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Freeze-dried ribavirin powder injection for injection and preparation method thereof

A technology for freeze-dried powder injection and ribavirin, which is applied in the field of medicine and its preparation, can solve the problems of high technical content requirements, complex operation process, long production cycle and the like, and achieves low technical requirements, uniform product quality and high production efficiency. short cycle effect

Inactive Publication Date: 2018-03-23
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, most of the clinically used ribavirin dosage forms are injection dosage forms. Among them, water injections are widely used due to their fast-acting and easy-to-preparation characteristics. For example, Chinese patent CN201410628733.X discloses a long-acting Ribavirin pharmaceutical composition injection, however, compared with water injection, freeze-dried powder injection not only has good curative effect, but also has advantages in transportation, storage, etc., and although there are some existing technologies for ribavirin Research on freeze-drying process and formula, but the formula and preparation method of freeze-dried powder injection in the prior art generally have problems such as long production cycle, low output, complicated operation process, and high technical content requirements

Method used

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  • Freeze-dried ribavirin powder injection for injection and preparation method thereof
  • Freeze-dried ribavirin powder injection for injection and preparation method thereof
  • Freeze-dried ribavirin powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] 1. Prescription

[0027]

[0028]

[0029] 2. Production process

[0030] 2.1 Control the cleaning and sterilization of antibiotic glass bottles

[0031] Controlled antibiotic glass bottles are removed from the outer packaging, passed into the bottle washing and drying room, cleaned by a bottle washing machine, dried with compressed air, dried and sterilized in a hot air tunnel oven at 310°C to 340°C for 5 minutes, and cooled.

[0032] 2.2 Cleaning and sterilization of butyl rubber

[0033] The butyl rubber stoppers are removed from the outer packaging and sent to the stopper washing room, cleaned by a stopper washing machine, sterilized by dry heat at 121°C for 30 minutes, and cooled for later use.

[0034] 2.3 Sterilization of aluminum-plastic combination caps

[0035] The aluminum-plastic cover is removed from the outer packaging, and then transferred to the aluminum cover sterilization room, sterilized in a dry box at 121°C for 30 minutes, cooled, and set a...

Embodiment 2

[0047] The difference between the present embodiment and embodiment 1 is that the prescription is different, and the prescription of the present embodiment is as follows:

[0048]

Embodiment 3

[0050] The difference between the present embodiment and embodiment 1 is that the prescription is different, and the prescription of the present embodiment is as follows:

[0051]

[0052] Stability study

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PUM

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Abstract

The invention provides a ribavirin freeze-dried powder for injection, which is formed by freeze-drying a ribavirin drug solution, the pH of the ribavirin drug solution is 4.5-5.5, and every 2000mL of the ribavirin Lin drug solution contains: ribavirin 80‑120g, lactose 12‑18g, glycerin 4‑6g, trehalose 18‑22g, vitamin C7‑12g, edetate sodium calcium 2‑5g, appropriate amount of pH regulator, and water margin. Appropriate auxiliary materials are added to the formula of the present invention, and the synergistic effect of each component can improve the appearance shape and porosity of the freeze-dried product of the present invention, and make the surface of the product more smooth, and at the same time, the properties of the drug are also more stable, which is convenient for the preparation of the drug. Storage and transportation. Moreover, the preparation process is simple, the technical requirements are not high, the production cycle is relatively short, the quality of the prepared product is stable and controllable, and it is beneficial to long-term storage.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a ribavirin freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Ribavirin: Chemical name: 1-β-D-ribofuranosyl-1H-1,2,4,-triazole-3-carboxamide, also known as ribavirin, ribavirin, Niscor, etc. , Ribavirin is a synthetic nucleoside antiviral drug. In vitro cell culture experiments showed that ribavirin has a selective inhibitory effect on respiratory syncytial virus (RSV). Ribavirin is a prodrug that interferes with the metabolism of RNA required for viral replication when the microbial genetic carrier resembles nucleotides of purine RNA. It is a broad-spectrum and powerful antiviral drug, which is widely used in the prevention and treatment of viral diseases. Common dosage forms include injections, tablets, oral liquids, aerosols, etc. [0003] At present, most of the clinically used ribavirin dosage forms are injecti...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K47/10A61K47/22A61K47/18A61K31/7056A61P31/12
CPCA61K9/0019A61K9/19A61K31/7056A61K47/10A61K47/183A61K47/22A61K47/26
Inventor 符成龙杨杰史秋萍陈玉珠符永红
Owner HAINAN GENERAL & KANGLI PHARMA
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