CN101926798A - 一种含有氨氯地平和缬沙坦的分散片 - Google Patents
一种含有氨氯地平和缬沙坦的分散片 Download PDFInfo
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Abstract
本发明公开了一种含有缬沙坦和氨氯地平的分散片，该分散片包括缬沙坦和氨氯地平活性成分及药用辅料，临床上用于治疗高血压。
Description
技术领域
本发明属于医药技术领域，特别涉及一种含有氨氯地平和缬沙坦的分散片。
背景技术
多种临床研究已经表明：降低高血压患者的血压可减少死亡率和发病率。尽管治疗该医学病症有各种类型的药物可供选择和使用，但并不总是能实现对血压的充分控制。使用药物组合物是实现所期望的治疗终点的一条途径，任意选择不同种类的抗高血压药进行组合治疗并不必然有助于在包括人在内的高血压哺乳动物中达到目标血压水平。因此，显然存在进一步开发治疗药物组合物的需要。
作为二氢吡啶类钙拮抗剂的氨氯地平具有充分且持久的血管扩张作用和难以引起心率过快的性质；血管紧张素II受体拮抗剂-缬沙坦，在治疗充血性心力衰竭和降低血压方面有效，不论年龄、性别或种族如何，对它的耐受性也很好，二者联合应用成为具有互补作用方式的抗高血压药物，具有广阔的发展前景。研究表明，缬沙坦的绝对口服利用度只有约25％，较宽的范围为10-35％，苯磺酸氨氯地平微溶于水，绝对生物利用度为64-90％。由于这些复杂的生物药学性质导致开发缬沙坦和氨氯地平的分散片面临挑战。
对于.难溶性的化合物，其溶出是药物在体内吸收和利用的限速步骤，常用的提高固体制剂溶出的方法主要有：改进处方中粘合剂崩解剂等的选择、改进原辅料混合工艺、固体分散技术及环糊精包合技术。目前，关于氨氯地平和缬沙坦复方制剂的相关专利对如何提高其固体制剂的溶出尚未有人深入探讨，并且人们也需要有一种商业上能接受的、对病人、尤其是对老人方便且能接受的口服制剂，本发明提供一种含有氨氯地平和缬沙坦的分散片。服用分散片具有释药速度快、生物利用度高、不良反应少等优点，临床用药既可以像普通片那样吞服，又可放入水中迅速分散后送服，有的还可以咀嚼或含吮服用，携带使用方便，兼有片剂和液体制剂的优点，这种速溶速效的片剂很方便老人和吞服困难者使用。
CN101237859A中公开了一种缬沙坦和氨氯地平的固体剂型及其制备方法，其保护的固体剂型为缬沙坦和氨氯地平组合的单层和双层普通固体片剂，与分散片相比，不具备速效速溶的特点，并且不适合吞服困难者使用。
发明内容
本发明的目的是提供一种含有氨氯地平和缬沙坦的分散片，这种分散片通过自身剂型的优势及改进填充剂的选择，可以使活性成分氨氯地平和缬沙坦更好的溶出，使治疗药物组合物更好的发挥药效。
本发明提供的氨氯地平和缬沙坦分散片，是一种含有可溶性填充剂的分散片，遇水能立即形成均匀混悬液，具有服用方便、溶出迅速、生产工艺简单的优点。
本发明提供的氨氯地平和缬沙坦分散片，临床用药既可以像普通片那样吞服，又可放入水中迅速分散后送服，有的还可以咀嚼或含吮服用，携带使用方便，兼有片剂和液体制剂的优点。
本发明提供的分散片，作为适合本发明的辅料含有填充剂、粘合剂、崩解剂、增溶剂、润滑剂、矫味剂。
本发明所提供的分散片，作为适合本发明的填充剂含有水溶性填充剂和水不溶性填充剂，其中水溶性填充剂可选自乳糖、山梨醇、甘露醇、蔗糖中的一种或多种，水不溶性填充剂可选自微晶纤维素、磷酸氢钙、淀粉、预胶化淀粉中的一种或多种。
本发明所提供的分散片，作为适合本发明的填充剂至少含有水溶性填充剂中的一种或多种。
本发明经过选择，所述辅料中崩解剂可选自羧甲基淀粉钠、低取代羟丙基纤维素、交联聚乙烯吡咯烷酮、交联羧甲基纤维素钠中的一种或多种。
本发明提供的氨氯地平和缬沙坦分散片，是一种含有泊罗沙姆作为增溶剂的分散片，该增溶剂的加入可显著提高有效成分的溶出度。
