CN105343427A - 一种腰息痛胶囊及其制备方法 - Google Patents

一种腰息痛胶囊及其制备方法 Download PDF

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CN105343427A
CN105343427A CN201510864815.9A CN201510864815A CN105343427A CN 105343427 A CN105343427 A CN 105343427A CN 201510864815 A CN201510864815 A CN 201510864815A CN 105343427 A CN105343427 A CN 105343427A
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radix
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Abstract

本发明公开了一种腰息痛胶囊及其制备方法，其特征在于取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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，制成腰息痛胶囊，崩解时间显著缩短，疗效显著优于市售腰息痛胶囊，取得了积极效果。

Description

一种腰息痛胶囊及其制备方法
技术领域
本发明涉及中药领域，具体涉及一种腰息痛胶囊及其制备方法。
背景技术
腰息痛胶囊舒筋活络，祛瘀止痛，活血驱风。用于风湿性关节炎,肥大性腰椎炎，肥大性胸椎炎，颈椎炎，坐骨神经痛，腰肌劳损。市售腰息痛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、疗效高的腰息痛胶囊及其制备方法。
发明实施方案如下：
取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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21～45Mpa，萃取温度20～45℃，分离器压力12～19Mpa，分离器温度39～59℃，分离时间1.7～3.4小时，二氧化碳流量每小时22～35L，得提取液；取提取液60～76℃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，制得腰息痛胶囊1200粒。
上述实施方案所提到的原材料标准如下：
蒺藜：中国药典2005年版一部标准。本品为蒺藜科植物蒺藜TribulusterrestrisL.的干燥成熟果实。秋季果实成熟时采割植株，晒干，打下果实，除去杂质。
香橼：中国药典2005年版一部标准。本品为芸香科植物构橼CitrusmedicaL．或香圆CitruswilsoniiTanaka的干燥成熟果实。秋季果实成熟时采收，趁鲜切片，晒干或低温干燥。香圆亦可整个或对剖两半后，晒干或低温干燥。
地骨皮：中国药典2005年版一部标准。本品为茄科植物枸杞LyciumchinenseMill.或宁夏枸杞LyciumbarbarumL.的干燥根皮。春初或秋后采挖根部，洗净，剥取根皮，晒干。
白芷：中国药典2005年版一部标准。本品为伞形科植物白芷Angelicadahurica（Fisch.exHOffm．）Benth.etHook.f.或杭白芷Angelicadahurica（Fisch.exHoffm.）Benth．etHook．f．var．formosana（Boiss.）ShanetYuan的干燥根。夏、秋间叶黄时采挖，除去须报及泥沙，晒干或低温干燥。
制草乌：中国药典2005年版一部标准。本品为草乌的炮制加工品。
独活：中国药典2005年版一部标准。本品为伞形科植物重齿毛当归AngelicapubescensMaxim．f．biserrataShanetYuan的干燥根。春初苗刚发芽或秋末茎叶枯萎时采挖，除去须根及泥沙，烘至半干，堆置2-3天，发软后再烘至全干。
续断：中国药典2005年版一部标准。本品为川续断科植物川续断DipsacusasperoidesC．Y．ChengetT．M．Ai的干燥根。秋季采挖，除去根头及须根，用微火烘至半干，堆置“发汗”至内部变绿色时，再烘干。
牛膝：中国药典2005年版一部标准。本品为苋科植物牛膝AchyranthesbidentataBl．的干燥根。冬季茎叶枯萎时采挖，除去须根及泥沙，捆成小把，晒至于皱后，将顶端切齐，晒干。
三七：中国药典2005年版一部标准。本品为五加科植物三七Punaxnotoginseng(Burk.)F．H.Chen的干燥根及根茎。秋季花开前采挖，洗净，分开主根、支根及根茎，干燥。支根习称“筋条”，根茎习称“剪口”。
防风：中国药典2005年版一部标准。本品为伞形科植物防风Saposhnikoviadivaricata（Turcz.）Schischk.的干燥根。春、秋二季采挖未抽花茎植株的根．除去须根及泥沙，晒干。
威灵仙：中国药典2005年版一部标准。本品为毛茛科植物威灵仙ClematischinensisOsbeck、棉团铁线莲ClematishexapetalaPall．或东北铁线莲ClematismanshuricaRupr.的干燥根及根茎。秋季采挖．除去泥沙．晒干。
秦艽：中国药典2005年版一部标准。本品为龙胆科植物秦艽GentianamacrophyllaPall.、麻花秦艽GentianastramineaMaxim．、粗茎秦艽Gentianacras-sicaulisDuthieexBurk．或小秦艽GentianadahuricaFisch.的干燥根。前三种按性状不同分别习称“秦艽”和“麻花艽”．后一种习称“小秦艽”。春、秋二季采挖，除去泥沙；素艽及麻花艽晒软，堆置“发汗”至表面呈红黄色或灰黄色时．摊开晒干，或不经“发汗”直接晒干；小秦艽趁鲜时搓去黑皮，晒干。
五加皮：中国药典2005年版一部标准。本品为五加科植物细柱五加AcanthopanaxgracilistylusW．W.Smith的干燥根皮。夏、秋二季采挖根部，洗净，剥取根皮，晒干。
防己：中国药典2010年版一部标准。本品为防己科植物粉防己StephaniatetrandraS.Moore的干燥根。秋季采挖，洗净，除去粗皮，晒至半干，切段，个大再纵切，干燥。
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。
杜仲：中国药典2005年版一部标准。本品为杜仲科植物杜仲EucommiaulmoidesOliv．的干燥树皮。4-6月剥取，刮去粗皮，堆置“发汗”至内皮呈紫褐色，晒干。
粉萆薢：中国药典2005年版一部标准。本品为著蓣科植物粉背薯蓣DioscoreahyposlaucaPali-bin的干燥根茎。秋、冬二季采挖，除去须根，洗净，切片，晒干。
何首乌：中国药典2005年版一部标准。本品为蓼科植物何首乌PolygonummultiflorumThunb的干燥块根。秋、冬二季叶枯萎时采挖，削去两端．洗净，个大的切成块，干燥。
红花：中国药典2005年版一部标准。本品为菊科植物红花CarthamustinctoriusL.的干燥花。夏季花由黄变红时采摘，阴干或晒干。
千年健：中国药典2005年版一部标准。本品为天南星种植物千年健Homalomenaocculta（Lour.）Schott的干燥根茎。春、秋二季采挖，洗净．除去外皮，晒干。
赤芍：中国药典2005年版一部标准。本品为毛茛科植物芍药PaeonialactifloraPall．或川赤芍PaeoniaveitchiiLynch的干燥根。春、秋二季采挖，除去根茎、须根及泥沙，晒干。
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。
以上腰息痛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
取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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21Mpa，萃取温度20℃，分离器压力12Mpa，分离器温度39℃，分离时间1.7小时，二氧化碳流量每小时22L，得提取液；取提取液60℃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，制得腰息痛胶囊1200粒。
本发明的具体实施例2
取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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45℃，分离器压力19Mpa，分离器温度59℃，分离时间3.4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，制得腰息痛胶囊1200粒。
本发明的具体实施例3
取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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33Mpa，萃取温度32℃，分离器压力16Mpa，分离器温度49℃，分离时间2.6小时，二氧化碳流量每小时28L，得提取液；取提取液68℃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，制得腰息痛胶囊1200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腰息痛胶囊。下面以实施例3制得的腰息痛胶囊考察本发明的实际效果：
（一）实施例3腰息痛胶囊和市售腰息痛胶囊崩解时限对比
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腰息痛胶囊和市售腰息痛胶囊崩解时限对比表
上述结果表明,本发明制备的腰息痛胶囊相对于市售腰息痛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腰息痛胶囊和市售腰息痛胶囊治疗风湿性关节炎,肥大性腰椎炎，肥大性胸椎炎，颈椎炎，坐骨神经痛，腰肌劳损疾病临床疗效观察
1病例情况
统计门诊和住院病例，共观察风湿性关节炎,肥大性腰椎炎，肥大性胸椎炎，颈椎炎，坐骨神经痛，腰肌劳损病例120例，平均年龄49岁。将患者分为两组，试验组服用实施例3腰息痛胶囊，对照组服用市售腰息痛胶囊。
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腰息痛胶囊和市售腰息痛胶囊临床疗效对比表
上述临床疗效观察结果表明，本发明制备的腰息痛胶囊在治疗风湿性关节炎,肥大性腰椎炎，肥大性胸椎炎，颈椎炎，坐骨神经痛，腰肌劳损疾病时,疗效显著高于市售腰息痛胶囊，p＜0.05。

