Method for measuring content of triamcinolone acetonide chloromycetin solution

A determination method, technology of triamcinolone acetonide acetate, applied in the field of content determination of triamcinolone acetonide chloramphenicol solution, can solve the problems of tedious and time-consuming, content control of naphazoline hydrochloride, unstable product quality, etc.

Inactive Publication Date: 2008-06-11
安军永
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Adopt colorimetric method to measure the content of triamcinolone acetonide acetate, after extracting and evaporating to dryness with chloroform for many times, get the residue and use triphenyltetrazolium chloride to develop color; Both are extremely tedious and time-consuming, and the specificity is not strong, and the content of naphazoline hydrochloride is not controlled
[0004] Triamcinolone acetonide chloramphenicol solution belongs to the compound preparation of antibacterial drugs and adrenal cortex hormones. If strict quality control is not carried out on the drugs, the quality of the obtained products will be unstable, which may make the curative effect of the obtained drugs inaccurate, and even cause serious injuries. Adverse reactions

Method used

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  • Method for measuring content of triamcinolone acetonide chloromycetin solution
  • Method for measuring content of triamcinolone acetonide chloromycetin solution
  • Method for measuring content of triamcinolone acetonide chloromycetin solution

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 edition two appendix V D).

[0110] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler, 0.2% sodium dodecyl sulfate (adjust the pH value to 3.5 with dilute phosphoric acid)-acetonitrile (50:50) as mobile phase; Wavelength: 237nm for 0~12min and 22~30min, 215nm for 12~22min. Take 30 μl of the system suitability test solution, inject it into the liquid chromatograph, and record the chromatogram. The separation degree of chloramphenicol and chloramphenicol diol should meet the requirements, and the number of theoretical plates should not be less than 4000 based on the peak of chloramphenicol.

[0111] Preparation of solution for system suitability test Take appropriate amount of chloramphenicol reference substance and chloramphenicol glycol substance reference substance, dissolve and dilute with mobile phase to make about 0.3mg of chlo...

Embodiment 2

[0114] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 edition two appendix V D).

[0115] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler, 0.25% sodium dodecyl sulfate (adjust the pH value to 2.5 with dilute sulfuric acid)-methanol (45:55) as mobile phase; detect Wavelength: 245nm for 0~12min and 22~30min, 223nm for 12~22min. Take 15 μl of the system suitability test solution, inject it into the liquid chromatograph, and record the chromatogram. The separation degree of chloramphenicol and chloramphenicol diol should meet the requirements, and the number of theoretical plates should not be less than 6000 based on the peak of chloramphenicol.

[0116] Preparation of solution for system suitability test Take appropriate amount of chloramphenicol reference substance and chloramphenicol glycol substance reference substance, dissolve and dilute with mobile phase to make about 0.3mg of ...

Embodiment 3

[0119] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 edition two appendix V D).

[0120] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler, 0.1% sodium dodecyl sulfate (adjust the pH value to 3.0 with dilute sulfuric acid)-acetonitrile (55:45) as mobile phase; detect Wavelength: 240nm for 0~12min and 22~30min, 220nm for 12~22min. Take 20 μl of the system suitability test solution, inject it into the liquid chromatograph, and record the chromatogram. The separation degree of chloramphenicol and chloramphenicol diol should meet the requirements, and the number of theoretical plates should not be less than 5000 based on the peak of chloramphenicol.

[0121] Preparation of solution for system suitability test Take appropriate amount of chloramphenicol reference substance and chloramphenicol glycol substance reference substance, dissolve and dilute with mobile phase to make about 0.3mg ...

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Abstract

The invention provides a method for measuring the high efficiency liquid chromatography by the content of triamcinolone acetonide chloramphenicol solution, which can simultaneously measuring the content of three active ingredients comprising acetic acid triamcinolone acetonide, chloramphenicol and naphazoline hydrochloride. The method is characterized in high accuracy, good specificity, high sensitivity, easy operation and low cost. Compared with the prior art, the content measuring method provided in the invention not only increases the method for controlling the content of the naphazoline hydrochloridem but also brings a better effect of each component separation and more sensitive and accurate measuring which can avoid the complicated and time-consuming operation, less specificity and no content measuring of the naphazoline hydrochloride prescribed in the active standard, and guarantees the advancement and accuracy of the quality standard, thus further effectively ensure the safe and effective use of the medicine for the people.

Description

technical field [0001] The invention relates to a content determination method of a triamcinolone acetonide chloramphenicol solution, belonging to the field of quality control of medicines. technical background [0002] Triamcinolone acetonide chloramphenicol solution is a compound preparation of antibacterial drugs and corticosteroids for local use. Its components are: every 1ml of liquid medicine contains 1mg of triamcinolone acetonide acetate, 15mg of chloramphenicol and 0.5mg of naphazoline hydrochloride. With the increase of human activities, the global temperature is warming, and the hot weather is increasing every year. The heat can easily cause mosquito bites. The redness, swelling and itching after mosquito bites make people uncomfortable. Hot weather is also a breeding ground for various skin diseases. Skin diseases such as urticaria, various dermatitis and eczema are increasing, especially in children, because they cannot move independently, and the incidence of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N33/15
Inventor 安军永
Owner 安军永
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