CN1724027A - 治疗肠道疾病的中药制剂及其制备方法 - Google Patents
治疗肠道疾病的中药制剂及其制备方法 Download PDFInfo
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- CN1724027A CN1724027A CN 200510031812 CN200510031812A CN1724027A CN 1724027 A CN1724027 A CN 1724027A CN 200510031812 CN200510031812 CN 200510031812 CN 200510031812 A CN200510031812 A CN 200510031812A CN 1724027 A CN1724027 A CN 1724027A
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Abstract
本发明公开了一种治疗肠道疾病的中药制剂及其制备方法，它是主要组成成分为盐酸小檗碱、木香、吴茱萸、白芍的复方黄连素滴丸或微丸或分散片或颗粒或胶囊或软胶囊。本发明的制备方法是：取部分木香药材与吴茱萸粉碎成细粉，过筛；未通过筛的粗粉与白芍和剩余的木香混匀，用乙醇作溶剂进行渗漉，收集漉液，漉液回收乙醇并浓缩成稠膏，加入上述细粉，混匀，干燥，粉碎，加入盐酸小檗碱，混匀，加入适量辅料，制成滴丸或微丸或分散片或颗粒或胶囊或软胶囊。本发明的优点是生物利用度高、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，尤其涉及一种治疗肠道疾病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颗粒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，已列入国家药典标准。
现有治疗肠道疾病的中药制剂复方黄连素片的工艺技术特点是取部分木香药材与吴茱萸粉碎成细粉，过筛，未通过筛的粗粉与白芍和剩余的木香混匀，照流浸膏与浸膏项下的渗漉法，用乙醇作溶剂进行渗漉，收集漉液，漉液回收乙醇并浓缩成稠膏，加入上述细粉，混匀，干燥，粉碎，加入盐酸小檗碱，混匀，制成颗粒，干燥，压制成1000片，包糖衣，即得。
现有的一种治疗肠道疾病的中药制剂复方黄连素片存在崩解时限长、糖尿病患者不能使用、生物利用度低、易起斑、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治疗肠道疾病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。
治疗肠道疾病的中药制剂，它是主要成分为盐酸小檗碱、木香、吴茱萸、白芍的复方黄连素滴丸或微丸或分散片或颗粒或胶囊或软胶囊。
其制备方法是：
(1)药物组成成分及其重量百分比如下：盐酸小檗碱5～15％，木香28～40％，吴茱萸8～15％，白芍40～50％；药物组成成分最佳重量百分比为：盐酸小檗碱8.6％，木香33.3％，吴茱萸11.5％，白芍46.6％；
(2)取木香重量百分比的50～80％与吴茱萸粉碎成细粉，过筛，细粉和未过筛的粗粉分器贮藏，备用；
(3)取(2)所得的未过筛的粗粉与白芍及剩余的木香混匀，用60～80％乙醇作溶剂进行渗漉，收集渗漉液，回收乙醇并浓缩成稠膏，备用；
(4)取(3)所得稠膏加入(2)所得细粉，混匀，干燥，粉碎，得混合细粉，备用；
(5)取(4)所得混合细粉加入盐酸小檗碱，混匀，得混合药粉，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；
(7)取(5)所得的混合药粉，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；
辅料为下列物料的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)所得混合药粉，加入适量辅料，混匀，制粒，干燥，整粒，包衣或不包衣，即制成颗粒；
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：甜菊糖、蛋白糖、木糖醇、高果糖、甜蜜素、β-环糊精、糊精、乳糖、糖精钠；
(9)其分散片的制备方法是：取(5)所得混合药粉，加入适量辅料，混合均匀，制粒、干燥、整粒后，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；
(10)取(5)所得混合药粉，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；
(11)取(5)所得混合药粉，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：
一种治疗肠道疾病的中药制剂，它是主要成分为盐酸小檗碱、木香、吴茱萸、白芍的复方黄连素滴丸或微丸或分散片或颗粒或胶囊或软胶囊。
本发明的中药制剂主要用于大肠湿热，赤白下痢，里急后重或暴注下泻，肛门灼热；肠炎、痢疾见上述证候者。
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：
盐酸小檗碱30g，木香116g，吴茱萸40g，白芍162g；
(2)取木香80g与吴茱萸粉碎成细粉，过筛，细粉和未过筛的粗粉分器贮藏，备用；
(3)取(2)所得的未过筛的粗粉与白芍及剩余的木香混匀，用70％乙醇作溶剂进行渗漉，收集渗漉液，漉液回收乙醇并浓缩成稠膏，备用；
