Water-soluble vitamin composition freeze-drying preparation for injection

A technology for water-soluble vitamins and freeze-dried preparations, which is applied in freeze-dried delivery, drug combination, active ingredients of heterocyclic compounds, etc., can solve the problem of no water-soluble vitamin raw materials, etc., and is conducive to popularization and use, and has a concentrated particle size distribution. , The effect of good product liquidity

Active Publication Date: 2010-12-08
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the prior art, in order to improve the temperature resistance of water-soluble vitamins, it is usually by optimizing the preparation method and adding excipients, but there has never been any relevant research on the water-soluble vitamin raw materials themselves. How to improve the preparation by improving the raw materials Stability has always been a difficult technical problem in the industry

Method used

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  • Water-soluble vitamin composition freeze-drying preparation for injection
  • Water-soluble vitamin composition freeze-drying preparation for injection
  • Water-soluble vitamin composition freeze-drying preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The preparation of embodiment 1 sodium pantothenate hydrate

[0053] At room temperature, dissolve 16.5g of anhydrous sodium pantothenate in 85ml of 75% ethanol solution, distill under normal pressure and then distill under reduced pressure until the compound is precipitated, and dry the compound in vacuum at 35°C for 2 hours to obtain sodium pantothenate dihydrate things. The moisture content measured by the combination of Karl Fischer moisture determination method and thermogravimetric analysis is within the error range with the theoretical moisture content of the dihydrate. Moisture content in sodium pantothenate hydrate is 12.98% (see figure 2 ).

Embodiment 2

[0054] The preparation of embodiment 2 sodium pantothenate hydrate

[0055] At room temperature, dissolve 16.5g of anhydrous sodium pantothenate in 85ml of 80% ethanol solution, distill at normal pressure and then distill under reduced pressure until the compound is precipitated, and dry the compound in vacuum at 30°C for 1.5 hours to obtain sodium pantothenate dihydrate things. The moisture content measured by the combination of Karl Fischer moisture determination method and thermogravimetric analysis is within the error range with the theoretical moisture content of the dihydrate. The water content in sodium pantothenate hydrate is 12.97%.

Embodiment 3

[0056] The preparation of embodiment 3 sodium pantothenate hydrate

[0057] At room temperature, dissolve 16.5g of anhydrous sodium pantothenate in 85ml of 80% ethanol solution, distill at normal pressure and then distill under reduced pressure until the compound is precipitated, and dry the compound in vacuum at 50°C for 1.5 hours to obtain sodium pantothenate dihydrate things. The moisture content measured by the combination of Karl Fischer moisture determination method and thermogravimetric analysis is within the error range with the theoretical moisture content of the dihydrate. The water content in sodium pantothenate hydrate is 12.99%.

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Abstract

The invention discloses a water-soluble vitamin composition freeze-drying preparation for injection. The freeze-drying preparation comprises the following raw materials and is prepared into 1,000 bottles: 2.8 to 3.4 grams of thiamine mononitrate, 36 to 44 grams of nicotinamide, 4.4 to 5.4 grams of pyridoxine hydrochloride, 14.8 to 18.1 grams of sodium pantothenate, 4.4 to 5.4 grams of riboflavin sodium phosphate, 102 to 124 grams of sodium vitamin C, 54 to 66 milligrams of biotin, 0.36 to 0.44 gram of folic acid, 124.5 to 6.0 milligrams of vitamin B, and 0.4 to 0.6 gram of methyl-p-hydroxy benzoate, wherein the nicotinamide is nicotinamide hydrate, and the sodium pantothenate is sodium pantothenate hydrate. The water-soluble vitamin for injection has adjustable grain size, concentrated grain size distribution, glabrous surface, high product fluidity, greatly improved stability and high dissolution rate, and a preparation process of the preparation is simple and is favorable for popularization and use.

Description

technical field [0001] The invention relates to a water-soluble vitamin, in particular to a freeze-dried preparation of a water-soluble vitamin composition for injection and a preparation method thereof. Background technique [0002] Vitamins are trace nutrients necessary to maintain the normal metabolic function of the human body. They mainly act on the energy transfer and metabolic regulation of the body. It is essential for drug metabolism, capture of free radicals, prevention of cell damage and peroxidation of cell membranes. Since it cannot be synthesized in the human body or the amount of synthesis is very small, it must be obtained from food in a quantitative and regular manner. The imitation injection of water-soluble vitamins is mainly used clinically for the prevention and treatment of water-soluble vitamin deficiency. Freeze-dried powder for injection has good stability, long shelf life, and is easier to store and transport than injection. [0003] Since water-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K31/51A61K31/455A61K31/4415A61K31/197A61K31/675A61K31/375A61K31/4188A61K31/519A61K31/235A61K9/19A61P3/02
Inventor 李明华李厥臣李志滨
Owner SHANDONG YUXIN PHARMA CO LTD
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