Pharmaceutical composition containing 13 kinds of vitamins

A vitamin and composition technology, applied in the field of pharmaceutical composition containing 13 vitamins and its preparation, can solve the problems of high toxicity of ingredients, decreased vitamin C content, easy oxidation, etc.

Inactive Publication Date: 2012-07-04
郑飞雄
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, most of the components in the 13 multivitamin preparations are easily oxidized, such as racemic α-tocopherol (vitamin E), vitamin C, etc. After a long time of storage, the content of racemic α-tocopherol and vitamin C decreased significantly
In order to overcome the above-mentioned defects, chelating agents, antioxidants and preservatives are used in the prior art to solve the problems of easy oxidation and easy contamination of bacteria, such as disodium edetate, sodium bisulfite, sodium metabisulfite, butyl hydroxyanisole, Di-tert-butyl p-cresol, sodium benzoate, sodium parabens, etc. However, some of these ingredients can only be used in water-soluble ingredients, and some can only be used in fat-soluble ingredients alone; and these The ingredients are highly toxic and have relatively large toxic and side effects on the human body, especially when these ingredients directly enter the blood through intravenous injection, the harm to the human body is even greater. Therefore, the drug regulatory departments of various countries have made strict restrictions on their dosage. Some It is even forbidden to be used as an additive in medicine. Therefore, it is necessary to find antioxidants and preservatives that are harmless to the human body and can act as antioxidants and preservatives on water-soluble and fat-soluble ingredients at the same time, so as to improve the injection of 13 kinds of multivitamins. The quality and safety of the preparations is a difficult problem that must be solved in the production of 13 kinds of multivitamin injection preparations with stable quality at present, but it has not been solved so far

Method used

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  • Pharmaceutical composition containing 13 kinds of vitamins
  • Pharmaceutical composition containing 13 kinds of vitamins
  • Pharmaceutical composition containing 13 kinds of vitamins

Examples

Experimental program
Comparison scheme
Effect test

experiment example 2

[0090] Experimental example 2 is a combination of embodiment 5 of the present invention;

experiment example 3

[0091] Experimental example 3 is the combination of Example 6 of the present invention.

[0092] Insoluble particles test results

[0093] In the research of the present invention, samples of experimental examples and comparative samples were taken for long-term stability research.

[0094] Investigation conditions: According to the guidelines for drug stability test in the appendix of the Chinese Pharmacopoeia 2005 edition, it was placed at a temperature of 25±2°C and a relative humidity of 60% ± 10% for 24 months.

[0095] Investigation items: character, pH, clarity, insoluble particles, content determination.

[0096] The experimental results showed that the properties, clarity, and pH of the preparations of the experimental example and the comparative example were not significantly changed during the placement process, which met the relevant quality requirements of the injection preparation. The 24-month content result also showed that the content of the experimental example and the...

Embodiment 1

[0107]

[0108]

[0109] Add the water for injection to 5000ml to make 1000 injections;

[0110] Preparation:

[0111] a. Heat in a water bath with water for injection, add the antioxidant to dissolve it for later use;

[0112] b. Take soybean phospholipid and glycocholic acid, add an appropriate amount of citric acid and cysteine ​​hydrochloride solution to dissolve in a nitrogen filled environment, and then add vitamin A palmitate and vitamin D 3 , Racemic α-tocopherol, vitamin K1, mix and dissolve to obtain a fat-soluble vitamin solution, ready for use:

[0113] c. Prepare sodium hydroxide solution, take folic acid and biotin, add an appropriate amount of sodium hydroxide solution to dissolve, and set aside;

[0114] d. Dissolve the remaining vitamins with a solution containing citric acid and cysteine ​​hydrochloride in a nitrogen-filled environment, combine with the above-mentioned standby solution, adjust the pH to 5.9, add activated carbon, stir, filter, add water for injection t...

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PUM

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Abstract

The invention discloses a pharmaceutical composition containing 13 kinds of vitamins, which is characterized in that the pharmaceutical composition is an injection preparation formed by vitamin A palmitate, tetrahydrate cocarboxylase, lactoflavin sodium phosphate, vitamin B12, vitamin D3, vitamin K1, vitamin B6, vitamin C, niacinamide, folacin, racemic alpha-tocopheryl, biotin, dexpanthenol, soybean phospholipid, glycocholic acid, citric acid, cysteine hydrochloride and excipients. According to the pharmaceutical composition, the deficiencies in the prior art are overcome; and indicated by experimental results, the formed injection preparation has the advantages of long-term stability in quality and more safety in clinical use.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a pharmaceutical composition containing 13 vitamins and a preparation method thereof. Background technique [0002] 13 kinds of multi-vitamin injections are parenteral nutrition intravenous injection preparations. This product is a multi-vitamin preparation containing water-soluble vitamins and fat-soluble vitamins. It can be used to supplement vitamins for adults and children over 11 years old. It is suitable for insufficient nutritional intake through the gastrointestinal tract. (Such as malnutrition or gastrointestinal malabsorption, etc.), or contraindications to gastrointestinal nutrition. It can be used for the emergency response of the body's metabolism and the lack of tissue nutrition under continuous severe nutritional status changes. This product can provide the intake of essential vitamins to maintain the body's normal response and repair. [0003] The prior art...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K31/675A61K31/593A61K31/519A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/355A61K31/23A61K31/164A61K31/122A61K47/12A61K47/20A61K9/08A61K9/19A61P3/02
Inventor 郑飞雄
Owner 郑飞雄
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