(4)取(3)所得稠膏加入(2)所得细粉，混匀，干燥，粉碎，得混合细粉，备用；
(5)取(4)所得混合细粉加入盐酸小檗碱，混匀，得混合药粉，备用；
(6)治疗肠道疾病的中药制剂滴丸是复方黄连素滴丸，其制备方法是：取聚乙二醇PEG6000 100g、硬脂酸30g、Poloxamer188 15g，待聚乙二醇PEG6000、硬脂酸、Poloxamer188加热至全部熔融后，加入(5)所得混合药粉，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，低温干燥包衣即得。
(7)治疗肠道疾病的中药制剂微丸是复方黄连微丸，其制备方法是：取(5)所得的混合药粉与100g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)治疗肠道疾病的中药制剂颗粒是复方黄连素颗粒，其制备方法是；取(5)所得混合药粉，加入B-环糊精20g，加入低聚乳糖30g充分搅拌，混匀，喷雾干燥，加入1g甜菊糖，制粒，干燥，即得。
(9)治疗肠道疾病的中药制剂分散片是复方黄连素分散片，其制备方法是：取(5)所制得混合药粉，加维膨淀P5000 35g、交联聚维酮INF-10 40g、PEG6000 30g和PEG400020g过100目筛，混合均匀，过80目筛二次，加过100目筛的二氧化硅、硬脂酸镁，混合均匀，过80目筛二次，压片即得。
(10)治疗肠道疾病的中药制剂胶囊是复方黄连素胶囊，其制备方法是取(5)所得混合药粉，加入微粉硅胶，淀粉等适量，制料、干燥、整粒后，灌入空心胶囊，即得。
(11)治疗肠道疾病的中药制剂软胶囊是复方黄连素软胶囊，其制备方法是：取(5)所得混合药粉，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：
生物利用度高、可控性和稳定性好，有利于提高疗效。
Claims (3)
1、一种治疗肠道疾病的中药制剂，其特征在于它是主要成分为盐酸小檗碱、木香、吴茱萸、白芍的复方黄连素滴丸或微丸或分散片或颗粒或胶囊或软胶囊。
2、一种治疗肠道疾病的中药制剂的制备方法，它是复方黄连素滴丸或微丸或分散片或颗粒或胶囊或软胶囊的制备方法，其特征在于：
(1)药物组成成分及其重量百分比如下：
盐酸小檗碱5～15％，木香30～35％，吴茱萸8～15％，白芍40～50％；
(2)取木香重量百分比的50～80％与吴茱萸粉碎成细粉，过筛，细粉和未过筛的粗粉分器贮藏，备用；
(3)取(2)所得的未过筛的粗粉与白芍及剩余的木香混匀，用60～80％乙醇作溶剂进行渗漉，收集渗漉液，回收乙醇并浓缩成稠膏，备用；
(4)取(3)所得稠膏加入(2)所得细粉，混匀，干燥，粉碎，得混合细粉，备用；
(5)取(4)所得混合细粉加入盐酸小檗碱，混匀，得混合药粉，加入适量辅料后，制成滴丸或微丸或颗粒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；
其微丸的制备方法是：取(5)所得的混合药粉，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；
辅料为下列物料的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；
其颗粒的制备方法是：取(5)所得混合药粉，加入适量辅料，混匀，制粒，干燥，整粒，包衣或不包衣，即得；
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：甜菊糖、蛋白糖、木糖醇、高果糖、甜蜜素、β-环糊精、糊精、乳糖、糖精钠；
其分散片的制备方法是：取(5)所得混合药粉，加入适量辅料，混合均匀，制粒、干燥、整粒后，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；
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；
软胶囊的制备方法是：取(5)所得混合药粉，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所述的一种治疗肠道疾病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：
盐酸小檗碱8.6％，木香33.3％，吴茱萸11.5％，白芍46.6％。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103652950A (zh) * | 2013-12-31 | 2014-03-26 | 陈慧婷 | 一种薏苡仁大枣分散片及制备方法 |
| CN108186584A (zh) * | 2017-06-19 | 2018-06-22 | 湖南中和制药有限公司 | 肠康片及其制备工艺 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103652950A (zh) * | 2013-12-31 | 2014-03-26 | 陈慧婷 | 一种薏苡仁大枣分散片及制备方法 |
| CN103652950B (zh) * | 2013-12-31 | 2015-04-22 | 陈慧婷 | 一种薏苡仁大枣分散片及制备方法 |
| CN108186584A (zh) * | 2017-06-19 | 2018-06-22 | 湖南中和制药有限公司 | 肠康片及其制备工艺 |
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