CN100475225C - 人参果软胶囊及其制备方法 - Google Patents
人参果软胶囊及其制备方法 Download PDFInfo
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- CN100475225C CN100475225C CNB2004100341784A CN200410034178A CN100475225C CN 100475225 C CN100475225 C CN 100475225C CN B2004100341784 A CNB2004100341784 A CN B2004100341784A CN 200410034178 A CN200410034178 A CN 200410034178A CN 100475225 C CN100475225 C CN 100475225C
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- soft capsule
- herba herminii
- acanthopanacis senticosi
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Abstract
本发明公开了一种人参果软胶囊及其制备方法，它是由下列成分制成的软胶囊：人参果甙200克，木糖醇50克，刺五加提取物100克，月见草油400克。所述制备方法包括人参果甙的制备、刺五加提取物的制备和将人参果甙200克、木糖醇50克、刺五加提取物100克混合后超微粉碎，粉碎成300目以上的细粉，加入月见草油400克，压制成软胶囊步骤。它是一种新的治疗II期糖尿病药物剂型。配方简单，克服了单味药用剂量大、不易服用、不易保存的缺点。
Description
所属技术领域
本发明是一种新的剂型的治疗II期糖尿病药物及其配制方法。
背景技术
糖尿病是中国传统医学的病名，是指以多饮、多尿、多食及消瘦、疲乏、尿甜为主要特征的综合病证。
H期：糖尿病症状期。
典型的糖尿病症状如多饮、多尿、多食、消瘦、乏力等；
血糖、尿糖、糖基化血红蛋白均高，血脂多数偏高；
可伴有高血压，无其他血管神经并发症。
病机特点：阴虚化热。
免疫能力低下常见于糖尿病，这与细胞免疫(尤其是T细胞)和体液免疫功能低下均有关。关键是控制糖尿病，纠正营养不良与蛋白质不足。
人体中已测得60种以上微量元素，其中14种已知具有特殊生理功能，为人体所必需，即铁、氟、锌、铜、钒、锡、硒、锰、碘、镍、钼、铬、钴、硅。小量的锂制剂作为糖尿病辅助治疗药物对糖尿病有好处。故共有15种必需微量元素。糖尿病人容易缺乏维生素和微量元素，因此治疗糖尿病时应适当补充维生素和微量元素。
现阶段治疗糖尿病药物较多，但软胶囊没有发现治疗糖尿病药物。
发明内容
人参：药理研究表明人参有降低血糖作用，对四氧嘧啶性糖尿病鼠有明显的降血糖作用。
本发明药物中人参果皂甙新药理作用，人参果皂甙研究表明：人参果中单体皂甙Rb2分子式为C53H90O22，相对分子量1079.24。人参果单体皂甙Rb2在体内代谢途径，首先在肠内菌转化形成的单体皂甙Rb2及单体皂甙GAG-Ppd又转化为单体皂甙Ginsenoside-F2、GA-Ppd在转化单体皂甙Compound K最后转化为单体皂甙20(S)-Ppd，进入血液。在现代中药学大辞典中记载对高脂血症有一定疗效。血睾酮水平显著提高，男性血雌三醇显著下降，血雌二醇/睾酮比值下降。血浆皮质醇、血浆cAMP等显著提高。高血糖患者治疗后血糖水平有所下降。
人参果皂甙Rb2，多次服用人参皂甙Rb2，明显降低总胆固醇游离胆固醇，低密度脂蛋白的含量，升高高密度脂蛋白的含量。对于糖尿病人，有降低血清血糖、3-羟基丁酸酯和乙酰乙酸酯含量的作用，人参皂甙Rb2有改善糖尿病酮酸症的作用。
此外人参转化产物，其中一个转化产物鉴定为：20-O-β-0-D-吡喃葡萄糖基-20(S)-原人参二醇，即：化合物K，这个产物和Rb2分解的产物一至对血糖高患者有明显的作用。同时人参果皂甙Rb2还有抗疲劳作用。
人参果甙中含微量元素铁4.14mg/kg、钾1213mg/kg、镁1287mg/kg、钙3775.9mg/kg、锂0.505mg/kg、钠14.8mg/kg、锌11.5mg/kg、锶20.5mg/kg、硒7.1mg/kg、钒0.92mg/kg，锗的含量为0.32mg/kg等30多种微量元素。维生素C3.9mg/kg，维生素B56.6mg/kg，维生素B20.4mg/kg，维生素B10.3mg/kg，维生素H9.2mg/kg。
本发明药物处方中月见草油药理
月见草又名夜来香的成熟种籽提炼制成的。主要有效成份为r-亚麻酸，配伍人参果甙制成的软胶囊制剂具有治疗糖尿病作用。
临床应用证明：服用月见草能明显抑制血小板聚集，可使血小板聚集亢进病人血浆中二高-r-亚麻酸含量提高6-9倍；能明显降低高血脂病人的血脂，其降低胆固醇能力大于单纯的亚油酸163倍；能有效地降低低密度脂蛋白，可使超常正常体重下降，皮肤变嫩；降低糖尿病人血糖，有很好的降脂、减肥作用。
