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Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition

A technology of tetracaine hydrochloride and its composition, which is applied in the field of medicine, can solve problems such as the inability to judge the nitrogen gas charged, the difficulty in guaranteeing the product quality, and the inability to detect it quickly, so as to meet the needs of large-scale production, good product quality, and avoid product The effect of inconsistent quality

Active Publication Date: 2014-07-16
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since this patent uses a nitrogen filling process, the requirements for the equipment are relatively high, and the nitrogen gas charged is colorless and tasteless, and it is impossible to judge whether the nitrogen gas charged is sufficient from the appearance. If an equipment failure occurs during the preparation process and the nitrogen filling is stopped, It cannot be detected quickly, and the product quality is difficult to guarantee

Method used

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  • Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition
  • Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition
  • Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: tetracaine hydrochloride for injection (calculated in 1000 bottles, unit: g)

[0028] tetracaine hydrochloride

[0029] Preparation process: Inject 800ml of water for injection into the liquid mixing tank, first add 0.5g of tartaric acid, stir to dissolve, then add 25g of tetracaine hydrochloride, stir to completely dissolve, add 0.1% activated carbon, keep stirring at 50°C for 15 minutes, use while hot Coarse filtration with 0.45 μm microporous membrane to obtain filtrate; add water for injection to nearly full amount, adjust pH to 4.8 with 0.1mol / L hydrochloric acid solution, add water for injection to full amount; use 0.22 μm microporous membrane for fine filtration, and conduct semi-finished product inspection, After passing the test, fill 1.0ml per bottle into 3ml vials; place in a freeze-drying box, pre-freeze at -40°C for 4 hours, start vacuuming, control the vacuum between 10-30Pa, raise the temperature to -25°C and keep for 12h , heat up...

Embodiment 2

[0030] Embodiment 2: tetracaine hydrochloride for injection (based on 1000 bottles, unit: g)

[0031] tetracaine hydrochloride

[0032] Preparation process: Inject 800ml of water for injection into the liquid mixing tank, first add 2.5g of tartaric acid, stir to dissolve, then add 25g of tetracaine hydrochloride, stir to dissolve completely, add 0.1% activated carbon, keep stirring at 50°C for 15 minutes, use while hot Coarse filtration with 0.45 μm microporous membrane to obtain filtrate; add water for injection to nearly full amount, adjust pH to 5.1 with 0.1mol / L hydrochloric acid solution, add water for injection to full amount; use 0.22 μm microporous membrane for fine filtration, and conduct semi-finished product inspection, After passing the test, fill 1.0ml per bottle into 3ml vials; place in a freeze-drying box, pre-freeze at -50°C for 1 hour, start vacuuming, control the vacuum between 10-30Pa, raise the temperature to 0°C and keep for 4 hours. Raise the te...

Embodiment 3

[0033] Embodiment 3: Prescription of tetracaine hydrochloride for injection (based on 1000 bottles, unit: g)

[0034] tetracaine hydrochloride

[0035] Preparation process: Inject 800ml of water for injection into the liquid mixing tank, first add 1.0g of tartaric acid, stir to dissolve, then add 25g of tetracaine hydrochloride, stir to completely dissolve, add 0.1% activated carbon, keep stirring at 50°C for 15 minutes, use while hot Coarse filtration with 0.45 μm microporous membrane to obtain filtrate; add water for injection to nearly full amount, adjust pH to 4.9 with 0.1mol / L hydrochloric acid solution, add water for injection to full amount; use 0.22 μm microporous membrane for fine filtration, and conduct semi-finished product inspection, After being qualified, fill 1.0ml per bottle into 3ml vials; place in a freeze-drying box, pre-freeze at -40°C for 3 hours, start vacuuming, control the vacuum between 10-30Pa, raise the temperature to -15°C and keep for 6h ...

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Abstract

The invention provides a novel tetracaine hydrochloride pharmaceutical composition for injection and a preparation method of the pharmaceutical composition. A small amount of tartaric acid is used in a prescription, so that the stability of the product is remarkably improved, the product can be further stored stable for a long time under the condition of high temperature, high humidity and light, and the storage time is prolonged. The preparation process is simple and free from nitrogen charge operation, and the demand on the production equipment is reduced, so that the invention is more suitable for production on a large scale.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a tetracaine hydrochloride pharmaceutical composition for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Tetracaine hydrochloride for injection, as a local anesthetic, acts on the peripheral nerve, stabilizes the cell membrane of the nerve tissue, reduces the influx of sodium ions, blocks the normal polarization and depolarization alternately, prevents the transmission of nerve impulses, and acts as an analgesic. . Clinically, it is mainly used for surface local anesthesia, nerve conduction block and intraspinal block. The formulations of marketed products include injection and freeze-dried powder for injection. Because tetracaine hydrochloride injection is unstable, it will decompose or precipitate out when placed for a long time, so it is particularly importa...

Claims

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Application Information

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IPC IPC(8): A61K47/12A61K31/245
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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