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Production method for preventing bottle body of plastic bottled glucose injection from turning yellow and liquor therein from turning turbid

A technique for glucose injection and a production method, which is applied in the field of preventing the yellowing of the bottle body of the glucose injection in plastic bottles and the turbidity of the liquid medicine, and can solve the problems of increasing the cost of manpower and material resources

Inactive Publication Date: 2015-12-30
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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The production method for preventing the bottle body of the plastic bottled glucose injection from turning yellow and the liquid medicine from being turbid comprises the following steps:

[0023] 1) Weighing: prepare raw and auxiliary materials;

[0024] 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 0.05% (w / v) charcoal for needles, heat, and boil for 15 Minutes, pressurize, decarburize until clear, and transfer to the diluted tank;

[0025] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 3.8-5.0, measure the glucose content to be 98.0-104.0% of the marked amount, and wait for filtration after passing the test; take a sample and check the properties of the liquid , content, pH value, after passing through the 0.45um pore size pleated filter element in series...

Embodiment 2

[0032] The production method for preventing the bottle body of the plastic bottled glucose injection from turning yellow and the liquid medicine from being turbid comprises the following steps:

[0033] 1) Weighing: prepare raw and auxiliary materials;

[0034] 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 0.05% (w / v) charcoal for needles, heat, and boil for 30 Minutes, pressurize, decarburize until clear, and transfer to the diluted tank;

[0035] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 3.8-5.0, measure the glucose content to be 98.0-104.0% of the marked amount, and wait for filtration after passing the test; take a sample and check the properties of the liquid , content, pH value, after passing through the 0.45um pore size pleated filter element in series...

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PUM

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Abstract

The invention discloses a production method for preventing a bottle body of a plastic bottled glucose injection from turning yellow and liquor therein from turning turbid. The production method comprises the following measures: (1) reducing external force damages of a blank bottle and a bottle body in a production process, and reducing attachment of film chippings and fiber inside and outside the bottle body; (2) additionally arranging a filtering device at a water outlet of a sterilization cabinet, and reducing accumulation of the film chippings in a sterilization pipeline and a heat exchanger; (3) strengthening a cleaning treatment to the sterilization cabinet, reducing attachment of yellowed film chippings generated after multiple high temperature and high heat, cleaning the filtering device at the water outlet of the sterilization cabinet every day, cyclically cleaning the sterilization cabinet and carrying out no-load sterilization once weekly by adopting a 2% NaOH solution. After all the measures are executed, the problems that the polypropylene bottled glucose injection for transfusion turns yellow and liquor in the bottle body turns turbid are solved, and the ratio of bottles of which the bottle bodies turn yellow and the liquid in the bottle bodies turns turbid is nearly zero.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method for preventing the bottle body of a plastic bottled glucose injection from turning yellow and the liquid from being turbid. 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 bloodstream. 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 hea...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7004A61J1/05
Inventor 阮传明吕亚平陈兴华彭洪专陈早邦王敏
Owner GUANGXI YUYUAN PHARMA
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