Long-acting ceftiofur hydrochloride injection and preparation method thereof

A technology of ceftiofur hydrochloride and injection, which is applied in the direction of medical preparations containing active ingredients, liquid delivery, and pharmaceutical formulations, can solve the problems of inconvenience in veterinary treatment and inadaptability to treatment of animals, and achieve simple preparation methods, Good stability, less irritation effect

Inactive Publication Date: 2012-05-30
SHANGHAI ANIMAL EPIDEMIC PREVENTION & CONTROL CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the maintenance time of the effective blood drug concentration of the above-mentioned preparations mostly between 24-32 hours, daily injections are required during clinical treatment, which brings inconvenience to the treatment work of veterinarians and also causes the incompatibility of treating animals.
At present, there is no report about the long-acting preparation of ceftiofur

Method used

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  • Long-acting ceftiofur hydrochloride injection and preparation method thereof
  • Long-acting ceftiofur hydrochloride injection and preparation method thereof
  • Long-acting ceftiofur hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0026] Example 1-3 , Preparation of long-acting ceftiofur hydrochloride injection

[0027] Prepare long-acting ceftiofur hydrochloride injection according to the formula shown in Table 1, and the specific operations are as follows:

[0028] Heat soybean oil for injection to 90°C in a sterilized container, then add additives Span-80, propylene glycol, and lecithin, stir continuously to mix and dissolve, continue heating to 150°C, and sterilize for 1 hour. After cooling, add ceftiofur hydrochloride, continue to stir for 20 minutes, supplement soybean oil for injection to 100% (1000ml), use a GZJ type high-shear homogenizer to stir and mix evenly, and import the suspension into a 10,000-class clean room for filling. Pack in 10ml / 50ml molded glass bottles, cover with butyl rubber stopper and aluminum cap, crimp the cap, and pack after light inspection.

[0029] During the preparation process, the purpose of using GZJ type high shear homogenizer for homogenization operation is to...

Embodiment 4

[0032] Example 4 ,clinical experiments

[0033] Get 12 pigs (body weight 30~40 kilograms, male and female half and half), divide into three groups at random, inject the long-acting ceftiofur hydrochloride injection prepared in embodiment 1~3 by intramuscular injection of 5 mg per kilogram of body weight, and inject cephalosporin hydrochloride Thiofur (Shandong Lukang Pharmaceutical Co., Ltd., batch number 071103) was used as a control example, and the intravenous injection of ceftiofur hydrochloride was used as a bioavailability control, and then blood was collected from the axillary vein to detect the blood drug concentration, and the following tests were performed.

[0034] 4.1. Detection of drug concentration in plasma

[0035] After the pigs were injected with the drug, blood was collected from the axillary vein, and the concentration of ceftiofur in the plasma was detected at various time points by ion exchange-high performance liquid chromatography. The results are sho...

Embodiment 5

[0048] Example 5 , product stability experiment

[0049] The long-acting ceftiofur hydrochloride injection described in Examples 1 to 3 was stored at an ambient temperature of 30°C. After 6 months of observation, it was found that the product remained a milky yellow oil suspension. After 10 days of strong light irradiation, The product stays the same color.

[0050] According to the relevant regulations in the appendix of "The Veterinary Pharmacopoeia of the People's Republic of China" 2005 edition, the main drug content, sedimentation volume ratio, and accelerated test of the long-acting ceftiofur hydrochloride injection described in Examples 1 to 3 are detected, specifically See Table 4.

[0051] Table 4

[0052] Example 1

Example 2

Example 3

main drug content

97.6％

97.9％

98.2％

sterile

qualified

qualified

qualified

Sedimentation volume ratio

0.97

0.97

0.98

accele...

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PUM

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Abstract

The invention discloses a long-acting ceftiofur hydrochloride injection and a preparation method thereof. The long-acting ceftiofur hydrochloride injection of the invention is prepared from the following raw materials in percentage by weight: 10.2%-10.8% of ceftiofur hydrochloride, 2.0%-6.5% of additive and balance of soybean oil for injection. The long-acting ceftiofur hydrochloride injection ofthe invention can slowly release drug effect; the duration time of the blood drug concentration of the long-acting ceftiofur hydrochloride injection is 72-84 hours, which is greatly longer than the duration time of the blood drug concentration of the current ceftiofur hydrochloride injection; and compared with the conventional injection which needs to be injected once per day, the long-acting ceftiofur hydrochloride injection only needs to be injected once every 3 days and has good stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a long-acting ceftiofur hydrochloride injection and a preparation method thereof. Background technique [0002] Ceftiofur (Ceftiofur), also known as Saidefu, was first synthesized by Bernard Labeeuw et al. in 1984. It was the first third-generation cephalosporin antibiotic dedicated to livestock and poultry; The company (Pharmacia & Upjohn) makes it into lyophilized powder of sodium salt and suspension of hydrochloride (trade name Naxcel, Excenel) for the treatment of animal diseases. [0003] Ceftiofur is absorbed quickly and has high bioavailability; it has a high binding rate with proteins in the body, forming a stock bactericidal effect, with a long half-life and long-lasting drug effect; compared with other antibiotics, the uniqueness of this drug lies in the content of the drug in infected tissues It is 2 to 4 times higher than that in non-infected ti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K31/546A61K47/44A61P31/04
Inventor 沈富林黄士新王蓓顾欣顾岳明蔡金华刘雅妮金凌艳
Owner SHANGHAI ANIMAL EPIDEMIC PREVENTION & CONTROL CENT
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