CN112451521A - 一种奥美沙坦酯硫酸软骨素复方胶囊及其制备方法 - Google Patents
一种奥美沙坦酯硫酸软骨素复方胶囊及其制备方法 Download PDFInfo
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Abstract
本发明涉及了一种奥美沙坦酯硫酸软骨素胶囊及其制备方法,具体而言,所述复方胶囊由以下重量份的组分制成:奥美沙坦酯10‑40份,硫酸软骨素60‑110mg份,填充剂15‑85份、崩解剂5‑25份、润滑剂0.4‑8份、粘合剂0.3‑3份。本发明的奥美沙坦酯硫酸软骨素复方胶囊,质量稳定、含量均匀度好、药物的溶出速率高,提高了生物利用度,适合规模化生产。
Description
技术领域
本发明属于药物制剂技术领域,具体涉及一种奥美沙坦酯硫酸软骨素复方胶囊及其制备方法。
背景技术
高血压是所有心脑血管疾病最重要的危险因素,高血压可以加重动脉硬化地进展,导致心、脑、肾靶器官地损害。目前我国高血压患者人数已达3.3亿,且每个70岁老人都有90%以上的概率患高血压。而随着生活条件的改善,我国人均预期寿命早已经超过 70岁,并且这个年龄仍在不断提高,而且我国的高血压患者越来越呈现出年轻化发展的趋势。我国高血压患病率正持续增长,全国年平均新增高血压患者1000万人。
奥美沙坦酯(olmesartan medoxomil)是一种新的非肽类血管紧张素Ⅱ受体拮抗剂,通过选择性和竞争性阻断血管紧张素Ⅱ受体AT1发挥降压作用。奥美沙坦酯多次口服给药的血浆半衰期为10-15小时。奥美沙坦酯具有高效、安全、作用持久和耐受性良好等特点,对高血压患者的心脏、血管和肾脏具有直接有效的保护作用,是目前一种较为理想的降压药。但长期服用奥美沙坦酯会出现不同程度的水肿、头痛、高血糖症、高胆固醇血症、高血脂症、关节疼痛、关节炎、肌肉疼痛等症状及恶心、肠胃炎、消化不良、腹胀、腹痛、纳差等胃肠道反应症状。
硫酸软骨素(Chondroitin sulfate)是从动物软骨组织中提取制备的一种天然酸性粘多糖,其用药安全性高,耐受性高,几乎无任何毒副作用,可治疗关节炎、缓解改善关节疼痛,可有效改善头痛症状,能显著降低血清总胆固醇、低密度脂蛋白及甘油三酯含量及降低血糖效果,硫酸软骨素还具有抗炎、抗菌、抗凝作用和改善调节胃肠道反应,而且硫酸软骨素还具有降血压的功效。硫酸软骨素及其衍生物在人体血浆中的半衰期约为15小时,与奥美沙坦酯的半衰期相似,因此,奥美沙坦酯联合硫酸软骨素用药,不仅可有效降低奥美沙坦酯的毒副作用,改善患者的顺从性,减轻患者的痛苦,而且能很好的产生联合降低血压的增效作用。
目前,国内外尚没有奥美沙坦酯硫酸软骨素复方胶囊及其制备方法相关报道。
发明内容
本发明的目的是提供一种奥美沙坦酯硫酸软骨素复方胶囊及其制备方法。
本发明是通过以下技术方案实现的:
一种奥美沙坦酯硫酸软骨素复方胶囊,其特征在于,具体而言,所述复方胶囊由以下重量份的组分制成:奥美沙坦酯10-40份,硫酸软骨素60-110份,填充剂15-85份、崩解剂5-25份、润滑剂0.4-8份、粘合剂0.3-3份。
所述填充剂为乳糖或乳糖一水合物;所述崩解剂为低取代羟丙基纤维素、羧甲基淀粉钠的一种或多种;所述润滑剂为硬脂酸镁、二氧化硅的一种或多种;所述粘合剂为微晶纤维素、聚维酮的一种或多种。
上述奥美沙坦酯硫酸软骨素复方胶囊的制备方法,该方法包括如下步骤:
(1)称量:将各原辅料按配方量称量、过筛,备用;
(2)混合:将过筛后的奥美沙坦酯、硫酸软骨素、填充剂、崩解剂、粘合剂充分混合均匀;
(3)制软材:将乙醇溶液加入步骤(2)获得的混合粉中搅拌制备软材;
(4)制粒:将(3)用22目筛制粒;
(5)干燥:将湿颗粒进行干燥;
(6)整粒:20目整粒;
(7)总混:将整理后的干颗粒加入处方量的润滑剂,混合均匀,混合时间为15分钟;
(8)灌装:将(7)混合后的颗粒装入胶囊壳,制得奥美沙坦酯硫酸软骨素复方胶囊成品。
所述的制备方法,步骤(1)中所述过筛至少过80目筛。
所述的制备方法,步骤(3)中所述乙醇溶液为70%的乙醇水溶液。
所述的制备方法,步骤(5)中所述干燥为60-70℃烘干。
所述的制备方法,步骤(5)中所述干燥水分控制在6%之内。
本发明制备的奥美沙坦酯硫酸软骨素复方胶囊,质量稳定、含量均匀度好、制备方法简单,适合规模化生产;由于奥美沙坦酯具有pH依赖性,酸性粘多糖硫酸软骨素产生酸性微环境有助于提高药物的溶解度,药物的溶出速率提高,提高了生物利用度,降低长期使用单独奥美沙坦酯造成的不良反应,提高了患者的用药依从性,减轻了患者的痛苦,具有较大的应用价值。
