CN105343336A - 一种消糖灵胶囊及其制备方法 - Google Patents

一种消糖灵胶囊及其制备方法 Download PDF

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CN105343336A
CN105343336A CN201510905122.XA CN201510905122A CN105343336A CN 105343336 A CN105343336 A CN 105343336A CN 201510905122 A CN201510905122 A CN 201510905122A CN 105343336 A CN105343336 A CN 105343336A
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carbon dioxide
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Abstract

本发明公开了一种消糖灵胶囊及其制备方法，其特征在于取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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，制成消糖灵胶囊，崩解时间显著缩短，疗效显著优于市售消糖灵胶囊，取得了积极效果。

Description

一种消糖灵胶囊及其制备方法
技术领域
本发明涉及中药领域，具体涉及一种消糖灵胶囊及其制备方法。
背景技术
消糖灵胶囊益气养阴，清热泻火，益肾缩尿。用于糖尿病。市售消糖灵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、疗效高的消糖灵胶囊及其制备方法。
发明实施方案如下：
取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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24～35Mpa，萃取温度16～43℃，分离器压力11～19Mpa，分离器温度42～58℃，分离时间1.7～3.3小时，二氧化碳流量每小时26～33L，得提取液；取提取液62～78℃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，制得消糖灵胶囊1000粒。
上述实施方案所提到的原材料标准如下：
沉香：中国药典2005年版一部标准。本品为瑞香料植物白木香Aquilariasinensis（Lour.）Gilg含有树脂的木材。全年均可采收，割取含树脂的木材．除去不含树脂的部分，阴干。
茯苓：中国药典2005年版一部标准。本品为多孔菌科真菌茯苓Poriacocos（Schw.）Wolf的干燥菌核。多于7-9月采挖，挖出后除去泥沙，堆置“发汗”后，摊开晾至表面干燥，再“发汗”，反复数次至现皱纹、内部水分大部散失后，阴干，称为“茯苓个”；或将鲜茯苓按不同部位切制，阴于，分别称为“茯苓皮”及“茯苓块”。
火麻仁：中国药典2005年版一部标准。本品为桑科植物大麻CannabissativaL.的干燥成熟果实。秋季果实成熟时采收，除去杂质，晒干。
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。
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。
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。
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。
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。
沙苑子：中国药典2005年版一部标准。本品为豆科植物扁茎黄芪AstragaluscomplanatusR．Br．的干燥成熟种子。秋末冬初果实成熟尚未开裂时采割植株，晒干，打下种子，除去杂质，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。
以上消糖灵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
取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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24Mpa，萃取温度16℃，分离器压力11Mpa，分离器温度42℃，分离时间1.7小时，二氧化碳流量每小时26L，得提取液；取提取液62℃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，制得消糖灵胶囊1000粒。
本发明的具体实施例2
取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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35Mpa，萃取温度43℃，分离器压力19Mpa，分离器温度58℃，分离时间3.3小时，二氧化碳流量每小时33L，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，制得消糖灵胶囊1000粒。
本发明的具体实施例3
取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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30Mpa，萃取温度30℃，分离器压力15Mpa，分离器温度50℃，分离时间2.5小时，二氧化碳流量每小时30L，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，制得消糖灵胶囊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消糖灵胶囊。下面以实施例3制得的消糖灵胶囊考察本发明的实际效果：
（一）实施例3消糖灵胶囊和市售消糖灵胶囊崩解时限对比
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消糖灵胶囊和市售消糖灵胶囊崩解时限对比表
上述结果表明,本发明制备的消糖灵胶囊相对于市售消糖灵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消糖灵胶囊和市售消糖灵胶囊治疗糖尿病临床疗效观察
1病例情况
统计门诊和住院病例，共观察糖尿病病例134例，平均年龄57岁。将患者分为两组，试验组服用实施例3消糖灵胶囊，对照组服用市售消糖灵胶囊。
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消糖灵胶囊和市售消糖灵胶囊临床疗效对比表
上述临床疗效观察结果表明，本发明制备的消糖灵胶囊在治疗糖尿病时,疗效显著高于市售消糖灵胶囊，p＜0.05。

Claims (3)

1.一种治疗糖尿病的中药，其特征是取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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24～35Mpa，萃取温度16～43℃，分离器压力11～19Mpa，分离器温度42～58℃，分离时间1.7～3.3小时，二氧化碳流量每小时26～33L，得提取液；取提取液62～78℃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，制得消糖灵胶囊。
2.根据权利要求1所述中药的制备方法，其特征是取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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24～35Mpa，萃取温度16～43℃，分离器压力11～19Mpa，分离器温度42～58℃，分离时间1.7～3.3小时，二氧化碳流量每小时26～33L，得提取液；取提取液62～78℃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，制得消糖灵胶囊。
3.根据权利要求1所述中药的制备方法，取沉香192g,茯苓96g,火麻仁19.2g,黄连30g,天花粉490g,杜仲88g,黄芪512g,丹参180g,枸杞子128g,沙苑子160g,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30Mpa，萃取温度30℃，分离器压力15Mpa，分离器温度50℃，分离时间2.5小时，二氧化碳流量每小时30L，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，制得消糖灵胶囊。
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CN111759963A (zh) * 2020-06-15 2020-10-13 孙晓宣 一种治疗糖尿病的代餐粉及其制备方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111759963A (zh) * 2020-06-15 2020-10-13 孙晓宣 一种治疗糖尿病的代餐粉及其制备方法

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