Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Method for detecting macromolecular substances in perhexiline injection

A technology of macromolecular substances and detection methods, which is applied in the field of detection of macromolecular substances in Guanxinning injection, can solve the problems of irregularity and achieve the effect of convenient operation

Active Publication Date: 2012-07-18
YABAO PHARMA GRP CO LTD
View PDF5 Cites 4 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This study was carried out based on this requirement, and established a simple and quick method to detect macromolecular substances in Guanxinning injection, and there is no existing method for the establishment of an exclusionary detection method for macromolecular substances in traditional Chinese medicine injections. Regulatory methods can refer to

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
  • Method for detecting macromolecular substances in perhexiline injection
  • Method for detecting macromolecular substances in perhexiline injection
  • Method for detecting macromolecular substances in perhexiline injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Chromatographic conditions: the chromatographic column is TSKgel G3000PWXL (7.8mm×300mm); the mobile phase is aqueous solution; the flow rate is 0.8ml / min; the column temperature is 30°C; the injection volume is 5μl;

[0069] Evaporative light scattering detector conditions Drift tube temperature: 110°C; carrier gas (air) flow rate: 3.0ml / min;

[0070] Accurately weigh 5 parts of dextran reference substances whose relative molecular weights are respectively 2500, 4600, 7100, 10000, 21400, and prepare each 1mg / ml solution with an aqueous solution to obtain the reference substance solution I. Meanwhile, the aqueous solution is taken as a blank control solution. Injection test, with retention time t R For the abscissa, the lgM of the molecular mass of dextran W Perform regression processing for the ordinate;

[0071] Accurately weigh the dextran reference substances with relative molecular masses of 4600 and 10000 respectively, dissolve them in aqueous solution to obtain...

Embodiment 2

[0076] Chromatographic conditions: the chromatographic column is TSKgel G3000PWXL (7.8mm×300mm); the mobile phase is aqueous solution; the flow rate is 0.5ml / min; the column temperature is 35°C; the injection volume is 8μl;

[0077] Evaporative light scattering detector conditions Drift tube temperature: 108°C; carrier gas (air) flow rate: 2.5ml / min;

[0078] Accurately weigh 5 parts of dextran reference substances with relative molecular masses of 2500, 4600, 7100, 10000, and 21400, and prepare 1.2 mg / ml solutions with aqueous solution to obtain the reference substance solution I. At the same time, take the aqueous solution as a blank control solution , injection test, with retention time t R For the abscissa, the lgM of the molecular mass of dextran W Perform regression processing for the ordinate;

[0079] Accurately weigh the dextran reference substances with relative molecular masses of 4600 and 10000 respectively, dissolve them in aqueous solution to obtain solutions w...

Embodiment 3

[0084] Chromatographic conditions: the chromatographic column is TSKgel G3000PWXL (7.8mm×300mm); the mobile phase is aqueous solution; the flow rate is 0.12ml / min; the column temperature is 25°C; the injection volume is 3μl;

[0085] Evaporative light scattering detector conditions Drift tube temperature: 112°C; carrier gas (air) flow rate: 3.5ml / min;

[0086] Accurately weigh 5 parts of dextran reference substances with relative molecular masses of 2500, 4600, 7100, 10000, and 21400 respectively, and prepare 0.8 mg / ml solutions with aqueous solution to obtain the reference substance solution I. At the same time, take the aqueous solution as a blank control solution , injection test, with retention time t R For the abscissa, the lgM of the molecular mass of dextran W Perform regression processing for the ordinate;

[0087] Accurately weigh the dextran reference substances with relative molecular masses of 4600 and 10000 respectively, dissolve and constant volume with aqueous s...

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 method for detecting macromolecular substances in a perhexiline injection. The method after being subjected to a series of investigation, testing and verification of specificity and linearity investigation, degree of precision, stability and the like, can detect the macromolecular substances in the perhexiline injection easily, conveniently and quickly. From an HPLC (High Performance Liquid Chromatography) spectrum, macromolecular substances with molecular weight greater than 2500 are not detected in five batches of detected perhexiline injection samples.

Description

field of invention [0001] The invention relates to the field of medicine, in particular to a method for detecting macromolecular substances in Guanxinning injection. Background technique [0002] Traditional Chinese medicine injections have complex chemical components and various types, and most of them are macromolecules. These macromolecules, such as proteins, polypeptides, sugars, tannins, and pectins, are both immunogenic and immunoreactive, so they have sensitization potential. possibility. Traditional Chinese medicine injections act directly on the vein and have a quick effect, but once there are side effects, serious consequences will occur. In July 2009, the State Food and Drug Administration issued the "Quality Control Points for Re-evaluation of the Safety of Traditional Chinese Medicine Injections", which clearly requires that for the large categories of ingredients that may exist under the process conditions of specific varieties but have not been detected in th...

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
IPC IPC(8): G01N30/88
Inventor 任武贤辛艳禹玉洪陈建林
Owner YABAO PHARMA GRP CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com