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Rocuronium bromide injection preparation and preparation method thereof

A technology of rocuronium bromide and injection, which is applied in the field of drug preparation and achieves the effect of good stability

Pending Publication Date: 2022-04-29
杭州泓友医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In order to solve the problem that the product storage condition in the prior art is 2-8 DEG C (36 months), and only 12 weeks can be preserved under 8-30 DEG C, the object of the present invention is to provide a kind of rocuronium bromide injection preparation and its preparation method

Method used

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  • Rocuronium bromide injection preparation and preparation method thereof
  • Rocuronium bromide injection preparation and preparation method thereof
  • Rocuronium bromide injection preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0033] The rocuronium bromide injection preparation has a pH value of 2.1 and consists of the following components:

[0034] Rocuronium bromide 50mg / 5mL; the dosage of hydrogen chloride is determined by the pH value of the rocuronium bromide injection preparation; the balance is water for injection.

[0035] A preparation method for rocuronium bromide injection preparation, comprising the steps of:

[0036] S1, the pH value in the water for injection is adjusted to below 2.0 with hydrochloric acid with a hydrogen chloride concentration of 37%;

[0037] S2, putting rocuronium bromide into the solution obtained in step S1, and adjusting the pH to between 2.1 with hydrochloric acid with a hydrogen chloride concentration of 37%;

[0038] S3, the solution prepared in step S2 is adjusted to volume, and sterilized by filtering through a 0.22um filter element;

[0039] S4, filling, stoppering and capping the solution obtained in step S3;

[0040] S5, the crimped and capped product ...

Embodiment 2

[0042] The rocuronium bromide injection preparation has a pH value of 4.0 and consists of the following components:

[0043] Rocuronium bromide 50mg / 5mL; the dosage of hydrogen chloride is determined by the pH value of the rocuronium bromide injection preparation; the balance is water for injection.

[0044] A preparation method for rocuronium bromide injection preparation, comprising the steps of:

[0045] S1, the pH value in the water for injection is adjusted to below 2.0 with hydrochloric acid with a hydrogen chloride concentration of 37%;

[0046] S2, putting rocuronium bromide into the solution obtained in step S1, and adjusting the pH to 4.0 with hydrochloric acid;

[0047] S3, the solution prepared in step S2 is adjusted to volume, and sterilized by filtering through a 0.22um filter element;

[0048] S4, filling, stoppering and capping the solution obtained in step S3;

[0049] S5, the crimped and capped product is sterilized by autoclaving at 121°C for 15 minutes, an...

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Abstract

The invention discloses a rocuronium bromide injection preparation. The pH (Potential of Hydrogen) value of the rocuronium bromide injection preparation is between 2.0 and 2.2 or between 3.8 and 4.2; comprising main medicines and auxiliary materials, wherein the content of the main drug in the rocuronium bromide injection preparation is 10 mg / mL; the main drug is rocuronium bromide; the auxiliary material is a pH regulator. The rocuronium bromide injection prepared by the preparation method provided by the invention has better stability, and can still meet the standard of the product in Chinese pharmacopoeia after being stored for 36 months at normal temperature.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a rocuronium bromide injection preparation and a preparation method thereof. Background technique [0002] Rocuronium bromide is a non-depolarizing intermediate neuromuscular blocking agent invented by ORGANON USA INC (Organon) in the Netherlands. ORGANON USA INC (Organon) is a pharmaceutical company headquartered in the Netherlands. It was acquired by Schering-Plough in 2007 and entered MSD in November 2009 with Schering-Plough. It is a relatively new steroidal muscle relaxant, and its main advantages are quick onset, small cardiovascular response, and no accumulation effect, especially for tracheal intubation during anesthesia. A large number of clinical studies have proved that 96% of patients with ROC of 2×ED90 can achieve good intubation conditions within 60s, and 500% of patients can achieve good intubation conditions within 90s. Compared with suc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/58A61K47/04A61P21/02
CPCA61K9/08A61K9/0019A61K31/58A61K47/02A61P21/02
Inventor 王再兴吴峰刘晓庆张英
Owner 杭州泓友医药科技有限公司
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