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Pharmaceutical composition containing 12 vitamins

A vitamin and composition technology, which is applied in the field of pharmaceutical compositions containing 12 kinds of vitamins and their preparation fields, can solve the problems of easy oxidation, easy contamination, high toxicity of components, etc.

Active Publication Date: 2012-06-13
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 12 kinds of multivitamin preparations are easily oxidized, such as racemic α-tocopherol (vitamin E), vitamin C, etc. After a long period 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, in order to improve the injection of 12 kinds of multivitamins. The quality and safety of the preparation, which is a difficult problem that must be solved in the production of injection preparations containing 12 kinds of multivitamins with stable quality, has not been solved so far.

Method used

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  • Pharmaceutical composition containing 12 vitamins
  • Pharmaceutical composition containing 12 vitamins
  • Pharmaceutical composition containing 12 vitamins

Examples

Experimental program
Comparison scheme
Effect test

experiment example 2

[0087] Experimental example 2 is the combination of embodiment 5 of the present invention;

experiment example 3

[0088] Experimental example 3 is the combination of embodiment 6 of the present invention.

[0089] Insoluble particle test results

[0090] 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.

[0091] Conditions for inspection: Refer to the guidelines for drug stability testing in the appendix of the Chinese Pharmacopoeia in 2005, and place for 24 months at a temperature of 25±2°C and a relative humidity of 60%±10%.

[0092] Inspection items: traits, pH, clarity, insoluble particles, content determination.

[0093] 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 ...

Embodiment 1

[0104]

[0105]

[0106] Make 1000 injections.

[0107] Preparation:

[0108] a. Heat the water for injection, add citric acid and cysteine ​​hydrochloride to dissolve and set aside;

[0109] 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, mix and dissolve to obtain a fat-soluble vitamin solution, and set aside;

[0110] c. Prepare sodium hydroxide solution, take folic acid and biotin, add appropriate amount of sodium hydroxide solution to dissolve, set aside;

[0111] d. Dissolve the remaining vitamins with a solution containing citric acid and cysteine ​​hydrochloride in a nitrogen-filled environment, combine with the above-mentioned reserve solution, adjust the pH to 5.5, add activated carbon, stir, filter, add water for injection to the full amount, fine filt...

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PUM

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Abstract

The invention discloses a pharmaceutical composition containing 12 vitamins, which is characterized that the pharmaceutical composition is an injection preparation prepared from vitamin A palmitate, cocarboxylase tetrahydrate, riboflavin sodium phosphate, vitamin B12, vitamin D3, vitamin B6, vitamin C, nicotinamide, folic acid, racemic alpha-tocopherol, biotin, dexpanthenol, soybean lecithin, glycocholic acid, citric acid, cysteine hydrochloride and an excipient. The pharmaceutical composition overcomes the insufficiency of the prior art, the test result shows that the prepared injection preparation possesses stable quality for long term and safer clinical usage.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition containing 12 kinds of vitamins and a preparation method thereof. Background technique [0002] 12 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 Applications(China)
IPC IPC(8): A61K9/19A61K9/08A61K31/714A61K47/18A61K47/12A61P3/02A61K31/07A61K31/355A61K31/375A61K31/4188A61K31/4415A61K31/592A61K31/593A61K31/455A61K31/519
Inventor 郑飞雄
Owner 郑飞雄
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