Preparation method and application of cefquinome sulfate sustained-release suspension injection

A technology of cefquinome sulfate and suspension injection, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, liquid delivery, etc., to achieve stable quality and reliable curative effect

Pending Publication Date: 2021-03-30
杭州爱力迈动物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Preparation method and application of cefquinome sulfate sustained-release suspension injection
  • Preparation method and application of cefquinome sulfate sustained-release suspension injection
  • Preparation method and application of cefquinome sulfate sustained-release suspension injection

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Embodiment 1

[0023] A kind of preparation method of cefquinome sulfate slow-release suspension injection, select optimal formula by optimal formula and orthogonal test, and use colloid mill to grind through, make injection reach suspension sustained-release effect; Concrete steps are as follows:

[0024] 1) Through screening experiment, the present invention takes ethyl oleate for injection as dispersion medium, hydrogenated castor oil is suspending agent, Span 85 is wetting agent, butylated hydroxytoluene (BHT) is antioxidant and uses normal Cross test optimization; And draw by orthogonal test analysis, the concentration of hydrogenated castor oil is 2.5%, the Span 60 concentration is 1%, and the BHT concentration is 0.3% to be optimal formula (as shown in table 1 and table 2);

[0025] 2) Add an appropriate amount of ethyl oleate for injection according to the N 2 Heating to 120°C under protection, and keeping warm for 2 hours;

[0026] 3) When the liquid is cooled to 80°C, add BHT, hyd...

Embodiment 2

[0033] An application of cefquinome sulfate sustained-release suspension injection, 12 SD rats were randomly divided into two groups of 6 rats in each group, half male and half male, six using the injection without improved technology, and six using the improved Injection solution after rubber milling (as shown in Table 3), administration method: intramuscular injection, administration dosage: 0.18mL / kg. Blood collection time: 5min, 15min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, a total of 14 blood collection points per SD rat. Table 4 shows the post-treatment process of blood collection.

[0034]

[0035] table 3

[0036] Area=Area 134.1 / α

[0037] Note: Area 134.1 To detect the quantitative ion pair (529 / 134.1) peak area. α is the ratio of the L6 peak area of ​​the quality control solution and the linear solution in the detection of each group of rats.

[0038] Blood drug mass percent concentration (peak area>QC) C=(Area+3779.3776) / 147.6353

[0...

Embodiment 3

[0044] A kind of ultra high performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS measures the mass percentage concentration of cefquinome sulfate in SD rat plasma, draws cefquinome sulfate drug-time curve (such as figure 1 shown), to calculate the relative bioavailability.

[0045]The present invention selects the best formula by optimizing the formula and orthogonal test, and uses the colloid mill to grind, and the cefquinome sulfate injection of the new technology is compared with the cephalosporin sulfate injection of the old technology, within 0 to 6 hours. , The new technology has the effect of slow absorption and slow release compared with the old technology preparation, and the sustained release effect is prolonged.

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Abstract

The invention belongs to the technical field of chemical pharmaceutical preparations, and particularly relates to a preparation method and application of a cefquinome sulfate sustained-release suspension injection, the optimal prescription ratio of the cefquinome sulfate injection is screened by an orthogonal design method, ethyl oleate for injection is used as a dispersing medium, hydrogenated castor oil is used as a suspending aid, span 85 is used as a wetting agent, the butylated hydroxytoluene is used as an antioxidant, the long-acting cefquinome sulfate injection which is more stable in quality and more reliable in curative effect is prepared by taking cefquinome sulfate as a raw material and butylated hydroxytoluene as an antioxidant, the preparation process is optimized through colloid mill grinding, and the colloid mill grinding time is 15-20 minutes. An optimal formula is selected through a preferable formula and an orthogonal test, a colloid mill is used for grinding, and compared with cefquinome sulfate injection of an old process, the cefquinome sulfate injection of the new process has the advantages that within 0-6 hours, the new process shows the effects of slow absorption and slow release compared with a preparation of the old process, and the slow release effect is prolonged; the quality is more stable and the curative effect is more reliable.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmaceutical preparations, in particular to a preparation method and application of cefquinome sulfate sustained-release suspension injection. Background technique [0002] Cefquinome, also known as cefquinole and cefquinome, is a fourth-generation cephalosporin antibiotic for animals developed by Hoechst Animal Health Products Company in Germany. It was first approved for marketing in 1993. In 1994, Intervet International Ltd. is also listed. The cephalosporin nucleus of the cefaquine sulfate brick-7-aminocephalosporanic acid (7-ACA) is an essential group for antibacterial activity. The difference from the third-generation cephalosporin is that there is a quaternary ammonium salt group at the position of the mother nucleus . Cefquinome is a zwitterion, the cephalosporin nucleus is negatively charged, the four-valent quaternary saddle ion group is positively charged, and the chemical structur...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K47/14A61K47/44A61K47/10A61K31/546A61P31/04A61P15/14A61P11/00
CPCA61K9/0019A61K9/0041A61K9/10A61K31/546A61K47/10A61K47/14A61K47/44A61P11/00A61P15/14A61P31/04
Inventor 陈剑英王宝贵游鑫标
Owner 杭州爱力迈动物药业有限公司
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