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Preparation method and pharmaceutical composition of rocuronium bromide

A technology of raw materials and crude products, which is applied in the field of preparation method of rocuronium bromide and its pharmaceutical composition, can solve the problems of dose dependence, fast action and slow onset of rocuronium bromide

Active Publication Date: 2018-10-19
北京市新里程医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The depolarizing neuromuscular blocking agent scoline succinylcholine is widely used for endotracheal intubation because of its rapid onset and short duration of action, however, it can cause a large number of adverse reactions and even serious complications (such as , malignant hyperthermia, hyperkalemia lead to arrhythmia)
Non-depolarizing neuromuscular blocking agents are safer than succinylcholine, but have slower onset and longer duration of action, which have disadvantages in some applications
Rocuronium bromide is fast-acting and dose-dependent

Method used

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  • Preparation method and pharmaceutical composition of rocuronium bromide
  • Preparation method and pharmaceutical composition of rocuronium bromide
  • Preparation method and pharmaceutical composition of rocuronium bromide

Examples

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Effect test

Embodiment 1

[0024] The preparation method of rocuronium bromide raw material is:

[0025] Take 100g of crude rocuronium bromide, first add 550ml of chloroform, stir to dissolve, cool down to 5-10°C, add 250ml of deionized water, stir evenly, and introduce CO 2 , CO 2 The flow rate was 15ml / min, 300ml of diethyl ether was added after 40min, allowed to stand, filtered, the filter cake was washed with diethyl ether, freeze-dried to obtain 81.2g of rocuronium bromide raw material.

Embodiment 2

[0027] The preparation method of rocuronium bromide raw material is:

[0028] Take 100g of crude rocuronium bromide, first add 850ml of chloroform, stir to dissolve, cool down to 5-10°C, add 400ml of deionized water, stir evenly, and introduce CO 2 , CO 2 The flow rate was 25ml / min, 500ml of diethyl ether was added after 20min, allowed to stand, filtered, the filter cake was washed with diethyl ether, freeze-dried to obtain 81.9g of rocuronium bromide raw material.

Embodiment 3

[0030] The preparation method of rocuronium bromide raw material is:

[0031] Take 100g of crude rocuronium bromide, first add 700ml of chloroform, stir to dissolve, cool down to 5-10°C, add 420ml of deionized water, stir evenly, and introduce CO 2 , CO 2 The flow rate was 20ml / min, 400ml of diethyl ether was added after 30min, allowed to stand, filtered, the filter cake was washed with diethyl ether, freeze-dried to obtain 83.8g of rocuronium bromide raw material. Comparative example 1:

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Abstract

The invention belongs to the technical field of biological medicine, and specifically relates to a preparation method and a pharmaceutical composition of rocuronium bromide. The preparation method ischaracterized by adding trichloromethane and water under a low-temperature condition, adding a certain amount of CO2, and adding diethyl ether for crystallization, thus obtaining a purified rocuroniumbromide raw material. After stability study is carried out on the raw material, increment of the contents of an impurity A and an impurity C of the raw material is less; in addition, the content of 3-bromopropylene (allyl bromide) in the raw material is smaller than 10ppm; an injection solution is prepared from the rocuronium bromide raw material obtained through the preparation method, the injection solution accords with all standards of a pharmacopoeia, and the increment of the impurity A, the impurity C and total impurity is remarkably lower than those in a commercially available product after cold-thermal cycling.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a preparation method of rocuronium bromide and a pharmaceutical composition thereof. Background technique [0002] Rocuronium bromide, as an adjuvant for general anesthesia, performs routine endotracheal intubation, and relaxes skeletal muscles during surgery or mechanical respiration, so as to facilitate surgical operations and improve the body's gas exchange. Indicated for general anesthesia, skeletal muscle relaxation and endotracheal intubation; Rocuronium bromide is a non-depolarizing 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. The depolarizing neuromuscular blocking agent scoline succinylcholine is widely used for endotracheal intubation because of its rapid onset...

Claims

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Application Information

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IPC IPC(8): C07J43/00A61K31/58A61K9/08A61P23/00
CPCA61K9/0019A61K9/08A61K47/32A61P23/00C07J43/003
Inventor 宋雪萍
Owner 北京市新里程医药科技有限公司
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