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Aqueous suspension injection of ceftiofur, and preparation method thereof

A water-based suspension, ceftiofur technology, applied in medical preparations containing active ingredients, liquid delivery, pharmaceutical formulations, etc., can solve the problems of difficult extraction and injection, high product cost, inconvenient use, etc., and achieve drug release Slow, extended shelf life, less painful effect

Active Publication Date: 2013-07-10
LUOYANG HUIZHONG ANIMAL MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the main components of the excipients of the above-mentioned ceftiofur suspension are still oily excipients, most of which are vegetable oil for injection or mineral oil for injection. The cost of using mineral oil is higher, resulting in a higher product cost

Method used

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  • Aqueous suspension injection of ceftiofur, and preparation method thereof
  • Aqueous suspension injection of ceftiofur, and preparation method thereof
  • Aqueous suspension injection of ceftiofur, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The selection of the water-soluble excipient in the ceftiofur aqueous suspension of the present invention of embodiment 1

[0053] 1. Solubility of ceftiofur in ceftiofur aqueous suspension without excipients

[0054] Put ceftiofur (produced by Luoyang Huizhong Veterinary Medicine Co., Ltd., batch number: 20100801) in 100ml water for injection at 25±2°C, leave it at room temperature for 2 hours, and shake vigorously for 30 seconds every 5 minutes. Leave it for 2 hours and observe. Ceftiofur sinks to the bottom of the water for injection and cannot be suspended. The solution was filtered, and the filtrate was taken, and the content of ceftiofur in the solution was determined by HPLC according to the method under the content determination item of ceftiofur in "The Veterinary Pharmacopoeia of the People's Republic of China". Through determination, the content of ceftiofur in water for injection is 98.2mg / ml.

[0055] Therefore, the solubility of ceftiofur in aqueous sus...

Embodiment 2

[0075] The preparation of the aqueous suspension of embodiment 2 ceftiofur

[0076] The raw material used in the examples of the present invention, ceftiofur, is produced by Luoyang Huizhong Veterinary Medicine Co., Ltd., batch number: 20100801. Ceftiofur hydrochloride, produced by Binzhou Xinda Chemical Co., Ltd., batch number: 11CF1015H. Ceftiofur crystalline free acid is prepared according to the method of Patent Example 2 whose publication number is CN1119016A. Ceftiofur sodium, produced by Zhejiang Hisun Pharmaceutical Co., Ltd., batch number: 100702.

[0077] The QYF-2600 jet mill produced by Kunshan Miyou Machinery Manufacturing Co., Ltd. was used for ultrafine pulverization. Set the pressure of the air compressor to 0.4Mpa, the speed of the classifying wheel to 7200 rpm, the crushing pressure of the main air valve to 0.8MPa, and the pressure to the blowback valve to 0.4-0.6MPa. The crushing amount is 5-10g / sec. After crushing, micronized ceftiofur with suitable par...

preparation example 1

[0078] Preparation Example 1: 5% w / v Ceftiofur Aqueous Suspension Injection (100ml)

[0079]

[0080]

[0081] Ceftiofur particle size inspection: check 400 micropowder particles under a microscope, of which 93.5% have a diameter in the range of 2-20 μm, 5.5% have a particle size in the range of 20-30 μm, and 30-40 μm The average particle size of micronized ceftiofur was 12.2 μm.

[0082]Preparation method: Weigh 10.0 g of sorbitol, 15.0 g of polyvinylpyrrolidone K30, 5.0 g of sodium citrate, 0.1 g of potassium dihydrogen phosphate, 0.5 g of poloxamer, 0.01 g of sodium formaldehyde sulfoxylate, and methyl p-hydroxybenzoate 0.01g, 0.005g of methyl p-hydroxybenzoate, add to 50ml of water, stir to dissolve completely.

[0083] Weigh 0.3 g of sodium carboxymethyl cellulose, add it to 30 ml of water, slowly heat to about 60° C., stir while heating until the sodium carboxymethyl cellulose is completely dissolved, and prepare 30 ml of a 1.0% sodium carboxymethyl cellulose solu...

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Abstract

The invention provides an aqueous suspension injection of ceftiofur. The aqueous suspension injection comprises 5-20% W / V of a ceftiofur micronized raw material, 8-15% W / V of a water-soluble excipient, 5-25% W / V of a suspending agent, 0.1-0.5% W / V of a suspending aid, and balance of injection water. Compared with traditional ceftiofur oily suspension liquids, no organic solvent is added into the ceftiofur aqueous suspension injection. The ceftiofur aqueous suspension injection is substantially a pure water solution. Therefore, problems of high viscosity and inconvenient application of current ceftiofur oily suspension liquids in market are solved.

Description

technical field [0001] The invention relates to an aqueous suspension of ceftiofur and a preparation method thereof, in particular to an aqueous suspension injection of ceftiofur with water as a carrier and a preparation method thereof. Background technique [0002] Ceftiofur (CEF) is a third-generation cephalosporin antibiotic for veterinary medicine and the first cephalosporin antibiotic for animals. Ceftiofur has a wide antibacterial spectrum and strong antibacterial activity. It has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria and some anaerobic bacteria. It is not easy to produce drug-resistant strains and cross-resistance. For many It has a good effect on various infections caused by animal sensitive bacteria. Therefore, ceftiofur has been widely used in the treatment of livestock and poultry diseases. [0003] The stability of ceftiofur in water is relatively poor. For example, in "The New Third-Generation Cephalosporin——Cefti...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/546A61P31/04
CPCY02A40/70
Inventor 张许科刘兴金张晓会
Owner LUOYANG HUIZHONG ANIMAL MEDICINE
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