CN105343632A - 一种健脑胶囊及其制备方法 - Google Patents

一种健脑胶囊及其制备方法 Download PDF

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CN105343632A
CN105343632A CN201510905077.8A CN201510905077A CN105343632A CN 105343632 A CN105343632 A CN 105343632A CN 201510905077 A CN201510905077 A CN 201510905077A CN 105343632 A CN105343632 A CN 105343632A
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Abstract

本发明公开了一种健脑胶囊及其制备方法，其特征在于海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,采用二氧化碳超临界萃取法提取，减压干燥，用高能纳米冲击磨粉碎成纳米干膏，加入功能性辅料，制成健脑胶囊，崩解时间显著缩短，疗效显著优于市售健脑胶囊，取得了积极效果。

Description

一种健脑胶囊及其制备方法
技术领域
本发明涉及中药领域，具体涉及一种健脑胶囊及其制备方法。
背景技术
健脑胶囊健脑益肾，安眠补身。用于用脑过度，记忆衰退，神经衰弱，头晕目眩，惊悸失眠，心烦易倦，畏寒体虚，身亏腰痛及老年痴呆等症。市售健脑胶囊由于组方和工艺原因，疗效不甚理想，制剂采用传统工艺制备，存在崩解迟缓、疗效低等不足。
发明内容
本发明为克服上述不足，提供一种崩解速度快、疗效高的健脑胶囊及其制备方法。
发明实施方案如下：
取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力18～45Mpa，萃取温度19～42℃，分离器压力13～19Mpa，分离器温度44～54℃，分离时间2.7～3.3小时，二氧化碳流量每小时24～35L，得提取液；取提取液63～76℃减压干燥，得干膏；取干膏加入甘露醇150～200g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素45～55g，交联聚乙烯吡咯烷酮45～55g，交联羧甲基纤维素钠35～45g，混合均匀，用50～70%乙醇湿法制粒，60℃～80℃干燥，外加羧甲基淀粉钠7～9g，硬脂酸镁1～3g，整粒，装入胶囊，制得健脑胶囊1000粒。
上述实施方案所提到的原材料标准如下：
海风藤：中国药典2010年版一部标准。本品为胡椒科植物风藤Piperkadsura(Choisy)OhWi的干燥藤茎。夏、秋二季采割，除去根、叶，晒干。
广藿香：中国药典2005年版一部标准。本品为唇形科植物广蓄香Pogostemoncablin（Blanco）Benth.的干燥地上部分。枝叶茂盛时采割，日晒夜闷，反复至干。
月采收，阴干。
荜澄茄：中国药典2005年版一部标准。本品为樟科植物山鸡椒Litseacubeba（Lour.）Pers.的干燥成熟果实。秋季果实成熟时采收，除去杂质．晒干。
黄芩：中国药典2005年版一部标准。本品为唇形科植物黄芩ScutellariabaicalensisGeorgi的干燥根。春、秋二季采挖，除去须根及泥沙，晒后撞去粗皮，晒干。
赤石脂：中国药典2005年版一部标准。本品为硅酸盐类矿物多水高岭石族多水高岭石。主含四水硅酸铝〔Al4（Si4O10）（OH）8·4H2O〕。采挖后．除去杂质。
当归：中国药典2005年版一部标准。本品为伞形科植物当归Angelicasinensis（Oliv.）Diels的干燥根。秋末采挖，除去须根及泥沙，待水分稍蒸发后，捆成小把，上棚，用烟火慢慢熏干。
天竺黄：中国药典2005年版一部标准。本品为禾本科植物青皮竹BambusatextilisMcClure或华思劳竹SchizostachyumchinenseRendle等秆内的分泌液干燥后的块状物。秋、冬二季来收。
肉苁蓉：中国药典2005年版一部标准。本品为列当科植物肉苁蓉CistanchededeserticolaY．C．Ma或管花肉发蓉Cistanchetubulosa（Schrenk）Wight的干燥带鳞叶的肉质茎。多于春季苗未出土或刚出土时采挖，除去花序，切段，晒干。
龙齿：中国药典1977年版一部标准。
山药：中国药典2005年版一部标准。本品为薯蓣科植物薯蓣DioscoreaoppositaThunb.的干燥根茎。冬季茎叶枯萎后采挖，切宏根头，洗净，除去外皮及须根，干燥；也有选择肥大顺直的干燥山药，置清水中，浸至无干心，闷透，切齐两端，用木板搓成圆柱状，晒干，打光，习称“光山药”。
天麻：中国药典2005年版一部标准。本品为兰科植物天麻GastrodiaelataBl．的干燥块茎。立冬后至次年清明前采挖，立即洗净，蒸透，敞开低温干燥。
柏子仁：中国药典2005年版一部标准。本品为柏科植物侧柏Platycladusorientalis（L.）Franco的干燥成熟种仁。秋、冬二季来收成熟种子，晒干．除去种皮．收集种仁。
丹参：中国药典2005年版一部标准。本品为唇形科植物丹参SalviamiltiorrhizaBge．的干燥根及根茎。春、秋二季采挖，除去泥沙，干燥。
