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Dexmedetomidine hydrochloride lyophilized powder injection and preparation method

A technology for injection of dexmedetomidine hydrochloride, which is applied in the field of dexmedetomidine hydrochloride freeze-dried powder injection and its preparation, can solve the problems of ineffective detection of impurities, unresolved substances, deepening of color, etc., and achieve complex Good solubility and stability, stable product quality, and stable effects of related substances

Inactive Publication Date: 2018-11-06
宁波蒙曼生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Color is also a reaction of the degradation of dexmedetomidine hydrochloride. The liquid phase of the current ultraviolet detector cannot effectively detect such impurities, and it needs to be distinguished by color
[0010] CN105168122A discloses a kind of dexmedetomidine hydrochloride injection and its preparation process, which uses dexmedetomidine hydrochloride, osmotic pressure regulator and metal ion complexing agent to prepare the injection, which solves the increase of related substances, which can be seen There is a tendency for foreign matter to increase, but the phenomenon of color deepening during long-term storage has not been resolved
[0011] CN103284945A discloses a prefilled dexmedetomidine hydrochloride injection, which solves the problem of convenience of use of dexmedetomidine hydrochloride injection, but fails to solve the phenomenon of increased related substances and deepened color during long-term storage

Method used

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  • Dexmedetomidine hydrochloride lyophilized powder injection and preparation method
  • Dexmedetomidine hydrochloride lyophilized powder injection and preparation method
  • Dexmedetomidine hydrochloride lyophilized powder injection and preparation method

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Experimental program
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Effect test

Embodiment 1

[0032] prescription

[0033]

[0034] The specific preparation process is:

[0035] (1) Take dextran and add 300ml of water for injection to dissolve, add 0.30% (g / v) activated carbon for needles, stir at 55°C for 30 minutes, filter and decarbonize;

[0036] (2) Weigh dexmedetomidine hydrochloride, after adding the citric acid-sodium citrate buffer solution with a pH value of 3.5 to dissolve, add step 1) in the solution after decarbonization, stir well, add water for injection to Full amount;

[0037] (3) Adjust the pH value of the medicinal solution to 5.5 with citric acid, sterilize and filter with a 0.22 μm microporous membrane, quantitatively fill in sterile clean vials, half-fill with rubber stoppers, and freeze-dry to obtain the product.

Embodiment 2

[0039] prescription

[0040]

[0041] The specific preparation process is:

[0042] (1) Take dextran and add 30% water for injection to dissolve it, add 0.05% (g / v) activated carbon for needles, at 25°C

[0043] Stir for 60 minutes, filter and decarbonize;

[0044] (2) Weigh dexmedetomidine hydrochloride, add citric acid-sodium citrate buffer solution with a pH value of 3.0 to dissolve, add step 1) in the solution after decarbonization, stir well, add water for injection to Full amount;

[0045] (3) Adjust the pH value of the medicinal solution to 5.0 with a pharmaceutically acceptable acid, sterilize and filter it with a 0.22 μm microporous membrane, quantitatively fill it into sterile clean vials, add half a rubber stopper, and freeze-dry to obtain the product.

Embodiment 3

[0047] prescription

[0048]

[0049] The specific preparation process is:

[0050] (1) Take dextran and add 30% water for injection to dissolve, add 0.5% (g / v) activated carbon for needles, stir at 80°C for 15 minutes, filter and decarbonize;

[0051] (2) Weigh dexmedetomidine hydrochloride, add citric acid-sodium citrate buffer solution with a pH value of 4.0 to dissolve, add step 1) in the solution after decarbonization, stir well, add water for injection to Full amount;

[0052] (3) Adjust the pH value of the medicinal solution to 6.0 with a pharmaceutically acceptable acid, sterilize and filter it with a 0.22 μm microporous membrane, fill quantitatively into sterile clean vials, half-fill with a rubber stopper, and freeze-dry to obtain the product.

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Abstract

The invention relates to a dexmedetomidine hydrochloride lyophilized powder injection and a preparation method, and belongs to the field of pharmaceutical preparations. The dexmedetomidine hydrochloride lyophilized powder injection comprises, by weight, 1 part of dexmedetomidine hydrochloride and 2-20 parts of middle molecular weight dextran. The method comprises the steps that the dextran is dissolved by adding part of injection water, and stirring and filtering are conducted; the dexmedetomidine hydrochloride is taken, after the dexmedetomidine hydrochloride is dissolved by adding in citricacid-sodium citrate buffering liquid, the dexmedetomidine hydrochloride is added to a decarburized solution, and the injection water is additionally added to the full amount; the PH value is adjustedto 5.0-6.0, microfiltration is conducted, and the injection is obtained after freezing drying is conducted. The injection has the advantages of being good in resolubility, and high in stability and safety.

Description

Technical field: [0001] The invention relates to a dexmedetomidine hydrochloride freeze-dried powder injection and a preparation method, belonging to the field of western medicine preparations. Background technique: [0002] Dexmedetomidine Hydrochloride (DexmedetomidineHydrochloride) is an α2-adrenoceptor agonist developed jointly by OrionPharma (Finland) and Abott (USA). calm down. The chemical name of dexmedetomidine hydrochloride is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride. The structural formula is as follows: [0003] [0004] The clinical experience of this product in the United States for more than 5 years shows that dexmedetomidine hydrochloride can produce stable sedative and awakening effects, and has a unique synergistic effect on the physical and psychological needs of critically ill patients, which can significantly reduce the time required for induction of anesthesia. The amount of anesthesia required; giving this product before...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K31/4174A61P25/20
CPCA61K9/0019A61K9/19A61K31/4174A61K47/26A61P25/20
Inventor 高正春
Owner 宁波蒙曼生物科技有限公司
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