直接印刷法研究润滑剂(硬脂酸镁)浓度变化对盐酸甲氧氯普胺片物理质量的影响

Valiandri Puspadina, Deny Budi Legowo, E. Fitriany, Andri Priyoherianto, W. Damayanti
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引用次数: 1

摘要

盐酸甲氧氯普胺用于缓解恶心和呕吐。以片剂、糖浆和注射剂的形式在市场上销售。患者最喜欢使用的药物是口服药物,因为它易于使用。咀嚼片是一种新产品,作为治疗儿童和成人患者吞咽药物困难的替代方法。本研究的目的是利用不同的润滑剂浓度来制备盐酸甲氧氯普胺咀嚼片制剂。采用直接印刷法对硬脂酸镁在浓度为1%、2%和3%时的变化进行了物理质量测试,包括感官、重量均匀性、大小均匀性、片剂硬度、片剂脆性、片剂粉碎时间、含量均匀性等。采用单因素方差分析(one - way ANOVA)对物理质量检验结果进行统计分析,以确定润滑剂浓度的变化对咀嚼片性能的影响。结果表明,在盐酸甲氧氯普胺咀嚼片生产过程中,硬脂酸镁润滑剂浓度的变化对盐酸甲氧氯普胺咀嚼片的物理质量有影响。采用硬脂酸镁的浓度为2%,可制得物理性能良好的盐酸甲氧氯普胺咀嚼片。
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EFFECT OF VARIATION OF LUBRICANT CONCENTRATION (MAGNESIUM STEARATE) ON THE PHYSICAL QUALITY OF METOCLOPRAMID HCl TABLETS WITH DIRECT PRINTING METHOD
Metoclopramide HCl is used to relieve nausea and vomiting. Market availability in the form of tablets, syrup and injection. The most preferred drug use by patients is oral medication because of its ease of use. Chewable tablets are a new product as an alternative for treatment in pediatric and adult patients who have difficulty swallowing drugs. This study aims to formulate the chewable tablet preparations of metoclopramide HCl using variations in lubricant concentrations. The variations of magnesium stearate with concentrations of 1%, 2%, and 3% using the direct printing method made to obtain a better physical quality test including organoleptics, weight uniformity, uniformity of size, tablet hardness, tablet brittleness, tablet crush time, uniformity of content. The results of the physical quality test were statistically analyzed using one way ANOVA to determine the effect of variations in the concentration of lubricants on the characteristics of chewable tablets. The results showed that variations in the concentration of magnesium stearate lubricant in the manufacture of metoclopramide HCl chewable tablets had an effect on the physical quality of metoclopramide HCl chewable tablets. The concentration of magnesium stearate which produces metoclopramide HCl chewable tablets with good physical properties is 2%.
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