CN114569688A - 一种中华肝灵片及其制备方法 - Google Patents
一种中华肝灵片及其制备方法 Download PDFInfo
- Publication number
- CN114569688A CN114569688A CN202011387221.0A CN202011387221A CN114569688A CN 114569688 A CN114569688 A CN 114569688A CN 202011387221 A CN202011387221 A CN 202011387221A CN 114569688 A CN114569688 A CN 114569688A
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- China
- Prior art keywords
- tablet
- ganling
- zhonghua
- radix
- ginseng
- Prior art date
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- Pending
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- Medicinal Preparation (AREA)
Abstract
本发明公开了一种中华肝灵片及其制备方法,中华肝灵片包括柴胡、糖参、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附、三七、包合剂、粘合剂、润滑剂。本发明以柴胡、厚朴、当归、木香、香附、川芎、鳖甲、郁金、青皮和枳实为原料,采用水进行提取,得到中华肝灵片提取物药液,浓缩后加入包合剂制备包合物,包合物再与糖参、三七细粉和其他辅料制备得到中华肝灵片。本发明的中华肝灵片产品质量稳定性好,患者服用顺应性好,不容易发生裂片,崩解快,生物利用度高。
Description
技术领域
本发明属于中医药领域,具体地说,涉及一种中华肝灵片及其制备方法。
背景技术
中华肝灵片是由柴胡(醋制)、糖参、厚朴(姜制)、三七、当归、木香、香附(醋制)、川芎、鳖甲(醋制)、郁金、青皮(醋制)、枳实(麸炒)12味药材精制而成,具有疏肝健脾、理气止痛、活血化瘀、软坚散结的功效,临床用于肝郁气滞血阻,积聚不消,两胁胀痛,食少便溏,舌有寒斑,脉沉涩无力患者。
申请号为CN01100804.0的中国申请公开了一种纳米中华肝灵制剂药物及其制备方法,是以纳米柴胡、纳米糖参、纳米厚朴、纳米三七、纳米当归、纳米木香、纳米香附、纳米川芎、纳米鳖甲、纳米郁金、纳米青皮、纳米枳实为原料,按比例配制,制成新的药物制剂,其颗粒细度达1200-1500目,粒径为0.1-200nm,其中绝大部分粒径小于100nm,并具有新的物性。采用微波萃取、减压浓缩、超音速射流技术喷雾干燥等步骤制成。上述方案中需要将各原料成分制备成纳米级后再制备成为各种剂型。
目前现有的中华肝灵片剂的制备方法中,都是提取物直接干燥后进行粉碎,然后加糖参和三七细粉混合后再制粒压片。例如,申请号为200910131289.X的中国专利公开了中华肝灵片的制备方法,将十二味原料,柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮二次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时,合并煎液,滤过,滤液浓缩成膏,75℃真空干燥;糖参、三七与所得干膏一起粉碎成细粉,过筛,85%乙醇制粒,干燥,整粒,加入硬脂酸镁,压制成1000片,包薄膜衣,即得。
但现有技术中的制备方法制备的药片在贮藏过程中容易出现裂片、松散等现象,给产品质量带来很大的隐患。另外,中成药由于具有其特有的气味,在一些患者中会出现服用困难的情况,对患者服药的顺应性造成很不好的影响。
为解决目前的问题,特提出本发明。有鉴于此特提出本发明。
发明内容
本发明要解决的技术问题在于克服现有技术的不足,提供一种中华肝灵片及其制备方法。本发明的制备方法制备得到的产品,产品质量稳定性好,不容易吸潮,避免发生裂片,崩解快,生物利用度高。
为解决上述技术问题,本发明采用技术方案的基本构思是:
本发明的第一目的是提供一种中华肝灵片,包括柴胡、糖参、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附、三七、包合剂、粘合剂、润滑剂。
