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Ramosetron hydrochloride/L-valine acid compound injection

A technology of ramosetron hydrochloride and valine, which is applied in the field of chemical medicine, can solve problems such as effectiveness impact, achieve good stability, solve stability problems, and reduce dosage

Inactive Publication Date: 2016-08-10
李香
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Intravenous injection of 0.3mg for adults, once a day, if the dosage is reduced in order to reduce the occurrence of adverse reactions, its effectiveness will be affected

Method used

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  • Ramosetron hydrochloride/L-valine acid compound injection
  • Ramosetron hydrochloride/L-valine acid compound injection
  • Ramosetron hydrochloride/L-valine acid compound injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A kind of ramosetron hydrochloride / L-valine compound injection of the present invention, prescription is as follows:

[0024]

[0025] The preparation method of above-mentioned compound injection, concrete steps comprise:

[0026] (1) Dissolve hydroxypropyl-β-cyclodextrin in water for injection of 30% formula quantity, then add ramosetron hydrochloride while stirring, and continue to stir for 20 minutes to obtain ramosetron hydrochloride hydroxypropyl- β-cyclodextrin inclusion complex solution;

[0027] (2) Add L-valine to the clathrate solution obtained in step (1), stir to make it dissolve completely;

[0028] (3) Adjust the pH to 6.5 with a sodium hydroxide solution with a mass concentration of 20%, use activated carbon to adsorb pyrogens (add activated carbon for injection, stir at 80°C for 20 minutes, then filter to remove carbon), add the remaining water for injection , filtered through a 0.22μm filter membrane, potted (0.1mg per bottle: 250mL), steam sterili...

Embodiment 2

[0030] A kind of ramosetron hydrochloride / L-valine compound injection of the present invention, prescription is as follows:

[0031]

[0032] The preparation method of above-mentioned compound injection, concrete steps comprise:

[0033] (1) Dissolve hydroxypropyl-β-cyclodextrin in water for injection of 50% formula quantity, then add ramosetron hydrochloride while stirring, and continue to stir for 40 minutes to obtain ramosetron hydrochloride hydroxypropyl- β-cyclodextrin inclusion complex solution;

[0034] (2) Add L-valine to the clathrate solution obtained in step (1), stir to make it dissolve completely;

[0035] (3) Adjust the pH to 7.0 with a sodium hydroxide solution with a mass concentration of 20%, use activated carbon to adsorb pyrogens (add activated carbon for injection, stir at 80°C for 20 minutes, then filter to remove carbon), add the remaining water for injection , filtered through a 0.22μm filter membrane, potted (0.1mg per bottle: 250mL), steam sterili...

Embodiment 3

[0037] A kind of ramosetron hydrochloride / L-valine compound injection of the present invention, prescription is as follows:

[0038]

[0039] The preparation method of above-mentioned compound injection, concrete steps comprise:

[0040] (1) Dissolve hydroxypropyl-β-cyclodextrin in water for injection of 30% formula quantity, then add ramosetron hydrochloride while stirring, and continue to stir for 40 minutes to obtain ramosetron hydrochloride hydroxypropyl- β-cyclodextrin inclusion complex solution;

[0041] (2) Add L-valine to the clathrate solution obtained in step (1), stir to make it dissolve completely;

[0042] (3) Adjust the pH to 6.5 with a sodium hydroxide solution with a mass concentration of 20%, use activated carbon to adsorb pyrogens (add activated carbon for injection, stir at 80°C for 20 minutes, then filter to remove carbon), add the remaining water for injection , filtered through a 0.22μm filter membrane, potted (0.1mg per bottle: 250mL), steam sterili...

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Abstract

The invention discloses a ramosetron hydrochloride / L-valine acid compound injection which uses ramosetron hydrochloride and L-valine acid as main drugs; hydroxypropyl-beta-cyclodextrin is used for clathration of ramosetron hydrochloride, wherein the substance amount ratio of the main drugs to hydroxypropyl-beta-cyclodextrin is 1:(5-8), and the substance amount ratio of ramosetron hydrochloride to L-valine acid is 1:(6-9). According to the invention, hydroxypropyl-beta-cyclodextrin is used for clathration of ramosetron hydrochloride, and then the obtained clathrate compound and L-valine acid are made into the compound injection; through the synergistic effect of ramosetron hydrochloride and L-valine acid, the therapeutic effect of relieving emeses caused by chemotherapeutic drugs is enhanced, and adverse drug reactions are greatly reduced. Moreover, hydroxypropyl-beta-cyclodextrin for clathration effectively solves the problem about stability.

Description

technical field [0001] The invention relates to an injection, in particular to a ramosetron hydrochloride / L-valine compound injection. It belongs to the technical field of chemical medicine. Background technique [0002] Because platinum, doxorubicin and other anti-tumor drugs will cause severe vomiting during the use, acute and severe nausea and vomiting may lead to dehydration, electrolyte imbalance and malnutrition in patients, and severe cases may lead to chemotherapy reduction or Termination of treatment will seriously affect the therapeutic effect. [0003] Ramosetron hydrochloride is widely used clinically to prevent or treat gastrointestinal symptoms such as nausea and vomiting caused by chemotherapy drugs, but ramosetron hydrochloride is unstable under light, humidity and heat conditions. [0004] In addition, the safety evaluation of ramosetron hydrochloride was carried out before marketing, and the adverse reactions mainly included body heat, headache, and heavy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4184A61K31/198A61K9/08A61K47/48A61P35/00A61P1/08
CPCA61K9/0019A61K9/08A61K31/198A61K31/4184A61K2300/00
Inventor 李香
Owner 李香
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