人参：中国药典2005年版一部标准。本品为五加科植物人参PanaxginsengC．A．Mey．的干燥根及根茎。多于秋季采挖，洗净经晒干或烘干。栽培的又称“园参”；播种在山林野生状态下自然生长的又称“林下参”，习称“籽海”。
野菊花：中国药典2005年版一部标准。本品为菊科植物野菊ChrysanthemumindicumL.的干燥头状花序。秋、冬二季花初开放时采摘，晒干，或蒸后晒干。
酸枣仁：中国药典2005年版一部标准。本品为鼠李科植物酸枣ZiziphusjujubaMill.var.spinosa（Bunge）HuexH．F．Chou的干燥成熟种子。秋末冬初采收成熟果实，除去果肉及核壳，收集种子，晒干。
枸杞子：中国药典2005年版一部标准。本品为茄科植物宁夏枸杞LyciumbarbarumL.的干燥成熟果实。夏、秋二季果实呈红色时采收，热风烘干，除去果梗，或晾至皮皱后，晒干，除去果梗。
甘露醇：中国药典2010年版二部标准。
微晶纤维素：中国药典2010年版二部标准。
交联聚乙烯吡咯烷酮：中国药典2010年版二部标准。
交联羧甲基纤维素钠：中国药典2010年版二部标准。
羧甲基淀粉钠：中国药典2010年版二部标准。
硬脂酸镁：中国药典2010年版二部标准。
以上健脑胶囊所用到的原材料均可从医药公司购买得到，只要满足国家标准均可用来实施本发明方案。
上述发明方案中所用术语为药学专用术语，如“减压”等皆遵从中国药典规定和相关药学规范。
本发明中的单位g也可以是其它重量份，不影响本发明方案的实施。
本发明方案中所述的设备市场均有销售，并不限于典型生产厂家，只要技术指标能够达到要求，均可用来实现本发明。
四具体实施方式
本发明的具体实施例1
取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力18Mpa，萃取温度19℃，分离器压力13Mpa，分离器温度44℃，分离时间2.7小时，二氧化碳流量每小时24L，得提取液；取提取液63℃减压干燥，得干膏取干膏加入甘露醇150g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素45g，交联聚乙烯吡咯烷酮45g，交联羧甲基纤维素钠35g，混合均匀，用50%乙醇湿法制粒，60℃干燥，外加羧甲基淀粉钠7g，硬脂酸镁1g，整粒，装入胶囊，制得健脑胶囊1000粒。
本发明的具体实施例2
取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力45Mpa，萃取温度42℃，分离器压力19Mpa，分离器温度54℃，分离时间3.3小时，二氧化碳流量每小时35L，得提取液；取提取液76℃减压干燥，得干膏取干膏加入甘露醇200g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素55g，交联聚乙烯吡咯烷酮55g，交联羧甲基纤维素钠45g，混合均匀，用70%乙醇湿法制粒，80℃干燥，外加羧甲基淀粉钠9g，硬脂酸镁3g，整粒，装入胶囊，制得健脑胶囊1000粒。
本发明的具体实施例3
取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力32Mpa，萃取温度30℃，分离器压力16Mpa，分离器温度49℃，分离时间3小时，二氧化碳流量每小时30L，得提取液；取提取液70℃减压干燥，得干膏取干膏加入甘露醇175g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素50g，交联聚乙烯吡咯烷酮50g，交联羧甲基纤维素钠40g，混合均匀，用60%乙醇湿法制粒，70℃干燥，外加羧甲基淀粉钠8g，硬脂酸镁2g，整粒，装入胶囊，制得健脑胶囊1000粒。
以上实施例说明，采用本发明实施方案的极端条件和优化条件均能制成健脑胶囊。下面以实施例3制得的健脑胶囊考察本发明的实际效果：
（一）实施例3健脑胶囊和市售健脑胶囊崩解时限对比
1崩解时限测定方法
按中国药典2010年版附录ⅫA测定。
2崩解时限对比
表1实施例3健脑胶囊和市售健脑胶囊崩解时限对比表
上述结果表明,本发明制备的健脑胶囊相对于市售健脑胶囊具有崩解速度快、生物利用度高等显著优点。
（二）实施例3健脑胶囊和市售健脑胶囊治疗记忆衰退，神经衰弱，头晕目眩，惊悸失眠，心烦易倦，畏寒体虚，身亏腰痛及老年痴呆临床疗效观察
1病例情况
统计门诊和住院病例，共观察记忆衰退，神经衰弱，头晕目眩，惊悸失眠，心烦易倦，畏寒体虚，身亏腰痛及老年痴呆病例122例，平均年龄59岁。将患者分为两组，试验组服用实施例3健脑胶囊，对照组服用市售健脑胶囊。
2疗效评定标准
依据中药新药治疗临床研究指导原则中医证候疗效判定标准：
临床痊愈：中医临床症状、体征消失或基本消失，证候积分减少≥95%。
显效：中医临床症状、体征明显改善，证候积分减少≥70%。
有效：中医临床症状、体征均有好转，证候积分减少≥30%。
无效：中医临床症状、体征均均无明显改善或者加重，证候积分减少＜30%。
计算公式：[（治疗前积分－治疗后积分）÷治疗前积分]×100%。
3临床观察结果
表2实施例3健脑胶囊和市售健脑胶囊临床疗效对比表
上述临床疗效观察结果表明，本发明制备的健脑胶囊在治疗记忆衰退，神经衰弱，头晕目眩，惊悸失眠，心烦易倦，畏寒体虚，身亏腰痛及老年痴呆时,疗效显著高于市售健脑胶囊，p＜0.05。

