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

A technology of tetracaine hydrochloride and a composition, applied in the field of medicine, can solve the problems of inability to judge the nitrogen charged, the product quality is difficult to guarantee, cannot be detected quickly, etc., so as to meet the needs of large-scale production, the product quality is good, and the product quality is avoided. Unstable quality effects

Active Publication Date: 2015-07-15
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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Tetracaine hydrochloride for injection (in 1000 bottles, unit: g)

[0028] tetracaine hydrochloride

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

Embodiment 2

[0030] Example 2: Tetracaine hydrochloride for injection (calculated in 1000 bottles, unit: g)

[0031] tetracaine hydrochloride

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

Embodiment 3

[0033] Example 3: Prescription of Tetracaine Hydrochloride for Injection (calculated in 1000 bottles, unit: g)

[0034] tetracaine hydrochloride

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

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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 pharmaceutical composition of tetracaine hydrochloride 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 peripheral nerves, stabilizes the cell membrane of nerve tissue, reduces the influx of sodium ions, blocks the normal polarization and depolarization alternately, prevents nerve impulse transmission, and plays an analgesic effect. . Clinically, it is mainly used for surface local anesthesia, nerve conduction block and spinal canal block. The dosage forms of the marketed products include injection and lyophilized powder for injection. Because tetracaine hydrochloride injection is unstable, it will decompose or precipitate out if it is placed for a long time, so it is particularly import...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/12A61K31/245
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD