Pharmaceutical composition containing 13 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: 2014-02-05
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 vitamins
  • Pharmaceutical composition containing 13 vitamins
  • Pharmaceutical composition containing 13 vitamins

Examples

Experimental program
Comparison scheme
Effect test

experiment example 2

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

experiment example 3

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

[0092] Insoluble particle test results

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

[0094] Inspection conditions: refer to the guidelines for drug stability testing in the appendix of the Chinese Pharmacopoeia in 2005, and place it for 24 months at a temperature of 25±2°C and a relative humidity of 60%±10%.

[0095] Inspection items: traits, pH, clarity, insoluble particles, content determination.

[0096] The experimental results show that the properties, clarity, and pH of the preparations of the experimental examples and the comparative examples do not change significantly during the placement process, which meets the relevant quality requirements for injection preparations, and the content results of 24 months also show that the product contents o...

Embodiment 1

[0107]

[0108]

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

[0110] Preparation:

[0111] a. heating in a water bath for injection, adding the antioxidant to dissolve and then standby;

[0112] b. Take soybean phospholipids and glycocholic acid, add appropriate amount of solution containing citric acid and cysteine ​​hydrochloride to dissolve in a nitrogen-filled environment, and then add vitamin A palmitate and vitamin D 3 , racemic α-tocopherol, and vitamin K1 are mixed and dissolved to obtain a fat-soluble vitamin solution for subsequent use:

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

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

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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 medicines, and in particular relates to a pharmaceutical composition containing 13 kinds of vitamins and a preparation method thereof. Background technique [0002] 13 kinds of multivitamin injections are parenteral nutrition intravenous injection preparations. This product is a multivitamin 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 absorption disorders, etc.), or those who are contraindicated in 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 normal response and rep...

Claims

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Application Information

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Patent Type & Authority Patents(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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