CN109602732A - 一种改善骨质疏松的组合物及其制备方法与应用 - Google Patents
一种改善骨质疏松的组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明属于保健产品技术领域,公开了一种改善骨质疏松的组合物及其制备方法与应用,所述组合物包括NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素和活性成分,所述活性成分为磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s‑腺苷蛋氨酸、γ‑氨基丁酸、虾青素、焦谷氨酸酯中的至少一种。上述成分协同作用,对细胞供氧量、钙的吸收有很大促进功效,可加速骨髓细胞造血,上述处方组分简单,对改善骨质疏松具有明显效果,临床观察其治疗率可达98.7%,组合物各组分的原生药材均为植物药,为药物的安全性提供了保障。
Description
技术领域
本发明属于保健产品技术领域,具体地说涉及一种改善骨质疏松的组合物、制剂及其制备方法与应用。
背景技术
随着人口老龄化日益加重,骨质疏松症(osteoporosis,OP)发病率逐年升高,世界卫生组织(WHO)调查显示,骨质疏松症已成为全球性健康问题,目前,全世界约2亿人患有骨质疏松症,骨质疏松发病率在慢性病中已跃居第七位。
骨质疏松症是一种以骨量减少、骨强度降低、骨脆性增加、显微结构发生退行性变化,并以骨折风险增加为特点的渐进性疾病,中医学研究认为骨质疏松症的病因主要与肝脾肾不足及血瘀有关,其中肝肾不足是骨质疏松的主要病机,脾虚失运也是一种重要病机,血瘀则是促进因素,加速了骨质疏松症的进程。目前,传统预防和治疗骨质疏松症的方法是口服碳酸钙片剂,补充钙确实,但是这种方法存在一定缺陷,如利用无机钙中和胃酸会引起嗳气、便秘等不良感应,且对骨质疏松的改善效果不明显,长期服用对骨吸收、骨形成并无明显促进作用。市面上也存在一些中成药产品,但是大多存在效果不佳或具有毒副作用等问题。
发明内容
为此,本发明正是要解决上述技术问题,从而提出一种效果显著、安全无毒副作用的改善骨质疏松的组合物、制剂及其制备方法与应用。
为解决上述技术问题,本发明的技术方案为:
本发明提供一种改善骨质疏松的组合物,其包括NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种;
优选的,所述活性成分为牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少五种。
作为优选,以重量份计,所述组合物包括如下组分:NADH 1-10份、NADPH 1-10份、人参皂苷PPD1-10份、人参皂苷Rh21-10份、硫酸软骨素1-10份、活性成分1-10份;
优选的,以重量份计,所述组合物包括如下组分:NADH 3-8份、NADPH 2-7份、人参皂苷PPD 2-8份、人参皂苷Rh2 3-9份、硫酸软骨素2-8份、活性成分2-9份;
优选的,以重量份计,所述组合物包括如下组分:NADH 5份、NADPH6份、人参皂苷PPD 5.5份、人参皂苷Rh2 7份、硫酸软骨素6份、活性成分7份。
作为优选,以重量份计,所述组合物包括如下组分:NADH 2-8份、NADPH 3-7份、人参皂苷PPD 4-9份、人参皂苷Rh2 3-8份、硫酸软骨素4-8份、牛磺酸0.2-0.8份、磷脂酰丝氨酸0.2-1份、熊去氧胆酸0.1-1.2份、燕窝酸0.5-1.3份、s-腺苷蛋氨酸1-1.5份、γ-氨基丁酸0.5-2份、虾青素0.3-1份、焦谷氨酸酯0.4-1份;
优选的,以重量份计,所述组合物包括如下组分:NADH6份、NADPH 5份、人参皂苷PPD6份、人参皂苷Rh25份、硫酸软骨素3.5份、牛磺酸0.5份、磷脂酰丝氨酸0.6份、熊去氧胆酸1份、燕窝酸0.9份、s-腺苷蛋氨酸1.2份、γ-氨基丁酸1份、虾青素0.8份、焦谷氨酸酯0.8份。
本发明还提供一种制备所述的组合物的方法,将所述改善骨质疏松的组合物各组分按照配比混合均匀,即得。
本发明还提供一种改善骨质疏松的组合物的应用,将所述组合物用于制备药物制剂或保健食品。
本发明还提供一种改善骨质疏松的药物制剂,其包括所述的组合物和辅料。
作为优选,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的至少一种;
优选地,所述辅料的重量份数为1-10份。
作为优选,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的三种。
作为优选,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成。
