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Sugammadex sodium freeze-dried powder injection and preparation method thereof

A technology of sugammadex sodium and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of high and low degradation impurities, and achieve the effects of high clarity, short reconstitution time and high stability

Pending Publication Date: 2021-10-01
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Studies have found that oxygen is the protective agent of carbon-sulfur bonds in the process of high-temperature sterilization. Sugammadex Sodium Injection is sterilized under high-temperature conditions. Or when the oxygen concentration is low, Sugammadex Sodium Injection is sterilized by carbon-sulfur bonds to form sulfhydryl groups, resulting in a large amount of degraded impurities with RRT=2.04, seriously exceeding the quality standard control range

Method used

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  • Sugammadex sodium freeze-dried powder injection and preparation method thereof
  • Sugammadex sodium freeze-dried powder injection and preparation method thereof
  • Sugammadex sodium freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription

[0027]

[0028] Accurately weigh 90% of the prescribed amount of water for injection; weigh the prescribed amount of sugammadex sodium and mannitol, slowly add to the water for injection, stir until dissolved, adjust the pH value to 7.50 with hydrochloric acid, stir for about 5 minutes, filter, The filtered filtrate is filled in vials at 5ml / bottle, and half-stoppered; the freeze dryer is cooled to -40°C in advance, and the filled samples are sent to the freeze-drying box, and the vacuum in the freeze-dryer is maintained at 0.15±0.02 mbar, keep it for 3h; keep the vacuum in the freeze dryer, raise the temperature of the shelf to -25°C at 0.5°C / h, and keep it warm for 5h; then raise the temperature of the shelf to -5°C at a rate of 1.5°C / h, and release the vacuum in the freeze dryer To standard atmospheric pressure, keep warm for 6 hours; vacuumize the freeze dryer and maintain 0.10±0.02mbar, then raise the shelf temperature to 20℃ at 2.0℃ / h, keep warm ...

Embodiment 2

[0030] prescription

[0031]

[0032] Accurately weigh 90% of the prescribed amount of water for injection; weigh the prescribed amount of sugammadex sodium and mannitol, slowly add to the water for injection, stir until dissolved, adjust the pH value to 7.47 with hydrochloric acid, stir for about 5 minutes, filter, The filtered filtrate is filled in vials at 5ml / bottle, and half-stoppered; the freeze dryer is cooled to -45°C in advance, and the filled samples are sent to the freeze-drying box, and the vacuum in the freeze-dryer is maintained at 0.15±0.02 mbar, keep it for 5h; the freeze dryer maintains vacuum, the shelf temperature rises to -20°C at 0.5°C / h, and keeps warm for 6h; the shelf temperature rises to -2°C at 1.5°C / h, and releases the vacuum in the freeze dryer To standard atmospheric pressure, keep warm for 6 hours; vacuumize the freeze dryer and maintain 0.10±0.02mbar, then raise the shelf temperature to 15℃ at 2.0℃ / h, keep warm for 8h; then raise the shelf tem...

Embodiment 3

[0034] prescription

[0035]

[0036] Accurately weigh 90% of the prescribed amount of water for injection; weigh the prescribed amount of sugammadex sodium and mannitol, slowly add to the water for injection, stir until dissolved, adjust the pH value to 7.51 with hydrochloric acid, stir for about 5 minutes, filter, The filtered filtrate is filled in vials at 5ml / bottle, and half-stoppered; the freeze dryer is cooled to -42°C in advance, and the filled samples are sent to the freeze-drying box, and the vacuum in the freeze-dryer is maintained at 0.15±0.02 mbar, keep for 4 hours; the freeze dryer maintains vacuum, the shelf temperature rises to -30°C at 0.5°C / h, and keeps warm for 5h; the shelf temperature rises to -8°C at 1.5°C / h, and releases the vacuum in the freeze dryer To standard atmospheric pressure, keep warm for 7 hours; vacuumize the freeze dryer and maintain 0.10±0.02mbar, then raise the shelf temperature to 25℃ at 2.0℃ / h, keep warm for 8h; then raise the shelf t...

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Abstract

The invention relates to the technical field of medicine technology, in particular to sugammadex sodium freeze-dried powder injection and a preparation method thereof. The preparation method of the sugammadex sodium freeze-dried powder injection comprises the following steps: adding sugammadex sodium into water for injection according to a prescription dosage, and stirring until sugammadex sodium is completely dissolved; adding a prescription amount of freeze-drying protection solution into the solution, stirring until the solution is completely dissolved, adjusting the pH value, stirring, filtering, filling and freeze-drying to obtain the target product. according to the method, the sugammadex sodium freeze-dried powder injection for injection is provided, and the problems that API serving as a cyclic molecular structure is unstable, and a large number of impurities are easily generated after high-temperature sterilization are solved; inert gas (nitrogen) is filled for protection after freeze-drying is finished, so that oxygen is effectively isolated, and the prepared sugammadex sodium freeze-dried powder injection has fewer impurities and is more stable; through optimization of a freeze-drying process, the prepared freeze-dried powder is shortest in redissolution time, the clarity and insoluble particles meet the requirements, the stability is higher, and the freeze-dried powder is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a sugammadex sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Sugammadex Sodium was first developed by Organon Biosciences. In 2008, Sugammadex Sodium was launched in Europe for the first time, and then it was launched in Japan, the United States and other countries, and now it is listed in 75 countries Sale. [0003] Sugammadex sodium, chemical name 6-full deoxy-6-full (2-carboxyethyl) thio-γ-cyclodextrin sodium salt, is a modified γ-cyclodextrin; it is the first It is also the only selective muscle relaxation antagonist (SRBA), which blocks the relaxation effect by encapsulating aminosteroid non-depolarizing muscle relaxants through a new and unique pathway, and can quickly and predictably reverse rocuronium bromide and Vecuronium causes muscle relaxation of any intensity with fewer side effects, allowing the use of muscle ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/724A61K47/10A61K47/26A61K47/32A61P21/00
CPCA61K31/724A61K9/19A61K47/10A61K47/32A61K47/26A61P21/00
Inventor 贾俊伟冯中刘忠
Owner LUNAN PHARMA GROUP CORPORATION
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