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Compound vitamin submicron emulsion lyophilized powder for injection and preparation method of compound vitamin submicron emulsion lyophilized powder

A technique for compound vitamins and freeze-dried powder injections, applied in the field of compound vitamin submicroemulsions for injection and its preparation, can solve the problems of potential safety hazards, hidden dangers for users, and inability to supplement at the same time, achieving good market prospects, non-toxic side effects

Inactive Publication Date: 2012-07-11
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Domestic multivitamin injection products only have multivitamin B injection, Shui Levita N freeze-dried sterile powder injection, fat-soluble vitamin injection Ⅰ and Ⅱ, and each injection can only supplement water-soluble or fat-soluble vitamins respectively, and cannot supplement at the same time
Products listed abroad include 12 kinds of multivitamins for Schneider injection (CLINTEC PARENTERAL SA, France), which are solution preparations, and use solubilizers to dissolve fat-soluble components in aqueous solutions, so that one injection can fully supplement various vitamins purpose, but there are security risks
The 12 or 13 multivitamin injections mentioned in domestic patents are also prepared into solutions by solubilization methods. In order to increase the solubility of fat-soluble vitamins in water, a large amount of organic solvents and surfactants are required. There are great security risks for users

Method used

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  • Compound vitamin submicron emulsion lyophilized powder for injection and preparation method of compound vitamin submicron emulsion lyophilized powder
  • Compound vitamin submicron emulsion lyophilized powder for injection and preparation method of compound vitamin submicron emulsion lyophilized powder
  • Compound vitamin submicron emulsion lyophilized powder for injection and preparation method of compound vitamin submicron emulsion lyophilized powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Vitamin A: 9 mg,

[0024] Vitamin D 2 : 0.05 mg,

[0025] Vitamin E: 0.1 mg,

[0026] Vitamin K 1 : 2.0 mg,

[0027] Vitamin C: 1.0 g,

[0028] Vitamin B 1 : 35 mg,

[0029] Riboflavin Sodium Phosphate: 40 mg,

[0030]Vitamin B 5 : 200 mg,

[0031] Vitamin B 6 : 40 mg,

[0032] Niacinamide: 400 mg,

[0033] Biotin: 0.10 mg,

[0034] Soybean oil: 1.5 g,

[0035] Soy lecithin: 1.0 g,

[0036] Sodium oleate: 0.1 g,

[0037] Sodium bicarbonate: 6g

[0038] Sodium thiosulfate pentahydrate: 0.1 g

[0039] Trehalose: 15 g

[0040] (1) Ultrasonic dissolve 1.0g soybean lecithin with 0.5mL absolute ethanol, mix with 1.5g soybean oil, stir and evaporate the ethanol in a water bath at 60°C, add four kinds of fat-soluble vitamins (vitamin A, vitamin D 2 , vitamin E, vitamin K 1 ), stirred until completely dissolved, used as the oil phase, and kept warm; (2) Dissolved 0.1g sodium oleate and 0.1 g sodium thiosulfate pentahydrate in water, kept at 70°C, used as the ...

Embodiment 2

[0056] Vitamin A: 8 mg,

[0057] Vitamin D 2 : 0.06 mg,

[0058] Vitamin E: 0.1 mg,

[0059] Vitamin K 1 : 2.0 mg,

[0060] Vitamin C: 1.0 g,

[0061] Vitamin B 1 : 35 mg,

[0062] Riboflavin Sodium Phosphate: 40 mg,

[0063] Vitamin B 5 : 150 mg,

[0064] Vitamin B 6 : 40 mg,

[0065] Niacinamide: 600 mg,

[0066] Biotin: 0.10 mg,

[0067] soybean oil: 2.0g,

[0068] Peanut Oil:

[0069] Soy lecithin: 4.0 g,

[0070] Sodium oleate: 0.3 g,

[0071] Sodium bicarbonate: 6g

[0072] Sodium thiosulfate pentahydrate: 0.5 g

[0073] Mannitol: 10 g

[0074] Sucrose: 10g

[0075] (1) Dissolve 4.0g soybean lecithin with 2.0mL absolute ethanol ultrasonically, mix it with 3.0 g soybean oil, stir and evaporate the ethanol in a water bath at 60°C, add four kinds of fat-soluble vitamins (vitamin A, vitamin D 2 , vitamin E, vitamin K 1 ), stirred until completely dissolved, used as the oil phase, and kept warm; (2) Dissolved 0.3g sodium oleate and 0.5g sodium thiosulfat...

