Preparation and content determination of extended-release tablets of altrenogest
10.16303/j.cnki.1005-4545.2024.06.20
- VernacularTitle:烯丙孕素缓释片的制备及其含量测定
- Author:
Yurou HUO
1
,
2
;
Qi ZHAO
;
Kai WANG
;
Jianxu ZHANG
;
Shiyao XU
;
Jiabin ZHANG
;
Yujie YANG
;
Haiquan GU
;
Qianxue LI
;
Xiuxia HE
Author Information
1. 长春理工大学生命科学技术学院,吉林长春 130022
2. 中国农业科学院长春兽医研究所,吉林长春 130122
- Keywords:
altrenogest;
extended-release tablets;
response surface methodology for central combina-tion design
- From:
Chinese Journal of Veterinary Science
2024;44(6):1248-1255
- CountryChina
- Language:Chinese
-
Abstract:
This study aims to prepare altrenogest extended-release tablets,evaluate their quality and establish a content determination method.The hydrophilic gel skeleton type,dosage and core thick-ness of altrenogest extended-release tablets were used as the investigating factors,and the release degree of the tablets was used as the investigating index,the prescription process of altrenogest ex-tended-release tablets was optimized by one-factor screening and central combinatorial design re-sponse surface method,and quality evaluation was carried out,the in vitro release model was es-tablished,and a high-performance liquid chromatography(HPLC)assay method was set up for the determination of altrenogest extended-release tablets.The results showed that the optimal pre-scription of altrenogest extended-release tablets was 2％as the main drug,70％as the solubilizer,0.5％as the lubricant,19.1％as the filler,8.4％as the hydrophilic gel skeleton material,and the thickness of the tablets was 3.8 mm.The in vitro drug release conformed to the Higuchi model,and the altrenogest showed a good linear relationship with the R2=0.999 98 in the range of 10-80 mg/L.The optimized process for the extended-release tablets was stable and had a good quality.The extended-release tablets were stable and had significant slow-release effect.The HPLC method is accurate and reliable and can be used for the determination of altrenogest in extended-release tablets.
