Stable cefquinome sulfate oil suspension injection

A technology of cefquinoxime sulfate and injection, which is applied in the field of antibacterial drug oil suspension type injection, and achieves the effects of less irritation, simple preparation process and improved dispersion effect

Inactive Publication Date: 2014-11-05
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the problems of oil suspension injection physical stability and long-term storage chemical stability of medicine

Method used

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  • Stable cefquinome sulfate oil suspension injection
  • Stable cefquinome sulfate oil suspension injection
  • Stable cefquinome sulfate oil suspension injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Preparation:

[0055] (1) Weigh silicon dioxide, Span-80, sodium tartrate, propyl gallate, chlorobutanol and ethyl oleate into a mixing tank according to the above prescription, stir into a uniform suspension, and set aside;

[0056] (2) add prescription quantity cefquinome sulfate in the suspension in (1), put and disperse in the colloid mill;

[0057] (3) Transfer the suspension in (2) to a high-pressure homogenizer for homogenization, sterilize after the particle size is qualified, and fill to obtain cefquinome sulfate oil suspension injection.

[0058] Quality Evaluation:

[0059] The cefquinoxime sulfate oil suspension type injection of the present invention is placed 3h and the settling volume ratio is 92%, illustrates that the settling velocity of the suspension is relatively slow; The redispersibility test result shows that the suspension is easily dispersed after shaking, and does not agglomerate; 90% of drug particles in the suspension have a particle...

Embodiment 2

[0064] Preparation

[0065] (1) Weigh cefquinome sulfate, vegetarian meat powder, Tween-80, sodium bicarbonate, vitamin E, phenol and soybean oil for injection according to the above prescription, and mix them uniformly through a colloid mill under sterile conditions After the particle size is qualified, it is filtered and filled to obtain cefquinome sulfate oil suspension injection.

[0066] Quality Evaluation:

[0067] The cefquinoxime sulfate oil suspension type injection of the present invention is placed 3h and the settling volume ratio is 90%, illustrates that the settling velocity of the suspension is relatively slow; The redispersibility test result shows that the suspension is easy to disperse and does not agglomerate after shaking; 90% of the drug particles in the suspension have a particle size of less than 5 μm, 97.8% of which are less than 10 μm, and 100% of which are less than 20 μm; meeting the requirements for suspension injections.

[0068] Stability ...

Embodiment 3

[0072] Preparation

[0073] (1) Filter and sterilize the raw and auxiliary materials in the prescription respectively;

[0074] (2) Under sterile conditions, weigh cefquinoxime sulfate, silicon dioxide, Span-60, sodium tartrate, tert-butyl p-methoxyphenol, phenol and isopropyl myristate respectively according to the above prescription, and mix Uniform;

[0075] (3) The above-mentioned mixture is repeatedly processed by a high-pressure homogenizer, filtered after the particle size is qualified, and filled to obtain cefquinoxime sulfate oil suspension injection.

[0076] Quality Evaluation:

[0077] The cefquinoxime sulfate oil suspension type injection of the present invention is placed 3h after the sedimentation volume ratio is 98%, does not settle substantially, illustrates that the suspension liquid sedimentation velocity is slower; The heavy dispersibility test result shows that the suspension liquid is easy to disperse after shaking, does not Agglomeration; 90% o...

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PUM

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Abstract

The invention provides a stable cefquinome sulfate oil suspension injection. The injection per 100mL comprises the following components: 1-5g of cefquinome sulfate, 0.2-2.5g of suspending agent, 0.2-1.0g of weakly alkaline ingredient, 1-6g of wetting agent, 0.05-0.2g of antioxidant, 0.01-1g of bacteriostatic agent, and oil or fat for injection added to 100mL. The oil suspension injection has the advantages of low viscosity, easily injectable property, good medicine suspension property and redispersibility, good chemical stability in long-term storage of the medicine, and the like.

Description

technical field [0001] The invention relates to a stable antibacterial drug oil suspension injection, in particular to a stable cefquinome sulfate oil suspension injection. Background technique [0002] Cefquinoxime sulfate is the first animal-specific fourth-generation cephalosporin antibiotic. Compared with the third-generation cephalosporins, cefquinome sulfate has a broad antibacterial spectrum, strong antibacterial activity, less toxic and side effects, and low residues. Clinically, it is mainly used for the treatment of respiratory infection in pigs and cattle, as well as mastitis and endometritis in dairy cows and sows. Pharmacokinetic studies in animals show that cefquinome sulfate is poorly absorbed after oral administration. Therefore, it is often administered clinically by intramuscular injection or breast perfusion. [0003] Cefquinome sulfate, English name: Cefquinome sulfate, chemical name: (6R,7R)-7-[(2Z)-(2-amino-4-thiazolyl)-(methoxyimino)acetamido]-3 -(...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/08A61K47/04A61K47/46A61K47/02A61K47/12A61P31/04
Inventor 肖衍宇余艾玲高士雅孟凡飞
Owner CHINA PHARM UNIV
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