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Sterile detection method of ceftiofur oil suspension injection

A technology of suspension injection and ceftiofur, which is applied in the direction of material inspection products and testing pharmaceutical preparations, etc., can solve the problems of inability to accurately judge negative or positive results, observation phenomenon is not obvious, prolonging the detection cycle, etc.

Active Publication Date: 2021-06-08
RINGPU TIANJIN BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is a document (CN201310665166.0) that records the sterility test method of ceftiofur oil suspension injection using 0.1% Tween-80% peptone solution for pretreatment. At the right time, the observation phenomenon is not obvious, and it is impossible to accurately judge the negative or positive results, and another step of inoculation treatment is required, that is, the culture solution is inoculated on the slant medium, and the bacteria are cultivated for 2 days, and the fungi are cultivated for 3 days. Check according to law
Not only consumes manpower, increases the risk of contamination, but also prolongs the detection cycle

Method used

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  • Sterile detection method of ceftiofur oil suspension injection
  • Sterile detection method of ceftiofur oil suspension injection
  • Sterile detection method of ceftiofur oil suspension injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1 Establishment of the method for sterility testing of ceftiofur oil suspension injection

[0039](1) The medium used in the test includes thioglycolate fluid medium, tryptone liquid medium, Sabouraud dextrose liquid medium and Sabouraud dextrose agar. Various media used in the examples of the present invention were prepared and sterilized according to the methods of Chinese Veterinary Pharmacopoeia. All the strains used in the test were supervised by the China Institute for the Control of Pharmaceutical and Biological Products.

[0040] (2) Results of culture medium sterility test

[0041] 5 bottles of the above-mentioned medium were randomly taken out, and each culture medium was placed at a specified temperature for 14 days of culture. The results are shown in Table 1 below. As can be seen from the table, the above-mentioned blank culture medium was cultured for 14 days and grew aseptically, which met the requirements of the sterility verification test.

...

Embodiment 2

[0051] Example 2 Sterility testing method and verification of ceftiofur oil suspension injection

[0052] When 6% Tween-80 thioglycolate fluid medium and 6% Tween-80-containing modified Martin medium are used in the process of sterility testing, the reaction temperature is controlled at 37°C for the best reaction of penicillinase Within the range of activity conditions, the purpose of adding Tween-80 to the medium is to disperse the oil phase evenly in the buffer solution, and the amount of penicillinase is deduced through the calculation of enzyme activity and penicillinase conversion number. Theoretically, it is 37 °C, within 4 hours, this added amount is sufficient to inactivate the entire amount of ceftiofur. At the same time, a sterility testing verification scheme was designed in the laboratory, and the feasibility of the operation of the sterility testing method was demonstrated. The specific verification method is as follows:

[0053] This verification test is divide...

Embodiment 3

[0059] Example 3 Comparative experiment of 5% ceftiofur oil suspension injection sterility detection method

[0060] Test sample: choose ceftiofur oil suspension injection, the content specification is 5%.

[0061] Test plan: Choose two detection methods for sterility comparison detection, which are:

[0062] Method ① Take an appropriate amount of Ceftiofur Oil Suspension Injection and shake it evenly, and mix it with an appropriate amount of penicillin enzyme solution to make a mixed solution of not less than 20,000 units per 1 mg of ceftiofur plus penicillin enzyme. Take 30ml of the mixed solution and add it to the In 270ml of thioglycolate fluid medium containing 6% Tween-80 and 270ml of 6% Tween-80 modified Martin medium, place the test product in a constant temperature water bath at 37°C for 1 hour; take the test product An appropriate amount of solution was inoculated in 20ml of thioglycolate fluid medium and 20ml of tryptone liquid medium according to the law, and the ...

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Abstract

The invention discloses a sterility detection method of a ceftiofur oil suspension injection, which comprises the following steps of: performing pretreatment: uniformly shaking ceftiofur, adding penicillin enzyme, and uniformly mixing to obtain a mixed solution; respectively adding the mixed solution into a thioglycolate fluid culture medium containing Tween-80 and an improved Martin culture medium containing Tween-80, uniformly shaking again, and carrying out constant-temperature treatment to obtain a test solution; and after constant-temperature treatment, directly inoculating the test solution for sterile detection. The sterile detection method has the best effect on ceftiofur oil suspension injections with the content of 5% and 10%. According to the method, the accuracy and reproducibility of detection data can be effectively improved, the operability is high, the specificity is good, and oily auxiliary materials have no interference on sterility inspection.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a sterility testing method for veterinary drug preparations, in particular to a sterility testing method for ceftiofur oil suspension injection. Background technique [0002] Ceftiofur, also known as Saidefu, is a third-generation cephalosporin for veterinary medicine successfully developed in the United States in the 1980s. The drug was first launched in the United States in 1988. Due to its excellent antibacterial activity and pharmacokinetics It has been officially approved by the United States, Canada, Japan and some European countries for the treatment of respiratory diseases in beef cattle, dairy cows, horses, pigs and sheep. Its chemical name is (6R,7R)-7-[2-(2-aminothiazol-4-yl)(methoxyimino)acetamido]-3-[(2-furylcarbonyl)thiomethyl Base]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, molecular formula C19H17N5O7S3, molecular weight 523.56, the chemic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15
CPCG01N33/15
Inventor 聂丽娜刘爱玲曹春芳李亚玲李守军李雪娇吴燕子
Owner RINGPU TIANJIN BIOLOGICAL PHARMA