Sustained-release microsphere preparation of goserelin composition

• Main Authors: XU ZHOUWEN, SHU SUIZHI, LI YUNKAI, ZHI QIN, YAO ZHIYONG
• Format: Patent
• Language: English
• Published: 25.03.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention belongs to the field of a pharmaceutical preparation, and relates to a sustained-release microsphere preparation of a goserelin composition and a preparation method of the sustained-release microsphere preparation. Specifically, the goserelin composition includes goserelin and a polypeptide composition capable of enhancing immunity, wherein the polypeptide capable of enhancing immunity comprises thymalfasin, thymopentin and thymosin beta4. The sustained-release microsphere consists of 0.1-40% (w/w) of goserelin and polypeptide capable of enhancing immunity in terms of the total weight of the microsphere, 60-99.9% of a biodegradable and biocompatible high polymer material which is 5,000-200,000Dalton in molecular weight in terms of the weight of the microsphere, and 0-10% of other pharmaceutically acceptable accessories in terms of the weight of the microsphere. The sustained-release microsphere disclosed by the invention is 5-20microns in average grain size and encapsulation efficiency is more than 80%. The sustained-release duration of the sustained-release microsphere can last for several days or several months, so that administration frequency is obviously reduced, bioavailability is improved, the toxic and side effects of medicine are reduced, and the sustained-release microsphere is conducive to clinic treatment. The production process of the finished product is good in reproducibility and good in feasibility.