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Anti-HIV medicine zidovudine powder injection and its preparation method thereof

A technology of zidovudine and powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of low temperature and light-proof storage, and affect product quality, and achieve the effects of simple production process, avoiding adverse reactions, and convenient transportation

Inactive Publication Date: 2003-03-26
刘万忠
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, when it is prepared as an injection in medicine, it needs to be prepared into a larger volume for use (as the current marketed commodity specification is to contain 0.1g of zidovudine in every 10ml solution), and a stabilizer needs to be added simultaneously in the prescription, so The prepared products also need to be stored at low temperature and away from light to prevent hydrolysis or photolysis reactions from occurring, which will affect product quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Embodiment 1: One of the preparation methods of zidovudine powder injection

[0011] Weigh zidovudine 100g, add 1mol / L NaOH solution 380ml (equivalent to sodium hydroxide 15g) and hot water for injection 2000ml, after making it dissolve, stir, add activated carbon 6g, continue stirring for 30min, add water for injection to 2600ml, remove Charcoal, sampling, after checking the pH (about 10) and the content is qualified, use a 0.22 μm microporous membrane filter to sterilize and return to the solution until the solution is clear. Under sterile conditions, the prepared sterile solution was filled in sterilized vials at a rate of 2.6ml / bottle, and after freeze-drying according to conventional methods, the samples were taken out and covered with butyl Rubber stopper; then rolled aluminum cap, light inspection, labeling, sampling for finished product inspection, that is. When in use, fully dissolve this product (0.1g / bottle) with an appropriate amount of water for injection ...

Embodiment 2

[0012] Embodiment 2: The preparation method two of zidovudine powder injection

[0013] Weigh 100g of zidovudine, add 250ml of 1mol / L NaOH solution (equivalent to 10g of sodium hydroxide) and 2000ml of hot water for injection, heat to dissolve, stir, add 5g of activated carbon, continue stirring for 30min, add water for injection to 2600ml, Decarburization, sampling, after checking the pH (about 9) and qualified content, use a 0.22 μm microporous membrane to filter and sterilize until the solution is clear. Under aseptic conditions, the prepared aseptic solution is filled in sterilized vials at a rate of 2.6ml / bottle, freeze-dried according to a conventional method, and packaged to obtain final product.

Embodiment 3

[0014] Embodiment 3: The third preparation method of zidovudine powder injection

[0015] Weigh 100g of zidovudine, add 400ml of 2mol / L NaOH solution (equivalent to 32g of sodium hydroxide) and 2000ml of hot water for injection to dissolve it, stir, add hydrochloric acid to adjust the pH to 12, add 6g of activated carbon, continue stirring for 30min, add Water for injection to 2600ml, decarbonized, sampled, after checking the pH (about 12) and content qualified, sterilized with a 0.22 μm microporous membrane and refluxed until the solution was clear. Under aseptic conditions, the prepared aseptic solution is filled in sterilized vials at a rate of 2.6ml / bottle, freeze-dried according to a conventional method, and packaged to obtain final product.

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PUM

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Abstract

The present invention discloses a medicine for resisting HIV-zidovudine powder injection and its preparation method. Said injection comprises zidovudine and sodium hydroxide according to their weight ratio of 3:1-10:1, and pH value of its aqueous solution is 9-12. Said invention not only possesses simple production process and convenient transportation, but also its stability is good, quality is high and storage time is long.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, more specifically to an anti-HIV medicine zidovudine powder injection, and also relates to a preparation method of the pharmaceutical preparation. Background technique [0002] Zidovudine (AZT, Zidovudine) is the first important drug for the treatment of HIV infection / AIDS, and is active against human HIV-1, HIV-2 and HTLV-I viruses. In vitro test results show that it is active against feline leukemia virus, hemophilia virus, Harvey murine sarcoma virus, murine hemophilia virus, and monkey T-lymphocyte virus. The in vitro pharmacodynamics test results of the strains isolated from patients infected with AIDS showed that the ID of zidovudine 50 Values ​​are 0.003-0.013 μg / ml, ID 90 The value is 0.03-0.3 μg / ml. The dosage forms currently on the market are mainly oral preparations and injections. Its oral bioavailability is about 60%, and its peak blood concen...

Claims

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Application Information

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IPC IPC(8): A61K31/7072A61P31/18
Inventor 刘万忠
Owner 刘万忠
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