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Stable rocuronium bromide composition for injection

A rocuronium bromide, stable technology, applied in the field of stable rocuronium bromide injection composition and its preparation, can solve the problems of increased impurity C content, high production cost, low sterility assurance level, etc., and achieve the reduction of impurities The effect of C

Inactive Publication Date: 2010-02-24
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

-

- ...

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

[0043] Preparation process: Weigh the prescribed amount of acetic acid according to the prescription in the above table, add more than 80% of the prescribed amount of water for injection to dissolve, add sodium hydroxide to adjust the pH value to 4.0, add other excipients and drugs in turn, stir to dissolve, sodium hydroxide or acetic acid Adjust the pH value to 4.0, add 0.1% (weight / volume) of the solution volume, stir and adsorb pyrogen with activated carbon, filter for decarburization, add water for injection to the full amount, divide into ampoules according to the unit dose of 5ml, seal, and keep at 115°C , autoclave for 30 minutes to get the finished product.

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

[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 prescription amount to dissolve in water for injection, add sodium hydroxide to adjust the pH value to within the range of 4.0, add other auxiliary materials and drugs in turn, Stir to dissolve, adjust the pH value to 4.0 with sodium hydroxide or acetic acid (citric acid), add 0.1% (weight / volume) activated carbon to the solution volume, stir to absorb pyrogen, filter for decarburization, and add water for injection to the full amount, according to the unit Dosage of 5ml is divided into ampoules, sealed, and sterilized at 115°C for 30 minutes by autoclaving to obtain the finished product.

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