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Levofolinic acid freeze-dried powder injection for injection and production method thereof

A technology of levofolinic acid and freeze-dried powder injection, applied in the field of medicine, can solve the problems of complex freeze-drying process, long cycle, high energy consumption, etc., and achieve the effect of high content, reduced dosage, and reduced impurity content

Pending Publication Date: 2021-03-12
NANJING HEALTHNICE MEDICAL TECH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-drying process in this patent is more complicated, there are repeated pre-freezing operations, the cycle is longer, more than 40h, and the energy consumption is high

Method used

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  • Levofolinic acid freeze-dried powder injection for injection and production method thereof
  • Levofolinic acid freeze-dried powder injection for injection and production method thereof
  • Levofolinic acid freeze-dried powder injection for injection and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] A levofolinic acid freeze-dried powder for injection, which is prepared from raw material levofolinic acid, sodium hydroxide and water for injection at a temperature of 10°C, sterilized and filtered, filled, and freeze-dried to obtain a finished product. Wherein, during the preparation process of the medicinal liquid, the pH value thereof is adjusted to 8.0 with a pH regulator, and each 1000 parts of the medicinal liquid contains the following components by weight: 50 parts of the active raw material levofolinic acid, hydrogenated Sodium 8 parts.

[0041] The detailed preparation process is as follows:

[0042] (1) Add a total of 80% of water for injection at 10°C in the liquid preparation tank, start stirring and continue to fill with nitrogen for protection, until the residual oxygen in the solution is less than 10ppm, add 50 parts of the raw material levofolinic acid and sodium hydroxide in sequence , wherein the levofolinic acid needs to be dispersed completely bef...

Embodiment 2

[0054] A levofolinic acid freeze-dried powder injection for injection, which is prepared from raw material levofolinic acid, sodium hydroxide and water for injection at a temperature of 20°C, sterilized and filtered, filled, and freeze-dried to obtain a finished product. Wherein, during the preparation process of the medicinal liquid, the pH value thereof is adjusted to 8.0 with a pH regulator, and each 1000 parts of the medicinal liquid contains the following components by weight: 50 parts of the active raw material levofolinic acid, hydrogenated Sodium 8 parts.

[0055] The detailed preparation process is as follows:

[0056] (1) Add a total of 80% of water for injection at 20°C in the liquid preparation tank, start stirring and continue to fill with nitrogen for protection, until the residual oxygen in the solution is less than 10ppm, add 50 parts of the raw material levofolinic acid and sodium hydroxide in sequence , wherein the levofolinic acid needs to be dispersed comp...

Embodiment 3

[0064] Except that freeze-drying process is different from embodiment 2, other content is identical with embodiment 2, and the process of freeze-drying is specifically as follows:

[0065] (1) The filled liquid medicine is fed at 15°C;

[0066] (2) Continue to cool down to -40°C and keep for 3 hours;

[0067] (3) Control the vacuum degree to 0.01Mpa~0.05Mpa, raise the temperature to -5°C, the heating time is 3 hours, and the holding time is 8 hours;

[0068] (4) Control the vacuum degree to 0.01Mpa-0.05Mpa, raise the temperature to 30°C, the heating time is 3 hours, and the holding time is 18 hours.

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Abstract

The invention relates to a levofolinic acid freeze-dried powder injection for injection and a production method thereof. The levofolinic acid freeze-dried powder injection for injection is prepared bythe following steps: preparing bulk drugs levofolinic acid, sodium hydroxide and water for injection into a liquid medicine at 10 to 20 DEG C, sterilizing, filtering, filling and freeze-drying to obtain the finished product. According to the invention, mannitol serving as an auxiliary material is not adopted, so that the dosage of the auxiliary material is reduced, the whole liquid medicine preparation process is controlled at a relatively low temperature, and damage of high temperature to bulk drugs is effectively avoided; sodium hydroxide is added as a cosolvent, and is salified and dissolved with the bulk drugs to obtain sodium levofolinate, so that the solubility of the bulk drugs is improved, and the medicine effect can be fully exerted. By adopting the freeze-drying process providedby the invention, repeated pre-freezing treatment is not needed, so that uniform freezing of the liquid medicine is ensured, the content of impurities in the liquid medicine is reduced, sublimation drying is facilitated, most of water in the product is removed, the freeze-drying period is remarkably shortened, the moisture content of the freeze-dried product is low, and the stability of the product is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried levofolinic acid powder for injection and a production method thereof. Background technique [0002] Levofolinic acid is mainly used to reduce the toxicity of folic acid antagonists such as methotrexate in cytotoxic therapy in adults and children, counteract their effects, and can also be used for overdose of folic acid antagonists in adults and children. [0003] There are currently two types of products on the market, one is the levofolinic acid injection that was launched by MEDAC in March 2008 at the British Medicines and Health Products Regulatory Authority. The levofolinic acid injection exists in the form of a solution and has poor stability. And it requires low temperature storage conditions of 2-8°C; one is levofolinic acid for injection, which was launched by Spectrum in the United States in October 2018, and the excipients are mannitol, sodi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/519A61K47/02A61K47/04A61P3/02
CPCA61K9/19A61K9/0019A61K31/519A61K47/02A61P3/02
Inventor 石文晶蔡信用王华娟辛妮
Owner NANJING HEALTHNICE MEDICAL TECH
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