Claims (3)

1.一种治疗记忆衰退，神经衰弱，头晕目眩，惊悸失眠，心烦易倦，畏寒体虚，身亏腰痛及老年痴呆的中药，其特征是取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力18～45Mpa，萃取温度19～42℃，分离器压力13～19Mpa，分离器温度44～54℃，分离时间2.7～3.3小时，二氧化碳流量每小时24～35L，得提取液；取提取液63～76℃减压干燥，得干膏；取干膏加入甘露醇150～200g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素45～55g，交联聚乙烯吡咯烷酮45～55g，交联羧甲基纤维素钠35～45g，混合均匀，用50～70%乙醇湿法制粒，60℃～80℃干燥，外加羧甲基淀粉钠7～9g，硬脂酸镁1～3g，整粒，装入胶囊，制得健脑胶囊。
2.根据权利要求1所述中药的制备方法，其特征是取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力18～45Mpa，萃取温度19～42℃，分离器压力13～19Mpa，分离器温度44～54℃，分离时间2.7～3.3小时，二氧化碳流量每小时24～35L，得提取液；取提取液63～76℃减压干燥，得干膏；取干膏加入甘露醇150～200g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素45～55g，交联聚乙烯吡咯烷酮45～55g，交联羧甲基纤维素钠35～45g，混合均匀，用50～70%乙醇湿法制粒，60℃～80℃干燥，外加羧甲基淀粉钠7～9g，硬脂酸镁1～3g，整粒，装入胶囊，制得健脑胶囊。
3.根据权利要求1所述中药的制备方法，取海风藤9g，广藿香4.5g，荜澄茄18g，黄芩13.5g,赤石脂13.5g,当归27g,天竺黄10g,肉苁蓉20g,龙齿10g,山药20g，天麻5g,柏子仁4g,丹参9g，人参9g,菊花5g,酸枣仁36g,枸杞子18g,粉碎成60目粗粉，采用二氧化碳超临界萃取法提取，萃取压力32Mpa，萃取温度30℃，分离器压力16Mpa，分离器温度49℃，分离时间3小时，二氧化碳流量每小时30L，得提取液；取提取液70℃减压干燥，得干膏取干膏加入甘露醇175g，采用高能纳米冲击磨粉碎成粒径200～300nm的混合干膏粉；取混合干膏粉，微晶纤维素50g，交联聚乙烯吡咯烷酮50g，交联羧甲基纤维素钠40g，混合均匀，用60%乙醇湿法制粒，70℃干燥，外加羧甲基淀粉钠8g，硬脂酸镁2g，整粒，装入胶囊，制得健脑胶囊。
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