CN113509533A - 一种桂灵片剂药物组合物及制备方法 - Google Patents
一种桂灵片剂药物组合物及制备方法 Download PDFInfo
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Abstract
本发明涉及中医制药技术领域,具体为一种桂灵片剂药物组合物及制备方法,其中麻黄、罂粟壳、炒苦杏仁、五味子、核桃仁、豆蔻能够收敛肺气,止咳定喘,用于肾虚作喘,肺虚久咳,款冬花、槐花、酸枣仁能够润肺下气,化痰止咳,宁心安神,养肝敛汗,凉血止血,清肝明目,同时治标又治本,预胶化淀粉和聚乙烯吡咯烷酮对片剂有润滑、助流和抗粘附作用,有利于药物成形和促进药物吸收的功能。本发明所述的一种桂灵片剂药物组合物的制备方法采用超微技术将部分中药材进行超微粉碎成5‑50μm细粉,提高了生药有效成份的溶出度,药物溶散时间短,溶出充分,生物利用度高,增强了药物的疗效。
Description
技术领域
本发明涉及中医制药技术领域,具体为一种桂灵片剂药物组合物及制备方法。
背景技术
桂灵片,本品为糖衣片,除去糖衣显棕褐色;气微香,味甘苦。主治收敛肺气,止咳定喘。用于肾虚作喘,肺虚久咳。
发明内容
为了解决上述的问题,本发明提供一种桂灵片剂药物组合物和桂灵片剂药物组合物的制备方法。
本发明解决其技术问题采用以下技术方案来实现:
一种桂灵片剂药物组合物,是由以下重量份数的药物制成的:
麻黄400份、罂粟壳300份、炒苦杏仁200份、五味子200份、核桃仁200份、豆蔻25份、款冬花10-15份、槐花8-14份、酸枣仁10-15份、预胶化淀粉10-30份、聚乙烯吡咯烷酮5-20份。
本发明最佳处方配比为:
麻黄400份、罂粟壳300份、炒苦杏仁200份、五味子200份、核桃仁200份、豆蔻25份、款冬花10份、槐花10份、酸枣仁14份、预胶化淀粉20份、聚乙烯吡咯烷酮15份。
本发明所述的一种桂灵片剂药物组合物的制备方法,包括以下步骤:
1)通过豆蔻提取挥发油,并收集药渣;
2)将步骤1)收集到的药渣与麻黄、罂粟壳、核桃仁、酸枣仁加水煎煮二次,第一次4小时,第二次2.5小时,合并煎液,200目纱布过滤,再将滤液浓缩,加1~2倍80%乙醇混匀,静置,再次200目纱布过滤,滤液回收乙醇,浓缩至稠浸膏;
3)炒苦杏仁压榨去油,与五味子共用80%乙醇回流提取二次,第一次2小时,第二次1小时,合并提取液,200目纱布过滤,滤液回收乙醇至无醇味,浓缩至稠浸膏;
4)合并水、步骤2)和3)制取的稠浸膏、款冬花、槐花,真空冷冻干燥,再粉碎成5-50μm的细粉,混匀;
5)聚乙烯吡咯烷酮用适量60-95%酒精分散溶解后,与预胶化淀粉一并加入步骤4)制取的细粉中配研,混匀;
6)在60℃以下干燥,取豆蔻挥发油加入适量吸收剂,混匀,兑入干颗粒中,混匀,压片,包糖衣,制成片剂,即得。
通过采用上述的技术方案,本发明的有益效果是:本发明所述的一种桂灵片剂药物组合物中麻黄、罂粟壳、炒苦杏仁、五味子、核桃仁、豆蔻能够收敛肺气,止咳定喘,用于肾虚作喘,肺虚久咳,款冬花、槐花、酸枣仁能够润肺下气,化痰止咳,宁心安神,养肝敛汗,凉血止血,清肝明目,同时治标又治本,预胶化淀粉和聚乙烯吡咯烷酮对片剂有润滑、助流和抗粘附作用,有利于药物成形和促进药物吸收的功能。本发明所述的一种桂灵片剂药物组合物的制备方法采用超微技术将部分中药材进行超微粉碎成5-50μm细粉,提高了生药有效成份的溶出度,药物溶散时间短,溶出充分,生物利用度高,增强了药物的疗效。
