相似因子法评价不同因素对复方头孢氨苄缓释微丸在体外释放的影响

Influencing factors on release of Compound Cefalexin sustained-release pellets in vitro by similarity factor

目的考察不同因素对复方头孢氨苄缓释微丸在体外释放的影响。方法采用单因素试验对可能影响体外释放的各因素进行考察,用相似因子法对释放曲线进行比较。结果包衣增重、致孔剂的种类和用量、包衣液固体聚合物的浓度、微丸抗黏用头孢氨苄粉末的用量对药物在体外的释放有较大影响,其他各因素对释放的影响不大。结论相似因子能很好地评价缓释制剂的体外释放。

OBJECTIVE To investigate the influencing factors on release of Compound Cefalexin sustained - release pellets in vitro. METHODS Single - factor method was used to investigate several factors affecting cefalexin release rate. Similarity factor was used to evaluate the effect of all those influencing factors on release profiles of cefalexin. RESULTS Many factors have significant influence on the release rate of cefalexin, such as the weight of coating, different kinds and content of pore former, the concentration of polymer in coating solution and the cefalexin powder added to prevent agglomeration during the preparation of pellets. Other factors have little influence on the drug release rate. CONCLUSION The similarity factor is fit for evaluating ＇sustained release preparation.