Pharmaceutical composition of lipid-soluble vitamin and preparation method thereof

A technology of fat-soluble vitamins and vitamins, which is applied in (II) and its preparation, and in the field of fat-soluble vitamin injections (I), which can solve problems such as the stability and resolubility to be improved, and the large amount of excipients, so as to achieve enhanced safety performance and reduced Impurities, improve the effect of easy operation

Inactive Publication Date: 2013-07-10
四川省惠达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The amount of excipients in this preparation is large, and its stability and resolubility need to be improved

Method used

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  • Pharmaceutical composition of lipid-soluble vitamin and preparation method thereof
  • Pharmaceutical composition of lipid-soluble vitamin and preparation method thereof
  • Pharmaceutical composition of lipid-soluble vitamin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The preparation method of vitamin A palmitate crystal compound is as follows: under nitrogen protection, vitamin A palmitate is dissolved in a mixed solvent of chloroform and petroleum ether at 1 °C, and the volume ratio of the mixed solvent of chloroform and petroleum ether is 3:1 , add isopropanol while stirring and cool down to -10°C, the ratio of the volume of added isopropanol to the volume of the mixed solvent of chloroform and petroleum ether is 1:1, the cooling speed is 0.5°C / min, and the stirring speed is 45 rpm / min; stand at 5°C for crystal growth for 5 hours, filter, wash, and vacuum-dry at 5°C to obtain a light yellow crystalline powder of vitamin A palmitate, and obtain vitamin A palmitate for low-temperature storage.

[0039] The compound crystal is detected by high-performance liquid chromatography, and the purity is 99.85%, and the yield is 97.3%; the X-ray powder diffraction pattern obtained by using Cu-Kα ray measurement is as follows: figure 1 shown....

Embodiment 2

[0041] The preparation method of vitamin A palmitate crystal compound is as follows: under nitrogen protection, vitamin A palmitate is dissolved in a mixed solvent of chloroform and petroleum ether at 2°C, and the volume ratio of the mixed solvent of chloroform and petroleum ether is 2:1 , add isopropanol while stirring and lower the temperature to -5°C, the ratio of the volume of added isopropanol to the volume of the mixed solvent of chloroform and petroleum ether is 1:3, the speed of cooling is 1.5°C / min, and the stirring speed is 30 rpm / min; stand at 5°C for crystal growth for 5 hours, filter, wash, and vacuum-dry at 5°C to obtain a light yellow crystalline powder of vitamin A palmitate, and obtain vitamin A palmitate for low-temperature storage.

[0042] The compound crystal is detected by high-performance liquid chromatography, and the purity is 99.84%, and the yield is 97.5%; the X-ray powder diffraction pattern obtained by using Cu-Kα ray measurement is as follows: fi...

Embodiment 3

[0044] Vitamin D 2 The preparation method of the crystalline compound is as follows: under nitrogen protection, vitamin D 2 Dissolve in a mixed solution of acetone and ethyl acetate at -5°C, the volume ratio of acetone and ethyl acetate is 3:1; add double distilled water at 5°C while stirring under nitrogen, and the stirring speed is 90 rpm; The ratio of the volume of double-distilled water to the volume of the mixed solution of acetone and ethyl acetate is 1:1; let the crystal grow for 5 hours, filter, wash, and vacuum-dry to obtain vitamin D 2 white crystalline powder. The compound was detected by high performance liquid chromatography, the purity was 99.97%, and the yield was 97.2%. The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 2 shown.

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Abstract

The invention relates to a pharmaceutical composition of lipid-soluble vitamin and a preparation method thereof. The composition comprises the following ingredients: 0.30 to 1.50mg of vitamin A palmitate, 2 to 15mu g of vitamin D2, 3 to 12g of vitamin E3, 0.05 to 0.5mg of vitamin K1, 0.1 to 2g of injection soybean oil, 0.1 to 0.36g of injection lecithin, and 0.1 to 0.6g of glycerol. The preparation is an injection or freeze-dried powder injection. The pharmaceutical composition with multiple vitamins is strong in stability, and is suitable for clinical application.

Description

technical field [0001] The present invention relates to a pharmaceutical composition, in particular to a fat-soluble vitamin injection (I), (II) and a preparation method thereof. Background technique [0002] Vitamins are a type of trace organic substances that humans and animals must obtain from food in order to maintain normal physiological functions, and play an important role in the growth, metabolism, and development of the human body. Vitamins are a huge family. There are dozens of known vitamins, which can be roughly divided into two categories: fat-soluble and water-soluble. Water-soluble vitamins do not need to be digested. After being directly absorbed from the intestines, they are circulated to the tissues needed by the body. Most of the excess is excreted in urine and stored in the body. Fat-soluble vitamins are dissolved in fat, emulsified by bile, absorbed in the small intestine, and enter various organs in the body through the lymphatic circulation system. T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/592A61K9/19A61K9/08A61P3/02A61K31/355A61K31/122A61K31/232
Inventor 梁宏平
Owner 四川省惠达药业有限公司
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