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Long shelf life chloromycetin eyedrops detection method

A detection method and technology of chloramphenicol, 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 shelf life 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 shelf life of chloramphenicol eye drops can be increased to more than 2 years. These material components directly affect the shelf life of chloramphenicol eye drops. The quality of chloramphenicol eye drops plays an important role, and some material components also have certain adjuvant therapeutic effects, but there is no identification or content determination of these substances in the detection method of chloramphenicol eye drops recorded in the Chinese Pharmacopoeia. There are certain defects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] TLC identification:

[0024] Take 5 ml of chloramphenicol eye drops, dilute it 10 times with anhydrous methanol, and use it as a sample solution, and take another soy isoflavone reference substance plus anhydrous methanol to make a solution containing 10 μg per ml of solution, as a standard solution, according to the Chinese Pharmacopoeia The thin-layer chromatography in the appendix stipulates that 6 μl of the sample solution and the standard solution are drawn, respectively spotted on the same silica gel GF254 thin-layer plate, with chloroform and anhydrous methanol at a volume ratio of 10:0.5 as the developing solvent, developed, and dried in the air. Placed under a UV lamp with a wavelength of 254nm for inspection, there are fluorescent spots of the same color on the positions corresponding to the chromatograms of the sample solution of chloramphenicol eye drops and the chromatograms of the standard solution.

Embodiment 2

[0026] Take 2 milliliters of chloramphenicol eye drops, dilute it with anhydrous methanol to a solution containing about 20 μg of soybean isoflavone per milliliter of the solution, inject it into a high-performance liquid chromatograph, and record the chromatogram. The chromatographic conditions are: octadecylsilane Bonded silica gel as a chromatographic column; the mobile phase is acetonitrile, water, and acetic acid solution with a volume ratio of 20:80:0.1, the column temperature is 40°C, and the detection wavelength is 254nm;

[0027] Separately take appropriate amount of genistein reference substance, daidzein reference substance, and daidzein reference substance, measure with the same method, and calculate the content of soy isoflavones in chloramphenicol eye drops with the external standard method.

Embodiment 3

[0029] a) Preparation of mixed strains:

[0030] Get Paenibacillus polymyxa CGMCC 1.794, Serratia marcescens CGMCC 1.203, Escherichia coli CGMCC 1.1232, and the mixed volume ratio of its expanded culture solution is 6: 1:5. (Contains 2×10 per milliliter of liquid 7 active cells or more).

[0031] b) Dilute the mixed strains with water at a volume ratio of 1:50, add the diluted mixed strains according to 1% (V / V) of the sample volume of chloramphenicol eye drops, and keep stirring at 30-35°C for 30 minutes , filter the yellow precipitate, get filtrate 5ml, as chloramphenicol eye drops sample, detect by the method for embodiment 1.

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Abstract

The invention discloses a method for determining an ophthalmic chloramphenicol solution with long shelf life, which comprises all detection items of chloramphenicol eye drop in Chinese Pharmacopoeia. The determination of soybean isoflavone is added in the determination items. Compared with the prior art, the method can determine soybean isoflavone 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 for chloramphenicol eye drops, in particular to a detection method for chloramphenicol eye drops containing soybean isoflavones. Background technique [0002] Chloramphenicol eye drops is a commonly used drug for the eyes. It used to be used in the market as an OTC class A drug. Sodium hyaluronate and glycerin are added to the eye solution 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 items. The two identification methods provided in the identification item are the identification methods of the main drug chloramphenicol. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N21/33G01N30/90
Inventor 方南
Owner 方南
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