ABSTRACT
Objective@#To investigate the effects of recombinant human interferon alpha 2b injection(P.putida)and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation.@*Methods@#Rats were randomly divided into two groups(hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group).5 million IU/ml recombinant human interferon alpha 2b injection or 6% hydroxyethyl starch 40 injection were given respectively, which were diluted with 0.9% sodium chloride injection in a radio of 1: 2.Both groups were given aerosol inhalation for 30 minutes once a day for 14 days.Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed.During the drug administration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week.At the end of drug administration and the end of recovery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determination, and histopathological examination were performed.@*Results@#The mass median aerodynamic diameter(MMAD)of the drug mist was 3.56 μm, and the geometric standard deviation(GSD)was 1.84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation.No abnormality in clinical signs, body weight and food consumption, hematology and blood biochemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity(paranasal sinus), larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other organs or tissues examined.@*Conclusion@#Results suggest the drug particle size of recombinant human interferon alpha 2b injection(pseudomonas)can reach the lower respiratory tract and deposit in the lower respiratory tract.Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.
ABSTRACT
Objective To investigate the effects of recombinant human interferon alpha 2b injection ( P. putida) and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation. Meth-ods Rats were randomly divided into two groups ( hydroxyethyl starch 40 group and recombinant human inter-feron alpha 2b group). 5 million IU/ml recombinant human interferon alpha 2b injection or 6％ hydroxyethyl starch 40 injection were given respectively, which were diluted with 0. 9％ sodium chloride injection in a radio of 1: 2. Both groups were given aerosol inhalation for 30 minutes once a day for 14 days. Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed. During the drug ad-ministration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week. At the end of drug administration and the end of re-covery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determi-nation, and histopathological examination were performed. Results The mass median aerodynamic diameter ( MMAD) of the drug mist was 3. 56 μm, and the geometric standard deviation ( GSD ) was 1. 84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation. No abnormality in clinical signs, body weight and food consumption, hematology and blood bio-chemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity ( paranasal sinus) , larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other or-gans or tissues examined. Conclusion Results suggest the drug particle size of recombinant human interferon alpha 2b injection (pseudomonas) can reach the lower respiratory tract and deposit in the lower respiratory tract. Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.
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Objective To evaluate the sensitizations of Hydroxyethyl Starch 40 Sodium Chloride Injection . Methods Active systemic anaphylaxis ( ASA) test, internal sensitive index ' s determination and screening and Passive Cutaneous Anaphylaxis ( PCA) test are carried out .Observe the allergy safety of the samples .Results We use guinea pigs to carry on ASA test and PCA test with Hydroxyethyl Starch 40 Sodium Chloride Injection from 45 batches of 3 companies and no changes have occurred .Measuring and comparing the sensitive index of HIS ,IgG, IgM and IgE in plasma, IgM and IgE are not obvious variation;HIS and IgG positive group and negative group and sample groups are different .Conclusions It is suggestion that Hydroxyethyl Starch 40 Sodium Chloride Injection safety evaluation should include allergic reactions , HIS and IgG sensitive index monitoring in clinical application of hydroxyethyl starch .
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Objective To study effects of hepatic microcirculation and hepatic function using low dose HSS40 preoperation on the partial hepatectomy patients.Methods Sixty-five partial hepatectomy patients were randomly divided into study group (32 cases with HSS40,4 mL/kg,in 30 min) and control group (33 cases with RL,4 mL/kg,in 30 min).Patients of two groups were monitored in liver microcirculation,hepatic function parameters at different times before and after the infusion.Results Compared with the study group,the control group were more infusion (2400 ± 1650) mL and blood transfusion (550 ± 190) mL,the differences were statistically significant (P ＜0.05).Control group of nitric oxide (NO) T3 time(17.84 ± 6.26) μmol/L in the preexpansion compared with preoperative T0 time(38.06 ± 9.34) μmol/L and the study groupT3 time (36.37 ± 9.15) μmol/L was significantly decreased (P ＜ 0.05),and endothelin (ET) (T3 time 185.16 ± 41.34 pg/mL) was significantly higher (P ＜ 0.05),and the study group(T3 time 99.75 ± 30.31 pg/mL) than the control group variation amplitude,time later,the difference was statistically significant (P ＜ 0.05) ; Control group ALT,AST,DBLI,TBLI rise after preexpansion (P ＜ 0.05),and significantly higher than the study group (P ＜ 0.01),and the study group than the control group variation amplitude,time later,differences were statistically significant (P ＜ 0.05) ; while no significant changes in the concentration ALB two groups,the difference was not statistically significant difference (P ＞ 0.05).Conclusion Using low dose HSS40 preoperation on the partial hepatectomy patients can improve cardiovascular stability,protective effect on ischemia-reperfusion injury of liver,can increase the tissue perfusion,and improve the hepatic microcirculation,better able to maintain the stability of the liver function.