当代化工

以对乙酰氨基酚为主药,稀释剂淀粉、稀释剂糊精、崩解剂羟丙甲纤维素等为辅料,通过湿法制粒压片法制备对乙酰氨基酚片剂。以外观、硬度、脆碎度、片重差异和崩解时限为考察指标,筛选出最优处方辅料种类,并通过正交实验筛选出对乙酰氨基酚片最优处方工艺。通过研究最佳处方工艺所制备的片剂在室温下放置的稳定性实验,用以评价片剂的质量是否达到片剂标准。结果表明:对乙酰氨基酚片最优处方辅料种类为淀粉浆作为黏合剂、羟丙甲纤维素作为崩解剂、硬脂酸镁作为润滑剂。最佳的制备工艺为:对乙酰氨基酚3 g、羟丙甲纤维素2 g、硬脂酸镁0.75 g、淀粉浆的浓度10%。该片剂在37℃保存3个月后无异常变化,表明该片剂质量稳定,制备工艺可靠。

Paracetamol tablets were prepared by wet granulation and compression method with paracetamol as the main drug, starch, dextrin,hydroxypropylmethylcellulose as auxiliary materials.Taking appearance, hardness, brittleness, tablet weight difference and disintegration time limit as inspection indexes, the optimal prescription of paracetamol tablet was selected.Whether the quality of the tablets can meet the standard was evaluated by the stability experiment of the tablets prepared by the best prescription technology at room temperature. The results showed that the optimal formulation of paracetamol tablets was as follows: binder starch paste, disintegrator hydroxypropylmethylcellulose, lubricant magnesium stearate.The best preparation process was as follows: paracetamol 3 g, hydroxylpropylmethylcellulose 2 g, magnesium stearate 0.75 g, and the concentration of starch slurry 10%. The results showed that the quality of the tablet was stable and the preparation process was reliable.