CN111345476A - 一种hmb氨糖骨胶肽颗粒剂 - Google Patents
一种hmb氨糖骨胶肽颗粒剂 Download PDFInfo
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- CN111345476A CN111345476A CN202010161308.XA CN202010161308A CN111345476A CN 111345476 A CN111345476 A CN 111345476A CN 202010161308 A CN202010161308 A CN 202010161308A CN 111345476 A CN111345476 A CN 111345476A
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- glucosamine
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- 108090000765 processed proteins & peptides Proteins 0.000 title claims abstract description 51
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 title claims abstract description 43
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 title claims abstract description 43
- 229960002442 glucosamine Drugs 0.000 title claims abstract description 43
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- OVRNDRQMDRJTHS-UHFFFAOYSA-N N-acelyl-D-glucosamine Natural products CC(=O)NC1C(O)OC(CO)C(O)C1O OVRNDRQMDRJTHS-UHFFFAOYSA-N 0.000 claims abstract description 15
- OVRNDRQMDRJTHS-FMDGEEDCSA-N N-acetyl-beta-D-glucosamine Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O OVRNDRQMDRJTHS-FMDGEEDCSA-N 0.000 claims abstract description 15
- MBLBDJOUHNCFQT-LXGUWJNJSA-N N-acetylglucosamine Natural products CC(=O)N[C@@H](C=O)[C@@H](O)[C@H](O)[C@H](O)CO MBLBDJOUHNCFQT-LXGUWJNJSA-N 0.000 claims abstract description 15
- 229950006780 n-acetylglucosamine Drugs 0.000 claims abstract description 15
- DLRVVLDZNNYCBX-RTPHMHGBSA-N isomaltose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)C(O)O1 DLRVVLDZNNYCBX-RTPHMHGBSA-N 0.000 claims abstract description 13
- CBOJBBMQJBVCMW-BTVCFUMJSA-N (2r,3r,4s,5r)-2-amino-3,4,5,6-tetrahydroxyhexanal;hydrochloride Chemical compound Cl.O=C[C@H](N)[C@@H](O)[C@H](O)[C@H](O)CO CBOJBBMQJBVCMW-BTVCFUMJSA-N 0.000 claims abstract description 11
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- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
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Abstract
本发明属于保健品和医药领域，公开了一种HMB氨糖骨胶肽颗粒剂。本发明所述HMB氨糖骨胶肽颗粒剂包含β‑羟基‑β‑甲基丁酸钙(HMB)、骨胶原蛋白肽、氨基葡萄糖盐酸盐(或硫酸盐)、N‑乙酰氨基葡萄糖、D‑核糖、低聚异麦芽糖、燕麦香精和药用辅料。所述HMB氨糖骨胶肽颗粒剂中HMB、骨胶原蛋白肽、氨基葡萄糖和D‑核糖等成分具有协同增效的功效，无毒副作用，共同用于防治肌肉衰减、增加骨密度的同时还可以提高机体免疫力，延缓机体衰老。
Description
技术领域
本发明涉及保健品和医药领域，具体是涉及一种HMB氨糖骨胶肽颗粒剂。
背景技术