具体实施例
下面将结合本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
按下述重量称取各原料:麻黄400g、罂粟壳300g、炒苦杏仁200g、五味子200g、核桃仁200g、豆蔻25g、款冬花10g、槐花8g、酸枣仁15g、预胶化淀粉10g、聚乙烯吡咯烷酮20g。
制备方法如下:
1)通过豆蔻提取挥发油,并收集药渣;
2)将步骤1)收集到的药渣与麻黄、罂粟壳、核桃仁、酸枣仁加水煎煮二次,第一次4小时,第二次2.5小时,合并煎液,200目纱布过滤,再将滤液浓缩,加1倍80%乙醇混匀,静置,再次200目纱布过滤,滤液回收乙醇,浓缩至稠浸膏;
3)炒苦杏仁压榨去油,与五味子共用80%乙醇回流提取二次,第一次2小时,第二次1小时,合并提取液,200目纱布过滤,滤液回收乙醇至无醇味,浓缩至稠浸膏;
4)合并水、步骤2)和3)制取的稠浸膏、款冬花、槐花,真空冷冻干燥,再粉碎成5-15μm的细粉,混匀;
5)聚乙烯吡咯烷酮用适量80%酒精分散溶解后,与预胶化淀粉一并加入步骤4)制取的细粉中配研,混匀;
6)在60℃以下干燥,取豆蔻挥发油加入适量吸收剂,混匀,兑入干颗粒中,混匀,压片,包糖衣,制成1000片,即得。
实施例2
按下述重量称取各原料:麻黄400g、罂粟壳300g、炒苦杏仁200g、五味子200g、核桃仁200g、豆蔻25g、款冬花15g、槐花10g、酸枣仁14g、预胶化淀粉20g、聚乙烯吡咯烷酮15g。
制备方法如下:
1)通过豆蔻提取挥发油,并收集药渣;
2)将步骤1)收集到的药渣与麻黄、罂粟壳、核桃仁、酸枣仁加水煎煮二次,第一次4小时,第二次2.5小时,合并煎液,200目纱布过滤,再将滤液浓缩,加1倍80%乙醇混匀,静置,再次200目纱布过滤,滤液回收乙醇,浓缩至稠浸膏;
3)炒苦杏仁压榨去油,与五味子共用80%乙醇回流提取二次,第一次2小时,第二次1小时,合并提取液,200目纱布过滤,滤液回收乙醇至无醇味,浓缩至稠浸膏;
4)合并水、步骤2)和3)制取的稠浸膏、款冬花、槐花,真空冷冻干燥,再粉碎成5-15μm的细粉,混匀;
5)聚乙烯吡咯烷酮用适量90%酒精分散溶解后,与预胶化淀粉一并加入步骤4)制取的细粉中配研,混匀;
6)在60℃以下干燥,取豆蔻挥发油加入适量吸收剂,混匀,兑入干颗粒中,混匀,压片,包糖衣,制成1000片,即得。
实施例3
按下述重量称取各原料:麻黄400g、罂粟壳300g、炒苦杏仁200g、五味子200g、核桃仁200g、豆蔻25g、款冬花10g、槐花10g、酸枣仁15g、预胶化淀粉30g、聚乙烯吡咯烷酮20g。
制备方法如下:
1)通过豆蔻提取挥发油,并收集药渣;
2)将步骤1)收集到的药渣与麻黄、罂粟壳、核桃仁、酸枣仁加水煎煮二次,第一次4小时,第二次2.5小时,合并煎液,200目纱布过滤,再将滤液浓缩,加1倍80%乙醇混匀,静置,再次200目纱布过滤,滤液回收乙醇,浓缩至稠浸膏;
3)炒苦杏仁压榨去油,与五味子共用80%乙醇回流提取二次,第一次2小时,第二次1小时,合并提取液,200目纱布过滤,滤液回收乙醇至无醇味,浓缩至稠浸膏;
