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Stable rocuronium bromide composition for injection

A technology of rocuronium bromide and injection, which is applied in the field of stable rocuronium bromide injection composition and its preparation, can solve the problems of increased content of impurity C, easily exceeding the standard, and low level of sterility assurance, so as to reduce impurities The effect of C

Inactive Publication Date: 2014-06-25
尹双保 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the shortcoming of existing injection prescription technology is: 1) if adopt aseptic production process, then the sterility guarantee level is low; The increase of the impurity C content in the injection solution will increase the production cost, and the impurity C content in the final product will also increase significantly and the increase rate is uncontrollable, and it is easy to exceed the standard; 3) During the storage of the injection, the impurity C content will also increase significantly.

Method used

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  • Stable rocuronium bromide composition for injection
  • Stable rocuronium bromide composition for injection
  • Stable rocuronium bromide composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031]The comparison of the stabilizing effect of different metal chelating agents of embodiment 1

[0032] The formula of rocuronium bromide injection is shown in Table 1:

[0033] Table 1 Rocuronium bromide injection formula table

[0034] prescription number 1 2 3 4 5 6 7 Rocuronium Bromide 50g 50g 50g 50g 50g 50g 50g acetic acid 10g 10g 10g 10g 10g 10g 10g EDTA-2Na 15g - - - - - - EDTA-2Na-Ca - 15g - - - - - Sodium cyclohexanediamine tetraacetate - - 15g - - - - Dimercaptopropanol - - - 15g - - - dimercaptosuccinic acid - - - - 15g - - Sodium Dithiopropanesulfonate - - - - - 15g - Diethylenetriaminepentaacetic acid - - - - - - 15g NaOH or acetic acid to adjust the pH to 4.02 4.01 3.99 4.03 4.02 ...

Embodiment 2

[0039] The screening of embodiment 2EDTA-2Na or EDTA-2Na-Ca concentration range

[0040] The formula of rocuronium bromide injection is shown in Table 3:

[0041] Table 3 Rocuronium Bromide Injection Formula Table

[0042] prescription number 1 2 3 4 5 6 7 8 9 10 Rocuronium Bromide 50g 50g 50g 50g 50g 50g 50g 50g 50g 50g acetic acid 10g 10g 10g 10g 10g 10g 10g 10g 10g 10g EDTA-2Na 0.1g - - - - - - - - EDTA-2Na 1g EDTA-2Na - 10g - - - - - - EDTA-2Na - - 30g - - - - - EDTA-2Na - - - 100g - - - - EDTA-2Na-Ca - - - - 0.1g - - - EDTA-2Na-Ca 1g EDTA-2Na-Ca - - - - 10g - - EDTA-2Na-Ca - - ...

Embodiment 3

[0046] The formula of rocuronium bromide injection is shown in Table 4:

[0047] Table 4 Rocuronium Bromide Injection Formula Table

[0048] prescription number 1 2 3 4 5 6 7 8 (commercially available prescription) Rocuronium Bromide 50g 50g 50g 50g 50g 50g 50g 50g citric acid 5g 25g 5g 25g - - - - acetic acid - - - - 5g 10g 25g 10g EDTA-2Na 5g 50g - - - - - - EDTA-2Na-Ca - - 5g 50g 5g 50g 50g - Sodium hydroxide or acetic acid (citric acid) Adjust pH to 4.05 4.03 4.06 4.04 4.01 4.03 4.02 4.02 Water for Injection 5000ml 5000ml 5000ml 5000ml 5000ml 5000ml 5000ml 5000ml

[0049] Preparation process: take the citric acid (or acetic acid) of the prescription amount according to the prescription in the above table, add more than 80% of the prescript...

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Abstract

The invention provides a stable rocuronium bromide composition for vein, which contains rocuronium bromide with treating effective dose, EDTA-2Na-Ca or EDTA-2Na and a pH value buffer system. The EDTA-2Na-Ca or the EDTA-2Na delays the hydrolysis of a rocuronium bromide 17-bit ester bond of the composition in the processes of preparation and storage; and on one hand, medicine liquid can resist the high temperature in the processes of hot press and sterilization, on the other hand, the content of rocuronium bromide deacetyl impurities in the composition in the process of storage is reduced. The invention also provides a reasonable method for preparing the medicine liquid, which can reduce the generation of the rocuronium bromide hydrolysis impurities in the process of preparation. The reduction of the rocuronium bromide hydrolysis impurities improves the quality controllability of the composition and ensures the safety and effectiveness of clinical use.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable rocuronium bromide injection composition and a preparation method thereof. Background technique [0002] Rocuronium Bromide (Roeuronium Bromide) is a medium-effect non-depolarizing sterol muscle relaxant. Since animal experiments first confirmed its reliable nerve-muscle blockade in 1989, literature and clinical application reports have reported and fully affirmed it. 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 minimal release of histamine. The above-mentioned 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 craniocere...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/58A61K9/08A61K47/12A61K47/18A61P21/02
Inventor 尹双保付劼谭剑平
Owner 尹双保
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