CN1720918A - 右美沙芬和异丙嗪的复方颗粒剂及其制备方法 - Google Patents
右美沙芬和异丙嗪的复方颗粒剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及医药用的右美沙芬和异丙嗪的复方颗粒剂及其制备方法。该颗粒剂每袋含有氢溴酸右美沙芬7.5~30mg、最好为14~16mg;含盐酸异丙嗪3.1~12.5mg、最好为5~7mg。还含有3~24%、最好为14~16%抗氧化稳定剂、黏合剂和90~97%、最好为94~95%矫味剂。特点是通过采用特殊的处方和制备方法,提高了药物的稳定性,从而保证了质量和疗效。
Description
技术领域 本发明涉及医药用的右美沙芬和异丙嗪的复方颗粒剂及其制备方法。
背景技术 右美沙芬是一有效的镇咳药物,除单方应用外多与其它解热镇痛药、抗组织胺药、祛痰药、血管收缩药等组合治疗感冒。异丙嗪具抗组织胺和镇静作用,与右美沙芬组合可以提高右美沙芬的镇咳效果,适用于治疗和缓解由感冒、急性或慢性支气管炎、支气管哮喘、咽喉炎、肺结核以及其他上呼吸道感染引发的咳嗽。
目前已上市的止咳药品很多,但有许多药物因某些原因并不够理想。如剂型是片剂或胶囊时,往往不适合儿童和吞咽困难的病人服用;剂型为糖浆剂或溶液剂时,又存在贮存、携带不便的问题,而且由于是糖浆剂或溶液剂,许多药物稳定性较差,如异丙嗪容易氧化而降低质量,这些都直接影响药物的疗效。
发明内容 本发明旨在克服已有止咳药稳定性差、不便于儿童和吞咽困难的病人应用的问题,保留了糖浆剂、溶液剂等液体剂型和片剂、胶囊剂、颗粒剂等固体剂型的各自的特点,制备了右美沙芬和异丙嗪的复方颗粒剂。通过采用特殊的处方和生产工艺,提高了产品的稳定性,从而保证了质量和疗效。其特点是:
(1)稳定性更好。由于颗粒剂始终处于干燥无水的状态,且包装严密,避免与空气接触,因而较糖浆剂、溶液剂等液体制剂更稳定。
(2)颗粒剂虽为固体制剂,但其在服用时加水冲服亦即组成了溶液剂,因而较片剂和胶囊吸收好、起效快、生物利用度高。
(3)适用人群更广。颗粒剂加水冲服时,形成类似溶液剂那样的清澈透明溶液,病人乐意接受,适合于2岁以上儿童和吞咽不便的病人服用。
(4)颗粒剂为单剂量包装,每次服用剂量较片剂、胶囊准确,而且不会像糖浆剂、溶液剂那样多次服用易造成污染,且病愈后剩余药品易于保管,日后还可应用。
(5)生产、运输、贮藏、携带和使用更方便。
本发明右美沙芬和异丙嗪的复方颗粒剂含有活性成分右美沙芬和异丙嗪、抗氧化稳定剂、黏合剂和芳香矫味剂,并采用特殊方法制备,以保证产品的稳定性。处方中每袋含有右美沙芬7.5~30mg、最好为14~16mg;含异丙嗪3.1~12.5mg、最好为5~7mg,右美沙芬和异丙嗪为常用的氢溴酸盐和盐酸盐。抗氧化稳定剂可用亚硫酸氢钠、亚硫酸钠、硫脲、盐酸半胱氨酸、依地酸钙钠、依地酸二钠、抗坏血酸、橘橼酸、苯甲酸钠、橘橼酸钠等,这些稳定剂可单独使用,亦可多种联合应用,用量为处方量的3~24%、最好为14~16%。黏合剂可采用淀粉浆和纤维素类如羧甲纤维素钠、乙基纤维素、羟丙纤维素、羟丙甲纤维素等的混合物,这些黏合剂既可使药物黏合成颗粒,又可在药物表面形成一层膜,对药物起到保护作用。这些黏合剂可单独应用,亦可以不同比例混合应用。制备黏合剂可用水、乙醇和乙醇水溶液。制粒时可采用传统方法用纤维素类黏合剂将全部物料同时制粒,也可分别制粒即先将药物和抗氧化稳定剂以及部分糖粉用纤维素类黏合剂制粒,然后再与其他糖粉的颗粒混匀即可。芳香矫味剂可为蔗糖、甘草酸、甜菊素、糖精钠、橘橼酸、酒石酸、人工合成和天然香料,用量为处方量的90~97%、最好为94~95%,以使制得的颗粒香甜可口,病人乐于接受。
具体实施方式 本发明可用下面的实施例加以说明。
实施例1 处方:
氢溴酸右美沙芬 15g
盐酸异丙嗪 6.25g
维生素C 10g
依地酸二钠 2g
