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Method for preparing rocuronium bromide injection

A technology of rocuronium bromide and injection, applied in the field of medicine, can solve problems such as high production environment requirements, unfavorable commercial production, and inability to final sterilization, and achieve the effect of simple production process and stable product quality

Active Publication Date: 2013-01-09
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The freeze-dried preparation can improve the stability of the drug, but because it cannot be finally sterilized, it needs to adopt an aseptic process throughout the process, which has high requirements on the production environment and is not conducive to commercial production

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Element

[0031] The preparation method is as follows: measure about 670g of water for injection cooled below 25°C, add the prescribed amount of sodium acetate and stir to dissolve, mix well, adjust the pH value of the solution to 3.83 with glacial acetic acid to obtain solution A; add rocuronium bromide In solution A, after stirring and dissolving, add water for injection to 950g to obtain solution B; adjust the pH value of solution B to 3.95 with glacial acetic acid, adjust the solution to isotonicity with sodium chloride, and then add water for injection to 1000.0g to obtain Solution C: Pass solution C through a 0.22 μm polyethersulfone filter membrane, fill it with 5ml, and sterilize at 115°C for 35 minutes.

Embodiment 2

[0033] Element

[0034] The preparation method is as follows: measure about 670g of water for injection cooled below 25°C, add the prescribed amount of sodium acetate and stir to dissolve, mix well, adjust the pH value of the solution to 3.83 with glacial acetic acid to obtain solution A; add rocuronium bromide In solution A, after stirring and dissolving, add water for injection to 950g to obtain solution B; adjust the pH value of solution B to 3.80 with glacial acetic acid, adjust the solution to isotonicity with sodium chloride and add water for injection to 1000.0g to obtain Solution C: Pass solution C through a 0.22 μm polyethersulfone filter membrane, fill it with 5ml, and sterilize at 115°C for 35 minutes.

Embodiment 3

[0036] Element

[0037] The preparation method is as follows: measure about 670g of water for injection cooled below 25°C, add the prescribed amount of sodium acetate and stir to dissolve, mix well, adjust the pH value of the solution to 3.83 with glacial acetic acid to obtain solution A; add rocuronium bromide In solution A, after stirring and dissolving, add water for injection to 950g to obtain solution B; adjust the pH value of solution B to 4.20 with glacial acetic acid, adjust the solution to isotonicity with sodium chloride and add water for injection to 1000.0g to obtain Solution C: Pass solution C through a 0.22 μm polyethersulfone filter membrane, fill it with 5ml, and sterilize at 115°C for 35 minutes.

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Abstract

The invention discloses a method for preparing rocuronium bromide injection. The method includes steps of cooling injection liquid to the temperature lower than 25 DEG C, adding and dissolving sodium acetate in the injection and regulating a pH (potential of hydrogen) value of the solution to range from 3.8 to 4.2 by glacial acetic acid; adding and dissolving a prescription amount of rocuronium bromide crude drugs into the solution and regulating a pH value of the solution to range from 3.8 to 4.2; adding sodium chloride to condition the solution until the solution is hypertonic; and filtering the solution via a microporous membrane with the aperture of 0.22 micrometer. 1ml of the injection contains, by weight, 10mg of the rocuronium bromide, 2.0mg of sodium acetate, a proper amount of sodium chloride and a proper amount of glacial acetic acid. The method is simple in process, and the quality of the product is stable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of rocuronium bromide injection. Background technique [0002] Rocuronium bromide is a nondepolarizing neuromuscular blocking agent that 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. Its compound structural formula is as follows: [0003] [0004] The rocuronium bromide preparation currently approved for marketing is rocuronium bromide injection, developed by N.V.Organon in the Netherlands. According to the published product instructions, the prescription ingredients are: 10 mg of rocuronium bromide per ml, 2 mg of so...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/58A61P21/02
Inventor 施祥杰胡李斌陈浩李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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