ABSTRACT
Objective:To explore the clinical efficacy and the effects on serum inflammatory factors of carbocisteine and budes-onide in the treatment of asthma. Methods:Totally 186 asthma patients were randomly divided into the observation group (93 cases) and the control group (93 cases). The control group received budesonide combined with the conventional treatment, the observation group was treated with carbocisteine and budesonide, and one week was a treatment course. The efficacy was observed. The airway re-sponsiveness and cough condition was respectively assessed by early respiratory resistance ( Rrsc) and Leicester cough questionnaire ( LCQ) . The improvement of day and night symptoms was observed, and the serum levels of inflammatory factors and the safety were also evaluated. Results:LCQ score of the observation group after the treatment was significantly higher than that of the control group, Rrsc score for day and night symptoms and serum IL-8, TNF-αand IgE levels were significantly lower than those in the control group, and the differences were statistically significant (P0. 05). The difference in the in-cidence of ADR between the groups was not statistically significant (P>0. 05). Conclusion: Carbocisteine and budesonide in the treatment of asthma can significantly improve asthma symptoms and reduce cough and inflammatory cytokines with promising safety.
ABSTRACT
Este estudo teve como objetivo avaliar a estabilidade de xaropes contendo carbocisteína, submetidos à degradação forçada, utilizando Desenho Experimental Fatorial (DEF). Os fatores avaliados foram pH (5,0; 6,5; 8,0), presença ou ausência de EDTA dissódico e metabissulfito de sódio (0,1%). Para o estudo de degradação forçada, as formulações foram submetidas a estresse térmico (50 °C e 75% UR) e oxidação com peróxido de hidrogênio a 3%. Posteriormente, as formulações foram analisadas quanto ao pH, propriedades organolépticas e teor de fármaco por CLAE-UV, nos tempos 0, 15 e 35 dias. Os resultados mostraram que as formulações submetidas à degradação forçada sofreram uma diminuição no teor do fármaco, enquanto que o pH se manteve relativamente estável. Em relação a cor, apenas as formulações que não possuíam antioxidantes mostraram-se mais escuras. A análise dos resultados do DEF mostrou interação significativa (p<0,05) para os fatores pH/metabissulfito e EDTA/metabissulfito. As formulações contendo metabissulfito em pH 5,0 apresentaram maior degradação e as formulações com metabissulfito sem EDTA também não foram eficientes para impedir a degradação da carbocisteína.
The aim of this study was to use Factorial Design (FD) to assess the stability of carbocisteine syrups subjected to forced degradation. The factors assessed were pH (5.0; 6.5; 8.0), presence or absence of disodium EDTA and sodium metabisulfite (0.1%). For the study of forced degradation, the formulations were subjected to thermal stress (50°C and 75% RH) and oxidation with 3% hydrogen peroxide. The formulations were analyzed for pH, organoleptic properties and drug content by HPLC-UV, at 0, 15 and 35 days. The results showed that the formulations exposed to forced degradation suffered a fall in drug content, while the pH remained relatively stable. Regarding the color, only the formulations without antioxidant exhibited a darker coloration. The results of FD revealed significant interactions (p<0.05) for pH/metabisulfite and EDTA / metabisulfite. Formulations containing metabisulfite at pH 5.0 showed the greatest degradation and those with metabisulfite and without EDTA were also not effective in preventing the degradation of carbocisteine.
Subject(s)
Carbocysteine/analysis , Drug Stability , Expectorants , Factor Analysis, StatisticalABSTRACT
Objective To establish a sensitive,valid and rapid high performance liquid chromatography-trap mass spectrometry (HPLC-MS) method for determining carbocisteine concentration in human plasma. Methods Plasma samples were pretreated by 100 mL/L perchloric acid to remove the interference protein. The supernatant was separated by reverse phase HPLC,electrospray MS was used to detect carbocisteine in plasma samples,and selective ion method of multiple reaction modes was used to determine the concentration of carbocisteine. Results The limit of detection was 0.01 ?g/mL and the linear range was 0.2-200.0 ?g/mL. The recovery rate was within the range of 89.2%-105.6%. Conclusion The proposed method could be used to determine carbocisteine in biological samples.