[关键词]
[摘要]
目的 探究硬脂酸镁与十二烷基硫酸钠连用对颗粒流动性以及溶出的影响。方法 设计四组硬脂酸镁与十二烷基硫酸钠不同比例的实验,考察颗粒的流动性以及片剂溶出度,筛选出最优的硬脂酸镁与十二烷基硫酸钠用量。结果 根据流动性、崩解时限、脆碎度、溶出度等因素综合考虑,硬脂酸镁与十二烷基硫酸钠连用,效果明显好于单用硬脂酸镁或单用十二烷基硫酸钠。使用最优处方,进行3批样品制备,考察样品的颗粒流动性、片剂的崩解时限、溶出度、含量、有关物质。同时考察样品的稳定性。结论 经过多批试验证明,硬脂酸镁与十二烷基硫酸钠连用,颗粒流动性及溶出度明显好于单用硬脂酸镁或单用十二烷基硫酸钠,且重现性及稳定性均较好。
[Key word]
[Abstract]
Objective To explore the effect of magnesium stearate combined with sodium lauryl sulfate on particle fluidity and dissolution. Methods Four groups of experiments with different ratios of magnesium stearate and sodium lauryl sulfate were designed to investigate the fluidity of the granules and the dissolution of tablets, and to screen out the optimal dosage of magnesium stearate and sodium lauryl sulfate. Results According to comprehensive considerations such as fluidity, disintegration time limit, friability and dissolution rate, magnesium stearate and sodium lauryl sulfate are used in combination, and the effect is significantly better than that of magnesium stearate alone or dodecyl sulfate alone. Using the best prescription, 3 batches of sample preparation were carried out to investigate the particle fluidity of the sample, the disintegration time limit of the tablet, the dissolution rate, the content, and related substances. The stability of the samples was also investigated. Conclusion It has been proved by many tests that the particle fluidity and dissolution of magnesium stearate combined with sodium lauryl sulfate are obviously better than that of magnesium stearate or sodium lauryl sulfate alone, and the reproducibility and stability are better.
[中图分类号]
[基金项目]