橘橼酸钠 3g
香料 15g
蔗糖粉 936g
EC/HPMC乙醇液 适量
制成 1000袋
制备方法:将氢溴酸右美沙芬、盐酸异丙嗪、维生素C、依地酸二钠、橘橼酸钠、蔗糖细粉混匀,用6%EC/HPMC的乙醇液制成适宜软材,用14目尼龙网制粒,于50℃以下干燥,加入香料,整粒,混合均匀后包装。
实施例2 处方:
氢溴酸右美沙芬 30g
盐酸异丙嗪 12.5g
维生素C 15g
依地酸二钠 5g
橘橼酸 8g
香料 20g
蔗糖粉 1400g
EC/HPMC乙醇液 适量
制成 1000袋
制备方法:将氢溴酸右美沙芬、盐酸异丙嗪、维生素C、依地酸二钠、橘橼酸和少量蔗糖细粉混匀,用EC/HPMC的乙醇液制成适宜软材,用14目尼龙网制粒,于50℃以下干燥制得药物颗粒。另将余下蔗糖粉采用传统方法制粒干燥制得辅料糖粉颗粒。将药物颗粒与辅料糖粉颗粒混合,加入香料,整粒,混合均匀后包装。
Claims (6)
1、右美沙芬和异丙嗪的复方颗粒剂及其制备方法。该颗粒剂含有活性药物、抗氧化稳定剂、黏合剂和芳香矫味剂。特点是通过采用特殊的处方和制备方法,提高了药物的稳定性,从而保证了质量和疗效。
2、权利要求1所述的右美沙芬和异丙嗪的复方颗粒剂剂型及其制备方法。右美沙芬和异丙嗪为常用的氢溴酸盐和盐酸盐。
3、权利要求1所述的颗粒剂每袋含有氢溴酸右美沙芬7.5~30mg、最好为14~16mg;含盐酸异丙嗪3.1~12.5mg、最好为5~7mg。
4、权利要求1所述的抗氧化稳定剂为亚硫酸氢钠、亚硫酸钠、硫脲、盐酸半胱氨酸、依地酸钙钠、依地酸二钠、抗坏血酸、橘橼酸、苯甲酸钠、橘橼酸钠等。这些稳定剂可单独使用,亦可多种联合应用,用量为处方量的3~24%、最好为14~16%。
5、权利要求1所述的黏合剂可采用淀粉浆和纤维素类如羧甲纤维素钠、乙基纤维素、羟丙纤维素、羟丙甲纤维素等的混合物,这些黏合剂既可使药物黏合成颗粒,又可在药物表面形成一层膜,对药物起到保护作用。这些黏合剂可单独应用,亦可以不同比例混合应用,制备黏合剂可用水、乙醇和乙醇水溶液。
6、权利要求1所述的特殊制备方法为采用传统方法用纤维素类黏合剂将全部物料同时制粒,也可分别制粒即先将药物和抗氧化稳定剂以及部分糖粉用纤维素类黏合剂制粒,然后再与其他糖粉的颗粒混匀。
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CN104922510A (zh) * | 2015-06-01 | 2015-09-23 | 袁志贤 | 一种祛痰平喘药物及其制备方法 |
CN105250755A (zh) * | 2015-10-19 | 2016-01-20 | 王迁 | 一种中西医治疗支气管炎的药物及其制备方法 |
CN108096203A (zh) * | 2018-02-09 | 2018-06-01 | 常州康普药业有限公司 | 一种盐酸异丙嗪片及其制备方法 |
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CN104922510A (zh) * | 2015-06-01 | 2015-09-23 | 袁志贤 | 一种祛痰平喘药物及其制备方法 |
CN105250755A (zh) * | 2015-10-19 | 2016-01-20 | 王迁 | 一种中西医治疗支气管炎的药物及其制备方法 |
CN108096203A (zh) * | 2018-02-09 | 2018-06-01 | 常州康普药业有限公司 | 一种盐酸异丙嗪片及其制备方法 |
CN108096203B (zh) * | 2018-02-09 | 2019-11-12 | 常州康普药业有限公司 | 一种盐酸异丙嗪片及其制备方法 |
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