Sulfamerazine-sugar glass dispersions의 溶出速度에 관한 연구

Abstract

난용성약물인 Sulfamerazine을 수용성 carrier인 Dextrose, Galactose 및 Sucrose와 1 : 9의 중량비로 하여 균질하게 혼합한 후 Glass dispersion technique으로 Sugar glass dispersion system을 調製하여 증류수 및 0.1N 염산에서 용출특성을 비교 검토하였다. 그 결과는 다음과 같다. 용출용매가 증류수인 경우에는 Sulfamerazine의 T_(50)%가 390.0분인데 비해, Dextrose, Galactose 및 Sucrose 와의 physical mixture에서는 26.4분, 26.5분 및 26.0분이었고 Sugar g1ass dispersion에서는 각각 1.5분, 3.5분 및 4.0분으로 control에 비해 용출속도가 증가 되었다. 용출용매가 0.1N 염산인 경우에서의 T_(50)%는 control이 54분인데 비해 Dextrose, Galactose 및 Sucrose와의 physical mixture에서는 2.4분, 2.3분 및 6.3분이었고 세 종류의 Sugar glass dispersion system은 모두 1분이내로 control에 비해 용출속도가 현저히 증가되었다. 용출속도가 약물의 bioavailability이 미치는 영향을 고려해 볼 때, 이 Glass dispersion system은 Sulfamerazine과 같은 난용성약물의 습윤성을 증가시켜 용출속도를 증대시키는 또 하나의 방법이 될 수 있다.;Three sugar glass dispersions of sulfamerazine were prepared by glass dispersion technique using dextrose, galactose and sucrose as the carriers, and the ratio of the drug-to-carrier was 1:9. The chemical stability of sulfamerazine in the glass dispersion system was studied using TLC. TLC revealed no additional spot and there was good correspondence with the sulfamerazine itself. T 50% of control was 390 minutes and that of dextrose glass dispersion system was 1.5 minutes, galactose glass dispersion system was 3.6 minutes and sucrose glass dispersion system was 4.0 minutes in distilled water. T 50% of physical mixture with dextrose, galactose and sucrose were 26.4 minutes, 26.5 minutes and 26.0 minutes respectively in distilled water. T 50% of control was 54 minutes and those of all of the glass dispersion systems were within 1 minute in 0.1N HCl. The effect on dissolution rates of sulfamerazine from sugar glass dispersion system in distilled water was greater than that in 0.1N HCl.