CN105343574A - 一种舒冠胶囊及其制备方法 - Google Patents

一种舒冠胶囊及其制备方法 Download PDF

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CN105343574A
CN105343574A CN201510905079.7A CN201510905079A CN105343574A CN 105343574 A CN105343574 A CN 105343574A CN 201510905079 A CN201510905079 A CN 201510905079A CN 105343574 A CN105343574 A CN 105343574A
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Abstract

本发明公开了一种舒冠胶囊及其制备方法，其特征在于取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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，制成舒冠胶囊，崩解时间显著缩短，疗效显著优于市售舒冠胶囊，取得了积极效果。

Description

一种舒冠胶囊及其制备方法
技术领域
本发明涉及中药领域，具体涉及一种舒冠胶囊及其制备方法。
背景技术
舒冠胶囊养阴活血，益气温阳。用于防治冠心病、心绞痛动脉粥样硬化高脂血症及抗血栓形成等。市售舒冠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、疗效高的舒冠胶囊及其制备方法。
发明实施方案如下：
取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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19～39Mpa，萃取温度21～40℃，分离器压力13～18Mpa，分离器温度42～54℃，分离时间1.9～3.6小时，二氧化碳流量每小时20～37L，得提取液；取提取液63～78℃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，制得舒冠胶囊1600粒。
上述实施方案所提到的原材料标准如下：
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。
香薷：中国药典2005年版一部标准。本品为唇形科植物石香薷MislachinensisMaxim．或江香薷Moslachinensis‘Jiangxiangru’的十燥地上部分。前者习称“青香薷”，后者习称“江香薷”。夏季茎叶茂盛、花盛时择晴天采割，除去杂质，阴干。
老鹳草：中国药典2005年版一部标准。本品为牻牛儿苗科植物牻牛儿苗Erodiumstephania-numWilld．、老鹤草GeraniumwilfordiiMaxim．或野老鹳草GeraniumcarolinianumL.的干燥地上部分，前者习称“长嘴老鹳草”，后两者习称“短嘴老鹳草”，夏、秋二季果实近成熟时采割，的捆成把，晒干。
川芎：中国药典2005年版一部标准。本品为伞形科植物川穹LigusticumchuanriongHort．的干燥根茎。夏季当茎上的节盘显著突出，并略带紫色时采挖，除去泥沙，晒后烘干，再去须根。
黄精：中国药典2005年版一部标准。本品为百合科植物滇黄精PolygonatumkingianumColl.etHemsl.、黄精PolygonatumsibiricumRed.或多花黄精PolygonatumcyrtonemaHua的干燥根茎。按形状不同，习称“大黄精”、“鸡头黄精”、“姜形黄精”。春、秋二季采挖，除去须根，洗净，置沸水中略烫或蒸至透心，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。
淫羊藿：中国药典2005年版一部标准。本品为小檗科植物淫羊藿EpimediumbrevicornumMaxim．、箭叶淫羊藿Epimediumsagittatum（Sieb．etZucc.）Maxim．、柔毛淫羊藿EpimediumpubescensMaxim．、巫山淫羊著EpimediumwushanenseT．S．Ying或朝鲜淫羊藿EpimediumkoreanumNabai的干燥地上部分。夏、秋季茎叶茂盛时采割，除去粗梗及杂质，晒干或阴干。
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。
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。
以上舒冠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
取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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19Mpa，萃取温度21℃，分离器压力13Mpa，分离器温度42℃，分离时间1.9小时，二氧化碳流量每小时20L，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，制得舒冠胶囊1600粒。
本发明的具体实施例2
取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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39Mpa，萃取温度40℃，分离器压力18Mpa，分离器温度54℃，分离时间3.6小时，二氧化碳流量每小时37L，得提取液；取提取液78℃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，制得舒冠胶囊1600粒。
本发明的具体实施例3
取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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29Mpa，萃取温度31℃，分离器压力15Mpa，分离器温度48℃，分离时间2.8小时，二氧化碳流量每小时29L，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，制得舒冠胶囊1600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舒冠胶囊。下面以实施例3制得的舒冠胶囊考察本发明的实际效果：
（一）实施例3舒冠胶囊和市售舒冠胶囊崩解时限对比
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舒冠胶囊和市售舒冠胶囊崩解时限对比表
上述结果表明,本发明制备的舒冠胶囊相对于市售舒冠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舒冠胶囊和市售舒冠胶囊治疗冠心病、心绞痛动脉粥样硬化高脂血症临床疗效观察
1病例情况
统计门诊和住院病例，共观察冠心病、心绞痛动脉粥样硬化高脂血症病例134例，平均年龄49岁。将患者分为两组，试验组服用实施例3舒冠胶囊，对照组服用市售舒冠胶囊。
2疗效评定标准
依据中药新药治疗冠心病心绞痛临床研究指导原则中医证候疗效判定标准：
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%。
加重：中医临床症状、体征均有加重，证候积分减少＜0。
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舒冠胶囊和市售舒冠胶囊临床疗效对比表
上述临床疗效观察结果表明，本发明制备的舒冠胶囊在治疗冠心病、心绞痛动脉粥样硬化高脂血症时,疗效显著高于市售舒冠胶囊，p＜0.05。

Claims (3)

1.一种治疗冠心病、心绞痛动脉粥样硬化高脂血症的中药，其特征是取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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29Mpa，萃取温度31℃，分离器压力15Mpa，分离器温度48℃，分离时间2.8小时，二氧化碳流量每小时29L，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，制得舒冠胶囊。
2.根据权利要求1所述中药的制备方法，其特征是取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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29Mpa，萃取温度31℃，分离器压力15Mpa，分离器温度48℃，分离时间2.8小时，二氧化碳流量每小时29L，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，制得舒冠胶囊。
3.根据权利要求1所述中药的制备方法，取天麻114g,香薷76g,老鹳草380g,川芎380g，黄精494g,红花418g,淫羊藿418g,丹参418g,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29Mpa，萃取温度31℃，分离器压力15Mpa，分离器温度48℃，分离时间2.8小时，二氧化碳流量每小时29L，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，制得舒冠胶囊。
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