罗红霉素片的制备及溶出度考察

发布时间：2018-05-14 07:27

本文选题：罗红霉素片 + Box-Behnken效应面法　；参考：《中国抗生素杂志》2017年09期

【摘要】：目的制备罗红霉素片并考察其体外溶出度。方法以罗红霉素原料药平均粒径(X1,μm),低取代羟丙基纤维素用量(X2,%)和泊洛沙姆188用量(X3,%)作为考察对象,以罗红霉素在30min的溶出度(Y,%)作为评价指标,采用Box-Behnken效应面法优化罗红霉素片处方;并通过f2相似因子法比较自研制剂和参比制剂的体外溶出相似性。结果经优化得到的罗红霉素片的处方为:罗红霉素原料药平均粒径为80μm,低取代羟丙基纤维素用量为7.5%,泊洛沙姆188用量为4.0%,在4种溶出介质中自制的罗红霉素片与参比制剂体外溶出具有较好的相似性。结论通过Box-Behnken效应面法优化得到的罗红霉素片处方与参比制剂体外溶出一致性良好,有望工业化生产。
[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.
【作者单位】：南通大学附属医院药学部;
【分类号】：R943

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