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Detection method for vestigial protein in amoxicillin prepared by using enzymic method

A technology for the preparation of amoxicillin and enzymatic method, which is applied in the field of pharmaceuticals, can solve the problems of patients' allergies, and achieve the effect of improving drug safety

Active Publication Date: 2012-08-22
内蒙古联邦动保药品有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, in the production process of enzymatic synthesis of amoxicillin, the penicillin G acylase (Novel penicillin G Acylase NPGA) used is an exogenous protein to the human body, and if it exists in the final product, it will be harmful to the patient. May cause allergic and other adverse reactions

Method used

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  • Detection method for vestigial protein in amoxicillin prepared by using enzymic method
  • Detection method for vestigial protein in amoxicillin prepared by using enzymic method
  • Detection method for vestigial protein in amoxicillin prepared by using enzymic method

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Experimental program
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Effect test

preparation example Construction

[0077] Preparation of the test solution: take 1.0g of each test in Table 2, accurately weigh it, put it in a 25ml volumetric flask, add an appropriate amount of 0.05mol / L phosphate buffer (pH 7.0), dropwise add 0.1mol / L sodium hydroxide solution, shake while adding dropwise, add dropwise until the test product is completely dissolved (solution is clear), and dilute to 25ml with 0.05mol / L phosphate buffer solution (pH7.0), that is, it is obtained.

[0078] Precisely measure 100 μL of each of the above solutions and inject them into a liquid chromatograph, record the peak area, and measure the content of residual protein by the external standard method. The results are shown in Table 2

[0079] Table 2 Determination results of amoxicillin raw materials

[0080]

[0081] *Test results below the limit of quantification are reported as "∠LOQ".

experiment example

[0083] 3. Methodological validation

[0084] 3.1 Exclusivity

[0085] By measuring the HPLC chart of penicillin G acyltransfer mold solution, blank solution, test solution, test sample recovery rate by the method in the above-mentioned embodiment, refer to Figure 2 to Figure 7 ,Depend on Figure 2 to Figure 7 It can be seen that the main amoxicillin peak does not interfere with the determination of the protein standard peak.

[0086] 3.2 Linear:

[0087] In the range of protease content from 0.0153 μg / mL to 15.3 μg / mL, the linear relationship is good ( Image 6 ), linear equation: y=18454X-118735, correlation coefficient, 0.9999.

[0088] 3 Detection and quantification limits

[0089] The limit of detection is calculated as S / N=3, LOD=0.072 ppm; the limit of quantification is calculated as S / N=10, LOQ=0.22 ppm.

[0090] 4 Stability of the solution

[0091] 4.1 Stability of standard solutions

[0092] Take about 80mg of protein standard, dissolve and dilute to 100mL wi...

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Abstract

The invention relates to the field of pharmacy, provides a detection method for vestigial protein in amoxicillin prepared by using an enzymic method, and comprises obtaining penicillin G acyltransferase standard substances, and using 0.05mol / L of phosphate buffer with the potential of hydrogen (pH) value of 7.0 for diluting to obtain standard substance liquid; obtaining products for testing, accurately weighting and placing the products for testing in a measuring flask, adding 0.05mol / L of phosphate buffer with the pH value of 7.0, adding 0.1mol / L of sodium hydroxide solution until the products for testing are dissolved and solution is clear, and using 0.05mol / L of phosphate buffer with the pH value of 7.0 for diluting to obtain product solution for testing; respectively and accurately measuring and obtaining 100mu L of the solution and injecting the solution in a high performance liquid chromatograph, and recording the peak area and measuring content of the vestigial protein by using an external standard method. The detection method can effectively detect the content of the vestigial protein in amoxicillin products, thereby being capable of effectively detecting quality of the products and improving pharmacy safety of medicines.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a method for detecting the quality of medicines, and more particularly to a method for measuring residual protein in amoxicillin prepared by an enzymatic method. Background technique [0002] At present, there are two methods for the synthesis of amoxicillin, namely chemical semi-synthesis method (referred to as chemical method) and enzymatic semi-synthesis method (referred to as "enzymatic method"). The chemical method was developed more than 30 years ago and is still used in amoxicillin. It is widely used in industrial production; the enzymatic method is a new process developed in recent years, which uses penicillin G acylase to couple with DHPG active acyl derivatives. Compared with the chemical method, the enzymatic method has fewer steps and reduces the use of organic solvents and chemicals. [0003] However, in the production process of enzymatic synthesis of amoxicillin, the penic...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 梁国艳
Owner 内蒙古联邦动保药品有限公司
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