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Treatment method for improving stability of dexmedetomidine hydrochloride injection and dexmedetomidine hydrochloride injection

A technology of dexmedetomidine hydrochloride and its treatment method, which is applied in the field of medicine, can solve the problems of body damage and high degree of harm, and achieve the effects of improving water resistance, improving stability, and increasing stability

Active Publication Date: 2018-06-05
石药银湖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since dexmedetomidine hydrochloride injection directly enters the body during clinical application, it absorbs quickly and acts rapidly, and this drug is mainly used in surgical patients under general anesthesia. Such patients are extremely weak, and the possible harm to excipients is even greater. Sensitive, so dexmedetomidine hydrochloride injection has more stringent requirements on the dosage, safety level, and type of excipients. Once the excipients have quality problems, they will quickly cause irreversible damage to the body, which is very harmful.

Method used

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  • Treatment method for improving stability of dexmedetomidine hydrochloride injection and dexmedetomidine hydrochloride injection
  • Treatment method for improving stability of dexmedetomidine hydrochloride injection and dexmedetomidine hydrochloride injection
  • Treatment method for improving stability of dexmedetomidine hydrochloride injection and dexmedetomidine hydrochloride injection

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Experimental program
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Effect test

Embodiment 1

[0041] Prescription: 0.236g of dexmedetomidine hydrochloride (0.2g as dexmedetomidine), 450g of sodium chloride, water for injection (pH=5) after adding nitrogen treatment to 50000mL, made into 1000 bottles.

[0042] A processing method for improving the stability of dexmedetomidine hydrochloride injection, comprising the steps of:

[0043] S1: Add Piranha solution (H 2 SO 4 :H 2 o 2 volume ratio=70:30), and treated at room temperature for 30 minutes to obtain a middle borosilicate glass bottle whose inner surface is hydroxylated, then ultrasonically washed, and dried in an oven at 105°C for later use;

[0044] S2: Add acetone solution of 3-triethoxy-propyl succinic anhydride silane with a volume fraction of 3% in a hydroxylated medium borosilicate glass bottle to carry out silanization reaction, the reaction temperature is 25°C, and the reaction time is 1h , to obtain a silanized medium borosilicate glass bottle, which was then rinsed three times with acetone solution, wa...

Embodiment 2

[0049] Prescription: 0.236g of dexmedetomidine hydrochloride (0.2g as dexmedetomidine), 450g of sodium chloride, water for injection (pH=6) after adding nitrogen treatment to 50000mL, made into 1000 bottles.

[0050] A processing method for improving the stability of dexmedetomidine hydrochloride injection, comprising the steps of:

[0051] S1: Add Piranha solution (H 2 SO 4 :H 2 o 2 volume ratio=70:30), and treated at room temperature for 30 minutes to obtain a middle borosilicate glass bottle whose inner surface is hydroxylated, then ultrasonically washed, and dried in an oven at 105°C for later use;

[0052] S2: Add a solution of 3-aminopropyltriethoxysilane in acetone with a volume fraction of 5% in a hydroxylated medium borosilicate glass bottle to carry out a silanization reaction, the reaction temperature is 15°C, and the reaction time is 0.5h. Obtain a silanized medium borosilicate glass bottle, rinse it three times with acetone solution, wash it three times with u...

Embodiment 3

[0057] Prescription: 0.236g of dexmedetomidine hydrochloride (0.2g as dexmedetomidine), 450g of sodium chloride, water for injection (pH=7) after adding nitrogen treatment to 50000mL, made into 1000 bottles.

[0058] A processing method for improving the stability of dexmedetomidine hydrochloride injection, comprising the steps of:

[0059] S1: Add Piranha solution (H 2 SO 4 :H 2 o 2 volume ratio=70:30), and treated at room temperature for 30 minutes to obtain a middle borosilicate glass bottle whose inner surface is hydroxylated, then ultrasonically washed, and dried in an oven at 105°C for later use;

[0060] S2: Add an acetone solution of 3-mercaptopropyltriethoxysilane with a volume fraction of 8% in a hydroxylated medium borosilicate glass bottle to carry out a silylation reaction, the reaction temperature is 30°C, and the reaction time is 1.5h. Obtain a silanized medium borosilicate glass bottle, rinse it three times with acetone solution, wash it three times with ul...

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Abstract

The invention discloses a treatment method for improving the stability of a dexmedetomidine hydrochloride injection and the dexmedetomidine hydrochloride injection. The treatment method comprises thefollowing steps: in the presence of nitrogen, filtering a prepared dexmedetomidine hydrochloride injection by using a micro-pore filter element, cooling to 35-40 DEG C, putting into a glass bottle ofwhich the inner surface is modified by active groups, and performing sterilization, so as to obtain the dexmedetomidine hydrochloride injection, wherein the active groups comprise one or more of amino, sulfydryl, carboxyl and anhydride. By adopting the method, the stability of the dexmedetomidine hydrochloride injection can be improved without any auxiliary material, and the injection is preventedfrom adverse influence caused by the auxiliary material.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a treatment method for improving the stability of dexmedetomidine hydrochloride injection and dexmedetomidine hydrochloride injection. Background technique [0002] Dexmedetomidine hydrochloride is a highly selective α2-adrenergic receptor agonist, which has the effects of sedative hypnosis, anxiolytic, analgesic, and block sympathetic nerves. It is an effective sedative, analgesic, anesthesia auxiliary drug. Dexmedetomidine hydrochloride was first jointly developed by Abbott of the United States and Olean of Finland. It has been marketed in more than 30 countries and regions around the world. Growing very rapidly. The drug provides a unique type of sedation, that is, "sedation with preserved consciousness", and can reduce the amount of anesthesia and analgesic drugs during the operation, effectively inhibit the stress state during the perianesthesia period, improv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4174A61K9/08A61K47/02A61P25/20A61P25/22A61J1/05A61J1/14
CPCA61J1/05A61J1/14A61J1/1468A61K9/0019A61K9/08A61K31/4174A61K47/02
Inventor 狄彩霞王振国康月菊郭良胡菲李晓林张俊燕姚春虎费晖娟高凯丽
Owner 石药银湖制药有限公司
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