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Determination method for large volume injection quality inspection

A quality inspection and measurement method technology, which is applied in the direction of material analysis by observing the influence of chemical indicators, and analysis by making materials undergo chemical reactions, can solve the problems of increasing the cost of manpower and material resources, and the difference in loading capacity of the enterprise , to achieve intuitive measurement results, reduce testing costs, and reduce disputes

Inactive Publication Date: 2016-12-07
GUANGXI YUYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

2. The difference in loading
4. Visible foreign matter
5. Insoluble particles
7. Residues of heavy metals and harmful elements
If a drug manufacturer changes or adds inspection items to the specified product quality inspection items, it needs to submit for approval again, which will increase the cost of manpower and material resources for the company.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0030] A method for measuring the quality of large-volume injections, comprising the following steps:

[0031] 1. The sample to be tested is: glucose sodium chloride injection, the specification is 250ml / bottle;

[0032] 2. Preparation before measurement:

[0033] ⑴Filtration membrane: Tianjin Jinteng microporous filtration membrane (water system), diameter 50mm, pore size 0.45μm, 50 pieces / box, choose intact and free of foreign matter for standby;

[0034] ⑵ Filtration system: Tianjin Jinteng diaphragm vacuum pump, model Gm-0.33; Tianjin Jinteng T-50 solvent filter;

[0035] (3) Clean the suction filter bottle with water for injection, and take 10 bottles of the test product to clean the outer surface of the container for later use;

[0036] 3. Determination:

[0037] Connect the filter and the diaphragm vacuum pump, fix the prepared filter membrane on the filter cup, moisten the filter membrane with a small amount of water for injection, take 1 bottle of sample, turn it c...

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PUM

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Abstract

The invention discloses a determination method for large volume injection quality inspection. A filter membrane filtration method is adopted for carrying out filter membrane filtration residual item inspection on quality of large volume injection. The determination method disclosed by the invention is accurate in determination result, strong in pertinence, broad in reflection plane, easy to operate and low in production cost, the determination result is visual and unquestioned, more importantly higher requirement is put forward for the large volume injection, quality safety risk of the large volume injection is reduced, and reasonable and safe medication is guaranteed; and compared with an existing large volume injection quality inspection item, the determination method disclosed by the invention is applicable to both quality check of an intermediate product in a production process of a pharmaceutical enterprise and quality inspection of a product before leaving a factory.

Description

technical field [0001] The invention relates to the technical field of quality detection of pharmaceutical preparations, in particular to a method for measuring the quality of large-volume injections. Background technique [0002] Injection is a kind of injection. Injections refer to raw materials or sterile liquid preparations prepared with suitable auxiliary materials for injection into the body, including solution-type, emulsion-type or suspension-type injections. Large-volume injections for intravenous infusion (unless otherwise specified, generally not less than 100ml, biological products generally not less than 50ml) can also be called infusions. Traditional Chinese medicine injections are generally not suitable for making suspension injections. [0003] Injections should meet the following regulations during production and storage. 1. Solution-type injections should be clarified; unless otherwise specified, the particle size of raw materials in suspension-type inje...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/78
CPCG01N21/78
Inventor 阮传明罗世东陈建琨陈兴华吕亚平
Owner GUANGXI YUYUAN PHARMA
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