Sustained Release composition comprising a water-soluble physiologically Active Peptide uniformly dispersed in a microcapsule

摘要

1.A sustained-release composition in which a physiologically active substance comprising a water-soluble physiologically Active Peptide is dispersed into a substantially uniform in a microcapsule comprising a polymer of lactic acid or its Salts,Where a physiologically active substance is contained in an amount of 15 to 35% (weight / weight) with respect to the total microcapsules, and the weight Average Molecular Weight (MP) of the polymer of lactic acid is approximately 11000 to approximately 27.000.2.The sustained Release composition according to claim 1, wherein the weight Average Molecular Weight (MP) of the polymer of lactic acid is any one selected from: (i) approximately 11600 to approximately 20000 and (ii) approximately 19000 to approximately At 27000. 3.The sustained Release composition according to claim 2, wherein the weight Average Molecular Weight of the polymer (MP) (i) of lactic acid is approximately 11600 approximately 20.000, which includes maintaining an effective level of the drug in blood for a period of 60 days to approximately 130 Days of release in vivo of the physiologically active substance Composition of sustained release. 4.The sustained Release composition according to claim 2, wherein the weight Average Molecular Weight of the polymer (MP) (ii) of lactic acid is approximately 19000 to approximately 27.000, which includes maintaining an effective level of drug in blood for a period of 120 days to approximately 400 days for release in vivo of the physiologically active substance Composition of sustained release. 5. - the sustained Release composition according to claim 1, wherein the physiologically active substance is a Derivative of lh-rh. 6.The sustained Release composition according to claim 1, wherein the physiologically active substance is a Peptide formula: 5 - oxo - Pro - His - Trp - Leu - Tyr and ARG pro Zen where and represents dleu, dala, dtrp, dser (tBu), d2nai DHIS (or lmbzl) and Z represents NH - C2H5 or Gly n H2, or a Salt thereof.