Development and validation of antibody sandwich enzyme-linked immunosorbent assay method for quantitation of GeXIVA1,2 in plasma of rats and Beagle dogs / 药学学报

GeXIVA[1,2] is a new type of conotoxin recently discovered in the transcriptome of Conus generalis and it is expected to be used clinically as a new type of analgesic. This study established and verified a sandwich enzyme-linked immunosorbent assay method for the marine drug GeXIVA[1,2] in the plasma of rats and Beagle dogs. The mouse monoclonal antibody 4B2 and biotin-labeled rabbit polyclonal antibody 2# were developed. The checkerboard method was used to optimize the antibody pairing concentration, minimum dilution ratio, incubation temperature, and incubation time to establish an antibody sandwich ELISA detection method. Verify the established testing methods. The established ELISA method has a quantitative range of 1.25-80 ng·mL-1 in rat and Beagle plasma. The precision, accuracy, selectivity, specificity, stability, dilution linearity, and hook effect all meet the requirements for biological sample analysis. All the procedures for the animal experiments were approved by the Animal Ethics Committee of the Institute (Permit Number: IACUC-DWZX-2020-698). This method can support the preclinical pharmacokinetic study of the marine drug GeXIVA.

Verification of method for microbial limit test on diatomite and pearlite / 中国输血杂志

【Objective】 To establish a microbial limit test method for diatomite and pearlite, and verify its applicability. 【Methods】 According to the requirements of general rule 1105, Microbial Limit Test for Non Sterile Products of Pharmacopoeia of the People′s Republic of China (2020 Edition), the applicability test of microbial counting methods for three batches of perlite and diatomite was conducted before the microbial limit test of samples. The microbial growth of filter aid was analyzed and the recovery rate of each test bacterium was calculated. 【Results】 The ratio of the colony number of the test group minus the colony number of the test sample control group to the bacterial liquid control group was in the range of 0.5~2.0. 【Conclusion】 The method is accurate, reliable and can be used for microbial limit test of diatomite and perlite.

Methodology establishment and validation of microbial limit examination of dilu-ted benzalkonium bromide solution / 药学实践杂志

Objective To establish a microbial limit examination method and a verified methodology for diluted benzalkonium bromide solution , and ensure the effectiveness of the method .Methods Microbial limit test of diluted benzalkonium bromide solution was used as the validation methodology according to the validation test requirements of appendix XI J of the second version of the “Chi-nese Pharmacopoeia” published in 2010.Results Membrane filtration method could be used for counting bacteria , mold and yeast count in the microbial limit examination of the diluted benzalkonium bromide solution;membrane filtration method could be adopted to control the bacteria .Conclusion Antibacterial activity of diluted benzalkonium bromide solution should be fully considered before ex -amination when building its examination method through microbial limit methodology validation .

Reproducibility of the Brazilian version of the Edmonton Frail Scale for elderly living in the community / Reprodutibilidade da versão brasileira adaptada da Edmonton Frail Scale para idosos residentes na comunidade / Reproductibilidad de la versión brasileña adaptada de la Edmonton Frail Scale para ancianos residentes en la comunidad

OBJECTIVE: to verify the inter and intra-rater reproducibility of the Brazilian adapted version of the Edmonton Frail Scale (EFS) in an elderly group of residents. METHOD: in order to test the inter-rater reproducibility, two assessments were independently conducted by two researchers on the same day but at different times, in a sample of 103 elderly. Concerning the intra-rater reproducibility, the instrument was administered to 83 elderly (80.6% of the initial sample) by the same researcher in a time gap of 15 days between the two assessments. RESULTS AND DISCUSSION: in relation to the inter-rater test, the Kappa was 0.81 (CI 0.61-1.00) and the Intraclass Correlation Coefficient (ICC) corresponded to 0.87 (CI 0.82-0.91, p<0.001). In relation to the intra-rater test, the Kappa was 0.83 (CI 0.72-0.94) and the ICC 0.87 (CI 0.81-1.00, p<0.001). CONCLUSION: the results show that the EFS is reliable and can be used as a tool to improve geriatric nursing care in Brazil. .

