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Arbidol hydrochloride injection preparation and preparation method thereof

A technology for arbidol hydrochloride and injection, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of low absolute bioavailability, short duration of drug effect, Short biological half-life and other issues, to achieve the effect of being convenient for clinical use, prolonging the administration time, and lasting for a long time

Inactive Publication Date: 2020-01-10
河南合智医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the drug is rapidly absorbed orally, with a short biological half-life, low absolute bioavailability, and short duration of drug effect
Arbidol hydrochloride is administered intravenously, and there is a phenomenon of unstable compatibility with glucose injection and normal saline, and there is a high risk of cross-contamination during clinical use

Method used

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  • Arbidol hydrochloride injection preparation and preparation method thereof
  • Arbidol hydrochloride injection preparation and preparation method thereof
  • Arbidol hydrochloride injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] 1) Prescription composition (1000 prescriptions)

[0032]

[0033] 2) Preparation process:

[0034] (1) Measure the phosphate buffer solution with a pH value of 2.0 of 30% of the prescription quantity in the liquid mixing tank;

[0035] (2) Add the propylene glycol of prescription quantity and make stirring, then slowly and evenly add the Arbidol hydrochloride of prescription quantity and make it fully dissolve;

[0036] (3) Adjust the pH value to 2.3, add 0.1% (w / v) activated carbon and stir evenly, keep the temperature at 60°C±5°C, and adsorb for 30 minutes;

[0037] (4) Decarburization, after detecting the content and pH of the filtrate, add a phosphate buffer solution with a pH value of 2.0, filter the solution through a two-stage 0.22-micron microporous membrane, and then fill it in a container that has been sterilized at >350°C for >5 minutes ampoule.

[0038] (5) Sterilization, water bath sterilization at 115°C for 30 minutes.

Embodiment 2

[0040] 1) Prescription composition (1000 prescriptions)

[0041]

[0042] 2) Preparation process:

[0043] (1) Measure 30% of the prescription amount of phosphate buffer solution with a pH value of 2.5 in the liquid mixing tank;

[0044] (2) Add the propylene glycol of prescription quantity and make stirring, then slowly and evenly add the Arbidol hydrochloride of prescription quantity and make it fully dissolve;

[0045] (3) Adjust the pH value to 2.7, add 0.1% (w / v) activated carbon, stir evenly, and keep the temperature at 60°C±5°C for 30 minutes;

[0046] (4) Decarburization, after detecting the content and pH of the filtrate, add a phosphate buffer solution with a pH value of 2.5, filter the solution through a two-stage 0.22 micron microporous membrane, and then fill it in a container that has been sterilized at >350°C for >5 minutes ampoule.

[0047] (5) Sterilization, water bath sterilization at 115°C for 30 minutes.

Embodiment 3

[0049] 1) Prescription composition (1000 prescriptions)

[0050]

[0051] 2) Preparation process:

[0052] (1) Measure the phosphate buffer solution with a pH value of 2.0 of 30% of the prescription quantity in the liquid mixing tank;

[0053] (2) Add the propylene glycol of prescription quantity and make stirring, then slowly and evenly add the Arbidol hydrochloride of prescription quantity and make it fully dissolve;

[0054] (3) Adjust the pH value to 2.2, add 0.1% (w / v) activated carbon, stir evenly, and keep the temperature at 60°C±5°C for 30 minutes;

[0055] (4) Decarburization, after detecting the content and pH of the filtrate, add a phosphate buffer solution with a pH value of 2.0, filter the solution through a two-stage 0.22-micron microporous membrane, and then fill it in a container that has been sterilized at >350°C for >5 minutes ampoule.

[0056] (5) Sterilization, water bath sterilization at 115°C for 40 minutes.

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Abstract

The invention discloses an arbidol hydrochloride injection preparation. The injection preparation is prepared from an active ingredient arbidol hydrochloride, a pharmaceutically acceptable co-solventand a buffer solution. The invention further discloses a preparation method of the arbidol hydrochloride injection preparation. The preparation method comprises the following steps: adding the buffersolution and the co-solvent, performing uniform stirring, and slowly and uniformly adding arbidol hydrochloride into the mixture to sufficiently dissolve the arbidol hydrochloride in the mixture; adjusting the pH value of the mixture, adding activated carbon into the mixture, and performing uniform stirring; performing decarbonization, filtering filtrate through a microfiltration membrane, fillinga sterilized ampoule with the filtrate, and sealing the sterilized ampolue; and finally, performing water-bath sterilization. The arbidol hydrochloride injection preparation is applicable to intramuscular injection and is mainly used for preventing and treating type A and type B influenza and other acute respiratory virus infections. The injection preparation can be used for improving the bioavailability of the arbidol hydrochloride, prolonging the administration time, effectively reducing cross contamination, improving the stability of the injection preparation and facilitating clinical application.

Description

technical field [0001] The invention relates to an injection dosage form of arbidol hydrochloride. [0002] The present invention also relates to a preparation method of an injection dosage form, in particular to a preparation method of an injection dosage form of arbidol hydrochloride. Background technique [0003] Arbidol hydrochloride is a new type of anti-influenza medicine, and it is mainly used as a high-efficiency drug for preventing and treating type A and type B influenza and other acute respiratory virus infections. [0004] Antiviral pharmacology is manifested in immune regulation and anti-influenza effects. It has special effects on eliminating influenza A and B viruses, can hinder virus contact and penetration into cells, and eliminate the combination of lipid membrane viruses and cell membranes. It can interfere with and induce stimulation of liquid cell immunity and phagocytosis of macrophages, improve tissue resistance to viral infection, reduce complicatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/12A61K47/18A61K31/4045A61P31/16A61P11/00
CPCA61K9/0019A61K9/08A61K31/4045A61K47/02A61K47/12A61K47/186A61P11/00A61P31/16
Inventor 王宇丰李大可王玉玲
Owner 河南合智医药科技有限公司
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