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出 处:《中国医药导刊》2010年第5期808-809,共2页Chinese Journal of Medicinal Guide
摘 要:目的:制备四珍力维胶囊,缩短崩解时限,确保产品质量。方法:采用正交试验,考察崩解剂、崩解剂用重(%)、加入方式、干颗粒水分这四个因素对崩解时限的影响,从而确定最后工艺。结果:通过处方工艺优化,选用5羧甲基淀粉钠(CMS),干颗粒水分为1%~3%,用外加法时,崩解时限最佳。加入方法和干颗粒的水分对崩解影响不显著。结论:崩解剂的用量为最主要的影响因素(P<0.01)其次为崩解剂种类(P<0.05),此正交试验为缩短四珍力维的崩解时限提供了依据。Objective: To prepare Sizhenliwei capsule and to short its disintegration time limiting make sure the quality of the production. Methods: The orthogonal test was used to test the main factors including disintegration, the addition method,desiccative particulate water amounts that affect the disintegration time limited and them make sure the final technology. Results:The optimal process was used 5%carboxy methyl starch sodium,3%~5% desiccative particulate water amounts, using external plus method ,the integration time limited was best. Conclusions: Amount of disintegrating as the most important factors (P〈0.01) followed by the disintegrating type(P〈0.05), the process selected in this experiment is practicable and applied to short disintegration time limited of Sizhenliwei capsule.
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