Detection reagent kit and method of heat-resistant microorganisms in elemene lipidosome injection semi-finished products

A technology of elemene lipid and testing method, which is applied in the fields of medical devices and testing methods to achieve the effects of saving manpower, improving testing efficiency and ensuring safety

Inactive Publication Date: 2016-07-20
JINGANG PHARMA DALIAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention solves the test kit and method for heat-resistant microorganisms in the semi-finished product of elemene liposome injection, especially sol...

Method used

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  • Detection reagent kit and method of heat-resistant microorganisms in elemene lipidosome injection semi-finished products
  • Detection reagent kit and method of heat-resistant microorganisms in elemene lipidosome injection semi-finished products
  • Detection reagent kit and method of heat-resistant microorganisms in elemene lipidosome injection semi-finished products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Elemene injection semi-finished heat-resistant microorganism test kit can be used 2-4 times.

[0037] Kit composition: 1. Sterile elemene injection, 10ml×20 tubes;

[0038] 2. Thioglycollate fluid medium (powder), 50-80g;

[0039] 3. Tryptone soy agar medium (powder), 65-90g;

[0040] 4. Tryptone soy liquid medium (powder), 50-75g;

[0041] 5. 10%-20% (mL / mL) sterile glycerin solution, 40-60ml;

[0042] 6.10 6 cfu / ml biological indicator Bacillus stearothermophilus, 10-30ml.

[0043] Store the liquid at 2-8°C after opening, shelf life: 1 year.

[0044] Preparation Example

[0045] Preparation method of sterile elemene injection: take 200ml of elemene injection semi-finished product, pack into 10ml glass ampoules, and sterilize in YXQ-LS-75SⅡ automatic vertical electric pressure steam sterilizer at 121℃ for 15min.

[0046] The formula of thioglycolate fluid medium powder is: tryptone 28-38g; sodium chloride 4-7g; yeast extract powder 8-15g; anhydrous glu...

Embodiment 2

[0049]Example 2 can be detected by using the Elemene Injection Semi-finished Heat-resistant Microorganism Testing Kit described in Example 1.

[0050] 1. Boiling test

[0051] 1.1 Take one sample each before, during and after potting, and use membrane filtration to trap microorganisms on a 0.45 μm filter membrane;

[0052] 1.2 Transfer the filter membrane after filtration and rinsing to a capped test tube containing 10ml sterile elemene injection;

[0053] 1.3 Place the test tube in a boiling water bath for heat treatment. When the test tube is immersed in the boiling water bath, start timing for about 1-4 minutes. After 15-30 minutes, quickly place the test tube in cold water to cool to room temperature;

[0054] 1.4 Inject about 50-100mL of thioglycolate fluid medium into the test tube;

[0055] 1.5 Place the test tube at 30-35 ° C for 48-72 hours, transfer 1-2 mL to another sterile capped empty test tube, inject about 50-100 mL of thioglycolate fluid medium, and replace t...

Embodiment 3

[0077] Embodiment 3 application kit of the present invention and the sterility detection result that detection method obtains are shown in the table below:

[0078] The specific implementation in 2015

[0079]

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Abstract

The invention relates to a detection reagent kit and method of heat-resistant microorganisms in elemene lipidosome injection semi-finished products and belongs to the technical field of medical instruments and detection means. The detection reagent kit contains sterile elemene standard injection and heat-resistant microorganism biological indicator. The detection steps include S1 screening heat-resistant microorganisms in the elemene lipidosome injection semi-finished products by the boiling water bath; S2, separating, identifying and storing heat-resistant bacteria of bacillus; S3, preparing spore liquid of the heat-resistant bacteria prepared in the step S2, and calibrating concentration of spore liquid; S4, preparing biological indicator by products obtained in the step S3, and calibrating concentration of the biological indicator; S5, boiling quantitatively. The detection reagent kit fills the blank of the related technology and forms the detection technology of a complete closed loop from inspection, evaluation and treatment of heat-resistant microorganisms. The detection reagent kit helps detectors detect the pollution state of elemene, labor is saved, and detection efficiency is improved.

Description

technical field [0001] The invention relates to the technical field of medical equipment and detection means, in particular to a test kit and a detection method for heat-resistant microorganisms in semi-finished products of elemene liposome injection. Background technique [0002] The method of elemene liposome injection combined with conventional radiotherapy and chemotherapy has increased the curative effect in the treatment of malignant tumors such as lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, brain tumor, and bone metastases, and has reduced the toxicity of radiotherapy and chemotherapy. side effect. At the same time, elemene liposome injection can also be used in the treatment of intervention, intracavitary chemotherapy and cancerous pleural effusion. Therefore, elemene liposome injection is widely used in the field of anticancer treatment. [0003] Elemene liposome injection currently on the market is a milky white homogeneous emulsion liqui...

Claims

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Application Information

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IPC IPC(8): C12Q1/06C12Q1/04
CPCC12Q1/06C12Q1/04
Inventor 王宇简卫光余渊于丽红
Owner JINGANG PHARMA DALIAN
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