【摘要】：目的:改進(jìn)原研制備工藝,仿制拉莫三嗪緩釋片,并考察其體外釋放行為。方法:采用羥丙基甲基纖維素(HPMC)E4M CR和HPMC K100LV CR制備緩釋骨架片芯,以尤特奇~?L30D-55為腸溶材料包衣,制備拉莫三嗪緩釋片。以與原研制劑體外釋放度的相似因子f_2為指標(biāo),采用單因素法篩選處方中乳糖用量、HPMC E4M CR和HPMC K100LV CR質(zhì)量比、HPMC用量及包衣增質(zhì)量。結(jié)果:片芯處方為拉莫三嗪50 mg、HPMC K100LV CR 40 mg、HPMC E4M CR 61.4 mg、乳糖128 mg,最佳包衣增質(zhì)量為3%。自制制劑和原研制劑在含0.5%十二烷基硫酸鈉的pH 6.8磷酸鹽緩沖液、pH 4.5乙酸-乙酸鈉緩沖液和水中的體外釋放行為均相似。結(jié)論:成功仿制了拉莫三嗪緩釋片,且工藝比原研制劑更加簡(jiǎn)單、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.
【作者單位】： 中國(guó)藥科大學(xué)藥學(xué)院藥劑系;國(guó)家食品藥品監(jiān)督管理總局藥品評(píng)審中心;
【分類號(hào)】：R943

【相似文獻(xiàn)】

相關(guān)期刊論文 前6條

1 何丹;譚群友;熊華蓉;王睿;張景R，

本文編號(hào)：2289933