Exploration of deferred informed consent in clinical research / 中国医学伦理学

Informed consent is an important ethical symbol in clinical research,and researchers have the responsibility to fully inform participants of the research information before conducting clinical research.However,it is difficult to obtain complete informed consent form participants or their guardians within a narrow treatment time period in clinical research conducted in emergency situations.Currently,in addition to traditional general informed consent,there are also reality-accepted informed consent,including exemption of informed consent,broad informed consent,and deferred informed consent.By introducing the origin and development process of deferred informed consent in clinical research,this paper sorted out the current application status of deferred informed consent,proposed the prerequisites for applying deferred informed consent in emergency situations,and explored the issues that need to be noted during the application process of deferred informed consent.It is hoped to provide an ethical defense and ethical procedure for the application of deferred informed consent in clinical research in emergency situations.

Study on the relationship between synonymous mutation of ABCA3 gene and neonatal respiratory distress syndrome of mongolian and han nationality in inner mongolia / 中华急诊医学杂志

Objective:To investigate whether the synonymous variation of the ATP-binding cassette transporter A3 (ABCA3) gene may increase the risk of respiratory distress syndrome (RDS) in Mongolian and Han newborns in Inner Mongolia.Methods:From January 2018 to June 2019, the children of Mongolian and Han nationality who were hospitalized in the Department of Neonatal Pediatrics, affiliated Hospital of Inner Mongolia Medical University and the control group were sequenced by ABCA3 exon gene to analyze whether there was synonymous mutation in ABCA3 gene.Results:A total of 101 children with RDS were enrolled, including 37 children with Mongolian and 64 with Han children. There were 113 patients in the control group, including 45 Mongolian children and 68 Han children. Children with Mongolian and Han nationality RDS and control group can detect multiple synonymous mutation sites, such as: F353F, P585P, A227A, V150V, L982L, A928A, S1372S, P1653P, E1618E, and A1027A, etc, among them, four synonymous variants of p.A227A, p.F353F, p.P585P and p.S1372S are common synonymous mutants. In both Mongolian and Han nationality, the frequency of ABCA3 gene synonymous mutation in RDS group was significantly higher than that in control group (Mongolian: χ2=9.402, P=0.002; Han: χ2=9.348, P=0.002 ). The mutation rates of F353F and P585P in Mongolian and Han children with RDS were higher than those in the control group, and the difference was statistically significant(Mongolian F353F: χ2=5.270, P=0.022; Han F353F: χ2=5.532, P=0.019.Mongolian P585P: χ2=4.711, P=0.030; Han P585P: χ2=4.480, P=0.034). Conclusions:The synonymous variation of ABCA3 gene may increase the risk of RDS in Mongolian and Han newborns in Inner Mongolia, and F353F and P585P may be one of the susceptible genes of RDS in Mongolian and Han newborns in Inner Mongolia.

Correlation among childhood trauma, obsessive-compulsive symptoms, and implicit and explicit memory in patients with obsessive-compulsive disorder / 中华行为医学与脑科学杂志

Objective:To explore the correlation among childhood trauma, obsessive-compulsive symptoms, and implicit and explicit memory in patients with obsessive-compulsive disorder(OCD).Methods:Fifty-two OCD patients were enrolled, and the childhood trauma was investigated by using the childhood trauma questionnaire short-form(CTQ-SF). The degree of obsessive-compulsive symptoms was assessed by using the Yale-Brown obsessive symptoms scale (Y-BOCS). In addition, the abilities of implicit memory and explicit memory were tested by vocabulary perception speed tasks and vocabulary recognition tasks.According to the scores of CTQ-SF, the patients were divided into abuse group( n=26) and neglect group( n=26). SPSS 22.0 software was used for t-test and Pearson correlation analysis. Results:Results of obsessive-compulsive symptoms, implicit memory, and explicit memory showed no differences between the abuse group and the neglect group( t=-1.959-1.839, P>0.05). The scores of obsessions symptoms(12.52±4.61) were positively correlated with the total scores of CTQ-SF (40.10±10.20)( r=0.331, P<0.05). On the subscale, the scores of obsessions were positively correlated with the scores of physical abuse(7.89±3.02), sexual abuse(6.47±2.28)( r=0.373, P<0.01, r=0.356, P<0.05). There was a negative correlation between the scores of physical abuse and the accuracy of explicit memory(68.75±13.33)( r=-0.281, P<0.05). The scores of physical neglect(8.98±2.67) was positively correlated with implicit memory response time(4 285.94±2 067.42)( r=0.314, P<0.05). Conclusion:Obsessions in patients with OCD are related to traumatic childhood experiences, especially physical abuse and sexual abuse.Physical trauma may influence the level of implicit and explicit memory in patients with OCD.

