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Alficetin eye solution detection method

An ophthalmic solution and detection method technology, applied in the direction of measuring devices, material inspection products, testing pharmaceutical preparations, etc., can solve the problems of affecting the use of patients, strong eye irritation, and no identification, and achieve easy production and uniform testing standards. Effect

Inactive Publication Date: 2008-07-09
方南
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The usual period of validity or shelf life of medicines is 2 years, while the validity period of chloramphenicol eye drops can only reach 8-12 months. This is because chloramphenicol in chloramphenicol eye drops is easily decomposed into chloramphenicol glycol , p-nitrobenzaldehyde, chloramphenicol diol and p-nitrobenzaldehyde are highly irritating to the eyes and affect the use of patients
Through research, it is found that by adjusting the material components in chloramphenicol eye drops, the validity period of chloramphenicol eye drops can be increased to more than 2 years, and these material components directly affect the validity period of chloramphenicol eye drops. The quality of chloramphenicol eye drops plays an important role, and some material components also have certain adjuvant therapeutic effects. However, the detection methods of chloramphenicol eye drops recorded in the Chinese Pharmacopoeia do not identify or determine the content of these substances. There are certain defects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] a) Preprocessing steps:

[0026] Preparation of mixed strains:

[0027] Take Paenibacillus polymyxa CGMCC 1.794, Serratia marcescens CGMCC 1.203, Escherichia coli CGMCC 1.1461, and the mixed volume ratio of the expanded culture solution is 6:1 : 6. (Contains 2×10 per milliliter of liquid 7 active cells or more).

[0028] Dilute the mixed strains with water according to the volume ratio of 1:50, add the diluted mixed strains according to 1% (V / V) of the sample volume of chloramphenicol eye drops, keep stirring at 30-35°C for 30 minutes, filter Yellow precipitation, that's it.

[0029] b) Color reaction identification step: Take 1 ml of chloramphenicol eye drops filtrate and add 2 drops of 0.2M ferrous sulfate solution that is now prepared, the solution will appear dark blue. ;

Embodiment 2

[0031] a) Preprocessing steps:

[0032] Preparation of mixed strains:

[0033] Take Paenibacillus polymyxa CGMCC 1.794, Serratia marcescens CGMCC 1.203, Escherichia coli CGMCC 1.1461, and the mixed volume ratio of the expanded culture solution is 1:1 : 0.8. (Contains 2×10 per milliliter of liquid 7 active cells or more).

[0034] Dilute the mixed strains with water according to the volume ratio of 1:50, add the diluted mixed strains according to 2% (V / V) of the sample volume of chloramphenicol eye drops, keep stirring at 30-35°C for 30 minutes, filter Yellow precipitation, that's it.

[0035] b) Ultraviolet spectrophotometry: take 10 milliliters of the chloramphenicol eye drop filtrate processed through the pretreatment step, add 1 milliliter of the existing 0.2 M ferrous sulfate solution, dilute to 25 milliliters with water, shake evenly, React in the dark at room temperature for 30 minutes, and measure the absorbance at a wavelength of 572nm according to the ultraviolet...

Embodiment 3

[0039] a) Preprocessing steps:

[0040] Preparation of mixed strains:

[0041] Take Paenibacillus polymyxa CGMCC 1.794, Serratia marcescens CGMCC 1.203, Escherichia coli CGMCC 1.1246, and the mixed volume ratio of the expanded culture solution is 6:5 : 7. (Contains 2×10 per milliliter of liquid 7 active cells or more).

[0042] Dilute the mixed strains with water at a volume ratio of 1:50, add the diluted mixed strains according to 3% (V / V) of the sample volume of chloramphenicol eye drops, keep stirring at 30-35°C for 30 minutes, filter Yellow precipitation, that's it.

[0043] b) Determination of content by high-performance liquid chromatography: take an appropriate amount of chloramphenicol eye drop filtrate treated in the pretreatment step, dilute it with anhydrous methanol to a solution containing 20 μg of rosmarinic acid per milliliter of solution, inject high-efficiency Liquid chromatograph, record chromatogram, chromatographic condition is: take octadecylsilane bond...

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Abstract

The invention discloses a method for determining an ophthalmic chloramphenicol solution, which comprises all detection items of chloramphenicol eye drop in Chinese Pharmacopoeia. The determination of rosmarinic acid is added in the determination items. Compared with the prior art, the method can determine rosmarinic acid influencing the validity period of chloramphenicol eye drop, thus ensuring the validity period of chloramphenicol eye drop above 2 years. Accordingly, the method facilitates unification of determination standard of chloramphenicol eye drop and facilitates production and sale for manufactures as well as usage for consumers.

Description

technical field [0001] The invention belongs to a detection method of chloramphenicol ophthalmic solution, in particular to a detection method of chloramphenicol ophthalmic solution containing rosmarinic acid. Background technique [0002] Chloramphenicol eye solution, namely chloramphenicol eye drops, is a commonly used drug for the eyes. It was once used as an OTC class A drug in the market. Its main ingredients are chloramphenicol, buffer, bacteriostat, Water, sodium hyaluronate and glycerin are also added to chloramphenicol eye drops to enhance the viscosity and improve the retention time in the eyes. "Chinese Pharmacopoeia" in 2005 edition two, the 778th page discloses the detection method of chloramphenicol eye drops, detection item includes character item, identification item, inspection item, content measurement item, category item, specification item, storage item, in The inspection items include the detection of PH value item, related substance item and other item...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N21/78G01N21/33G01N30/02
Inventor 方南
Owner 方南
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