Penicillin antibiotic appearance evaluation method

A technology of antibiotics and penicillin, applied in the direction of color/spectral characteristic measurement, etc., can solve the problems of large subjective influence factors, insufficient objective science, visual fatigue, etc., and achieve the effect of eliminating degradation, low cost, and avoiding degradation

Active Publication Date: 2014-11-05
NORTH CHINA PHARM GRP SEMISYNTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, it is difficult to define white and off-white. Different people have different standards, and there are too many subjective factors.
The method of judging the quality of drugs b

Method used

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  • Penicillin antibiotic appearance evaluation method
  • Penicillin antibiotic appearance evaluation method
  • Penicillin antibiotic appearance evaluation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The appearance evaluation method of ampicillin comprises the following steps:

[0042] A. Take 1 part of ampicillin each with white, off-white and yellow appearance by visual inspection, take 1.7g of each drug, put it into 3ml of purified water under constant stirring, add 3ml of 10% ammonia water dropwise under stirring, dilute to 10ml, and prepare the same Three parts of fixed wave solutions with the same concentration, the concentration of fixed wave solutions is 0.17g / ml, and water is used as blank control to carry out full-wavelength scanning to three parts of fixed wave solutions, compare the full-wavelength scanning results of three parts of fixed wave solutions, and find that three parts Ampicillin solution has a large difference in absorbance at 325nm, so it is determined that the wavelength for detecting ampicillin solution is 325nm;

[0043] B. Take 3 batches of ampicillin samples whose visual appearance is white, and prepare three calibration solutions with ...

Embodiment 2

[0052] The appearance evaluation method of amoxicillin comprises the following steps:

[0053] A. Take 1 part of white, off-white and yellow amoxicillin with visual appearance, take 2.5g of each drug, add 10ml of purified water under constant stirring, add triethylamine dropwise to dissolve under stirring, and set the volume to 20ml. Prepare three parts of fixed wave solutions of the same concentration, the concentration of fixed wave solutions is 0.125g / ml, use water as a blank control to carry out full-wavelength scanning of three parts of fixed wave solutions, compare the results of full-wavelength scanning of three parts of fixed wave solutions, it is found that The absorbance at 328nm of the three fixed wave solutions is very different, so the wavelength for detecting the amoxicillin solution is determined to be 328nm;

[0054] B. Take 3 batches of amoxicillin samples whose visual appearance is white, and prepare three calibration solutions with the same concentration acc...

Embodiment 3

[0063] 6-APA appearance evaluation method, including the following steps:

[0064] A. Take 1 part each of white, off-white and yellow 6-APA, take 1.2g of each drug, add 8.5ml of purified water under constant stirring, add 30% ammonia solution dropwise under constant stirring until dissolved, and constant volume to 10ml, prepared into three fixed wave solutions of the same concentration, the concentration of the fixed wave solution is 0.12g / ml, using water as a blank control, carry out full-wavelength scanning on the three fixed wave solutions, and compare the full-wavelength scanning results of the three fixed wave solutions , it was found that the absorbance of the three fixed wave solutions was very different at 325nm, so it was determined that the detection wavelength of the 6-APA solution was 325nm;

[0065] B. Get 3 batches of 6-APA samples whose visual appearance is white and are prepared into three calibration solutions of the same concentration according to the method ...

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Abstract

The invention discloses a penicillin antibiotic appearance evaluation method which is as follows: determining appearance standards of a certain penicillin antibiotic by use of spectrophotometric method, and comparing the determined appearance standards with the absorbance of other batches of solutions of the penicillin antibiotic to evaluate wether the appearance of the penicillin antibiotic product of the to-be tested batch is qualified. A penicillin antibiotic appearance naked eye observation method is replaced by the penicillin antibiotic appearance evaluation method, the appearance standard is quantifiable, easy to control, objective and accurate, and does not change with time, place, personnel changes. The penicillin antibiotic appearance evaluation method has the advantages of low cost, high precision and high efficiency in the popularization and application in industrial production.

Description

technical field [0001] The invention relates to the field of drug quality control, in particular to a method for evaluating the appearance of penicillin antibiotics. Background technique [0002] The appearance color of a drug is an objective characterization of the internal quality of the drug, and the difference from the prescribed color can reflect the purity of the drug to a certain extent. The pharmacopoeias of various countries regard the color of the drug or the color of the drug solution as an important inspection item for drug quality control. [0003] Penicillin antibiotics are antibiotics containing a β-lactam ring, the structure of which is shown in Formula I. In an environment with a pH of about 4, the β-lactam ring in the penicillin antibiotic molecule will undergo molecular rearrangement to generate penicillenic acid, the structure of which is shown in Formula II. Penicramic acid has an oxazolone structure, which is easy to absorb moisture and cause yellowin...

Claims

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Application Information

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IPC IPC(8): G01N21/31
Inventor 左丽华严正人黄娟刘慧勤张春青王虹
Owner NORTH CHINA PHARM GRP SEMISYNTECH CO LTD
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