本文選題：羅紅霉素片 + Box-Behnken效應面法�。� 參考：《中國抗生素雜志》2017年09期

【摘要】：目的制備羅紅霉素片并考察其體外溶出度。方法以羅紅霉素原料藥平均粒徑(X1,μm),低取代羥丙基纖維素用量(X2,%)和泊洛沙姆188用量(X3,%)作為考察對象,以羅紅霉素在30min的溶出度(Y,%)作為評價指標,采用Box-Behnken效應面法優(yōu)化羅紅霉素片處方;并通過f2相似因子法比較自研制劑和參比制劑的體外溶出相似性。結(jié)果經(jīng)優(yōu)化得到的羅紅霉素片的處方為:羅紅霉素原料藥平均粒徑為80μm,低取代羥丙基纖維素用量為7.5%,泊洛沙姆188用量為4.0%,在4種溶出介質(zhì)中自制的羅紅霉素片與參比制劑體外溶出具有較好的相似性。結(jié)論通過Box-Behnken效應面法優(yōu)化得到的羅紅霉素片處方與參比制劑體外溶出一致性良好,有望工業(yè)化生產(chǎn)。
[Abstract]:Objective to prepare roxithromycin tablets and investigate its dissolution in vitro. Methods the average particle size of roxithromycin was X 1, 渭 m, low substituted hydroxypropyl cellulose was used, and Poloxamer 188 was used as the object of investigation. The dissolution of roxithromycin in 30min was used as the evaluation index. The formulation of roxithromycin tablets was optimized by Box-Behnken effect surface method, and the dissolution similarity of self-made and reference preparations was compared by f2 similarity factor method. Results the optimized formulation of roxithromycin tablets was as follows: the average particle size of roxithromycin was 80 渭 m, the dosage of low substituted hydroxypropyl cellulose was 7.5, the dosage of Poloxamer 188 was 4.0. The dissolution of reference preparation in vitro has good similarity. Conclusion the formulation of roxithromycin tablets optimized by Box-Behnken effect surface method is in good agreement with that of reference preparation in vitro and is expected to be produced in industrial production.
【作者單位】： 南通大學附屬醫(yī)院藥學部;
【分類號】：R943

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本文編號：1886932