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Disinfection preparation containing levorotatory folinic acid sodium

A technology of sodium levofolinate and sodium sulfite, which can be used in medical preparations containing active ingredients, organic active ingredients, drug delivery and other directions, and can solve problems such as side effects, slow infusion of calcium levofolinate, and usage and dosage restrictions.

Inactive Publication Date: 2012-10-24
NANJING HEALTHNICE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Among them, the preparation of calcium leucovorin has low solubility in calcium salt, so it is not easy to make high-concentration preparations, and its usage and dosage are limited; on the other hand, excessive calcium ion concentration in plasma may cause unnecessary side effects. Therefore, leucovorin often requires slow infusion

Method used

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  • Disinfection preparation containing levorotatory folinic acid sodium
  • Disinfection preparation containing levorotatory folinic acid sodium
  • Disinfection preparation containing levorotatory folinic acid sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] prescription:

[0017]

[0018] Preparation process: Weigh the prescribed amount of sodium sulfite and dissolve it in an appropriate amount of water for injection, add the prescribed amount of levofolinic acid and stir evenly, slowly add 5% sodium hydroxide solution until the solution is clear, add an appropriate amount of pH regulator to adjust the pH value to 6.5- 8.5, add 0.1% activated carbon for needles, stir evenly, decarbonize by filtration, add water for injection to a sufficient amount, fill, inject nitrogen, seal, put in a sterilizer and sterilize with damp heat at 121°C for 8 minutes, and the product is ready.

Embodiment 2

[0020] prescription:

[0021]

[0022] Preparation process: Weigh the prescribed amount of sodium sulfite and dissolve it in an appropriate amount of water for injection, add the prescribed amount of levofolinic acid and stir evenly, slowly add 5% sodium hydroxide solution until the solution is clear, add an appropriate amount of pH regulator to adjust the pH value to 6.5- 8.5, add 0.1% activated carbon for needles, stir evenly, decarbonize by filtration, add water for injection to a sufficient amount, fill, inject nitrogen, seal, put in a sterilizer and sterilize with damp heat at 121°C for 8 minutes, and the product is ready.

Embodiment 3

[0024] prescription:

[0025]

[0026] Preparation process: Weigh the prescribed amount of sodium metabisulfite and dissolve it in an appropriate amount of water for injection, add the prescribed amount of levofolinic acid and stir evenly, slowly add 5% sodium hydroxide solution until the solution is clear, add an appropriate amount of pH regulator to adjust the pH value to 6.5 -8.5, add 0.1% activated carbon for needles, stir evenly, filter to decarbonize, add water for injection to a sufficient amount, fill, inject nitrogen, seal, put in a sterilizer and sterilize with damp heat at 121°C for 8 minutes, and the product is ready.

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Abstract

The present invention relates to a disinfection preparation containing levorotatory folinic acid sodium and a preparation method thereof. The levorotatory folinic acid sodium is a pharmaceutical composition, which is prepared from a main component of levorotatory folinic acid sodium and pharmaceutically acceptable excipients. The disinfection preparation has advantage that an injection disinfection preparation with high level of sterility assurance is prepared by addition of pharmaceutically acceptable stabilizer and inert gas protection and through terminal disinfection process.

Description

technical field [0001] The invention relates to a preparation method of a sterilized preparation containing sodium levofolinate, which is mainly used as an antidote for treating anemia and used in combination with antineoplastic drugs. Background technique [0002] Malignant tumors have become one of the most common diseases in our country. With the aging of the population and the deterioration of the environment, the incidence and mortality of malignant tumors will continue to increase. With the development of chemotherapy, radiotherapy and other treatment methods, the five-year survival rate of cancer patients is increasing year by year. At present, chemotherapy is one of the main means of comprehensive treatment of tumors. With the continuous emergence of new chemotherapy drugs and adjuvant chemotherapy drugs, how to reasonably select and match various anti-tumor drugs is crucial to improving the cure rate, prolonging the survival period of patients, and improving the su...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/519A61P35/00A61P7/06
Inventor 邹巧根王宏响
Owner NANJING HEALTHNICE MEDICAL TECH
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