CN109289038A - 一种组合物及其制备方法和应用 - Google Patents
一种组合物及其制备方法和应用 Download PDFInfo
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- CN109289038A CN109289038A CN201811392909.0A CN201811392909A CN109289038A CN 109289038 A CN109289038 A CN 109289038A CN 201811392909 A CN201811392909 A CN 201811392909A CN 109289038 A CN109289038 A CN 109289038A
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Abstract
本发明涉及骨质疏松症的防治领域,具体而言,涉及一种组合物及其制备方法和应用。一种组合物,包括以下组分:按重量份计,初乳碱性蛋白10‑20份、碳酸钙5‑10份、酪蛋白磷酸肽1‑3份、壳寡糖3‑5份、藤茶提取物1‑2份、维生素C 0.3‑0.7份、维生素K 0.5‑0.6份。本发明人意外发现,一定含量的藤茶提取物与初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽、壳寡糖以及一些特定的维生素,能够有效促进成骨细胞的增殖、分化,显著提升骨密度。
Description
技术领域
本发明涉及骨质疏松症的防治领域,具体而言,涉及一种组合物及其制备方法和应用。
背景技术
骨质疏松即骨质疏松症,是多种原因引起的一组骨病,骨组织有正常的钙化,钙盐与基质呈正常比例,以单位体积内骨组织量减少为特点的代谢性骨病变。在多数骨质疏松中,骨组织的减少主要由于骨质吸收增多所致。以骨骼疼痛、易于骨折为特征。
碳酸钙、初乳碱性蛋白、硫酸软骨素和维生素D3是增加骨密度、防治骨质疏松症的常见药物,但这几种的应用效果还有待进一步提升。
有鉴于此,特提出本发明。
发明内容
本发明的目的在于提供一种组合物,本发明人意外发现,不同的组分配合食用,具有协同增强效果,并通过综合调整人体机能,达到了显著的提高骨密度的功效。
为了实现本发明的上述目的,特采用以下技术方案:
一种组合物,包括以下组分:按重量份计,初乳碱性蛋白10-20份、碳酸钙5-10份、酪蛋白磷酸肽1-3份、壳寡糖3-5份、藤茶提取物1-2份、维生素C 0.3-0.7份、维生素K 0.5-0.6份。
藤茶提取物主要组分为二氢杨梅素,二氢杨梅素具有清除自由基、抗氧化、抗血栓、抗肿瘤、消炎等多种功效,常用于保肝护肝、解酒醒酒。
本发明人意外发现,一定含量的藤茶提取物与初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽、壳寡糖以及一些特定的维生素,能够有效促进成骨细胞的增殖、分化,显著提升骨密度。
本发明中,初乳碱性蛋白直接作用于骨骼细胞,促进骨骼新陈代谢,协调成骨细胞和破骨细胞的活动,保持两者的动态平衡,促进骨骼生长,修复骨质;碳酸钙主要起到补充钙质的效果;酪蛋白磷酸肽具有促进钙质吸收的作用;壳寡糖分子量低、水溶性好、功能作用大、易被人体吸收、生物活性高,其具有辅助促进肠道对钙质的吸收的效果;维生素C具有很强的还原性,以保持各组分的活性的作用;维生素K参与合成BGP(维生素K依赖蛋白质),BGP能调节骨骼中磷酸钙的合成;藤茶提取物通过清除自由基、抗氧化,使得各组分中的活性组分能更长久的保持其活性,到达骨骼细胞,各组分相互配合协同增强,能有效促进骨细胞的增殖、分化,显著提升骨密度。
进一步地,按重量份计,初乳碱性蛋白10-15份、碳酸钙5-6份、酪蛋白磷酸肽2-3份、壳寡糖3-4份、藤茶提取物1.5-2份、维生素C0.3-0.4份、维生素K 0.5-0.6份。
进一步地,所述有效成分还包括蛹虫草肽粉20-30份。
蛹虫草,药理作用现代科学论证科茸蛹虫草不仅具有特殊的营养价值,而且有明显的药用价值。具备四大虫草成分:虫草素、虫草酸、虫草多糖和虫草SOD。
