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Epirubicin hydrochloride lyophilized injectable powder and preparation method thereof

A technology of epirubicin hydrochloride and freeze-dried powder for injection, which is applied in the field of epirubicin hydrochloride for injection freeze-dried powder for injection and its preparation field, can solve problems such as potential safety hazards, improve safety, avoid allergies, Good reconstituted effect

Active Publication Date: 2013-04-03
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] ①The excipient used is lactose, but currently there is no injectable grade of lactose in the world
Most pharmaceutical manufacturers use lactose as an auxiliary material for injections after refining, but there are still certain safety hazards. The State Food and Drug Administration of China is cautious about the use of lactose in injections

Method used

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  • Epirubicin hydrochloride lyophilized injectable powder and preparation method thereof
  • Epirubicin hydrochloride lyophilized injectable powder and preparation method thereof
  • Epirubicin hydrochloride lyophilized injectable powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Preparation of Epirubicin Hydrochloride Lyophilized Powder for Injection

[0023]

[0024] Preparation Process:

[0025] Weigh the prescribed amount of epirubicin hydrochloride and mannitol, dissolve in about 60% of the prepared volume of water for injection, add 0.1% (w / v) activated carbon for needles according to the mass volume ratio, stir for 20 minutes, decarbonize and filter to The liquid medicine is clarified.

[0026] Add water for injection to the full amount, stir evenly, adjust the pH value to 4.5 with a pre-prepared 0.1M hydrochloric acid / sodium hydroxide solution, filter the liquid medicine through 0.45 μm and 0.22 μm microporous membranes in turn, and fill the filtrate after testing In vials, each bottle is filled with about 1ml, half stoppered, and placed in a freeze-drying box.

[0027] Freeze-drying: Turn on the freeze-dryer, lower the freeze-drying shelf to -40°C~-50°C, wait for the product temperature to drop to -40°C, pre-freeze and keep warm fo...

Embodiment 2

[0029] Preparation of Epirubicin Hydrochloride Lyophilized Powder for Injection

[0030]

[0031] Preparation Process:

[0032] Weigh the prescribed amount of epirubicin hydrochloride and mannitol, dissolve in about 60% of the prepared volume of water for injection, add 0.1% (w / v) activated carbon for needles according to the mass volume ratio, stir for 20 minutes, decarbonize and filter to The liquid medicine is clarified.

[0033] Add water for injection to the full amount, stir evenly, adjust the pH value to 5.2 with a pre-prepared 0.1M hydrochloric acid / sodium hydroxide solution, filter the liquid medicine through 0.45 μm and 0.22 μm microporous membranes in turn, and fill the filtrate after testing In vials, each bottle is filled with about 1ml, half stoppered, and placed in a freeze-drying box.

[0034] Freeze-drying: Turn on the freeze-dryer, lower the freeze-drying shelf to -40°C~-50°C, wait for the product temperature to drop to -40°C, and pre-freeze for about 4 ...

Embodiment 3

[0036] Preparation of Epirubicin Hydrochloride Lyophilized Powder for Injection

[0037]

[0038] Preparation Process:

[0039] Weigh the prescribed amount of epirubicin hydrochloride and mannitol, dissolve in about 60% of the prepared volume of water for injection, add 0.1% (w / v) activated carbon for needles according to the mass volume ratio, stir for 20 minutes, decarbonize and filter to The liquid medicine is clarified.

[0040] Add water for injection to the full amount, stir evenly, adjust the pH value to 6.0 with a pre-prepared 0.1M hydrochloric acid / sodium hydroxide solution, filter the liquid medicine through 0.45μm and 0.22μm microporous membranes in turn, and fill the filtrate after testing In vials, each bottle is filled with about 1ml, half stoppered, and placed in a freeze-drying box.

[0041] Freeze-drying: Turn on the freeze-dryer, lower the freeze-drying shelf to -40°C~-50°C, wait for the product temperature to drop to -40°C, and pre-freeze for about 5 ho...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and provides epirubicin hydrochloride lyophilized injectable powder and a preparation method of the epirubicin hydrochloride lyophilized injectable powder. According to the preparation method, mannitol is adopted and used as a propping agent during preparing the epirubicin hydrochloride lyophilized injectable powder, the pH (Potential of Hydrogen) of the liquid medicine is adjusted to 4.5 to 6.0 by hydrochloric acid or sodium hydroxide solution, and therefore, the hydrolyzing of the main medicine is inhibited, and the stability of the main medicine is improved; the pre-freezing temperature is controlled to below -40 DEG C, and the sublimation temperature in lyophilization is controlled to -15 DEG C, and as a result, the stability of the medicine can be improved. The prepared epirubicin hydrochloride lyophilized injectable powder is stable, and can prevent the human body from damage due to the anaphylaxis of lactose in an original preparation and preservative methylparaben, thus the safety of the epirubicin hydrochloride lyophilized injectable powder can be improved.

Description

technical field [0001] The invention relates to a new pharmaceutical preparation, in particular to a freeze-dried powder preparation of epirubicin hydrochloride for injection and a preparation method thereof. Background technique [0002] Epirubicin is an isomer of doxorubicin, and its mechanism of action is to intercalate directly between DNA base pairs, interfere with the transcription process, prevent the formation of mRNA, and thus inhibit the synthesis of DNA and RNA. In addition, epirubicin hydrochloride also has an inhibitory effect on topoisomerase Ⅱ, which is a cell cycle non-specific drug and is effective for a variety of transplanted tumors. Compared with doxorubicin, the efficacy is equal or slightly higher, but the toxicity to the heart is less. [0003] Epirubicin hydrochloride currently on the market at home and abroad is all injections, including freeze-dried powder injections (10 mg and 50 mg) and injections. The injections are easy to degrade during steril...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/704A61K47/26A61P35/00A61P31/00
Inventor 赵志全石其德孙建合
Owner SHANDONG NEWTIME PHARMA
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