CN110051758A - 一种射干抗病毒口服制剂及其制备方法 - Google Patents
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Abstract
一种射干抗病毒口服制剂及其制备方法，其原料药组成为：射干4500～5500重量份，金银花3500～4500重量份，板蓝根3500～4500重量份，佩兰2500～3500重量份，大青叶2500～3500重量份，蒲公英2000～3000重量份，茵陈1500～2500重量份，柴胡1000～2000重量份。本发明采用蒸馏提取、煎煮提取相结合的方法将上述药物的主要药效成分提取出来，并加入相应的辅料按已有口服制剂的方法制备成相应的口服制剂。避免了注射给药首过效应、患者疼痛等不良反应多的缺陷，而且服用方便、无痛苦，特别适于儿童患者接受；经过药效学实验证明，对病毒性感冒疾病治疗具有突出的治疗效果。
Description
技术领域
本发明属于药物制剂技术领域，具体涉及一种射干抗病毒口服制剂及其制备方法。
背景技术
射干抗病毒注射液是以射干、金银花、板蓝根、佩兰、大青叶、蒲公英、茵陈、柴胡等八味主药为主要原料制成的纯中药复方制剂，是一种新型的纯中药抗病毒及抗菌消炎药。射干抗病毒注射液制剂主要用于抗病毒及抗菌消炎，也可与其他药物配合使用治疗流行性出血热早期病症。虽然射干抗病毒注射液已经上市多年，临床应用疗效肯定。但是由于注射剂使用不方便、容易引发患者不良反应，特别是尤为不适用于儿童患者的问题，限制了此品种的推广与使用。
发明内容
本发明的目的在于提供一种射干抗病毒口服制剂及其制备方法，以克服现有射干抗病毒注射液存在的不足。
本发明是通过以下技术方案实现的：
一种射干抗病毒口服制剂，所述制剂原料药组成为：射干4500～5500重量份，金银花3500～4500重量份，板蓝根3500～4500重量份，佩兰2500～3500重量份，大青叶2500～3500重量份，蒲公英2000～3000重量份，茵陈1500～2500重量份，柴胡1000～2000重量份。
所述射干抗病毒口服制剂的制备方法一：
步骤1：取所述重量份的射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶八味药物，投入多功能提取罐内，然后加入药物重量份6-8倍体积份的纯化水，经水蒸汽蒸馏得到初馏液5000-6000体积份，再将初馏液进行重蒸馏，得到精馏液2000-3000体积份，备用；
步骤2：向多功能提取罐内再加入药物重量份6-8倍体积份的纯化水，对蒸馏后的药渣进行煎煮提取2次，每次1小时，将两次提取液滤过合并后，浓缩至相对密度为1.05～1.20(55～70℃)，加乙醇使含醇量达75％，冷藏放置24小时以上，滤过，滤液回收乙醇,再加乙醇至含醇量达85％，冷藏放置24小时以上，滤过，滤液回收乙醇后得到提取液3000-5000体积份，备用；
步骤3：将步骤1得到的精馏液与步骤2得到的提取液合并，混匀,加蔗糖1500-2000重量份，加注射用水3000-5000体积份，再调节pH值至5.0～7.0，混匀，灌封，灭菌，即得射干抗病毒口服液；
所述重量份与体积份的关系为g/mL的关系。
所述射干抗病毒口服制剂的制备方法二：
步骤1：取所述重量份的射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶八味药物，投入多功能提取罐内，然后加入药物重量份6-8倍体积份的纯化水，经水蒸汽蒸馏得到初馏液5000-6000体积份，再将初馏液进行重蒸馏，得到精馏液2000-3000体积份，备用；
步骤2：向多功能提取罐内再加入药物重量份6-8倍体积份的纯化水，对蒸馏后的药渣进行煎煮提取2次，每次1小时，将两次提取液滤过合并后，浓缩至相对密度为1.05～1.20(55～70℃)，加乙醇使含醇量达75％，冷藏放置24小时以上，滤过，滤液回收乙醇,再加乙醇至含醇量达85％，冷藏放置24小时以上，滤过，滤液回收乙醇后得到提取液3000-5000体积份，备用；
步骤3：将步骤1得到的精馏液与步骤2得到的提取液合并，混匀,加入微晶纤维素40-50重量份，制粒，干燥，整粒，加硬脂酸镁，淀粉适量，填充，即得射干抗病毒胶囊；
所述重量份与体积份的关系为g/mL的关系。
本发明与现有射干抗病毒注射液相比，将注射给药改为口服给药，避免了注射给药首过效应、患者疼痛等不良反应多的缺陷，而且服用方便、无痛苦，特别适于儿童患者接受；经过药效学实验证明，对病毒性感冒疾病治疗具有突出的治疗效果。
具体实施方式
1、本发明所述制剂原料药组成为：
