Production method for preventing liquid medicine turbidity of plastic bottled dextrose injection

A technology for glucose injection and production method, which is applied in the field of preventing the turbidity of plastic bottled glucose injection, and can solve the problems of increasing manpower and material costs

Inactive Publication Date: 2015-12-09
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

[0024] The production method for preventing the turbidity of the plastic bottled glucose injection liquid comprises the following steps:

[0025] 1) Weighing: prepare raw and auxiliary materials;

[0026] 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;

[0027] 3) Dilute preparation: add water for injection to the full amount in the dilute preparation tank, circulate until clear, adjust the pH value to 5.0, 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, an...

Embodiment 2

[0035] The production method for preventing the turbidity of the plastic bottled glucose injection liquid comprises the following steps:

[0036] 1) Weighing: prepare raw and auxiliary materials;

[0037]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;

[0038] 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, ...

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PUM

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Abstract

The invention discloses a production method for preventing liquid medicine turbidity of a plastic bottled dextrose injection. The production method includes the following measures that firstly, external force damage caused in the production process of bottle embryos and bottles is reduced, and film scraps and fibers attached inside and outside bottle bodies are reduced; secondly, a sterilization cabinet draining opening filtering device is added, and accumulation of film scraps in a sterilization pipeline and a heat exchanger is reduced; thirdly, cleaning of the sterilization cabinet is strengthened, attachment of yellowed film scraps after multiple times of high-temperature heating is reduced, the sterilization cabinet draining opening filtering device is cleaned every day, a 2% NaOH solution is used for cyclically cleaning the sterilization cabinet every week, and no-load sterilization is conducted a time. After the measures are adopted, the problem of liquid medicine turbidity in the bottle bodies of the polypropylene infusion bottled dextrose injection is solved, and the probability of liquid medicine turbidity in the bottle bodies is almost zero. According to the production method, polypropylene new materials, recycled first-level polypropylene granule materials and thermoplastic elastomers are evenly mixed to manufacture a lifting ring according to the weight ratio of 2:2:1 through formula adjustment, the product quality is ensured while the production cost is reduced, and the lifting ring cannot be broken.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method for preventing turbidity of plastic bottled glucose injection liquid. 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 nutrit...

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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