CN1709369A - 温中健脾的中药制剂及其制备方法 - Google Patents
温中健脾的中药制剂及其制备方法 Download PDFInfo
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- CN1709369A CN1709369A CN 200510031820 CN200510031820A CN1709369A CN 1709369 A CN1709369 A CN 1709369A CN 200510031820 CN200510031820 CN 200510031820 CN 200510031820 A CN200510031820 A CN 200510031820A CN 1709369 A CN1709369 A CN 1709369A
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- Medicinal Preparation (AREA)
Abstract
本发明公开了一种温中健脾的中药制剂及其制备方法，它是主要组成成分为附子(制)、党参、白术(炒)、干姜、甘草的附子理中滴丸或微丸或分散片或胶囊或软胶囊。本发明的制备方法是：取附子粉碎成细粉，党参、甘草加水煎煮，滤过，滤液浓缩成稠膏；白术、干姜粉碎成粗粉，用乙醇作溶剂，进行渗漉，收集漉液，回收乙醇，浓缩成稠膏；将两种稠膏同细粉混匀，加入适量辅料，制成滴丸或微丸或分散片或胶囊或软胶囊。本发明的优点是携带、服用方便，生物利用度高，可控性和稳定性好，有利于提高疗效。
Description
技术领域：
本发明涉及一种中药制剂及其制备方法，尤其涉及一种温中健脾的中药制剂及其制备方法。
背景技术：
中药制剂中的滴丸或微丸或分散片或胶囊或软胶囊作为一种药物剂型，根据我国药品管理的相关法规，改变剂型作为新药研究管理。本品现有剂型为片剂，已列入国家药品部颁标准。
现有温中健脾的中药制剂附子理中片的工艺技术特点将附子粉碎成细粉；党参、甘草加水煎煮两次，合并煎液，滤过，滤液浓缩成稠膏；白术、干姜粉碎成粗粉，照流浸膏剂与浸膏剂项下的渗漉法，用乙醇作溶剂，进行渗漉，收集漉液，回收乙醇，浓缩成稠膏；将上述粉末与两种稠膏混匀，干燥，粉碎成细粉，用乙醇制粒，加硬脂酸镁，拌匀，压制成片，包糖衣，即得。
现有的温中健脾的中药制剂附子理中片存在崩解时限长、生物利用度低、内在质量不易控制等缺点。
发明内容：
本发明的目的是提供一种温中健脾的中药制剂及其制备方法，克服现有技术的上述弊端，提高产品的质量和疗效，更好地满足医疗的需要。
本发明的目的是通过如下技术方案实现的。
温中健脾的中药制剂，它是主要成分为附子(制)、党参、白术(炒)、干姜、甘草的附子理中滴丸或微丸或分散片或胶囊或软胶囊。
其制备方法是：
(1)药物组成成分及其重量百分比如下：
附子(制)、干姜、甘草各10～20％，党参25～35％，白术(炒)20～30％；
(2)取附子粉碎成细粉，备用；
(3)取党参、甘草加水煎煮1～3次，每次1～3小时，合并煎液，滤过，滤液浓缩成稠膏，备用；
(4)取白术、干姜粉碎成粗粉，用50～70％乙醇作溶剂，进行渗漉，收集漉液，回收乙醇，浓缩成稠膏，备用；
(5)取(2)所得的细粉与(3)和(4)所得的稠膏混匀，干燥，粉碎，得混合药物细粉，备用；
(6)将硬脂酸或单硬脂酸甘油酯或虫蜡或蜂蜡或聚乙二醇(PEG4000或PEG6000)或硬脂酸钠或甘油明胶或聚氧乙烯单硬脂酸酯(S-40)或Poloxamer188的一种或多种或其它适宜的辅料，按任意比例混用，加热至全部熔融后加入(5)所得的混合药物细粉，搅拌均匀后迅速转移至储液瓶中，密闭并保温在70～100℃，在保温条件下由滴丸机滴入液体冷却剂(液体石蜡或甲基硅油或植物油或水或乙醇)中，冷凝固化成丸，将成型的滴丸沥尽并除去冷却剂，干燥包衣即得。
