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Injection containing 13 compound vitamins and preparation technology thereof

A technology for compound vitamins and injections, which is applied in the direction of medical preparations containing active ingredients, drug combinations, active ingredients of hydroxyl compounds, etc. It can solve the problems of easy oxidation, unsuitable for high-temperature sterilization, water-soluble vitamins and fat-soluble vitamins that are not resistant to high temperature and other issues, to achieve stable content, reduce clinical side effects, and safe efficacy

Inactive Publication Date: 2018-11-16
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to solve the problems that water-soluble vitamins and fat-soluble vitamins in the above-mentioned compound vitamins are not resistant to high temperature and are not suitable for high-temperature sterilization, and are easy to oxidize, the present invention provides an injection containing 13 kinds of compound vitamins and its preparation method

Method used

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  • Injection containing 13 compound vitamins and preparation technology thereof
  • Injection containing 13 compound vitamins and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] prescription:

[0051] Each 5ml bottle of 1 ampoule injection contains: vitamin C 150mg, vitamin B 1 (calculated as thiamine) 5mg, riboflavin sodium phosphate (calculated as riboflavin) 2.6mg, vitamin B 6 10mg, Niacinamide 30mg, Dexpanthenol 12mg, Vitamin A Palmitate 2600IU, Vitamin D 3 230IU, vitamin E 20IU, vitamin K 1 0.10mg, the dosage of polysorbate 40 is 5mg, and the pH regulator adjusts the pH value to 6.5.

[0052] Each 5ml bottle of 2 ampoules of injection contains: folic acid 400μg, biotin 30μg, vitamin B 12 10 μg, 1.8 g of propylene glycol, and a pH regulator to adjust the pH to 6.5.

[0053] Preparation:

[0054] Preparation of 1 bottle of ampoule injection: fill the water for injection with nitrogen for 50 minutes, weigh vitamin A palmitate and vitamin D according to the prescribed amount 3 , vitamin E, vitamin K 1 , polysorbate 40, placed in a container, stirred at 15°C until evenly mixed to obtain an oil phase solution; weigh vitamin C and vita...

Embodiment 2

[0057] prescription:

[0058] 1 bottle of ampule, each 5ml injection contains: vitamin C 200mg, vitamin B 1 (calculated as thiamine) 6mg, riboflavin sodium phosphate (calculated as riboflavin) 5mg, vitamin B 6 6mg, Niacinamide 40mg, Dexpanthenol 15mg, Vitamin A Palmitate 3300IU, Vitamin D 3 200IU, Vitamin E 10IU, Vitamin K 1 0.15mg, the dosage of polysorbate 80 is 10mg, the pH regulator adjusts the pH value to 5.8,

[0059] The volume of each 5ml bottle of 2 ampoules of injection contains the following ingredients: folic acid 600μg, biotin 60μg, vitamin B 12 5 μg, 1.5 g of propylene glycol, and a pH regulator to adjust the pH to 6.0.

[0060] Preparation:

[0061] Preparation of 1 bottle of ampoule injection: fill the water for injection with nitrogen for 60 minutes, weigh vitamin A palmitate and vitamin D according to the prescription amount 3 , vitamin E, vitamin K 1 , polysorbate 80, placed in a container, stirred at 35°C until evenly mixed to obtain an oil phase...

Embodiment 3

[0064] prescription:

[0065] Each 5ml bottle of 1 ampoule injection contains: vitamin C 250mg, vitamin B 1 (calculated as thiamine) 8mg, riboflavin sodium phosphate (calculated as riboflavin) 8mg, vitamin B 6 8mg, Niacinamide 65mg, Dexpanthenol 8mg, Vitamin A Palmitate 3900IU, Vitamin D 3 150IU, vitamin E 16IU, vitamin K 1 0.25mg, castor oil consumption is 8mg, and the pH regulator adjusts the pH value to 7.0.

[0066] Each 5ml bottle of 2 ampoules contains: folic acid 900μg, biotin 80μg, vitamin B 12 8 μg, 1.0 g of propylene glycol, 0.5 mg of co-solvent, and a pH regulator to adjust the pH to 7.0.

[0067] Preparation:

[0068] Preparation of 1 bottle of ampoule injection: fill the water for injection with nitrogen for 20 minutes, weigh vitamin A palmitate and vitamin D according to the prescribed amount 3 , vitamin E, vitamin K 1 , castor oil, placed in a container, stirred at 55°C until evenly mixed to obtain an oil phase solution; take vitamin C and vitamin B a...

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Abstract

The invention relates to an injection containing 13 compound vitamins and a preparation technology thereof. The injection contains two ampoule bottles, per 5ml of the injection in bottle 1 contains: 70-300mg of vitamin C, 3-10mg of vitamin B1 (in terms of thiamine), 2.6-9.6mg of riboflavin sodium phosphate (in terms of riboflavin), 3-10mg of vitamin B6, 30-80mg of nicotinamide, 5-20mg of dexpanthenol, 2600-3900IU vitamin A palmitate, 100-260IU vitamin D3, 8-20IU vitamin E, 0.10-0.25mg of vitamin K1, a cosolvent and a pH regulator; and per 5ml of the injection in bottle 2 contains: 400-900microg of folic acid, 30-80microg of biotin, 3-10microg of vitamin B12, a stabilizer and a pH regulator. Preparation of the bottle 1 injection includes preparation and mixing of oil phase and water phase medicinal liquid, pH regulation, filtration, filling and the like; and preparation of bottle 2 injection includes medicinal liquid preparation, pH regulation, filtration, filling and other steps. The preparation technology provided by the invention does not use antioxidant, employs sterilization and filtration to achieve aseptic condition, makes the vitamin content more stable, and increases the medication safety.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an injection containing 13 kinds of compound vitamins and a preparation process thereof. Background technique [0002] Vitamins are a type of trace organic substances that the human body must obtain from food to maintain normal physiological functions. There are many kinds of it, with different chemical structures, most of which are the components of coenzymes (or prosthetic groups) of certain enzymes, and are indispensable compounds to maintain the normal growth of the body (growth, health, reproduction and production functions). It plays a catalytic role in the body to promote the synthesis and degradation of major nutrients (protein, fat, carbohydrates, etc.), thereby controlling metabolism. Vitamins are essentially low-molecular organic compounds, they cannot be synthesized in the body, or the amount of synthesis is difficult to meet the needs of the bo...

Claims

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Application Information

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IPC IPC(8): A61K31/714A61K9/08A61P3/02A61K31/07A61K31/122A61K31/164A61K31/355A61K31/375A61K31/4415A61K31/455A61K31/51A61K31/519A61K31/525A61K31/59
CPCA61K9/0019A61K9/08A61K31/07A61K31/122A61K31/164A61K31/355A61K31/375A61K31/4415A61K31/455A61K31/51A61K31/519A61K31/525A61K31/59A61K31/714A61P3/02A61K2300/00
Inventor 高扬徐春海张颖彭艳丽李鹏王丽伟许庆栋张作平厉芳
Owner JINAN KANGHE MEDICAL TECH
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