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Method for detecting skin permeability of metronidazole gel

A metronidazole gel and metronidazole technology, applied in measuring devices, material inspection products, testing pharmaceutical preparations, etc., can solve problems such as poor patient tolerance, large side effects, prone to anaphylactic shock and nervous system diseases , to achieve the effect of high accuracy and convenient detection method

Inactive Publication Date: 2018-12-25
ZHUZHOU QIANJIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] As the most commonly used drug for bacterial vaginosis, metronidazole has a high degree of clinical acceptance; the preferred option in the "2010 Guidelines for the Treatment of Vaginitis by the US Centers for Disease Control" and the "Guidelines for the Diagnosis and Treatment of Bacterial Vaginosis (Draft)" drafted by the Chinese Medical Association Both are metronidazole; but oral or injection preparations have large side effects, are prone to anaphylactic shock and nervous system diseases, and are poorly tolerated by patients

Method used

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  • Method for detecting skin permeability of metronidazole gel
  • Method for detecting skin permeability of metronidazole gel
  • Method for detecting skin permeability of metronidazole gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Take the prescription screening sample (batch number: 20161201) and the marketed original research sample (batch number: KAAU) produced by Zhuzhou Qianjin Pharmaceutical Co., Ltd., and use the artificial skin membrane to conduct the test according to the following in vitro skin penetration test method:

[0041] (1) Set the release area to 0.6cm 2 The artificial skin film is fixed at one end of the release pool of the transdermal absorption instrument, the rough surface of the artificial skin film faces the release pool, and 0.15 g of metronidazole gel test product is evenly coated on the rough surface of the artificial skin film ;

[0042] (2) adjust the temperature of the water in the heat preservation tank of the transdermal tester to be constant at 32°C, and turn on the magnetic stirring; the release pool is fixed on the receiving pool, and the 0.9% sodium chloride solution of 5ml is added as the receiving liquid in the receiving pool, Ensure that the side of the ar...

Embodiment 2

[0052] The prescription screening sample (batch number: 20170410) and the marketed original research sample (batch number: KAAU) produced by Zhuzhou Qianjin Pharmaceutical Co., Ltd. were taken, and the same method as in Example 1 was used for testing.

[0053] The results are shown in Table 2.

[0054] Table 2: Determination results of cumulative drug penetration of self-developed samples and original marketed samples (n=6)

[0055]

[0056] Conclusion: With time (h) as the abscissa and permeation (μg) as the ordinate, linear fitting is performed, and the R of the self-developed preparation (20170410 batches) and the reference preparation 2 The values ​​are all greater than 0.98, conforming to the zero-order transdermal law, and the slope of the self-developed preparation is similar to that of the reference preparation, indicating that the self-developed preparation is equivalent to the skin penetration performance of the reference preparation.

Embodiment 3

[0058] The prescription screening sample (batch number: 20170414) and the marketed original research sample (batch number: KAAU) produced by Zhuzhou Qianjin Pharmaceutical Co., Ltd. were taken, and the same method as in Example 1 was used for testing.

[0059] The results are shown in Table 3.

[0060] Table 3: Determination results of cumulative drug penetration of self-developed samples and original marketed samples (n=6)

[0061]

[0062] Conclusion: With time (h) as the abscissa and permeation (μg) as the ordinate, linear fitting is performed, and the R of the self-developed preparation (batch number 20170414) and the reference preparation 2 The values ​​are all greater than 0.98, conforming to the zero-order transdermal law, and the slope of the self-developed preparation is similar to that of the reference preparation, indicating that the self-developed preparation is equivalent to the skin penetration performance of the reference preparation.

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Abstract

The invention relates to a method for detecting skin permeability of metronidazole gel. The method comprises the following steps: (1) uniformly coating metronidazole gel samples for test on the surface of one side of a test skin, contacting the surface of the other side with a receiving liquid that is a 0.8-1% sodium chloride aqueous solution; and making the samples for test pass through the testskin and enter into the receiving liquid in a constant temperature water bath environment of 31 to 33 degrees centigrade; (2) taking multiple sets of receiving samples from the receiving liquid regularly; (3) respectively injecting each set of the receiving samples obtained by timed sampling into a high performance liquid chromatograph, and measuring the concentration of metronidazole in each setof the receiving samples using an external standard method by regarding metronidazole as a reference substance; and (4) calculating the cumulative permeation of metronidazole, and calculating to determine whether it meets the zero-order kinetic release law. The detection method provided by the invention is convenient, efficient and accurate, can be used for evaluating the transdermal absorption effect of metronidazole gel in industrial production, and then used for evaluating the product quality of metronidazole gel.

Description

technical field [0001] The invention relates to the field of treatment of gynecological diseases and related medicines, in particular to a method for detecting the skin permeability of metronidazole gel. Background technique [0002] Bacterial vaginosis (BV) is a mixed infection caused by Gardnerella vaginalis and some anaerobic bacteria, which leads to the imbalance of microecological balance in the vagina, resulting in increased vaginal secretions, vaginal discharge with fishy smell and genital itching and burning. syndrome. Can be divided into Haemophilus vaginitis, Corynebacterium vaginitis, Anaerobic vaginitis, Gardnerella vaginitis and so on. [0003] As the most commonly used drug for bacterial vaginosis, metronidazole has a high degree of clinical acceptance; the preferred option in the "2010 Guidelines for the Treatment of Vaginitis by the US Centers for Disease Control" and the "Guidelines for the Diagnosis and Treatment of Bacterial Vaginosis (Draft)" drafted by ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N33/15
CPCG01N30/02G01N33/15
Inventor 张英帅白璐凌勇根龚云王伶刘逆夫
Owner ZHUZHOU QIANJIN PHARMA
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