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Medicinal composition containing 12 vitamins and used for intravenous injection

A vitamin and composition technology, applied in the field of medicine, can solve the problems of reduced absorption, reduced absorption of fat-soluble and water-soluble vitamins, allergic irritation and the like

Inactive Publication Date: 2015-06-10
TIANJIN HANRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] (1) Insufficient supply in the diet: Whether the vitamin content in the diet is sufficient or not depends on the content in various foods, food processing and cooking techniques and other factors
[0005] (2) Decreased absorption and utilization of the human body: when the digestive system eats, absorbs and utilizes dysfunction, such as oral diseases, digestive tract or biliary tract obstruction, bile and gastric acid secretion is restricted, or dietary composition changes lead to reduced absorption, such as high fiber diet, low Protein diet, low-fat diet, etc. can reduce the absorption of certain fat-soluble and water-soluble vitamins
[0016] The inventor found through research that the use of glycocholic acid can play a role in solubilization, and it is less irritating and allergic to the skin. However, due to potential liver toxicity, this compound has not been approved for marketing in China, the United States and other countries Sales, and when the dosage is increased, polysorbate 80 and mannitol can also achieve the purpose of solubilization, but the potential allergic irritation has brought potential huge risks to patients

Method used

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  • Medicinal composition containing 12 vitamins and used for intravenous injection
  • Medicinal composition containing 12 vitamins and used for intravenous injection
  • Medicinal composition containing 12 vitamins and used for intravenous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Preparation of multivitamins (12) for injection

[0038] (1) Take the prescribed amount of polysorbate 80 and lecithin, add the prescribed amount of vitamin A palmitate, vitamin D3, and racemic α-tocopherol in a nitrogen-filled environment, mix and dissolve to obtain solution A, and set aside;

[0039] (2) Take 40% of the prescribed amount of water for injection (50±2°C) filled with nitrogen to saturation, slowly add solution A into the water for injection and stir to dissolve to obtain solution B. Take an appropriate amount of water for injection (50±2°C) to wash the remaining solution A in the container several times, and transfer it to solution B;

[0040] (3) Add 40% of the prescribed amount of water for injection, filled with nitrogen to saturation, at room temperature, and add the prescribed amount of vitamin B12, vitamin B6, dexpanthenol, riboflavin sodium phosphate, nicotinamide, Biotin, vitamin C, cocarboxylase tetrahydrate and mannitol to obtain solu...

Embodiment 2

[0049] Example 2 Comparison of reconstitution effects of multivitamins (12) for injection with different prescriptions

[0050] Prepare sample 1 and sample 2 respectively according to the following prescription, and prepare three batches of multivitamin (12) (sample 3) samples for injection according to the prescription of the present invention, and compare the reconstitution effect according to the quality standard. The experimental results are shown in Table 1 below Show.

[0051] Vitamin A Palmitate 9.83g Vitamin D3 0.0275g racemic a-tocopherol 51g Vitamin C 625g cocarboxylase tetrahydrate 29g riboflavin sodium phosphate 28.35g Vitamin B6 27.5g Vitamin B12 0.03g folic acid 2.07g Dexpanthenol 80.75g Biotin 0.345g Nicotinamide 230g Glycocholic acid 150g Lecithin 150g sodium hydroxide Appropriate amount Water for Injection 25L production 5000 pieces

[0052] ...

Embodiment 3

[0054] Example 3 Comparison of Vascular Stimulation Experiments of Different Prescriptions of Multivitamins (12) for Injection

[0055] Sample 1 and sample 2 were prepared according to the method described in Example 1, and three batches of multivitamin (12) (sample 3) samples for injection were prepared according to the prescription of the present invention, and a comparative experiment of vascular irritation was carried out.

[0056] Take 18 healthy rabbits weighing 2.5-3.0kg and divide them into three groups, 6 in each group. Use the method of self-contrast on the left and right sides of the same body. Slowly inject the test solution with a concentration of 8mg / ml into the vein of the right ear margin respectively, and the administration volume is 2ml / kg. 0.9% Sodium Chloride Injection was injected in the left ear vein at the same speed and in the same way, once a day for 5 consecutive days. During the administration period, it was observed with the naked eye every da...

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Abstract

The invention relates to a medicinal composition containing 12 vitamins and used for intravenous injection, and a preparation method. The medicinal composition is prepared by using fat-soluble vitamins, water-soluble vitamins and a solubilizer. The medicinal composition has the characteristics of few auxiliary materials, simple preparation process, safe and reliable quality, and convenient storage.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a preparation method of a pharmaceutical composition containing 12 kinds of vitamins for intravenous injection. The invention also relates to the application of the pharmaceutical composition in the treatment of vitamin deficiency and related diseases. Background technique [0002] Vitamins are essential to the human body, but the human body cannot synthesize them or synthesize too little to meet their needs. Therefore, a certain amount must be taken from the diet every day to meet their physiological needs. Although the required amount is extremely small, it cannot be lacking. Water-soluble vitamins have less storage in the body than fat-soluble vitamins, and are easily excreted from the body. Therefore, they need to be replenished more often. If the intake is insufficient, vitamin deficiency may occur within a short period of time, which will affect health. [000...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61P3/02A61K31/675A61K31/593A61K31/519A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/355A61K31/23A61K31/164
Inventor 严洁李轩
Owner TIANJIN HANRUI PHARMA
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