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Detection method for simultaneously determining various antibacterial agents in eye drops

A detection method and technology of eye drops, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the difficulties of simultaneous qualitative and quantitative detection of antibacterial agents, drug ingredient screening, preparation process, scientific research, supervision and inspection , bacteriostatic agent types and dosage differences, etc., to achieve stable and reliable effects, fast detection speed, and wide application range

Active Publication Date: 2016-08-17
SHANGHAI INST FOR FOOD & DRUG CONTROL
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AI Technical Summary

Problems solved by technology

[0004] At present, there are significant differences in the types and doses of bacteriostatic agents added to various eye drops, which poses certain difficulties for drug ingredient screening, preparation technology, scientific research, supervision and inspection, etc.
For the determination of the type and dosage of bacteriostatic agents in eye drops, the existing methods can only measure a specific bacteriostatic agent, or measure several bacteriostatic agents of a certain type, and cannot simultaneously complete multiple Qualitative and quantitative detection of types and large quantities of antibacterial agents

Method used

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  • Detection method for simultaneously determining various antibacterial agents in eye drops
  • Detection method for simultaneously determining various antibacterial agents in eye drops
  • Detection method for simultaneously determining various antibacterial agents in eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045]A certain batch of lincomycin hydrochloride eye drops sold in the market was screened and determined, and the chromatogram was obtained as attached image 3 Shown:

[0046] image 3 The components detected in the figure 1 By comparison, it was confirmed that the detected component was ethyl p-hydroxybenzoate, and the chromatographic peak area 3629 was brought into the ethyl p-hydroxybenzoate standard curve Y=175.9X+21.72, and the calculated concentration was 20.51 μg / ml.

Embodiment 2

[0048] A certain batch of chondroitin sulfate eye drops sold in the market was screened and determined, and the chromatograms obtained were as follows: Figure 4 shown.

[0049] Figure 4 The components detected in the figure 1 By comparison, it was confirmed that the detected component was chlorobutanol, and the chromatographic peak area 4.640 was brought into the chlorobutanol standard curve Y=1.224X+1.303, and the calculated concentration was 2.726 μg / ml.

Embodiment 3

[0051] A certain batch of compound neomycin polymyxin eye drops sold in the market was screened and determined, and the chromatograms obtained were as follows: Figure 5 Shown:

[0052] Figure 5 The components detected in the figure 1 By comparison, it was confirmed that the detected component was sodium thimerosal, and the chromatographic peak area of ​​137.1 was brought into the sodium thimerosal standard curve Y=15.36X-44.52, and the calculated concentration was 6.025 μg / ml.

[0053] On the basis of the above-mentioned technical scheme, further, since both benzalkonium chloride and benzalkonium chloride are cationic bacteriostatic agents, their anions do not have antibacterial effect, and both have the same cation, only the anion is different, so this The technique is also applicable to the determination of benzalkonium bromide without any adjustment, and there is no problem with the system suitability.

[0054] The method provided by the embodiments of the present inve...

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Abstract

The invention discloses a detection method for simultaneously determining various antibacterial agents in eye drops. Detection of eleven antibacterial agents (comprising chlorhexidine, benzyl alcohol, chlorobutanol, sorbic acid, benzoic acid, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, thimerosal, benzalkonium chloride and benzalkonium bromide) belonging to six types in the eye drops can be completed only through one-time experiment by adopting the method. The method adopting liquid chromatography has the advantages of good specialty, accurate qualitative and quantitative effects, high quantity of types and kinds of the simultaneously detected antibacterial agents, fast detection speed, suitableness for different brands of eye drops produced in different manufacturers, wide application range, and stable and reliable effect.

Description

technical field [0001] The invention relates to a method for measuring antibacterial agents in eye drops, in particular to a method for simultaneously measuring multiple antibacterial agents in eye drops. Background technique [0002] Eye drops refer to eye drops in ophthalmic preparations, which are liquid sterile preparations in which pharmaceutical ingredients and pharmaceutical additives are uniformly mixed into a matrix and prepared into solutions, suspensions, and emulsions. Eye drops directly act on the eyes and are absorbed through local mucous membranes, most of which play a local therapeutic role. [0003] The drug in the eye drops can directly contact the site of action of the drug, and take advantage of the fast absorption speed of the eye mucous membrane to complete the drug absorption and distribution quickly. role. According to the 2015 edition of the Chinese Pharmacopoeia, the current legal minimum standard for pharmaceuticals in China, eye drops are liquid...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 赵敬丹秦峰闻宏亮范迪裘亚缪天瑶刘浩杨美成
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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