提高盐酸吡格列酮片溶出度的工艺研究

Study on the Technique of Improved Dissolution of Pioglitazone Hydrochloride Tablets

摘要: 目的研究提高盐酸吡格列酮片溶出度的工艺。方法采用单因素试验法优化制剂工艺，包括黏合剂的加入量、搅拌速度、剪切速度、压片机主压力等项目，测定颗粒粒度分布、片剂硬度、崩解时间、溶出度等指标。结果调整工艺参数后，控制黏合剂用量为26.26%，制粒时搅拌速度为280 r·min^-1，制得的盐酸吡格列酮片的质量指标符合要求且溶出度明显提高，符合药典以及企业内控标准。结论该方法处方合理，工艺简单，适合于产业化生产的要求。

Abstract: OBJECTIVE To study the technique of improving the dissolution of pioglitazone hydrochloride tablets. METHODS Using the single-factor experiment method to study the effect of adhesive concentration, milling time, stirring velocity, shear velocity and pressure on the pioglitazone hydrochloride tablets. RESULTS By adjusting the process parameters, the amount of adhesive as 26.26%, granulation stirring speed as 280 r·min^-1, dissolution of pioglitazone hydrochloride tablets was much better. CONCLUSION The method is reasonable and practical. It is suitable for manufacturing industries.