CN107456480A - 一种苦参提取物肠溶微丸的制备工艺 - Google Patents
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Abstract
本发明公开了一种苦参提取物肠溶微丸的制备工艺，主要是将中药苦参提取浓缩，再将大孔树脂进行处理。将制得的苦参提取浓缩液与大孔树脂进行混合均匀并干燥，得到肠溶微丸的丸心。将此丸心用丙烯酸树脂进行流化床包衣，再行干燥，即可得到苦参提取物肠溶微丸。本发明制备的苦参提取物肠溶微丸，可以避免苦参的苦寒对胃气的伤害，同时增加了其有效成分在肠道的浓度。本法制备苦参肠溶微丸工艺简洁，具有很大的经济价值。
Description
技术领域
本发明“一种苦参提取物肠溶微丸的制备工艺”属于中药制剂领域，尤其属于中药肠溶微丸制剂领域。
背景技术
传统的中药口服制剂，如丸剂、散剂、颗粒剂、片剂、胶囊剂及液体制剂等，大多在胃内崩解或溶解，对胃粘膜有刺激性，影响到患者的胃口等。尤其是苦参等药性寒凉的中药，久服有伤胃气，影响脾胃功能，使人的正气受到伤害。此外，胃液中的盐酸也常常会对药物的有效成分起到破坏的作用，从而影响到药物的疗效。肠道是药物吸收的主要部位。肠道感染时，尤其需要有足够浓度的药物或中药的有效成分作用于病灶局部，既提高了疗效，减少了副作用的发生，也降低了药物的用量。因此，中药药性寒凉和对上消化道有刺激性的药物，非常适合制备成肠溶制剂。特别是治疗腹泻等下消化道感染时，肠溶制剂能发挥更好的疗效。
发明内容
本发明“一种苦参提取物肠溶微丸的制备工艺”，其特征在于：将苦参饮片倒入5~10倍重量的沸水中，保持沸腾5~15分钟，趁热用200~300目筛网保温过滤，所得滤液1备用。得到的药渣再加入5~10倍重量的水煎煮两次，每次煮沸后保持沸腾30~60分钟，趁热过滤，分别得到滤液2与滤液3。合并滤液1、滤液2及滤液3，将此三次滤液60~75℃减压浓缩至相对密度为1.05~1.10的浓缩液。另一方面，将大孔树脂加入5~10倍重量的去离子水中，于50~60℃保温浸泡12~24小时，时时搅拌，每2~4小时换一次水。最后一次换水后，将沥干水分的大孔树脂再加入5~10倍重量的60% ~80% 食用酒精中，于室温浸泡2~3次，每次浸泡2~4小时。将经酒精浸泡处理后的大孔树脂置真空旋转蒸发干燥器中回收酒精，再将回收了酒精的大孔树脂转移到真空干燥箱中于50~80℃减压干燥4~8小时，过40~80目筛，去细粉，得到经处理后的大孔树脂颗粒。以此大孔树脂为肠溶微丸的丸心，将前述苦参提取浓缩液按重量比取1~3份，与前述处理后的大孔树脂按重量比7~9份充分混合均匀， 50~60℃减压干燥8~24小时，得到含药大孔树脂。将此含药大孔树脂作为肠溶微丸的丸心，用流化床包衣法包上含药大孔树脂丸心重量3%~10%的丙烯酸树脂II，干燥即得成品。
苦参有清热燥湿，杀虫，利尿的作用。临床常用于热痢、便血、黄疸尿闭、赤白带下、湿疹等。其药性甚为苦寒，口服对脾胃功能有伤害，服药的顺应性不佳。将其制备成肠溶微丸，使其只在肠道的pH环境下才崩解、释放，解决了其苦寒伤胃气的弊端，减少了其苦味对口腔粘膜的不适感，同时，也提高了其有效成分在肠道部位作用和吸收的浓度，增加了其清下焦湿热的功能。
具体实施方式
实施例1
将苦参饮片倒入8倍重量的沸水中，保持沸腾10分钟，趁热用200目筛网保温过滤，所得滤液备用。药渣再加入5倍重量的水煎煮两次，每次煮沸后保持沸腾60分钟，趁热过滤。合并三次滤液，将其减压浓缩至相对密度为1.05的浓缩液。另一方面，将大孔树脂加入8倍重量的去离子水中，于50℃保温浸泡12小时，时时搅拌，每2小时换一次水。将沥干水分的大孔树脂再加入5倍重量的60% 食用酒精，于室温浸泡2次，每次浸泡2小时。将经酒精浸泡处理后的大孔树脂置真空旋转蒸发干燥器中回收酒精后，再转移到真空干燥箱中于50℃减压干燥6小时，过60目筛去细粉，得到处理后的大孔树脂颗粒。将前述的苦参提取浓缩液2份，与处理后的大孔树脂颗粒8份充分混合均匀， 55℃减压干燥12小时，得到含药大孔树脂丸心。将此含药大孔树脂丸心用流化床包衣法包上含药树脂丸心重量3%~10%的丙烯酸树脂II，干燥即得成品。
