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Thiamphenicol glycinate hydrochloride freeze-dried powder injection and preparation method thereof

A technology of thiamphenicol hydrochloride and freeze-dried powder injection, which is applied in the field of medicine, can solve unscientific problems, and achieve the effects of low related substances, stable quality, easy transportation and storage

Active Publication Date: 2010-12-08
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, thiamphenicol hydrochloride glycinate has very good water solubility, so adding a solubilizer is obviously unnecessary and unscientific

Method used

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  • Thiamphenicol glycinate hydrochloride freeze-dried powder injection and preparation method thereof
  • Thiamphenicol glycinate hydrochloride freeze-dried powder injection and preparation method thereof
  • Thiamphenicol glycinate hydrochloride freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0125] prescription

[0126] Name of raw and auxiliary materials Quantity for 1000 sticks (g)

[0127] Thiamphenicol Hydrochloride Glycinate 631.25g

[0128] Add water for injection to 3000ml

[0129] Preparation Process

[0130] 1. Measure 80% of the prescribed amount of water for injection cooled to room temperature, adjust the pH to 1.8-2.4 with hydrochloric acid, add the prescribed amount of thiamphenicol hydrochloride glycinate, stir to dissolve, and add water for injection cooled to room temperature to the full amount.

[0131] 2. Add 0.05% (g / ml) activated carbon to the liquid medicine, stir for 30 minutes, decarburize and filter to obtain the filtrate.

[0132] 3. Measure the pH and content of the intermediate solution.

[0133] 4. 0.22μm microporous membrane filtration.

[0134] 5. Filling.

[0135] 6. Freeze-drying:

[0136] (1) Turn on the front box refrigeration to lower the temperature of the product to below -40°C and keep it for 2-3 hours.

[0137] (2) ...

Embodiment 2

[0144] prescription

[0145] Name of raw and auxiliary materials Quantity for 1000 sticks (g)

[0146] Thiamphenicol Hydrochloride Glycinate 631.25g

[0147] Add water for injection to 3000ml

[0148] The preparation process is the same as in Example 1, wherein the temperature of the water for injection is 20° C., and the pH value of the intermediate solution is adjusted to 1.8.

[0149] After testing the intermediate solution and finished product obtained by the above method, the related substances were 0.55% and 0.71% respectively.

Embodiment 3

[0151] prescription

[0152] Name of raw and auxiliary materials Quantity for 1000 sticks (g)

[0153] Thiamphenicol Hydrochloride Glycinate 631.25g

[0154] Add water for injection to 3000ml

[0155] The preparation process is the same as in Example 1, wherein the temperature of the water for injection is 25° C., and the pH value of the intermediate solution is adjusted to 2.0.

[0156] After testing the intermediate solution and finished product obtained by the above method, the related substances were 0.49% and 0.68% respectively.

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PUM

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Abstract

The invention relates to a thiamphenicol glycinate hydrochloride freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicines. The proper pH value range and the proper freeze-drying conditions of an intermediate solution are screened out by researching the thiamphenicol glycinate formulation technology, therefore, the obtained freeze-dried powder injection has the advantages of low related substances, stable quality, easy transportation and storage and high safety.

Description

field of invention [0001] The invention relates to thiamphenicol hydrochloride glycinate freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Thiamphenicol is also called thiamycin, and its chemical name is 1-p-methylsulfonyl-phenyl-2-dichloroacetamide-1,3 propanediol. Its structure is similar to chloramphenicol. It is a broad-spectrum antibacterial drug synthesized in 1952. Its antibacterial spectrum is basically similar to that of chloramphenicol. However, due to its poor water solubility, the dosage form is limited. Currently, the thiamphenicol preparations widely used clinically are all solid preparations, such as tablets, capsules and the like. [0003] Thiamphenicol hydrochloride glycinate is a derivative of thiamphenicol and a congener of chloramphenicol. Its antibacterial spectrum and antibacterial effect are similar to those of chloramphenicol, and it has a broad-spectrum antimi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/223A61P31/04
Inventor 张建立曹相林蔡刚李海冰吴王民
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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