骨骼矿物质密度是骨骼强度的主要指标，是骨质量的一个重要标志，是反映骨质疏松程度，预测骨折危险性的重要依据，骨密度越高，骨质强度越好。人的骨密度在30岁左右到达峰值后就会随年龄的增长逐年因骨丢失而下降。据报道，无论男女，60岁以后，骨丢失量一般达峰值时的20％～30％，最多的可达40％。随着年龄的增长，与相同营养条件下的30岁以下的年轻人相比，中老年人仍不可避免地出现骨质大量丢失，骨质密度下降，骨强度降低，逐渐变得疏松易折，因而中老年人常因骨密度下降导致骨质疏松而发生无诱因的骨折。
在中国逐步进入老龄化社会之际，关爱中老年人健康，防治骨质疏松，已成为保健品和医药领域普遍关注的问题。然而，目前市面上增加骨密度的产品多是单纯的补钙，补充的钙吸收率较低，且单纯的补钙会导致骨骼的韧性减弱、脆性增加，更易造成骨折，未被吸收的钙如不能及时排出体外，在体内积累很容易造成胆结石等疾病，反而对身体不利。
骨胶原蛋白可以使钙有效沉淀在骨骼上，提高钙的吸收率，人体所吸收的钙，正是通过胶原蛋白的连接作用才被骨骼有效利用，只有补充足够的骨胶原，才能保证骨骼成分的合理比例。氨基葡萄糖是单糖葡萄糖的氨基衍生物，其盐通常具有很强的抗氧化活性，可以改善、预防、治疗及修复结缔组织损伤，对骨骼和关节炎发炎有一定的疗效，有利于延缓骨质疏松的发展。然而，老龄人因脏腑机能逐浙衰退，免疫功能也随之减退，单独补充骨胶原蛋白或氨基葡萄糖难以达到增加骨密度、提高机体免疫力和延缓衰老的效果。如今人们越来越注重生活质量，开发兼具增加骨密度、提高机体免疫力和延缓衰老功效的保健食品十分必要并具有积极的现实意义。
发明内容
本发明为了克服上述背景技术的不足，顺应人们的需求，提供了一种HMB氨糖骨胶肽颗粒剂，所述HMB氨糖骨胶肽颗粒剂中不仅包含骨胶原蛋白肽、氨基葡萄糖，还包含β-羟基-β-甲基丁酸钙(HMB)、N-乙酰氨基葡萄糖和D-核糖等成分，这些成分具有协同增效的功效，无毒副作用，共同用于防治肌肉衰减、增加骨密度的同时还可以提高机体免疫力，延缓机体衰老。
为达到本发明的目的，本发明的HMB氨糖骨胶肽颗粒剂包含HMB、骨胶原蛋白肽、氨基葡萄糖可药用盐、N-乙酰氨基葡萄糖、D-核糖和低聚异麦芽糖。
优选地，所述HMB、骨胶原蛋白肽、氨基葡萄糖可药用盐、N-乙酰氨基葡萄糖、D-核糖的质量比为3-4：1-2：1-2：1-2：0.8-1.5。
进一步优选地，按重量份数计，所述HMB氨糖骨胶肽颗粒剂包含30-40份HMB、10-20份骨胶原蛋白肽、10-20份氨基葡萄糖可药用盐、10-20份N-乙酰氨基葡萄糖、8-15份D-核糖和15-30份低聚异麦芽糖。
进一步地，所述氨基葡萄糖可药用盐为氨基葡萄糖盐酸盐或氨基葡萄糖硫酸盐。
进一步地，所述药用辅料包含香精、粘合剂、润湿剂和润滑剂。
优选地，所述香精为燕麦香精。
进一步地，所述粘合剂为微晶纤维素、羟丙基纤维素、共聚维酮或聚维酮。
进一步地，所述润湿剂为乙醇、丙二醇、甘油、聚乙二醇或吐温-80。
进一步地，所述润滑剂为氢化植物油、微粉硅胶、滑石粉或二氧化硅。
本发明所述HMB氨糖骨胶肽颗粒剂中HMB、骨胶原蛋白肽、氨基葡萄糖、D-核糖都容易被人体吸收，共同帮助防治肌肉衰减、增加骨密度，恢复骨功能，具有协同增效的功效，且β-羟基-β-甲基丁酸钙(HMB)每天用量小于3g即可提高心血供养、增强抵抗力、养颜护肤。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合实施例，对本发明进行进一步详细说明。本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。应当理解，以下描述仅仅用以解释本发明，并不用于限定本发明。
本文中所用的术语“包含”、“包括”、“具有”、“含有”或其任何其它变形，意在覆盖非排它性的包括。例如，包含所列要素的组合物、步骤、方法或制品不必仅限于那些要素，而是可以包括未明确列出的其它要素或此种组合物、步骤、方法或制品所固有的要素。
使用本领域常规湿法制粒、干法制粒或喷雾制粒方法制备本发明所述HMB氨糖骨胶肽颗粒剂即可，制备过程中温度不宜太高，以免破坏药物活性，所制备的HMB氨糖骨胶肽颗粒剂每日服用剂量为5克，每克中HMB的含量为0.4-0.55g。
实施例1
按重量份数计，取35份HMB、15份骨胶原蛋白肽、15份氨基葡萄糖盐酸盐、15份N-乙酰氨基葡萄糖、11份D-核糖、20份低聚异麦芽糖、15份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例2
按重量份数计，取30份HMB、10份骨胶原蛋白肽、10份氨基葡萄糖硫酸盐、10份N-乙酰氨基葡萄糖、8份D-核糖、15份低聚异麦芽糖、10份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例3
按重量份数计，取40份HMB、20份骨胶原蛋白肽、20份氨基葡萄糖盐酸盐、20份N-乙酰氨基葡萄糖、15份D-核糖、30份低聚异麦芽糖、20份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例4
按重量份数计，取35份HMB、15份骨胶原蛋白肽、15份氨基葡萄糖盐酸盐、15份N-乙酰氨基葡萄糖、20份低聚异麦芽糖、15份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例5
按重量份数计，取35份HMB、15份骨胶原蛋白肽、15份N-乙酰氨基葡萄糖、11份D-核糖、20份低聚异麦芽糖、15份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例6
按重量份数计，取35份HMB、15份骨胶原蛋白肽、15份氨基葡萄糖盐酸盐、11份D-核糖、20份低聚异麦芽糖、15份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例7
