The invention relates to a method for preparing a
prostaglandin E1 lipid
microsphere injection of a charging non-homogeneous phase (comprising a water phase, an oil / water interfacial film phase and an
oil phase) dispersion
system, of which the surface of the lipid
microsphere can be charged with positive
electricity or negative
electricity. The
prostaglandin E1 is alprostadil, of which the
chemical structure comprises a basic skeleton of 20-carbon
fatty acid with a 5-carbon ring and two side chains, wherein one
side chain is provided with a hydrophilic
carboxylic acid group, so that the
prostaglandin E1 has the characteristic of light surface activity action. By utilizing the characteristic, and according to the formula and the preparation process provided in the invention, the
prostaglandin E1 has an unique
drug-carrying mode in a solution of lipid
microsphere with the non-homogeneous phase dispersion
system, and the prepared lipid microsphere injection is fundamentally different from an
alprostadil injection(Kaishi, and is prepared by adopting the technology of the Japanese business corporation LTT Bio-Pharma Co., Ltd. already sold in markets, and the difference lies in that the
drug-carrying mode is completely different, the content of degradation products in the preparation such as impurities is more than 50 percent lower than that of in the Kaishi, so that the
prostaglandin E1 lipid microsphere injection and the
alprostadil injection are fundamentally different. The invention relates to a method for preparing the
prostaglandin E1 lipid microsphere injection and the
drug-carrying characteristics thereof in a three-phase
system; in the formula, 0.0001 to 0.1 weight portion of prostaglandin E1 is used as a drug, the prostaglandin E1 is added with auxiliary materials for medical purpose to prepare the prostaglandin E1 lipid microsphere injection, and the auxiliary materials for medical purpose comprises the following materials in portion by weight: 5 to 20.