作为优选,所述药物制剂为片剂、口服液剂、胶囊剂、颗粒剂、注射剂、酊剂、栓剂、贴剂、丸剂、糖浆剂、合剂、散剂、膜剂、滴丸中的一种。
本发明的上述技术方案相比现有技术具有以下优点:
本发明所述的改善骨质疏松的组合物,包括NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素、牛磺酸和活性成分,所述活性成分为磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种,所述NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素、牛磺酸和活性成分协同作用,对细胞供氧量、钙的吸收有很大促进功效,可加速骨髓细胞造血,上述处方组分简单,对改善骨质疏松具有明显效果,临床观察其治疗率可达98.7%,组合物各组分的原生药材均为植物药,为药物的安全性提供了保障。在传统配方的基础上,首次提出加用NADH(烟酰胺腺嘌呤二核苷酸的还原态,还原型辅酶Ⅰ)、NADPH(还原型烟酰胺腺嘌呤二核苷酸磷酸,还原型辅酶Ⅱ)、人参皂苷PPD、人参皂苷Rh2的成分,现有报道中,NADH、PPD、Rh2四者仅仅单独作为原料被使用,本发明中西医理论相呼应,加入各类特定的活性成分能够显著提高方中其它药材对改善骨质疏松具有促进效果。
具体实施方式
为了使本发明的内容更容易被清楚的理解,下面根据本发明的具体实施例对本发明作进一步详细的说明。
实施例1
本实施例提供一种改善骨质疏松的组合物,其包括NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种。
其中,所述活性成分可以是包括牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的一种即可;也可以是,所述活性成分至少包括牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的几种;优选的是,所述活性成分至少包括牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少五种;优选的,至少四种;优选的,至少三种,优选的,至少两种。还可以是,所述活性成分包括牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯。
本实施例中,所述活性成分为磷脂酰丝氨酸。其中,以重量份计,所述组合物包括:NADH 1份、NADPH 10份、人参皂苷PPD1份、人参皂苷Rh210份、硫酸软骨素1份、牛磺酸1份。
本实施例还提供一种制备所述组合物的方法:将上述组分按照比例混合均匀,即得改善骨质疏松的组合物。
所述改善骨质疏松的组合物可用于制备药物制剂或保健食品,其中药物制剂可为片剂、胶囊剂、颗粒剂、注射剂、酊剂、栓剂、贴剂、丸剂、糖浆剂、合剂、散剂、膜剂、滴丸中的一种。
对于药物制剂,其包括所述改善骨质疏松的组合物和辅料,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀、硫酸钙、气相二氧化硅、乳糖中的至少一种,本实施例中,所述辅料为尼泊金复合酯,其重量份为1份。
本实施例中,所述药物制剂为口服液剂,所述口服液剂通过如下方法制备:将干燥好的组合物和辅料分别过30-80目筛,使粒度分布均匀,流动性更好,组合物和辅料保持干燥,然后进行配比称重,加水在25-40℃下充分搅拌均匀后,升温至50℃,搅拌1h,即得。
本实施例还提供一种保健食品,所述保健食品包括所述组合物和适量可接受的食品辅料,所述食品辅料包括乳粉、麦芽糊精、果胶、麦芽糖、磷脂、柠檬酸中的至少一种。
实施例2
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH10份、NADPH 1份、人参皂苷PPD10份、人参皂苷Rh21份、硫酸软骨素10份、熊去氧胆酸5份、燕窝酸5份。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为10份,所述辅料包括富马酸、磷酸盐、微晶纤维素,上述辅料组分的质量比为1:2:1。本实施例中,所述药物制剂为颗粒剂,其通过如下方法制备:将干燥好的组合物和辅料分别过60目筛,使颗粒粒度分布均匀,流动性更好,所述组合物和辅料保持干燥,然后将组合物和辅料配比称重后,搅拌均匀,并在制粒机中进行制粒,即得颗粒剂。
实施例3
