CN110623961A - 一种含有药物美洛昔康和辅助材料的组合物 - Google Patents
一种含有药物美洛昔康和辅助材料的组合物 Download PDFInfo
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Abstract
本发明提供一种含有药物美洛昔康和辅助材料的组合物,辅助材料包括药用淀粉、乳糖、聚维酮K30和纯化水。按重量份数计,各组分的含量分别为:美洛昔康为5至10份,药用淀粉为30至90份,乳糖为20至60份,聚维酮K30为1至4份,纯化水为10至40份。本发明的组合物能有效的治疗风湿性、类风湿性的疾病,药物毒性小。
Description
技术领域
本发明涉及医药领域,特别涉及一种含有药物美洛昔康和辅助材料的组合物。
背景技术
美洛昔康是一种非甾体消炎药,美洛昔康最大的特点是一种选择性抑制II型环氧合酶(COX-2)抑制剂。该品具有显著而持久的抗炎作用和一定的解热镇痛作用。美洛昔康还具备良好的药动学性质,如吸收快、血药浓度高、生物利用度高、血浆蛋白结合率也很高,特别是可选择性进入发炎部位,因而抗炎作用较强而持久。利用美洛昔康制备的药物常用来治疗风湿性、类风湿性的疾病。
发明内容
本发明的目的是提供一种治疗风湿性、类风湿性的疾病的含有药物美洛昔康和辅助材料的组合物。
为了实现上述目的,本发明提供一种含有药物美洛昔康和辅助材料的组合物,辅助材料包括药用淀粉、乳糖、聚维酮K30和纯化水。
进一步的方案是,按重量份数计,各组分的含量分别为:美洛昔康为5至10份,药用淀粉为30至90份,乳糖为20至60份,聚维酮K30为1至4份,纯化水为10至40份。
更进一步的方案是,美洛昔康为7.5份,药用淀粉为60份,乳糖为40份,聚维酮K30为2.6份,纯化水为23.4份。
本发明的有益效果是,临床证明,本发明的含有美洛昔康的组合物能有效的治疗风湿性、类风湿性的疾病,药物毒性小。
具体实施方式
配方实施例
本发明的一种含有药物美洛昔康的和辅助材料的组合物,辅助材料包括药用淀粉、乳糖、聚维酮K30和纯化水,按制成1000粒计算,各组分的含量分别是:美洛昔康为5g至10g、药用淀粉为30g至90g、乳糖为20g至60g、聚维酮K30为1g至4g、纯化水为10g至40g,优选地,美洛昔康为7.5g、药用淀粉为60g、乳糖为40g、聚维酮K30为2.6g、纯化水为23.4g。
制备方法实施例
1.称量备料
将乳糖粉碎后过80目筛备用,美洛昔康过200目筛备用、药用淀粉过80目筛备用,将工艺量的乳糖、美洛昔康、药用淀粉均分为2份备用。
2.制粒、干燥、整粒、总混
2.1粘合剂制备
准确称取处方量的聚维酮K30,用纯化水制成10wt%的聚维酮K30溶液作粘合剂,即2.6kg聚维酮K30加入23.4kg纯化水中溶解即得。
2.2制粒
将步骤1中的其中1份的美洛昔康、药用淀粉和乳糖置于湿法混合制粒机内搅拌,低速(设置搅拌速度为25Hz)混合40分钟。从加料孔向湿法混合制粒机内投加预先制好的粘合剂,设置制粒搅拌速度40Hz、设置制粒时间为300秒;同时启动搅拌与制粒,制粒300秒后出料。
2.3干燥
按规定安装好沸腾干燥机的过滤布袋,将连续制得的两锅湿颗粒投入沸腾干燥机的干燥料斗内,并推入沸腾室。启动沸腾干燥机开关电源、打开压缩空气阀门,打开顶升按钮,是料斗与设备主体密封。开启引风电源开关、开启搅拌,然后开启蒸汽加热阀门,干燥温度为60℃至70℃,干燥约120 min后至排风温度大于或等于60℃出料,出料中的水分控制小于等于3.5%。
2.4整粒
干燥后的干颗粒再经摇摆颗粒机30目筛整粒,对整粒后的干颗粒立即交总混进行混合。
2.5总混
将整粒后的干颗粒加入V型混合机内总混,设置混合速度为25Hz,混合30分钟,出料。
3.充填
将总混后的干颗粒填充至胶囊内,重量差异合格范围控制在±7.5%内。
4.抛光
对已填充的胶囊进行抛光,并分选出不合符规定的破囊、变形、有斑点、砂眼、不规则的胶囊
5.铝塑包装
对合格的美洛昔康胶囊进行铝塑包装,包装在定型模具中进行,铝塑包装机运行速度25至42次/分钟、成型温度110℃至130℃、热封温度170℃至185℃、压缩空气0.3 MPa至0.8MPa。
6.外包装
将铝塑包装好的美洛昔康胶囊与说明书一起装入包装盒中。
需要注意的是,上述制备工艺中,称量备料、制粒、干燥、整粒、总混、充填、抛光和铝塑包装需要在D级清洁区进行,其中称量备料、干燥、总混和充填工艺为质量控制点。
本发明的技术构思并不仅限于上述实施例,还可以依据本发明的构思得到许多不同的具体方案,如对各物料的配比进行简单的调整、对混合时搅拌的速度及时间进行调整等等,此等微小改变以及等效变换均应包含在权利要求所述范围之内。
Claims (3)
1.一种含有药物美洛昔康和辅助材料的组合物,其特征在于:
所述辅助材料包括药用淀粉、乳糖、聚维酮K30和纯化水。
2.根据权利要求1所述的组合物,其特征在于
按重量份数计,各组分的含量分别为:所述美洛昔康为5至10份,所述药用淀粉为30至90份,所述乳糖为20至60份,所述聚维酮K30为1至4份,所述纯化水为10至40份。
3.根据权利要求2所述的组合物,其特征在于:
所述美洛昔康为7.5份,所述药用淀粉为60份,所述乳糖为40份,所述聚维酮K30为2.6份,所述纯化水为23.4份。
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