Method for determining dissolution curve of lanthanum carbonate chewable tablets

A measurement method and technology of chewable tablets, which are applied in the field of analytical chemistry, can solve the problems of ineffective distinction, poor applicability, and less use of the reciprocating cylinder method, and achieve the effects of quality and curative effect, consistency, and quality assurance

Inactive Publication Date: 2019-08-09
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
View PDF4 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reciprocating cylinder method is used less and has poor domestic applicability. The paddle method (50rpm) cannot effectively distinguish the in vitro release of lanthanum carbonate chewable tablets, and the influence of prescription and process variables on in vitro release cannot be effectively distinguished. Therefore, it is necessary to establish a discriminative dissolution curve determination method to distinguish the dissolution behavior of different sources of lanthanum carbonate chewable tablets, so as to distinguish the intrinsic quality of the product

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 curve of lanthanum carbonate chewable tablets
  • Method for determining dissolution curve of lanthanum carbonate chewable tablets
  • Method for determining dissolution curve of lanthanum carbonate chewable tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Dissolution method: paddle method, 75 rpm

[0041] Medium volume: 1000ml

[0042] Medium: 0.25N hydrochloric acid

[0043] Medium temperature: 37.0°C

[0044] Sampling time: 15, 30, 45, 60, 90, 120min

[0045] Sampling volume: take 12 parts each time, 10ml each (simultaneously supplement the dissolution medium with the same volume and the same temperature)

[0046] The test solution: 0.45μm membrane filter, take the subsequent filtrate as the test solution.

[0047] Reference substance solution: Take lanthanum ion standard solution (c=1.000mg / L) and dilute it with dissolution medium 2 times as the reference substance solution.

[0048] Get need testing solution and reference substance solution and carry out ion chromatography detection, record collection of graphs, calculate dissolution rate.

[0049] The dissolution data is shown in Table 2, and the release curve comparison is shown in figure 1 .

[0050] Table 2 Dissolution in 0.25N hydrochloric acid, 75 rpm

...

Embodiment 2

[0054] Dissolution method: paddle method

[0055] Speed: 65 rev / min

[0056] Medium volume: 1000ml

[0057] Medium: 0.25N hydrochloric acid

[0058] Medium temperature: 37.0°C

[0059] Sampling time: 15, 30, 45, 60, 90, 120min

[0060] Sampling volume: take 12 parts each time, 10ml each (simultaneously supplement the dissolution medium with the same volume and the same temperature)

[0061] The test solution: 0.45μm membrane filter, take the subsequent filtrate as the test solution.

[0062] Reference substance solution: Take lanthanum ion standard solution (c=1.000mg / L) and dilute it with dissolution medium 2 times as the reference substance solution.

[0063] Get need testing solution and reference substance solution and carry out ion chromatography detection, record collection of graphs, calculate dissolution rate.

[0064] The dissolution data is shown in Table 3, and the release curve comparison is shown in figure 2 .

[0065] Table 3 Dissolution in 0.25N hydrochlo...

Embodiment 3

[0069] Dissolution method: paddle method

[0070] Speed: 50 rev / min

[0071] Medium volume: 1000ml

[0072] Medium: 0.25N hydrochloric acid

[0073] Medium temperature: 37.0°C

[0074] Sampling time: 15, 30, 45, 60, 90, 120min

[0075] Sampling volume: take 12 parts each time, 10ml each (simultaneously supplement the dissolution medium with the same volume and the same temperature)

[0076] The test solution: 0.45μm membrane filter, take the subsequent filtrate as the test solution.

[0077] Reference substance solution: Take lanthanum ion standard solution (c=1.000mg / L) and dilute it with dissolution medium 2 times as the reference substance solution.

[0078] Get need testing solution and reference substance solution and carry out ion chromatography detection, record collection of graphs, calculate dissolution rate.

[0079] The dissolution data is shown in Table 4, and the release curve comparison is shown in image 3 .

[0080] Table 4 Dissolution in 0.25N hydrochl...

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

PropertyMeasurementUnit
volumeaaaaaaaaaa
Login to view more

Abstract

The invention relates to the field of analytical chemistry, in particular to a method for determining a dissolution curve of lanthanum carbonate chewable tablets. An oar method is adopted, wherein a dissolution medium is 0.25 N hydrochloric acid solution, and the rotating speed is 50-75 revolutions per minute. The method for determining the dissolution curve of the lanthanum carbonate chewable tablets has the characteristics of science, durability, reproducibility and the like, the influence of different prescriptions and process variables on the in vitro release of the lanthanum carbonate chewable tablets can be effectively distinguished, the method for determining the dissolution curve of the lanthanum carbonate chewable tablets can be used for quality consistency evaluation of generic drugs and original research drugs, guarantee can be provided for consistency of quality between batches of drugs, the quality of the drugs is further ensured, and consistency of quality and curative effect is achieved.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for measuring the dissolution curve of lanthanum carbonate chewable tablets. Background technique [0002] Since 2012, the State Food and Drug Administration (CFDA) has launched the quality consistency evaluation of generic drugs. The generic drugs that have been approved for marketing will be carried out in stages and batches according to the principle of consistent quality and efficacy with the original drugs. Evaluation, so that generic drugs are consistent with original drugs in terms of quality and efficacy. Among them, formulating a scientific and reasonable solid preparation dissolution curve is an important step to improve the success rate of bioequivalence tests in vivo, and provides a basis for including the characteristic dissolution curve of the drug in the corresponding quality standards, and provides a basis for the consistency of drug quality between ba...

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): G01N30/96G01N30/06G01N30/14
CPCG01N30/06G01N30/14G01N30/96G01N2030/146
Inventor 宋更申石红燕郑红兵谭云红张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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