蛹虫草肽粉为蛹虫草的酶解物,其中有效成分为小分子多肽和虫草多糖,完全保留了蛹虫草的有效生物活性成分,更易于人体吸收,其为棕黄色粉末,可购自西安斯诺特生物技术有限公司。蛹虫草具有提高免疫和造血功能,本发明人意外发现,添加一定含量的蛹虫草肽能提升促进骨细胞的增殖分化的水平,达到更显著的提升骨密度的功效。
进一步地,所述有效成分还包括蛹虫草肽粉25-30份。
进一步地,所述组合物为固态或液态,所述固态包括粉剂、颗粒剂。
本发明还提供了一种产品,包括上述的组合物,如该组合物可以制成保健品、功能性食品、饮料以及药物等等。
根据临床的要求,药物可制成各种剂型。进一步地,所述药物还包括药学上可接受的辅料。
进一步地,所述药学可接受的辅料包括稀释剂、赋形剂、崩解剂、填充剂、粘合剂、润滑剂、矫味剂、表面活化剂、稳定剂中的任一种或多种组合。
进一步地,所述赋形剂包括甘露醇、乳糖、淀粉、右旋糖酐、微晶纤维素中的任一种或多种组合。
进一步地,所述崩解剂包括聚乙烯吡咯烷酮、羧甲基纤维素、羧甲基纤维素钠、羟丙甲基纤维素中的任一种或多种组合。
进一步地,所述润滑剂包括滑石粉、硬脂酸镁中的任一种或两种组合。
进一步地,所述药物的剂型包括片剂、冲剂、颗粒剂、丸剂、胶囊剂中的任一种。
本发明中涉及的稀释剂如水等;填充剂如淀粉、蔗糖等;粘合剂,如淀粉浆、糊精、糖浆、蜂蜜、葡萄糖溶液、微晶纤维素、阿拉伯胶浆、明胶浆、羧甲基纤维素钠、甲基纤维素、羟丙基甲基纤维素、乙基纤维素、丙烯酸树脂、卡波姆、聚乙烯吡咯烷酮、聚乙二醇等;表面活化剂如阳离子型、阴离子型、两性离子型和非离子型;稳定剂如硬脂酸镉、硬脂酸锌、二巯基乙酸异辛酯二正辛基锡、二月桂酸二正丁基锡等等。
本发明提供的药物的剂型按照本领域的常规方法制备即可。如为了将本发明的有效成分制成片剂,可以广泛使用本领域公知的各种赋形剂,包括稀释剂、粘合剂、润湿剂、崩解剂、润滑剂、助流剂。稀释剂可以是淀粉、糊精、蔗糖、葡萄糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素、硫酸钙、磷酸氢钙、碳酸钙等;湿润剂可以是水、乙醇、异丙醇等;粘合剂可以是淀粉浆、糊精、糖浆、蜂蜜、葡萄糖溶液、微晶纤维素、阿拉伯胶浆、明胶浆、羧甲基纤维素钠、甲基纤维素、羟丙基甲基纤维素、乙基纤维素、丙烯酸树脂、卡波姆、聚乙烯吡咯烷酮、聚乙二醇等;崩解剂可以是干淀粉、微晶纤维素、低取代羟丙基纤维素、交联聚乙烯吡咯烷酮、交联羧甲基纤维素钠、羧甲基淀粉钠、碳酸氢钠与枸橼酸、聚氧乙烯山梨糖醇脂肪酸酯、十二烷基磺酸钠等;润滑剂和助流剂可以是滑石粉、二氧化硅、硬脂酸盐、酒石酸、液体石蜡、聚乙二醇等。
还可以将片剂进一步制成包衣片,例如糖包衣片、薄膜包衣片、肠溶包衣片,或双层片和多层片。
如:为了将给药单元制成胶囊剂,可以将本发明的有效成分与稀释剂、助流剂混合,将混合物直接置于硬胶囊或软胶囊中。也可将有效成分先与稀释剂、黏合剂、崩解剂制成颗粒或微丸,再置于硬胶囊或软胶囊中。用于制备本发明化合物片剂的各稀释剂、黏合剂、润湿剂、崩解剂、助流剂品种也可用于制备本发明化合物的胶囊剂。
此外,如需要,也可以向药物制剂中添加着色剂、防腐剂、香料、矫味剂或其它添加剂。
本发明还提供了所述的组合物的制备方法,所述组合物为粉剂,将各组分混匀即可。
进一步地,所述混匀为:
初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
所述第一混合物和所述第二混合物混匀即可。
本发明还提供了另一种组合物的制备方法,所述组合物为粉剂,将各组分混匀即可。
进一步地,所述混匀为:
蛹虫草肽粉、初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
所述第一混合物和所述第二混合物混匀即可。
本发明提供的组合物具有突出的提升骨密度的功效。此外,还具有明显的提升免疫力的效果。
与现有技术相比,本发明的有益效果为:
(1)本发明人意外发现,一定含量的藤茶提取物与初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽、壳寡糖以及一些特定的维生素,能够有效促进成骨细胞的增殖、分化,显著提升骨密度。
