Compound diisopropylamine dichloroacetate freeze dried injection and preparation method thereof

A technology of compound diisopropylamine dichloroacetate and diisopropylamine dichloroacetate, applied in the field of medicine, can solve the problems of labor resource consumption, inconvenient storage and transportation, unreasonable design, etc., and achieves the reduction of packaging materials and labor resources. Waste, good for transportation and preservation, improve the effect of stroke sequelae

Inactive Publication Date: 2005-06-22
刘力
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, at present, the market only has water needle supply, diisopropylamine dichloroacetate (C 8 h 17 o 2 NCl 2 ) is unstable when exposed to heat, and in the state of solution, the decomposition increases. inconvenient
And the water injection only has 20mg / 1ml, 40mg / 2ml specifications, while the clinical daily dose of diisopropylamine dichloroacetate is 20-60mg, which reflects that the unit dose of the main drug of diisopropylamine dichloroacetate water injection is low. Formulation point of view, its design is unreasonable
Therefore, this not only wastes more than 1-2 times of packaging materials in many cases, but also consumes more labor resources, which is a great waste of social wealth! And it is very inconvenient to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Under clean conditions, take 20g of diisopropylamine dichloroacetate, 19g of sodium gluconate, 200g of arginine, 10g of 2-hydroxypropyl β-cyclodextrin, and 0.5g of sodium bisulfite at 20°C Add an appropriate amount of water for injection, stir to dissolve; adjust the pH value with dilute hydrochloric acid, add 1g of activated carbon for needles, stir for 20min, filter and decarbonize with a 10μm titanium filter rod, after the pH value and content are qualified, use a 0.45-0.8um microporous filter membrane Filter, and then filter with a 0.2-0.22um microporous membrane; sterilize, remove pyrogens, and pack in vials according to dosage, so that the unit dose of diisopropylamine dichloroacetate in each vial is 20 mg, and the unit dose of sodium gluconate 19mg, add rubber stopper, place the subpackaged vial in a lyophilizer, freeze for 2 hours, make the temperature reach -45°C, make the vacuum degree in the machine 10Pa, dry in low temperature vacuum for 18 hours, ...

Embodiment 2

[0023] Example 2: Under clean conditions, take 40g of diisopropylamine dichloroacetate, 38g of sodium gluconate, 10g of sodium chloride, 10g of lysine, 5g of 2-hydroxypropyl β-cyclodextrin, 20g of nicotinamide, Add 0.1g of L-cysteine ​​hydrochloride in an appropriate amount of water for injection at 20°C, stir and dissolve; adjust the pH with glucuronic acid and sodium hydroxide, filter through a 5μm titanium filter rod, add water for injection, and wait for the pH value and content to be determined After passing the test, two times of ultrafiltration to sterilize, remove pyrogens, and divide into vials according to the dose, so that the unit dose of diisopropylamine dichloroacetate in each vial is 40 mg, and the unit dose of sodium gluconate is 38 mg, and add a rubber stopper. , Place the subpackaged vials in a lyophilizer, freeze for 2 hours, make the temperature reach -50°C, make the vacuum degree in the machine 10Pa, dry in vacuum at low temperature for 30 hours, raise the ...

Embodiment 3

[0024] Example 3: Under clean conditions, take 60g of diisopropylamine dichloroacetate, 57g of sodium gluconate, 1000g of glucose, 100g of arginine, 20g of 3-hydroxypropyl β-cyclodextrin, 50g of sodium pantothenate, and sodium metabisulfite Dissolve 2 g in an appropriate amount of water for injection at 20°C; adjust the pH with hydrochloric acid and sodium hydroxide, filter through a 10 μm titanium filter rod, add water for injection, stir well, and after the pH value and content are qualified, sterilize by ultrafiltration twice, Remove the pyrogen, pack in vials according to the dose, make the unit dose of diisopropylamine dichloroacetate in each vial be 60 mg, and the unit dose of sodium gluconate be 57 mg, add rubber stoppers, put the vials that have been divided into In the freeze dryer, freeze for 2 hours, make the temperature reach -40°C, make the vacuum degree inside the machine 10Pa, dry in low temperature vacuum for 30 hours, raise the temperature to 30°C, dry in vacuu...

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PUM

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Abstract

Disclosed is a compound diisopropylamine dichloroacetate freeze dried preparation, which comprises unit dosage of tensicor 10-200mg, sodium gluconate 9.5-200mg, and at least one pharmaceutically acceptable carrier, the carrier comprises excipient, pH modifier, anti-oxidant agent, stabilizer, and is provided in the form of unit amount in the container.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound diisopropylamine dichloroacetate freeze-dried powder preparation and a preparation method thereof. Background technique [0002] The compound diisopropylamine dichloroacetate can provide the methyl group needed by the body to synthesize choline, and the effect of choline and fatty liver is conducive to the transfer of fat from the liver to the outside of the liver, reducing the accumulation of fat in the liver; it can reduce the glycerol in the arteries and the concentration of free fatty acids, reduce the liver's absorption of glycerol, and inhibit the synthesis of triglycerides in the liver; activate the pyruvate dehydrogenase complex by inhibiting pyruvate dehydrogenase, and at the same time increase the oxygen uptake of liver cells, promote the oxidation of lactic acid, and reduce blood Medium lactic acid level improves the body's acid-base metabolism, t...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/195A61P1/16A61P31/12
Inventor 刘力
Owner 刘力
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