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Compound dichloroacetic acid diisopropylamin powder-injection and its preparation method

A technology of compound diisopropylamine dichloroacetate powder and diisopropylamine dichloroacetate, which can be used in powder transportation, digestive system, peptide/protein components, etc., and can solve problems such as inconvenience, economic loss of enterprises, and easy breakage of injections , to achieve the effect of clear and transparent solution, satisfying clinical use, and good resolubility

Inactive Publication Date: 2005-03-23
王玫
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the dosage form for injection in China is compound diisopropylamine dichloroacetate injection. Since the injection is easily broken during transportation, the broken medicine will contaminate other medicines in the same box, often causing the whole box of medicine to be invalidated, thus bringing great harm to the enterprise. Economic losses also bring inconvenience to the hospital’s clinical medication, especially because the water needles of injections are frozen during transportation in the northern region and crystallize, which will also cause the entire box of medicines to be invalidated, thereby bringing economic losses to the enterprise. Inconvenience caused by clinical medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: Preparation of compound diisopropylamine dichloroacetate powder for injection by freeze-drying method

[0018] Prescription: (1000 bottles, 20mg / bottle)

[0019] Diisopropylamine dichloroacetate 20g

[0020] Sodium Gluconate 19g

[0021] Mannitol 100g

[0022] Water for injection 1000ml

[0023] Makes 1000 bottles

[0024] Weigh the prescribed amount of sodium gluconate, dissolve it in an appropriate amount of water for injection, add acetic acid to adjust the pH value to between 4.0-6.5, weigh the prescribed amount of diisopropylamine dichloroacetate and add it to the above solution, stir to dissolve it, Add the prescribed amount of mannitol, stir to make it dissolve, add 0.1% (w / v) activated carbon, stir for 20 minutes, coarsely filter and decarbonize, add water for injection to the full amount, mix well, and use 0.22 micron Fine filtration with microporous membrane, aseptic filling, freeze-drying, capping, and finished p...

Embodiment 2

[0025] Embodiment 2: Preparation of compound diisopropylamine dichloroacetate powder for injection by freeze-drying

[0026] Prescription: (1000 bottles, 20mg / bottle)

[0027] Diisopropylamine dichloroacetate 20g

[0028] Sodium Gluconate 16g

[0029] Hydroxypropyl-β-cyclodextrin 1000g

[0030] Water for injection 10000ml

[0031] Makes 1000 bottles

[0032] Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, dissolve it in an appropriate amount of water for injection, add the prescribed amount of sodium gluconate, adjust the pH value of the solution to 4.0-6.5 with dilute hydrochloric acid, add dichloroacetic acid Diisopropylamine, stir to make it dissolve, add activated carbon for adsorption, filter, add water for injection to the full amount, after the intermediate is qualified, filter it with a 0.22 micron microporous membrane, put it into a large plate for sterile freeze-drying, crush it, and pack it separately. The gland is ready...

Embodiment 3

[0033] Embodiment 3: Preparation of compound diisopropylamine dichloroacetate powder for injection by spray drying method

[0034] Prescription: (1000 bottles, 20mg / bottle)

[0035] Diisopropylamine dichloroacetate 20g

[0036] Sodium Gluconate 22g

[0037] Propylene glycol 500ml

[0038] Water for injection up to 1000ml

[0039] Makes 1000 bottles

[0040] Take the sodium gluconate of prescription quantity, be dissolved in the appropriate amount of water for injection, add tartaric acid to adjust the pH value between 4.0-6.5, take the prescription quantity of diisopropylamine dichloroacetate and prescription quantity of propylene glycol, add in the above solution, Stir to make it dissolve, add 0.1% (w / v) activated carbon, stir for 20 minutes, decarbonize by coarse filtration, and add water for injection to the full amount. Finely filter with a microporous membrane, spray dry, subpackage, press cap, and obtain it after passing the inspection.

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PUM

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Abstract

A powder injection of compound diisopropylamine dichloroacetate is prepared from diisopropylamine dichloroacetate, sodium gluconate, mannitol and the water for injection through dissolving sodium gluconate in the water for injection, adding acetic acid to regulate pH-4.0-6.5, adding others, stirring and freeze drying.

Description

technical field [0001] The invention relates to pharmaceutical preparations, and particularly provides a powder injection preparation for treating liver diseases, which contains diisopropylamine dichloroacetate and sodium gluconate. Background technique [0002] Diisopropylamine dichloroacetate is a drug for treating liver diseases. Its clinical efficacy has been widely recognized in Europe, America and Japan. Due to the increasing number of patients with liver diseases, many drug manufacturers are actively researching and developing related products of diisopropylamine dichloroacetate. Products to meet the needs of clinical treatment of liver diseases. At present, the dosage form for injection in China is compound diisopropylamine dichloroacetate injection. Since the injection is easily broken during transportation, the broken medicine will contaminate other medicines in the same box, often causing the whole box of medicine to be invalidated, thus ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/195A61P1/16
Inventor 张海茹李晓峰张晓鹏
Owner 王玫
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