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Method for rapidly evaluating in-vitro release of external preparation

An external preparation and rapid technology, applied in the direction of testing pharmaceutical preparations, instruments, surface/boundary effects, etc., can solve the problems of difficult animal skin acquisition and large individual differences, achieve effective in vitro release evaluation, eliminate individual differences, and the method is simple and easy line effect

Pending Publication Date: 2020-06-26
苏州高迈药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The embodiment of the present invention provides a method for quickly evaluating the in vitro release of external preparations, which solves the technical problems of the prior art method that the use of animal skin is difficult to obtain and the individual differences are large, and achieves a simple and easy method that does not require animal dissection, eliminating the need for The technical effect of individual differences in animal skin

Method used

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  • Method for rapidly evaluating in-vitro release of external preparation
  • Method for rapidly evaluating in-vitro release of external preparation
  • Method for rapidly evaluating in-vitro release of external preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0050] Selection of test equipment

[0051] There are many measuring devices for in vitro release tests of semi-solid preparations, such as the fourth method of the United States Pharmacopoeia-FlowThrough Cell, Franz Diffusion cells, dynamic immersion cells, and improved semi-solid Accommodating method, the paddle-and-disk method of Chinese Pharmacopoeia. The Franz diffusion cell method is the most convenient and practical. This application is based on the Franz diffusion cell method for method development.

[0052] Diffusion Cell System Selected: Diffusion cell system with standard open cap ground glass like surface, 15mm diameter injection hole, 25mm overall system diameter.

Embodiment 2

[0054] Choice of artificial membrane

[0055] The Franz diffusion cell system needs to install an artificial membrane, which is produced by Merck Millipore. The Membrane artificial membrane is used as the artificial membrane in the in vitro release test system, and the diameter of the membrane is 25mm.

Embodiment 3

[0057] The choice of receiving liquid temperature

[0058] Referring to USP, when performing in vitro release test of semi-solid preparations for non-vaginal administration, the temperature of the receiving solution should be kept at 32°C±1°C.

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Abstract

The invention discloses a method for rapidly evaluating in-vitro release of an external preparation, and relates to the technical field of in-vitro release of medicines. Test equipment employed by thedevice is based on a Franz diffusion cell method; a proper inert and commercial artificial membrane is installed in a Franz diffusion cell system; in-vitro release test parameters are set; and an in-vitro release test of the model drug is tested. The technical effects that the method is simple and easy to implement, animal dissection is not needed, and individual differences of animal skin are eliminated are achieved.

Description

technical field [0001] The invention relates to the technical field of drug in vitro release, in particular to a method for rapidly evaluating the in vitro release of external preparations. Background technique [0002] The in vitro release test is an effective method currently recognized for evaluating semi-solid preparations (such as creams, ointments, gels, etc.), and is an in vitro manifestation of the in vivo drug efficacy of the preparation. In vitro release has the characteristics of strong operability, good reproducibility and high sensitivity. Therefore, the development of an appropriate in vitro release test method will help the development of transdermal formulations. [0003] At present, most of the methods for evaluating the in vitro release of external preparations are to use isolated rat abdominal skin or isolated Panama pig skin and Franz diffusion cell to investigate the skin penetration rate and skin retention rate of drugs. [0004] However, the applican...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N13/04
CPCG01N33/15G01N13/04G01N2013/003
Inventor 付任重姜建华
Owner 苏州高迈药业有限公司
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