(2)本发明人发现,在促进骨细胞的增殖分化的同时,选用一定含量的蛹虫草肽粉能更显著的提升骨密度的功效。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述,但是本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应视为限制本发明的范围。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂、原料或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
实施例1
一种组合物,由以下组分制成:
组1:按重量份计,初乳碱性蛋白15份、碳酸钙6份、酪蛋白磷酸肽2份,混合即可。
组2:按重量份计,取以下组分:初乳碱性蛋白15份、碳酸钙6份、酪蛋白磷酸肽2份、壳寡糖4份、藤茶提取物1.5份、维生素C 0.4份、维生素K 0.6份;
初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
第一混合物和第二混合物混匀即可。
组3:按重量份计,取以下组分:初乳碱性蛋白15份、碳酸钙6份、酪蛋白磷酸肽2份、壳寡糖4份、藤茶提取物1.5份、维生素C 0.4份、维生素K 0.6份、蛹虫草肽粉25份;
蛹虫草肽粉粉、初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
第一混合物和第二混合物混匀即可。
不同组别制得的组合物进行大鼠急性毒性实验,未见明显异常。
不同组别制得的组合物进行效果检测,具体如下:
实验动物:SD大鼠,雌雄各半,每个体重在18-22g。分为假手术组、去卵巢组、去卵巢并服用雌激素组、去卵巢并服用实施例组1-组3组合物的实验组1-3,实验组1-3分为低剂量和高剂量。
假手术组:麻醉,行假卵巢切除手术,即找到卵巢后取出观察,然后放回,缝合;
去卵巢组:麻醉后,切开,找到卵巢,结扎后切除,缝合;
去卵巢并服用雌激素组:同上行卵巢切除术后,每天灌胃给予炔雌醇(100μg/kg),共10周。
实验组1:同上行卵巢切除术后,每天灌胃给予组1组合物(低剂量100mg/kg;高剂量500mg/kg),共10周。
实验组2:同上行卵巢切除术后,每天灌胃给予组2组合物(低剂量100mg/kg;高剂量500mg/kg),共10周。
实验组3:同上行卵巢切除术后,每天灌胃给予组3组合物(低剂量100mg/kg;高剂量500mg/kg),共10周。
每个组别10只大鼠;各组动物在同等条件下饲养和给药,假手术组和去卵巢模型组每天同时灌胃等量的生理盐水。所有动物均在相关规定的适宜条件下饲养,每周称重一次,根据体重每周调整给药量,全部大鼠在处死前10天皮下注射盐酸四环素25mg/kg,在处死前2天于其背部皮下注射钙黄绿素5mg/kg。
实验结束,麻醉,打开胸腔,经一定的处置后,分离胫骨,去除肌肉,胫骨上端踝间隆起前方行额状面锯开,暴露骨髓腔,然后将其分为三段:上端为胫骨近端,主要观察骨松质;中段为胫骨中部,主要观察骨皮质;下段为胫骨远端,用于观察成年骨部位以及黄骨髓部位。将三段骨样本迅速置于10%磷酸盐缓冲液配置的福尔马林中固定48小时,再经70%乙醇脱水后,用特殊骨染料染色5天。以后从50%乙醇开始逐级脱水及丙酮脱脂,最后用甲基丙烯酸甲酯包埋不脱钙骨,包埋块干后锯成300mm骨片,切成20mm薄片再次梯度脱水,透明封片。
用骨组织计量学方法测量各骨组织的形态学参数,结果如表1所示。
表1各骨组织的情况
从表1可以看出,相比于假手术组,去卵巢组骨量降低显著,表现为骨小梁面积百分率(percent trabecular area,Tb.Ar)减少68%,骨小梁厚度减少,骨小梁数目降低65%,骨小梁间隙增加326%。说明了去卵巢后大鼠出现了明显的骨质疏松症。
与去卵巢组比较,实验组1-实验组3对骨质疏松症均有一定的改善作用,其中以实验组2和实验组3对骨质疏松症改善作用最为明显,特别是实验组3,高剂量的灌胃量使得大鼠的骨质疏松症症状基本消失。说明本发明提供的组合物各组合物之间具有协同增强效果,起到了预料不到的改善骨质疏松症状的作用。
