Monodisperse nano cefquinome sulfate liposome preparation and preparation method thereof

A kind of technology of cefquinoxime sulfate and liposome preparation, which is applied in the field of monodisperse nanometer cefquinoxime sulfate liposome preparation and preparation thereof, and can solve the problem of difficulty in guaranteeing insoluble particles, poor stability and uniformity, inability to meet quality requirements, etc. problem, to achieve the effect of improving drug availability, good stability and uniform size

Inactive Publication Date: 2014-03-19
湖北领盛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a kind of monodisperse nano cefquinoxime sulfate liposome preparation and preparation method thereof, mainly solve the stability and the homogeneity that prior art prepares injection cefquinoxime sulfate preparation is relatively poor, in the sterilization process The product is unstable, it is difficult to ensure insoluble particles in the aseptic production process, and the related substances increase a lot after long-term storage, and it is difficult to store at room temperature, and cannot meet the quality requirements within the validity period. It provides more reliable technical support, reduces the toxicity of the product, and improves the curative effect of the product

Method used

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  • Monodisperse nano cefquinome sulfate liposome preparation and preparation method thereof
  • Monodisperse nano cefquinome sulfate liposome preparation and preparation method thereof
  • Monodisperse nano cefquinome sulfate liposome preparation and preparation method thereof

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Effect test

Embodiment 1

[0032] formula:

[0033]

[0034] Preparation Process:

[0035] 1) Preparation of continuous phase: add sterile cefquinome sulfate to the reactor at room temperature and suspend it in water for injection; add sterile L-lysine to adjust the pH value to make it completely dissolved to obtain cefquinome sulfate / lysine Aqueous acid solution. After adding, adjust the pH value to 5.6; wherein the weight of aseptic cefquinoxime sulfate is C 23 H 24 N 6 O 5 S 2 ·H 2 SO 4 ·H 2 O meter.

[0036] 2) Preparation of disperse phase: dissolving phospholipid for injection, cholesterol and antioxidant in ethanol in the reactor, and stirring to obtain disperse phase solution;

[0037] 3) Preparation of monodisperse nano cefquinoxime sulfate liposome preparation: The dispersed phase is uniformly injected into the continuous phase through the porous membrane under the action of pressure (0.1 kPa), and the ethanol is removed under reduced pressure. Filtration through a microporous me...

Embodiment 2

[0039] formula:

[0040]

[0041] Preparation Process:

[0042] 1) Preparation of continuous phase: add sterile cefquinome sulfate to the reactor at room temperature and suspend it in water for injection; add sterile L-lysine to adjust the pH value to make it completely dissolved to obtain cefquinome sulfate / lysine Aqueous solution of amino acid; after adding, adjust pH value to 6.1; wherein the weight of aseptic β-cefaquime sulfate is C 23 H 24 N 6 O 5 S 2 ·H 2 SO 4 ·H 2 O meter.

[0043] 2) Preparation of dispersed phase: dissolving phospholipids for injection, cholesterol and vitamin E in ethanol in a reactor to obtain a dispersed phase;

[0044] 3) Preparation of monodisperse nano cefquinoxime sulfate liposome preparation: the dispersed phase is uniformly injected into the continuous phase through the porous membrane under pressure, the ethanol is removed under reduced pressure, and then filtered with a 0.45 μm microporous membrane , finally filtered through a...

Embodiment 3

[0046] formula:

[0047]

[0048] Preparation Process:

[0049] 1) Preparation of continuous phase: add sterile cefquinome sulfate to the reactor at room temperature and suspend it in water for injection; add sterile L-lysine to adjust the pH value to make it completely dissolved to obtain cefquinome sulfate / lysine The aqueous solution of amino acid; After adding, adjust pH value 6.5; Wherein the weight of aseptic cefquinoxime sulfate is C 23 H 24 N 6 O 5 S 2 ·H 2 SO 4 ·H 2 O meter.

[0050] 2) Preparation of dispersed phase: dissolving phospholipid for injection, cholesterol and antioxidant in ethanol in a reactor to obtain a dispersed phase;

[0051] 3) Preparation of monodisperse nano cefquinoxime sulfate liposome preparation: the dispersed phase is uniformly injected into the continuous phase through the porous membrane under pressure, the ethanol is removed under reduced pressure, and then filtered with a 0.45 μm microporous membrane , finally filtered throug...

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Abstract

The invention relates to a monodisperse nano cefquinome sulfate liposome preparation and a preparation method thereof. The monodisperse nano cefquinome sulfate liposome preparation is prepared by adopting a membrane emulsification technique. The preparation method comprises the following steps: directly suspending sterile cefquinome sulfate into injection water, adding sterile L-lysine to adjust the PH value, and completely dissolving the sterile cefquinome sulfate to obtain the aqueous solution of cefquinome sulfate / L-lysine, wherein the the aqueous solution of cefquinome sulfate / L-lysine is a continuous phase; dissolving an anti-oxidant-containing injection phospholipid and cholesterol in ethyl alcohol, wherein the obtained solution is a dispersed phase; dispersing the dispersed phase in the continuous phase through a porous membrane under the action of a pressure; removing the ethyl alcohol under reduced pressure; sterilizing, packaging, and freeze-drying to finally obtain the monodisperse nano cefquinome sulfate liposome preparation for injection. The preparation method provided by the invention is simple; the prepared particles are uniform in size, high in encapsulation rate and high in stability; in an emulsification process, the energy consumption is low, the conditions are mild, and the reproducibility is high; the stability of a cefquinome sulfate medicament is stable, toxic or side effects are reduced, and the medicament utilization degree is improved; moreover, the preparation process is simple and is suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing nanometer cefquinome sulfate and a preparation method thereof, in particular to a monodisperse nanometer cefquinome sulfate liposome preparation and a preparation method thereof. Background technique [0002] Cefquinol is also known as cefquinol, cefquinome, and its trade name is Cobactan. It is the first animal-specific fourth-generation cephalosporin antibiotic developed by Hoechst AG in Germany. Intervet also went public. Cefquinol has the formula C 23 H 24 N 6 0 5 S 2 , the relative molecular mass is 528.60Da, the chemical name is: (6R-7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[ (5,6,7,8-tetrahydroquinolinyl-1-methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-carboxylate Cefquinol is well received by veterinary clinicians due to its broad antibacterial spectrum, strong antibacterial activity and low tolerance. - ) showed good antibacterial activity. Highly ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/127A61K31/546A61K47/18A61P31/04A61P15/14
Inventor 龚俊
Owner 湖北领盛制药有限公司
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