Rocuronium bromide-containing injection

A technology for injections and injection preparations, applied in the field of medicine, can solve the problems of easily exceeding the standard, low sterility assurance level, and increased impurity C content.

Active Publication Date: 2013-03-06
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] 1) If the aseptic production process is adopted, the sterility assurance level is low;
[0019] 2) If high-purity rocuronium bromide raw materials are used to offset the increase in the content of impurity C caused by autoclaving, the production cost will be high, and the content of impurity C in the final product will also increase significantly and the increase rate is uncontrollable , easy to exceed the standard;
[0020] 3) During the storage of the injection, the content of impurity C will also increase;
[0021] 4) The addition of metal ion chelating agents introduces additional excipients, increasing safety risks

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1. Rocuronium Bromide Injection (5ml / support)

[0051] prescription:

[0052]

[0053] Preparation:

[0054] 1. Take 90% of the prescribed amount of water for injection, add glacial acetic acid and sodium chloride in sequence, and stir to dissolve.

[0055] 2. Take the prescribed amount of rocuronium bromide and add it to the solution obtained above, stir to dissolve completely.

[0056] 3. Adjust the pH value of the solution to 4.0 with 10% acetic acid or sodium hydroxide.

[0057] 4. Dilute the above solution to 5000ml with water for injection.

[0058] 5. With a tangential flow ultrafiltration system equipped with a molecular weight cut-off of 5000 Daltons, filter the above-mentioned obtained medicinal solution to remove pyrogens and possible microorganisms, and detect the content of rocuronium bromide therein.

[0059] 6. Divide the liquid medicine obtained above into colorless medium borosilicate glass ampoules, 5ml / bottle, fill with nitrogen, an...

Embodiment 2

[0063] Embodiment 2. Rocuronium Bromide Injection (2.5ml / support)

[0064] prescription:

[0065]

[0066] Preparation:

[0067] 1. Take 90% of the prescribed amount of water for injection, add glacial acetic acid and sodium chloride in sequence, and stir to dissolve.

[0068] 2. Take the prescribed amount of rocuronium bromide and add it to the solution obtained above, stir to dissolve completely.

[0069] 3. Adjust the pH value of the solution to 4.0 with 10% acetic acid or sodium hydroxide.

[0070] 4. Dilute the above solution to 5000ml with water for injection.

[0071] 5. With a tangential flow ultrafiltration system equipped with a molecular weight cut-off of 5000 Daltons, filter the above-mentioned obtained medicinal solution to remove pyrogens and possible microorganisms, and detect the content of rocuronium bromide therein.

[0072] 6. Divide the liquid medicine obtained above into colorless medium borosilicate glass ampoules, 2.5ml / bottle, fill with nitrogen...

Embodiment 3

[0076] Embodiment 3. Rocuronium Bromide Injection (10ml / support)

[0077] prescription:

[0078]

[0079] Preparation:

[0080] 1. Take 90% of the prescribed amount of water for injection, add glacial acetic acid and sodium chloride in sequence, and stir to dissolve.

[0081] 2. Take the prescribed amount of rocuronium bromide and add it to the solution obtained above, stir to dissolve completely.

[0082] 3. Adjust the pH value of the solution to 4.0 with 10% acetic acid or sodium hydroxide.

[0083] 4. Dilute the above solution to 5000ml with water for injection.

[0084] 5. With a tangential flow ultrafiltration system equipped with a molecular weight cut-off of 5000 Daltons, filter the above-mentioned obtained medicinal solution to remove pyrogens and possible microorganisms, and detect the content of rocuronium bromide therein.

[0085] 6. Divide the liquid medicine obtained above into colorless medium borosilicate glass ampoules, 10ml / bottle, fill with nitrogen, ...

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PUM

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Abstract

The invention relates to a rocuronium bromide-containing injection. The injection is prepared from rocuronium bromide serving as an active ingredient and a pharmaceutically-acceptable carrier as accessories. The pH value of a system is maintained by adding a 1-5 percent acetate buffer solution, so that the stability of the solution is enhanced, the pH value of a system is maintained at the same time, degradation of main medicaments in a preparation process is suppressed, the stability of the main medicaments is enhanced, and the quantity of rocuronium bromide impurities C in an autoclave sterilizing process is reduced. Finally, a rocuronium bromide injection which has high stability and stable quality and is suitable for storing for a long time is obtained.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection containing rocuronium bromide and a preparation method thereof. Background technique [0002] Rocuronium bromide is a moderate-effect non-depolarizing sterol muscle relaxant. Since animal experiments first confirmed its reliable nerve-muscle blocking effect in 1989, literature and clinical application reports have successively reported and fully affirmed its Its characteristics are fast onset, no accumulation in the body, weak inhibitory effect on the cardiovascular system, no increase in intraocular pressure and intracranial pressure, no allergic reactions, and little impact on the release of histamine. The above advantages have made it a muscle relaxant that people have been seeking to replace succinylcholine for nearly 20 years. In addition to providing intubation conditions similar to succinylcholine, it is also suitable for anesthesia in cranial su...

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 李宝齐董凯孙长海姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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