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Production method for preventing medicine liquor turbidity of glucose injection packaged in plastic bottle

A technology for glucose injection and production method, which is applied in the field of preventing turbidity of glucose injection in plastic bottles, can solve problems such as increasing labor and material costs, and achieve the effects of reduced probability of pollution, good stability, and no shedding.

Inactive Publication Date: 2015-12-16
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] A production method for preventing turbidity of plastic bottled glucose injection liquid, comprising the steps of:

[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 -30 minutes, pressurize, decarburize until clear, transfer to dilute 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 35.0, 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, and wait for filling ...

Embodiment 2

[0032] A production method for preventing turbidity of plastic bottled glucose injection liquid, comprising the steps of:

[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 15 -30 minutes, pressurize, decarburize until clear, transfer to dilute 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, 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, and wait for fillin...

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PUM

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Abstract

The invention discloses a production method for preventing medicine liquor turbidity of glucose injection packaged in a plastic bottle. The production method comprises the following steps that firstly, external force damage of a bottle blank and the bottle in the production process is reduced, and film scraps and fibers attached inside and outside a bottle body are reduced; secondly, a filtering device is additionally arranged at a water discharging port of a sterilization cabinet, and accumulation of the film scraps in a sterilization pipeline and a heat exchanger is reduced; thirdly, cleaning treatment of the sterilization cabinet is enhanced, attached film scraps becoming yellowish after multiple times of high temperature and large heat are reduced, the filtering device arranged at the water discharging port of the sterilization cabinet is cleaned every day, the sterilization cabinet is circularly cleaned through a 2% NaOH solution every week, and empty sterilization is carried out once every week. After the measures are taken, the problem of medicine liquor turbidity in the polypropylene infusion bottled glucose injection bottle body is solved, and the ratio of medicine liquor turbidity in the bottle body is almost zero.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method for preventing turbidity of glucose injection liquid in plastic bottles. 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 heart failure. Glucose in total intravenous nutrition...

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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