| abstract |
The invention discloses an abiraterone acetate soft capsule and a preparation method thereof. The soft capsule is composed of contents and a capsule shell, the contents comprising abiraterone acetate, caprylic acid mono- and diglycerides, Tween 80, Span 80 and butylated hydroxyanisole; the capsule shell is composed of soft capsules. Capsule material composition, the composition includes: gelatin, water, glycerin, sorbitol sorbitan solution, and the ratio of each component is 1:0.74:0.35:0.35. After the abiraterone acetate soft capsule provided by the present invention is taken orally on an empty stomach, compared with the original research drug Zytiga (specification 250 mg), there is no need to go through the dissolution step of the original research drug Zytiga in the digestive tract, the oral bioavailability is increased to 12.5 times, and the inter-individual variation It also eliminates the significant increase in abiraterone exposure caused by postprandial administration of the original drug Zytiga. |