临床统计表明：95％的糖尿病属于II型。糖尿病起因是体内胰细胞分泌胰岛素数量不足，从而造成病人体内血糖过高。长期高血糖会引发一系列的疾病，如视物模糊、下肢溃疡等等，故对于糖尿病人来说，日常生活中最重要的是正确控制饭量以及选择适当的降血糖食品作为辅助疗法。
本发明药物中木糖醇药理
木糖醇为白色结晶粉末，无臭，味甜，有引湿性，分子式C6H12O5，本品在体内代谢迅速而完全，当体内胰岛素缺乏时代谢不受影响，具有补充热量、改善糖代谢消除血症的作用，用作糖尿病患者糖的代用品。
木糖醇在人体内有两种代谢途径。一是葡萄糖醛酸--木酮糖循环代谢中的肝脏线粒体中由L2木酮糖转变为D2木酮糖的中间体；二是输入的木糖醇经细胞浆中的艾杜糖脱氢(L2iditoldchydrongenase：一种己糖醇脱氢酶)脱氢转变为D2木酮糖。D2木酮糖经过磷酸化变为52磷酸D2木酮糖进入磷酸戊糖旁路。木糖醇注射液通过静脉注射后，85％及10％分别由肝脏和肾脏代谢，小部分被血液细胞、肾上腺皮质和其他组织所利用。由于利用完全，在尿中几乎无木糖醇排泄。进入肝脏的木糖醇，一部分通过合成肝糖原转变为葡萄糖(依对葡萄糖的需要而定，约占总量之20％～80％)，另一部分无氧酵解成丙酮酸或乳酸，或全部被氧化生成H2O和CO2，同时释放能量供人体利用，每克可产热4.06千卡，与葡萄糖相当。
木糖醇作用机制
抗生酮作用，木糖醇能抑制生物组织中的脂肪酸合成，减少血浆游离脂肪酸、丙酮酸水平，具有抗生酮作用。
能纠正蛋白质、脂肪和类固醇的代谢异常，由于木糖醇能供给脱氢酶(NASPH2)，而且能通过磷酸戊糖旁路生成的NADPH(还原性辅酶II)抑制在体内合成脂肪酸、胆固醇、类固醇等必需物质时所需的氢，故可纠正蛋白质、脂肪、类固醇等物质的代谢异常，能避免碳水化合物不必要地向脂肪转化。
木糖醇的临床应用
糖尿病人可降血糖，抗生酮作用，改善临床症状，冯根宝等用木糖醇治疗非胰岛素依赖型糖尿病121例，显效66例(54.5％)，有效36例(29.8％)，有效率为84.3％。与D860(甲苯磺丁脲)组比较，显效率两组间差异显著(p＜0.05)。申延宏等用木糖醇治疗35例II型糖尿病，显效18例(51.4％)，有效9例(25.7％)，总有效率77.1％。
本发明药物处方中刺五加药理
刺五加运动生理学方面，已确实证明具有减缓心跳次数及减低需氧量的效能，可增加人体氧气吸收量及细胞氧气交换率，对体力、耐力及持久力也有明显增强。此外，刺五加尚含有超氧化物歧化酶(SOD)复合物，具有抗氧化的功能，能促进人体免疫及抵抗自由基(Freeradicals)所产生的衰老效果。
刺五加提取物的生理功能与保健功效：
治疗抑郁症脑血栓高血脂底血压冠心病糖尿病白细胞减少症。
本发明配方
人参果甙200克，
木糖醇50克，
刺五加提取物100克，
月见草油400克，
制成1200粒。
人参果甙加工工艺，将鲜人参果压汁去除果核，投入提取罐，用60度乙醇，3倍量乙醇提取三次，每次6小时，放出药液放置24小时沉淀后取上清液，脱色后放置8小时沉淀后取上清液，减压回收乙醇，浓缩比重1.15-1.20喷雾干燥。刺五加加工工艺，将刺五加切成1-3cm长投入提取罐，用4倍量水每次煮2小时，合并药液过滤，浓缩比重为1.15-1.20喷雾干燥。将人参果甙200克，木糖醇50克，刺五加提取物100克比例混合后超微粉碎，粉碎成300目以上的细粉，再加入月见草油400克，压制成软胶囊。
本工艺发明优点在于喷雾干燥，之后采用超微组织破碎技术，不仅人参果皂甙不被分解，而且完全保留了其微量元素等营养成分，使各种功效物质处于有原有的活性及天然状态，并无任何毒副作用。
本工艺主要发明配方简单，克服单味药用剂量大，不易服用，不易保存的缺点。
本发明在吉林中医学院，临床治疗120例II型糖尿病，显效87例(72.5％)，有效19例(15.8％)，总有效率88.3％。
净含量：0.619克/粒
人参果皂甙含量：18.12％
功能作用：治疗II型糖尿病。
食用方法用量：每次1粒，每日2次。
Claims (2)
1、一种人参果软胶囊，其特征在于它是由下列成分制成的软胶囊：人参果甙200克，木糖醇50克，刺五加提取物100克，月见草油400克。
2、一种如权利要求1所述的人参果软胶囊的制备方法，其特征在于它包括下列步骤：
1)人参果甙的制备，将鲜人参果压汁去除果核，投入提取罐，用60度乙醇，3倍量乙醇提取三次，每次6小时，放出药液放置24小时沉淀后取上清液，减压回收乙醇，浓缩比重1.15-1.20喷雾干燥；
2)刺五加提取物的制备，将刺五加切成1-3cm长投入提取罐，用4倍量水每次煮2小时，合并药液过滤，浓缩比重1.15-1.20喷雾干燥；
3)将人参果甙200克、木糖醇50克、刺五加提取物100克混合后超微粉碎，粉碎成300目以上的细粉，加入月见草油400克，压制成软胶囊。
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