(7)取(5)所得的混合药物细粉，加入适量的辅料，混合均匀，制粒，包衣或不包衣，制成直径小于2.5mm的微丸；
辅料为下列物料中一种或多种组合或其它适宜的辅料，按任意比例混用：乙基纤维素(EC)、聚丙烯聚硅氧烷、蜡类、聚乙二醇(PEG)、硬脂酸、虫胶、丙烯酸树脂、聚乙烯醇、聚乙烯吡咯烷酮(PVP)、甲基纤维素、羟丙基纤维素、丙酸纤维素、丙烯酸树脂水分散体、乙基纤维素伪胶乳、邻苯二甲酸醋酸纤维素(CAP)胶乳、聚苯二甲酸醋酸乙烯脂(PVAP)水分散体、丙二醇、甘油、甘油三醋酸酯、乙酰单甘油酸酯、邻苯二甲酸酯、聚山梨酯80、十二烷基硫酸钠、乳糖、果糖、蔗糖。
(8)取(5)所得混合药物细粉，加入适量辅料，混合均匀，压制成分散片；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料，按任意比例混用：低取代羟丙基纤维素、维澎淀5000、交联聚维酮1NF-10、聚乙二醇类、聚乙烯吡咯烷酮类、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、邻苯二甲酸醋酸纤维素、苯二甲酸羟丙基甲基纤维素、羟甲基乙基纤维素、微晶纤维素、枸橼酸、胆酸、富马酸、琥珀酸、酒石酸、胶性二氧化硅、硬脂酸镁、滑石粉。
(9)取(5)所得混合药物细粉，加入适量辅料，混合均匀，制粒、干燥、整粒，颗粒分装入空心胶囊，即得胶囊；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料，按任意比例混用：乳糖、淀粉、羧甲基淀粉钠、预胶化淀粉、蔗糖、葡萄糖、甘露醇、山梨醇、糖浆、微晶纤维素、甲基纤维素、羧甲基纤维素、乙基纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、羧甲基纤维素钙、硫酸钙、磷酸氢钙、磷酸钙、碳酸钙、轻质氧化镁、滑石粉、微粉硅胶、氢氧化铝、硼酸或氯化钠、糊精、硬脂酸镁、氢化植物油、聚乙二醇。
(10)取(5)所得混合药物细粉，加入适量辅料，混合均匀，压制或滴制成软胶囊；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料，按任意比例混用：PEG400、植物油、芳香烃酯类、甘油、异丙醇、吐温。
具体实施方案：
本发明结合具体实施例进一步说明如下：
一种温中健脾的中药制剂，它是主要成分为附子(制)、党参、白术(炒)、干姜、甘草的附子理中滴丸或微丸或分散片或胶囊或软胶囊。
本发明的中药制剂能温中健脾。用于脾胃虚寒，脘腹冷痛，呕吐泄泻，手足不温。
本发明的中药制剂的制备方法是：
(1)药物组成成分及其重量用量如下：
附子(制)、干姜、甘草各100g，党参200g，白术(炒)150g；
(2)取附子粉碎成细粉，备用；
(3)取党参、甘草加水煎煮两次，每次2小时，合并煎液，滤过，滤液浓缩成稠膏，备用；
(4)取白术、干姜粉碎成粗粉，用60％乙醇作溶剂，进行渗漉，收集漉液，回收乙醇，浓缩成稠膏，备用；
(5)取(2)所得的细粉与(3)和(4)的稠膏混匀，干燥，粉碎，得混合药物细粉，备用；
(6)温中健脾的中药制剂滴丸是附子理中滴丸，其制备方法是：取聚乙二醇PEG6000200g、硬脂酸60g、Poloxamer188 40g，待聚乙二醇PEG6000、硬脂酸、Poloxamer188加热至全部熔融后加入(5)所得的混合药物细粉，搅拌均匀后迅速转移至储液瓶中，密闭并保温在80℃，在保温条件由滴入液体石蜡中，冷凝成丸，将成型的滴丸沥尽并擦除液体石蜡，低温干燥即得。