配方1：射干5000重量份，金银花4000重量份，板蓝根4000重量份，佩兰3000重量份，大青叶3000重量份，蒲公英2500重量份，茵陈2000重量份，柴胡1500重量份。
配方2：射干4500重量份，金银花4500重量份，板蓝根3500重量份，佩兰3500重量份，大青叶2500重量份，蒲公英3000重量份，茵陈1500重量份，柴胡2000重量份。
配方3：射干5500重量份，金银花3500重量份，板蓝根4500重量份，佩兰2500重量份，大青叶3500重量份，蒲公英2000重量份，茵陈2500重量份，柴胡1000重量份。
2、本发明所述制剂为口服液的制备方法：
步骤1：取所述重量份的射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶八味药物，投入多功能提取罐内，然后加入药物重量份6-8倍体积份的纯化水，经水蒸汽蒸馏得到初馏液5000-6000体积份，再将初馏液进行重蒸馏，得到精馏液2000-3000体积份，备用；
步骤2：向多功能提取罐内再加入药物重量份6-8倍体积份的纯化水，对蒸馏后的药渣进行煎煮提取2次，每次1小时，将两次提取液滤过合并后，浓缩至相对密度为1.05～1.20(55～70℃)，加乙醇使含醇量达75％，冷藏放置24小时以上，滤过，滤液回收乙醇,再加乙醇至含醇量达85％，冷藏放置24小时以上，滤过，滤液回收乙醇后得到提取液3000-5000体积份，备用；
步骤3：将步骤1得到的精馏液与步骤2得到的提取液合并，混匀,加蔗糖1500-2000重量份，加注射用水3000-5000体积份，再调节pH值至5.0～7.0，混匀，灌封，灭菌，即得射干抗病毒口服液；
所述重量份与体积份的关系为g/mL的关系。
3、本发明所述制剂为口服胶囊的制备方法：
步骤1：取所述重量份的射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶八味药物，投入多功能提取罐内，然后加入药物重量份6-8倍体积份的纯化水，经水蒸汽蒸馏得到初馏液5000-6000体积份，再将初馏液进行重蒸馏，得到精馏液2000-3000体积份，备用；
步骤2：向多功能提取罐内再加入药物重量份6-8倍体积份的纯化水，对蒸馏后的药渣进行煎煮提取2次，每次1小时，将两次提取液滤过合并后，浓缩至相对密度为1.05～1.20(55～70℃)，加乙醇使含醇量达75％，冷藏放置24小时以上，滤过，滤液回收乙醇,再加乙醇至含醇量达85％，冷藏放置24小时以上，滤过，滤液回收乙醇后得到提取液3000-5000体积份，备用；
步骤3：将步骤1得到的精馏液与步骤2得到的提取液合并，混匀,加入微晶纤维素40-50重量份，制粒，干燥，整粒，加硬脂酸镁，淀粉调至适量，填充，即得射干抗病毒胶囊；
所述重量份与体积份的关系为g/mL的关系。
本发明采用蒸馏提取、煎煮提取相结合的方法，将射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶中的主要药效成分提取出来，并加入相应的辅料按已有口服制剂的方法制备成相应的口服制剂。当然，所述口服制剂不仅仅包括口服液、口服胶囊，还包括临床上经口服给药的其他剂型。
经药效学实验证明，本发明对多种细菌有不同程度的抑制和杀灭作用，如金黄色葡萄球菌、大肠杆菌、甲乙型链球菌、肺炎球菌、流感嗜血杆菌。对志贺氏痢疾杆菌、伤寒杆菌、副伤寒杆菌、霍乱弧菌、绿脓杆菌、人型结核杆菌、脑膜炎双球菌、流感病毒等有显著抑制作用，特别是可抑制耐药铜绿假单胞菌。对疱疹病毒有一定的延迟作用，能够抑制或延缓鼻病毒、腺病毒、柯萨奇病毒、埃可病毒、疱疹病毒致细胞病变作用。还具有抗内毒素作用以及增强免疫功能和解热作用。
本发明主要功能与主治：抗病毒及抗菌消炎药，也可与其他药物配合使用治疗流行性出血热早期病症。本发明通过口服制剂起到治疗作用，避免了注射剂给药疼痛和不良反应较多的缺点，尤为适用于儿童患者，为本发明的推广与使用创造了良好条件。本发明所述口服液的日用剂量为每次10～20ml，一日3次；所述口服胶囊的日用剂量为一次2～4粒，一日3次。
上述实施例，只是本发明的较佳实施例，并非用来限制本发明的实施范围，故凡以本发明权利要求所述内容所做的等同变化，均应包括在本发明权利要求范围之内。
Claims (3)
1.一种射干抗病毒口服制剂，其特征是所述制剂原料药组成为：射干4500～5500重量份，金银花3500～4500重量份，板蓝根3500～4500重量份，佩兰2500～3500重量份，大青叶2500～3500重量份，蒲公英2000～3000重量份，茵陈1500～2500重量份，柴胡1000～2000重量份。
2.一种权利要求1所述射干抗病毒口服制剂的制备方法，其特征是：