OBJETIVO: verificar a reprodutibilidade inter e intraobservadores da versão adaptada para o Brasil da Edmonton Frail Scale, em um grupo de idosos domiciliados. METODOLOGIA: para testar a reprodutibilidade interobservador, duas avaliações foram realizadas de forma independente por dois pesquisadores, no mesmo dia, porém, em horários diferentes, em uma amostra de 103 idosos. Para a reprodutibilidade intraobservador, o instrumento foi aplicado pelo mesmo pesquisador em um intervalo de tempo de 15 dias, entre as duas medidas, em 83 idosos (80,6% da amostra inicial). RESULTADOS E DISCUSSÃO: no teste interobservador, o Kappa foi de 0,81 (IC 0,61-1,00) e o coeficiente de correlação intraclasse de 0,87 (IC 0,82-0,91, p<0,001). No intraobservador, o Kappa foi de 0,83 (IC 0,72-0,94) e o coeficiente de correlação de 0,87 (IC 0,81-1,00, p<0,001). CONCLUSÃO: os resultados demonstram que a Edmonton Frail Scale é confiável e poderá ser utilizada como ferramenta para melhora da assistência de enfermagem gerontogeriátrica no Brasil. .

OBJETIVO: verificar la reproductibilidad inter e intraobservadores de la versión adaptada para Brasil de la Edmonton Frail Scale (EFS), en un grupo de ancianos domiciliados. METODOLOGÍA: para testar la reproductibilidad interobservador, fueron efectuadas dos evaluaciones de manera independiente por dos investigadores, en el mismo día pero en horas diferentes, en una muestra de 103 ancianos. Para la reproductibilidad intraobservador, el instrumento fue aplicado por el mismo investigador en un intervalo de tiempo de 15 días entre las dos medidas, en 83 ancianos (80,6% de la muestra inicial). RESULTADOS Y DISCUSIÓN: en el test interobservador, el Kappa correspondió a 0,81 (IC 0,61-1,00) y el Coeficiente de Correlación Intraclase (CCI) a 0,87 (IC 0,82-0,91, p<0,001). En el intraobservador, el Kappa fue igual a 0,83 (IC 0,72-0,94) y el CCI a 0,87 (IC 0,81-1,00, p<0,001). CONCLUSIÓN: los resultados demuestran que la EFS es confiable y que podrá ser utilizada como herramienta para mejorar la atención de Enfermería gerontogeriátrica en Brasil. .

Validação de método analítico para doseamento de flavonoides totais em cápsulas contendo extrato seco de Passiflora incarnata L / Validation of analytical method for assay of total flavonoids in capsules containing dry extract of Passiflora incarnata L

Este trabalho teve como objetivo desenvolver e validar metodologia analítica por espectrofotometria no UV para a quantificação de flavonóides totais, expressos em vitexina, em cápsulas contendo extrato seco de Passiflora incarnata L. O método foi desenvolvido a partir da metodologia de doseamento de flavonóides totais descrita na monografia do extrato seco de P. incarnata L, disponível na Farmacopeia Britânica (2010). A validação da metodologia analítica de doseamento foi realizada de acordo com a Anvisa RE N° 899/2003 e diretrizes da International Conference on Harmonization. O método mostrou-se seletivo, pois não houve interferência dos adjuvantes na leitura das absorbâncias nas soluções analisadas. Apresentou coeficiente de correlação linear (r) de 0,9999, confirmando a linearidade do método. Os valores de desvio padrão relativo, obtidos tanto para precisão, nos níveis de repetibilidade e precisão intermediária, quanto para exatidão não excederam o máximo de 15% determinado nos critérios de aceitação para métodos bioanalíticos, considerando a complexidade da matéria-prima vegetal.

The aim of this study was to develop and validate an analytical method using UV spectrophotometry to determine total flavonoids, expressed in vitexin, in capsules containing a dry extract of Passiflora incarnata L. The analytical method was based on the spectrophotometric assay described in the British Pharmacopoeia (2010), for the dry extract of P. incarnata L. The validation of this method of quantitation was done in accordance with ANVISA resolution 899/2003 and the International Conference on Harmonization guidelines. The method was selective, because there was no interference from additives in the reading of the absorbance of solutions analyzed. It showed a linear regression correlation coefficient (r) of 0.9999, confirming the linearity of the method. The values of relative standard deviation calculated for precision (both repeatability and intermediate precision) and for accuracy did not exceed the maximum of 15% allowed in the acceptance criteria for bioanalytical methods, considering the complexity of the plant raw material.

Bioanalytical Methodology Validation / 中国药房

OBJECTIVE: To introduce the methodology validation and quality control in bioanalytical procedures and its expected trend of development.METHODS: According to the bioanalytical validation reflected in FDA guidelines and other publications,based on the guidance of SFDA and the standard operating procedure of our phase I clinical trial lab,we summarized the procedure and questions of bioanalytical methodology validation.RESULTS: The methodology validation and quality control in bioanalytical procedures and the possible risks involved in the methodology validation were summarized.CONCLUSIONS: The established methodology validation in bioanalytical procedure and quality control contents were basically consummate,but the standards for the methodology validation should be formulated based on reality.