(7)温中健脾的中药制剂微丸是附子理中微丸，其制备方法是：取(5)所得的混合药物细粉与200g糊精混合均匀，5％PVP醇液为粘合剂，首先制备60目的颗粒作母核，再以5％PVP醇液为粘合剂，加混合药粉放大制成40目的微丸，即得。
(8)温中健脾的中药制剂分散片是附子理中分散片，其制备方法是：取(5)所制得混合药物细粉，加交联聚乙烯基吡咯烷酮24g、低取代羟丙纤维素36g、微晶纤维106g，过100目筛，混合均匀，过80目筛二次，压片即得。
(9)温中健脾的中药制剂胶囊是附子理中胶囊，其制备方法是取(5)所得混合药物细粉，加入微粉硅胶、淀粉等适量，制粒、干燥、整粒后，灌入空心胶囊，即得。
(10)温中健脾的中药制剂软胶囊是附子理中软胶囊，其制备方法是：取(5)所得混合药物细粉，加水制成混悬液，加适量PEG400，混匀，压制或滴制成软胶囊。
本发明的优点是：
携带、服用方便，生物利用度高，可控性和稳定性好，有利于提高疗效。
Claims (3)
1、一种温中健脾的中药制剂，其特征在于它是主要成分为附子(制)、党参、白术(炒)、干姜、甘草的附子理中滴丸或微丸或分散片或胶囊或软胶囊。
2、一种温中健脾的中药制剂的制备方法，它是附子理中滴丸或微丸或分散片或胶囊或软胶囊的的制备方法，其特征在于：
(1)药物组成成分及其重量百分比如下：
附子(制)、干姜、甘草各10～20％，党参25～35％，白术(炒)20～30％；
(2)取附子粉碎成细粉，备用；
(3)取党参、甘草加水煎煮1～3次，每次1～3小时，合并煎液，滤过，滤液浓缩成稠膏，备用；
(4)取白术、干姜粉碎成粗粉，用50～70％乙醇作溶剂，进行渗漉，收集漉液，回收乙醇，浓缩成稠膏，备用；
(5)取(2)所得的细粉与(3)和(4)所得的稠膏混匀，干燥，粉碎，得混合药物细粉，加入适量辅料后，再将其制成滴丸或微丸或分散片或胶囊或软胶囊；
其滴丸的制备方法是：将硬脂酸或单硬脂酸甘油酯或虫蜡或蜂蜡或聚乙二醇(PEG4000或PEG6000)或硬脂酸钠或甘油明胶或聚氧乙烯单硬脂酸酯(S-40)或Poloxamer188的一种或多种或其它适宜的辅料，按任意比例混用，加热至全部熔融后加入(5)所得的混合药物细粉，搅拌均匀后迅速转移至储液瓶中，密闭并保温在70～100℃，在保温条件下由滴丸机滴入液体冷却剂(液体石蜡或甲基硅油或植物油或水或乙醇)中，冷凝固化成丸，将成型的滴丸沥尽并除去冷却剂，干燥，包衣或不包衣，即得；
其微丸的制备方法是：取(5)所得的混合药物细粉，加入适量的辅料，混合均匀，制粒，包衣或不包衣，制成直径小于2.5mm的微丸；
辅料为下列物料中一种或多种组合或其它适宜的辅料，按任意比例混用：乙基纤维素(EC)、聚丙烯聚硅氧烷、蜡类、聚乙二醇(PEG)、硬脂酸、虫胶、丙烯酸树脂、聚乙烯醇、聚乙烯吡咯烷酮(PVP)、甲基纤维素、羟丙基纤维素、丙酸纤维素、丙烯酸树脂水分散体、乙基纤维素伪胶乳、邻苯二甲酸醋酸纤维素(CAP)胶乳、聚苯二甲酸醋酸乙烯脂(PVAP)水分散体、丙二醇、甘油、甘油三醋酸酯、乙酰单甘油酸酯、邻苯二甲酸酯、聚山梨酯80、十二烷基硫酸钠、乳糖、果糖、蔗糖；
其分散片的制备方法是：取(5)所得混合药物细粉，加入适量辅料，混合均匀，压制成分散片；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料，按任意比例混用：低取代羟丙基纤维素、维澎淀5000、交联聚维酮1NF-10、聚乙二醇类、聚乙烯吡咯烷酮类、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、邻苯二甲酸醋酸纤维素、苯二甲酸羟丙基甲基纤维素、羟甲基乙基纤维素、微晶纤维素、枸橼酸、胆酸、富马酸、琥珀酸、酒石酸、胶性二氧化硅、硬脂酸镁、滑石粉；