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH 3份、NADPH 2份、人参皂苷PPD 2份、人参皂苷Rh2 3份、硫酸软骨素2份、活性成分2份,所述活性成分包括牛磺酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯,所述活性成分中各组分的质量比为1:1:2:1:1。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为8份,所述辅料包括木糖醇、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉,上述辅料组分的质量比为2:3:1:2:3:1。所述药物制剂为片剂,其通过如下方法制备:首先由实施例2所述的方法制得颗粒,然后将颗粒放入压片机,调节压片机参数进行压片,理论片重为500mg,最后进行薄膜包衣、检验和包装。
实施例4
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH 8份、NADPH 7份、人参皂苷PPD 8份、人参皂苷Rh2 9份、硫酸软骨素8份、活性成分9份,所述活性成分包括磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素,所述活性成分中各组分的质量比为1:1:3:2:1:3。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为7份,所述辅料包括尼泊金复合酯、富马酸、磷酸盐、木糖醇、硫酸钙、气相二氧化硅、乳糖,上述辅料组分的质量比为1:2:1:2:3:1:2。
所述药物制剂为胶囊剂中的软胶囊,其通过如下方法制备:
(1)配制内容物:首先将干燥好的组合物和辅料分别过60目筛并保持干燥,然后将组合物和辅料配比称重,均和均匀。
(2)软胶囊体制备:先将甘油和水加入溶胶罐中,随后分别加入明胶和相关辅料,搅拌,真空脱气,制得软胶囊体。
(3)制备软胶囊:将所述内容物和软胶囊体经过压丸、定型干燥、洗丸、晾丸、捡丸和包装等步骤,制得软胶囊。
实施例5
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH 5份、NADPH 6份、人参皂苷PPD 5.5份、人参皂苷Rh2 7份、硫酸软骨素6份、活性成分7份,所述活性成分包括熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯,所述活性成分中各组分的质量比为1:2:1:3:1:3。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为7.5份,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成,上述辅料中各组分的质量比为1:2:1:3:1:2:3:1.5:2:1:1:1.2:3。
所述药物制剂为胶囊剂中的硬胶囊,其通过如下方法制备:
S1:取活性成分碎成粗颗粒,加5倍量70%的乙醇加热回流提取2h,滤过;药渣再加3倍量70%的乙醇加热回流提取1h,滤过,滤液合并,回收乙醇并减压浓缩至60℃下相对密度为1.35~1.40的稠膏,备用。
S2:将步骤1所得的产物加7倍量的水,加热回流提取挥发油4h,分取分层的挥发油,备用;药渣和药液粗滤,滤液离心分离,上清液和药渣分别保存备用。
S3:取NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素、牛磺酸与S2步骤得到的挥发油后药渣合并,加水煎煮提取二次,第一次加18倍量水提取2h,第二次加12倍量水提取1h,粗滤,滤液离心分离,两次提取的上清液与S2步骤得到的提取挥发油后的上清液合并,减压浓缩至60℃下相对密度为1.35~1.40的稠膏,备用。
S4:取糊精、微粉硅胶,混匀,加入到上述S1步骤得到的水提浓缩稠膏与S3步骤得到的醇提浓缩稠膏中,充分搅拌均匀,铺层,真空干燥,粉碎,加入糊精,喷入S2步骤得到的挥发油,过筛,混匀,装入胶囊。
实施例6
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH 2份、NADPH 7份、人参皂苷PPD 4份、人参皂苷Rh2 8份、硫酸软骨素4份、牛磺酸0.2份、磷脂酰丝氨酸1份、熊去氧胆酸0.1份、燕窝酸1.3份、s-腺苷蛋氨酸1份、γ-氨基丁酸2份、虾青素0.3份、焦谷氨酸酯1份。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为5份,所述辅料包括交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙,上述辅料中各组分的质量比为1:2:1:3,所述药物制剂为片剂,其采用实施例3所述的方法制备。