Chanllenges and countermeasures of breastfeeding for preterm infants in neonatal intensive care units in China / 中国小儿急救医学

Through the analysis of premature infants, preterm mothers and clinical medical workers, there are many difficulties and challenges on breastfeeding for premature infants in neonatal intensive care unit.In order to solve these problems, a team focusing on lactation consultant should be formed.

Expression of miRNA-1 in colorectal cancer tissues and its effect on proliferation and invasion of colorectal cancer DLD1 cells / 肿瘤研究与临床

Objective@#To investigate the expression of miRNA-1 (miR-1) in colorectal cancer (CRC) tissues and its effect on proliferation and invasion of CRC cells in vitro as well as its mechanism.@*Methods@#A total of 180 CRC tissues from the hospitalized patients who underwent excision surgery and 114 adjacent cancer tissues in the Affiliated Cancer Hospital of Shanxi Medical University between June 2015 and December 2015 were collected. Real-time quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of miR-1 in 58 cases of CRC tissues and adjacent cancer tissues. Immunohistochemistry was used to detect the expression of stromal cell-derived factor-1 (SDF-1) protein in 122 CRC tissues and effect of overexpression or knockdown of miR-1 on the proliferation, colony formation and invasiveness of DLD1 cells, respectively. Western blot was used to determine the effect of overexpression or knockdown of miR-1 on the expression of SDF-1 in DLD1 cells.@*Results@#RT-qPCR results showed that the expression of miR-1 in CRC tissues was decreased compared with the corresponding adjacent cancer tissues (the relative expression level ratio < 0.5), and the low expression rate of miR-1 in CRC was 82.8% (48/58). Immunohistochemistry results showed that the positive expression rate of SDF-1 in CRC tissues was higher than that in adjacent cancer tissues [81.1% (99/122) vs. 8.9% (5/56), χ2 = 82.415, P < 0.01]. Cell function experiment showed that, compared with the control group, the proliferative activity of DLD1 cells that transfected miR-1 mimics was decreased, meanwhile, the colony formation, invasion and SDF-1 expression were reduced (P < 0.05). The proliferative activity, colony formation, invasion and SDF-1 expression in DLD1 cells that transfected miR-1 inhibitor were improved compared with those in the control group (P < 0.05).@*Conclusions@#The expression of miR-1 in CRC tissues is low and it may act as a tumor suppressor gene through affecting proliferation and invasive potential of CRC cells by regulating the expression of SDF-1.

Further discussion of general movements quality assessment(writhing movements) in early prediction validity of motor developmental outcome of high-risk infants / 中国小儿急救医学

Objective@#To study the predictive value of general movements(GMs) quality assessment technique(writhing movements)on the motor development outcome of high-risk infants, so as to provide a reference basis for clinical diagnosis and treatment.@*Methods@#A retrospective analysis was made on the high-risk infants who were hospitalized in the Neonatal Department of the Affiliated Hospital of Inner Mongolia Medical University from January 1, 2017 to December 31, 2018, and the GMs quality assessment was finished and followed up to 12-month-old among high-risk infants.The clinical diagnostic criteria for patients with cerebral palsy and Peabody Development Motor Scales-2(PDMS-2)were used to evaluate the motor development outcome of 12-month-old high-risk infants.Furthermore, the predictive value of GMs writhing movements on the motor development outcome of high-risk infants were evaluated.@*Results@#The predictive validity of writhing movements phase[cramped synchronized(CS)+ poor repertoire(PR)]for motor retardation and cerebral palsy in high-risk infants who met the inclusion criteria were as follows: the sensitivity, specificity, positive predictive value, negative predictive value were 94.44%, 23.03%, 11.04%, 97.62% and 100%, 21.88%, 2.60%, 100%, respectively.The predictive sensitivity and negative predictive value of writhing movements PR for motor retardation and cerebral palsy were 92.31%, 100%; 98.18%, 100% respectively.The predictive sensitivity, specificity and negative predictive value of writhing movements CS for motor retardation and cerebral palsy were 100%, 95.81%, 100% and 100%, 95.31% and 100%, respectively.@*Conclusion@#GMs quality assessment(writhing movements)has high reliability in predicting the motor development outcome of high-risk infants, especially cramped-synchronized has significant value in early screening of children with motor retardation and cerebral palsy.

