CN1709367A - 治疗痢疾、肠炎的中药制剂及其制备方法 - Google Patents
治疗痢疾、肠炎的中药制剂及其制备方法 Download PDFInfo
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- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
本发明公开了一种治疗痢疾、肠炎的中药制剂及其制备方法，它是主要成分为黄连(吴茱萸制)、木香的香连滴丸或微丸或分散片或颗粒。本发明的制备方法是：取木香蒸馏提取挥发油，水煎液滤过，浓缩至稠膏，干燥，粉碎成细粉；黄连醇提，回收乙醇并浓缩成稠膏，干燥，粉碎成细粉；合并上述两种细粉，加适量辅料，混匀，喷入木香挥发油，制成滴丸或微丸或分散片或颗粒。本发明的优点生物利用度高，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，尤其涉及一种治疗痢疾、肠炎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。
现有治疗痢疾、肠炎的中药制剂香连片的工艺技术特点是取木香蒸馏提取挥发油，收集挥发油，水煎液滤过，浓缩至稠膏状，干燥，粉碎成细粉；黄连用乙醇提取三次，合并提取液，回收乙醇并浓缩成稠膏状，干燥，粉碎成细粉。合并上述两种细粉，加辅料适量，混匀，制成颗粒，干燥，喷加木香挥发油，混匀，压制成片，包糖衣或薄膜衣，即得。
现有的治疗痢疾、肠炎的中药制剂香连片存在崩解时限长、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治疗痢疾、肠炎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。
治疗痢疾、肠炎的中药制剂，它是主要成分为黄连(吴茱萸制)、木香的香连滴丸或微丸或分散片或颗粒。
其制备方法是：
(1)药物组成成分及其重量百分比如下：
黄连(吴茱萸制)70～90％，木香10～30％；
药物组成成分最佳重量百分比为：
黄连(吴茱萸制)80％，木香20％；
(2)取木香用水蒸气蒸馏法提取挥发油，收集挥发油，备用；水煎液滤过，浓缩至稠膏状，干燥，粉碎成细粉，备用；
(3)取黄连用60～80％乙醇于70～85℃提取2～4次，每次1～3小时，合并提取液，回收乙醇并浓缩至稠膏状，干燥，粉碎成细粉，备用；
(4)合并(2)和(3)所得的细粉，混匀，得混合药物细粉，备用；
(5)取(4)所得的混合药物细粉，喷入(2)所得的挥发油，得混合药物，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，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(4)所得的混合药物细粉，加入适量的辅料，混合均匀，制粒，喷入(2)所得的挥发油，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(4)所得混合药物细粉，加入适量辅料，混合均匀，制粒、干燥、整粒后，喷入(2)所得的挥发油，混匀，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(4)所得混合药物细粉，加入适量辅料，混匀，制粒，干燥，整粒，喷入(2)所得的挥发油，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、乙醇、水。
具体实施方案：
本发明结合具体实施例进一步说明如下：
一种治疗痢疾、肠炎的中药制剂，它是主要成分为黄连(吴茱萸制)、木香的香连滴丸或微丸或分散片或颗粒。
本发明的中药制剂主要用于大肠湿热所致的痢疾，症见大便脓血、里急后重、发热腹痛；肠炎、细菌性痢疾见上述证候者。
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：
黄连800g，木香200g；
(2)取木香用水蒸气蒸馏法提取挥发油，收集挥发油，备用；水煎液滤过，浓缩至稠膏状，干燥，粉碎成细粉，备用；
(3)取黄连用70％乙醇于75～80℃提取3次，第一次2小时，第二、三次各1小时，合并提取液，回收乙醇并浓缩至稠膏状，干燥，粉碎成细粉，备用；
(4)合并(2)和(3)所得的细粉，混匀，得混合药物细粉，备用；
(5)取(4)所得的混合药物细粉，喷入(2)所得的挥发油，得混合药物，备用；
(6)治疗痢疾、肠炎的中药制剂滴丸是香连滴丸，其制备方法是：取聚乙二醇PEG6000100g、硬脂酸20g、Poloxamer188 10g，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，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)治疗痢疾、肠炎的中药制剂微丸是香连微丸，其制备方法是：取(4)所得的混合药物细粉与180g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，喷入(2)所得的挥发油，即得。
(8)治疗痢疾、肠炎的中药制剂颗粒是香连颗粒，其制备方法是：取(4)所得混合药物细粉，加入B-环糊精30g，加入低聚乳糖80g充分搅拌，混匀，喷雾干燥，加入1.5g甜菊糖，制粒，干燥，整粒后，喷入(2)所得的挥发油，即得。
(9)治疗痢疾、肠炎的中药制剂分散片是香连分散片，其制备方法是：取(4)所制得混合药物细粉，加维膨淀P5000 80g，交联聚维酮INF-10 30g，PEG600020g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，喷入(2)所得的挥发油，密闭闷润12小时，压片即得。
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、一种治疗痢疾、肠炎的中药制剂，其特征在于它是主要成分为黄连(吴茱萸制)、木香的香连滴丸或微丸或分散片或颗粒。
2、一种治疗痢疾、肠炎的中药制剂的制备方法，它是香连滴丸或微丸或分散片或颗粒的制备方法，其特征在于：
(1)药物组成成分及其重量百分比如下：
黄连(吴茱萸制)70～90％，木香10～30％；
(2)取木香用水蒸气蒸馏法提取挥发油，收集挥发油，备用；水煎液滤过，浓缩至稠膏状，干燥，粉碎成细粉，备用；
(3)取黄连用60～80％乙醇于70～85℃提取2～4次，每次1～3小时，合并提取液，回收乙醇并浓缩至稠膏状，干燥，粉碎成细粉，备用；
(4)合并(2)和(3)所得的细粉，混匀，得混合药物细粉，备用；
(5)取(4)所得的混合药物细粉，喷入(2)所得的挥发油，混匀，得混合药物，加入适量辅料后，再将其制成滴丸或微丸或颗粒或分散片；
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，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(4)所得的混合药物细粉，加入适量的辅料，混合均匀，制粒，喷入(2)所得的挥发油，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(4)所得混合药物细粉，加入适量辅料，混合均匀，制粒、干燥、整粒后，喷入(2)所得的挥发油，混匀，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；
其颗粒的制备方法是：取(4)所得混合药物细粉，加入适量辅料，混匀，制粒，干燥，整粒，喷入(2)所得的挥发油，包衣或不包衣，制成颗粒，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、乙醇、水。
3、根据权利要求2所述的一种治疗痢疾、肠炎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：
黄连(吴茱萸制)80％，木香20％。
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