30 results about "Alprostadil Injection" patented technology

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<TM>, 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 thatthe 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 provides an alprostadil injection preparation and a preparation method thereof. The alprostadil injection preparation is prepared from alprostadil, dioleoyl phosphatidylglycerole, cholesterol, polyethylene glycol 2000 and trehalose. Compared with the prior art, the preparation greatly improves the stability and bioavailability of the preparation, drug release is stable, the quality of the preparation product is improved, and the curative effect is more significant.

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 lungand being beneficial to improving the bioavailability, thus further improving the drug effect.

The invention belongs to the field of a pharmaceutical preparation, and in particular relates to an alprostadil injection. The injection consists of 0.001-0.05mg / ml of alprostadil, 0.01-100mg / ml of an oil phase, 10-500mg / ml of phospholipid and the balance of an organic solvent. The injection disclosed by the invention is constantly an anhydrous system in storage process, and is used right as long as being ready, so that the injection can prevent oxidization reaction of the phospholipid and degradation reaction of the medicine, and can improve the stability of the alprostadil injection. An alprostadil composition provided by the invention can prepare the alprostadil injection which is excellent in stability, and the preparation process is quite simple.

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.

The invention relates to a sterilization process of alprostadil fat emulsion. Use 915MHz or 2450MHz frequency microwave equipment to irradiate the 1ml and 2ml ampoule alprostadil injection placed in the microwave equipment to raise the temperature of the ampoule to 65-140°C and maintain it for 10 seconds to 5 minutes for sterilization , can completely kill the microorganisms in the preparation. The determination of the main drug PGE1 and impurity PGA1 in the preparation adopts the method of freeze-drying to de-emulsify, so that the sample becomes an oily substance, and then extracts the oily substance with an organic solvent to obtain a test solution. At the place, PGE1 and PGA1 were determined according to the external standard method or internal standard method. The invention effectively reduces the main drug degradation of the alprostadil fat emulsion caused by the traditional sterilization process.

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 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.

The invention provides an alprostadil injection. Every 1000ml of alprostadil injection comprises the following raw materials: 5mg of alprostadil, 90-110g of soybean oil, 15-20g of phosphatide, 2-3g of oleic acid, 22.1-25g of isoosmotic agent, and appropriate pH modifier, wherein the content of the pH modifier is enough to regulate the pH of the injection to be 5.0-6.0. The invention also provides a preparation method for the alprostadil injection. Compared with the prior art, the alprostadil injection prepared by the method has higher encapsulation efficiency and content of main drug, contains fewer related substances, has good stability, and provides safety guarantee for clinical medication.

The invention belongs to the technical field of medicines and discloses an injection preparation prepared from alprostadil serving as a raw material. The injection preparation is characterized by comprising the following components in part by weight: 0.01 part of alprostadil, 200 parts of soybean oil, 36 parts of phospholipid, 50 parts of glycerin and 4.8 parts of oleic acid. Through a preferabletest of a preparation process, the preparation process of adjusting the pH value of foremilk to be between 5.4 and 6.0 and treating the foremilk by using a nanomachine for 5 times under the pressure of 50MPa so as to prepare lipid microspheres with the average uniform particle size of between 100 and 280nm and performing flowing steam sterilization at the temperature of 121 DEG C for 15 minutes is determined. The preparation process has the advantages of high stability, small impurity quantity and the like.

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.

The invention discloses a detection method of alprostadil injection. The method comprises: taking 20 μL of alprostadil reference substance solution for HPLC sample analysis; Used for HPLC injection analysis; calculate the encapsulation efficiency of alprostadil injection according to the external standard method. The detection method of the invention has high precision, good reproducibility and good stability, and can accurately measure the encapsulation efficiency of the alprostadil 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.