拉莫三嗪缓释片的制备及体外释放行为考察

发布时间：2018-10-23 17:13

【摘要】：目的:改进原研制备工艺,仿制拉莫三嗪缓释片,并考察其体外释放行为。方法:采用羟丙基甲基纤维素(HPMC)E4M CR和HPMC K100LV CR制备缓释骨架片芯,以尤特奇~?L30D-55为肠溶材料包衣,制备拉莫三嗪缓释片。以与原研制剂体外释放度的相似因子f_2为指标,采用单因素法筛选处方中乳糖用量、HPMC E4M CR和HPMC K100LV CR质量比、HPMC用量及包衣增质量。结果:片芯处方为拉莫三嗪50 mg、HPMC K100LV CR 40 mg、HPMC E4M CR 61.4 mg、乳糖128 mg,最佳包衣增质量为3%。自制制剂和原研制剂在含0.5%十二烷基硫酸钠的pH 6.8磷酸盐缓冲液、pH 4.5乙酸-乙酸钠缓冲液和水中的体外释放行为均相似。结论:成功仿制了拉莫三嗪缓释片,且工艺比原研制剂更加简单、易行。
[Abstract]:Aim: to improve the preparation process of lamotriazine sustained-release tablets and investigate its release behavior in vitro. Methods: hydroxypropyl methyl cellulose (HPMC) E4M CR and HPMC K100LV CR were used to prepare sustained-release matrix tablets. Uttage ~? L30D-55 was used as enteric coated material to prepare lamotriazine sustained-release tablets. In this paper, the similar factor flife _ 2, which is similar to the in vitro release rate of the preparation, was used to screen the dosage of lactose, the mass ratio of HPMC E _ 4M CR and HPMC K100LV CR, the amount of HPMC and the quality of coating by single factor method. Results: lamotrigine 50 mg,HPMC K100LV CR 40 mg,HPMC E 4M CR 61.4 mg, lactose 128 mg, was used as the best coating material for the core tablets. The release behavior of self-made and original preparation in pH 6.8 phosphate buffer containing 0.5% sodium dodecyl sulfate, pH 4.5 acetic acid-sodium acetate buffer and water was similar. Conclusion: lamotriazine sustained release tablets were successfully imitated, and the process was simpler and easier than the original preparation.
【作者单位】：中国药科大学药学院药剂系;国家食品药品监督管理总局药品评审中心;
【分类号】：R943

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