Claims (3)

1.一种治疗风湿性关节炎,肥大性腰椎炎，肥大性胸椎炎，颈椎炎，坐骨神经痛，腰肌劳损疾病的中药，其特征是取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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21～45Mpa，萃取温度20～45℃，分离器压力12～19Mpa，分离器温度39～59℃，分离时间1.7～3.4小时，二氧化碳流量每小时22～35L，得提取液；取提取液60～76℃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，制得腰息痛胶囊。
2.根据权利要求1所述中药的制备方法，其特征是取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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21～45Mpa，萃取温度20～45℃，分离器压力12～19Mpa，分离器温度39～59℃，分离时间1.7～3.4小时，二氧化碳流量每小时22～35L，得提取液；取提取液60～76℃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，制得腰息痛胶囊。
3.根据权利要求1所述中药的制备方法，取蒺藜78g,香橼26g,地骨皮70g,白芷78g,制草乌52g,独活52g,续断52g,牛膝52g,三七47g,防风52g,威灵仙52g,秦艽26g,五加皮52g,防己78g,海风藤78g,杜仲46g,粉萆薢39g,何首乌69g,红花52g,千年健52g,赤芍60g,桂枝52g，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33Mpa，萃取温度32℃，分离器压力16Mpa，分离器温度49℃，分离时间2.6小时，二氧化碳流量每小时28L，得提取液；取提取液68℃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，制得腰息痛胶囊。
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