山嵛酸甘油酯作为片剂润滑剂的研究

Study on Glyceryl Behenate as a Lubricant in Tablets

目的研究山嵛酸甘油酯作为润滑剂在片剂中的应用。方法将一定量的山嵛酸甘油酯分别混合在乳糖、磷酸氢钙、微晶纤维素中,测定粉末流动性、片剂推片力,同时比较制备参数对分别含2%山嵛酸甘油酯、0.5%硬脂酸镁的乳糖片剂的崩解时限的影响。结果山嵛酸甘油酯加到乳糖、磷酸氢钙或者微晶纤维素中,都会使得休止角降低;可以使含有乳糖或者微晶纤维素的片子具有较低的推片力(<6 kg);混合速度、混合时间、压片速度对含山嵛酸甘油酯的乳糖片剂的崩解时限影响很小(<90 s)。结论山嵛酸甘油酯是一种性能稳定的润滑剂。

OBJECTIVE Study on glyceryl behenate as a lubricant in tablets. METHODS Glyceryl behenate was mixed with lactose, calcium hydrophosphate, or microcrystalline cellulose, the flowability of blend was tested. Making tablets with these blends, recording the ejection force, and comparing the disintegration time of lactose tablets with 2% glyceryl behenate and 0.5% magnesium stearate, respectively. RESULTS If glyceryl behenate was mixed with lactose, calcium hydrophosphate, or microcrystalline cellulose, the angle of repose would decrease. And the ejection force of lactose, microcrystalline cellulose tablet would be low（〈6 kg）. Preparing parameter, such as blending speed, blending time or press speed had little effect on the disintegration time of lactose tablets with glyceryl behenate as lubricant, which was quite different from magnesium stearate.CONCLUSION Glyceryl behenate is a stable lubricant.