按重量份数计，取25份HMB、25份骨胶原蛋白肽、15份氨基葡萄糖盐酸盐、15份N-乙酰氨基葡萄糖、11份D-核糖、20份低聚异麦芽糖、15份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
实施例8
按重量份数计，取25份HMB、15份骨胶原蛋白肽、25份氨基葡萄糖盐酸盐、15份N-乙酰氨基葡萄糖、11份D-核糖、20份低聚异麦芽糖、15份燕麦香精以及适量羟丙基纤维素、聚乙二醇、微粉硅胶等药用辅料制备HMB氨糖骨胶肽颗粒剂。
效果检测试验
实施例1制备的HMB氨糖骨胶肽颗粒剂按50mg/kg.bw的剂量经口给予小鼠30天，能明显增加小鼠的抗体生成细胞数，表明本发明所述HMB氨糖骨胶肽颗粒剂能增强小鼠的免疫功能，具有免疫调节作用。
选择年龄在50～60岁之间，患有骨关节病及骨质疏松，且病症较重的270例受试者，男女各半，采用自身和组间两种对照设计，根据随机双盲的要求进行分组，使用各实施例中制备的HMB氨糖骨胶肽颗粒剂进行效果检验。
按受试者骨质疏松的情况随机分为试食组1-8和对照组，尽可能考虑影响结果的主要因素如年龄、性别、饮食等，进行均衡性检验，以保证组间的可比性，每组受试者30例，男女各15人。试食组每人每天服用本发明HMB氨糖骨胶肽颗粒剂1次，每次5g，对照组服用氨基葡萄糖盐酸盐，连续服用60天，为进一步验证本发明HMB氨糖骨胶肽颗粒剂的免疫调节功效和养颜效果，期间受试者未使用任何养颜护肤的化妆品或保健品。其中试食组1-8分别服用实施例1-8的HMB氨糖骨胶肽颗粒剂。
症状积分观察：按骨关节病及骨质疏松症状的轻重累计积分(重症3分、中度2分、轻度1分)。
试食前试食组1-8和对照组的血、尿、便常规及肝肾功能等检查均在正常范围，且各组受试者年龄、性别、症状积分均无明显差异。试食组与对照组在试验期间正常饮食，不改变原来的饮食习惯，60天后进行比较。60天内和60天后，在试验过程中都未发现毒副作用，试食60天前后平均症状积分如表1所示。
表1试食组1-8和对照组试食前后平均症状积分
| 观察项 | 试食前 | 试食后 |
| 对照组 | 2.89 | 2.12 |
| 试食组1 | 2.88 | 0.66 |
| 试食组2 | 2.89 | 0.69 |
| 试食组3 | 2.89 | 0.61 |
| 试食组4 | 2.89 | 1.35 |
| 试食组5 | 2.89 | 1.58 |
| 试食组6 | 2.88 | 1.76 |
| 试食组7 | 2.89 | 1.20 |
| 试食组8 | 2.88 | 1.45 |
此外，在试验过程中发现试食组1-3的患者身体素质明显提高，抵抗力增强，皮肤皱纹、雀斑等有淡化趋势，对照组、试食组4-8的患者身体素质的改善则没有试食组1-3明显。典型的，例如试食组1中59岁的邓女士，试食前身体疲乏、面部长痘及雀斑，试食60天后，邓女士感觉精力充沛，气色红润，脸上的痘痘不见了，雀斑淡化了；又如试食组1的李女士，56岁，试食前眼角鱼尾纹很深，鼻梁表情纹清晰可见，有少量雀斑，试食60天后，李女士的鱼尾纹和鼻梁表情纹都明显变浅了，雀斑几乎看不见了；对照组、试食组4-8中也有有雀斑和鱼尾纹的女性患者，但60天后鱼尾纹和雀斑变化不明显。
本领域的技术人员容易理解，以上所述仅为本发明的实例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (9)
1.一种HMB氨糖骨胶肽颗粒剂，其特征在于，所述HMB氨糖骨胶肽颗粒剂包含HMB、骨胶原蛋白肽、氨基葡萄糖可药用盐、N-乙酰氨基葡萄糖、D-核糖和低聚异麦芽糖。
2.根据权利要求1所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述HMB、骨胶原蛋白肽、氨基葡萄糖可药用盐、N-乙酰氨基葡萄糖、D-核糖的质量比为3-4：1-2：1-2：1-2：0.8-1.5。
3.根据权利要求1所述的HMB氨糖骨胶肽颗粒剂，其特征在于，按重量份数计，所述HMB氨糖骨胶肽颗粒剂包含30-40份HMB、10-20份骨胶原蛋白肽、10-20份氨基葡萄糖可药用盐、10-20份N-乙酰氨基葡萄糖、8-15份D-核糖和15-30份低聚异麦芽糖。
4.根据权利要求1所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述氨基葡萄糖可药用盐为氨基葡萄糖盐酸盐或氨基葡萄糖硫酸盐。
5.根据权利要求1所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述药用辅料包含香精、粘合剂、润湿剂和润滑剂。
6.根据权利要求5所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述香精为燕麦香精。
7.根据权利要求5所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述粘合剂为微晶纤维素、羟丙基纤维素、共聚维酮或聚维酮。
8.根据权利要求5所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述润湿剂为乙醇、丙二醇、甘油、聚乙二醇或吐温-80。
9.根据权利要求5所述的HMB氨糖骨胶肽颗粒剂，其特征在于，所述润滑剂为氢化植物油、微粉硅胶、滑石粉或二氧化硅。
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