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CN-121987565-A - Ceftiofur injection and preparation method and application thereof

CN121987565ACN 121987565 ACN121987565 ACN 121987565ACN-121987565-A

Abstract

The invention provides ceftiofur injection and a preparation method and application thereof, and belongs to the technical field of veterinary medicine preparations. The ceftiofur injection prepared by the invention takes propylene glycol as a solvent, and each 1000 mL g of the ceftiofur injection comprises 80-120 g of ceftiofur hydrochloride, 50-80 g of hydroxypropyl-beta-cyclodextrin, 400-220 mL of polyethylene glycol, 40-60 mL of medical grade glycerol, 2-5 mL of laurocapram and 0.8-1.2 g of ascorbyl palmitate. The peak time of the ceftiofur injection prepared by the invention is obviously shortened, the drug concentration at the infected part is obviously improved, the drug action time is effectively prolonged, the bacterial drug resistance risk is reduced, the survival rate of piglets can be obviously improved, the death risk caused by bacterial infection is effectively reduced, and the ceftiofur injection is suitable for prevention and control of bacterial infection secondary to the blue-ear disease in a large-scale pig farm.

Inventors

  • LI XIAOWEN
  • LI SHEN
  • FAN MINGYU
  • REN JING
  • Dai Pengxiu
  • WANG ZHIHAO
  • TAO ZHIYONG

Assignees

  • 聊城大学

Dates

Publication Date
20260508
Application Date
20260318

Claims (7)

  1. 1. The preparation method of the ceftiofur injection for improving the survival rate of the blue-ear disease of the piglets is characterized in that the injection takes propylene glycol as a solvent, and each 1000 mL g of the injection comprises 80-120 g of ceftiofur hydrochloride, 50-80 g of hydroxypropyl-beta-cyclodextrin, 400-220 mL of polyethylene glycol, 40-60 mL of medicinal glycerin, 2-5 mL of laurocapram and 0.8-1.2 g of ascorbyl palmitate; The preparation method comprises the following steps: 1) Taking 55-65% by volume of propylene glycol, adding ascorbyl palmitate, adding hydroxypropyl-beta-cyclodextrin, slowly adding ceftiofur hydrochloride after dissolution, and heating to dissolve to form a ceftiofur-HP-beta-CD inclusion compound dispersion system; 2) Sequentially adding polyethylene glycol 400 and pharmaceutical grade glycerol into the composite dispersion system in the step 1), mixing, and adding laurocapram to obtain uniform, bright yellow, clear and transparent liquid medicine; 3) And (3) filtering the liquid medicine in the step (2) under pressure, and adding the residual propylene glycol to obtain the ceftiofur injection.
  2. 2. The method according to claim 1, wherein the temperature is raised to 35-37 ℃ in step 1), and the dissolution time is 30-40 min.
  3. 3. The method of claim 1, wherein the liquid medicine in step 2) has a particle size of 100 nm or less.
  4. 4. The method according to claim 1, wherein the pressure filtration in the step 3) is carried out by using a 0.22 μm polyethersulfone membrane and filtering under a pressure of 0.4 to 06 MPa.
  5. 5. The preparation method according to claim 1, wherein the ceftiofur injection in step 3) has a pH of 5.2-5.6 and a viscosity of 1.5-2.8 mPa s。
  6. 6. A ceftiofur injection prepared by the preparation method of any one of claims 1-5.
  7. 7. Use of the ceftiofur injection according to claim 6 for the preparation of a medicament for treating blue-ear disease of piglets.

Description

Ceftiofur injection and preparation method and application thereof Technical Field The invention relates to the technical field of veterinary medicine preparations, in particular to ceftiofur injection and a preparation method and application thereof. Background Porcine Reproductive and Respiratory Syndrome (PRRS) is a highly contagious disease caused by Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), and is characterized by fever, respiratory disorder, high mortality and reproductive disorder of pregnant sows, which has become the first infectious disease facing the global pig industry. The disease transmission speed is high, and the disease is easier to burst in large-scale pig farms with dense pig groups and frequent flow, so that huge economic loss is caused for pig industry. After the piglet is infected with blue ear disease, obvious immunosuppression can occur, bacterial infection such as streptococcus suis, haemophilus parasuis, actinobacillus pleuropneumoniae and the like is very easy to happen, and the death rate is greatly increased. Most of the piglets in the delivery room develop after 7 days of age, the incidence peaks of the nursery pigs are concentrated at 8-9 weeks of age, the death rate of the piglets before weaning can reach 80-100%, the death rate after weaning is 20-50%, and the death rate is higher in multiple infection. At present, ceftiofur injection is mainly adopted clinically to control bacterial infection and improve the survival rate of piglets. The existing ceftiofur injection has a plurality of short plates, namely, the drug lacks targeting property, the whole body distribution causes insufficient concentration of the drug at an infected part, the drug at a non-infected part is wasted and is easy to cause intestinal flora disorder, the single antibacterial effect is focused, the death rate of piglets caused by blue ear diseases is difficult to reduce from a root source without designing a solution for immunosuppression of the piglets, the suitability of needleless injection is poor, the existing product can only meet the basic needle-through property, the drug release mechanism is designed without combining with the pathological characteristics of fever of the piglets of blue ear diseases, the drug penetration efficiency is low and the absorption is slow during intradermal injection, the stability is to be improved, the color change and the precipitation are easy to occur after long-term storage, and the drug degradation rate is high. Although partial imported ceftiofur injection and domestic ceftiofur injection can improve the survival rate of piglets to a certain extent, the pain points of the composite technology with insufficient targeting, lack of immune regulation, solvent stimulation, poor needle-free suitability and limited stability can not be solved. Therefore, developing a ceftiofur injection with targeting antibacterial, immune synergetic, intelligent release, needleless adaptation and green low-irritation characteristics becomes an urgent need for clinical prevention and control in pig industry. Disclosure of Invention The invention aims to provide a preparation method of ceftiofur injection for improving the survival rate of blue-ear disease of piglets, which can obviously improve the survival rate of piglets. In order to achieve the above object, the present invention provides the following technical solutions: The preparation method of the ceftiofur injection for improving the survival rate of the blue-ear disease of the piglets comprises the steps of taking propylene glycol as a solvent, wherein each 1000 mL g of the injection comprises 80-120 g of ceftiofur hydrochloride, 50-80 g of hydroxypropyl-beta-cyclodextrin, 400-220 mL of polyethylene glycol, 40-60 mL of medicinal glycerin, 2-5 mL of laurocapram and 0.8-1.2 g of ascorbyl palmitate; The preparation method comprises the following steps: 1) Taking 55-65% by volume of propylene glycol, adding ascorbyl palmitate, adding hydroxypropyl-beta-cyclodextrin, slowly adding ceftiofur hydrochloride after dissolution, and heating to dissolve to form a ceftiofur-HP-beta-CD inclusion compound dispersion system; 2) Sequentially adding polyethylene glycol 400 and pharmaceutical grade glycerol into the composite dispersion system in the step 1), mixing, and adding laurocapram to obtain uniform, bright yellow, clear and transparent liquid medicine; 3) And (3) filtering the liquid medicine in the step (2) under pressure, and adding the residual propylene glycol to obtain the ceftiofur injection. Preferably, in the step 1), the temperature is raised to 35-37 ℃, and the dissolution time is 30-40 min. Preferably, the grain size of the liquid medicine in the step 2) is less than or equal to 100 nm. Preferably, the pressure filtration in the step 3) is carried out by using a 0.22 mu m polyethersulfone filter membrane and filtering under the pressure of 0.4-06 MPa. Preferably, the ceftiofur injection in the step 3) ha