Production method of glucose injection

A technology of glucose injection and production method, which is applied in the production field of glucose injection, can solve the problems of increasing manpower and material costs, and achieve the effect of reducing visible foreign matter and stabilizing quality

Inactive Publication Date: 2017-01-04
GUANGXI YUYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the existing technology, drugs such as glucose injection are generally produced according to the process steps recommended by the State Food Administration or Pharmacopoeia and other guidance documents. If a drug manufacturer changes the production process for a product that has already received approval, it needs to reapply for approval. , will increase the cost of manpower and material resources

Method used

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  • Production method of glucose injection
  • Production method of glucose injection
  • Production method of glucose injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A kind of production method of glucose injection, comprises the steps:

[0029] 1) Weighing: prepare raw and auxiliary materials;

[0030] 2) Concentrated preparation: place the weighed glucose in a concentrated preparation tank with water for injection to prepare a 60% (w / w) concentrated solution, add medical hydrochloric acid and 0.05% (w / v) charcoal for needles and mix Control the pH at 3.8, heat, boil for 15-30 minutes, pressurize, decarbonize until clear, and transfer to the diluted tank;

[0031] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 4.3, measure the glucose content to be 98.0-104.0% of the marked amount, and filter after passing the test; take samples to check the properties and content of the liquid , pH value, after passing the test, filter through a 0.45um pore size pleated filter element connected in series with a 0.45um pore size pleated filter element,...

Embodiment 2

[0038]A kind of production method of glucose injection, comprises the steps:

[0039] 1) Weighing: prepare raw and auxiliary materials;

[0040] 2) Concentrated preparation: place the weighed glucose in a concentrated preparation tank with water for injection to prepare a 40% (w / w) concentrated solution, add medicinal hydrochloric acid and 0.05% (w / v) charcoal for needles and mix Control the pH at 4.0, heat, boil for 15-30 minutes, pressurize, decarbonize until clear, and transfer to the dilute tank;

[0041] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 4.1, measure the glucose content to 98.0-104.0% of the marked amount, and filter after passing the test; take samples to check the properties and content of the liquid , pH value, after passing the test, filter through a 0.45um pore size pleated filter element connected in series with a 0.45um pore size pleated filter element, an...

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Abstract

The invention discloses a production method of a glucose injection. By studying influences of the pH value on visible foreign matter of the glucose injection, it is shown that dextrin in glucose powder can be effectively pushed to be fully hydrolyzed by adding hydrochloric acid during high concentration preparation to control the pH value to range from 3.8 to 4.0, flocculation containing protein can be effectively adsorbed by activated carbon after dextrin is fully hydrolyzed, impurities in the glucose injection can be effectively removed, and therefore the glucose injection product is more transparent and clearer. During low concentration preparation, the pH value is controlled to range from 4.1 to 4.3, the visible foreign matter of the glucose injection is greatly reduced, and therefore the quality is more stable.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method of glucose injection. Background technique [0002] Glucose injection, chemical name: D-(+)-glucopyranose-hydrate, chemical structural formula: molecular formula: C 6 h 12 o 6 ˙H 2 O, molecular formula: 198.17, excipients: water for injection. This product is colorless or almost colorless clear liquid; sweet taste. Glucose is given intravenously directly into the blood circulation. Glucose is completely oxidized in the body to produce CO 2 And water, excreted through the lungs and kidneys, while producing energy. Can also be converted into glycogen and fat storage. Generally, the ability of a normal human body to utilize glucose per minute is 6 mg / kg. Too fast and too much fluid can cause palpitations, arrhythmia, and even acute left heart failure. Glucose in total intravenous nutrition therapy is the most important energy supply ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/04A61K31/7004A61J3/00A61J1/05
CPCA61K9/08A61J1/05A61J3/00A61K9/0019A61K31/7004A61K47/02
Inventor 阮传明吕亚平王亚军陈兴华罗世东王敏
Owner GUANGXI YUYUAN PHARMA
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