实施例2
将苦参饮片倒入10倍重量的沸水中，保持沸腾30分钟，趁热用300目筛网保温过滤，所得滤液备用。药渣再加入8倍重量的水煎煮两次，每次煮沸后保持沸腾30分钟，趁热过滤。合并三次滤液，将其减压浓缩至相对密度为1.10的浓缩液。另一方面，将大孔树脂加入10倍重量的去离子水中，于60℃保温浸泡24小时，时时搅拌，每4小时换一次水。将沥干水分的大孔树脂再加入8倍重量的80% 食用酒精，于室温浸泡3次，每次浸泡4小时。将经酒精浸泡处理后的大孔树脂置真空旋转蒸发干燥器中回收酒精后，再转移到真空干燥箱中于60℃减压干燥8小时，过80目筛去细粉，得到处理后的大孔树脂颗粒。将前述的苦参提取浓缩液3份，与处理后的大孔树脂颗粒7份充分混合均匀， 55℃减压干燥24小时，得到含药大孔树脂丸心。将此含药大孔树脂丸心用流化床包衣法包上含药树脂丸心重量3%~10%的丙烯酸树脂II，干燥即得成品。
Claims (3)
1.一种苦参提取物肠溶微丸的制备工艺，其特征在于：将苦参饮片倒入5~10倍重量的沸水中，保持沸腾5~15分钟，趁热用200~300目筛网保温过滤，所得滤液1备用；药渣再加入5~10倍重量的水煎煮两次，每次煮沸后保持沸腾30~60分钟，趁热过滤，分别得到滤液2与滤液3；合并滤液1、滤液2及滤液3，将此三次滤液减压浓缩至相对密度为1.05~1.10的浓缩液。
2.根据权利要求1所述的一种苦参提取物肠溶微丸的制备工艺，其特征在于：将大孔树脂加入5~10倍重量的去离子水中，于50~60℃保温浸泡12~24小时，每2~4小时换一次水，将沥干水分的大孔树脂再加入5~10倍重量的60% ~80% 食用酒精，于室温浸泡2~3次，每次浸泡2~4小时，将经酒精浸泡处理后的大孔树脂置真空旋转蒸发干燥器中回收酒精后，再转移到真空干燥箱中于50~60℃减压干燥4~8小时，过60~80目筛去细粉，得到处理后的大孔树脂颗粒。
3.根据权利要求1所述的一种苦参提取物肠溶微丸的制备工艺，其特征在于：将权利要求1中的苦参提取浓缩液1~3份，与权利要求2中经处理后的大孔树脂7~9份充分混合均匀，50~60℃减压干燥8~24小时，得到含药大孔树脂丸心，将此含药大孔树脂丸心用流化床包衣法包上含药大孔树脂丸心重量3%~10%的丙烯酸树脂II，干燥即得成品。
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| CN1813899A (zh) * | 2005-12-02 | 2006-08-09 | 王衡新 | 一种抗癌的中药制剂及其制备方法 |
| CN101036684A (zh) * | 2006-03-15 | 2007-09-19 | 上海医药工业研究院 | 一种板蓝根提取物及其提纯方法和药物组合物 |
| CN102178709A (zh) * | 2011-04-11 | 2011-09-14 | 黑龙江大学 | 榛叶提取物的微丸及其制备方法 |
| CN107158063A (zh) * | 2017-05-11 | 2017-09-15 | 临沂大学 | 一种利用金银花有效部位组合物制成的肠溶微丸及其制备方法 |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1813899A (zh) * | 2005-12-02 | 2006-08-09 | 王衡新 | 一种抗癌的中药制剂及其制备方法 |
| CN101036684A (zh) * | 2006-03-15 | 2007-09-19 | 上海医药工业研究院 | 一种板蓝根提取物及其提纯方法和药物组合物 |
| CN102178709A (zh) * | 2011-04-11 | 2011-09-14 | 黑龙江大学 | 榛叶提取物的微丸及其制备方法 |
| CN107158063A (zh) * | 2017-05-11 | 2017-09-15 | 临沂大学 | 一种利用金银花有效部位组合物制成的肠溶微丸及其制备方法 |
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