实施例7
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH 8份、NADPH 3份、人参皂苷PPD 9份、人参皂苷Rh2 3份、硫酸软骨素8份、牛磺酸0.8份、磷脂酰丝氨酸0.2份、熊去氧胆酸1.2份、燕窝酸0.5份、s-腺苷蛋氨酸1.5份、γ-氨基丁酸0.5份、虾青素1份、焦谷氨酸酯0.4份。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为5.8份,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成,上述辅料组分等质量,所述药物制剂为颗粒剂,其采用实施例2所述的方法制备。
实施例8
本实施例提供一种改善骨质疏松的组合物,以重量份计,所述组合物包括:NADH6份、NADPH 5份、人参皂苷PPD 6份、人参皂苷Rh2 5份、硫酸软骨素3.5份、牛磺酸0.5份、磷脂酰丝氨酸0.6份、熊去氧胆酸1份、燕窝酸0.9份、s-腺苷蛋氨酸1.2份、γ-氨基丁酸1份、虾青素0.8份、焦谷氨酸酯0.8份。。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为4份,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成,上述辅料组分的质量比为1:1:0.8:2:1.3:2:3:1.2:2:1:1:0.8:2,所述药物制剂为颗粒剂,其采用实施例2所述的方法制备。
实验例
1、选择2014年1月至2017年6月住院治疗的骨质疏松、腰痛肾虚型患者180例,其中,男性68例,女性112例,将患者随机分为三组:本发明组、对照中药1组和对照中药2组,各组病例样本数见表1,各组病理年龄、病程疼痛程度评分见表2。统计学分析结果显示,各组患者性别、年龄、病程、疼痛程度评分差异无统计学意义(P>0.05),具有可比性。
表1
组别 | 入组病例 | 脱落 | 剔除 | 有效病例 |
本发明组 | 60 | 5 | 1 | 54 |
对照中药1组 | 60 | 4 | 0 | 56 |
对照中药2组 | 60 | 5 | 2 | 53 |
表2
组别 | 病例数(例) | 年龄(岁) | 病程(月) | VAS评分(分) |
本发明组 | 54 | 60.8±5.1 | 15.5±2.4 | 7.94±1.24 |
对照中药1组 | 56 | 59.6±6.2 | 16.2±3.1 | 7.58±1.58 |
对照中药2组 | 53 | 60.0±7.1 | 15.9±3.0 | 7.83±1.43 |
注:各组年龄、病程、VAS评分比较,P>0.05。
2、诊断标准
2.1中医诊断标准
根据《中华人民共和国中医药行业标准中医病证诊断疗效标准ZY/T001.1-94》(国家中医药管理局.中医病证诊断疗效标准[S].南京大学出版社,1994:48-49.),选取骨质疏松肾虚型腰痛患者。
2.2西医诊断标准
参照《中国人骨质疏松症建议诊断标准(第二稿)》(中国老年学学会骨质疏松委员会骨质疏松诊断标准学科组.中国人骨质疏松症建议诊断标准(第二稿)[J].中国骨质疏松杂志,2000,6(1):1-3.)。
3、纳入标准
(1)符合骨质疏松肾虚型腰痛诊断标准者;
(2)年龄在45-75岁之间;
(3)有意愿参与本研究,签署知情同意书者。
以上任何一项不满足要求者,均不能作为受试者纳入试验研究。
4、排除标准
(1)合并严重原发性心脑血管、肝、肾、造血、神经等系统疾病,精神病患者;
(2)在本实验观察期间,接受除本实验方法之外的其他治疗方法的患者;
(3)对药剂过敏患者;
(4)妇女妊娠、月经期患者;
(5)正在参加其他临床试验的患者。
5、治疗方法
治疗组:服用按照实施例的方法制备的片剂,其中各原料药配比如实施例3所述,口服,早晚各一次,每次2片。
对照中药组:市面上常用的骨质疏松药物,口服,早晚各一次。
两周为一个疗程,连续使用两个疗程。治疗后1个月随访。
6、观察指标
患者疼痛评价采用视觉模拟评分法(visualanaloguescale,VAS)(Wewers ME,Lowe NK.Acritical review of visual analogue scales in the measurementofclinical phenomena[J].Res Nurs Health,1990,13(4):227-236.),由患者指出疼痛程度,0分表示无疼痛,10分表示疼痛剧烈无法忍受,分值范围0~10分,分数越高疼痛程度越严重。分别于治疗前、治疗后、治疗后1个月随访时采集患者VAS分值。
