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Technique for preparing compound ceftiofur oil suspension injection

A suspension injection and preparation technology, which is applied in the field of preparation technology of compound ceftiofur oil suspension injection, can solve the problems that the quality standard has not been released, and there are no patents for compound ceftiofur hydrochloride oil suspension injection.

Inactive Publication Date: 2009-04-15
HENAN AGRICULTURAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In terms of preparations, foreign preparations include ceftiofur sodium for injection and ceftiofur hydrochloride oil suspension injection. The production of ceftiofur sodium raw material and ceftiofur hydrochloride oil suspension injection has been approved in China in 2007, but there is no domestic and foreign Patent for Compound Ceftiofur Hydrochloride Oil Suspension Injection, the quality standard has not yet been issued

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation process of compound ceftiofur oil suspension injection of the present invention is as follows:

[0024] (1) Filter 98mL neutral soybean oil, heat it in a pressure cooker or autoclave to 115.5°C, and after sterilizing for 30 minutes, take out 20mL and let it cool to 60°C, add aluminum stearate 1.8 Gram in it, made into 6% gel, heated to 110°C, kept for 30 minutes, diluted with filtered and sterilized soybean oil into 1.8% oil gel, filtered again, and set aside;

[0025] (2), take 4.5 grams of ceftiofur hydrochloride and 2.25 grams of sulbactam according to the formula, and mix them with 30 mL of oil gelatin, grind them, add 0.05 grams of lecithin while grinding until they are evenly ground; after that, grind them The ceftiofur hydrochloride / sulbactam hydrochloride was transferred to a graduated cylinder, and 30 mL of oil gel was added. When the temperature of the oil gel was not lower than 70 ° C, 0.9 mL of benzyl alcohol, 0.15 g of Span-80 (span-80 and o...

Embodiment 2

[0027] The preparation process of compound ceftiofur oil suspension injection is as follows:

[0028] (1) Filter 99mL of neutral soybean oil, heat it in a pressure cooker or autoclave to 118°C, and after sterilizing for 35 minutes, take out 23mL and let it cool to 65°C, add aluminum stearate 1.9 Gram in it, made into 7% gel, and heated to 112 ° C, kept for 35 hours, diluted with filtered and sterilized soybean oil into 1.9% oil gel, filtered again, and set aside;

[0029] (2), take 4.8 grams of ceftiofur hydrochloride and 2.3 grams of sulbactam according to the formula, and mix them with 35 mL of oil gel, grind them, add 0.055 grams of lecithin while grinding until they are evenly ground; after that, grind them Transfer ceftiofur hydrochloride / sulbactam to a graduated cylinder, add 35 mL of oil gel, and add 0.9 mL of benzyl alcohol, 0.16 g of Span-80, and 0.16 g of vitamin E to the graduated cylinder when the temperature of the oil gel is not lower than 75°C Stir while adding...

Embodiment 3

[0031] The preparation process of compound ceftiofur oil suspension injection is as follows:

[0032] (1) Filter 100mL neutral soybean oil, put it in a pressure cooker or autoclave and heat it to 120°C, after sterilizing for 45 minutes, take out 28mL and let it cool to 70°C, add aluminum stearate 2 Gram in it, made into 8% gel, heated to 118°C, kept for 45 minutes, diluted with filtered and sterilized soybean oil into 2% oil gel, filtered again, and set aside;

[0033] (2), take 5 grams of ceftiofur hydrochloride and 2.5 grams of sulbactam according to the formula, and mix them with 38mL oil gel, grind, add 0.06 grams of lecithin while grinding, until it is well ground; after that, grind it well Transfer ceftiofur hydrochloride / sulbactam to a graduated cylinder, add 37mL of oil gel, when the temperature of the oil gel is not lower than 78°C, add 1mL of benzyl alcohol, 0.18g of Span-80, and 0.18g of vitamin E into the graduated cylinder , Stir while adding, add oil glue to 100...

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Abstract

The invention discloses a preparation process for compound recipe ceftiofur oil suspensoid injection. The preparation process comprises the following steps: (1) taking neutral soybean oil, filtrating, heating and sterilizing and cooling down the soybean oil, adding aluminum stearate into the soybean oil to prepare gel, diluting the gel into factice of 2+-0.2 percent through the filtrated and sterilized soybean oil, and filtrating the factice through a No.3 sintered glass funnel for standby; and (2) taking hydrochloric acid ceftiofur / sulbactam according to a recipe, mixing the hydrochloric acid ceftiofur / sulbactam with the factice, grinding the mixture, adding lecithin into the mixture till the mixture is ground evenly, and then obtaining the compound recipe ceftiofur oil suspensoid injection through shifting the ground hydrochloric acid ceftiofur / sulbactam into a graduated cylinder and so on. As the invention adopts the preparation method, compared with a single recipe ceftiofur preparation, the compound recipe ceftiofur oil suspensoid injection has the advantage that the compound recipe ceftiofur oil suspensoid injection has antibacterial activity against bacteria capable of resisting the single recipe ceftiofur, that is, the compound recipe ceftiofur oil suspensoid injection can effectively treat bacterial infection generating ESBLs.

Description

technical field [0001] The invention relates to a medicine, in particular to a preparation process of compound ceftiofur oil suspension injection. Background technique [0002] Ceftiofur, also known as Ceftiofur, is the first animal-specific cephalosporin antibiotic developed by Pharmacia Upjohn in the United States. Our country has already imitated successfully and will soon approve production. It has a wide antibacterial spectrum and strong antibacterial activity, and has strong antibacterial activity against clinical and standard strains. Since it was approved by the FDA in 1988 for the treatment of respiratory infections in cattle, because of its excellent antibacterial activity and dynamic process in vivo, it is now The application of veterinary clinical treatment at home and abroad is becoming more and more extensive. [0003] In terms of preparations, foreign preparations include ceftiofur sodium for injection and ceftiofur hydrochloride oil suspension injection. Th...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/546A61K31/43A61P31/04
Inventor 胡功政潘玉善莫娟司红彬
Owner HENAN AGRICULTURAL UNIVERSITY
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