摘要
目的:优化盐酸普萘洛尔择时释药片的处方。方法:采用干法压制包衣法制备盐酸普萘洛尔择时释药片,以释药时滞(Tlag)和8 h累积释药百分率为评价指标,以包衣中羟丙甲纤维素(HPMC)、微晶纤维素(MCC)、乳糖的用量为考察因素,采用星点设计-效应面法优化制剂处方,并进行处方验证。结果:最优处方为HPMC 85 mg,MCC 45 mg,乳糖20 mg。实测释药时滞为4.2 h,8 h累积释药百分率为87.0%。与预测值的偏差分别为4.8%和1.7%。结论:采用星点设计-效应面法优化出最优处方,所建立的数学模型预测性好,所得制剂具有良好的择时释药制剂特性。
Objective:To optimize the formulation of propranolol hydrochloride time-controlled release tablets.Methods:Propranolol hydrochloride time-controlled release tablets were prepared by a dry-compression coating technique.Central composite designresponse surface methodology was used to optimize the formulation with Tlagand the cumulative release percent within 8 h as the indices.The factors included the amounts of HPMC,MCC and lactose in the coating film.Validation test was also conducted.Results:The optimal formulation contained HPMC 85 mg,MCC 45 mg and lactose 20 mg.The tablets showed the lag time of about 4.2 h and the cumulative release of over 87.0%within 8 h.The bias between the observed values and the predicted values for the lag time and the cumulative release were 4.8%and 1.7%,respectively.Conclusion:Central composite design-response surface methodology can optimize the formulation and the model is highly predictive.The obtained tablets have good time-controlled release property.
作者
李彩艳
乔俊亭
任建萍
韩薇
Li Caiyan;Qiao Junting;Ren Jianping;Han Wei(Collegeof Pharmacy,Shanxi Health Vocational College,Shanxi Jinzhong 030600,China;College of Pharmacy,Shenyang Pharmaceutical University)
出处
《中国药师》
CAS
2021年第5期859-862,888,共5页
China Pharmacist
基金
山西省卫生健康委科研课题计划(编号:2019093)
山西省中医药管理局科研课题计划(编号:2019ZYYZ016)。
关键词
盐酸普萘洛尔
择时释药片
星点设计-效应面法
处方优化
Propranolol hydrochloride
Time-controlled release tablets
Central composite design-response surface methodology
Formulation optimization
作者简介
通信作者:韩薇,Tel:(0351)2776679,E-mail:635021251@qq.coni。