Embodiment 3

[0089] Vitamin A: 8 mg,

[0090] Vitamin D 2 : 0.06 mg,

[0091] Vitamin E: 0.1 mg,

[0092] Vitamin K 1 : 2.0 mg,

[0093] Vitamin C: 1.0 g,

[0094] Vitamin B 1 : 35 mg,

[0095] Riboflavin Sodium Phosphate: 40 mg,

[0096] Vitamin B 5 : 150 mg,

[0097] Vitamin B 6 : 40 mg,

[0098] Niacinamide: 600 mg,

[0099] Biotin: 0.10 mg,

[0100] soybean oil: 2.0g,

[0101] Peanut oil: 1.0g

[0102] Soy lecithin: 1.0 g,

[0103] Polysorbate-80: 1.0g

[0104] Sodium oleate: 0.05 g,

[0105] Sodium bicarbonate: 6g

[0106] Sodium thiosulfate pentahydrate: 0.2 g

[0107] Lactose: 15 g

[0108] Glucose: 5 g

[0109] (1) 1.0 g soybean lecithin was ultrasonically dissolved in 1.0 mL absolute ethanol, mixed with 3.0 g mixture of soybean oil and peanut oil, stirred in a water bath at 60°C to evaporate the ethanol, and four fat-soluble vitamins (vitamin A, vitamin D 2 , vitamin E, vitamin K 1 ), stirred until completely dissolved, used as the oil phase, and kept warm; (2...

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Abstract

The invention provides compound vitamin submicron emulsion lyophilized powder for injection; the oil phase of the prepared submicron emulsion is soybean oil for injection only; the emulsifying agent is soybean phospholipids for injection, which are safely degraded and have no toxic or side effects, so the emulsifying agent has great safety advantage. The compound vitamin submicron emulsion lyophilized powder comprises compound vitamin, emulsifying agent, oil, sodium oleate, sodium bicarbonate, sodium thiosulfate pentahydrate, cryoprotectant and injection water; each 100 ml of lyophilized powder comprises 0.01 mg-2.0 g of compound vitamin, 0.5-3.0 g of oil, 0.5-4.0 g of emulsifying agent, 0.05-0.3 g of sodium oleate, 2-10 g of sodium bicarbonate, 0.1-0.5 g of sodium thiosulfate pentahydrate, cryoprotectant and injection water. According to the invention, a plurality of vitamins with different dissolubility are held in a preparation, so that compound vitamin injection, which can carry medicine successfully, is safe to take and has no toxic, is prepared.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound vitamin submicron emulsion for injection and a preparation method thereof. Background technique [0002] Parenteral Nutrition (PN) is widely used in the treatment of diseases such as congenital gastrointestinal malformations, moderate to severe malnutrition, and gastrointestinal diseases. At the same time, it is suitable for critically ill newborns who cannot eat normally, patients with severe gastrointestinal reactions caused by radiotherapy and chemotherapy, children with stress exhaustion, and nutritional support for patients during surgery. For patients who cannot eat through the digestive tract within a short period of time after surgery and have poor nutritional status, total parenteral nutrition support and appropriate supplementation of vitamins, amino acids, electrolytes, etc. can improve nutritional status, promote wound healing, and enabl...

Claims

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Application Information

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IPC IPC(8): A61K31/675A61K31/592A61K31/525A61K31/51A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/355A61K31/203A61K31/122A61K9/19A61P3/02
Inventor 胡海洋陈大为
Owner SHENYANG PHARMA UNIVERSITY
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