<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2221-2450</journal-id>
<journal-title><![CDATA[Revista CENIC Ciencias Biológicas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. CENIC Cienc. Biol]]></abbrev-journal-title>
<issn>2221-2450</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Investigaciones Científicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2221-24502022000100032</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Validación del método SDS-PAGE para la determinación de la composición de proteínas en un extracto alergénico de soya]]></article-title>
<article-title xml:lang="en"><![CDATA[Validation of SDS-PAGE method for the proteins composition determination in an allergenic extract from soybean]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramírez González]]></surname>
<given-names><![CDATA[Wendy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Mateo Morejón]]></surname>
<given-names><![CDATA[Mayteé]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cruz Jiménez]]></surname>
<given-names><![CDATA[Raysa]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García Freijó]]></surname>
<given-names><![CDATA[Anette]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Labrada Rosado]]></surname>
<given-names><![CDATA[Alexis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional de Biopreparados  ]]></institution>
<addr-line><![CDATA[Bejucal Mayabeque]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<volume>53</volume>
<numero>1</numero>
<fpage>32</fpage>
<lpage>42</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2221-24502022000100032&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2221-24502022000100032&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2221-24502022000100032&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN   La soya es uno de los principales alergenos alimentarios agrupados en el denominado grupo de los &#8220;grandes 8&#8221;. La validación de métodos analíticos evalúa su desempeño como control de calidad en la industria farmacéutica. El objetivo de este trabajo fue validar el método de SDS-PAGE para un extracto alergénico de soya. Se evaluó la Precisión (Repetibilidad y Precisión Intermedia) en la determinación del contenido relativo de las bandas principales. Como parámetro de Especificidad se determinó la posible interferencia del glicerol, comparando con la referencia liofilizada. Se determinó la Exactitud en la determinación del peso molecular y el Límite de Detección. Los componentes alergénicos fueron identificados comparando los patrones de electroforesis con las bandas identificadas por IgE mediante Western Blotting, además se determinaron las bandas reconocidas por los anticuerpos bloqueadores IgG4. Todos los criterios de aceptación establecidos se cumplieron. El coeficiente de variación fue menor de 5% en todos los casos. No hubo diferencias significativas entre diferentes analistas, (Fischer, p&#707;0.05). Se demostró la Exactitud en la determinación de pesos moleculares, no se evidenciaron diferencias significativas entre el valor medio hallado para las bandas principales y los valores teóricos de los alergenos (p&#707;0.05). No existieron diferencias significativas entre los porcentajes de las bandas principales entre el extracto liofilizado y la formulación glicerinada (p&#707;0.05). El límite de detección de la técnica fue 0.5 µg de proteínas. En conclusión, la técnica SDS-PAGE quedó validada para un extracto alergénico de soya y puede emplearse en el control de la calidad del producto terminado.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Soybean is one of the foods that most frequently cause food allergies. Obtaining allergenic extracts makes possible the specific diagnosis of allergic sensitization through skin tests. Proteins composition is an essential quality requirement for allergenic extracts. Validation of analytical methods evaluates their performance for their use as quality control in the pharmaceutical industry. The aim of this work was to validate SDS-PAGE method for the proteins composition determination in an allergenic extract from soybean. Precision (Repeatability and Intermediate precision) was evaluated in determining the protein relative content of the main bands. The possible interference of glycerol (excipient of the finished product) was determined to evaluate the Specificity of the method. Were also analyzed the Accuracy and Limit of Detection of the method in the determination of the molecular weight of the extract main proteins. The bands of the main protein components were identified by comparing the electrophoresis patterns with the bands identified by IgE/IgG4 Immunoblotting. All pre-established acceptance criteria were met. The coefficient of variation was less than 5% in all cases. There were no significant differences between different analysts, within or between tests (Fischer, p&#707;0.05). Accuracy was demonstrated in the determination of molecular weights, there were no significant differences between the mean value found for the main bands and the theoretical values &#8203;&#8203;of the allergens (p&#707;0.05). There was no interference from glycerol in the formulation, there were no significant differences in the percentages of the main bands between the lyophilized extract and the glycerinated formulation (p&#707;0.05). The detection limit of the technique was 0.5 µg of proteins. In conclusion, the SDS-PAGE technique was validated for allergenic soybean extracts and can be used to control the quality of the finished product.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[soya]]></kwd>
<kwd lng="es"><![CDATA[validación]]></kwd>
<kwd lng="es"><![CDATA[SDS-PAGE]]></kwd>
<kwd lng="es"><![CDATA[extractos alergénicos]]></kwd>
<kwd lng="en"><![CDATA[Soybean]]></kwd>
<kwd lng="en"><![CDATA[validation]]></kwd>
<kwd lng="en"><![CDATA[SDS-PAGE]]></kwd>
<kwd lng="en"><![CDATA[allergenic extracts]]></kwd>
</kwd-group>
</article-meta>
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