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A kind of succinylcholine chloride injection and preparation method thereof

A technology of succinylcholine chloride and injection, applied in the field of medicine, can solve problems such as adverse effects on drug effectiveness and safety, strict production process requirements, inconvenience in commercial production, etc. Impurity content, the effect of ease of commercial production

Active Publication Date: 2022-05-13
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the main drug, succinylcholine chloride, is easily degraded under high temperature conditions. Therefore, it brings great inconvenience to commercial production, has strict requirements on the production process, and also easily affects product quality.
In addition, methylparaben and propylparaben are easily degraded into solutions to produce more impurities, which will adversely affect the effectiveness and safety of drugs
According to the IIG database (drug inactive ingredient database) published by the FDA, the maximum dosage of methylparaben administered by injection is only 0.75% W / V, and the maximum dosage of propylparaben administered by injection is only 0.2%W / V, the lower dosage of the two in injections reflects the higher safety risks they may bring

Method used

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  • A kind of succinylcholine chloride injection and preparation method thereof
  • A kind of succinylcholine chloride injection and preparation method thereof
  • A kind of succinylcholine chloride injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037] A kind of succinylcholine chloride injection, by weight, every 1000 parts of said injection contains the following components by weight: 20 parts of succinylcholine chloride, 9 parts of benzyl alcohol, 5 parts of sodium chloride and The volume of water for injection is adjusted to 1000 parts, and the pH value is adjusted to 3.0-4.5 with a pH regulator during the preparation process.

Embodiment 2

[0039] The preparation method of succinylcholine chloride injection in embodiment 1 is as follows:

[0040] (1) Add 80% of the total amount of water for injection at 30° C. into the liquid preparation tank, feed sterile nitrogen gas and bubble for 30 minutes, and control the dissolved oxygen in the water for injection to not be higher than 10 ppm. Start stirring and continue nitrogen protection, add and dissolve sodium chloride, bacteriostatic agent and succinylcholine chloride in sequence, wherein each material added is fully dissolved before adding the next material.

[0041](2) Use a pH regulator (1.0mol / L hydrochloric acid solution or 1.0mol / L sodium hydroxide solution) to adjust the pH value of the solution obtained in step (1) to 3.0-4.5, add the remaining water for injection to constant volume, fill with nitrogen and Stir to obtain liquid medicine.

[0042] (3) Filter and sterilize the liquid medicine after it is prepared, fill it, and continuously feed nitrogen gas du...

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Abstract

The invention relates to a succinylcholine chloride injection and a preparation method thereof. Each 1000 L part of the injection contains the following components by weight: 20 parts of succinylcholine chloride, 1-10 parts of bacteriostat, chlorine 5 parts of sodium chloride; the bacteriostatic agent is phenylethyl alcohol, benzoic acid or benzyl alcohol; during its preparation, the pH value is adjusted to 3.0-4.5 with a pH regulator. In the process of preparing succinylcholine chloride injection, the present invention comprehensively controls the temperature of water for injection, the amount of dissolved oxygen, the selection of bacteriostatic agent, pH regulation, continuously feeds nitrogen in the process of filling, and controls the concentration of the drug. The headspace residual oxygen content of the solution and other means have effectively controlled the increase of impurities and the decrease of the effective substance content, improved the utilization rate of the injection, greatly reduced the risk of using the succinylcholine chloride injection, and improved the The effectiveness and application prospect of the injection, the preparation method is simple, and it is easy to produce commercially.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a succinylcholine chloride injection and a preparation method thereof. Background technique [0002] Succinylcholine chloride is a white or off-white crystalline powder, odorless, salty, and easily soluble in water. After binding to nicotinic receptors, it produces a stable depolarization effect and causes skeletal muscle relaxation. It is mainly used clinically as a depolarizing skeletal muscle relaxant, and can be used for tracheal intubation during general anesthesia and intraoperative maintenance of muscle relaxation. [0003] The succinylcholine chloride injection developed by HOSPIRA was approved by the FDA on January 5, 1953, and was launched in the United States under the product name of QUELICIN, with a specification of 200mg / 10mL and an NDA application number of N008845. [0004] At present, the 200mg / 10mL product of succinylcholine chloride injection has ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/225A61K47/10A61K47/12A61P21/02
CPCA61K9/08A61K9/0019A61K31/225A61K47/10A61K47/12A61P21/02
Inventor 唐咏群黄锡伟荣先觉胡铮田欣欣
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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