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Preparation method for rocuronium bromide injection in low impurity level

A technology of rocuronium bromide and injection, which is applied in the field of medicine and can solve the problems of increasing impurity content and instability

Inactive Publication Date: 2018-10-19
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This preparation method requires terminal sterilization, but rocuronium bromide is unstable at high temperature and will increase the impurity content in the terminal sterilization process

Method used

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  • Preparation method for rocuronium bromide injection in low impurity level
  • Preparation method for rocuronium bromide injection in low impurity level

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Experimental program
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Embodiment

[0022] After research it was found that:

[0023] 1. When the bacterial endotoxin in the raw and auxiliary materials is strictly controlled, the preparation process does not need to add activated carbon for adsorption and heat removal, and the endotoxin of the final product also meets the standard requirements.

[0024] 2. The main degradation impurity of rocuronium bromide is impurity C. Rocuronium bromide is unstable under high temperature conditions. If it is treated at 121°C for 20 minutes, the impurity content of impurity C will increase by 3 times.

[0025] 3. Rocuronium bromide is stable under acidic conditions. After being treated with 1mol / L hydrochloric acid, the content of impurity C does not change significantly, but it is unstable under alkaline conditions, and the content of impurity C increases significantly. Therefore, in the preparation process, reducing the pH of the solution is beneficial to ensure the stability of rocuronium bromide injection.

[0026] 4. ...

Embodiment 1

[0053] The composition and consumption of the injection in the table 5 embodiment 1

[0054] Element

Dosage

Rocuronium Bromide

10.0

Sodium acetate

2.0

glacial acetic acid

Appropriate amount

Sodium chloride

3.3

sodium hydroxide

Appropriate amount

Water for Injection

Appropriate amount

Total

1000.0

[0055] According to the above table 5, the preparation method is as follows: measure about 850 g of water for injection cooled to below 25°C, aerate with nitrogen, cool the solution to 8-12°C, adjust the pH to 2.9-3.1 with glacial acetic acid to obtain solution A, and Add the prescribed amount of rocuronium bromide to solution A, stir and dissolve to obtain solution B, add the prescribed amount of sodium acetate and sodium chloride to solution B, adjust the pH of the solution to 2.9-3.1 with glacial acetic acid, and add water for injection to 1000.0g , adjust the pH of solution B to 3.9-4.1 wi...

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Abstract

The invention discloses a preparation method for rocuronium bromide injection in a low impurity level. In a preparation process of the rocuronium bromide injection, the content of an impurity C is reduced to 0.1% as possible, and the condition that the impurities of the rocuronium bromide injection do not exceed a standard (a shelf life standard: 1.5%) within a validity period is guaranteed. Whilebacterial endotoxin of a raw material and an auxiliary material is controlled, activated carbon does not need to be added in a prescription process for performing a pyrogen removing operation, and the bacterial endotoxin of a finished product of the rocuronium bromide injection is still qualified. A temperature of prepared chemical is reduced, dissolved oxygen in solution is removed by nitrogen aeration and a solution pH value in the preparation process is reduced, the content of the impurity C is helpful to reduce, and the stability of the rocuronium bromide injection is helpful to improve.

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 with low impurity level. Background technique [0002] The original research company of rocuronium bromide injection is Holland Organon Company, and its published product manual contains 10 mg of rocuronium bromide per ml, 2 mg of sodium acetate, sodium chloride to adjust to isotonicity, glacial acetic acid or hydrogen Sodium oxide adjusts the pH of the liquid to 4.0. But the preparation method of rocuronium bromide injection is not disclosed. [0003] CN102048684 discloses a preparation method of rocuronium bromide injection, the preparation process is as follows: a. cooling water for injection to room temperature; b. preparing acetic acid-sodium acetate buffer; c. measuring water for injection cooled to room temperature, Add acetic acid-sodium acetate buffer and mix well; d. Add sodium chloride and stir until c...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/58A61K47/12A61K47/02
CPCA61K9/0019A61K9/08A61K31/58A61K47/02A61K47/12
Inventor 汤征王小镒周亚兵杜芳张鑫周敏周敏慧丁云晖
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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