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Vitamin C injection and preparation method thereof

A technology for the preparation of injections and vitamins, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as hypocalcemia, time-consuming, etc., to improve antioxidant properties, Improve the antioxidant performance, the effect of increasing the content

Active Publication Date: 2014-11-19
国药集团容生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Vitamin C is sensitive to temperature. In the traditional preparation method of vitamin C injection, circulating steam is usually used for sterilization, which takes a long time, because vitamin C is oxidized and hydrolyzed by heat.
[0007] Edetate disodium is usually used as a complexing agent in traditional vitamin C injection formulations, because edetate disodium is easy to complex with calcium ions to form blood calcium, resulting in hypocalcemia

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A. Vitamin C Injection Formula

[0036] Vitamin C 5.000Kg, sodium bicarbonate 2.500Kg, sodium metabisulfite 40.000g, L-cysteine ​​hydrochloride 40.000g, sodium dithionite 40.000g, thioglycerol 30.000g, edetate calcium sodium 10.000g, for 767 type injection Activated carbon 60.000g, add water for injection to 20L.

[0037] B. The method for preparing the vitamin C injection of the above formula is as follows:

[0038] (1) Add 8000ml of water for injection into a 316L stainless steel bucket, cool down to 25°C, and inject carbon dioxide into the bucket to make the pH 4.0; take another 316L stainless steel bucket and put in the prescribed amount of calcium sodium edetate , add 2000ml of water for injection and stir to dissolve, then add to the concentrated blending barrel; sequentially add the formula amount of sodium metabisulfite, L-cysteine ​​hydrochloride, sodium dithionite, and thioglycerol into the concentrated blending barrel, and stir for 5 minutes; Alternately ad...

Embodiment 2

[0044] A. Vitamin C Injection Formula

[0045] Vitamin C 5.000Kg, sodium bicarbonate 2.498Kg, sodium metabisulfite 39.970g, L-cysteine ​​hydrochloride 40.020g, sodium dithionite 40.010g, thioglycerol 29.990g, edetate calcium sodium 9.993g, for 767 type injection Activated carbon 59.968g, add water for injection to 20L.

[0046] B. The method for preparing the vitamin C injection of the above formula is as follows:

[0047] (1) Add 6000ml of water for injection into the stainless steel concentrated mixing tank, cool down to 30°C, and inject carbon dioxide into the concentrated mixing tank to make the pH 4.5; take another stainless steel tank and put the formula amount of edetate calcium sodium, add 1000ml The water for injection was stirred and dissolved, and then added to the concentrated blending barrel; the formula amount of sodium metabisulfite, L-cysteine ​​hydrochloride, sodium dithionite, and thioglycerol were added into the concentrated blending barrel in turn, and...

Embodiment 3

[0053] A. Vitamin C Injection Formula

[0054] Vitamin C 5.000Kg, sodium bicarbonate 2.499Kg, sodium metabisulfite 40.018g, L-cysteine ​​hydrochloride 39.980g, sodium dithionite 39.980g, thioglycerol 29.996g, edetate calcium sodium 10.010g, for 767 type injection Activated carbon 60.010g, add water for injection to 20L.

[0055] B. The method for preparing the vitamin C injection of the above formula is as follows:

[0056] (1) Add 10,000ml of water for injection into the stainless steel concentrated bucket, cool down to 28°C, and inject carbon dioxide into the concentrated bucket to make the pH 4.1; take another stainless steel bucket and put the formula amount of edetate calcium sodium, add 3000ml of water for injection was stirred and dissolved, and then added to the concentrated blending barrel; sequentially added the amount of sodium metabisulfite, L-cysteine ​​hydrochloride, sodium dithionite, and thioglycerol into the concentrated blending barrel, and the stirr...

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Abstract

The invention discloses a vitamin C injection and a preparation method thereof. The vitamin C injection is prepared from the following components by weight: 5.000kg of vitamin C, 2.498-2.502kg of sodium bicarbonate, 39.970-40.020g of sodium metabisulfite, 39.980-40.020g of L-cysteine hydrochloride, 39.980-40.010g of sodium hydrosulfite, 29.990-30.020g of thioglycerol, 9.990-10.010g of sodium calcium edentate, 59.960-60.010g of activated carbon for 767 type injections and water for injection which is added until the volume of the mixture is 20L. The invention further discloses a preparation method of the vitamin C injection. The novel formula of combination of four antioxidants sodium metabisulfite, L-cysteine hydrochloride, sodium hydrosulfite and thioglycerol is adopted, so that the oxidation resistance of vitamin C is effectively improved, the impurity content is reduced, and the product appearance is changed from a general light yellow clear liquid into a transparent clear liquid.

Description

technical field [0001] The invention relates to vitamin C injection and a preparation method thereof, belonging to the technical field of medicine preparation. Background technique [0002] Vitamin C, also known as ascorbic acid, is an acidic polyhydroxy compound containing 6 carbon atoms with the molecular formula C 6 h 8 o 6 , The molecular weight is 176.1. There are two types of naturally occurring ascorbic acid, L-type and D-type, the latter of which has no biological activity. Vitamin C is a colorless and odorless flaky crystal, easily soluble in water and insoluble in fat solvents. Stable in an acidic environment, it can promote its oxidative destruction when it encounters oxygen, heat, light, and alkaline substances in the air, especially in the presence of oxidase and trace copper, iron and other metal ions. Oxidases are generally abundant in vegetables, so they are lost to varying degrees during storage. But the bioflavonoids contained in some fruits can prote...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/375A61K47/20A61K47/02A61K47/18
Inventor 周越唐燕秋王卫士王现国李向东
Owner 国药集团容生制药有限公司
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