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Production process of calcium levofolinate lyophilized powder for injection

A technology of calcium levofolinate and freeze-dried powder injection, applied in the field of medicine, can solve the problems of re-contaminated product content, low content of medicinal liquid, difficult to control, etc., and achieves shortening of liquid dispensing process time, low moisture content, and favorable safety. and effective

Active Publication Date: 2018-08-14
KINDOS PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent adopts the traditional activated carbon adsorption process to reduce endotoxin, which may introduce re-pollution and cause product content to decrease; the process adjusts pH after constant volume, which may easily cause low drug content and is difficult to control

Method used

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  • Production process of calcium levofolinate lyophilized powder for injection

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Effect test

Embodiment 1

[0031] A production process of calcium levofolinate freeze-dried powder for injection, comprising the following steps:

[0032] (1) Add water for injection at 40°C in the liquid mixing tank;

[0033] (2) By mass, add 1 part of mannitol and stir until dissolved, keeping the liquid temperature at 40°C;

[0034] (3) Add 1 part of calcium levofolinate raw material and stir until dissolved, lower the temperature of the liquid medicine to 20°C, adjust the pH to 7.8, add water for injection to dilute to 1000 parts;

[0035] (4) After sterilizing and filtering, filling and freeze-drying, the preparation product is obtained.

Embodiment 2

[0037] A production process of calcium levofolinate freeze-dried powder for injection, comprising the following steps:

[0038] (1) Add water for injection at 50°C in the liquid distribution tank;

[0039] (2) By mass, add 1 part of mannitol and stir until dissolved, keeping the liquid temperature at 50°C;

[0040] (3) Add 1 part of calcium levofolinate raw material and stir until dissolved, lower the temperature of the liquid medicine to 30°C, adjust the pH to 8.2, add water for injection to dilute to 1000 parts;

[0041] (4) After sterilizing and filtering, filling and freeze-drying, the preparation product is obtained.

[0042] The endotoxin of the bulk drug is less than 0.500 EU / mg, and the endotoxin of mannitol is less than 2.5 EU / g.

[0043] Described (3) step adopts 0.05mol / L sodium hydroxide solution to adjust the pH value.

Embodiment 3

[0045] A production process of calcium levofolinate freeze-dried powder for injection, comprising the following steps:

[0046] (1) Add 90% of the demanded water for injection at 45°C in the liquid distribution tank;

[0047] (2) By mass, add 1 part of mannitol and stir until dissolved, keeping the liquid temperature at 45°C;

[0048] (3) Add 1 part of calcium levofolinate raw material and stir until dissolved, lower the temperature of the liquid medicine to 25°C, adjust the pH to 8.0, add the remaining demanded amount of water for injection and set the volume to 1000 parts;

[0049] (4) After sterilizing and filtering, filling and freeze-drying, the preparation product is obtained.

[0050] The endotoxin of the bulk drug is less than 0.500 EU / mg, and the endotoxin of mannitol is less than 2.5 EU / g.

[0051] Described (3) step adopts 0.05mol / L hydrochloric acid solution to adjust pH value.

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Abstract

The invention provides a production process of calcium levofolinate lyophilized powder for injection. The production process comprises the following steps: (1) adding 40-50-DEG C water for injection in a liquid preparation tank; (2) adding 1 part by mass of mannitol, stirring until dissolving, and keeping the temperature of liquid medicine to 40-50 DEG C; (3) adding 1 part of calcium levofolinateraw medicine, stirring until dissolving, reducing the temperature of the liquid medicine to 20-30 DEG C, regulating pH to 7.8-8.2, and adding the water for injection and setting the volume to 1000 parts; and (4) performing sterilization and filtration, filling and freeze-drying, thereby obtaining the preparation product. Through the adoption of the production process, the impurity level in the finished product can be effectively controlled, so that the calcium levofolinate lyophilized powder is superior to a commercial original drug in the USA.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a production process of calcium levofolinate freeze-dried powder for injection. Background technique [0002] Calcium levofolinate for injection is often used clinically to prevent severe toxic effects caused by methotrexate overdose or high-dose treatment. When oral folic acid is not effective, it is also used for sprue, malnutrition, megaloblastic anemia caused by pregnancy or infancy, but it is not suitable for vitamin B12 deficiency anemia. In recent years, calcium folinate has also been used as an adjuvant therapy for colon and rectal cancer, and combined with fluorouracil, it can prolong the survival period. [0003] Invention patent CN03121530.0 discloses an injection of calcium levofolinate, which contains mannitol, dextran, glucose, sodium chloride, hydrolyzed protein, at least one auxiliary material, water for injection as a solvent, and the main drug and The weight ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/519A61K47/10A61P39/02A61P1/12A61P1/14A61P7/06A61P35/00F26B5/06
Inventor 屈倩倩史宣宇李方年田欣欣
Owner KINDOS PHARM CO LTD
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