Preparation process of dexmedetomidine hydrochloride injection

A technology for preparing dexmedetomidine hydrochloride and a preparation process, which is applied in the field of preparation of liquid medicine for injection, can solve problems such as short validity period, difficulty in controlling the validity period, and changes in the pH value of the liquid medicine, and achieve improved stability, easy product quality, The effect of stable content

Inactive Publication Date: 2020-06-09
TIANJIN PHARMA GROUP XINZHENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The inventors believe that the dexmedetomidine hydrochloride compound contains hydrochloric acid groups, which will free acidic ions in the aqueous solution, and be directly filled in any existing commercially available ampoule that has not been generally treated, and have a slight interaction with the glass surface. However, no pH buffer reagent is added to the product, which will lead to changes in the pH value of the drug solution. After 12 months of long-term storage, the pH value will rise. The change in pH value and content will cause the quality and curative ef

Method used

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  • Preparation process of dexmedetomidine hydrochloride injection
  • Preparation process of dexmedetomidine hydrochloride injection

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Embodiment 1

[0022] A preparation process for dexmedetomidine hydrochloride injection, comprising the following steps:

[0023] A. Soak 1ml of neutral borosilicate ampoule in 0.1M hydrochloric acid solution and ultrasonically clean it for 1 hour, then dry it with compressed air, rinse it with purified water and water for injection in sequence, and then sterilize and dry it in a tunnel oven at 330°C to obtain acid Dispose of neutral borosilicate ampoules, spare;

[0024] B. Weigh 59g of dexmedetomidine hydrochloride and 4.5kg of sodium chloride, add 500L of water for injection to dissolve, and stir well to obtain pH 5.2, containing 0.1mg / ml of dexmedetomidine hydrochloride and 9mg / ml of sodium chloride. The crude product of dexmedetomidine hydrochloride injection of ml;

[0025] C. The crude product of dexmedetomidine hydrochloride injection is filtered through 0.45μm and 0.22μm filter membranes successively, and filled in 1ml acid-treated neutral borosilicate ampoules with a filling volum...

Embodiment 2

[0028] A preparation process for dexmedetomidine hydrochloride injection, comprising the following steps:

[0029] A. Soak 2ml of neutral borosilicate ampoule in 0.1M hydrochloric acid solution and ultrasonically clean it for 1 hour, then dry it with compressed air, rinse it with purified water and water for injection in sequence, and then sterilize and dry it in a tunnel oven at 330°C to obtain acid Dispose of neutral borosilicate ampoules, spare;

[0030] B. Weigh 59g of dexmedetomidine hydrochloride and 4.5kg of sodium chloride, add 500L of water for injection to dissolve, stir well to obtain pH 5.5, containing 0.1mg / ml of dexmedetomidine hydrochloride, and 9mg / ml of sodium chloride. The crude product of dexmedetomidine hydrochloride injection of ml;

[0031] C. The crude product of dexmedetomidine hydrochloride injection is filtered through 0.45μm and 0.22μm filter membranes successively, and filled into 2ml acid-treated neutral borosilicate ampoules with a filling volume...

Embodiment 3

[0034] A preparation process for dexmedetomidine hydrochloride injection, comprising the following steps:

[0035] A. Soak 2ml of neutral borosilicate ampoule in 0.1M hydrochloric acid solution and ultrasonically clean it for 2 hours, then dry it with compressed air, rinse it with purified water and water for injection in sequence, and then sterilize and dry it in a tunnel oven at 330°C to obtain acid Dispose of neutral borosilicate ampoules, spare;

[0036] B. Weigh 118g of dexmedetomidine hydrochloride and 9kg of sodium chloride, add 1000L of water for injection to dissolve, stir well to obtain pH5.5, containing 0.1mg / ml of dexmedetomidine hydrochloride, and 9mg / ml of sodium chloride crude dexmedetomidine hydrochloride injection;

[0037] C. The crude product of dexmedetomidine hydrochloride injection is filtered through 0.45μm and 0.22μm filter membranes successively, and filled into 2ml acid-treated neutral borosilicate ampoules with a filling volume of 2ml±0.1ml, and the...

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Abstract

The invention relates to a preparation method of liquid medicine for injection, in particular to a preparation process of dexmedetomidine hydrochloride injection. The process comprises the following steps: A, soaking a neutral borosilicate ampoule in an inorganic acid solution, performing ultrasonic cleaning, performing blow-drying with compressed air, performing flushing, and performing sterilization and drying with a tunnel oven to obtain an acid-treated neutral borosilicate ampoule for later use; B, weighing dexmedetomidine hydrochloride and sodium chloride, adding water for injection for dissolving, and performing uniform stirring to obtain a dexmedetomidine hydrochloride injection crude product; and C, filtering the dexmedetomidine hydrochloride injection crude product, encapsulatingthe filtered crude product in the acid-treated neutral borosilicate ampoule, and carrying out high-pressure steam sterilization to obtain the finished product dexmedetomidine hydrochloride injection.The process is simple to operate and can effectively control the PH value, and the PH stability is high.

Description

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Claims

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Application Information

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Owner TIANJIN PHARMA GROUP XINZHENG
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