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Water-soluble vitamin composition for injection and quality control method thereof

A technology for water-soluble vitamins and injections, which can be used in drug combinations, active ingredients of heterocyclic compounds, drug delivery, etc., and can solve problems such as insufficient stability, insufficient synthesis amount, and vitamin deficiency.

Inactive Publication Date: 2016-11-16
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

③ Most of the vitamins cannot be synthesized by the body or the amount of synthesis is insufficient to meet the needs of the body and must be obtained from food frequently
④The human body has a very small requirement for vitamins, and the daily requirement is often calculated in milligrams (mg) or micrograms (μg), but once it is deficient, it will cause corresponding vitamin deficiency and cause damage to human health
[0013] Due to the problem of insufficient stability of each active substance in the water-soluble vitamin powder injection for injection, and the complex composition, its quality control method has brought great challenges to those skilled in the art

Method used

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  • Water-soluble vitamin composition for injection and quality control method thereof
  • Water-soluble vitamin composition for injection and quality control method thereof
  • Water-soluble vitamin composition for injection and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0219] Embodiment 1: Preparation of water-soluble vitamin composition for injection

[0220] Weight ratio per bottle: thiamine nitrate 3.1mg, nicotinamide 40mg, pyridoxine hydrochloride 4.9mg, sodium pantothenate 16.5mg, riboflavin sodium phosphate 4.9mg, vitamin C sodium 113mg, biotin 60ug, folic acid 0.4mg, 5.0 ug vitamin B 12 , Methylparaben 0.5mg, Glycine 300mg, Disodium edetate 0.5mg.

[0221] Preparation method:

[0222] (1) Weigh 12 kinds of materials, add water for injection (the amount is 800 times the weight of thiamine nitrate), stir evenly, adjust the pH value to 5.7-6.0 with 1mol / L sodium hydroxide solution or hydrochloric acid solution, raw and auxiliary materials Dissolve completely, add water for injection to 1000 times the weight of thiamine nitrate, add activated carbon at 0.1w / v% by volume of the drug solution for adsorption for 30min, filter for decarburization, and adjust the pH value of the solution to 5.7-6.0 with an acid-base regulator;

[0223] (2) ...

Embodiment 2

[0225] Embodiment 2: Preparation of water-soluble vitamin composition for injection

[0226] Weight ratio per bottle: thiamine nitrate 3.4mg, nicotinamide 39mg, pyridoxine hydrochloride 5.3mg, sodium pantothenate 15.5mg, riboflavin sodium phosphate 5.3mg, vitamin C sodium 110mg, biotin 65ug, folic acid 0.38mg, 5.9 ug vitamin B 12 , Methylparaben 0.45mg, Glycine 325mg, Disodium edetate 0.4mg.

[0227] Preparation method: Carry out as in Example 1, but use freeze-drying curve B to carry out freeze-drying.

Embodiment 3

[0228] Embodiment 3: Preparation of water-soluble vitamin composition for injection

[0229] Weight ratio per bottle: thiamine nitrate 2.9mg, nicotinamide 43mg, pyridoxine hydrochloride 4.7mg, sodium pantothenate 17.5mg, riboflavin sodium phosphate 4.8mg, vitamin C sodium 123mg, biotin 58ug, folic acid 0.43mg, 5.0 ug vitamin B 12 , Methylparaben 0.60mg, Glycine 275mg, Disodium edetate 0.6mg.

[0230] Preparation method: carry out according to embodiment 1.

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PUM

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Abstract

The invention relates to a water-soluble vitamin composition for injection and a quality control method thereof. Specifically, the invention relates to the method for quality control of the water-soluble vitamin freeze-dried powder injection composition for injection; the composition contains the following components by weight: 2.8-3.4 mg of thiamine nitrate, 36-44 mg of nicotinamide, 4.4-5.4 mg of pyridoxine hydrochloride, 14.8-18.1 mg of sodium pantothenate, 4.4-5.4 mg of riboflavin sodium phosphate, 102-124 mg of sodium vitamin C, 54-66 [mu]g of biotin, 0.36-0.44 mg of folic acid, 4.5-6.0 [mu]g of vitamin B12, 0.4-0.6 mg of methyl p-hydroxybenzoate, 250-350 mg of glycine, and 0.3-0.7 mg of ethylenediaminetetraacetic acid disodium salt. The invention also relates to the composition. The method provided by the invention has excellent effects as described in the specification.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, in particular, relates to a pharmaceutical composition of water-soluble vitamin powder injection for injection and a quality control method thereof, in particular to a pharmaceutical composition of water-soluble vitamin powder injection for injection containing B vitamins and its quality control method. Background technique [0002] Vitamins are a type of trace organic substances necessary for humans and animals to maintain normal physiological functions. They play an important role in the process of human growth, metabolism, and development. When humans and animals lack vitamins, they cannot grow normally and develop specific lesions. , the so-called vitamin deficiency. [0003] Vitamins are also known as vitamins. Generally speaking, they are life-sustaining substances. They are a type of organic substances necessary to maintain human life activities, and are also important ...

Claims

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Application Information

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IPC IPC(8): A61K31/714A61K31/675A61K31/519A61K31/51A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/235A61K31/197A61K31/198A61K9/19A61P3/02G01N33/15G01N5/04G01N21/84G01N21/90G01N30/02
CPCA61K47/02G01N5/045G01N21/84G01N21/90G01N30/02G01N33/15A61K9/0019A61K9/19A61K31/197A61K31/198A61K31/235A61K31/375A61K31/4188A61K31/4415A61K31/455A61K31/51A61K31/519A61K31/675A61K31/714G01N2030/027A61K2300/00
Inventor 方专陈娟吴国庆张莲莲伍隆霞赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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