为了改善药片的口味，还可以添加适量矫味剂，如阿司巴甜、甘草甜素、三氯蔗糖、药用香精等，为了保证主药的稳定，还可以添加适量抗氧化剂和防腐剂等。
本发明公开的分散片，用于治疗高血压。
具体实施方式
通过以下实施例来对本发明的组合物及其制备方法做进一步具体说明，但并不仅限于以下实例。
对比实施例1：
制备工艺：称取处方量的缬沙坦、苯磺酸氨氯地平、微晶纤维素、交联聚维酮、十二烷基硫酸钠过筛混合均匀后，制软材，制粒，干燥，整粒；加入处方比例的硬脂酸镁、柠檬酸混匀，压片即得。
实施例1：
制备工艺：按处方量称取缬沙坦、苯磺酸氨氯地平、乳糖、交联聚维酮和泊罗沙姆过筛混匀，制软材，制粒，干燥，整粒；加入处方比例的硬脂酸镁、柠檬酸混匀，压片即得。
实施例2：
制备工艺：按处方量称取缬沙坦、苯磺酸氨氯地平、木糖醇、羧甲基淀粉钠、泊罗沙姆，混匀，制软材，过筛制粒，干燥，整粒；加入处方比例的葡萄香精、硬脂酸镁混匀，压片。
实施例3
制备工艺：按处方量称取缬沙坦、苯磺酸氨氯地平、甘露醇、低取代羟丙基纤维素、泊罗沙姆，混匀，制软材，过筛制粒，干燥，整粒；加入处方比例的哈密瓜香精、硬脂酸镁混匀，压片。
实施例1～3与对比实施例1、市售普通片剂缬沙坦溶出度比较(n＝6，X±SD)
实施例1～3与对比实施例1、市售普通片剂氨氯地平溶出度比较(n＝6，X±SD)
结果表明：本发明所研制的分散片，缬沙坦和氨氯地平在各个时间点的溶出速度均显著高于市售普通片剂，并且实施例1制得样品在各个时间点的溶出均优于对比实施例1的样品。
Claims (9)
1.一种含有氨氯地平和缬沙坦的分散片，其特征在于包括氨氯地平的苯磺酸盐和缬沙坦及可药用的辅料。
2.根据权利要求1所述的分散片，其特征在于所述辅料包括填充剂、粘合剂、崩解剂、矫味剂、增溶剂和润滑剂。
3.根据权利要求2所述的分散片，其特征在于所述的填充剂包括水溶性填充剂和水不溶性填充剂。
4.根据权利要求3所述的分散片，其特征在于所述的水溶性填充剂选自乳糖、山梨醇、甘露醇、蔗糖中的一种或多种，水不溶性填充剂选自微晶纤维素、磷酸氢钙、淀粉、膨速中的一种或多种。
5.根据权利要求3所述的分散片，其特征在于所述的填充剂至少含有一种水溶性填充剂。
6.根据权利要求2所述的分散片，其特征在于所述的崩解剂选自羧甲基淀粉钠、低取代羟丙基纤维素、交联聚乙烯吡咯烷酮、交联羧甲基纤维素钠中的一种或多种。
7.根据权利要求2所述的分散片，其特征在于所述的增溶剂为泊罗沙姆。
8.根据权利要求1至4中任何一项所述，其特征在于药物中还可以包含矫味剂、抗氧剂、防腐剂中的一种或多种。
9.根据权利要求1所述的分散片，其特征在于临床上用于治疗高血压。
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| CN101229372A (zh) * | 2007-01-26 | 2008-07-30 | 鲁南制药集团股份有限公司 | 一种治疗高血压的药物组合物 |
| CN101237859A (zh) * | 2005-08-17 | 2008-08-06 | 诺瓦提斯公司 | 缬沙坦和氨氯地平的固体剂型及其制备方法 |
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| CN101229372A (zh) * | 2007-01-26 | 2008-07-30 | 鲁南制药集团股份有限公司 | 一种治疗高血压的药物组合物 |
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| CN104000790A (zh) * | 2014-04-28 | 2014-08-27 | 万特制药(海南)有限公司 | 拉西地平分散片及其制备方法 |
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