盐酸头孢替安酯片的研制及质量研究

Study on preparation and quality of cefotiam hexetil hydrochloride tablet

目的研究盐酸头孢替安酯片的制备工艺及质量。方法以药物的崩解时限和溶出度为主要指标,采用原研片参比单因素考察法对盐酸头孢替安酯片的处方工艺进行优化,并对其质量进行研究。结果实验确定最优处方:以无水枸橼酸、α-环糊精、微晶纤维素、羟丙纤维素、二氧化硅、硬脂酸镁、薄膜包衣预混剂(胃溶型)为辅料,采用干法制粒制备盐酸头孢替安酯片。盐酸头孢替安酯片各项指标符合日本药局方(JPXV)标准。结论盐酸头孢替安酯片的制备工艺可行,产品质量具有良好的稳定性。

Objective To study the preparation technology and quality of cefotiam hexetil hydrochloride tablet.Methods The disintegration time limit and dissolution of drug were taken as the main index.The original piece of reference was used to optimize the prescription process and preliminary study on its quality.Results The best prescription was determined by experiments:cefotiam hexetil hydrochloride tablets were prepared by dry granulation with anhydrous citric acid,alpha-cyclodextrin,microcrystalline cellulose,hydroxypropyl cellulose,silica,magnesium stearate and film-coated premix(gastric-soluble).The indexes of cefotiam hexetil hydrochloride tablet conformed to the Japanese Pharmaceutical Bureau Prescription(JPXV)standard.Conclusion The preparation technology of cefotiam hexetil hydrochloride tablet was feasible and the product had good stability.