CN105412693A - 一种骨刺消痛胶囊及其制备方法 - Google Patents
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Abstract
本发明公开了一种骨刺消痛胶囊及其制备方法,其特征在于取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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,制成骨刺消痛胶囊,崩解时间显著缩短,疗效显著优于市售骨刺消痛胶囊,取得了积极效果。
Description
技术领域
本发明涉及中药领域,具体涉及一种骨刺消痛胶囊及其制备方法。
背景技术
骨刺消痛胶囊祛风止痛。用于骨质增生,风湿性关节炎,风湿痛。市售骨刺消痛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、疗效高的骨刺消痛胶囊及其制备方法。
发明实施方案如下:
取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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15~41Mpa,萃取温度20~36℃,分离器压力12~19Mpa,分离器温度41~54℃,分离时间2.2~3.4小时,二氧化碳流量每小时25~35L,得提取液;取提取液64~77℃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,制得骨刺消痛胶囊1000粒。
上述实施方案所提到的原材料标准如下:
佩兰:中国药典2005年版一部标准。本品为菊科植物佩兰EupatoriumfortuneiTurcz.的干燥地上部分。夏、秋二季分两次采割,除去杂质,晒干。
密蒙花:中国药典2005年版一部标准。本品为马钱科植物密蒙花BuddlejaofficinalisMaxim.的干燥花蕾及其花序。春季花未开放时采收.除去杂质,干燥。
川芎:中国药典2005年版一部标准。本品为伞形科植物川穹LigusticumchuanriongHort.的干燥根茎。夏季当茎上的节盘显著突出,并略带紫色时采挖,除去泥沙,晒后烘干,再去须根。
制川乌:中国药典2005年版一部标准。本品为川乌的炮制加工品。
制草乌:中国药典2005年版一部标准。本品为草乌的炮制加工品。
秦艽:中国药典2005年版一部标准。本品为龙胆科植物秦艽GentianamacrophyllaPall.、麻花秦艽GentianastramineaMaxim.、粗茎秦艽Gentianacras-sicaulisDuthieexBurk.或小秦艽GentianadahuricaFisch.的干燥根。前三种按性状不同分别习称“秦艽”和“麻花艽”.后一种习称“小秦艽”。春、秋二季采挖,除去泥沙;素艽及麻花艽晒软,堆置“发汗”至表面呈红黄色或灰黄色时.摊开晒干,或不经“发汗”直接晒干;小秦艽趁鲜时搓去黑皮,晒干。
白芷:中国药典2005年版一部标准。本品为伞形科植物白芷Angelicadahurica(Fisch.exHOffm.)Benth.etHook.f.或杭白芷Angelicadahurica(Fisch.exHoffm.)Benth.etHook.f.var.formosana(Boiss.)ShanetYuan的干燥根。夏、秋间叶黄时采挖,除去须报及泥沙,晒干或低温干燥。
薏苡仁:中国药典2005年版一部标准。本品为禾本科植物薏苡Coixlacryma-jobiL.var.ma-yuen(ROman.)Stapf的干燥成熟种仁。秋季果实成熟时采割植株,晒干,打下果实,再晒干,除去外壳、黄褐色种皮及杂质,收集种仁。
天南星:中国药典2005年版一部标准。本品为天南星科植物天南星Arisaemaerubescens(Wall.)Schott、异叶无南星ArisaemaheterophyllumBl.或东北天南星ArisaemaamurenseMaxim.的干燥块茎。秋、冬二季茎叶枯萎时采挖,除去须根及外皮,干燥。
红花:中国药典2005年版一部标准。本品为菊科植物红花CarthamustinctoriusL.的干燥花。夏季花由黄变红时采摘,阴干或晒干。
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。
徐长卿:中国药典2005年版一部标准。本品为萝藦科植物徐长卿CynanCHUMpaniculatum(Bge.)Kitag.的干燥根及根茎。秋季采挖,除去杂质,阴干。
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。
以上骨刺消痛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”、“炙”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
取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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15Mpa,萃取温度20℃,分离器压力12Mpa,分离器温度41℃,分离时间2.2小时,二氧化碳流量每小时25L,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,制得骨刺消痛胶囊1000粒。
本发明的具体实施例2
取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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41Mpa,萃取温度36℃,分离器压力19Mpa,分离器温度54℃,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,制得骨刺消痛胶囊1000粒。
本发明的具体实施例3
取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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28Mpa,萃取温度28℃,分离器压力16Mpa,分离器温度48℃,分离时间2.8小时,二氧化碳流量每小时30L,得提取液;取提取液64~77℃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,制得骨刺消痛胶囊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骨刺消痛胶囊。下面以实施例3制得的骨刺消痛胶囊考察本发明的实际效果:
(一)实施例3骨刺消痛胶囊和市售骨刺消痛胶囊崩解时限对比
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骨刺消痛胶囊和市售骨刺消痛胶囊崩解时限对比表
上述结果表明,本发明制备的骨刺消痛胶囊相对于市售骨刺消痛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骨刺消痛胶囊和市售骨刺消痛胶囊骨质增生,风湿性关节炎,风湿痛疾病临床疗效观察
1病例情况
统计门诊和住院病例,共观察骨质增生,风湿性关节炎,风湿痛病例130例,平均年龄29岁。将患者分为两组,试验组服用实施例3骨刺消痛胶囊,对照组服用市售骨刺消痛胶囊。
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骨刺消痛胶囊和市售骨刺消痛胶囊临床疗效对比表
上述临床疗效观察结果表明,本发明制备的骨刺消痛胶囊在治疗骨质增生,风湿性关节炎,风湿痛疾病时,疗效显著高于市售骨刺消痛胶囊,p<0.05。
Claims (3)
1.一种治疗骨质增生,风湿性关节炎,风湿痛的中药,其特征是取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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15~41Mpa,萃取温度20~36℃,分离器压力12~19Mpa,分离器温度41~54℃,分离时间2.2~3.4小时,二氧化碳流量每小时25~35L,得提取液;取提取液64~77℃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,制得骨刺消痛胶囊。
2.根据权利要求1所述中药的制备方法,其特征是取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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15~41Mpa,萃取温度20~36℃,分离器压力12~19Mpa,分离器温度41~54℃,分离时间2.2~3.4小时,二氧化碳流量每小时25~35L,得提取液;取提取液64~77℃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,制得骨刺消痛胶囊。
3.根据权利要求1所述中药的制备方法,取佩兰42.6g,密蒙花213g,川芎112g,制川乌56g,制草乌56g,秦艽56g,白芷88g,薏苡仁96g,天南星(炙)70g,红花130g,当归68g,徐长卿195g,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28Mpa,萃取温度28℃,分离器压力16Mpa,分离器温度48℃,分离时间2.8小时,二氧化碳流量每小时30L,得提取液;取提取液64~77℃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,制得骨刺消痛胶囊。
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