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Vitamin C injection and preparation method thereof

A vitamin and injection technology, applied in pharmaceutical formulations, drug delivery, inorganic inactive ingredients, etc., can solve problems such as time-consuming, low blood calcium, etc., and achieve the effects of improving antioxidant properties, content, and antioxidant properties.

Active Publication Date: 2016-08-17
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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  • Vitamin C injection and preparation method thereof
  • Vitamin C injection and preparation method thereof

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 it 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 it into the formula 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; Alternate...

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; another stainless steel tank is put into the formulated amount of calcium sodium edetate, and 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, a...

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; another stainless steel bucket is put into the formulated amount of calcium sodium edetate, and 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 stirrin...

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Abstract

The invention discloses a vitamin C injection and a preparation method thereof. The formula consists of: vitamin C 5.000Kg, sodium bicarbonate 2.498-2.502Kg, sodium metabisulfite 39.970-40.020g, L-cysteine ​​hydrochloride 39.980-40.020g , sodium dithionite 39.980~40.010g, thioglycerol 29.990~30.020g, calcium sodium edetate 9.990~10.010g, 59.960~60.010g activated carbon for 767-type injection, add water for injection to 20L, and disclose its preparation method. Using the new formula of sodium metabisulfite, L-cysteine ​​hydrochloride, sodium dithionite, and thioglycerol in combination with four antioxidants, it effectively improves the antioxidant activity of vitamin C, reduces the impurity content, and the appearance of the product changes from the usual The yellowish clear liquid changed into a colorless 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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Patent Type & Authority Patents(China)
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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