Further discussion of general movements quality assessment( writhing movements) in early prediction validity of motor developmental outcome of high-risk infants / 中国小儿急救医学

Objective To study the predictive value of general movements( GMs) quality assess-ment technique(writhing movements)on the motor development outcome of high-risk infants,so as to pro-vide a reference basis for clinical diagnosis and treatment. Methods A retrospective analysis was made on the high-risk infants who were hospitalized in the Neonatal Department of the Affiliated Hospital of Inner Mongolia Medical University from January 1,2017 to December 31,2018,and the GMs quality assessment was finished and followed up to 12-month-old among high-risk infants. The clinical diagnostic criteria for patients with cerebral palsy and Peabody Development Motor Scales-2 ( PDMS-2) were used to evaluate the motor development outcome of 12-month-old high-risk infants. Furthermore, the predictive value of GMs writhing movements on the motor development outcome of high-risk infants were evaluated. Results The predictive validity of writhing movements phase[cramped synchronized(CS) +poor repertoire(PR)]for mo-tor retardation and cerebral palsy in high-risk infants who met the inclusion criteria were as follows:the sensi-tivity,specificity, positive predictive value, negative predictive value were 94. 44%, 23. 03%, 11. 04%, 97. 62% and 100%,21. 88%,2. 60%,100%,respectively. The predictive sensitivity and negative predictive value of writhing movements PR for motor retardation and cerebral palsy were 92. 31%,100%;98. 18%, 100% respectively. The predictive sensitivity,specificity and negative predictive value of writhing movements CS for motor retardation and cerebral palsy were 100%,95. 81%,100% and 100%,95. 31% and 100%, respectively. Conclusion GMs quality assessment(writhing movements)has high reliability in predicting the motor development outcome of high-risk infants,especially cramped-synchronized has significant value in ear-ly screening of children with motor retardation and cerebral palsy.

Expression of miRNA-1 in colorectal cancer tissues and its effect on proliferation and invasion of colorectal cancer DLD1 cells / 肿瘤研究与临床

Objective To investigate the expression of miRNA-1 (miR-1) in colorectal cancer (CRC) tissues and its effect on proliferation and invasion of CRC cells in vitro as well as its mechanism. Methods A total of 180 CRC tissues from the hospitalized patients who underwent excision surgery and 114 adjacent cancer tissues in the Affiliated Cancer Hospital of Shanxi Medical University between June 2015 and December 2015 were collected. Real-time quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of miR-1 in 58 cases of CRC tissues and adjacent cancer tissues. Immunohistochemistry was used to detect the expression of stromal cell-derived factor-1 (SDF-1) protein in 122 CRC tissues and effect of overexpression or knockdown of miR-1 on the proliferation, colony formation and invasiveness of DLD1 cells, respectively. Western blot was used to determine the effect of overexpression or knockdown of miR-1 on the expression of SDF-1 in DLD1 cells. Results RT-qPCR results showed that the expression of miR-1 in CRC tissues was decreased compared with the corresponding adjacent cancer tissues (the relative expression level ratio < 0.5), and the low expression rate of miR-1 in CRC was 82.8％ (48/58). Immunohistochemistry results showed that the positive expression rate of SDF-1 in CRC tissues was higher than that in adjacent cancer tissues [81.1％ (99/122) vs. 8.9％ (5/56), χ2= 82.415, P< 0.01]. Cell function experiment showed that, compared with the control group, the proliferative activity of DLD1 cells that transfected miR-1 mimics was decreased, meanwhile, the colony formation, invasion and SDF-1 expression were reduced (P< 0.05). The proliferative activity, colony formation, invasion and SDF-1 expression in DLD1 cells that transfected miR-1 inhibitor were improved compared with those in the control group (P< 0.05). Conclusions The expression of miR-1 in CRC tissues is low and it may act as a tumor suppressor gene through affecting proliferation and invasive potential of CRC cells by regulating the expression of SDF-1.

