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关于润滑剂用量对片剂性质影响的实验研究。

An experimental investigation of the effect of the amount of lubricant on tablet properties.

机构信息

Department of Chemical Engineering, École Polytechnique de Montréal, Montreal, Quebec, H3C 3A7, Canada.

出版信息

Drug Dev Ind Pharm. 2011 Feb;37(2):234-42. doi: 10.3109/03639045.2010.505013. Epub 2010 Aug 12.

Abstract

BACKGROUND

Magnesium stearate (MgSt) is widely used as a lubricant in the production of tablets. However, the amount added to a formulation is often too high or it is poorly mixed, which can lead to the production of tablets whose properties are out of specifications.

METHOD

The objective of this work was to investigate by means of a new method based on gamma-ray flux measurement and to study the impact of the amount of MgSt on the mass, thickness, hardness, friability, and disintegration time of tablets containing a 50 : 50 wt.% microcrystalline cellulose and spray-dried lactose pre-blend. Other blends were lubricated with sodium lauryl sulfate (SLS) to compare the performance of the two lubricants in equal amounts.

RESULTS

It was observed that, contrary to SLS, a greater amount of MgSt increased the variability of the tablet mass. The tablet hardness decreased with an increasing amount of MgSt, whereas it remained relatively unaffected by the presence of SLS. No solid conclusion could be drawn concerning the relationship between the lubricant concentration and the tablet friability.

CONCLUSION

An amount of 0.25 wt.% MgSt and 0.75 wt.% SLS were found to be sufficient amounts of lubricants to obtain a proper compression.

摘要

背景

硬脂酸镁(MgSt)作为片剂生产中的润滑剂被广泛应用。然而,制剂中添加的量往往过高或混合不均匀,这可能导致片剂的性能超出规格。

方法

本工作旨在通过一种基于伽马射线通量测量的新方法进行研究,并研究硬脂酸镁用量对含有 50:50wt%微晶纤维素和喷雾干燥乳糖预混料的片剂的质量、厚度、硬度、脆碎度和崩解时间的影响。其他混合物用十二烷基硫酸钠(SLS)润滑,以比较两种等量润滑剂的性能。

结果

与 SLS 相反,观察到添加更多的 MgSt 会增加片剂质量的可变性。随着硬脂酸镁用量的增加,片剂硬度降低,而 SLS 的存在对其影响相对较小。对于润滑剂浓度与片剂脆碎度之间的关系,无法得出明确的结论。

结论

发现 0.25wt%的硬脂酸镁和 0.75wt%的 SLS 是获得适当压缩的足够润滑剂用量。

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