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Pharmaceutical composition comprising lipid-soluble vitamin for injection and preparation method of pharmaceutical composition

A fat-soluble vitamin and vitamin technology, which can be used in drug combinations, pharmaceutical formulations, medical preparations with inactive ingredients, etc. Types of solvent excipients and effects of improving safety

Active Publication Date: 2014-01-22
HAISCO PHARMA GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The present invention overcomes the deficiencies of the above schemes, and discloses a pharmaceutical composition of fat-soluble vitamins for injection using water-soluble carboxylated chitosan as a solubilizer and a preparation method thereof. The composition prepared by the preparation method can be Significantly enhance the solubility of fat-soluble vitamins in water, solve the common problem of poor clarity after reconstitution in the prior art of fat-soluble vitamins for injection, and help improve the safety of the preparation composition in clinical use

Method used

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  • Pharmaceutical composition comprising lipid-soluble vitamin for injection and preparation method of pharmaceutical composition
  • Pharmaceutical composition comprising lipid-soluble vitamin for injection and preparation method of pharmaceutical composition
  • Pharmaceutical composition comprising lipid-soluble vitamin for injection and preparation method of pharmaceutical composition

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Embodiment 1

[0048] The preparation of the pharmaceutical composition of embodiment 1 fat-soluble vitamin for injection

[0049] prescription:

[0050]

[0051] The preparation method is prepared according to the following steps:

[0052] (1) Dissolve water-soluble carboxylated chitosan in water for injection to prepare a 10 mg / mL solution;

[0053] (2) Weigh vitamin A palmitate, vitamin E, and vitamin K according to the prescription amount 1 , Vitamin D 2 , added to the water-soluble chitosan solution of the prescription amount prepared in step (1), and stirred evenly;

[0054] (3) Weigh the prescribed amount of mannitol, add 50% of the total preparation amount of water for injection and stir to dissolve, cool to room temperature, slowly add the mannitol solution into the vitamin solution obtained in step (2) while stirring, and mix well to obtain a clear solution ;

[0055] (4) Add activated carbon for needles at 0.1% (w / v), stir for 10 minutes, decarbonize and filter, adjust the...

Embodiment 2

[0060] The preparation of the pharmaceutical composition of embodiment 2 fat-soluble vitamins for injection

[0061] prescription:

[0062]

[0063] The preparation method is prepared according to the following steps:

[0064] (1) Dissolve water-soluble carboxylated chitosan in water for injection to prepare a 10 mg / mL solution;

[0065] (2) Weigh vitamin A palmitate, vitamin E, and vitamin K according to the prescription amount 1 , Vitamin D 2 , added to the water-soluble chitosan solution of the prescription amount prepared in step (1), and stirred evenly;

[0066] (3) Weigh the prescribed amount of mannitol, add 80% of the total preparation amount of water for injection and stir to dissolve, cool to room temperature, slowly add the mannitol solution into the vitamin solution obtained in step (2) while stirring, and mix well to obtain a clear solution ;

[0067] (4) Add activated carbon for needles at 0.1% (w / v), stir for 15 minutes, decarbonize and filter, adjust th...

Embodiment 3

[0072] The preparation of the pharmaceutical composition of embodiment 3 injection fat-soluble vitamins

[0073] prescription:

[0074]

[0075] The preparation method is prepared according to the following steps:

[0076] (1) Dissolve water-soluble carboxylated chitosan in water for injection to prepare a 10 mg / mL solution;

[0077] (2) Weigh vitamin A palmitate, vitamin E, and vitamin K according to the prescription amount 1 , Vitamin D 2 , added to the water-soluble chitosan solution of the prescription amount prepared in step (1), and stirred evenly;

[0078] (3) Weigh the prescribed amount of mannitol, add 60% of the total preparation amount of water for injection and stir to dissolve, cool to room temperature, slowly add the mannitol solution into the vitamin solution obtained in step (2) while stirring, and mix well to obtain a clear solution ;

[0079] (4) Add activated carbon for needles at 0.1% (w / v), stir for 15 minutes, decarbonize and filter, adjust the pH...

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Abstract

The invention relates to a pharmaceutical composition comprising lipid-soluble vitamin for injection, which improves water solubility, and a preparation method of the pharmaceutical composition. The pharmaceutical composition comprises vitamin A palmitate, vitamin D2, vitamin E, vitamin K1, water-soluble carboxylation chitosan and mannite. The preparation method comprises the steps of medicine liquid preparation, activated carbon adsorption, decarburization, filtering sterilization, filling, freeze-drying and the like. The pharmaceutical composition comprising lipid-soluble vitamin for injection utilizes the water-soluble carboxylation chitosan as a solubilizer, and has the advantages of few accessories, good water solubility, stable and controllable quality, high safety, simple preparation method, easiness in industrialization and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of fat-soluble vitamins for injection and a preparation method thereof. Background technique [0002] Parenteral nutrition (PN) is widely used in the treatment of various diseases and the nutritional support of patients during surgery. Vitamins, as an important cofactor of metabolism, are the main components of parenteral nutrition. Clinically, it is mainly used for patients who cannot eat due to surgery, large area burns, fractures and other traumas, severe infections and coma, and need parenteral nutrition. [0003] Vitamins are a class of low-molecular organic compounds necessary for various organisms to maintain normal physiological functions. They can generally be divided into two categories: fat-soluble vitamins and water-soluble vitamins. Fat-soluble vitamins include vitamins A, D, E, and K, and water-soluble vitamins include vitamin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/592A61K9/19A61K47/36A61P3/02A61K31/355A61K31/23A61K31/122
Inventor 杨平莫毅
Owner HAISCO PHARMA GRP INC
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