RESUMEN
Um método de validação de limpeza foi desenvolvido e validado, baseado na amostragem por swab e na determinação cromatográfica simultânea de resíduos de gestodeno e etinilestradiol. O método apresenta limite de quantificação de 0,036µg/mL de etinilestradiol e 0,009µg/mL de gestodeno. Este foi considerado seletivo, preciso, exato e robusto de acordo com as normas da ANVISA. O fator de recuperação para etinilestradiol foi 90,45% e para gestodeno foi 83,52% em superfície de inox e 87,31% para etinilestradiol e 81,21% para gestodeno em superfície emborrachada. O método foi aplicado com sucesso no teste de amostragem por swab de todos os pontos de superfície dos equipamentos. O método de limpeza foi considerado validado...
A cleaning technique validation method was developed and validated, based on swab sampling and simultaneous chromatographic determination of gestodene and ethynyl estradiol residues. The method exhibited limits of quantitation (LOQs) of 0.036µg/mL for ethynyl estradiol and 0.009µg/mL for gestodene. It was considered selective, precise, accurate and robust, according to the standards set by ANVISA, the Brazilian regulatory agency. Mean swab recovery factors were 90.45% for ethynyl estradiol and 83.52 % for gestodene on an inox surface and 87.31% for ethynyl estradiol and 81.21 % for gestodene on a rubberized surface. The method was successfully applied to the assay of actual swab samples collected from all points on equipment surfaces. The cleaning method was validated...
Asunto(s)
Estrógenos , Etinilestradiol/normas , Vigilancia Sanitaria , Preparaciones FarmacéuticasRESUMEN
Objective To investigate the antitumor effect of 17aα-D-homo-ethynylestradiol-3-acetae on the mice transplanted with melanoma (B16) tumor cells,and to explore the possible synergistic effect with irradiation.Methods IRM-2 mice transplanted with B16 cells were randomly classified into control group,irradiation group,17aα-D-homo-ethynylestradiol-3-acetae drug ( high dose,medium dose,low dose) groups,and drug and irradiation combination group.Mice in drug group and the combination group were intraperitoneally injected with 5,7.5,and 10 mg/kg drug for 7 days.Mice in the irradiation and combination group received 1 Gy total body irradiation at 4 d after drug injection and then once a day for 5 days.The tumor inhibition efficiency,the number of bone marrow cells,thymus indices,and spleen indices were evaluated.Results Tumor weights in each drug group were significantly lower than those of the control( t =4.58,9.07,6.67,P ＜ 0.05 ).Drug combinated with 137Csγ-rays enhanced the antitumor effect so that the tumor weights in the combination group were significantly decreased ( t =8.06,10.35,6.71,P ＜0.05 ) in comparison with the control groups.Moreover,the numbers of marrow nucleated cells,thymus index and spleen index in the drug group were higher than those in the control group ( t =2.64,3.80,2.84,P ＜ 0.05 ).Conclusions 17aα-D-homo-ethynylestrudiol-3-acetae can inhibit cell growth of B16 melanoma in mice and may also have radioprotective effect on the hematopoietic system and immune system of mice.
RESUMEN
Objective The paper reports anti-tumor activities and tumor radio-sensitivity research of the novel Estrogen compound 17a?-D-Homo Ethynylestradiol-3-Acetate to U_ 14 and S_ 180 sarcomas;and overall test high-activity and low toxicity traits of 17a?-D-Homo Ethynylestradiol-3-Acetate by the indexes of thymus gland,spleen,etc.Methods The mouse cervical cancer U_ 14 was selected and implanted in IRM-2 mice for anti-tumor assay,and sarcoma S_ 180 was selected for tumor radio-sensitivity assay,the drug was administered to all mice by i.v.way.Results 17a?-D-Homo Ethynylestradiol-3-Acetate has obvious anti-tumor activity to U_ 14 tumor,the best inhibitory rates is U_ 14 64.3%,and17a?-D-Homo Ethynylestradiol-3-Acetate has hardly any influence to hematogenous system(spleen index),immune system(thymus index);Nevertheless,the positive control drug CCP has obvious damage to spleen index and thymus index(P