Vitamin C injection and preparation method thereof

A vitamin and injection technology, applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of discoloration and yellowing, insufficient production technology, unstable properties, etc. Neutralization reaction occurs, improves drug stability and safety, and reduces the effect of impurities

Active Publication Date: 2019-08-30
CHENGDU HAITONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, due to insufficient production technology, vitamin C injection will have quality problems such as unstable pH value, unstable properties, discoloration and yellowing during storage

Method used

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  • Vitamin C injection and preparation method thereof

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Embodiment 1

[0022] The preparation of embodiment 1 vitamin C injection of the present invention

[0023] Formula: vitamin C 100g, sodium bicarbonate 96g, sodium metabisulfite 3g, edetate disodium 2g, cysteine ​​hydrochloride 1g, activated carbon for injection 2g, water for injection 2000ml

[0024] Process:

[0025] (1) Add 2 / 3 of the total volume of water for injection into the concentrated preparation tank, and after passing nitrogen gas for more than 10 minutes, the temperature is controlled between 50±5°C.

[0026] (2) Continue to feed nitrogen, alternately add vitamin C and sodium bicarbonate in 3 times, and stir while adding, until the prescribed amount of vitamin C and sodium bicarbonate are all thrown in, and stir until completely dissolved.

[0027] (3) Add the prescribed amounts of sodium metabisulfite, edetate disodium, and cysteine ​​hydrochloride in sequence, respectively, and continue to stir for 10 minutes after the dissolution is complete. Check the pH of the liquid, and ...

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Abstract

The present invention provides a vitamin C injection and a preparation method thereof. The preparation method uses nitrogen gas, dissolves drugs in a multiple-time manner and adds a specific antioxidant to prevent a neutralization reaction, reduce generation of impurities and improve stability and safety of the drugs.

Description

technical field [0001] The invention relates to vitamin C injection and a preparation method thereof. Background technique [0002] Vitamin C injection is widely used in the treatment of various acute and chronic diseases, especially in patients receiving chronic hemodialysis, gastrointestinal diseases (long-term diarrhea, after gastric or ileal resection), AIDS, tuberculosis, cancer, ulcer disease, hyperthyroidism , fever, infection, trauma, burns, surgery, etc., or due to strict control or choice of diet, patients receiving parenteral nutrition, malnutrition, sudden weight loss, and during pregnancy and lactation, or use barbiturates , tetracyclines, salicylic acid, or when vitamin C is used as a urinary system acidifying drug, the demand for it increases significantly. [0003] However, due to the deficiency of the production process, the vitamin C injection will have quality problems such as unstable pH value, unstable properties, discoloration and yellowing during stor...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K47/18A61K31/375A61P3/02
CPCA61K9/0019A61K9/08A61K31/375A61K47/02A61K47/183A61P3/02
Inventor 史凌洋任军
Owner CHENGDU HAITONG PHARMA
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