实施例2
一种组合物,由以下组分制成:
按重量份计,取以下组分:初乳碱性蛋白10份、碳酸钙5份、酪蛋白磷酸肽1份、壳寡糖3份、藤茶提取物1份、维生素C 0.7份、维生素K 0.6份、蛹虫草肽粉30份;
蛹虫草肽粉、初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
第一混合物和第二混合物混匀即可。
实施例3
一种组合物,由以下组分制成:
按重量份计,取以下组分:初乳碱性蛋白20份、碳酸钙10份、酪蛋白磷酸肽3份、壳寡糖3份、藤茶提取物2份、维生素C 0.3份、维生素K 0.5份、蛹虫草肽粉20份;
蛹虫草肽粉、初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
第一混合物和第二混合物混匀即可。
实施例4
一种组合物,由以下组分制成:
按重量份计,取以下组分:初乳碱性蛋白15份、碳酸钙10份、酪蛋白磷酸肽2份、壳寡糖5份、藤茶提取物2份、维生素C 0.4份、维生素K 0.5份、蛹虫草肽粉25份;
蛹虫草肽粉、初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
第一混合物和第二混合物混匀即可。
实施例2-4制得的组合物与实施例1的方法进行大鼠实验,灌胃量同实施例1高剂量,得到,骨量指标基本同假手术组一致。
临床例
以实施例1组3制得的组合物进行临床使用检验效果,共实验了50人,年龄分布在55-65岁,共5人为男性,其余为女性。每日早晚一次,每次量为15g,温水冲服。跟踪统计服用效果。
服用前测量骨密度,测量骨密度采用ExA-3000型骨密度仪,检测受试者非受力侧前臂尺挠骨中远端1/3处骨密度。骨峰值分别在0.405-0.437、0.257-0.315间。服用1个月后按上述方法测量骨密度,骨峰值提高范围为5%-10%,服用至1年,骨密度提高范围为8%-15%。
尽管已用具体实施例来说明和描述了本发明,然而应意识到,在不背离本发明的精神和范围的情况下可以作出许多其它的更改和修改。因此,这意味着在所附权利要求中包括属于本发明范围内的所有这些变化和修改。
Claims (10)
1.一种组合物,其特征在于,包括以下组分:按重量份计,初乳碱性蛋白10-20份、碳酸钙5-10份、酪蛋白磷酸肽1-3份、壳寡糖3-5份、藤茶提取物1-2份、维生素C 0.3-0.7份、维生素K 0.5-0.6份。
2.根据权利要求1所述的组合物,其特征在于,按重量份计,初乳碱性蛋白10-15份、碳酸钙5-6份、酪蛋白磷酸肽2-3份、壳寡糖3-4份、藤茶提取物1.5-2份、维生素C 0.3-0.4份、维生素K 0.5-0.6份。
3.根据权利要求1所述的组合物,其特征在于,所述有效成分还包括蛹虫草肽粉20-30份。
4.根据权利要求3所述的组合物,其特征在于,所述有效成分还包括蛹虫草肽粉25-30份。
5.根据权利要求1-4任一项所述的组合物,其特征在于,所述组合物为固态或液态,所述固态包括粉剂、颗粒剂。
6.权利要求1-2任一项所述的组合物的制备方法,其特征在于,所述组合物为粉剂,将各组分混匀即可;
进一步地,所述混匀为:
初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
所述第一混合物和所述第二混合物混匀即可。
7.权利要求3-4任一项所述的组合物的制备方法,其特征在于,所述组合物为粉剂,将各组分混匀即可;
进一步地,所述混匀为:
蛹虫草肽粉、初乳碱性蛋白、碳酸钙、酪蛋白磷酸肽和藤茶提取物混匀,得到第一混合物;
壳寡糖、维生素C、维生素K混匀,得到第二混合物;
所述第一混合物和所述第二混合物混匀即可。
8.一种产品,其特征在于,由权利要求6或7所述的组合物制成。
9.权利要求1-4任一项所述的组合物在提升提高骨密度产品中的应用。
10.权利要求1-4任一项所述的组合物以及权利要求6或7制得的组合物在提升免疫力产品中的应用。
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