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Vitamin C freeze-dried powder for injection and preparation method thereof

A technology of freeze-dried powder injection and vitamins, which is applied in the field of medicine, can solve the problems of clinical drug safety, unsafe environment, large quantities, etc., and achieve the effects of favorable drug efficacy, energy saving, and fast forming

Inactive Publication Date: 2013-08-14
BOSEN BIO PHARMA SHANXI PROVINCE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Another purpose of the present invention is to overcome the large amount of carbon dioxide bubbles produced by traditional vitamin C for injection during clinical medication, the environment is not guaranteed during clinical dispensing, and there are potential safety hazards in clinical medication.

Method used

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  • Vitamin C freeze-dried powder for injection and preparation method thereof
  • Vitamin C freeze-dried powder for injection and preparation method thereof
  • Vitamin C freeze-dried powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038]

[0039] Production Process:

[0040] 1).Preparation of liquid medicine: 60% of the prescription amount of water for injection is saturated with carbon dioxide, add antioxidant and antioxidant synergist and stir to dissolve, then add vitamin C to dissolve, add sodium carbonate to fully stir to dissolve, and wait until the bubbles are exhausted Stir for 30 minutes, add mannitol, stir to dissolve.

[0041] 2). Depyrogenation: add 0.15% medicinal activated carbon, stir and adsorb for 30 minutes, decarbonize by coarse filtration, add water for injection filled with carbon dioxide in advance to the full amount, and test the intermediate product.

[0042] 3). Sterilization and filtration: After passing the inspection, filter with a 0.22-micron microporous membrane, and carry out under a local laminar flow hood under the 10,000-level.

[0043] 4). Filling: Adjust the filling volume to 2ml, and divide into controlled antibiotic glass bottles. The liquid is filled with carbo...

Embodiment 2

[0052]

[0053] Production Process:

[0054]1).Preparation of liquid medicine: 60% of the prescription amount of water for injection is saturated with carbon dioxide, add antioxidant and antioxidant synergist and stir to dissolve, then add vitamin C to dissolve, add sodium carbonate to fully stir to dissolve, and wait until the bubbles are exhausted Stir for 30 minutes, add mannitol, stir to dissolve.

[0055] 2). Depyrogenation: add 0.15% medicinal activated carbon, stir and adsorb for 30 minutes, decarbonize by coarse filtration, add water for injection filled with carbon dioxide in advance to the full amount, and test the intermediate product.

[0056] 3). Sterilization and filtration: After passing the inspection, filter with a 0.22-micron microporous membrane, and carry out under a local laminar flow hood under the 10,000-level.

[0057] 4). Filling: adjust the filling volume to 3ml, and divide it into controlled antibiotic glass bottles. The liquid medicine is inflat...

Embodiment 3

[0066]

[0067] Production Process:

[0068] 1).Preparation of liquid medicine: 60% of the prescription amount of water for injection is saturated with carbon dioxide, add antioxidant and antioxidant synergist and stir to dissolve, then add vitamin C to dissolve, add sodium carbonate to fully stir to dissolve, and wait until the bubbles are exhausted Stir for 30 minutes, add mannitol, stir to dissolve.

[0069] 2). Depyrogenation: add 0.15% medicinal activated carbon, stir and adsorb for 30 minutes, decarbonize by coarse filtration, add water for injection filled with carbon dioxide in advance to the full amount, and test the intermediate product.

[0070] 3). Sterilization and filtration: After passing the inspection, filter with a 0.22-micron microporous membrane, and carry out under a local laminar flow hood under the 10,000-level.

[0071] 4). Filling: Adjust the filling volume to 6ml, and divide into controlled antibiotic glass bottles. The liquid is filled with carbo...

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PUM

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Abstract

The invention relates to a vitamin C freeze-dried powder for injection and a preparation method thereof. The invention belongs to the field of medical technology. The vitamin C freeze-dried powder for injection is composed of vitamin C, sodium carbonate, an excipient, an anti-oxidant, an antioxidant synergist and injection water. The preparation method comprises seven steps: filling the injection water with carbon dioxide until the mixture is saturated, preparing a liquid medicine, removing pyrogen, degerming, filtering, loading, freeze-drying and capping. The product provided by the invention has advantages of good external properties, good stability, definite therapeutic effect, simple operation and low cost, and can be widely used in the field of preparations of medicines which are not stable at normal temperature.

Description

technical field [0001] The invention relates to a vitamin C freeze-dried powder for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Vitamin C, also known as ascorbic acid, is a water-soluble vitamin. It is mainly used for the prevention and treatment of scurvy, various acute and chronic infectious diseases and purpura and other adjuvant treatments. Large-dose intravenous injection is used for Keshan syndrome and rescue in cardiogenic shock. This product can also be used in the treatment of chronic iron poisoning and idiopathic methemoglobinemia. The drug has been used clinically for a long time, with definite curative effect and no obvious adverse reactions. It is welcomed by doctors and patients, and the market prospect is promising. [0003] The enol formula in the vitamin C structure makes it extremely unstable, easy to oxidize and change color when exposed to air, stable in acidic solutions, and eas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/375A61P3/02A61P7/00A61P9/02
Inventor 刘艳玲王英胥清泉
Owner BOSEN BIO PHARMA SHANXI PROVINCE
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