步骤1：取所述重量份的射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶八味药物，投入多功能提取罐内，然后加入药物重量份6-8倍体积份的纯化水，经水蒸汽蒸馏得到初馏液5000-6000体积份，再将初馏液进行重蒸馏，得到精馏液2000-3000体积份，备用；
步骤2：向多功能提取罐内再加入药物重量份6-8倍体积份的纯化水，对蒸馏后的药渣进行煎煮提取2次，每次1小时，将两次提取液滤过合并后，浓缩至相对密度为1.05～1.20(55～70℃)，加乙醇使含醇量达75％，冷藏放置24小时以上，滤过，滤液回收乙醇,再加乙醇至含醇量达85％，冷藏放置24小时以上，滤过，滤液回收乙醇后得到提取液3000-5000体积份，备用；
步骤3：将步骤1得到的精馏液与步骤2得到的提取液合并，混匀,加蔗糖1500-2000重量份，加注射用水3000-5000体积份，再调节pH值至5.0～7.0，混匀，灌封，灭菌，即得射干抗病毒口服液；
所述重量份与体积份的关系为g/mL的关系。
3.一种权利要求1所述射干抗病毒口服制剂的制备方法，其特征是：
步骤1：取所述重量份的射干、金银花、佩兰、蒲公英、柴胡、茵陈、板蓝根、大青叶八味药物，投入多功能提取罐内，然后加入药物重量份6-8倍体积份的纯化水，经水蒸汽蒸馏得到初馏液5000-6000体积份，再将初馏液进行重蒸馏，得到精馏液2000-3000体积份，备用；
步骤2：向多功能提取罐内再加入药物重量份6-8倍体积份的纯化水，对蒸馏后的药渣进行煎煮提取2次，每次1小时，将两次提取液滤过合并后，浓缩至相对密度为1.05～1.20(55～70℃)，加乙醇使含醇量达75％，冷藏放置24小时以上，滤过，滤液回收乙醇,再加乙醇至含醇量达85％，冷藏放置24小时以上，滤过，滤液回收乙醇后得到提取液3000-5000体积份，备用；
步骤3：将步骤1得到的精馏液与步骤2得到的提取液合并，混匀,加入微晶纤维素40-50重量份，制粒，干燥，整粒，加硬脂酸镁，淀粉适量，填充，即得射干抗病毒胶囊；
所述重量份与体积份的关系为g/mL的关系。
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101181439A (zh) * | 2007-11-19 | 2008-05-21 | 北京诚创康韵医药科技有限公司 | 一种抗病毒和抗菌口服液及其制备方法 |
| US20090060879A1 (en) * | 2007-09-04 | 2009-03-05 | The Procter & Gamble Company | Oral Compositions, Products and Methods Of Use |
| CN101422539A (zh) * | 2007-11-02 | 2009-05-06 | 天津瑞普生物技术集团有限公司 | 一种用于治疗畜禽病毒细菌混合感染的中药口服液 |
| CN106474288A (zh) * | 2016-11-25 | 2017-03-08 | 威海恒基伟业信息科技发展有限公司 | 射干抗病毒注射液、其制备方法及静脉给药射干抗病毒注射液 |
-
2019
- 2019-05-20 CN CN201910419882.8A patent/CN110051758A/zh active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090060879A1 (en) * | 2007-09-04 | 2009-03-05 | The Procter & Gamble Company | Oral Compositions, Products and Methods Of Use |
| CN101422539A (zh) * | 2007-11-02 | 2009-05-06 | 天津瑞普生物技术集团有限公司 | 一种用于治疗畜禽病毒细菌混合感染的中药口服液 |
| CN101181439A (zh) * | 2007-11-19 | 2008-05-21 | 北京诚创康韵医药科技有限公司 | 一种抗病毒和抗菌口服液及其制备方法 |
| CN106474288A (zh) * | 2016-11-25 | 2017-03-08 | 威海恒基伟业信息科技发展有限公司 | 射干抗病毒注射液、其制备方法及静脉给药射干抗病毒注射液 |
Non-Patent Citations (1)
| Title |
|---|
| 贾佳 等: "射干抗病毒口服液的质量控制研究", 《中国药业》 * |
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