具体实施方法
下面结合具体的实施例对本发明所述的奥美沙坦酯硫酸软骨素复方胶囊及其制备方法做进一步说明,但是本发明的保护范围并不限于此。
实施例1
一种奥美沙坦酯硫酸软骨素复方胶囊,奥美沙坦酯10g、硫酸软骨素60g、乳糖15g、羧甲基淀粉钠5g、硬脂酸镁0.4g、微晶纤维素0.3g。
制备方法包括如下步骤:
(1)称量:将各原辅料按配方量称量、过80目筛,备用;
(2)混合:将过筛后的奥美沙坦酯、硫酸软骨素、乳糖、羧甲基淀粉钠、微晶纤维素充分混合均匀;
(3)制软材:将70%的乙醇水溶液加入步骤(2)获得的混合粉中搅拌制备软材;
(4)制粒:将(3)用22目筛制粒;
(5)干燥:将湿颗粒进行60℃干燥,水分控制在4%左右;
(6)整粒:20目整粒;
(7)总混:将整理后的干颗粒加入硬脂酸镁,混合均匀,混合时间为15分钟;
(8)灌装:将(7)混合后的颗粒装入胶囊壳,制得奥美沙坦酯硫酸软骨素复方胶囊成品。
实施例2
一种奥美沙坦酯硫酸软骨素复方胶囊,奥美沙坦酯40g、硫酸软骨素110g、乳糖一水合物85g、低取代羟丙基纤维素25g、硬脂酸镁8g、微晶纤维素3g。
制备方法包括如下步骤:
(1)称量:将各原辅料按配方量称量、过90目筛,备用;
(2)混合:将过筛后的奥美沙坦酯、硫酸软骨素、乳糖一水合物、低取代羟丙基纤维素、微晶纤维素充分混合均匀;
(3)制软材:将70%的乙醇水溶液加入步骤(2)获得的混合粉中搅拌制备软材;
(4)制粒:将(3)用22目筛制粒;
(5)干燥:将湿颗粒进行70℃干燥,水分控制在5%左右;
(6)整粒:20目整粒;
(7)总混:将整理后的干颗粒加入硬脂酸镁,混合均匀,混合时间为15分钟;
(8)灌装:将(7)混合后的颗粒装入胶囊壳,制得奥美沙坦酯硫酸软骨素复方胶囊成品。
实施例3
一种奥美沙坦酯硫酸软骨素复方胶囊,奥美沙坦酯20g、硫酸软骨素80g、乳糖60g、羧甲基淀粉钠15g、二氧化硅4g、聚维酮K30 2g。
制备方法包括如下步骤:
(1)称量:将各原辅料按配方量称量、过100目筛,备用;
(2)混合:将过筛后的奥美沙坦酯、硫酸软骨素、乳糖、羧甲基淀粉钠、聚维酮K30充分混合均匀;
(3)制软材:将70%的乙醇水溶液加入步骤(2)获得的混合粉中搅拌制备软材;
(4)制粒:将(3)用22目筛制粒;
(5)干燥:将湿颗粒进行65℃干燥,水分控制在3%左右;
(6)整粒:20目整粒;
(7)总混:将整理后的干颗粒加入二氧化硅,混合均匀,混合时间为15分钟;
(8)灌装:将(7)混合后的颗粒装入胶囊壳,制得奥美沙坦酯硫酸软骨素复方胶囊成品。
对本发明实施例1、实施例2、实施例3按照中国药典2020版标准检测奥美沙坦酯硫酸软骨素复方胶囊的重量差异、溶出度(45分钟)、含量均匀度、含量。
测定结果见表1
Claims (7)
1.一种奥美沙坦酯硫酸软骨素复方胶囊,其特征在于,具体而言,所述复方胶囊由以下重量份的组分制成:奥美沙坦酯10-40份,硫酸软骨素60-110份,填充剂15-85份、崩解剂5-25份、润滑剂0.4-8份、粘合剂0.3-3份。
2.根据权利要求1所述的奥美沙坦酯硫酸软骨素复方胶囊,其特征在于,所述填充剂为乳糖或乳糖一水合物;所述崩解剂为低取代羟丙基纤维素、羧甲基淀粉钠的一种或多种;所述润滑剂为硬脂酸镁、二氧化硅的一种或多种;所述粘合剂为微晶纤维素、聚维酮的一种或多种。
3.根据权利要求1所述的奥美沙坦酯硫酸软骨素复方胶囊的制备方法,其特征在于,其包括如下步骤:
(1)称量:将各原辅料按配方量称量、过筛,备用;
(2)混合:将过筛后的奥美沙坦酯、硫酸软骨素、填充剂、崩解剂、粘合剂充分混合均匀;
(3)制软材:将乙醇溶液加入步骤(2)获得的混合粉中搅拌制备软材;
(4)制粒:将(3)用22目筛制粒;
(5)干燥:将湿颗粒进行干燥;
(6)整粒:20目整粒;
(7)总混:将整理后的干颗粒加入处方量的润滑剂,混合均匀,混合时间为15分钟;
(8)灌装:将(7)混合后的颗粒装入胶囊壳,制得奥美沙坦酯硫酸软骨素复方胶囊成品。
4.根据权利要求3所述的制备方法,其特征在于,步骤(1)中所述过筛至少过80目筛。
5.根据权利要求3所述的制备方法,其特征在于,步骤(3)中所述乙醇溶液为70%的乙醇水溶液。
6.根据权利要求3所述的制备方法,其特征在于,步骤(5)中所述干燥为60-70℃烘干。
7.根据权利要求3所述的制备方法,其特征在于,步骤(5)中所述干燥水分控制在6%之内。
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