Micronized composition containing Levonorgestrel

Abstract

The invention relates to a micronized composition containing Levonorgestrel, and aiming at the problem of low dissolution rate of the Levonorgestrel enteric coated preparation in the prior art, the invention provides the micronized composition containing Levonorgestrel. In the invention, 70 to 100 percent of Levonorgestrel is micronized to particles, and the grain diameter of each particle is less than or equal to 20 nanometers; the particles are combined with 60 to 97.9 percent of excipient to be prepared into a medicine core; and the medicine core is coated by a coating layer. The composition greatly improves the releasing degree and the peak time of the Levonorgestrel and Tmax.

Description

technical field

[0001] The invention relates to a micronized pharmaceutical composition for contraception, in particular to a micronized levonorgestrel-containing composition. Background technique

[0002] Levonorgestrel is used as a progestogen for contraception, especially emergency contraception. Emergency contraception refers to remedial measures taken to prevent pregnancy after intercourse without any contraceptive measures or after contraceptive failure: or taking emergency contraceptive pills within 72 hours after intercourse without contraceptive measures; or placing intrauterine within 5 days IUD. The purpose of taking emergency contraception is to prevent fertilization or implantation of fertilized eggs in the shortest possible time. The dissolution rate of the drug is an important factor affecting the time of action of the drug, so in order to better achieve the purpose of emergency contraception, the dissolution rate of the emergency contraceptive drug should b...