| abstract |
The present invention relates to a release-controlled preparation of a natural drug, and contains a complex herbal extract extracted by mixing 12 kinds of herbal medicines, and relates to a release-controlled preparation suitable for oral administration once a day, and specifically, the present invention relates to a Leila extract ( As a dry matter) and a first release-controlling phase comprising a swellable polymer; And a second release-controlling phase comprising a sustained-release controlling polymer selected from hydrophilic polymers as a matrix, wherein the first release-controlling phase is uniformly dispersed in the second release-controlling phase As a release-controlling formulation having a 2-phases release-control system, the Korean Pharmacopoeia second elution method (paddle method) is used at 50 rpm, at a neutral pH of 37±0.5°C (e.g., water or buffer). Aqueous solution) or acidic (e.g., 0.1N HCl) dissolution rate of acantoside D contained in Leila extract is 20-40% in 4 hours, 40-60% in 10 hours, 80 in 18 hours ~100%, and the average maximum blood concentration of acantoside D of 6 to 10 ng/ml at 2 to 4.5 hours after administration is obtained in vivo, and after repeated administration every 24 hours under steady state conditions, an average of 10 to 14 It relates to a controlled release formulation containing Leila extract that obtains an average minimum blood concentration of 3 to 5 ng/ml up to the time period. |