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Method for preparing rocuronium bromide injection

A technology of rocuronium bromide and injection, which is applied in the field of preparation of rocuronium bromide injection, can solve the problems of high manufacturing cost and long process flow of freeze-dried preparations, and achieve low manufacturing cost, stable quality and simple process Effect

Inactive Publication Date: 2011-05-11
华北制药集团制剂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the process of freeze-dried preparations is long and the manufacturing cost is high

Method used

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  • Method for preparing rocuronium bromide injection
  • Method for preparing rocuronium bromide injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (a) take by weighing rocuronium bromide 40.0g, sodium acetate 15.0g, sodium chloride 0.8g;

[0028] (b) cooling the water for injection to room temperature;

[0029] (c) preparing acetic acid-sodium acetate buffer solution (pH3.8);

[0030] (d) Measure 3000ml of water for injection cooled to room temperature, add acetic acid-sodium acetate buffer, and mix well;

[0031] (e) Add sodium chloride, stir until completely dissolved; put rocuronium bromide into it, stir to dissolve; adjust the pH value of the solution to 4.0 with 1mol / L acetic acid;

[0032] (f) Add 2 g of activated carbon, stir at room temperature for 30 minutes, and measure the content of the decarbonized filtration intermediate; add water for injection according to the results, so that the marked content is 100%;

[0033] (g) Sterilize by filtration through a 0.22 μm microporous membrane; dispense into controlled antibiotic bottles, 5ml (2.5ml) per bottle, press rubber stoppers, and roll aluminum caps; st...

Embodiment 2

[0035] (a) take by weighing rocuronium bromide 50.0g, sodium acetate 10.0g, sodium chloride 1g;

[0036] (b) cooling the water for injection to room temperature;

[0037] (c) preparing acetic acid-sodium acetate buffer solution (pH3.8);

[0038] (d) Measure 3000ml of water for injection cooled to room temperature, add acetic acid-sodium acetate buffer, and mix well;

[0039] (e) Add sodium chloride, stir until completely dissolved; add rocuronium bromide, stir to dissolve; adjust the pH value of the solution to 4.0 with 1mol / L acetic acid;

[0040] (f) Add 1 g of activated carbon, stir at room temperature for 30 minutes, measure the content of the decarbonized filtration intermediate; add water for injection according to the results, so that the marked content is 100%;

[0041] (g) Sterilize by filtration through a 0.22 μm microporous membrane; dispense into controlled antibiotic bottles, 5ml (2.5ml) per bottle, press rubber stoppers, and roll aluminum caps; sterilize by aut...

Embodiment 3

[0043]

[0044] Pretreatment includes: a, cooling water for injection to room temperature; b, preparation of acetic acid-sodium acetate buffer (pH3.8); c, measuring 3000ml of water for injection cooled to room temperature, adding acetic acid-sodium acetate buffer, mixing Evenly; d, add sodium chloride, stir until completely dissolved; e, add rocuronium bromide to the above solution, stir to dissolve; adjust the pH value of the solution to 4.0 with 1mol / L acetic acid; f, add activated carbon, room temperature Stir for 30 minutes, decarbonize and filter; g, take a sample to measure the content of the intermediate; add water for injection according to the result to make the content 100%; h, filter and sterilize through a 0.22 μm microporous membrane; fill and sterilize : Divided into regulated antibiotic bottles, 5ml per bottle, fully pressed rubber stopper, rolled aluminum cap; sterilized by autoclaving at 121°C for 20min.

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Abstract

The invention discloses a method for preparing rocuronium bromide injection, which comprises the following steps of: making each 50,000ml of injection contain the following components by weight: 20 to 70.0g of rocuronium bromide, 1 to 20.0g of sodium acetate and 0.5 to 2.0g of sodium chloride; cooling water for injection to room temperature; adding acetic acid-sodium acetate buffer solution, and mixing uniformly; dissolving the sodium chloride and the rocuronium bromide; regulating the pH value of the solution to be 4.0 by using 1mol / L acetic acid; adding active carbon, removing carbon, filtering, and filtering to remove bacteria through a 0.22 mu m microporous filtering film; and filling and sterilizing. The method is simple in process, and the product quality is stable.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of rocuronium bromide injection. technical background [0002] Rocuronium bromide is a nondepolarizing neuromuscular blocking agent structurally similar to vecuronium and pancuronium. Like other non-depolarizing drugs, it competitively binds to cholinergic receptors on motor nerve terminal synapses to antagonize the effects of acetylcholine. In clinical practice, it is used as an adjunct to general anesthesia for routine endotracheal intubation, and to relax skeletal muscles during surgery or mechanical respiration, so as to facilitate surgical operations and improve the body's gas exchange. For general anesthesia, skeletal muscle relaxation and endotracheal intubation. Savage D.S. is equal to synthesized this compound in 1990; CN101323636A discloses a kind of method for synthesizing this compound more easily; DE discloses a kind of co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/58A61K47/12A61P21/02
Inventor 赵霞路玉锋王志良刘书睿
Owner 华北制药集团制剂有限公司
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