Detection method of remimazolam hydrobromide bacterial endotoxin

A technology for remimazolam hydrobromide and bacterial endotoxin, which is applied in the field of bacterial endotoxin detection, can solve the problem of inability to perform remazolam hydrobromide bacterial endotoxin inspection, etc., and achieves the effect of eliminating the interference effect.

Active Publication Date: 2021-03-09
HAINAN LEVTEC PHARMA
View PDF24 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Bacterial endotoxin inspection in Pharmacopoeia generally dissolves, dilutes with the water for bacterial endotoxin inspection, yet, the inventor finds in research process, dissolves and dilutes Remimazolam Hydrobromide with bacterial endotoxin inspection water (BET water), to Its bacterial endotoxin detection has the effect of inhibiting interference, and the detection of remimazolam hydrobromide bacterial endotoxin cannot be carried out

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Detection method of remimazolam hydrobromide bacterial endotoxin
  • Detection method of remimazolam hydrobromide bacterial endotoxin
  • Detection method of remimazolam hydrobromide bacterial endotoxin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Interference pre-test: take the test product remazolam hydrobromide, and conduct the interference pre-test with the Limulus reagent (λ=0.25EU / ml) from two manufacturers. The results are shown in Table 2.

[0032] Preparation of the test solution (A): Precisely weigh an appropriate amount of the test product, dissolve the test product with an aqueous solution of 10 mg / mL polysorbate 80 (for injection) to a concentration of 100 mg / mL, and use water for bacterial endotoxin testing. Dilute the test solution to 2.5mg / mL, 1.25mg / mL, 0.625mg / mL.

[0033] Bacterial endotoxin standard solution positive control (C): Take the bacterial endotoxin working standard, add 1.0 mL of test water to dissolve, vortex for 15 minutes, and dilute with bacterial endotoxin test water at 1.0 EU / mL and 0.5 EU / mL.

[0034] Positive control of the test product (B): respectively take an equal volume of the solution containing bacterial endotoxin 1.0EU / ml and the same volume of the test solution 5mg / m...

Embodiment 2

[0043] Interference pre-test: take the test product remazolam hydrobromide, and conduct the interference pre-test with the Limulus reagent (λ=0.25EU / ml) from two manufacturers. The results are shown in Table 3.

[0044] Preparation of test solution (A): Accurately weigh an appropriate amount of the test product, dissolve the test product with an aqueous solution of 20mg / mL polysorbate 80 (for injection) to a concentration of 100mg / mL, and use water for bacterial endotoxin testing. Dilute the test solution to 2.5mg / mL, 1.25mg / mL, 0.625mg / mL.

[0045] Bacterial endotoxin standard solution positive control (C): Take the bacterial endotoxin working standard, add 1.0 mL of test water to dissolve, vortex for 15 minutes, and dilute with bacterial endotoxin test water at 1.0 EU / mL and 0.5 EU / mL.

[0046] Positive control of the test product (B): respectively take an equal volume of the solution containing bacterial endotoxin 1.0EU / ml and the same volume of the test solution 5mg / mL, 2....

Embodiment 3

[0052] Interference pre-test: take the test product remazolam hydrobromide (batch number: 180102), and conduct the interference pre-test with the Limulus reagent (λ=0.25EU / ml) from two manufacturers. The results are shown in Table 4.

[0053] Preparation of test solution (A): Accurately weigh an appropriate amount of the test product, dissolve the test product with an aqueous solution of 30 mg / mL polysorbate 80 (for injection) to a concentration of 100 mg / mL, and use water for bacterial endotoxin testing. Dilute the test solution to 2.5mg / mL, 1.25mg / mL, 0.625mg / mL.

[0054] Bacterial endotoxin standard solution positive control (C): Take the bacterial endotoxin working standard, add 1.0 mL of test water to dissolve, vortex for 15 minutes, and dilute with bacterial endotoxin test water at 1.0 EU / mL and 0.5 EU / mL.

[0055] Positive control of the test product (B): Take an equal volume of the solution containing bacterial endotoxin 1.0EU / ml and the same volume of the test solutio...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention discloses a detection method of remimazolam hydrobromide bacterial endotoxin. The detection method comprises the following steps: rechecking the sensitivity of a tachypleus amebocyte lysate; determining the limit value and the minimum dilution concentration of the remimazolam hydrobromide bacterial endotoxin; performing an interference experiment to confirm the concentration of a test sample without interference, wherein in the experiment, the test sample is dissolved by using an aqueous polysorbate-80 solution with a concentration of 10-30 mg/mL, and diluted by using water for bacterial endotoxin detection to obtain a test sample solution; and detecting the remimazolam hydrobromide bacterial endotoxin by dissolving a remimazolam hydrobromide test sample via the aqueous polysorbate-80 solution with the concentration of 10-30 mg/mL, and diluting the test sample to an effective concentration without interference by using water for bacterial endotoxin detection before conduction of detection on the bacterial endotoxin. According to the method, the aqueous polysorbate-80 solution with a certain concentration is used for dissolving the sample, so the interference effect ofthe test sample on bacterial endotoxin can be eliminated; and the method is simple, convenient, easy to operate and high in practicability.

Description

technical field [0001] The invention relates to the technical field of bacterial endotoxin detection, in particular to a method for detecting bacterial endotoxin of remazolam hydrobromide. Background technique [0002] Bacterial endotoxin is a macromolecular substance with various biological activities produced by gram stealth bacteria. Its main chemical component is lipopolysaccharide, and endotoxin is the main pollutant in injection drugs (raw materials, etc.). [0003] Limulus test method is a common detection method for bacterial endotoxin. It utilizes the mechanism of the agglutination reaction between Limulus reagent and endotoxin to qualitatively or quantitatively detect bacterial endotoxin in drugs or blood. [0004] In the Pharmacopoeia, bacterial endotoxin test is generally dissolved and diluted with bacterial endotoxin test water. However, the inventor found in the research process that using bacterial endotoxin test water (BET water) to dissolve and dilute remazo...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N33/50G01N33/579G01N1/28G01N1/38
CPCG01N33/15G01N33/50G01N33/579G01N1/28G01N1/38Y02A50/30
Inventor 宫学金陈羽刘雨佳李凤英罗鸣黄浩喜苏忠海
Owner HAINAN LEVTEC PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap