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Quantitative measurement method for basic lanthanum carbonate impurities in lanthanum carbonate chewable tablets

A technology of lanthanum carbonate and chewable tablets, which is applied in measuring devices, material analysis using radiation diffraction, instruments, etc., can solve the problems of excipient interference and cumbersome result processing, and achieve good specificity

Inactive Publication Date: 2019-08-06
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lanthanum carbonate will be degraded into lanthanum carbonate crystalline form I and lanthanum carbonate crystalline form II under high temperature and high humidity conditions. At present, there is no simple and rapid determination method for the quantitative determination of lanthanum carbonate content. At present The follow-up results of existing detection methods (such as "CN101484798 Assay method for basic lanthanum carbonate") are cumbersome to deal with, and this product has the problem of interference from auxiliary materials. This patented method has good specificity, strong operability, and high Accuracy and Precision

Method used

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  • Quantitative measurement method for basic lanthanum carbonate impurities in lanthanum carbonate chewable tablets
  • Quantitative measurement method for basic lanthanum carbonate impurities in lanthanum carbonate chewable tablets
  • Quantitative measurement method for basic lanthanum carbonate impurities in lanthanum carbonate chewable tablets

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0032] 1) Preparation of the test product: Take 10 lanthanum carbonate chewable tablets, grind them, mix them evenly, take the powder through a 100-mesh sieve, accurately weigh 1261 mg of the sieved fine powder, containing 577.2 mg of lanthanum carbonate, and weigh two in parallel ; Take a fine powder as the test product;

[0033] 2) Preparation of reference substance: Take another portion of the fine powder and add 24.95 mg of lanthanum basic carbonate crystal form I passing through a 100 mesh sieve, and 27.72 mg of lanthanum basic carbonate crystal form II passing through a 100 mesh sieve, and mix well. Reference substance

[0034] 3) Measurement and calculation: Measured by X-ray diffraction method, using Cu target as light source, θ~2θ linkage continuous scanning, scanning interval 0.1, scanning rate 0.4s / step, and the diffraction angle 2θ is 15°~50° In a single scan, the test article and the reference substance were measured, and each sample was measured 3 times in parallel; ...

Embodiment 1

[0035] Example 1 Specificity study

[0036] Blank excipients: directly take samples of blank excipients (glucose, silicon dioxide, and magnesium stearate prepared according to the mass ratio of 1:1:1), pass a 100-mesh sieve, and take the sieved sample.

[0037] Raw material medicine: Take a sample of the raw material medicine (lanthanum carbonate) directly, pass a 100-mesh sieve, and take the sieved sample.

[0038] Preparation: Take this product (lanthanum carbonate chewable tablet, 500mg specification), grind it through a 100 mesh sieve, and take the sieved sample.

[0039] Basic lanthanum carbonate crystal form I: Take the basic lanthanum carbonate crystal form I reference substance (reference substance level, this sample is used in the experimental scheme of the present invention) after a 100-mesh sieve.

[0040] Basic lanthanum carbonate crystal form II: Take the basic lanthanum carbonate crystal form II reference substance (reference level, this sample is used in the experimental ...

Embodiment 2

[0046] Example 2 Linear study

[0047] Take 15 pieces of this product (lanthanum carbonate chewable tablets, 500mg specifications) and grind them through a 100-mesh sieve. Take the fine powder of this product after sieving and proceed as follows.

[0048] Test product: Take 1261 mg of fine powder of this product (equivalent to 577.2 mg of lanthanum carbonate).

[0049] Quantitative limit concentration + preparation: take this product fine powder 1261mg (equivalent to 577.2mg of lanthanum carbonate), add basic lanthanum carbonate I4.70mg, basic lanthanum carbonate II 5.29mg, mix the above powders uniformly, determine (crystal form I 0.8 %, Form II 0.9%)]

[0050] Limit concentration 60% + preparation: take this product fine powder 1261mg (equivalent to lanthanum carbonate 577.2mg), add basic lanthanum carbonate I6.38mg, basic lanthanum carbonate II 7.09mg, mix the above powders uniformly, determine (crystal form I 1.08%, crystal form II 1.2%).

[0051] Limit concentration 80% + prepara...

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Abstract

The invention provides a quantitative measurement method for basic lanthanum carbonate impurities in lanthanum carbonate chewable tablets. The basic lanthanum carbonate includes a basic lanthanum carbonate crystal form I and / or a basic lanthanum carbonate crystal form II; and a test substance and a reference substance are measured through an X-ray diffraction method; with an angle 2theta ranging from 24.3 degrees to 24.7 degrees adopted as the characteristic diffraction peak of the basic lanthanum carbonate crystal form I, and an angle 2theta ranging from 38.0 degrees to 38.4 degrees adopted as the characteristic diffraction peak of the basic lanthanum carbonate crystal form II, linear regression is carried out. The method provided by the invention can quantitatively measure the content ofthe basic lanthanum carbonate impurities in the lanthanum carbonate chewable tablets. The method has the advantages of rapidness, high operability, high accuracy and high precision.

Description

Technical field [0001] The invention relates to the technical field of substance detection, in particular to a method for quantitatively determining impurities in lanthanum carbonate chewable tablets lanthanum basic carbonate. Background technique [0002] Lanthanum carbonate is currently the new drug with the best selectivity for the treatment of hyperphosphatemia in nephropathy. It has been marketed in more than 20 countries around the world, including the United States, Britain, France, Germany, Canada, Switzerland and other countries. In 1998, the new non-aluminum, non-calcium and phosphorus binding agent SEVELAMER (Sevelamer, trade name RENA GLER) was approved by the US FDA for marketing. In 2004, the new FOSRENOL (lanthanum carbonate) was another non-aluminum and non-calcium phosphorus binding agent. Animal experiments have proved that SEVELAMER and FOSRENOL can effectively reduce blood phosphorus, and rarely cause hypercalcemia and increase the calcium and phosphorus produ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N23/207G01N23/2005
CPCG01N23/20G01N23/2005
Inventor 宋更申安百锋李同进张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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