Tensicor freeze-drying formulation and its making method

A technology of diisopropylamine dichloroacetate and freeze-dried preparation, applied in the field of diisopropylamine dichloroacetate freeze-dried preparation and preparation thereof, can solve the problems such as easy deterioration, unfavorable preservation and transportation of injection, and achieve stable performance, high efficiency and high efficiency. The effect of facilitating mass production, transportation and storage convenience

Active Publication Date: 2004-12-29
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Injection has fast onset of action, strong effect, and is easy to be accepted clinically, but it is not conducive to storage and transportation; in addition, it needs to be protected from light during storage, otherwise it will easily deteriorate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0031] Take an appropriate amount of diisopropylamine dichloroacetate (manufactured by Tianjin Zifu Pharmaceutical Technology Development Co., Ltd.), an appropriate amount of mannitol (Shandong Jiejing Group), sodium gluconate (Zhejiang Jintian Chemical Co., Ltd.) and add an appropriate amount of water for injection, and stir until completely Dissolve, use phosphoric acid-sodium dihydrogen phosphate buffer solution, sodium gluconate, phosphoric acid-sodium dihydrogen phosphate buffer solution, and NaOH solution to control the pH value to 4, 5.7, 5.7, 7.5, to obtain diisopropylamine dichloroacetate per milliliter 20mg, sodium gluconate 19mg, mannitol 50mg solution. Add activated carbon according to the dosage of 0.05, 0.5, 1, and 2% (g / ml), respectively, stir at 20, 25, 30, and 40°C for 50, 30, 20, and 15 minutes, decarbonize and filter, and obtain the filtrate with 0.22μm Sterilization by microporous membrane fine filtration. Under aseptic conditions, the resulting solution i...

Embodiment 5

[0033] Take an appropriate amount of diisopropylamine dichloroacetate, sodium gluconate and lactose (imported), add an appropriate amount of water for injection, stir to make it completely dissolved, add sodium hydroxide solution to adjust the pH value of the solution to about 7.4, and obtain dichloroacetate containing dichloroacetate per milliliter. A solution of isopropylamine 20mg, sodium gluconate 19mg and lactose 60mg. Add activated carbon according to the dosage of 1% (g / ml), stir at 30° C. for 30 minutes, decarbonize and filter, and the resulting filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, the resulting solution is placed in a sterile vial, freeze-dried in a freeze dryer for about 25 hours, and then aseptically sealed to obtain the diisopropylamine dichloroacetate freeze-dried powder preparation E of the present invention.

Embodiment 6

[0035] Take an appropriate amount of diisopropylamine dichloroacetate and sodium chloride, add an appropriate amount of water for injection, and stir to completely dissolve it. Add NaH 2 PO 4 The pH value of the solution was adjusted to about 6.5 to obtain a solution containing 20 mg of diisopropylamine dichloroacetate and 70 mg of sodium chloride per milliliter. Activated carbon was added according to the dosage of 2% (g / ml), stirred at 25° C. for 30 minutes, decarbonized and filtered, and the resulting filtrate was sterilized by fine filtration with a 0.22 μm microporous membrane. Put the obtained solution in a sterile vial under aseptic conditions, freeze-dry it in a freeze dryer for 28 hours, and then seal it aseptically to obtain the diisopropylamine dichloroacetate freeze-dried powder preparation F of the present invention.

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PUM

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Abstract

The freeze dried dichloro diisopropylamine acetate preparation is prepared with solution containing dichloro diisopropylamine acetate and pharmaceutically acceptable excipient selected from mannitol, sodium chloride, lactose, etc. and with pH value of 4.0-8.5, and through freeze drying. The solution may contain sodium gluconate, pharmaceutically acceptable pH regulator or other supplementary material. The freeze dried preparation has stable performance, fast dissolution, and convenient storage, transportation and use.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of diisopropylamine dichloroacetate and a preparation method thereof. technical background [0002] Diisopropylamine dichloroacetate is a vitamin B 15 , the active ingredient of pangemic acid, has a strong lipotropic effect, can inhibit and reduce fat precipitation in the liver, prevent liver cell damage, and promote the regeneration of damaged liver cells. It can also improve the utilization rate of oxygen in the brain tissue, increase the blood flow of the brain, thereby strengthening the metabolism of the brain tissue, increasing the respiration of the brain tissue and promoting the process of glycolysis and aerobic glycolysis. It can be used for the treatment of acute and chronic hepatitis, fatty liver, cirrhosis, jaundice and other liver diseases. It can also be used for sequelae of stroke, cerebral hemorrhage, encephalomalac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/195A61P1/16A61P9/00A61P9/10A61P9/12
Inventor 邵梅张庆华石秀伟
Owner YAOPHARMA CO LTD
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