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

Method for determining dissolution rate of DMSA (Dimercaptosuccinic Acid) preparation

A dimercaptosuccinic acid and dissolution technology, which is applied in the field of medical testing, can solve problems such as defects in quality standards and the inability to guarantee the effectiveness of clinical medication, and achieve high sensitivity, improve quality control standards, and improve quality controllability Effect

Active Publication Date: 2017-12-08
HEFEI LIFEON PHARMA
View PDF5 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is no dissolution test method for dimercaptosuccinic acid preparations, which has caused serious defects in the quality standards of this variety, and also makes it impossible to guarantee the effectiveness of clinical medication.

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 determining dissolution rate of DMSA (Dimercaptosuccinic Acid) preparation
  • Method for determining dissolution rate of DMSA (Dimercaptosuccinic Acid) preparation
  • Method for determining dissolution rate of DMSA (Dimercaptosuccinic Acid) preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] 1.1 Chromatographic conditions: adopt Kromasil C-18 chromatographic column, particle diameter is 5um, column length is 150mm, column diameter is 4.6mm, LC Solution chromatographic workstation, with acetonitrile as mobile phase A, with 0.05mol / L potassium dihydrogen phosphate aqueous solution ( Phosphoric acid was used to adjust the pH value to 2.5) as mobile phase B, the ratio of mobile phase A to B was 10:90, the detection wavelength was 210nm, the column temperature was 30°C, and the flow rate was 1.0mL / min.

[0042] 1.2 Preparation of dissolution medium

[0043] Sodium lauryl sulfate, sodium bisulfite are placed in water, constant volume, obtain 1000mL stripping medium, the mass concentration of sodium lauryl sulfate in the stripping medium is 0.2%, the mass concentration of sodium bisulfite in the stripping medium 0.1%.

[0044] 1.3 Preparation of test solution and control solution

[0045] Accurately weigh 25 mg of the contents of the dimercaptosuccinic acid cont...

Embodiment 2

[0055] 2.1 Chromatographic conditions are the same as 1.1.

[0056] 2.2 According to the description in the 2015 edition of the Chinese Pharmacopoeia, dimercaptosuccinic acid is slightly soluble in methanol or ethanol, and almost insoluble in water or chloroform. Experimental investigation of the solubility of dimercaptosuccinic acid in water, mass concentration of 0.1% sodium lauryl sulfate aqueous solution, mass concentration of 0.2% sodium lauryl sulfate aqueous solution, pH4.5 and pH6.8 phosphate buffer , the results are shown in Table 2 below.

[0057] Table 2 raw material solubility test result

[0058] solvent

Solubility (mg / mL)

Whether the sink condition is met

water

0.2

no

0.05% sodium lauryl sulfate water soluble

0.5

no

0.1% sodium lauryl sulfate aqueous solution

0.8

yes

pH4.5 phosphate buffered saline solution

1.0

yes

pH6.8 phosphate buffered saline solution

0.3

no

[0059]...

Embodiment 3

[0062] 3.1 Chromatographic conditions are the same as 1.1.

[0063] 3.2 Preparation of dissolution medium

[0064] Sodium lauryl sulfate is placed in water, constant volume, obtains 1000mL dissolution medium, and the mass concentration of sodium lauryl sulfate in the dissolution medium is 0.2%.

[0065] 3.3 Take dimercaptosuccinic acid capsules (1 capsule, the specification is 50mg / capsule), according to the dissolution test method (Chinese Pharmacopoeia 2015 Edition Four General Rules 0931 First Method), add 1000mL of the dissolution medium obtained in 3.2, and the rotation speed is 100r / min, operate according to the law, after 45min, take 5-8mL of the solution, filter, and take the subsequent filtrate as the test solution.

[0066] Another dimercaptosuccinic acid was taken as a control, dissolved in methanol, and then diluted with a dissolution medium to prepare a solution containing 50 μg of dimercaptosuccinic acid per 1 mL, as a control solution. Precisely measure 20 μL...

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 provides a method for determining the dissolution rate of a DMSA (Dimercaptosuccinic Acid) preparation. The method comprises the following steps: dissolving out the DMSA preparation by utilizing a water solution containing a surfactant and an antioxidant as a solvent medium, thus obtaining a test production solution; carrying out HPLC (High Performance Liquid Chromatography) detection on the test product solution, and determining the dissolution rate of the DMSA preparation according to a detection result. According to the method provided by the invention, an important means of medicine in-vitro dissolution evaluation is supplemented, and the quality control standard is improved, so that the quality controllability of DMSA capsules is greatly increased.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a method for measuring the dissolution rate of a dimercaptosuccinic acid preparation. Background technique [0002] Most oral solid preparations must be absorbed into the blood circulation after administration, and can only be effective after reaching a certain blood concentration. Before being absorbed, the drug in the solid preparation must go through the process of disintegration and dissolution and then turn into a solution. The absorption rate of the drug in the body is often determined by the speed of dissolution. [0003] Dissolution rate refers to the dissolution rate and degree of the active ingredient of the drug from the preparation under specified conditions. As an important indicator for the quality evaluation of oral solid preparations, it is widely used in drug research and development, production control and market product supervision. Therefore, the ac...

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): G01N30/02
CPCG01N30/02
Inventor 郑文平夏军
Owner HEFEI LIFEON PHARMA
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