Preparation method of ceftiofur acid long-acting injection

Abstract

The invention belongs to the technical field of preparation of medicines and in particular relates to a preparation method of ceftiofur acid long-acting injection. The preparation method comprises the followings steps of: adding ceftiofur acid and 2-hydroxypropyl-beta-cyclodextrin in a molar ratio of 1:(1-2) to a ball mill for uniformly mixing; sufficiently grinding under the room temperature, and sufficiently uniformly and sieving to obtain a ceftiofur acid clathrate compound; dissolving sodium alginate in sterile water and adding poloxamer 407 and poloxamer 188, storing for 12-24 hours under the temperature condition of 4 DEG C, so that the poloxamer 407 and the poloxamer 188 are completely dissolved and sterilized under the temperature of 121 DEG C, carrying out ice-bath cooling to obtain a transparent solution; magnetically stirring under the temperature condition of 4 DEG C and the rotation speed condition of 150r / min; adding the ceftiofur acid clathrate compound in a weight ratio of the sodium alginate to the ceftiofur acid clathrate compound of (0.1-0.3):(5-10), so that the ceftiofur acid clathrate compound is sufficiently dispersed uniformly to obtain the ceftiofur acid long-acting injection. According to the preparation method of the ceftiofur acid long-acting injection, the preparation process is simple, the product intramuscular injection half-life period is long, the dissolution degree of the ceftiofur acid is high, the production and treatment cost is low, the cure rate is high and the environment is friendly.

Description

Technical field: [0001] The invention belongs to the technical field of medicine preparation, and relates to a preparation method of ceftiofuric acid long-acting injection, which adopts the combination of cyclodextrin inclusion technology and temperature-sensitive in-situ gel slow-release technology to provide a new type of cefotaxime The production process of Fu long-acting injection. Background technique: [0002] Ceftiofur is a third-generation antibiotic for animals. The prototype of ceftiofur is ceftiofur acid, which is insoluble in water. Ceftiofur sodium salt is easily soluble in water. It has poor stability after dissolution and needs to be used immediately for injection. It is prepared now and has a short half-life after injection, so frequent administration is required; ceftiofur hydrochloride, namely ceftiofur hydrochloride, is insoluble in water and is often used to prepare ceftiofur hydrochloride long-acting suspension injection. Clinical routine preparations m...

AI Technical Summary

Problems solved by technology

Clinical routine preparations mainly include ceftiofur sodium freeze-dried powder, which needs to be injected once a day. The stress caused by frequent injections has a certain impact on the therapeutic effect, and the growth of animals is inhibited to varying degrees, resulting in economic benefits. Reduced; the existing domestic ceftiofur long-acting suspension injection Using solid dispersion technology and using hydrogenated castor oil as a slow-release carrier, the long-acting preparation of ceftiofur hydrochloride was prepared by emulsification of organic reagents. The addition of organic reagents enhances the toxicity of the preparation, and the preparation is layered. Shake well before use, which may easily lead to uneven injection ; Imported ceftiofur long-acting preparations are mostly used by Pfizer Animal Health of the United States This product uses ceftiofur acid to prepare ceftiofur crystalline free acid. Although it overcomes the short half-life of ceftiofur intramuscular injection, the preparation has local irritation, and the single point injection should not exceed 2mL. Shake well before use, and the preparation has a high viscosity , injection is relatively difficult, and its price is high, reducing the economic benefits of production