抗骨质疏松产品-骨元肽结肠靶向胶囊地综合评价与衡量与衡量之一

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1、实用标准文案抗骨质疏松产品－骨元肽结肠靶向胶囊的综合评价（之一）李延平刘义吴科锋邓亦峰艾春梅龚先玲吕应年崔燎（广东天然药物研究与开发重点试验室，湛江524023）摘要目的综合评价抗骨质疏松产品－骨元肽结肠靶向胶囊。方法抗骨质疏松试验采用新生SD大鼠成骨细胞体外培养法，测定MTT、ALK和矿化骨结节。体内试验：对SD大鼠实施手术去除双侧卵巢，造成骨质疏松模型，口服三种（5.0、20.0、80.0mg.kg-1.d-1）剂量骨元肽结肠靶向胶囊，检测血清中雌二醇（E2）、骨钙素（BGP）、转化生长因子（TGF-β

2、1）、碱性磷酸酶（ALK）；骨密度、24小时尿液中Ca、P含量；测定骨元肽分子量分布及大鼠在体结肠吸收率。结果骨元肽对新生SD大鼠成骨细胞有明显增殖作用，ALK活性增强、矿化骨结节数量增多；骨元肽结肠靶向胶囊组可明显提高去卵巢大鼠血清中E2、TGF-β，增加BMD，降低血清中ALK、BGP和24小时尿Ca、P含量；骨元肽Mw为189~1000D,其中189-512D组分占68.5%以上；口服4h结肠平均吸收率为49.61％。结论骨元肽结肠靶向胶囊一种安全、有效，质量可控，增加骨密度、防治中老年人骨质疏松症的

3、健康产品。关键词骨元肽结肠靶向胶囊；抗骨质疏松；综合评价中国分类号：R9文献标识码：A文章编号：ComprehensiveevaluationoncolontargetingcapsuleofGuyuanpeptideforanti-osteoporosisproductLIYan-ping，LIUYi，WUKe-feng，Dengyifeng，AIChun-mei，GONGxian-ling，LVying-nian，Cuiliao.（GuangdongkeyLaboratoryforResearchand

4、DevelopmentofNaturalDrugs，zhanjiang524023，China）Abstract:ObjectiveToperformcomprehensiveevaluationoncolontargetingcapsuleofGuyuanpeptide（GYP）foranti-osteoporosisaction.MethodsInvitroanti-osteoporosisproductwasinvestigatedbyMTTmethod,detectingalkalinephosph

5、atase(ALK)andmineralizednodesinosteoblastsfromSDrats.InvivotheratmodelsofosteoporosiswereinducedbyovariectomyandtreatedwiththreedosesofcolontargetingcapsuleofGYP(5.0,20.0,80.0mg.kg-1.d-1).Theserumlevelsofestradiol(E2),osteocalcin(BGP),transforminggrowthfac

6、tors(TGF-β1)andALK,bonemineraldensity(BMD),andthecontentsofcalcium(Ca)andphosphorus(P)in24hurineweredetected.ThedistributionandabsorptionofGYP’sMWinthecolonofratswerealsoinvestigated.ResultsGYPenhancedcellproliferation,ALKactivityandthenumberofmineralizedn

7、odesinrats’osteoblasts.ThecolontargetingcapsuleofGYPweresignificantlyincreasedtheserumlevelofE2，TGF-β1，andBMD，decreasedtheserumlevelofALK,BGPandthecontentsofCa，Pin24hurine,andthecapsuleshadnosideeffectsandtheshelflifeofthemreached24months.TheMwofGYPisbetwe

8、en189-1000D,inwhichthecomponentof189-512Dtakes68.5%orabove.Theaverageabsorptionrateis49.61％inthecolonofrats.ConclusionThecolontargetingcapsuleofGuyuanpeptideisaneffectiveandsafeproductwithcontrollablequalityf