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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0178] Example 1: Preparation of Lipstick -soluble vitamin injection concentrated solution (Ⅱ) Sample 1

[0179] Its composition is as follows:

[0180] Vitamin A 0.99 grams

[0181] Vitamin D2 5 mg

[0182] Vitamin E 9.1 grams

[0183] Vitamin K1 0.15 grams

[0184] Soybean oil 5 grams

[0185] 57 grams of medium -chain fatty acid triglyceride (Critamol GTCC)

[0186] 1, 2-propylene glycol 8 grams

[0187] Epikuron 170, Degussa 7 grams

[0188] Twen 80 3.1 grams

[0189] Polymid glycol duisal hydroxyl fatty lipate (SOLUTOL HS 15, BASF) 9.6 grams

[0190] The preparation method of this fat -soluble vitamin injection concentration solution (Ⅱ) is as follows:

[0191] 1) Under 45 ℃, the above -mentioned weight vitamin A, vitamin D2, vitamin E, vitamin K1, soy lecithin, soybean oil and medium -chain fatty acid glycerin triglyceride are mixed, and under 8000rpm, stir until it forms a transparent clear solutionIt

[0192] 2) Under 20 ° C conditions, the above weight 1, 2-propylene glyc...

Embodiment 2

[0194] Example 2: Preparation of Lipstick -soluble vitamin injection concentrated solution (Ⅱ) Sample 2

[0195] Its composition is as follows:

[0196] Vitamin A 0.5 grams

[0197] Vitamin D2 2.5 mg

[0198] Vitamin E 4.55 grams

[0199] Vitamin K1 0.075 grams

[0200] Soybean oil 27 grams

[0201] Miglyol 812, SASOL) 28.5 grams

[0202] 1, 2-propylene glycol 9 grams

[0203] Epikuron 170, Degussa 12 grams

[0204] 3.2 grams of poly glycolic hydride

[0205] Polymid glycol duisal hydroxyl fatty lipate (Solutol HS 15, BASF) 11 grams

[0206] Twen 80 4 grams

[0207] 0.15 grams of oleic acid

[0208] The preparation method of this fat -soluble vitamin injection concentration solution (Ⅱ) is as follows:

[0209] To form a transparent clear solution;

[0210] 2) Under 25 ° C conditions, the above weight 1, 2-propylene glycol, polyethylene glycol duisol hydroxyl fatty acid ester, vomiting temperature 80, and oil acid adds step 1) products, and continue to stir under 1000rpm stirring c...

Embodiment 3

[0212] Example 3: Preparation of Lipstick -soluble vitamin injection concentrated solution (Ⅱ) Sample 3

[0213] Its composition is as follows:

[0214] Vitamin A 0.99 grams

[0215] Vitamin D2 5 mg

[0216] Vitamin E 9.1 grams

[0217] Vitamin K1 0.15 grams

[0218] Soybean oil 47 grams

[0219] 1, 2-propylene glycol 10 grams

[0220] Epikuron 170, Degussa 12 grams

[0221] 0.6 grams of poly glycolic hydride

[0222] Polymid glycol duisal hydroxyl fatty lipate (SOLUTOL HS 15, BASF) 13 grams

[0223] Twen 80 7 grams

[0224] 0.1 grams of oleic acid

[0225] The preparation method of this fat -soluble vitamin injection concentration solution (Ⅱ) is as follows:

[0226] 1) Under 40 ° C conditions, mix the above -mentioned weight vitamin A, vitamin D2, vitamin E, vitamin K1, soy lecithin, poly -glycolic hydolidate and soybean oil, and stir until a transparent clear solution is formed at 6000rpm conditions;

[0227] 2) Under 25 ° C conditions, the above weight 1, 2-propylene glycol, po...

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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 (II), 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 adults who need to receive intravenous nutrition with a daily dose of fat-soluble vitamin.

Description

Technical field [0001] The invention is a pharmacy and pharmaceutical field, involving fat -soluble vitamin injection concentrated solution (Ⅱ), and its preparation methods and uses. Background technique [0002] Lipstick -soluble vitamins are an essential part of nutrition. For children and adults to lipopolytic vitamin A, vitamin D 2 , Vitamin E, Vitamin K 1 Different nutritional needs, currently used in the clinical fat -soluble vitamin injection liquid is divided into a fat -soluble vitamin injection (Ⅰ) for children under 11 years of age, and a fat -soluble vitamin injection (Ⅱ) suitable for adults. These two drugs areAll fat milk is used as a dosage carrier, and the auxiliary materials contained in each 10ml drug preparation are 1g of soybean oil, 0.12 grams of lecithin, 0.22 grams of glycerin, and water; in terms of active ingredients, fat -soluble vitamin injection (Ⅰ) Components contain: 0.69mg vitamin A, 10 μg vitamin D 2 , 6.4mg Vitamin E, 0.2mg Vitamin K 1 ; Lipstick ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/592A61K9/107A61P3/02A61K31/355A61K31/122A61K31/07
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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