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Method for detecting bacterial endotoxin in dexmedetomidine hydrochloride by gel process

A technology for dexmedetomidine hydrochloride and bacterial endotoxin, which is applied in the field of drug analysis, can solve the problems of affecting the recovery of bacterial endotoxin, the recovery rate is less than 50%, and low popularity, so as to achieve accurate and reliable detection results and low detection cost , The effect of eliminating interference

Pending Publication Date: 2020-10-16
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When using NaOH solution to adjust the pH value of the sample solution or using diluent I to slow down the chelation and adjust the pH value, it will cause dexmedetomidine hydrochloride to separate out from the aqueous solution, and this separation has affected the recovery of bacterial endotoxin, the recovery rate Less than 50%
However, photometric detection is complicated to operate, and the test requires professional equipment such as a microplate reader, and its popularity is low.

Method used

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  • Method for detecting bacterial endotoxin in dexmedetomidine hydrochloride by gel process
  • Method for detecting bacterial endotoxin in dexmedetomidine hydrochloride by gel process
  • Method for detecting bacterial endotoxin in dexmedetomidine hydrochloride by gel process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] 1. Solution preparation

[0052] 1. Dilution of the test solution

[0053] Weigh about 10 mg of dexmedetomidine hydrochloride, add about 1 mL of DMSO, completely dissolve and mix to obtain a 10 mg / mL dexmedetomidine hydrochloride DMSO solution. Finally, use diluent I and BET water, and gradually dilute to the test solution of 0.3mg / mL (2c) and 0.15mg / mL (c) according to the following dilution methods. In the need testing solution of 0.15mg / mL (c), the volume concentration of DMSO is 1.5%, and the volume concentration of diluent I is 23.5%.

[0054]

[0055] 2. Preparation of Bacterial Endotoxin Standards

[0056] Dissolve 1 bacterial endotoxin standard in BET water, mix continuously with a vortex mixer for 20-30 minutes, dilute with BET water, and mix for at least 30 seconds before proceeding to the next dilution. Diluted successively to 0.03EU / mL (2λ),

[0057] 0.015EU / mL (λ), 0.0075EU / mL (0.5λ), 0.00375EU / mL (0.25λ).

[0058] 3. Preparation of Bacterial Endoto...

Embodiment 2

[0081] 1. Solution preparation

[0082] 1. Dilution of the test solution

[0083]Weigh about 10 mg of dexmedetomidine hydrochloride, add about 1 mL of DMSO, completely dissolve and mix to obtain a 10 mg / mL dexmedetomidine hydrochloride DMSO solution. Finally, use diluent I and BET water, and gradually dilute to the test solution of 0.3mg / mL (2c) and 0.15mg / mL (c) according to the following dilution methods. In the need testing solution of 0.15mg / mL (c), the volume concentration of DMSO is 2.25%, and the volume concentration of diluent I is 47.75%.

[0084]

[0085] 2. Preparation of Bacterial Endotoxin Standards

[0086] Referring to Example 1.

[0087] 3. Preparation of Bacterial Endotoxin Test Solution

[0088] Referring to Example 1.

[0089] 2. Limulus reagent interference test

[0090] 1. Test process

[0091] Take 30 tubes of Limulus reagent (0.015EU / mL) dissolved in BET water, 0.1 mL per tube. Add 2λ, λ, 0.5λ, 0.25λ concentrations of bacterial endotoxin stand...

Embodiment 3 2

[0135] Embodiment 3 dimethyl sulfoxide (DMSO) interference test

[0136] Tests in Example 1 confirm that using DMSO-dissolved dexmedetomidine hydrochloride to prepare 10 mg / mL dexmedetomidine hydrochloride solution, adding an appropriate amount of diluent I in the subsequent dilution process will not cause the sample to separate out, and can eliminate dexmedetomidine hydrochloride Interfering effect of detomidine on detection of bacterial endotoxin.

[0137] In order to verify whether the above-mentioned DMSO addition method and the amount itself will destroy the bacterial endotoxin, DMSO also carried out 1 interference pre-test and 3 interference tests.

[0138] 1. DMSO interference pre-test

[0139] 1. Preparation of the test solution: Take DMSO and gradually dilute it with BET water to obtain dilutions with DMSO concentrations of 20%, 10%, 5%, 2.5%, and 1.25%, respectively, and record this series of solutions as NPC.

[0140] 2. Preparation of bacterial endotoxin standard...

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Abstract

The invention relates to a method for detecting bacterial endotoxin in dexmedetomidine hydrochloride by a gel process. The method comprises the following steps of: preparing a dexmedetomidine hydrochloride solution by using dimethyl sulfoxide as a solvent, and diluting the prepared dexmedetomidine hydrochloride solution by using dimethyl sulfoxide and / or a diluent I and bacterial endotoxin inspection water until a concentration not lower than a minimum effective active concentration to prepare a test solution; and carrying out bacterial endotoxin detection by adopting a gel process. By adopting the detection method, the interference effect of dexmedetomidine hydrochloride on bacterial endotoxin can be eliminated, the dilution multiple is small, the detection result is accurate and reliable, the operation is simple and convenient, the detection cost is low, and compared with photometric detection, the operation is convenient and simple.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for detecting bacterial endotoxin in dexmedetomidine hydrochloride by a gel method. Background technique [0002] Bacterial endotoxins are cell wall components of Gram-negative bacteria that are released when the bacteria die or autolyse. Therefore, bacterial endotoxins widely exist in nature. When endotoxin enters the human body through the digestive tract, it does not cause harm, but when endotoxin enters the blood through injection or other means, it will cause different diseases. After a small amount of endotoxin enters the blood, it is inactivated by liver cells and does not cause damage to the body. A large amount of endotoxin entering the blood will cause a fever reaction - "pyrogen reaction", and even lead to death. Therefore, preparations such as biological products, injections, chemicals, radiopharmaceuticals, antibiotics, vaccines, dialysis fluids, and medical e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/579
CPCG01N33/579
Inventor 唐咏群冷玲
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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