Epidemiology of painful procedures in premature and influencing factors in intensive care unit / 中国小儿急救医学

Objective To report epidemiological data on neonatal pain collected from a geographi-cally defined region,and analyze its influencing factors. Methods We prospectively collected data on all painful procedures from the first 3 days of admission from 106 premature by using self-made questionnaire. Results One hundred and six premature infants experienced 8 167 first-attempt procedures during the first 3 days of admission,26 painful procedures per premature per day. The top seven were respectively plaster re-moval 1 661(20. 3%),nasal aspiration 1 416(17. 3%),blood sugar testing 982(12. 0%),foil removal 833 (10. 2%),intravenous cannula 806(9. 9%),removal of intravenous line 803(9. 8%),arterial puncture 696 (8.5%); 640(7.8%)supplemental attempts were performed. Arterial puncture 274(42.8%)and intrave-nous cannula 235 (36. 7%) were the top two painful procedures easily failed. Non-invasive ventilation,me-chanical ventilation,neonatal respiratory distress syndrome and low weight were the risk factors of painful procedures. Conclusion In neonatal intensive care unit,large number of painful procedures are performed in the first 3 days of admission. Healthcare providers should develop individualized measures to promote the man-agement of premature pain.

Effects of group psychotherapy on damage of theory of mind in patients with early-onset schizophrenia / 中国心理卫生杂志

Objective:To explore the effect of group psychotherapy on damage of theory of mind (TOM) in patients with early-onset schizophrenia.Methods:Totally 60 patients with early-onset schizophrenia were included and divided into the intervention group (n ＝ 30) and the health education group (n ＝ 30).The patients in the intervention group were offered 10 twice a week 2-hour sessions of group psychotherapy,and those in the control were offered group health education twice a week.All participants completed baseline measures and post-intervention measures with the Eye Emotion Recognition and Theory of mind Picture-sequencing Task (TOM-PST).Results:Totally 23 patients in the intervention group and 29 patients in the health education group finished the post-intervention measures.After 5-week intervention,subscores of sad and fear and total score of emotion recognition,total score of TOM-PST,understanding first order error belief,second order error belief,third order error belief,sense of reality,detecting fraud compared to baseline had statistically significant difference in intervention group.In health education group,subscores of joy emotion recognition,understanding first order error belief,third order error belief,total score of TOM-PST compared to baseline had statstically significant difference.The patients with group psychotherapy got higher scores of total score of TOM-PST and understanding second order error belief and third order error belief than the health education group after 5-week intervention (P ＜ 0.05).Conclusion:This study suggests the group psychotherapy could partially improve theory of mind with early-onset schizophrenia,and promote the recovery of social cognition.

Positive report time, distribution and antimicrobial resistance of pathogens from blood culture at a maternity and child health care hospital / 中国感染控制杂志

Objective To analyze the positive report time,distribution and antimicrobial resistance of pathogens isolated from blood culture at a hospital,so as to provide laboratory basis for prevention,contro1 ,and rational antimicrobialuse for bloodstream infection.Methods From January 2013 to January 2015,blood culture specimens of outpatients and inpatients were performed bacterial identification and antimicrobial susceptibility testing, antimicrobial resistance was analyzed.Results A total of 1 973 blood culture specimens were sent by clinical depart-ments,219 (11 .10%)of which were isolated pathogens.Most positive blood culture specimens were from depart-ment of paediatrics (n = 199 ).Isolation rates of gram-negative bacteria,gram-positive bacteria,and fungi were 44.34% (n=98),50.23% (n=111),and 5.43% (n=12)respectively;the main pathogens was coagulase-negative staphylococcus (n=53,23.98%),followed by Escherichia coli (n=39,17.65%),Staphylococcus aureus (n=23, 10.41 %),Klebsiella pneumoniae (n =15,6.79%),and Pseudomonas aeruginosa (n =13,5.88%),the average positive blood culture report time of top five pathogens was 1 -2 days.The detection rates of extended-spectrumβ-lactamase-producing Escherichia coli and Klebsiella pneumoniae accounted for 53.85% and 53.33% respectively, susceptibility of gram-negative bacilli to carbapenems was relatively high(76.92% - 100%);methicillin-resistant isolates accounted for 39.13% among Staphylococcus aureus and 64.15% among coagulase-negative staphylococ-cus,vancomycin-resistant and teicoplanin-resistant strains were not found;resistant rate of Candida glabrata to 5-fluorocytosine was 14.29%,but was susceptible to amphotericin B.Conclusion The major pathogens isolated blood culture are gram-positive bacteria,in order to reduce the emergence of drug-resistant strains,clinicians should choose antimicrobial agents according to blood culture results and antimicrobial susceptibility testing results.

