CN109288959A - 益心舒片及其制备方法 - Google Patents
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Abstract
本发明涉及一种益心舒片及其制备方法,具体由人参、麦冬、五味子、黄芪、丹参、川芎、山楂为原料,提取制备而成,该片剂的制备,以75%乙醇制粒,其粘性较强,适用于质地疏松、弹性较强的植物性药物,制得的颗粒经整粒后,片子硬度,口感好,压片制成片剂后片面光滑平整,具备良好的运用价值。
Description
技术领域
本发明涉及中成药片剂及其制备领域,具体涉及一种益心舒片及其制备方法。
背景技术
心脑血管疾病是目前影响人类健康,造成死亡的最重要因素之一,据文献报道,每年全世界死于心脑血管疾病的人数超过2000万,我国近40万。中医在该病的诊治方面积累了丰富的临床经验,中药方剂在治疗心脑血管疾病方面具有独特的优势。胸痛及冠心病心绞痛属中医“胸痹”范畴。胸痹其病因与寒邪内侵、饮食不当、情志失调、年迈体虚等有关,按证候可分为心血瘀阻、痰浊雍塞、阴寒凝滞、心肾阴虚、气阴两虚、阳气虚衰等症型。“心脉痹阻”为本病的主要病理机制,临床大多虚实夹杂,呈本虚表实之候,治疗此病倡用以补为主以,通为用原则,补,主要补气阴,旨在调脏腑气血偏盛偏衰,以治本虚之证,通,主要活血通阳,意在宣通脉络之痹阻,以治标实之侯。
益心舒胶囊处方以古方“生脉饮”加味活血药而成,标本兼治。“生脉饮”为治疗胸痹常用基础方,以生脉饮加味在冠心病临床研究方面有众多文献见诸报道,疗效显著。益心胶囊属于国家基本药物(2004年),同时又属于《基本医疗保险和工伤保险药品目录》2004年版中成药乙类,效果良好,服用方便,深受广大患者青睐。
公开号为103784726A的中国专利申请中公开了一种益心舒片的制备方法,该方法操作过程中乙醇浓度越大,湿润后粘性越低,造成制得的湿颗粒目数分布范围广而不均匀、细粉多,造成压片时出现花片、裂片等现象,制得的益心舒片崩解时间长且在储藏一段时间后会出现崩解时限不合格、稳定性差、微生物不合格等现象。
发明内容
本发明提供了一种益心舒片,该益心舒片崩解时限短、微生物限度合格,该制备方法工序简单、质量可控且适于工业化生产,具体内容如下:
一种益心舒片,以10000片计,由益心舒干膏及其辅料压片制成,所述的益心舒干膏是以200~280重量份人参、200~250重量份麦冬、100~135重量份五味子、140~200重量份黄芪、200~300重量份丹参、100~180重量份川芎、180~250重量份山楂为原料提取而成的;
上述的一种益心舒片,所述的益心舒干膏的制备方法如下:
(1)将人参粉碎后得到人参细粉,备用;
(2)将五味子、丹参用70~85%的乙醇回流提取2次,得到的提取液滤过,合并后减压浓缩至密度为1.15~1.12得到醇浸膏A;
(3)将麦冬、黄芪、川芎和山楂用水煎煮2次,合并煎液,滤过,滤液浓缩至原体积的10~12%,再加入95%的乙醇,充分搅拌后,静置过夜,滤去沉淀物,滤液回收乙醇并浓缩至相对密度1.15~1.25,得到浸膏B;
(4)将醇浸膏A和浸膏B合并后加入步骤(1)得到的人参细粉后混匀得到所述的益心舒干膏。
上述的益心舒片的制备方法,包括以下步骤:
(1)取处方量的益心舒干膏粉碎过100目筛,加入适量淀粉充分混匀、备用;
(2)将二氧化硅、羧甲淀粉钠、1~5%重量的益心舒干膏粉采用等量递增法混合均匀,得到原辅料;
(3)按上述益心舒干膏粉用75%的乙醇一步制粒,在70℃条件下烘干,整粒,再加入1%-1.5%硬脂酸镁得到的原辅料混合均匀,压片得到所述的益心舒片。
同现有技术相比,本发明的有益效果体现在:
1)以75%乙醇制粒,其粘性较强,适用于质地疏松、弹性较强的植物性药物,制得的颗粒经整粒后,片子硬度,口感好,压片制成片剂后片面光滑平整,崩解时限等指标都符合要求。
2)通过辅料的精心筛选,所制成的颗粒粒度均匀,释放度,口感好、崩解时限、片子光洁度方面都有优于传统工艺制成的颗粒。
3)该方法制备时间短、物料损耗少、劳动强度低、受外界污染低和成品颗粒整齐,只需配备少量人员,更合适以规模化生产。
具体实施方式
以下通过实施例进一步解释或是说明本发明内容,但是所提供的实施例不应被理解为对本发明保护范围构成限制。
实施例1
处方:1500g人参、1500g麦冬、950g五味子、1500g黄芪、2400g丹参、950g川芎、1500g山楂
制备方法:(1)以上七味,取1500g人参粉碎细粉后备用。950g五味子、2400g丹参用85%的乙醇回流提取2次,第一次加85%乙醇6倍量,回流提取3小时,第二次加95%乙醇5倍量,回流提取1.5小时,滤过,合并滤液,减压浓缩至相对密度1.15~1.12(20℃),得醇浸膏。再将1500g麦冬、1500g黄芪、950g川芎和1500g山楂加水煎煮2次,第一次加水10倍量(重量),煎煮2.5小时,第二次加水8倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至3500ml,加入等量的85%乙醇,充分搅拌后,静置过夜,滤去沉淀物,滤液回收乙醇并浓缩至相对密度1.15(80℃),将上述二种浸膏合并后再加入人参细粉混合均匀得到益心舒干膏,备用。
