Preparation method of vitamin C freeze dried powder injection

A freeze-dried powder injection and vitamin technology, applied in the field of chemical preparations, can solve the problems of incomplete removal of impurities, unqualified rate of clarity, poor product stability, etc., and achieve the effects of improved clarity, good solubility and increased stability

Inactive Publication Date: 2006-09-13
阿尔贝拉医药控股(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the vitamin C freeze-dried powder for injection in the domestic market is produced by many companies, all of which are prepared by traditional techniques. The existing products have poor stability, strong irritation, poor solubility, high failure rate of clarity, and curative effect. Problems such as instability can not be solved, the main reason is that some impurities such as protein, tannin, etc. are not completely removed during the preparation process, which affects clinical application

Method used

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  • Preparation method of vitamin C freeze dried powder injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A) Take 10% fresh water for injection, add disodium edetate and sodium bisulfite in the prescription, stir and dissolve, add 0.1% activated carbon, heat and boil for 40 minutes, cool down to 45°C in circulation, and use 0.45μm micropore The filter membrane was decarbonized and filtered to obtain the filtrate I.

[0025] B) Take fresh water for injection with a preparation volume of 70%, lower the temperature to 20°C, pass in carbon dioxide for 30 minutes to make it saturated, avoid light, add vitamin C in the prescription, stir to dissolve, then slowly add sodium bicarbonate in the prescription, and stir for 5 minutes , ultrafiltration with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain ultrafiltrate II.

[0026] C) Add filtrate II to filtrate I, stir evenly, add carbon dioxide-saturated water for injection to the prepared amount, adjust the pH value to 6.2, and after passing the inspection of the intermediate product, pass the liquid me...

Embodiment 2

[0028] A) Take fresh water for injection with a prepared volume of 15%, add disodium edetate and sodium bisulfite in the prescription, stir and dissolve, add 0.4% activated carbon, heat and boil for 25 minutes, cool down to 60°C in circulation, and use 0.45μm micropore The filter membrane was decarbonized and filtered to obtain the filtrate I.

[0029] B) Take fresh water for injection with a preparation volume of 85%, lower the temperature to 30°C, pass in carbon dioxide for 20 minutes to make it saturated, avoid light, add vitamin C in the prescription, stir to dissolve, then slowly add sodium bicarbonate in the prescription, and stir for 15 minutes , ultrafiltration with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain ultrafiltrate II.

[0030] C) Add filtrate II to filtrate I, stir evenly, add carbon dioxide-saturated water for injection to the prepared amount, adjust the pH value to 6.0, and pass the intermediate product inspection, sterili...

Embodiment 3

[0032] A) Take fresh water for injection with a prepared volume of 5%, add disodium edetate and sodium bisulfite in the prescription, stir and dissolve, add 0.3% activated carbon, heat and boil for 30 minutes, cool down to 30°C in circulation, and use 0.45μm micropore The filter membrane was decarbonized and filtered to obtain the filtrate I.

[0033] B) Take fresh water for injection with a preparation volume of 80%, lower the temperature to 40°C, inject carbon dioxide for 15 minutes to make it saturated, add vitamin C in the prescription in the dark, stir to dissolve, then slowly add sodium bicarbonate in the prescription, and stir for 10 minutes , ultrafiltration with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain ultrafiltrate II.

[0034] C) Add filtrate II to filtrate I, stir evenly, add carbon dioxide-saturated water for injection to the prepared amount, adjust the pH value to 5.9, and pass the intermediate product inspection, sterilize ...

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Abstract

A freeze-dried powder injection of VC for preventing and treating scurvy, acute and chronic infectious diseases, purpura, Keshan disease, etc is prepared from VC, sodium hydrogen sulfate, and disodium versenate through ultrasonic treating, adding CO2 saturated water for injection in dark condition and N2 atmosphere, regulating pH value and temp, etc.

Description

technical field [0001] The invention relates to a preparation method of a vitamin C freeze-dried powder injection for vitamin drug injection, in particular to a freeze-dried powder injection whose main component is vitamin C. Dissolve vitamin C in water for injection saturated with carbon dioxide, prepare it together with sodium bicarbonate and perform ultrafiltration treatment to obtain vitamin C ultrafiltrate, then mix with disodium edetate and sodium bisulfite filtrate, fill with nitrogen, After being freeze-dried, capping is packed and the vitamin C freeze-dried powder preparation for injection is made into a finished product, which belongs to the field of chemical preparations. The product can be injected intramuscularly or intravenously. Vitamin C participates in the metabolism of amino acids, the synthesis of neurotransmitters, the synthesis of collagen and tissue interstitium, which can reduce the permeability of capillaries, accelerate blood coagulation, stimulate blo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/375A61K9/19A61P7/00A61P9/02A61P39/02
Inventor 郭智华
Owner 阿尔贝拉医药控股(通化)有限公司
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