CN105456763A - 一种肾康宁胶囊及其制备方法 - Google Patents

一种肾康宁胶囊及其制备方法 Download PDF

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CN105456763A
CN105456763A CN201510892158.9A CN201510892158A CN105456763A CN 105456763 A CN105456763 A CN 105456763A CN 201510892158 A CN201510892158 A CN 201510892158A CN 105456763 A CN105456763 A CN 105456763A
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Abstract

本发明公开了一种肾康宁胶囊及其制备方法,其特征在于取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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,制成肾康宁胶囊,崩解时间显著缩短,疗效显著优于市售肾康宁胶囊,取得了积极效果。

Description

一种肾康宁胶囊及其制备方法
技术领域
本发明涉及中药领域,具体涉及一种肾康宁胶囊及其制备方法。
背景技术
肾康宁胶囊温肾,益气,和血,渗湿。用于慢性肾炎,肾气亏损,肾功能不全所引起的腰酸、疲乏、畏寒及夜尿增多。市售肾康宁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、疗效高的肾康宁胶囊及其制备方法。
发明实施方案如下:
取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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20~42Mpa,萃取温度21~43℃,分离器压力12~18Mpa,分离器温度42~54℃,分离时间2.1~3.5小时,二氧化碳流量每小时21~32L,得提取液;取提取液64~76℃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,制得肾康宁胶囊1700粒。
上述实施方案所提到的原材料标准如下:
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。
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。
薤白:中国药典2005年版一部标准。本品为百合科植物小根蒜AlliummacrostemonBge.或薤AlliumchinensisG.Don的干燥鳞茎。夏、秋二季来挖,洗净,除去须根,蒸透或置沸水中烫透,晒干。
黄芪:中国药典2005年版一部标准。本品为豆科植物蒙古黄芪Astragalusmembranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalusmembranaceus(Fisch.)Bge,的干燥根。春、秋二李采挖,除去须根及根头,晒干。
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。
泽泻:中国药典2005年版一部标准。本品为泽泻科植物泽泻Alismaorientalis(Sam.)Juzep.的干燥块茎。冬季茎叶开始枯萎时采挖,洗净,干燥,除去须根及粗皮。
益母草:中国药典2005年版一部标准。本品为唇形科植物益母草LeonurusjaponicusHoutt.的新鲜或干燥地上部分。鲜品春季幼苗期至初夏花前期采割;干品夏季茎叶茂盛、花木开或初开时采割,晒干,或切段晒干。
锁阳:中国药典2010年版一部标准。本品为锁阳科植物锁阳CynomoriumsongaricumRupr.的干燥肉质茎。春季采挖,除去花序,切段,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。
以上肾康宁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
取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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20~42Mpa,萃取温度21℃,分离器压力12Mpa,分离器温度42℃,分离时间2.1小时,二氧化碳流量每小时21L,得提取液;取提取液64℃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,制得肾康宁胶囊1700粒。
本发明的具体实施例2
取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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43℃,分离器压力18Mpa,分离器温度54℃,分离时间3.5小时,二氧化碳流量每小时32L,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,制得肾康宁胶囊1700粒。
本发明的具体实施例3
取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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31Mpa,萃取温度32℃,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27L,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,制得肾康宁胶囊1700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肾康宁胶囊。下面以实施例3制得的肾康宁胶囊考察本发明的实际效果:
(一)实施例3肾康宁胶囊和市售肾康宁胶囊崩解时限对比
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肾康宁胶囊和市售肾康宁胶囊崩解时限对比表
上述结果表明,本发明制备的肾康宁胶囊相对于市售肾康宁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肾康宁胶囊和市售肾康宁胶囊治疗慢性肾炎,肾气亏损,肾功能不全所引起的腰酸、疲乏、畏寒及夜尿增多临床疗效观察
1病例情况
统计门诊和住院病例,共观察慢性肾炎,肾气亏损,肾功能不全所引起的腰酸、疲乏、畏寒及夜尿增多病例144例,平均年龄47岁。将患者分为两组,试验组服用实施例3肾康宁胶囊,对照组服用市售肾康宁胶囊。
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肾康宁胶囊和市售肾康宁胶囊临床疗效对比表
上述临床疗效观察结果表明,本发明制备的肾康宁胶囊在治疗慢性肾炎,肾气亏损,肾功能不全所引起的腰酸、疲乏、畏寒及夜尿增多疾病时,疗效显著高于市售肾康宁胶囊,p<0.05。

Claims (3)

1.一种治疗慢性肾炎,肾气亏损,肾功能不全所引起的腰酸、疲乏、畏寒及夜尿增多的中药,其特征是取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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20~42Mpa,萃取温度21~43℃,分离器压力12~18Mpa,分离器温度42~54℃,分离时间2.1~3.5小时,二氧化碳流量每小时21~32L,得提取液;取提取液64~76℃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,制得肾康宁胶囊。
2.根据权利要求1所述中药的制备方法,其特征是取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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20~42Mpa,萃取温度21~43℃,分离器压力12~18Mpa,分离器温度42~54℃,分离时间2.1~3.5小时,二氧化碳流量每小时21~32L,得提取液;取提取液64~76℃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,制得肾康宁胶囊。
3.根据权利要求1所述中药的制备方法,取五加皮45g,天竺黄22.5g,薤白225g,黄芪380g,丹参90g,泽泻180g,益母草450g,锁阳337.5g,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31Mpa,萃取温度32℃,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27L,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,制得肾康宁胶囊。
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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN112791146A (zh) * 2021-04-06 2021-05-14 温文斌 一种慢性肾功能衰竭治疗中药组合物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112791146A (zh) * 2021-04-06 2021-05-14 温文斌 一种慢性肾功能衰竭治疗中药组合物

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