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Stable injection composite of 12 complex vitamins and preparation method thereof

A technology of complex vitamins and vitamins, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, drug combinations, etc., can solve problems that threaten the safety of clinical medication, and achieve the effect of low manufacturing cost

Inactive Publication Date: 2010-05-26
北京京卫信康医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In practice, dark-proof storage can be solved by packaging in brown glass bottles and opaque outer packaging boxes; isolation of oxygen can generally be solved in the production process, such as pressing rubber stoppers under vacuum conditions for samples after freeze-drying or samples after freeze-drying Backfilling the box with an inert gas (such as nitrogen) can be solved. In a certain sense, within the validity period of the preparation sample (generally 2 to 3 years), dark storage and oxygen isolation can be realized once and for all, and low temperature can be achieved once and for all. Due to sample transportation, unexpected power outages, differences in temperature between the north and the south, and the four seasons, there will be unavoidable risks. Product quality problems will seriously threaten the safety of clinical medication

Method used

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  • Stable injection composite of 12 complex vitamins and preparation method thereof
  • Stable injection composite of 12 complex vitamins and preparation method thereof
  • Stable injection composite of 12 complex vitamins and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0196] prescription:

[0197] Raw materials Prescription

[0198] Vitamin A palmitate 3500000IU

[0199] Vitamin D 3 220000IU

[0200] Racemic alpha-tocopherol 10.2g

[0201] Vitamin C 125g

[0202] Cocarboxylase Tetrahydrate 5.8g

[0203] Riboflavin Sodium Phosphate 5.67g

[0204] Vitamin B 6 5.5g

[0205] Vitamin B 12 0.006g

[0206] Folic acid 0.414g

[0207] Dexpanthenol 16.15g

[0208] Biotin 0.069g

[0209] Niacinamide 46g

[0210] Polysorbate 80 200g

[0211] Glycine 550g

[0212] sodium hydroxide solution

[0213] Add water for injection to 5000ml

[0214]

[0215] Makes 1000 bottles

[0216] Preparation Process:

[0217] (1) In a light-proof operation room, weigh vitamin A palmitate, racemic α-tocopherol, and vitamin D 3 , added to polysorbate 80, charged with nitrogen, stirred to dissolve, added with water for injection, stirred, and pla...

Embodiment 2

[0223] prescription:

[0224] Raw materials Prescription

[0225] Vitamin A palmitate 3500000IU

[0226] Vitamin D3 220000IU

[0227] Vitamin E 11.2g

[0228] Vitamin C 125g

[0229] Cocarboxylase Tetrahydrate 5.8g

[0230] Riboflavin Sodium Phosphate 5.67g

[0231] Vitamin B 6 5.5g

[0232] Vitamin B 12 0.006g

[0233] Folic acid 0.414g

[0234] Dexpanthenol 16.15g

[0235] Biotin 0.069g

[0236] Niacinamide 46g

[0237] Polysorbate 80 90g

[0238] Mannitol 460g

[0239] sodium hydroxide solution

[0240] Add water for injection to 5000ml

[0241]

[0242] Makes 1000 bottles

[0243] Preparation process: except that vitamin E is replaced with racemic α-tocopherol and mannitol is replaced with glycine, other preparations are carried out as in Example 1, and the product is obtained.

Embodiment 3

[0245] prescription:

[0246] Raw materials Prescription

[0247] Vitamin A palmitate 3500000IU

[0248] Vitamin D 3 220000IU

[0249] Racemic alpha-tocopherol 10.2g

[0250] Vitamin C 125g

[0251] Cocarboxylase Tetrahydrate 5.8g

[0252] Riboflavin Sodium Phosphate 5.67g

[0253] Vitamin B 6 5.5g

[0254] Vitamin B 12 0.006g

[0255] Folic acid 0.414g

[0256] Dexpanthenol 16.15g

[0257] Biotin 0.069g

[0258] Niacinamide 46g

[0259] Polysorbate 80 200g

[0260] Mannitol 480g

[0261] sodium hydroxide solution

[0262] Add water for injection to 5000ml

[0263]

[0264] Makes 1000 bottles

[0265] Preparation process: except that mannitol is replaced by glycine, other preparations are carried out as in Example 1, and the product is obtained.

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Abstract

The invention belongs to the field of medicinal preparation and in particular relates to a stable injection composite of 12 complex vitamins and a preparation method thereof. The composite is prepared by freezing and drying 12 vitamins of vitamin A palmitate, vitamin D3, racemization alpha-tocopheryl, vitamin C, cocarboxylase tetrahydrate, riboflavin sodium phosphate, vitamin B6, vitamin B12, folic acid, dexpanthenol, biotin and nicotinamide or analogues thereof as well as polysorbate cosolvent and medical acceptable auxiliary materials and carriers. Compared with the prior art, the inventive composite has better stability and obvious progress.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable freeze-dried preparation containing 12 kinds of multivitamins and a preparation method thereof. technical background [0002] Parenteral nutrition plays an important supportive role in the treatment of diseases. Parenteral nutrition plays an important role in maintaining life for patients with functional gastrointestinal diseases, cancer and those patients who need a temporary "rest" of the gastrointestinal tract. Parenteral nutrition enables patients to obtain various nutrients needed for metabolism, thereby avoiding the occurrence of starvation, malnutrition and "nutrition-related complications", and shortening the length of hospital stay. Parenteral nutrition is widely used in the treatment of patients with the following diseases, such as congenital gastrointestinal malformations, moderate to severe malnutrition, gastrointestinal diseases (sever...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K31/675A61K31/593A61K31/519A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/355A61K31/23A61K31/164A61P3/02A61K47/26
Inventor 胡军谷景斌刘烽张勇
Owner 北京京卫信康医药科技发展有限公司
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