其胶囊的制备方法是：取(5)所得混合药物细粉，加入适量辅料，混合均匀，制粒、干燥、整粒，颗粒分装入空心胶囊，即得胶囊；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料，按任意比例混用：乳糖、淀粉、羧甲基淀粉钠、预胶化淀粉、蔗糖、葡萄糖、甘露醇、山梨醇、糖浆、微晶纤维素、甲基纤维素、羧甲基纤维素、乙基纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、羧甲基纤维素钙、硫酸钙、磷酸氢钙、磷酸钙、碳酸钙、轻质氧化镁、滑石粉、微粉硅胶、氢氧化铝、硼酸或氯化钠、糊精、硬脂酸镁、氢化植物油、聚乙二醇；
其软胶囊的制备方法是：取(5)所得混合药物细粉，加入适量辅料，混合均匀，压制或滴制成软胶囊；
辅料为下列物料中一种或多种的混合物或其他适宜的辅料，按任意比例混用：
PEG400、植物油、芳香烃酯类、甘油、异丙醇、吐温。
3、根据权利要求2所述的一种温中健脾的中药制剂的制备方法，其特征在于其主要组成成分的最佳重量百分比为：
附子(制)、干姜、甘草各15.4％，党参30.8％，白术(炒)23％。
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103829043A (zh) * | 2012-11-20 | 2014-06-04 | 四川铁骑力士实业有限公司 | 预防仔猪腹泻的中草药添加剂及其制备方法 |
| CN104001137A (zh) * | 2014-06-06 | 2014-08-27 | 济南科纳信息科技有限公司 | 一种治疗腹泻的中药组合物 |
| CN104274547A (zh) * | 2014-10-28 | 2015-01-14 | 贵州黄平美娘冲民族服饰有限公司 | 一种治疗寒湿腹泻的足浴粉 |
| CN108553434A (zh) * | 2018-05-25 | 2018-09-21 | 李红光 | 一种荆芥、生姜、薄荷分散片 |
| CN109260452A (zh) * | 2018-12-14 | 2019-01-25 | 新乡医学院第附属医院 | 一种用于预防胃肠痉挛的中药组合物及其制备方法、口服液和应用 |
| CN113750214A (zh) * | 2021-10-28 | 2021-12-07 | 天津中医药大学 | 一种用于中枢神经损伤合并继发性肺感染中药组合物及其用途 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103829043A (zh) * | 2012-11-20 | 2014-06-04 | 四川铁骑力士实业有限公司 | 预防仔猪腹泻的中草药添加剂及其制备方法 |
| CN104001137A (zh) * | 2014-06-06 | 2014-08-27 | 济南科纳信息科技有限公司 | 一种治疗腹泻的中药组合物 |
| CN104274547A (zh) * | 2014-10-28 | 2015-01-14 | 贵州黄平美娘冲民族服饰有限公司 | 一种治疗寒湿腹泻的足浴粉 |
| CN108553434A (zh) * | 2018-05-25 | 2018-09-21 | 李红光 | 一种荆芥、生姜、薄荷分散片 |
| CN109260452A (zh) * | 2018-12-14 | 2019-01-25 | 新乡医学院第附属医院 | 一种用于预防胃肠痉挛的中药组合物及其制备方法、口服液和应用 |
| CN113750214A (zh) * | 2021-10-28 | 2021-12-07 | 天津中医药大学 | 一种用于中枢神经损伤合并继发性肺感染中药组合物及其用途 |
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