目前现有的中华肝灵片直接由提取的干膏与三七、糖参细粉混合后压片制得,容易吸潮。由于中药提取物都有比较大的粘性,导致吸潮后药物不能快速的崩解,容易裂片、松散,也导致产品在贮藏过程中崩解时限时间延长,降低生物利用度。另外,中华肝灵片药味较重,患者服药的顺应性存在一定的问题。
本发明的中华肝灵片中,添加了包合剂,包合剂可以与浓缩的中华肝灵片提取溶液混合先制备包合物,再与三七、糖参细粉混合,并与其他辅料制备得到中华肝灵片;从而提高中华肝灵片的质量稳定性,避免后续生产过程中的裂片现象,也可以提高中华肝灵片的崩解速度,提高生物利用度。
进一步的方案,所述的中华肝灵片由如下成分制成:
进一步的方案,所述包合剂包括环糊精、环糊精衍生物;优选的,所述包合剂为β环糊精。
优选的方案,所述包合剂的用量为100~150重量份。
进一步的方案,所述粘合剂选自纯化水、乙醇、淀粉浆中的至少一种,优选乙醇;
进一步优选为50%乙醇。
进一步的方案,所述润滑剂选自硬脂酸镁、微粉硅胶、滑石粉中的至少一种,优选硬脂酸镁。
本发明的第二目的是提供一种如上所述的中华肝灵片的制备方法,包括以下步骤:
1)将柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮两次,合并煎液,滤过,滤液浓缩至,趁热加入包合剂进行搅拌,再进行喷雾干燥,得到包合物;
2)糖参、三七粉碎成细粉过筛网,加入到步骤1)所得包合物中,混匀;再加入粘合剂制成软材;过筛制粒,干燥;
3)加入处方量的润滑剂混合,过筛整粒;
4)压片,包薄膜衣,包装。
进一步的方案,步骤1)中,喷雾条件为:进风温度130℃,出风温度80℃,流量2.5ml/min,雾化器转速270rpm。
进一步的方案,步骤1)中,滤液浓缩至相对密度为1.1-1.5;优选1.2。
进一步的方案,步骤1)中,趁热加入包合剂搅拌1-2小时。
进一步的方案,步骤1)中,加水煎煮两次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时。
上述制备方法,采用包合剂与浓缩的提取物混合制备包合物后,再与糖参、三七粉混合,进一步与其他辅料混合制备得到中华肝灵片。该种方式既能够提高中华肝灵片的质量稳定性,不容易吸湿,避免后续生产过程中的裂片现象,也可以提高中华肝灵片的崩解速度,提高生物利用度,制备的药物还无明显的气味,提高了患者服药的顺应性。
采用上述技术方案后,本发明与现有技术相比具有以下有益效果:
1、由于现有技术都是提取物直接干燥后进行粉碎,然后加糖参和三七细粉制成相应的成品,而这样会导致容易吸潮,而因为中药提取物都有比较大的粘性,导致吸潮后药物不能快速的崩解,从而影响药物的生物利用度。本发明的中华肝灵片不容易吸潮,从而能够克服现有技术生物利用度低的不足,产品质量稳定,避免发生裂片,崩解快,生物利用度高。
2、本发明的中华肝灵片的制备方法中添加包合剂,包合剂与除糖参、三七外的原料药材的提取物浓缩液混合制成包合物后再与糖参、三七细粉混合,制得的产品不易吸湿,稳定性好,崩解快,生物利用度高,无不良气味。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将对实施例中的技术方案进行清楚、完整地描述,以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1
本实施例的中华肝灵片的组分及含量如下表1所示:
表1
原辅料 | 重量(g) |
柴胡 | 60 |
糖参 | 40 |
郁金 | 200 |
当归 | 300 |
川芎 | 100 |
鳖甲 | 200 |
木香 | 100 |
厚朴 | 300 |
青皮 | 300 |
枳实 | 300 |
香附 | 200 |
三七 | 40 |
β环糊精 | 100 |
50%乙醇 | 100 |
硬脂酸镁 | 1.5 |
胃溶型薄膜包衣粉 | 6 |
制备方法:
1)以上十二味,柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮二次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时,合并煎液,滤过,滤液浓缩至相对密度1.2,趁热加入β环糊精进行搅拌1小时,再进行喷雾干燥,喷雾条件:进风温度130℃,出风温度80℃,流量2.5ml/min,雾化器转速270,得β环糊精包合物;
2)糖参、三七粉碎成细粉过80目筛网,加入到β环糊精包合物中,混匀;再加入50%乙醇适量制成软材;24目筛制粒,70℃干燥;
3)加入硬脂酸镁混合,用22目筛整粒;
4)压片,包薄膜衣,制成1000片。
