CN105343324A - 一种胃炎康胶囊及其制备方法 - Google Patents

一种胃炎康胶囊及其制备方法 Download PDF

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CN105343324A
CN105343324A CN201510913455.7A CN201510913455A CN105343324A CN 105343324 A CN105343324 A CN 105343324A CN 201510913455 A CN201510913455 A CN 201510913455A CN 105343324 A CN105343324 A CN 105343324A
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Abstract

本发明公开了一种胃炎康胶囊及其制备方法，其特征在于取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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，制成胃炎康胶囊，崩解时间显著缩短，疗效显著优于市售胃炎康胶囊，取得了积极效果。

Description

一种胃炎康胶囊及其制备方法
技术领域
本发明涉及中药领域，具体涉及一种胃炎康胶囊及其制备方法。
背景技术
胃炎康胶囊舒肝和胃，缓急止痛。主治胃脘疼痛，呕恶泛酸、烧灼不适。用于十二指肠溃疡、胆汁返流性胃炎、慢性胃炎等具有以上症状者。市售胃炎康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、疗效高的胃炎康胶囊及其制备方法。
发明实施方案如下：
取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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16～42Mpa，萃取温度16～39℃，分离器压力12～19Mpa，分离器温度37～55℃，分离时间2.8～3.4小时，二氧化碳流量每小时21～35L，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，制得胃炎康胶囊1000粒。
上述实施方案所提到的原材料标准如下：
苏合香：中国药典2005年版一部标准。本品为金缕梅科植物苏合香树LiquidambarorientalisMill.的树干渗出的香树脂经加工精制而成。
甘松：中国药典2005年版一部标准。RADIXETRHIZOMANARDOSTACHYOS本品为败酱科植物甘松NardostachyschinensisBatal.或匙叶甘松NardostachysjatamansiDC．的干燥根及根茎。春、秋二季采挖，除去泥沙及杂质，晒干或阴干。
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。
白芍：中国药典2005年版一部标准。本品为毛茛科植物芍药PaeonialactifloraPall.的干燥根。夏、秋二季来挖、洗净，除去头尾及细根，置沸水中煮后除去外皮或去应后再煮、晒干。
甘草：中国药典2005年版一部标准。本品为豆科植物甘草GlycyrrhizuralensisFisch．、胀果甘草GlycyrrhizainflataBat.或光果甘草Glycyrrhizagla-braL．的干燥报及根茎。春、积二季采挖，除去须根，晒干。
桂枝：中国药典2005年版一部标准。本品为樟科植物肉桂CinnamomumcassiaPresl的干燥嫩枝。春、夏二季采收，除去叶，晒干，或切片晒干。
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。
以上胃炎康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
取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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16Mpa，萃取温度16℃，分离器压力12Mpa，分离器温度37℃，分离时间2.8小时，二氧化碳流量每小时21L，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，制得胃炎康胶囊1000粒。
本发明的具体实施例2
取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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42Mpa，萃取温度39℃，分离器压力19Mpa，分离器温度55℃，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，制得胃炎康胶囊1000粒。
本发明的具体实施例3
取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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28℃，分离器压力16Mpa，分离器温度46℃，分离时间3.1小时，二氧化碳流量每小时28L，得提取液；取提取液71℃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，制得胃炎康胶囊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胃炎康胶囊。下面以实施例3制得的胃炎康胶囊考察本发明的实际效果：
（一）实施例3胃炎康胶囊和市售胃炎康胶囊崩解时限对比
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胃炎康胶囊和市售胃炎康胶囊崩解时限对比表
上述结果表明,本发明制备的胃炎康胶囊相对于市售胃炎康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胃炎康胶囊和市售胃炎康胶囊治疗脘疼痛，呕恶泛酸、烧灼不适临床疗效观察
1病例情况
统计门诊和住院病例，共观察脘疼痛，呕恶泛酸、烧灼不适病例158例，平均年龄39岁。将患者分为两组，试验组服用实施例3胃炎康胶囊，对照组服用市售胃炎康胶囊。
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胃炎康胶囊和市售胃炎康胶囊临床疗效对比表
上述临床疗效观察结果表明，本发明制备的胃炎康胶囊在治疗脘疼痛，呕恶泛酸、烧灼不适时,疗效显著高于市售胃炎康胶囊，p＜0.05。

Claims (3)

1.一种治疗脘疼痛，呕恶泛酸、烧灼不适的中药，其特征是取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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16～42Mpa，萃取温度16～39℃，分离器压力12～19Mpa，分离器温度37～55℃，分离时间2.8～3.4小时，二氧化碳流量每小时21～35L，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，制得胃炎康胶囊。
2.根据权利要求1所述中药的制备方法，其特征是取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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16～42Mpa，萃取温度16～39℃，分离器压力12～19Mpa，分离器温度37～55℃，分离时间2.8～3.4小时，二氧化碳流量每小时21～35L，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，制得胃炎康胶囊。
3.根据权利要求1所述中药的制备方法，其特征是取苏合香11.2g,甘松56g,地骨皮48g,白芍120g,甘草72g,桂枝56g，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28℃，分离器压力16Mpa，分离器温度46℃，分离时间3.1小时，二氧化碳流量每小时28L，得提取液；取提取液71℃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，制得胃炎康胶囊。
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