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A kind of freeze-drying treatment method of calcium folinate freeze-dried powder injection

A technology of freeze-dried powder injection and calcium folinate, which is applied in the direction of freeze-drying transportation, drying, powder transportation, etc., can solve the problem of poor resolubility of calcium folinate freeze-dried powder injection, and achieve good resolubility and stability , not easy to pollute, simple freeze-drying treatment method

Active Publication Date: 2018-01-19
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The freeze-drying treatment method of the calcium folinate freeze-dried powder injection of the present invention can not only effectively avoid the phenomenon of poor freeze-dried appearance of the preparation, but also solve the problem of poor resolubility of the freeze-dried calcium folinate powder injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Adjust the pH value of the calcium folinate solution with a concentration of 50mg / ml to 6.0 with 0.1mol / L sodium hydroxide solution, add activated carbon, place it in a water bath at 80°C for 10 minutes, cool it rapidly to 30°C, and then decarbonize it. After filtering, the treated calcium folinate solution is obtained, and the temperature of the eutectic point of the treated calcium folinate solution is -15°C.

Embodiment 2

[0029] Adjust the pH value of the calcium folinate solution with a concentration of 50mg / ml to 9.0 with 0.1mol / L sodium hydroxide solution, add activated carbon, place it in a water bath at 80°C for 10 minutes, cool it rapidly to 30°C, and then decarbonize it. After filtering, the treated calcium folinate solution is obtained, and the temperature of the eutectic point of the treated calcium folinate solution is -15°C.

Embodiment 3

[0031] (1) Fill 2 ml of the treated calcium folinate solution in Example 1 with a eutectic temperature of -15°C and a concentration of 50 mg / ml into a 5 ml vial, and complete the half stoppering work;

[0032] (2) Put it into a freeze dryer at 0°C, drop the temperature from 0°C to -45°C within 2 hours and 10 minutes, and keep it at -45°C for 2 hours for pre-freezing; then perform sublimation drying , the vacuum during the whole sublimation drying process is 300e -3 mbar, the temperature of the cold trap used is below -50°C. The specific steps are: raise the temperature to -22°C within 1 hour, and keep it at -22°C for 1.5 hours, raise the temperature to -17°C within 1 hour, and keep it at -17°C for 2 hours, and keep the temperature at -22°C for 1.5 hours. Rise to -10°C within 15 minutes, and keep warm at -10°C for 10 hours until the watermark disappears completely, raise the temperature to 0°C within 30 minutes, and keep warm for 2 hours;

[0033] (3) Raise the temperature to...

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Abstract

The invention discloses a freeze-drying processing method of a calcium folinate freeze-dried powder injection for injection. The method comprises the following steps: (1) filling a processed calcium folinate solution into a 5ml penicillin bottle to finish partially stoppered operation; (2) placing the penicillin bottle into a freeze dryer at 0 DEG C, and hermetically capping an aluminum plastic combined cover to obtain the calcium folinate freeze-dried powder injection for injection bottled by the 5ml penicillin bottle after the 5ml penicillin bottle is sequentially pre-frozen, lyophilized, pressed and stopped and discharged sequentially. The calcium folinate freeze-dried powder injection for injection provided by the invention is filled by the 5ml penicillin bottle instead of a 10ml penicillin bottle, therefore the air shrinkage, bubbling and autolysis of the calcium folinate freeze-dried powder injection for injection can be prevented in the freeze drying process.

Description

technical field [0001] The invention belongs to the field of preparation of freeze-dried powder injections, in particular to a freeze-drying treatment method of calcium folinate freeze-dried powder injections. Background technique [0002] Currently commercially available calcium folinate injections are unstable, easily degraded when exposed to light, and have poor storage stability. In order to further improve the stability of calcium folinate preparations, clinical use often adopts the form of freeze-dried powder injections. [0003] Calcium folinate after freeze-drying treatment has poor resolubility when redissolved in water, and a large number of crystals are easily precipitated when placed in a low temperature environment, so that there are more tiny particles in the reconstituted preparation. Visible foreign matter, insoluble particles and unqualified clarity are easy to appear during the process, which seriously affects the normal use in clinical practice. [0004] ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/519F26B5/06
Inventor 夏春森施猛陈伙德孙大鹏钟艳红
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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