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Fat-soluble vitamin injection concentrated solution (I), preparation method and application thereof

A fat-soluble vitamin and concentrate technology, which can be used in pharmaceutical formulations, emulsion delivery, organic active ingredients, etc., and can solve problems such as hidden dangers of drug safety.

Inactive Publication Date: 2015-06-17
天津迈迪瑞康生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such preparations cannot be tested for clarity, and clarity testing is a must-test item for injections, which brings hidden dangers to drug safety.
Also, existing fat emulsions require specialized equipment to sterilize under high pressure

Method used

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  • Fat-soluble vitamin injection concentrated solution (I), preparation method and application thereof
  • Fat-soluble vitamin injection concentrated solution (I), preparation method and application thereof
  • Fat-soluble vitamin injection concentrated solution (I), preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0180] Embodiment 1: Preparation of fat-soluble vitamin injection concentrate (I) sample 1

[0181] Its composition is as follows:

[0182] Vitamin A 0.69 g

[0183] Vitamin D2 10mg

[0184] Vitamin E 6.4g

[0185] Vitamin K1 0.2 g

[0186] soybean oil 5 grams

[0187] Medium chain fatty acid triglycerides (Crodamol GTCC) 60g

[0188] 1,2-Propanediol 8g

[0189] Soy Lecithin (Epikuron 170, Degussa) 7g

[0190] Tween 80 3.1 g

[0191] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 9.6 g

[0192] The preparation method of the fat-soluble vitamin injection concentrate (I) is as follows:

[0193] 1) At 45°C, mix the vitamin A, vitamin D2, vitamin E, vitamin K1, soybean lecithin, soybean oil and medium-chain fatty acid triglycerides in the above weight, and stir at 8000rpm until a transparent and clear solution is formed ;

[0194] 2) At 20°C, add the above-mentioned weight of 1,2-propanediol, Tween 80, and polyethylene glycol lauryl hydroxystearate to ...

Embodiment 2

[0196] Embodiment 2: Preparation of fat-soluble vitamin injection concentrate (I) sample 2

[0197] Its composition is as follows:

[0198] Vitamin A 0.35g

[0199] Vitamin D2 5 mg

[0200] Vitamin E 3.2g

[0201] Vitamin K1 0.1 g

[0202] 28.5g soybean oil

[0203] Glyceryl caprylate (Miglyol 812, SASOL) 28.5g

[0204] 1,2-propanediol 9 grams

[0205] Soy Lecithin (Epikuron 170, Degussa) 12g

[0206] Polyglyceryl Oleate 3.2g

[0207] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 11 g

[0208] Tween 80 4g

[0209] Oleic acid 0.15g

[0210] The preparation method of the fat-soluble vitamin injection concentrate (I) is as follows:

[0211] 1) At 30°C, mix vitamin A, vitamin D2, vitamin E, vitamin K1, soybean lecithin, polyglycerol oleate, soybean oil and caprylic capric glyceride in the above weight, and stir at 6000rpm To form a transparent clear solution;

[0212] 2) At 25°C, add the above-mentioned weight of 1,2-propanediol, polyethylene glycol...

Embodiment 3

[0214] Embodiment 3: Preparation of fat-soluble vitamin injection concentrate (I) sample 3

[0215] Its composition is as follows

[0216] Vitamin A 0.69 g

[0217] Vitamin D2 10mg

[0218] Vitamin E 6.4g

[0219] Vitamin K1 0.2 g

[0220] soybean oil 50g

[0221] 1,2-Propanediol 10g

[0222] Soy Lecithin (Epikuron 170, Degussa) 12g

[0223] Polyglyceryl Oleate 0.6g

[0224] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 13 g

[0225] Tween 80 7g

[0226] Oleic acid 0.1g

[0227] The preparation method of the fat-soluble vitamin injection concentrate (I) is as follows:

[0228] 1) At 40°C, mix vitamin A, vitamin D2, vitamin E, vitamin K1, soybean lecithin, polyglycerol oleate and soybean oil in the above weight, and stir at 6000rpm until a transparent and clear solution is formed;

[0229] 2) At 25°C, add the above-mentioned weight of 1,2-propanediol, polyethylene glycol lauryl hydroxystearate, Tween 80, and oleic acid to the product of step 1), an...

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Abstract

The invention belongs to the field of pharmacology and pharmaceutics and relates to a fat-soluble vitamin injection concentrated solution (I), a preparation method and an application thereof. According to the invention, the defect that a traditional fat emulsion preparation technology is complex and has poor stability is overcome. The preparation technology provided by the invention is simple; the general physical stirring process is only needed; and no homogenization technology is required. A product prepared in the invention can be sterilized through a 0.22-micron microfiltration membrane; in clinical use, the product can be spontaneously emulsified after diluted by the use of an aqueous solution such as normal saline or a glucose solution, etc. and slightly oscillated; and under optimized conditions, average particle size is about 0.2 micron, and injection fat emulsion characteristics are fully embodied. The product has good fluidity, will not be retained on the wall, is single-phase, transparent and clear in appearance, can undergo clarification detection, will not cause preparation stratification after multigelation and is used in providing children who need to receive intravenous nutrition with a daily dose of fat-soluble vitamin.

Description

technical field [0001] The invention belongs to the field of pharmacy and pharmacy, and relates to a fat-soluble vitamin injection concentrate (I), its preparation method and application. Background technique [0002] Fat-soluble vitamins are an essential part of nutrition, for children and adults to fat-soluble vitamin A, vitamin D 2 , vitamin E, vitamin K 1 Different nutritional needs, fat-soluble vitamin injections currently used in clinical practice are divided into fat-soluble vitamin injections (I) for children under 11 years old, and fat-soluble vitamin injections (II) for adults. Both use fat emulsion as the drug delivery carrier, and the excipients contained in every 10ml of pharmaceutical preparations are 1g of soybean oil, 0.12g of lecithin, 0.22g of glycerin, and the rest of water; in terms of active ingredients, fat-soluble vitamin injection ( Ⅰ) The components contain: 0.69mg vitamin A, 10μg vitamin D 2 , 6.4mg vitamin E, 0.2mg vitamin K 1 ; Fat-soluble vit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/592A61K9/107A61K47/44A61P3/02A61K31/355A61K31/122A61K31/07
Inventor 杨杰其他发明人请求不公开姓名
Owner 天津迈迪瑞康生物医药科技有限公司
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