摘要
以扑热息痛为主药,淀粉为稀释剂、羟丙甲纤维素为崩解剂、硬脂酸镁为润滑剂,通过湿法制粒压片生产工艺方法制备扑热息痛分散片。通过外观、硬度、脆碎度、片重差异和崩解时限作为考察因素指标,筛选出分散片最佳辅料种类。通过单因素试验方法筛选出扑热息痛分散片最佳处方工艺,并将最佳处方工艺所制备的分散片剂进行验证性实验,用以评价片剂的质量是否达到质量标准。通过扑热息痛分散片的稳定性实验,考察分散片的耐热、耐湿耐水性以及长期稳定性。结果表明,扑热息痛分散片最优处方辅料种类为:黏合剂为淀粉浆、崩解剂为羟丙甲纤维素、润滑剂为硬脂酸镁。最佳的制备工艺为:扑热息痛3g、淀粉量5g、羟丙甲纤维素1.5 g、硬脂酸镁1 g、淀粉浆的质量分数10%。所制备的分散片在高热、高湿环境下放置保存3个月后无异常变化,表明该片剂质量稳定,制备工艺可靠。
Taking paracetamol as the main medicine, starch as a diluent, hypromellose as a disintegrant, magnesium stearate as a lubricant, paracetamol dispersible tablets were prepared through the production process of wet granulation and tableting. Taking appearance, hardness, friability, tablet weight difference and disintegration time limit as the inspection indicators, the optimal excipient types of dispersible tablets were screened out.The best prescription technology of paracetamol dispersible tablets was screened by single factor stability experiment of acetaminophen dispersible tablets to investigate the heat resistance, moisture resistance and water resistance and long-term stability of the dispersible tablets. The dispersible tablets prepared by the best prescription technology were subjected to confirmatory experiments to evaluate whether the quality of the tablets reached the quality standard. The results showed that the best prescription excipients for paracetamol dispersible tablets were as follows: starch slurry as a binder, hypromellose as a disintegrant, and magnesium stearate as a lubricant.The best preparation process was as follows: paracetamol 3 g, starch 5 g, hypromellose 1.5 g, magnesium stearate 1 g, and starch slurry mass fraction 10%.The prepared dispersible tablet had no abnormal changes after being stored for 3 months under high heat and humidity environment, indicating that the tablet quality was stable and the preparation process was reliable.
作者
张振梁
赵明
ZHANG Zhen-liang;ZHAO Ming(The First Affiliated Hospital of Hebei North University,Zhangjiakou 075000,China)
出处
《当代化工》
CAS
2021年第6期1362-1365,共4页
Contemporary Chemical Industry
基金
河北省医学科学研究重点课题计划(项目编号:20180818)
张家口市科技计划项目(项目编号:1821039D)。
关键词
扑热息痛
分散片
稳定性研究
Paracetamol
Dispersible tablets
Stability study
