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Preparation method of pre-filled dexmedetomidine hydrochloride injection

A technology for dexmedetomidine hydrochloride and injection, which is applied in the field of preparation of pre-filled dexmedetomidine hydrochloride injection, can solve problems such as inconvenience in use, pollution, etc. Effect

Inactive Publication Date: 2013-09-11
SICHUAN BAILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method is ingenious in conception and simple in operation, which can effectively solve the problems of contamination and inconvenient use of dexmedetomidine hydrochloride injection in clinical use, and ensure fast and safe operation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. Clean the dosing system before dosing: wash the dosing tanks, pipelines and other equipment with water for injection three times before dosing, and drain them clean.

[0019] 2. Feeding and preparation: ①Take 80% of the total amount of water for injection (65°C). ② Add the prescribed amount of dexmedetomidine hydrochloride. ③ Stir to dissolve for 5 minutes. ④ Add water for injection to the full amount. ⑤ Convection and stirring to dissolve for 10 minutes. ⑥Filter with 0.22um filter. ⑦ Detection of intermediates.

[0020] 3. Intermediate testing: testing according to the quality standards of intermediates.

[0021] 4. Arranging pre-filled containers.

[0022] 5. The filling and sealing process is as follows: filtration, nitrogen filling, filling, nitrogen filling, plugging and sealing

[0023] 6. Boarding, sterilization and leak detection

[0024] The sterilization temperature is 121° C., and the sterilization time is 15 minutes.

[0025] 7. The vacuum degree...

Embodiment 2

[0032] 1. Clean the dosing system before dosing: wash the dosing tanks, pipelines and other equipment with water for injection three times before dosing, and drain them clean.

[0033] 2. Feeding and preparation: ① Take 80% of the total amount of water for injection (60°C). ② Add the prescribed amount of dexmedetomidine hydrochloride. ③ Stir to dissolve for 8 minutes. ④ Add water for injection to the full amount. ⑤ Convection and stirring to dissolve for 8 minutes. ⑥Filter with 0.22um filter. ⑦ Detection of intermediates.

[0034] 3. Intermediate testing: testing according to the quality standards of intermediates.

[0035] 4. Arranging pre-filled containers.

[0036] 5. The filling and sealing process is as follows: filtration, nitrogen filling, filling, nitrogen filling, plugging and sealing

[0037] 6. Boarding, sterilization and leak detection

[0038] The sterilization temperature is 117°C and the time is 30min.

[0039] 7. The vacuum degree of leak detection mus...

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Abstract

The invention discloses a preparation method of a pre-filled dexmedetomidine hydrochloride injection. The preparation method of the pre-filled dexmedetomidine hydrochloride injection comprises the following steps of: A, preparing 80% of prescribed dose of water for injection, adding the prescribed dose of dexmedetomidine hydrochloride, stirring to dissolve for 5-8 minutes, then adding the water for injection to full dose, carrying out convection, and stirring and dissolving for 8-10 minutes; B, filtering a solution obtained by step A by virtue of a filter, and detecting an intermediate; and C, carrying out nitrogen filling, prefilling, encapsulation and sterilization on a solution obtained by step B, thus the pre-filled dexmedetomidine hydrochloride injection is obtained. The preparation method of the pre-filled hydrochloric acid dexmedetomidine injection has the advantages that concept is skilful, operation is simple, the problem that the dexmedetomidine hydrochloride injection is polluted in clinical application and inconvenient to use can be effectively solved, and rapidity and safety of an operation process can be guaranteed.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy and relates to a preparation method of prefilled dexmedetomidine hydrochloride injection. Background technique [0002] Dexmedetomidine hydrochloride, chemical name (+)-4-(S)-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole hydrochloride, is an alpha2-adrenal hormone receptor agonist, has a sedative effect. [0003] Dexmedetomidine hydrochloride injection is a sterilized aqueous solution of dexmedetomidine hydrochloride. This product is a colorless or almost colorless clear liquid. It is suitable for the sedation of intubated and ventilated patients during intensive care treatment, and it is suitable for the sedation of non-tracheal intubated patients before or during surgery and other operations. [0004] At present, in the clinical use of dexmedetomidine hydrochloride injection, it is temporarily prepared before use, which increases the use process and the possibility of contamination. In ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4174A61P25/20
Inventor 朱义王一茜梁臻
Owner SICHUAN BAILI PHARM CO LTD
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