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Drug detection method and quality control method of compound calcium gluconate oral solution

A quality control method, the technology of calcium gluconate, applied in the field of drug quality testing, can solve the problems that quality standards cannot be perfect and effectively control product quality, and achieve the effect of effectively controlling product quality

Pending Publication Date: 2021-07-30
SICHUAN YABAO GUANGTAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is that the current quality standards of some drugs have the detection of items such as traits, identification, inspection, and content, but the inspection items have no aluminum element impurity control items. This quality standard cannot perfect and effectively control product quality. The purpose is to Provide drug detection methods and quality control methods for compound calcium gluconate oral solution to solve the above problems

Method used

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  • Drug detection method and quality control method of compound calcium gluconate oral solution
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  • Drug detection method and quality control method of compound calcium gluconate oral solution

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Embodiment 1

[0042] The drug detection method of the present invention includes the detection of aluminum element. The present invention adds the inspection item of aluminum element in the drug detection method, the aluminum element inspection is not mentioned in the existing drug detection index, and the aluminum element in the drug cannot be monitored; there are many aluminum element determination methods, mainly including spectroscopic Spectrophotometry, atomic absorption method, inductively coupled plasma method, etc., the present invention preferably uses inductively coupled plasma mass spectrometry to detect the aluminum element in medicine.

Embodiment 2

[0044]The quality control method of the compound calcium gluconate oral solution of the present invention includes the inspection of aluminum element; the present invention applies the aluminum element inspection to specific medicines, and specifically strengthens the quality monitoring of the compound calcium gluconate oral solution.

[0045] In order to ensure that the product quality is effectively controlled, the present invention studies the quality standard of compound calcium gluconate oral solution, determines the inspection of increasing aluminum element in the quality standard of compound calcium gluconate oral solution, and the present invention passes through to compound calcium gluconate oral solution The inspection of aluminum element can control the product quality more scientifically and effectively, and solve the problem that there is no elemental impurity control item in the inspection item in the current quality standard of compound calcium gluconate oral solu...

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Abstract

The invention discloses a drug detection method and a quality control method of a compound calcium gluconate oral solution. The drug detection method comprises aluminum element inspection. According to the invention, aiming at the defect that the quality control standard of medicines, especially a compound calcium gluconate oral solution, is not perfect, the quality control method of the preparation is researched, and aluminum inspection is added on the basis of the original quality control standard, so that the quality control standard of the preparation is improved so as to ensure the quality of the product and the clinical curative effect of the preparation.

Description

technical field [0001] The invention relates to a drug quality detection method, in particular to a drug detection method and a quality control method for compound calcium gluconate oral solution. Background technique [0002] At present, the current quality standards of most drugs include the detection of traits, identification, inspection, content and other items, but there is no aluminum impurity control item in the inspection items, and this quality standard cannot improve and effectively control product quality; , and the harm to the human body is very terrible. The World Health Organization officially identified aluminum as a food pollutant in 1989. When the content of aluminum in the human body is too high, it will affect the intestinal absorption of phosphorus, strontium, iron, calcium and other elements. Insoluble aluminum phosphate is formed in the intestinal tract and excreted with feces, and phosphorus deficiency affects the absorption of calcium (not enough calc...

Claims

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Application Information

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IPC IPC(8): G01N27/62G01N1/28
CPCG01N27/62G01N1/28
Inventor 徐辉杰严丹谢莉
Owner SICHUAN YABAO GUANGTAI PHARMA
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