The relationship among the aggressive behavior, hostile attribution bias and childhood trauma in schizophrenic patients / 中华行为医学与脑科学杂志

ObjectiveTo explore the relationship among the aggressive behavior,hostile attribution bias and childhood trauma in schizophrenic patients.Methods 135 schizophrenic patients were tested with Modified Overt Aggression Scale (MOAS),the Chinese-version of the Ambiguous Intentions Hostility Questionnaire (AIHQ-C) and Childhood Trauma Questionnaire (CTQ).According to the score of the MOAS,the patients were divided into the aggressive group ( n =58 ) and the non-aggressive group ( n =77 ).The hostile attribution bias and the childhood trauma were compared between the two groups,and correlation and hierarchical regression analysis were used to investigate the relationships of the variables.ResultsCompared with the non-aggressive patients,the aggressive patients had significantly higher AIHQ-C total hostility bias score (6.27 ± 1.20 vs 5.90 ± 0.97,P ＜0.05 ),total blame bias score (8.04 ± 1.97 vs 6.91 ± 2.10,P ＜ 0.01 ) and total aggression bias score ( 6.17 ±1.02 vs 5.59 ± 1.04,P ＜ 0.01 ).Correlation analysis showed that the MOAS score,AIHQ scores and the total score of CTQ were significantly positively correlated with each other ( r =0.171 ～ 0.350,P ＜ 0.05 ～0.01 ).Regression analysis indicated the hostile attribution bias directly predicted the aggressive behavior( β =0.342,P ＜0.05) and completely mediated the relationship between the childhood trauma and the aggressive behavior.ConclusionThe aggressive behavior in schizophrenic patients is associated with the experience of childhood trauma and the attribution style.The childhood trauma indirectly influences the aggressive behavior by the mediating of the hostile attribution bias.

Effects of CYP2C19 polymorphism on pharmacokinetic profile and comparative bioavailability of omeprazole / 中国药理学通报

Aim To investigate the effects of CYP2C19 polymorphism on the pharmacokinetics and comparative bioavailability of omeprazole in Chinese population.Methods Eighteen healthy male volunteers were selected,of whom 6 were CYP2C19 wild type(w/w),6 were CYP2C19 heterozygous variant(w/m) and the rest were CYP2C19 homozygous variant(m/m).A randomized two-period crossover study was performed.Subjects were assigned to receive test or reference omeprazole as a single oral dose of 40 mg randomly.After a washout period of one week,subjects received the alternative omeprazole formulation.Multiple blood samples of 3 ml were obtained over 12 h after dosing and plasma concentrations of omeprazole were measured by LC/MS method.The modeling of individual pharmacokinetics and the pharmacokinetic parameters of omeprazole were estimated by 3P97.Results The AUC and Cmax of reference omeprazole formulation in w/w,w/m,m/m groups were 1178.44±340.24,2328.10±1011.83,5062.02±1097.29 μg·h·L~(-1) and 602.87±118.25,926.43±134.48,1406.29±233.58 μg·L~(-1),respectively,with significant differences among the three groups(P<0.05).Significant differences were also observed in other pharmacokinetic parameters such as k_e、CL/F、t_(1/2) and Vd/F among the three groups(P<0.05).With regard to test omeprazole formulation,the AUC and C_(max) in w/w,w/m,m/m groups were 1224.82±531.67,2723.34±519.29,5692.49±1575.35 μg·h·L~(-1) and 618.74±231.43,910.67±125.99,1303.31±152.01 μg·L~(-1),respectively,which,as well as k_e,CL/F,t_(1/2) and Vd/F were significant different among the three groups(P<0.05).No significant differences were observed in comparative bioavailability among groups with the values of 94.29%±14.06%,93.08%±11.22%,91.84%±13.03% in w/w,w/m,m/m groups respectively(P>0.05).Conclusions Different CYP2C19 genotypes,leading to functional heterogeneity of CYP2C19,may affect pharmacokinetic profile of omeprazole.Therefore,genotyping CYP2C19 gene before omeprazole therapy will be of great benefit for optimizing individual therapy regimen.There is no significant difference of omeprazole comparative bioavailability with regard to CYP2C19 genetic polymorphism.

