一项所述组合物的制备方法,其特征在于,将所述骨架材料、崩解剂、凝胶剂、乳化稳定剂和助流剂共混;之后再加入润滑剂共混;将共混物压片制成素片,得到长效饱腹组合物。
11.根据权利要求10所述的制备方法,其特征在于,所述素片的硬度为13~20kg。
12.如权利要求1~9任意一项所述的组合物作为减肥食品或者减肥药物的用途。
13.如权利要求1~9任意一项所述的组合物作为缓释药物载体的用途。
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