CN105456700A - 一种益肾补骨胶囊及其制备方法 - Google Patents
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Abstract
本发明公开了一种益肾补骨胶囊及其制备方法,其特征在于取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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,制成益肾补骨胶囊,崩解时间显著缩短,疗效显著优于市售益肾补骨胶囊,取得了积极效果。
Description
一技术领域
本发明涉及中药领域,具体涉及一种益肾补骨胶囊及其制备方法。
二背景技术
益肾补骨胶囊滋补肝肾,强壮筋骨。用于肝肾不足,劳伤腰痛,筋骨折伤。市售益肾补骨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。
三发明内容
本发明为克服上述不足,提供一种崩解速度快、疗效高的益肾补骨胶囊及其制备方法。
发明实施方案如下:
取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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16~36Mpa,萃取温度21~38℃,分离器压力13~19Mpa,分离器温度41~59℃,分离时间2.5~3.6小时,二氧化碳流量每小时26~37L,得提取液;取提取液65~77℃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,制得益肾补骨胶囊1000粒。
上述实施方案所提到的原材料标准如下:
石韦:中国药典2005年版一部标准。本品为水龙骨科植物庐山石韦Pyrrosiasheareri(Bak.)Ching、石韦Pyrrosialingua(Thunb.)Farwell或有柄石韦Pyrrosiapetiolosa(Christ)Chinp的干燥叶。全年均可采收.除去根茎及根,晒干或阴干。
金樱子:中国药典2005年版一部标准。本品为蔷薇科植物金樱子RosalaevigataMichx.的干燥成熟果实。10-11月果实成熟变红时采收,干燥.除去毛刺。
防风:中国药典2005年版一部标准。本品为伞形科植物防风Saposhnikoviadivaricata(Turcz.)Schischk.的干燥根。春、秋二季采挖未抽花茎植株的根.除去须根及泥沙,晒干。骨碎补:中国药典2005年版一部标准。本品为水龙骨科植物槲蕨Drynariafortunei(Kunze)J.Sm.的干燥根茎。全年均可采挖,除去泥沙,干燥.或再燎去茸毛(鳞片)。
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”。
续断:中国药典2005年版一部标准。本品为川续断科植物川续断DipsacusasperoidesC.Y.ChengetT.M.Ai的干燥根。秋季采挖,除去根头及须根,用微火烘至半干,堆置“发汗”至内部变绿色时,再烘干。
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。
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。
熟地黄:中国药典2005年版一部标准。本品为生地黄的炮制加工品。
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。
陈皮:中国药典2005年版一部标准。本品为芸香科植物橘CitrusreticulataBlanco及其栽培变种的干燥成熟果皮。药材分为“陈皮”和“广陈皮”。采摘成熟果实,剥取果皮,晒干或低温干燥。
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。
以上益肾补骨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
取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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21℃,分离器压力13Mpa,分离器温度41℃,分离时间2.5小时,二氧化碳流量每小时26L,得提取液;取提取液65℃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,制得益肾补骨胶囊1000粒。本发明的具体实施例2
取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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36Mpa,萃取温度38℃,分离器压力19Mpa,分离器温度59℃,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77℃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,制得益肾补骨胶囊1000粒。本发明的具体实施例3
取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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26Mpa,萃取温度30℃,分离器压力16Mpa,分离器温度50℃,分离时间3.2小时,二氧化碳流量每小时32L,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,制得益肾补骨胶囊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益肾补骨胶囊。下面以实施例3制得的益肾补骨胶囊考察本发明的实际效果:
(一)实施例3益肾补骨胶囊和市售益肾补骨胶囊崩解时限对比
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益肾补骨胶囊和市售益肾补骨胶囊崩解时限对比表
上述结果表明,本发明制备的益肾补骨胶囊相对于市售益肾补骨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益肾补骨胶囊和市售益肾补骨胶囊治疗肝肾不足,劳伤腰痛,筋骨折伤临床疗效观察
1病例情况
统计门诊和住院病例,共观察肝肾不足,劳伤腰痛,筋骨折伤病例130例,平均年龄55岁。将患者分为两组,试验组服用实施例3益肾补骨胶囊,对照组服用市售益肾补骨胶囊。
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益肾补骨胶囊和市售益肾补骨胶囊临床疗效对比表
上述临床疗效观察结果表明,本发明制备的益肾补骨胶囊在治疗肝肾不足,劳伤腰痛,筋骨折伤时,疗效显著高于市售益肾补骨胶囊,p<0.05。
Claims (3)
1.一种治疗肝肾不足,劳伤腰痛,筋骨折伤的中药,其特征是取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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16~36Mpa,萃取温度21~38℃,分离器压力13~19Mpa,分离器温度41~59℃,分离时间2.5~3.6小时,二氧化碳流量每小时26~37L,得提取液;取提取液65~77℃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,制得益肾补骨胶囊。
2.根据权利要求1所述中药的制备方法,其特征是取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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16~36Mpa,萃取温度21~38℃,分离器压力13~19Mpa,分离器温度41~59℃,分离时间2.5~3.6小时,二氧化碳流量每小时26~37L,得提取液;取提取液65~77℃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,制得益肾补骨胶囊。
3.根据权利要求1所述中药的制备方法,取石韦88g,金樱子77g,防风28.5g,骨碎补44g,茯苓66g,续断70g,当归63g,党参75g,熟地黄63g,黄精75g,陈皮14.25g,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26Mpa,萃取温度30℃,分离器压力16Mpa,分离器温度50℃,分离时间3.2小时,二氧化碳流量每小时32L,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,制得益肾补骨胶囊。
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