7、数据处理
应用SPSS 17.0统计软件处理所得数据,计量资料以表示,采用t检验,P<0.05为差异有统计学意义。
8、治疗结果
8.1疼痛缓解情况
各组患者治疗后、治疗后1个月随访时VAS分值统计结果见表3。
表3
组别 | 病例数(例) | 治疗前 | 治疗后 | 治疗后1个月 |
本发明组 | 54 | 7.94±1.24 | 1.87±0.57 | 1.94±0.60 |
对照中药1组 | 56 | 7.58±1.58 | 4.35±0.98* | 5.99±0.74# |
对照中药2组 | 53 | 7.83±1.43 | 4.02±0.73* | 6.47±1.02# |
结果表明,治疗后各组均能显著降低患者腰痛症状,治疗前后的VAS分值差异具有统计学意义(P<0.05);对治疗后的VAS分值进行组间比较,对照中药1组、对照中药2组的VAS分值与本发明中药组的VAS分值的差异均具有统计学意义(P<0.05);治疗后1个月随访,各组患者疼痛症状有所加重,其中本发明中药组的VAS分值在治疗后和随访时的差异不具有统计学意义(P>0.05),其他2组的VAS分值在治疗后和随访时的差异具有统计学意义(P<0.05)。由此可见,本发明的中药组合物外用治疗骨质疏松腰痛症,能有效缓解患者疼痛,且疗效稳定持久,不易复发,显著优于其他各组的药物。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种改善骨质疏松的组合物,其特征在于,包括NADH、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种;
优选的,所述活性成分为牛磺酸、磷脂酰丝氨酸、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少五种。
2.根据权利要求1所述的改善骨质疏松的组合物,其特征在于,以重量份计,所述组合物包括如下组分:NADH 1-10份、NADPH 1-10份、人参皂苷PPD 1-10份、人参皂苷Rh2 1-10份、硫酸软骨素1-10份、活性成分1-10份;
优选的,以重量份计,所述组合物包括如下组分:NADH 3-8份、NADPH 2-7份、人参皂苷PPD 2-8份、人参皂苷Rh2 3-9份、硫酸软骨素2-8份、活性成分2-9份;
优选的,以重量份计,所述组合物包括如下组分:NADH 5份、NADPH 6份、人参皂苷PPD5.5份、人参皂苷Rh2 7份、硫酸软骨素6份、活性成分7份。
3.根据权利要求2所述的改善骨质疏松的组合物,其特征在于,以重量份计,所述组合物包括如下组分:NADH 2-8份、NADPH 3-7份、人参皂苷PPD 4-9份、人参皂苷Rh2 3-8份、硫酸软骨素4-8份、牛磺酸0.2-0.8份、磷脂酰丝氨酸0.2-1份、熊去氧胆酸0.1-1.2份、燕窝酸0.5-1.3份、s-腺苷蛋氨酸1-1.5份、γ-氨基丁酸0.5-2份、虾青素0.3-1份、焦谷氨酸酯0.4-1份;
优选的,以重量份计,所述组合物包括如下组分:NADH6份、NADPH 5份、人参皂苷PPD6份、人参皂苷Rh25份、硫酸软骨素3.5份、牛磺酸0.5份、磷脂酰丝氨酸0.6份、熊去氧胆酸1份、燕窝酸0.9份、s-腺苷蛋氨酸1.2份、γ-氨基丁酸1份、虾青素0.8份、焦谷氨酸酯0.8份。
4.一种制备如权利要求1-3任一项所述的组合物的方法,其特征在于,将所述改善骨质疏松的组合物各组分按照配比混合均匀,即得。
5.一种改善骨质疏松的组合物的应用,其特征在于,将权利要求1所述的组合物用于制备药物制剂或保健食品。
6.一种改善骨质疏松的药物制剂,其特征在于,包括如权利要求1-3任一项所述的组合物和辅料。
7.根据权利要求6所述的药物制剂,其特征在于,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的至少一种;
优选的,所述辅料的重量份数为1-10份。
8.根据权利要求7所述的药物制剂,其特征在于,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的三种。
9.根据权利要求8所述的药物制剂,其特征在于,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成。
10.根据权利要求6-9任一项所述的药物制剂,其特征在于,所述药物制剂为片剂、口服液剂、胶囊剂、颗粒剂、注射剂、酊剂、栓剂、贴剂、丸剂、糖浆剂、合剂、散剂、膜剂、滴丸中的一种。
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