A device and method for detecting polyvinyl alcohol content in microsphere preparations

A technology of polyvinyl alcohol and microspheres, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of accurate and quantitative analysis of infinitely small amounts of polyvinyl alcohol content, etc., and achieve the effect of low detection limit, good repeatability and accurate results

Active Publication Date: 2021-07-13
ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there is no method for accurate quantitative analysis of very small amounts of polyvinyl alcohol in the domestic pharmaceutical industry

Method used

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  • A device and method for detecting polyvinyl alcohol content in microsphere preparations
  • A device and method for detecting polyvinyl alcohol content in microsphere preparations
  • A device and method for detecting polyvinyl alcohol content in microsphere preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Such as figure 1 As shown, the present invention provides a kind of device that detects polyvinyl alcohol content in microsphere preparation, comprises: transparent container 1, is used to hold microsphere preparation and organic solvent-water system; Emulsifier 2, is used to hold in The microsphere preparation and the organic solvent-water system in the transparent container 1 are emulsified; the image collector 3 is used to capture the outline of the liquid film after the emulsification treatment; the image processor 4 is connected to the image collector 3 and used to receive the liquid film Contour, calculate the contour area of ​​the liquid film, and calculate the polyvinyl alcohol content in the microspheres according to the area-concentration standard curve of the emulsified liquid film formed by the known concentration of polyvinyl alcohol.

[0048] A further technical solution is that the transparent container 1, the emulsifier 2 and the image collector 3 are su...

Embodiment 2

[0055] (1) Weigh 100mg of leuprolide acetate microspheres into a transparent container, add 30ml of organic solvent dichloromethane-water system (1:1), turn on the emulsifier to 3000rpm, homogenize until the microspheres are completely dissolved, and obtain Transparent layered two-phase solution, constant temperature to 25°C;

[0056] (2) Turn on the emulsifier to 10000rpm and emulsify for 2 minutes. After the residual polyvinyl alcohol can form stable microemulsion droplets at the water-oil interface, stop the emulsification, remove the emulsifier, and let it stand until the microemulsion droplets form a continuous microemulsion at the water-oil interface. single-layer emulsion liquid film;

[0057] (3) The image collector located under the transparent container captures the contour of the emulsified liquid film from bottom to top at the first time, and transmits it to the image processor through the data line. The image processor uses CAD area software to calculate the area ...

Embodiment 3

[0069] (1) Weigh 50mg of risperidone microspheres into a transparent container, add 30ml of organic solvent dichloromethane-water system (1:1), turn on the emulsifier to 3000rpm, homogenize until the microspheres are completely dissolved, and obtain a transparent fraction layer two-phase solution, constant temperature to 25 ° C;

[0070] (2) Turn on the emulsifier to 10000rpm and emulsify for 2 minutes. After the residual polyvinyl alcohol can form stable microemulsion droplets at the water-oil interface, stop the emulsification, remove the emulsifier, and let it stand until the microemulsion droplets form a continuous microemulsion at the water-oil interface. single-layer emulsion liquid film;

[0071] (3) The image collector located under the transparent container captures the contour and area of ​​the emulsified liquid film from bottom to top at the first time, and transmits it to the image processor through the data line. The image processor uses CAD area software to calcu...

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Abstract

The invention discloses a device and method for detecting the content of polyvinyl alcohol in a microsphere preparation. The device comprises: a transparent container for containing the microsphere preparation and an organic solvent-water system; an emulsifier for containing the polyvinyl alcohol in the microsphere preparation The microsphere preparation in the transparent container and the organic solvent-water system are emulsified; the image collector is used to capture the liquid film profile after the emulsification process; the image processor is connected with the image collector to receive the liquid film profile and calculate the liquid film profile. Membrane outline area, and according to the emulsion film area-concentration standard curve that the polyvinyl alcohol of known concentration forms, calculates the polyvinyl alcohol content in the microsphere. This detection method uses the emulsification effect of polyvinyl alcohol to indirectly measure its concentration. The detection device of the invention has the advantages of simple operation, good repeatability and accurate results, provides specific measures for quantitatively detecting the content of polyvinyl alcohol in microsphere preparations, and scientifically and effectively solves the problem of difficult quantification of polyvinyl alcohol.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a detection device and a detection method for residual polyvinyl alcohol in microsphere preparations. Background technique [0002] Polyvinyl alcohol (Polyvinyl Alcohol, PVA) is a synthetic water-soluble compound, which is obtained by alkali-catalyzed alcoholysis of polyvinyl acetate with methanol as a solvent. Polyvinyl alcohol itself is non-toxic to the human body, has no side effects, is non-irritating to the skin, and has good biocompatibility. It is an excellent pharmaceutical excipient and process aid, and has a wide range of applications in the medical field. The molecular structure of polyvinyl alcohol contains hydrophilic alcoholic hydroxyl groups and lipophilic polyethylene long chains, which can reduce the interfacial tension of water and oil and achieve the emulsification effect of water and oil. It is often used as an emulsifier and stabilizer i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/84
CPCG01N21/8422G01N2021/8405
Inventor 于崆峒荆志宇蒋朝军彭忠华
Owner ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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