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Compound vitamin (3) freeze-dried powder injection for injection and preparation method and analysis method thereof

A technology of compound vitamin and freeze-dried powder injection, which is applied in the field of compound vitamin freeze-dried powder injection for injection and its preparation, to achieve the effects of avoiding curative effect reduction, avoiding degradation, and good storage stability

Active Publication Date: 2012-07-11
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Third, there are certain limitations in the transportation and storage conditions of aqueous injection preparations

Method used

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  • Compound vitamin (3) freeze-dried powder injection for injection and preparation method and analysis method thereof
  • Compound vitamin (3) freeze-dried powder injection for injection and preparation method and analysis method thereof
  • Compound vitamin (3) freeze-dried powder injection for injection and preparation method and analysis method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 1. Prescription:

[0044]

[0045]

[0046] 2. Preparation method:

[0047] 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 successively to the glycine solution, stirred and dissolved, and water for injection was added to about 90% of the total liquid volume, and stirred evenly; the pH value was adjusted to the specified range with sodium hydroxide solution, and 0.03% (g / ml) Activated carbon for needles, filled with nitrogen, stirred and adsorbed for 15 minutes, then decarbonized and filtered; the filtrate was supplemented with water for injection to the full amount of the solution, filtered through a 0.22 μm filter, and the filtrate was aseptically filled; the filled medicinal solution was freeze-dried: put When the plate temperature drops to -45°C and the product temperature drops below -36°C, return the shelf to about -30 to -15°C, then cool the shelf to...

Embodiment 2

[0049] 1. Prescription:

[0050]

[0051] 2. Preparation method:

[0052] Weigh glycine, add water for injection to prepare 10% glycine solution, and then weigh vitamin B 1 , riboflavin sodium phosphate, vitamin C, add in the glycine solution successively and stir to dissolve, add water for injection to about 80% of the total liquid volume, stir evenly; adjust the pH value to the specified range with sodium hydroxide solution, add 0.03% (g / ml) Activated carbon for needles, filled with nitrogen, stirred and adsorbed for 15 minutes, then decarbonized and filtered; the filtrate was supplemented with water for injection to the full amount of the solution, filtered through a 0.22 μm filter, and the filtrate was aseptically filled; the filled medicinal solution was freeze-dried: put When the plate temperature drops to -45°C and the product temperature drops below -36°C, return the shelf to about -35 to -10°C, then cool the shelf to below -45°C for 1 to 6 hours, and start the va...

Embodiment 3

[0054] 1. Prescription:

[0055]

[0056] 2. Preparation method:

[0057] 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 successively and stir to dissolve, add water for injection to about 90% of the total liquid volume, stir evenly; use citric acid solution to adjust the pH value to the specified range, add 0.03% (g / ml) Activated carbon for needles, filled with nitrogen, stirred and adsorbed for 15 minutes, then decarbonized and filtered; the filtrate was supplemented with water for injection to the full amount of the solution, filtered through a 0.22 μm filter, and the filtrate was aseptically filled; the filled medicinal solution was freeze-dried: put When the plate temperature drops to -45°C and the product temperature drops below -36°C, return the shelf to about -30 to -10°C, then cool the shelf to below -45°C for 1 to 4 hours, and start the vacuum pu...

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Abstract

The invention provides a compound vitamin freeze-dried powder injection for injection, which comprises vitamin B15-15 parts by weight, riboflavin sodium phosphate 3-8 parts by weight (counting by reducing crystal water), vitamin C 150-250 parts by weight, glycine 350-500 parts by weight and water for injection 1000-5000 parts by weight which is used as a solvent during preparation and is finally removed. The compound vitamin freeze-dried powder injection for injection is good in stability, high in safety and convenient to store and transport. The invention further provides a preparation method of the compound vitamin freeze-dried powder injection for injection. The compound vitamin freeze-dried powder injection for injection prepared through the preparation method is good in stability and high in safety. The invention further provides an analysis method of the compound vitamin freeze-dried powder injection for injection, and the analysis method is particularly specific to relevant substance of unstable basic medicines.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a compound vitamin (3) freeze-dried powder injection for injection and a preparation method and an analysis method thereof. Background technique [0002] Vitamins are a class of low-molecular organic compounds that maintain the normal functions of the human body. They are neither raw materials for forming body tissues nor energy-supplying substances in the body. They act as coenzymes or participate in the formation of coenzymes to catalyze the synthesis of other nutrients. It plays an important role in regulating substance metabolism, promoting growth and development, and maintaining physiological functions. The human body needs a small amount of vitamins, but they need to be ingested from the outside world, and cannot be synthesized or synthesized in insufficient amounts. If a certain vitamin is deficient for a long time, it will lead to disease. Vitamin C deficie...

Claims

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Application Information

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IPC IPC(8): A61K31/675A61K31/375A61K31/51A61K9/19A61P3/02G01N30/02
Inventor 郑伟
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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