Oxytetracycline hydrochloride microbial limit inspection method

An oxytetracycline hydrochloride, microbial limit technology, applied in the directions of microorganism-based methods, microbial determination/inspection, biochemical equipment and methods, etc., can solve problems such as difficulty in carrying out microbial limit testing, short dissolution time, and impact on test results. , to achieve the effect of improving colony recovery rate, good dissolution effect and high detection accuracy

Inactive Publication Date: 2021-02-02
HEBEI SHENGXUE DACHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the solubility problem of this product, oxytetracycline hydrochloride has the problem of short dissolution time in aqueous solution and crystallization in a short period of time, which makes it difficult to carry out the microbial limit test of this product and affects the test results. Therefore, it is urgent to develop a method that can increase the sample size. Test method for solution stability

Method used

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  • Oxytetracycline hydrochloride microbial limit inspection method
  • Oxytetracycline hydrochloride microbial limit inspection method
  • Oxytetracycline hydrochloride microbial limit inspection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: adopt prior art to prepare sample solution:

[0031] On the ultra-clean workbench in the clean room, add 10g of oxytetracycline hydrochloride sample into a 250ml stoppered Erlenmeyer flask, accurately measure 100ml of sterilized water with a sterilized measuring cylinder, shake fully, and use it as a 1:10 sample solution;

[0032] From the 1:10 sample solution, use a sterilized tip to accurately draw 10ml into a 250ml conical flask, then use a sterilized graduated cylinder to measure 90ml of sterilized water into the conical flask, shake it fully, and use it as 1: 100 of the sample solution.

[0033] From the 1:100 sample solution, use a sterilized tip to accurately draw 10ml into a 250ml conical flask, then use a sterilized graduated cylinder to measure 90ml of sterilized water into the conical flask, shake it fully, and use it as 1: 1000 of the sample solution.

[0034] From the 1:1000 sample solution, use a sterilized tip to accurately draw 10ml into ...

Embodiment 2

[0035] Embodiment 2: diluent is selected the sample solution preparation of 20% sterile polyethylene glycol 200 for use

[0036] On the ultra-clean workbench in the clean room, add 10g of oxytetracycline hydrochloride sample into a 250ml Erlenmeyer flask with a stopper, accurately measure 200 to 100ml of 20% sterile polyethylene glycol with a sterilized measuring cylinder, shake fully, and use as 1 : 10 sample solutions;

[0037] From the 1:10 sample solution, use a sterilized tip to accurately draw 10ml into a 250ml conical flask, then use a sterilized graduated cylinder to measure 90ml of 20% sterile polyethylene glycol 200 into the conical flask, Shake well, as a 1:100 sample solution.

[0038] From the 1:100 sample solution, use a sterilized tip to accurately draw 10ml into a 250ml conical flask, then use a sterilized graduated cylinder to measure 90ml of 20% sterile polyethylene glycol 200 into the conical flask, Shake well, as a 1:1000 sample solution.

Embodiment 3

[0039] Embodiment 3: diluent is selected the sample solution preparation of 20% aseptic glycerol formal

[0040] Put 10g of oxytetracycline hydrochloride sample into a 250ml Erlenmeyer flask with a stopper on the ultra-clean workbench in a clean room, accurately measure 20% sterile glycerin formal to 100ml with a sterilized measuring cylinder, and shake it fully, as 1:10 the sample solution;

[0041] From the 1:10 sample solution, use a sterilized tip to accurately draw 10ml into a 250ml conical flask, then use a sterilized measuring cylinder to measure 90ml of 20% sterile glycerol formal into the conical flask, shake fully Shake, as a 1:100 sample solution.

[0042] From the 1:100 sample solution, use a sterilized tip to accurately draw 10ml into a 250ml conical flask, then use a sterilized graduated cylinder to measure 90ml of 20% sterile glycerol formal into the conical flask, shake fully Shake, as a 1:1000 sample solution.

[0043] 2. Verification of mold and yeast test...

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Abstract

The invention belongs to the technical field of microbial limit inspection, and particularly relates to an oxytetracycline hydrochloride microbial limit inspection method. The method comprises the steps of preparing a culture medium and a diluent, preparing an experimental tool, preparing a detection sample solution, detecting total number samples of moulds and saccharomycetes, reporting the totalcolony number of the moulds and the saccharomycetes, detecting the total number samples of aerobic bacteria and reporting the total colony number of the aerobic bacteria. Through selection of polyethylene glycol 200 or glyceryl formal and the concentration of the polyethylene glycol 200 or the glyceryl formal, the dissolvability of the samples is improved, a very good sample dissolving effect isachieved, the detection precision is improved, and the colony recovery rate is increased.

Description

technical field [0001] The invention belongs to the technical field of microbial limit testing, and in particular relates to a microbial limit testing method of oxytetracycline hydrochloride. Background technique [0002] The microbial limit test is a method for checking the degree of microbial contamination of non-sterile preparations, raw materials, and excipients. The inspection items include the inspection of the total number of aerobic bacteria, the number of molds and the total number of yeasts. The microbial limit inspection should be carried out in a local B-level one-way flow air area with an environmental cleanliness not lower than D-level, and the entire inspection process should strictly abide by aseptic operation to prevent microbial re-contamination. And regularly check the planktonic bacteria, sedimentation bacteria, dust particles, and surface microorganisms on the work surface and the environment to ensure that the inspection environment meets the testing r...

Claims

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Application Information

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IPC IPC(8): C12Q1/06C12Q1/14C12Q1/24C12R1/725C12R1/685C12R1/385C12R1/125C12R1/445
CPCC12Q1/06C12Q1/14C12Q1/24G01N2333/31G01N2333/21G01N2333/32G01N2333/40G01N2333/38
Inventor 李金钟王红李文杰贾晓乐
Owner HEBEI SHENGXUE DACHENG PHARMA
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