Relative bioavailability of three formulations of citalopra hydrobromide in Chinese healthy volunteers / 中国临床药理学与治疗学

AIM:To study the pharmacokinetics and relative bioavailability of citalopra hydrobromide in human plasma.METHODS:The citalopra hydrobromide concentrations in plasma were determined by HPLC-UV.The column was Lichrospher ODS(5 ?m,250 mm?4.6 mm).The mobile phase was acetonitrile-0.1 mol/L KH2PO4 buffer-triethylamine(35:65:0.3,v/v/v).The flow rate was 1 mL/min.The detection wavelength was 240 nm.The test and reference formulations of citalopra were given to 18 healthy male volunteers.RESULTS:The calibration curve was linear within the range of 2-128 ?g/L,r=0.9992.The minimum detection limit was 1 ?g/L.The recovery was 80%-88%,the RSDs of inter-day and intra-day were not more than 15%.After a single oral dose of 20 mg citalopra hydrobromide was given,the main pharmacokinetic parameters tmax were(4.6?1.0),(4.4?1.4) and(4.0?1.4) h;Cmax were(70?19),(71?17) and(66?21) ?g/L;and t1/2 were(37?9),(37?6) and(36?6) h respectively.CONCLUSION:No significant difference exists among the pharmacokinetic parameters of the three formulations.They are bioequivalent.

Researches on drug metabolism enzyme NAT2 / 中国药理学通报

NAT2 is an important drug metabolizing enzymes in humans.Polymorphisms in NAT2 gene produce variants at amino acid including seven mutation sites.In vivo NAT2 takes part in 20 kinds of drugs metabolism and activation of carcinogen.Polymorphism of NAT2 has been related to some diseases.This paper reviews the polymorphisms and genotyping about NAT2 and their implications in drug and clinical research.

Design and Application of Multimedia Courseware in Inorganic Chemistry / 中华医学教育探索杂志

By taking the 《Inorganic Chemistry》of the national standard textbook for the pharmaceutical speciality as a chief source (chief editonHou Xinchu), adopting the softwares of powerpoint, ISIS/ Draw, formula edit tool...etc., and combining the download from the internet, video and refering to the related coursewares in other colleges ...etc., we have and manufactured the multimedia courseware of 《Inorganic Chemistry 》,composed perfectly of various means such as writing, picture, showbiz, animation, voice...etc. This courseware has already been applied in 2001 class,2002 class of the pharmaceutical specialty in our college and has achieved a good result.

The relative bioavailability of glipizide in human body / 医学研究生学报

Objectives:To study the pharmacokinetics and relative bioavailability of glipizide in healthy male volunteers. Methods:The glipizide concentrations in plasma were determined by HPLC UV. The column: Lichrospher C18 (5 ?m,150 mm?4.6 mm),the mobile phase: methanl∶0.01 mol/L sodium acetale buffer (pH 4.8) (59 ∶41); the flow rate:1 ml/min, the detection wavelength: 225 nm. The test and reference formulations of glipizide were given to 20 healthy male volunteers. Results: The calibration curve was linear within the range of (25～1 000)?g/L, r =0.999 4. The minimum detection limit was 25 ?g/L. The mean recovery was 89.84%, CV of inter day and intra day were no more than 5%.After a single oral dose of 10 mg glipizide test or reference tablet, the main pharmacokinetic parameters AUC 0-15, AUC 0-∞, T max ,C max and t 1/2 were (3 502.78?635.82) , (3 214.23?590.46)?g/( L?h),(3 868.22?699.93), (3 593.94?638.60)?g/(L?h),(3.85?1.44), (3.76?1.13)h, (550.80?110.19), (531.15?148.42)?g/L,(3.57?1.11)h and (3.80?1.06)h ,respectively. The relative bioavailability F 0-15 ,F 0-∞ were (110.6?19.8)% and (108.8?17.9)%. Conclusions: No significant difference exists among the pharmacokinetic parameters for the experimental tablets and the reference. The two formulations were bioequivalent.

