【摘要】：以自制馬西替坦片和原研制劑(Opsumit)在含0.1%十六烷基三甲基溴化銨(CTAB)的pH 6.8磷酸鹽緩沖液中溶出曲線的相似因子f_2為主要考察指標(biāo),片劑的性質(zhì)(如顆粒流動(dòng)性、崩解時(shí)間等)為輔助指標(biāo),采用單因素試驗(yàn)和正交設(shè)計(jì)篩選了馬西替坦片片芯的最優(yōu)處方,即過200目篩的原料藥30 g,一水乳糖116.9 g,聚維酮K30 6.6 g,微晶纖維素和羧甲淀粉鈉在制濕顆粒前加入11.7和4.2g,在整粒后加入剩余的35.1和4.2 g,黏合劑采用0.2%Tween-80溶液。經(jīng)包薄膜衣后得到3批優(yōu)化自制片,與原研制劑相比,在pH 1.0鹽酸、pH 4.5乙酸鹽緩沖液、pH 6.8磷酸鹽緩沖液及水中溶出曲線的相似因子(f_2)值均大于65。影響因素試驗(yàn)結(jié)果顯示自制片具有較好的穩(wěn)定性。
[Abstract]:The dissolving curve similarity factor f2 of maxititan tablets and (Opsumit) in pH 6.8 phosphate buffer solution containing 0.1% cetyltrimethylammonium bromide (CTAB) was used as the main index of investigation. The properties of the tablets (such as particle fluidity, disintegration time, etc.) were used as auxiliary indexes. The optimal formulation of Masititan tablets core was screened by single factor test and orthogonal design. The microcrystalline cellulose and sodium carboxymethyl starch were added 11.7 and 4.2 g before the wet granules, and the remaining 35.1 and 4.2 g were added after the whole grain. The adhesive was 0.2%Tween-80 solution. Three batches of optimized tablets were obtained by coating the film. Compared with the original preparation, the similar factor (f _ 2) of pH 1.0 hydrochloric acid, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and water dissolution curve (f _ 2) were all greater than 65. The experimental results show that the self-made sheet has good stability.
【作者單位】： 中國醫(yī)藥工業(yè)研究總院上海醫(yī)藥工業(yè)研究院上海藥物合成工藝過程工程技術(shù)研究中心;中國藥科大學(xué);
【分類號(hào)】：R943
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本文編號(hào)：2378258