CN105412408A - 一种甘露消渴胶囊及其制备方法 - Google Patents
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Abstract
本发明公开了一种甘露消渴胶囊及其制备方法,其特征在于取海风藤88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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,制成甘露消渴胶囊,崩解时间显著缩短,疗效显著优于市售甘露消渴胶囊,取得了积极效果。
Description
技术领域
本发明涉及中药领域,具体涉及一种甘露消渴胶囊及其制备方法。
背景技术
甘露消渴胶囊滋阴补肾,健脾生津。用于非胰岛素依赖型糖尿病。市售甘露消渴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、疗效高的甘露消渴胶囊及其制备方法。
发明实施方案如下:
取海风藤88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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21~42Mpa,萃取温度20~37℃,分离器压力12~18Mpa,分离器温度39~53℃,分离时间2.7~3.5小时,二氧化碳流量每小时27~38L,得提取液;取提取液62~78℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊1300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。
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。
罗布麻叶:中国药典2005年版一部标准。本品为夹竹桃科植物罗布麻叶ApocynumvenetumL.的干燥叶。夏季采收,除去杂质,干燥。
旋覆花:中国药典2005年版一部标准。本品为菊科植物旋覆花InulajaponicaThunb.或欧亚旅覆花InulabritannicaL.的干燥头状花序。夏、秋二季花开放时采收,除去杂质,阴干或晒干。
地黄:中国药典2005年版一部标准。本品为玄参科植物地黄RehmanniaglutinosaLibosch.的新鲜或干燥块根。秋季采挖,除去芦头、须根及泥沙,鲜用;或将地黄缓缓烘焙至约八成干。前者习称“鲜地黄”,后者习称“生地黄”。
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。
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。
山茱萸:中国药典2005年版一部标准。本品为山茱萸英科植物山茱萸CornusofficinalisSieb.etZucc.的干燥成熟果肉。秋末冬初果皮变红时采收果实,用文火烘或置沸水中略烫后,及时除去果核,干燥。
党参:中国药典2005年版一部标准。本品为桔梗科植物党参Codonopsispilosula(Franch.)Nannf.、素花党参CodonopsispilosulaNannf.var.modesta(Nannf.)LT.Shen或川党参CodonopsistangshenOliv.的干燥根。秋季采挖,洗净,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。
菟丝子:中国药典2005年版一部标准。本品为旋花科植物菟丝子CuscutachinensisLam.的干燥成熟种子。秋季果实成熟时采收植株,晒干,打下种子,除去杂质。
天花粉:中国药典2005年版一部标准。本品为葫芦科植物栝楼TrichosantheskirilowiiMaxim.或双边栝楼TrichosanthesrosthorniiHarms的干燥根。秋、冬二季采挖,洗净,除去外皮,切段或纵剖成瓣,干燥。
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。
黄连:中国药典2005年版一部标准。本品为毛茛科植物黄连CoplischinensisFranch.、三角叶黄连CoptisdeltoideaC.Y.ChengetHsiao或云连CoptisteetaWall.的干燥根茎。以上三种分别习称“味连”、“雅连”、“云连”。秋季来挖,除去须根及泥沙,干燥,撞去残留须根。
白术:中国药典2005年版一部标准。本品为菊科植物白术AtractylodesmacrocephalaKoldz.的干燥根茎。冬季下部叶枯黄、上部叶变脆时采挖,除去泥沙,烘干或晒干,再除去须根。
桑螵蛸:中国药典2005年版一部标准。本品为螳螂科昆虫大刀螂TenoderasinensisSaussure、小刀螂Statiliamaculata(Thunherg)或巨斧螳螂Hierodulapatellifera(Serville)的干燥卵鞘。以上三种分别习称“团螵蛸”、“长螵蛸”及“黑螵蛸”。深秋至次春采收,除去杂质,蒸至虫卵死后,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。
预胶化淀粉: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。
交联聚维酮: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。
以上甘露消渴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88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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2.7小时,二氧化碳流量每小时27L,得提取液;取提取液62℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊1300粒。
本发明的具体实施例2
取海风藤88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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37℃,分离器压力18Mpa,分离器温度53℃,分离时间3.5小时,二氧化碳流量每小时38L,得提取液;取提取液78℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊1300粒。
本发明的具体实施例3
取海风藤88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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29℃,分离器压力15Mpa,分离器温度46℃,分离时间3.1小时,二氧化碳流量每小时33L,得提取液;取提取液70℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊1300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甘露消渴胶囊。下面以实施例3制得的甘露消渴胶囊考察本发明的实际效果:
(一)实施例3甘露消渴胶囊和市售甘露消渴胶囊崩解时限对比
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甘露消渴胶囊和市售甘露消渴胶囊崩解时限对比表
上述结果表明,本发明制备的甘露消渴胶囊相对于市售甘露消渴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甘露消渴胶囊和市售甘露消渴胶囊治疗非胰岛素依赖型糖尿病临床疗效观察
1病例情况
统计门诊和住院病例,共观察非胰岛素依赖型糖尿病病例126例,平均年龄56岁。将患者分为两组,试验组服用实施例3甘露消渴胶囊,对照组服用市售甘露消渴胶囊。
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甘露消渴胶囊和市售甘露消渴胶囊临床疗效对比表
上述临床疗效观察结果表明,本发明制备的甘露消渴胶囊在治疗非胰岛素依赖型糖尿病时,疗效显著高于市售甘露消渴胶囊,p<0.05。
Claims (3)
1.一种治疗非胰岛素依赖型糖尿病的中药,其特征是取海风藤88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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21~42Mpa,萃取温度20~37℃,分离器压力12~18Mpa,分离器温度39~53℃,分离时间2.7~3.5小时,二氧化碳流量每小时27~38L,得提取液;取提取液62~78℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊。
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88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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21~42Mpa,萃取温度20~37℃,分离器压力12~18Mpa,分离器温度39~53℃,分离时间2.7~3.5小时,二氧化碳流量每小时27~38L,得提取液;取提取液62~78℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊。
3.根据权利要求1所述中药的制备方法,取海风藤88g,广藿香17.6g,荜澄茄44g,罗布麻叶33g,旋覆花8.8g,地黄66g,枸杞子44g,地骨皮66g,山茱萸44g,党参39.6g,黄芪52.8g,菟丝子52.8g,天花粉26.4g,当归17.6g,黄连8.8g,白术35.2g,桑螵蛸22g,泽泻22g,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29℃,分离器压力15Mpa,分离器温度46℃,分离时间3.1小时,二氧化碳流量每小时33L,得提取液;取提取液70℃减压干燥,得干膏;取干膏加入预胶化淀粉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,交联聚维酮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,制得甘露消渴胶囊。
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