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Preparation of injecting soluble vitamines

A technology for water-soluble vitamins and water for injection, which can be applied to medical preparations containing active ingredients, pharmaceutical formulations, organic active ingredients, etc., and can solve the problems of low storage temperature of water-soluble vitamins.

Inactive Publication Date: 2007-04-04
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the above problems, the object of the present invention is to provide a preparation method of water-soluble vitamins for injection, which can improve the oxidation resistance of the preparation and solve the problem of low storage temperature of the above-mentioned existing water-soluble vitamins for injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Add 300 g of glycine to water for injection, heat and stir in a hot water bath to completely dissolve it, and at the same time, feed nitrogen. Add cysteine ​​hydrochloride 0.2g, edetate disodium 0.5g, methyl p-hydroxybenzoate 0.5g, vitamin C sodium 113g, folic acid 0.4g, thiamine nitrate 3.1g, riboflavin sodium phosphate 4.9g, vitamin B 6 4.9g, biotin 60mg, vitamin B 12 5.0mg, sodium pantothenate 16.5g, nicotinamide 40g, stir to dissolve. Adjust the pH to 5.6-6.1 with sodium bicarbonate, add water for injection to the full amount, stir for 2 hours, and filter aseptically with a 0.20 μm filter element. Filling, 2.5ml per bottle, pre-freezing at -35°C for 10 hours, vacuuming, and then repressurizing with nitrogen, then pre-freezing for 3 hours, vacuuming, raising the temperature to 30°C, holding for 10 hours, and the freeze-drying is complete. Inflate nitrogen until the vacuum degree is 4000 Pa, press the plug, and roll the cap to obtain the water-soluble vitamin for i...

Embodiment 2

[0027] Add 300 g of glycine to water for injection, heat and stir in a hot water bath to completely dissolve it, and at the same time, feed carbon dioxide gas. Add cysteine ​​hydrochloride 0.2g, edetate disodium 0.5g, methyl p-hydroxybenzoate 0.5g, vitamin C sodium 113g, folic acid 0.4g, thiamine nitrate 3.1g, riboflavin sodium phosphate 4.9g, vitamin B 6 4.9g, biotin 60mg, vitamin B 12 5.0mg, sodium pantothenate 16.5g, nicotinamide 40g, stir to dissolve. Adjust the pH to 5.6-6.1 with sodium bicarbonate, add water for injection to the full amount, stir for 2 hours, and filter aseptically with a 0.20 μm filter element. Filling, 2.5ml per bottle, pre-freezing at -40°C for 5 hours, vacuuming, and then repressurizing with carbon dioxide gas, pre-freezing for 3 hours, vacuuming, raising the temperature to 35°C, keeping it warm for 6 hours, and the freeze-drying is complete. Inflate carbon dioxide gas to a vacuum degree of 6000 Pa, press the plug, and roll the cap to obtain the w...

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PUM

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Abstract

A process for preparing the injection of water-soluble vitamin includes such steps as thermally dissolving glycine in the water for injection while filling inertial gas, adding 12 compounds including cysteine hydrochloride, endrate disodium, vitamin C sodium, folic acid, etc, stirring, regulating pH=5.6-6.1, adding the water for injection, stirring, aseptic filtering, pouring in containers, pre-freezing, vacuumizing, filling inertial gas, pre-freezing, heating to 30-35 deg.C, holding the temp for 6-10 hr, filling inertial gas, and sealing.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of water-soluble vitamins for injection. Background technique [0002] Water-soluble vitamins include B vitamins and vitamin C, which are micronutrients necessary to maintain normal physiological functions and material and energy metabolism of the human body. As a component of dozens of coenzymes in the body, it is essential for enzymes that catalyze carbohydrate, lipid and protein metabolism; it is also necessary for drug metabolism, free radical capture, prevention of cell damage and peroxidation of organelle membranes . At the same time, water-soluble vitamins are a group of compounds that are difficult to synthesize and store in the body, and must be obtained from food in a quantitative and regular manner. Although the normal human body needs very little, insufficient intake can cause a variety of diseases. [0003] Water-soluble vitamins for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K9/08A61P3/02
Inventor 唐志春李志亮丘能军
Owner YAOPHARMA CO LTD
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