Method for detecting cyclosporine pharmaceutical preparation and auxiliary materials thereof

A pharmaceutical preparation and detection ring technology, applied in the field of analysis and detection in medicinal chemistry, can solve the problems of unfavorable drug quality research and reverse research, no detectable method, etc., and achieve the effect of simple operation, high efficiency and good sensitivity

Pending Publication Date: 2021-12-17
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] OP-40, povidone, and polyoxyethylene hydrogenated castor oil can be used as pharmaceutical excipients. However, there is no detection method that can effec

Method used

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  • Method for detecting cyclosporine pharmaceutical preparation and auxiliary materials thereof
  • Method for detecting cyclosporine pharmaceutical preparation and auxiliary materials thereof
  • Method for detecting cyclosporine pharmaceutical preparation and auxiliary materials thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] After freeze-drying 10mL cyclosporine eye drops, in 2mL0.05M NaNO 3Shake and dissolve in the solution; prepare a solution containing OP-40 at a concentration of 2.5mg / mL, povidone at a concentration of 15mg / mL, and polyoxyethylene hydrogenated castor oil at a concentration of 50mg / mL, as the test solution, let it stand for 30min, and use Filter through a 0.22 micron microporous membrane and pour into the sample bottle.

[0083] Take 100 μL of the filtered test solution obtained by the above method. Detection was performed by gel chromatography exclusion method. Record the chromatogram as figure 1 As shown, the analysis and separation of the excipients in the cyclosporine eye drops sample was completed.

[0084] Detection conditions:

[0085] Chromatographic column: Waters chromatographic column Ultrahydrogel 250 and Ultrahydrogel 500 connected in series;

[0086] Mobile phase: 0.1M NaNO 3 Aqueous solution (pH9, pH regulator: Na 2 HPO 4 );

[0087] Column temper...

Embodiment 2

[0094] Take an appropriate amount of OP40 to a 10ml volumetric flask, and use 0.05M NaNO 3 Shake and dissolve in the solution, prepare OP-40 with a concentration of 5.0mg / mL as the test solution, let it stand for 30min, filter it with a 0.22 micron microporous membrane, and inject it into the sample bottle.

[0095] Take 100 μL of the filtered test solution obtained above, and detect it by gel chromatography exclusion method. Record the chromatogram, the result is as follows figure 2 As shown, the detection of the OP-40 sample was completed.

[0096] Detection conditions:

[0097] Chromatographic column: Waters chromatographic column Ultrahydrogel 250 and Ultrahydrogel 500 connected in series;

[0098] Mobile phase: 0.1M NaNO 3 Aqueous solution (pH9, pH regulator: Na 2 HPO 4 );

[0099] Column temperature: set the Waters GPC column oven heater to 40°C;

[0100] Flow rate: mobile phase flow rate is 0.6mL / min;

[0101] Analysis time: 80min;

[0102] Injection volume: ...

Embodiment 3

[0106] Take an appropriate amount of polyoxyethylene hydrogenated castor oil to a 10ml volumetric flask, and use 0.05M NaNO 3 Shake and dissolve in the solution, prepare polyoxyethylene hydrogenated castor oil with a concentration of 50mg / mL as the test solution, let it stand for 30min, and inject it into the sample bottle after filtering with a 0.22 micron microporous filter membrane.

[0107] Take 100 μL of the filtered test solution obtained above and use the gel chromatography exclusion method to detect with the following detection conditions. Record the chromatogram, the result is as follows image 3 shown.

[0108] Chromatographic conditions:

[0109] Chromatographic column: Waters chromatographic column Ultrahydrogel 250 and Ultrahydrogel 500 connected in series;

[0110] Mobile phase: 0.1M NaNO 3 Aqueous solution (pH9, pH regulator: Na 2 HPO 4 );

[0111] Column temperature: set the Waters GPC column oven heater to 40°C;

[0112] Flow rate: mobile phase flow ra...

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Abstract

The invention provides a method for detecting a cyclosporine pharmaceutical preparation, which comprises the following steps of: 1) treating the cyclosporine pharmaceutical preparation with a diluent to obtain a cyclosporine pharmaceutical preparation solution to be detected; and (2) detecting the cyclosporine pharmaceutical preparation solution to be detected obtained in the step (1) through using a gel chromatography exclusion method, wherein a chromatographic column adopted in the gel chromatography exclusion method detection is formed by connecting at least two water-soluble GPC chromatographic columns in series. The method can effectively separate povidone, OP-40 and polyoxyethylene hydrogenated castor oil, has the outstanding advantages of being good in stability, easy and convenient to operate, rapid, high in efficiency, good in sensitivity and the like, can achieve effective separation when the concentration of povidone, OP-40 and polyoxyethylene hydrogenated castor oil is low, and can provide a basis for further research on specific properties of any two or three of povidone, OP-40 and polyoxyethylene hydrogenated castor oil, such as cyclosporin eye drops.

Description

technical field [0001] The invention relates to the field of analysis and detection in medicinal chemistry, in particular, the invention relates to a method for detecting cyclosporine pharmaceutical preparations and auxiliary materials thereof. Background technique [0002] Povidone, polyvinylpyrrolidone (polyvinyl pyrrolidone), referred to as PVP, is a non-ionic polymer compound. As a synthetic water-soluble polymer compound, PVP has film-forming, cohesive, and hygroscopic properties. It also has excellent solubility and physiological compatibility, because it is soluble in both water and most organic solvents, with low toxicity and good physiological compatibility. It is closely related to people's health in medicine, food and cosmetics. favored in the field. In addition, PVP has excellent physiological inertia, does not participate in human metabolism, has excellent biocompatibility, and does not cause any irritation to skin, mucous membranes, eyes, etc. Pharmaceutical-...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 杨保姣何乐玥田俊锋杨波李雷
Owner WUHAN WUYAO SCI & TECH
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