4)合并水、步骤2)和3)制取的稠浸膏、款冬花、槐花,真空冷冻干燥,再粉碎成40-50μm的细粉,混匀;
5)聚乙烯吡咯烷酮用适量90%酒精分散溶解后,与预胶化淀粉一并加入步骤4)制取的细粉中配研,混匀;
6)在60℃以下干燥,取豆蔻挥发油加入适量吸收剂,混匀,兑入干颗粒中,混匀,压片,包糖衣,制成1000片,即得。
实验例
(1)鉴别:取本品2片,除去糖衣,研细,加三氯甲烷20ml,超声处理30分钟,滤过,滤液蒸干,残渣加三氯甲烷lml使溶解,作为供试品溶液。另取五味子对照药材1g,同法制成对照药材溶液。再取五味子甲素对照品,加三氯甲烷制成每1ml含1mg的溶液,作为对照品溶液。照薄层色谱法(通则0502)试验,吸取上述三种溶液各2μl,分别点于同一硅胶GF254薄层板上,以石油醚(60-90℃)-甲酸乙酯-甲酸(10:5:1)的上层溶液为展开剂,展开,取出,晾干,置紫外光灯(254nm)下检视。供试品色谱中,在与对照药材色谱和对照品色谱相应的位置上,显相同颜色的斑点。
取吗啡对照品、盐酸麻黄碱对照品、盐酸伪麻黄碱对照品、磷酸可待因对照品、盐酸罂粟碱对照品,加甲醇制成每1ml含吗啡10μg、盐酸麻黄碱30μg、盐酸伪麻黄碱20μg、磷酸可待因2μg、盐酸罂粟碱0.5μg的混合溶液,作为对照品溶液。照(含量测定)项下的色谱条件试验,吗啡、盐酸麻黄碱、盐酸伪麻黄碱、磷酸可待因的检测波长为210nm,盐酸罂粟碱的检测波长为251nm,分别吸取(含量测定)项下的供试品溶液和上述对照品溶液各5μl,注入液相色谱仪。供试品色谱图中,应呈现与对照品色谱峰保留时间相对应的色谱峰。
(2)含量的测定
以十八烷基硅烷键合硅胶为填充剂;以乙腈为流动相A,以0.1%磷酸溶液为流动相B,按下表中的规定进行梯度洗脱;检测波长210nm。理论板数按吗啡峰计算应不低于6000。
时间(分钟) | 流动性A(%) | 流动性B(%) |
0-25 | 4 | 96 |
25~35 | 4→10 | 96→90 |
35~45 | 10→20 | 90→80 |
45~55 | 20 | 80 |
55~60 | 20→25 | 80→75 |
(3)对照品溶液的制备:
取吗啡对照品、盐酸麻黄碱对照品、盐酸伪麻黄碱对照品适量,精密称定,加甲醇制成每1ml含吗啡10μg、盐酸麻黄碱30μg、盐酸伪麻黄碱20μg的混合溶液,即得。
(4)供试品溶液的制备:
取本品10片,除去糖衣,精密称定,研细,取约0.5g,精密称定,置具塞锥形瓶中,精密加入0.1mol/L盐酸溶液50ml,密塞,称定重量,超声处理(功率250W,频率40kHz)1小时,放冷,再称定重量,用0.1mol/L盐酸溶液补足减失的重量,摇匀,离心(每分钟5000转)10分钟,取上清液,滤过,精密量取续滤液10ml,加在固相萃取柱(以混合型阳离子交换反相吸附剂为填充剂,150mg,6ml,用甲醇、水各6ml预洗)上,依次用0.1mol/L盐酸溶液、甲醇各6ml洗脱,弃去洗脱液,继用新制的乙腈-浓氨试液(95:5)混合溶液10ml洗脱,收集洗脱液置10ml量瓶中,加上述混合溶液稀释至刻度,摇匀,即得。
(4)测定法分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