Detection of IgG2b Monoclonal Antibodies Against LDH-C4 in Sera of Mice Bearing Hybridoma Backpack Tumors by Quantitative ELISA / 昆明医科大学学报

The levels of IgG2b monoclonal antibodies against LD H-C4 in sera of mice bearing hybridoma backpack tumors secreting anti-LDH-C4-IgG2b were detected by quantitative ELISA． The accuracy between batches is 7.04%～l3.30 %, the intra-assay variation is 3.6l%～l0.20%． Standard curveof monoclonal lgG2b was well correlated (r=0.962　　884～0.996　　795)． The sensitivit y of the assay reach e dup to0.0l?mg/L． The present modified ELISA offers a reproducible, se nsitive, specific method in determination of antigen-specific IgG2b antibody in sera．

Determination of total and free amitriptyline and nortriptyline in human plasma by RP-HPLC / 中国药理学通报

AIM　To develop a sensitive, specific and reliable reversed-phase high performance liquid chromatographic method(RP-HPLC) to determine the total and unbound(free) concentrations in human plasma of amitriptyline and its major metabolite, nortriptyline. METHODS The assay involved a simple extraction procedure. The mobile phase consisted of acetonitrile and distilled water(30∶70, V/V), containing triethylamine(0.5%) and orthophosphoric acid(0.3%), pH 3.1. Separation was achieved on the C18 ODS column and the effluent was measured for UV absorption at 240 nm. RESULTS　The calibration curves were linear in the range of 4～400 μg*L-1 for total concentration, and in the range of 4～64 μg*L-1 for free concentration for both amitriptyline and nortriptyline. The lowest limits of detection were 4 μg*L-1 for both compounds. The absolute recovery rates were 102.0%±3.77% for amitriptyline and 99.3%±7.13% for nortriptyline. The precision values(RSD) of intra-day and inter-day for both amitriptyline and for nortriptyline were determined to be <5%, and <8%, respectively. The method was applied to determine the total and free concentrations in plasma of the healthy volunteers after a single oral dose of 50 mg amitriptyline. CONCLUSION　The assay was simple, repid, highly selective and sensitive. It is suitable for the routine analysis of total and free drug concentrations in plasma using readily available instruments with lower cost.

Bioequivalence of naftopidil capsule vs tablet in Chinese healthy male volunteers / 中国临床药理学与治疗学

AIM: To study the pharmacokinetics and rela ti ve bioavailability of naftopidil in healthy male volunteers. METHODS: The naftopidil concentrations in plasma were determined by HPLC. The test and reference formulations of naftopidil were given to 18 healthy male volunteer s. The calibration curve was linear within the range of 1.6 - 400 ?g?L -1 , r=1. The minimum detection limit was 1 ?g?L -1 . The mean recovery rate was 85.2 %- 89.9 %, RSDs of inter-day and i ntra-day were no more than 8.0 %. RESULTS: After a single o ral dose of 50 mg naftopidil test capsules or reference tablets, the main pharma cokinetic parameters AUC 0-24 : 295.6 ? 90.9 and 291.6 ? 89.3 ?g?L -1 ?h -1 ; AUC 0-∞ : 320.0 ? 97.2 and 318.0 ? 98.3 ?g?L -1 ?h -1 ; T max : 0.6 ? 0.2 and 0 .6 ? 0.2 h ; C max : 129.1 ? 60.7 and 138.3 ? 72.5 ?g? L -1 ; T 1/2 : 5.9 ? 1.7 and 6.4 ? 2.1 h , respectively. The relative bioavailability F 0-24 ,F 0-∞ were 101.9 ? 12.9 % and 101.2 ? 12.3 %, respectively. CONCLUSION: No signifi cant difference exists among the pharmacokinetic parameters for the test capsule s and the reference tablets of naftopidil. The two formulations were bioequivale nt.