实施例2
本实施例的中华肝灵片的组分及含量如下表2所示:
表2
原辅料 | 重量(g) |
柴胡 | 60 |
糖参 | 40 |
郁金 | 200 |
当归 | 300 |
川芎 | 100 |
鳖甲 | 200 |
木香 | 100 |
厚朴 | 300 |
青皮 | 300 |
枳实 | 300 |
香附 | 200 |
三七 | 40 |
β环糊精 | 50 |
50%乙醇 | 100 |
硬脂酸镁 | 1.5 |
胃溶型薄膜包衣液 | 6 |
制备方法:
1)以上十二味,柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮二次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时,合并煎液,滤过,滤液浓缩至相对密度1.2,趁热加入β环糊精进行搅拌1小时,再进行喷雾干燥,喷雾条件:进风温度130℃,出风温度80℃,流量2.5ml/min,雾化器转速270,得β环糊精包合物;
2)糖参、三七粉碎成细粉过80目筛网,加入到β环糊精包合物中,混匀;再加入50%乙醇适量制成软材;24目筛制粒,70℃干燥;
3)加入硬脂酸镁混合,用22目筛整粒;
4)压片,包薄膜衣,制成1000片。
实施例3
本实施例的中华肝灵片的组分及含量如下表3所示:
表3
原辅料 | 重量(g) |
柴胡 | 60 |
糖参 | 40 |
郁金 | 200 |
当归 | 300 |
川芎 | 100 |
鳖甲 | 200 |
木香 | 100 |
厚朴 | 300 |
青皮 | 300 |
枳实 | 300 |
香附 | 200 |
三七 | 40 |
β环糊精 | 150 |
50%乙醇 | 100 |
硬脂酸镁 | 1.5 |
胃溶型薄膜包衣液 | 6 |
制备方法:
1)以上十二味,柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮二次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时,合并煎液,滤过,滤液浓缩至相对密度1.2,趁热加入β环糊精进行搅拌1小时,再进行喷雾干燥,喷雾条件:进风温度130℃,出风温度80℃,流量2.5ml/min,雾化器转速270,得β环糊精包合物;
2)糖参、三七粉碎成细粉过80目筛网,加入到β环糊精包合物中,混匀;再加入50%乙醇适量制成软材;24目筛制粒,70℃干燥;
3)加入硬脂酸镁混合,用22目筛整粒;
4)压片,包薄膜衣,制成1000片。
实施例4
本实施例的中华肝灵片的组分及含量如下表4所示:
表4
制备方法:
1)以上十二味,柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮二次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时,合并煎液,滤过,滤液浓缩至相对密度1.2,趁热加入β环糊精进行搅拌1小时,再进行喷雾干燥,喷雾条件:进风温度130℃,出风温度80℃,流量2.5ml/min,雾化器转速270,得β环糊精包合物;
2)糖参、三七粉碎成细粉过80目筛网,加入到β环糊精包合物中,混匀;再加入纯化水适量制成软材;24目筛制粒,70℃干燥;
3)加入硬脂酸镁混合,用22目筛整粒;
4)压片,包薄膜衣,制成1000片。
对比例1
如申请号为200910131289.X的实施例1所示,现有技术中华肝灵片的制备方法如下:
原料:
表5
原辅料 | 重量(g) |
柴胡 | 60 |
糖参 | 40 |
郁金 | 200 |
当归 | 300 |
川芎 | 100 |
鳖甲 | 200 |
木香 | 100 |
厚朴 | 300 |
青皮 | 300 |
枳实 | 300 |
香附 | 200 |
三七 | 40 |
制备方法:
以上十二味,柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮二次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时,合并煎液,滤过,滤液浓缩成膏,75℃真空干燥;糖参、三七与所得干膏一起粉碎成细粉,过筛,85%乙醇制粒,干燥,整粒,加入硬脂酸镁,压制成1000片,包薄膜衣,即得。
试验例1崩解时限
分别取对比例1中和本申请实施例1-4的方法制备的中华肝灵片,按照崩解时限检查法(中国药典2015年版四部0921),分别测定不同制备方法制得的中华肝灵片的崩解时限,结果如以下表6所示。
