(EN)
It is intended to provide a sustained release fine granular preparation of human growth hormone having both of biodegradability and sustained-release performance with the use of an organic solvent in a minimized amount, ensuring the release of human growth hormone over 3 days or longer, showing regulated initial burst release, being able to have human growth hormone at a content of 10% or more, allowing the quantitative adsorption/encapsulation of sustained-release fine granules of human growth hormone up to 20%, and having favorable dispersion and needle penetration properties, and a process for producing the same. This preparation comprises a porous apatite derivative, human growth hormone and a water-soluble divalent metal compound.
(ZH) 本发明提供如下的人体生长激素的缓释性微粒制剂及其制造方法,即,可以极力避免有机溶剂的使用而同时具有生物体内分解性及缓释性能,延续3天或以上地缓慢释放人体生长激素,抑制了初期爆发性释放,人体生长激素含有率也在10%或以上,最大可以定量地吸附封入20%的人体生长激素,并且分散性、穿针性也良好。其包括多孔性磷灰石衍生物、人体生长激素及水溶性2价金属化合物。