Compound menonine and Vitamin B1 freeze-dried injection and its preparation

A technology of methionine and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of inconvenient storage and transportation of water injection, turbidity or precipitation, instability when exposed to heat, etc., so as to be beneficial to transportation and storage and improve stability. , the effect of prolonging the storage period

Inactive Publication Date: 2005-09-07
罗靖 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, at present, the market only supplies water injections, compound methionine and vitamin B 1 Unstable when exposed to heat, in solution state, vitamin B 1 Easy to decompose, prone to turbidity or precipitation, compound methionine vitamin B for water injection after high temperature sterilization 1 The content decreases due to hydrolysis, and the storage and transportation of water needles are not convenient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: Under clean conditions, get methionine 40g, vitamin B hydrochloride respectively 1 4g, 20g of arginine, 20g of meglumine, 10g of 2-hydroxypropyl β-cyclodextrin, and 2g of sodium bisulfite were dissolved in an appropriate amount of water for injection at 20°C; Use activated carbon, stir for 20 minutes, filter with a 10μm titanium filter rod for decarbonization, after the pH value and content are qualified, filter with a 0.45um microporous membrane, and then filter with a 0.22um microporous membrane; Divide into vials so that the unit dose of methionine in each vial is 40 mg, and the unit dose of vitamin B1 hydrochloride is 4 mg, add rubber stoppers, place the divided vials in a freeze dryer, and freeze 2 hour, make the temperature reach -40°C, make the vacuum degree inside the machine be 10Pa, dry in vacuum at low temperature for 18 hours, raise the temperature to 35°C, dry in vacuum for 5 hours, press the cap to get it, and control the weight percentage of...

Embodiment 2

[0023] Embodiment 2: Under clean conditions, get methionine 40g, vitamin B 1 Hydrochloride 4g, tromethamine 20g, lysine 40g, 2-hydroxypropyl β-cyclodextrin 5g, L-cysteine ​​hydrochloride 0.1g in

[0024] Dissolve in an appropriate amount of water for injection at 20°C; adjust the pH with gluconic acid and sodium hydroxide, filter through a 5 μm titanium filter rod, add water for injection, and after the pH value and content are qualified, perform ultrafiltration twice to remove the pyrogen. Packed in vials according to dose, so that the unit dose of methionine in each vial is 40mg, vitamin B 1 The unit dose of hydrochloride is 4mg, with a rubber stopper, put the subpackaged vials in a freeze dryer, freeze for 2 hours, make the temperature reach -40°C, make the vacuum degree in the machine 10Pa, and dry in a vacuum at low temperature After 30 hours, the temperature was raised to 30° C., vacuum-dried for 10 hours, and the lid was pressed to obtain the product. The water content...

Embodiment 3

[0025] Embodiment 3: Under clean conditions, get methionine 100g, vitamin B respectively 1 Hydrochloride 10g, glucose 1000g, xylitol 100g, 3-hydroxypropyl β-cyclodextrin 20g, sodium metabisulfite 2g in an appropriate amount of water for injection at 20°C, stir and dissolve; adjust pH with hydrochloric acid and sodium hydroxide, 10μm titanium Material filter rod, decarbonized by filtration, added water for injection, stirred evenly, after the pH value and content determination were qualified, ultrafiltration was sterilized twice, and the pyrogen was removed, and the dosage was divided into cillin bottles to make the content of methionine in each vial The unit dose is 100 mg, the unit dose of vitamin B1 hydrochloride is 10 mg, add a rubber stopper, put the subpackaged vial in a freeze dryer, freeze for 2 hours, make the temperature reach -40°C, and make the machine vacuum The temperature is 10Pa, vacuum-dried at low temperature for 30 hours, the temperature is raised to 30°C, va...

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PUM

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Abstract

Compound methilanin thiamin is used to assist treat that acute and chronic hepatitis, fatty liver, early cirrhosis of liver, toxic hepatitis brought by arsenic and barbiturate and other diseases in clinic. But, there is only liquid drugs injection supplied in market at present. Compound methilanin thiamin is unstable to heat; thiamin is easy to decompose on condition of solution, opacification or precipitate; after sterilization at high temperature, content of thiamin in liquid drugs injection will decrease for decomposition; meantime the storage and transport for liquid drugs injection is not convenient. The invention overcomes the shortage of methilanin thiamin liquid drugs injection, increases stability of drug, is propitious to transport and storage; and avoids freezing easily in winter and affecting quality of drug, prolongs drug storage life, improves quality of drug, in order to treat patients more safely and effectively.

Description

technical field [0001] The invention relates to the field of medicine, in particular to compound methionine vitamin B 1 Freeze-dried powder preparation and preparation method thereof. Background technique [0002] Vitamin B Compound Methionine 1 , has the effect of increasing endogenous choline. When the liver suffers from disease, it is often accompanied by the infiltration and accumulation of lipids in the liver. It is an important pathological change of liver disease and is considered a precursor to cirrhosis. And choline can form lipoprotein with fat and protein, which is easily soluble in blood plasma and helps to transfer the lipid in the liver to achieve the purpose of preventing and treating fatty liver. It is also clinically used to treat chronic hepatitis, toxic hepatitis caused by arsenic and barbiturates. [0003] However, at present, the market only supplies water injections, compound methionine and vitamin B 1 Unstable when exposed...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/51A61P1/16
Inventor 罗靖刘力
Owner 罗靖
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