表6
实验组 | 崩解时限(分钟) |
对比例1 | 35 |
实施例1 | 10 |
实施例2 | 15 |
实施例3 | 12 |
实施例4 | 13 |
上表中的结果说明,与对比例1相比,本申请实施例1-4中添加了包合剂的中华肝灵片,崩解速度更快。其中,实施例1的中华肝灵片的崩解速度更快。
试验例2吸湿性考察
在相对湿度75%±5%和90%±5%条件下,分别对对比例1的中华肝灵片和以本发明实施例1-4的方法制备得到的中华肝灵片进行吸湿性考察,结果如下表7所示。
表7
上表中的结果说明,与对比例1相比,本申请实施例1-4中添加了包合剂的中华肝灵片,更不容易吸潮。其中,实施例1的产品更不容易吸潮。
试验例3稳定性考察加速试验
按照《中国药典》2015年版四部附录9001原料药物与制剂稳定性试验指导原则的规定,分别对对比例1制备的中华肝灵片和本发明的实施例1的方法制备的中华肝灵片进行稳定性考察。加速试验条件:温度40℃±2℃,相对湿度75%±5%;具体结果如下表8所示。
表8
上表中的结果说明,与对比例1相比,本申请实施例1中添加了包合剂的中华肝灵片,质量更稳定,试验6个月后,崩解时限、橙皮苷含量及水分等均无明显变化。
对本发明其它实施例所制得的中华肝灵片也进行了上述试验,其获得的结果相似。
试验例4稳定性考察长期试验
按照《中国药典》2015年版四部附录9001原料药物与制剂稳定性试验指导原则的规定,分别对对比例1制备的中华肝灵片和本发明的实施例1的方法制备的中华肝灵片进行稳定性考察。长期试验条件:25℃±2℃,相对湿度60%±10%;具体结果如下表9所示。
表9
上表中的结果说明,与对比例1相比,本申请实施例1中添加了包合剂的中华肝灵片,质量更稳定,试验6个月后,崩解时限、橙皮苷含量及水分等均无明显变化。
对本发明其它实施例所制得的中华肝灵片也进行了上述试验,其获得的结果相似。
试验例5气味考察
分别将对比例1制备的中华肝灵片和本发明实施例1-4制备的中华肝灵片进行气味考察。结果如下表10所示。
表10
上表中的结果说明,与对比例1相比,本申请实施例1-4中添加了包合剂的中华肝灵片,均无明显气味,可以提高患者服药的顺应性。
以上所述仅是本发明的较佳实施例而已,并非对本发明作任何形式上的限制,虽然本发明已以较佳实施例揭露如上,然而并非用以限定本发明,任何熟悉本专利的技术人员在不脱离本发明技术方案范围内,当可利用上述提示的技术内容作出些许更动或修饰为等同变化的等效实施例,但凡是未脱离本发明技术方案的内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰,均仍属于本发明方案的范围内。
Claims (10)
1.一种中华肝灵片,其特征在于,包括柴胡、糖参、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附、三七、包合剂、粘合剂、润滑剂。
3.根据权利要求1或2所述的一种中华肝灵片,其特征在于,所述包合剂包括环糊精、环糊精衍生物;优选的,所述包合剂为β环糊精。
4.根据权利要求1-3任意一项所述的一种中华肝灵片,其特征在于,所述粘合剂选自纯化水、乙醇、淀粉浆中的至少一种,优选乙醇。
5.根据权利要求1-4任意一项所述的一种中华肝灵片,其特征在于,所述润滑剂选自硬脂酸镁、微粉硅胶、滑石粉中的至少一种,优选硬脂酸镁。
6.一种如权利要求1-5任意一项所述的中华肝灵片的制备方法,其特征在于,包括以下步骤:
1)将柴胡、郁金、当归、川芎、鳖甲、木香、厚朴、青皮、枳实、香附加水煎煮两次,合并煎液,滤过,滤液浓缩,趁热加入包合剂进行搅拌,再进行喷雾干燥,得到包合物;
2)糖参、三七粉碎成细粉过筛网,加入到步骤1)所得包合物中,混匀;再加入粘合剂制成软材;过筛制粒,干燥;
3)加入处方量的润滑剂混合,过筛整粒;
4)压片,包薄膜衣,包装。
7.根据权利要求6所述的制备方法,其特征在于,步骤1)中,喷雾条件为:进风温度130℃,出风温度80℃,流量2.5ml/min,雾化器转速270rpm。
8.根据权利要求6所述的制备方法,其特征在于,步骤1)中,滤液浓缩至相对密度为1.1-1.5;优选1.2。
9.根据权利要求6所述的制备方法,其特征在于,步骤1)中,趁热加入包合剂搅拌1-2小时。
10.根据权利要求6-9任意一项所述的制备方法,其特征在于,步骤1)中,加水煎煮两次,第一次加10倍量水煎煮3小时,第二次加8倍量水煎煮2小时。
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