Compound vitamin (3) pharmaceutical composition for injection and preparation method thereof

A technology for compound vitamins and vitamins, which is applied in the directions of drug combinations, active ingredients of heterocyclic compounds, and medical preparations of non-active ingredients, etc., can solve the problems affecting product quality and safety, the stability of active ingredients, etc. The effect of stable and controllable, easy preparation method and simple preparation method

Inactive Publication Date: 2013-07-17
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the concentration of pH regulators (such as sodium hydroxide) in the drug solution will increase with the sublimation of water during the preparation process of the lyophilized preparation, the pH range of the drug solution may exceed a certain limit, thus affecting the active ingredient. impact on stability, which in turn affects product quality and safety

Method used

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  • Compound vitamin (3) pharmaceutical composition for injection and preparation method thereof
  • Compound vitamin (3) pharmaceutical composition for injection and preparation method thereof
  • Compound vitamin (3) pharmaceutical composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Each 1000 vials of freeze-dried powder injection contains the following components:

[0028] Vitamin B 1 10g

[0029] Riboflavin sodium phosphate 6.355g (calculated after deducting crystal water)

[0030] Vitamin C200g

[0031] Glycine 400g

[0032] Thiourea 6.2g

[0033] Weigh glycine, add water for injection to prepare 20% glycine solution, and then weigh vitamin B 1 , Riboflavin Sodium Phosphate, and Vitamin C were added to glycine solution and stirred to dissolve in sequence, and water for injection was added to 90% of the total liquid volume of 3000ml, and stirred evenly; 0.03% (g / ml) activated carbon for needles was added, and nitrogen was filled to stir and adsorb After 15 minutes, decarbonize and filter; add water for injection to the filtrate until the total volume of the solution is 3000ml, filter through a 0.22μm filter, and aseptically fill the filtrate into 1000 vials to be freeze-dried.

[0034]Freeze-drying: When the temperature of the shelf drops t...

Embodiment 2

[0036] Each 1000 vials of freeze-dried powder injection contains the following components:

[0037] Vitamin B 1 10g

[0038] Riboflavin sodium phosphate 6.355g (calculated after deducting crystal water)

[0039] Vitamin C200g

[0040] Glycine 450g

[0041] Thiourea 6.2g

[0042] Weigh glycine, add water for injection to prepare 10% glycine solution, and then weigh vitamin B 1 , riboflavin sodium phosphate, vitamin C, add in glycine solution and stir to dissolve in turn, add water for injection to 80% of the total liquid volume of 3000ml, stir evenly; add 0.03% (g / ml) activated carbon for needles, fill with nitrogen and stir for adsorption After 15 minutes, decarbonize and filter; add water for injection to the filtrate until the total volume of the solution is 3000ml, filter through a 0.22μm filter, and aseptically fill the filtrate into 1000 vials to be freeze-dried.

[0043] Freeze-drying: When the temperature of the shelf drops to -45°C and the temperature of the prod...

Embodiment 3

[0045] Each 1000 vials of freeze-dried powder injection contains the following components:

[0046] Vitamin B 1 18g

[0047] Riboflavin sodium phosphate 9g (calculated after deducting crystal water)

[0048] Vitamin C270g

[0049] Glycine 500g

[0050] Thiourea 8g

[0051] Weigh glycine, add water for injection to prepare 35% glycine solution, and then weigh vitamin B 1 , riboflavin sodium phosphate, vitamin C, add in glycine solution and stir to dissolve in turn, add water for injection to 90% of the total liquid volume of 3000ml, stir evenly; add 0.03% (g / ml) activated carbon for needles, fill with nitrogen and stir for adsorption After 15 minutes, decarbonize and filter; add water for injection to the filtrate until the total volume of the solution is 3000ml, filter through a 0.22μm filter, and aseptically fill the filtrate into 1000 vials to be freeze-dried.

[0052] Freeze-drying: When the temperature of the shelf drops to -45°C and the temperature of the product dr...

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Abstract

The invention provides a compound vitamin (3) pharmaceutical composition for injection and a preparation method thereof. The composition is powder injection and comprises vitamin B1, riboflavin sodium phosphate (namely vitamin B2 sodium phosphate), vitamin C, stabilizer glycine and antioxidant thiourea. The preparation method comprises the following steps: preparing liquid medicine, performing activated carbon adsorption, decarburizing, filtering and degerming, filling and performing freeze-drying. The compound vitamin (3) pharmaceutical composition for injection does not contain a pH regulator and is high in stability and high in safety.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a compound vitamin (3) pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Parenteral nutrition plays an important supportive role in the treatment of diseases. Parenteral nutrition plays an important role in maintaining life for patients with functional gastrointestinal diseases, cancer and those patients who need a temporary "rest" of the gastrointestinal tract. Parenteral nutrition enables patients to obtain various nutrients needed for metabolism, thereby avoiding the occurrence of starvation, malnutrition and "nutrition-related complications", and shortening the length of hospital stay. Parenteral nutrition is widely used in the treatment of patients with the following diseases, such as congenital gastrointestinal malformations, moderate to severe malnutrition, gastrointestinal diseases (severe diarr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/525A61K47/20A61K9/14A61P3/02A61K31/51A61K31/375
Inventor 冯卫杨平张晓琳莫毅
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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