30 results about "Alprostadil Injection" patented technology

The invention discloses a stable alprostadil injection latex which takes alprostadil as active ingredient, contains oil for injection, emulsifier, glycerin for injection and water for injection which are accepted by pharmacy, and is prepared by emulsification technology. Compared with the existing alprostadil injection latex on the market, the stable alprostadil injection latex prepared by the invention can remarkably enhance the thermal stability of the alprostadil, prolong the period of validity of the alprostadil injection latex while reducing the degradation of the alprostadil at the lung and being beneficial to improving the bioavailability, thus further improving the drug effect.

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.

The invention relates to a preparation method of an alprostadil injection. The alprostadil injection consists of alprostadil, oil for injection, emulsifier, stabilizer and other agents, pH regulator and water for injection. Compared with the commercially available products, the quality standard of the prepared product is significantly improved, and the safety of clinical medication is increased.

The invention relates to an alprostadil injection and a preparation method thereof. The alprostadil injection has a prescription as follows: a, a main drug is alprostadil with concentration of 5mu g-15mu g/ml; b, an oil phase is soybean oil with concentration of respectively 10.0-12.0 percent; c, soyabean lecithin and poloxamer 188 are selected as emulsifying agents and have concentrations of respectively 1.0-1.8 percent and 0.02-0.2 percent; d, citric acid is adopted as a pH regulating agent with concentration of 5nM to 50Mm and pH of 5.0-6.0; e, glycerol is adopted as an osmotic pressure regulating agent with concentration of respectively 2.0-2.5 percent; and f, the balance is injection water.

An alprostadil lipid emulsion for injection and a preparation method therefor. The lipid emulsion contains alprostadil, phosphatidylcholine, phosphatidylglycerol, oil for injection and a lyophilized protective agent. Based on 1 part by weight of the alprostadil, the content of the phosphatidylcholine is 1200 to 4000 parts by weight, the content of the phosphatidylglycerol is 12 to 120 parts by weight, the content of the oil for injection is 2000 to 20000 parts by weight, and the content of the lyophilized protective agent is 16000 to 60000 parts by weight.

A bactericiding process for the fatty emulsion of prostaglandin E1 features that said fatty emulsion in the ampules is heated to 65-140 deg.C for 10s-5 min by microwaves at 915 or 2450 MH2. A method for measuring its main component PGE1 and impurity PGA1 includes such steps as freeze drying for demulsifying to obtain oily sample, extracting in organic solvent, and efficient liquid-phase chromatography at 204-214 nm in wavelength to measure PGE1 and PGA1.

The invention discloses a method for measuring prostaglandin E1 and/or prostaglandin A1 in alprostadil fat emulsion injection, which comprises the following steps: (1) ultrasonically processing the alprostadil fat emulsion injection, obtaining an alprostadil solution of which the fat phase is removed; and (2) performing high performance liquid chromatography measurement to the alprostadil solution of which the fat phase is removed, obtaining the content of the prostaglandin E1 and/or prostaglandin A1, wherein the conditions of the high performance liquid chromatography measurement are as follows: stationary phase: octadecyl ether-bonded monolithic silica is filling agent, mobile phase: the ratio of phosphate buffer to acetonitrile is equal to 1-6:1, and the detection wavelength is 278 nm. The method can accurately measure the alprostadil and the degradation products thereof in the alprostadil fat emulsion injection.

The invention relates to a content detection method of an alprostadil injection. The content detection method of the alprostadil injection comprises the following steps: preparing a beta-naphthol internal standard solution; preparing beta-naphthol internal standard solutions with the same concentration from a test solution and a reference solution, then carrying out column separation on alprostadil by using a high performance liquid chromatography, taking 1 mol/L of a KOH solution as a reaction solution by using a post-column derivatization method, controlling the temperature of a reaction tank to be 60 DEG C, finally detecting alprostadil and beta-naphthol peak area on a wavelength of 278 nm, and calculating the content of alprostadil by using an internal standard method. By adopting the method provided by the invention to detect the content of the alprostadil injection, the problem of small beta-naphthol peak area in the existing method for detecting the content of the alprostadil injection is effectively solved, the detection accuracy of the content of the alprostadil injection is improved, and the content detection method of the alprostadil injection is applicable to detection of the content of the alprostadil injection in different prescriptions.

The invention provides an alprostadil injection and a preparation method thereof. The alprostadil injection is composed of alprostadil, oil for injection, an oleophylic emulsifying agent, an isotonic agent for injection and a stabilizing agent. The alprostadil injection contains alprostadil particles with an average particle size being 100-300nm and D90 being 150-350nm, and particle size change of the alprostadil injection is smaller than or equal to 10% after the alprostadil injection is placed for 12 months at the temperature of 2-8 DEG C.

The invention relates to a preparation method of an alprostadil injection. The preparation method comprises the following steps: adding egg yolk lecithin and polyethylene glycol 2000 into an organic solvent to dissolve, adding alprostadil to stir and dissolve, decompressing and drying to obtain alprostadil compound powder, and further preparing into an emulsion injection. Active ingredients have high affinity with an oil phase, the alprostadil is enabled to be wrapped in emulsion stably, at the same time the metabolic inactivation of the alprostadil injection emulsion in alkaline environment is reduced, so that the stability and safety of drugs are improved, and the toxic and side effects of the drugs are reduced.

The invention discloses a preparation method of an alprostadil injection. The method comprises the following steps: preparing an alprostadil inclusion compound; preparing alprostadil inclusion compound liposome suspension liquid; preparing an alprostadil inclusion compound liposome; preparing an alprostadil injection. In addition, the invention also discloses the alprostadil injection obtained bythe method. The alprostadil injection is small in average particle size and narrow in particle size distribution; meanwhile, high encapsulation efficiency can be realized; moreover, the alprostadil injection has a slow release effect and can obviously improve the bioavailability.

The invention relates to a medicine composition containing alprostadil and a preparation method of the medicine composition. The prescription of the composition containing alprostadil injection comprises the following components: balance of water for injection.