本品每片含麻黄以盐酸麻黄碱(C10H15NO·HCl)与盐酸伪麻黄碱(C10H15NO·HCl)的总量计,通过上述的实验例对实施例1-3进行检测,其中实施例2的盐酸麻黄碱(C10H15NO·HCl)与盐酸伪麻黄碱(C10H15NO·HCl)总重量最高,为3.9mg;含罂粟壳以吗啡计,实施例2中的吗啡含量为0.23mg,符合中国药典1990年版一部附录11页的各项规定。
虽然在上文中已经参考实施例对本发明进行了描述,然而在不脱离本发明的范围的情况下,可以对其进行各种改进并且可以用等效物替换其中的部件。尤其是,只要不存在结构冲突,本发明所披露的实施例中的各项特征均可通过任意方式相互结合起来使用,在本说明书中未对这些组合的情况进行穷举性的描述仅仅是出于省略篇幅和节约资源的考虑。因此,本发明并不局限于文中公开的特定实施例,而是包括落入权利要求的范围内的所有技术方案。
Claims (3)
1.一种桂灵片剂药物组合物,其特征在于,是由以下重量份数的药物制成的:
麻黄400份、罂粟壳300份、炒苦杏仁200份、五味子200份、核桃仁200份、豆蔻25份、款冬花10-15份、槐花8-14份、酸枣仁10-15份、预胶化淀粉10-30份、聚乙烯吡咯烷酮5-20份。
2.根据权利要求1所述的桂灵片剂药物组合物,其特征在于:是由以下重量份数的药物制成的:
麻黄400份、罂粟壳300份、炒苦杏仁200份、五味子200份、核桃仁200份、豆蔻25份、款冬花10份、槐花10份、酸枣仁14份、预胶化淀粉20份、聚乙烯吡咯烷酮15份。
3.权利要求1或2所述的一种桂灵片剂药物组合物的制备方法,其特征在于,包括以下步骤:
1)通过豆蔻提取挥发油,并收集药渣;
2)将步骤1)收集到的药渣与麻黄、罂粟壳、核桃仁、酸枣仁加水煎煮二次,第一次4小时,第二次2.5小时,合并煎液,200目纱布过滤,再将滤液浓缩,加1~2倍80%乙醇混匀,静置,再次200目纱布过滤,滤液回收乙醇,浓缩至稠浸膏;
3)炒苦杏仁压榨去油,与五味子共用80%乙醇回流提取二次,第一次2小时,第二次1小时,合并提取液,200目纱布过滤,滤液回收乙醇至无醇味,浓缩至稠浸膏;
4)合并水、步骤2)和3)制取的稠浸膏、款冬花、槐花,真空冷冻干燥,再粉碎成5-50μm的细粉,混匀;
5)聚乙烯吡咯烷酮用适量60-95%酒精分散溶解后,与预胶化淀粉一并加入步骤4)制取的细粉中配研,混匀;
6)在60℃以下干燥,取豆蔻挥发油加入适量吸收剂,混匀,兑入干颗粒中,混匀,压片,包糖衣,制成片剂,即得。
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CN102688435A (zh) * | 2012-03-21 | 2012-09-26 | 江西天施康中药股份有限公司 | 一种桂灵制剂的制备方法 |
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CN1742977A (zh) * | 2005-09-23 | 2006-03-08 | 北京阜康仁生物制药科技有限公司 | 桂灵制剂及新的制备方法 |
CN102688435A (zh) * | 2012-03-21 | 2012-09-26 | 江西天施康中药股份有限公司 | 一种桂灵制剂的制备方法 |
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