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Cefquinome sulfate oil suspension and preparation method thereof

A technology of cefquinome sulfate and oil suspension, which is applied in the field of medicine and can solve the problems of difficult preparation of oil suspension and no product report of main content.

Active Publication Date: 2017-01-25
CHENGDU QIANKUN VETERINARY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation of oil suspensions, especially oil suspensions for injection, is relatively difficult. To obtain products with better physical stability, needle penetration and redispersibility, it is very critical to determine the type and amount of suitable excipients. Moreover, oil Suspensions have high requirements on the storage environment, and improving their storage stability is also a factor that needs to be considered during the preparation process
[0004] In the existing cefquinoxime sulfate oil suspension, the main drug content is usually between 1% and 5%, and there is no report of products with higher main content

Method used

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  • Cefquinome sulfate oil suspension and preparation method thereof
  • Cefquinome sulfate oil suspension and preparation method thereof
  • Cefquinome sulfate oil suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The preparation of embodiment 1 cefquinome sulfate oil suspension of the present invention

[0032] Take an appropriate amount of soybean oil, add 30mL of ethyl oleate, 20mL of benzyl benzoate, and 20mL of isopropyl myristate, heat (60°C-70°C) and mix well, then add a colloidal protective agent (1.7g of aluminum magnesium silicate + hard aluminum stearate 1.7g+magnesium stearate 1.7g) dissolved, then add suspending agent (polyethylene glycol 6000 2.0g+polyvinylpyrrolidone K30 2.0g) after melting, stir evenly, add surfactant (soybean lecithin 0.3g, spit Wen-80 0.3g and Span-80 0.3g), after cooling at about 25°C, add 2.5g of cefquinoxime sulfate, stir evenly, dilute to 100mL with soybean oil, homogenize to obtain 2.5% cefquinoxime sulfate oil mixture Suspension (weight / volume ratio).

Embodiment 2

[0033] The screening of embodiment 2 oil phase kind

[0034] A mixture composed of each oil phase or different volume ratios of each oil phase, together with surfactant Span-80 (5%), antioxidant p-hydroxytert-butyl anisole (BHA) (0.02%), thickener Aluminum stearate (1%) and main drug cefquinome sulfate (2.5%) were used to prepare different suspensions, and their sedimentation volume ratio, needle penetration, and dispersion after centrifugation were investigated. The results are shown in Table 1.

[0035] Table 1 Screening of oil phase types

[0036]

[0037] As can be seen from the results in Table 1, soybean oil 30%, ethyl oleate 10%-30%, benzyl benzoate 10%-40% and isopropyl myristate 10%-40% are used as preparation cefquinome sulfate When the solvent of the suspension is used, the quality standard of the suspension can be met. Among them, soybean oil 30% + ethyl oleate 30% + benzyl benzoate 20% + isopropyl myristate 20% is the best.

[0038] However, using oils or fa...

Embodiment 3

[0039] The screening of embodiment 3 surfactants

[0040] Select oily surfactant Tween-80, Span-80 and lecithin as surfactant, with solvent (ethyl oleate 30%+benzyl benzoate 20%+isopropyl myristate 20%+soybean oil 30%) to prepare 2.5% cefquinoxime sulfate suspension, and investigate its sedimentation volume ratio, needle penetration, dispersion after centrifugation, the results are shown in Table 2.

[0041] Table 2 Screening of surfactants

[0042]

[0043] As can be seen from the table 2 results, the quality of the suspension prepared by each group of surfactants all meets the requirements, showing that Span-80, Tween-80, and soybean lecithin are all suitable for use in the suspension of the present invention as surfactants . On the whole, 0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin is better as a surfactant, so 0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin is preferred as a surfactant.

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Abstract

The invention discloses a cefquinome sulfate oil suspension. Every 100mL of the suspension contains the following raw and auxiliary materials: 2-15g of cefquinome sulfate, 0.9-1.0g of surfactant, 5.0-5.1g of colloid protective agent, 2.0-8.0g of suspending agent, 0-0.1g of antioxidant and the balance of oil phase. The high-quality cefquinome sulfate oil suspension with the main drug content of 2-15% is obtained by screening the formula. The used auxiliary materials lower the drug sedimentation volume and sedimentation rate. The product has the advantages of low flowability, low sedimentation rate, high sedimentation volume, high needle penetration property and favorable dispersity after centrifugation. In addition, the inspection on the stability under different temperature conditions further proves the high quality of the suspension.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a cefquinome sulfate oil suspension and a preparation method thereof. Background technique [0002] Cefquinoxime sulfate, a third-generation cephalosporin for animals, is mainly used for bacterial infections in cattle, pigs, poultry and other animals, such as Marcellobacter hemolyticus, Marcellobacter multocida, Salmonella, Escherichia coli , Streptococcus, Staphylococcus aureus, Corynebacterium, Haemophilus somnus, Serratia marcescens, Actinomyces pyogenes, Klebsiella, Proteus, Citrobacter, Clostridium, Lobar pneumonia Actinomyces, Erysipelas suis and so on. The injection of cefquinome sulfate is recorded in the standard issued by the Ministry of Agriculture, and its specification is 2.5%. [0003] Oil suspension is a heterogeneous liquid preparation formed by dispersing insoluble drugs in the oil phase. Its biggest feature is to prolong the drug's action time, reduce the f...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/546A61K47/44A61P31/04
CPCA61K9/10A61K31/546A61K47/44
Inventor 杨海涵黄兴刘海燕欧红萍房春林
Owner CHENGDU QIANKUN VETERINARY PHARMA
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