一种前列地尔药物组合物、其制备方法及用途

Alprostadil pharmaceutical composition and preparation method and use thereof

Abstract

The invention discloses an alprostadil pharmaceutical composition and a preparation method and application thereof, and belongs to the field of medicine and pharmacy. The alprostadil pharmaceutical composition overcomes the defects of complex preparation process and poor stability of a traditional lipid microsphere preparation. The alprostadil pharmaceutical composition is simple in preparation process only needing simple physical mixing without homogenization process. The product can be sterilized through a 0.22 mum millipore filter film, and can spontaneously emulsify during clinical use by dilution with normal saline or glucose solution and other water solutions and slight oscillation, and under the optimal conditions, average particle size is about 0.2 mum, the narrow particle size distribution is narrow, has the prostaglandin E1 (PGE1) encapsulation rate maintained above 95%,, and fully shows lipid microsphere properties. The alprostadil pharmaceutical composition product does not contain water or water solution, and can maintain the stability at room temperature for a long time without PGE1 degradation phenomenon. The alprostadil pharmaceutical composition product can be used in the treatment of diseases such as cerebral vascular disease, severe hepatitis, diabetes complications or erectile dysfunction and the like.
一种前列地尔药物组合物、其制备方法及用途,属于药物学和制药学领域。本发明克服了传统脂质微球制剂制备工艺复杂、稳定性差的缺点。本发明制备工艺简单,仅需普通物理搅拌过程,无需均质工艺,本发明制备的产品,可通过0.22μm微孔滤膜除菌,临床使用时经生理盐水或葡萄糖溶液等水溶液稀释并轻微振荡后,能够自发乳化,在优选条件下,平均粒径0.2μm左右,粒径分布狭小,对PGE1包封率保持95%以上,充分体现脂质微球特性;本发明产品的组成及制备工艺,不含水或水溶液,能够在室温下长久地保持稳定性,没有发生PGE1降解的现象。本发明的产品用于治疗脑血管疾病、重症肝炎、糖尿病并发症或勃起功能障碍等疾病。

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    Title
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