(2)益心舒干膏粉碎过100目筛,蔗糖粉碎过80目筛,备用。
(3)将二氧化硅40g、硬脂酸镁25g、羧甲淀粉钠90g、益心舒干膏粉50g混合均匀,备用。
(4)按上述益心舒干膏粉用75%的乙醇一步制粒,在70℃条件下烘干,整粒,再加入1%-1.5%硬脂酸镁得到的原辅料混合均匀,压片得到所述的益心舒片。
实施例2
处方:1200g人参、1500g麦冬、1000g五味子、1200g黄芪、2000g丹参、1000g川芎、1200g山楂
制备方法:(1)以上七味,取1200g人参粉碎细粉后备用。1000g五味子、2000g丹参用85%的乙醇回流提取2次,第一次加85%乙醇6倍量,回流提取3小时,第二次加95%乙醇5倍量,回流提取1.5小时,滤过,合并滤液,减压浓缩至相对密度1.15~1.12(20℃),得醇浸膏。再将1500g麦冬、1200g黄芪、1000g川芎和1200g山楂加水煎煮2次,第一次加水10倍量(重量),煎煮2.5小时,第二次加水8倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至3500ml,加入等量的85%乙醇,充分搅拌后,静置过夜,滤去沉淀物,滤液回收乙醇并浓缩至相对密度1.15(80℃),将上述二种浸膏合并后再加入人参细粉混合均匀得到益心舒干膏,备用。
(2)益心舒干膏粉碎过100目筛,蔗糖粉碎过80目筛,备用。
(3)将二氧化硅40g、硬脂酸镁25g、羧甲淀粉钠90g、益心舒干膏粉50g混合均匀,备用。
(4)按上述益心舒干膏粉用75%的乙醇一步制粒,在70℃条件下烘干,整粒,再加入1%-1.5%硬脂酸镁得到的原辅料混合均匀,压片得到所述的益心舒片。
实施例3
处方:1800g人参、1600g麦冬、1100g五味子、1400g黄芪、2200g丹参、1100g川芎、1300g山楂
制备方法:(1)以上七味,取1800g人参粉碎细粉后备用。1100g五味子、2200g丹参用85%的乙醇回流提取2次,第一次加85%乙醇6倍量,回流提取3小时,第二次加85%乙醇5倍量,回流提取1.5小时,滤过,合并滤液,减压浓缩至相对密度1.15~1.12(20℃),得醇浸膏。再将1600g麦冬、1400g黄芪、1100g川芎和1300g山楂加水煎煮2次,第一次加水10倍量(重量),煎煮2.5小时,第二次加水8倍量,煎煮1.5小时,合并煎液,滤过,滤液浓缩至3500ml,加入等量的85%乙醇,充分搅拌后,静置过夜,滤去沉淀物,滤液回收乙醇并浓缩至相对密度1.15(80℃),将上述二种浸膏合并后再加入人参细粉混合均匀得到益心舒干膏,备用。
(2)益心舒干膏粉碎过100目筛,蔗糖粉碎过80目筛,备用。
(3)将二氧化硅40g、硬脂酸镁25g、羧甲淀粉钠90g、益心舒干膏粉50g混合均匀,备用。
(4)按上述益心舒干膏粉用75%的乙醇一步制粒,在70℃条件下烘干,整粒,再加入1%-1.5%硬脂酸镁得到的原辅料混合均匀,压片得到所述的益心舒片。
Claims (3)
1.一种益心舒片,以10000片计,由益心舒干膏及其辅料压片制成,其特征在于:所述的益心舒干膏是以200~280重量份人参、200~250重量份麦冬、100~135重量份五味子、140~200重量份黄芪、200~300重量份丹参、100~180重量份川芎、180~250重量份山楂为原料提取而成的;
2.根据权利要求1所述的一种益心舒片,所述的益心舒干膏的制备方法如下:
(1)将人参粉碎后得到人参细粉,备用;
(2)将五味子、丹参用70~85%的乙醇回流提取2次,得到的提取液滤过,合并后减压浓缩至密度为1.15~1.12得到醇浸膏A;
(3)将麦冬、黄芪、川芎和山楂用水煎煮2次,合并煎液,滤过,滤液浓缩至原体积的10~12%,再加入95%的乙醇,充分搅拌后,静置过夜,滤去沉淀物,滤液回收乙醇并浓缩至相对密度1.15~1.25,得到浸膏B;
(4)将醇浸膏A和浸膏B合并后加入步骤(1)得到的人参细粉后混匀得到所述的益心舒干膏。
3.根据权利要求1或2所述的益心舒片的制备方法,包括以下步骤:
(1)取处方量的益心舒干膏粉碎过100目筛,加入适量淀粉充分混匀、备用;
(2)将二氧化硅、羧甲淀粉钠、1~5%重量的益心舒干膏粉采用等量递增法混合均匀,得到原辅料;
(3)按上述原辅料用75%的乙醇一步制粒,在70℃条件下烘干,整粒,再加入1%-1.5%硬脂酸镁得到的原辅料混合均匀,压片得到所述的益心舒片。
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