The Sino-US Joint Clinical and Molecular Laboratory (JCML) is a comprehensive clinical research laboratorywith main focus on study of hematopoetic diseases including myelodysplastic syndrome, leukemias and lymphomas.The JCML is located in the Shanghai Medical College of Fudan University (formerly Shanghai Medical University)in Shanghai, China and was established as part of a large multi-center, international study of benzene health effectin China that is sponsored by the international consortium on benzene health effect.

Objective To evaluate the efficacy and safety of testa triticum tricum purif for the treatment of functional constipatiofi(FC) in the late middle-aged and elderly patients.Methods This study was designed as a multicenter randomized controlled trial.Patients who met Rome Ⅲ diagnostic criteria of FC were enrolled,with age between 55-85 years old.Those with organic diseases were excluded.The patients were randomly allocated to receive testa triticum tricum purif (3.5 g bid) or polyethylene glycol 4000 powder (PEG4000,10g bid) for 8 weeks,followed by single dose of maintenance therapy for 4 weeks.Follow-up visits were at 4 and 12 weeks after treatment discontinuation.The independent investigators in each center evaluated the constipation symptoms scores.The primary endpoints included rates of significant improvement,improvement and overall improvement at the end of 2,4 and 8 weeks of therapy,which were calculated by the reduction of symptom scores ≥ 75 ％,50％-74％,≥ 25 ％ respectively.Results A total of 127 FC subjects were enrolled from 3 centers,and 122 cases valid for final analysis.The mean age was (69.4 ± 6.9) years old,including 62 cases in testa triticum tricum purif group and 60 cases in PEG4000 group.The demographic data,constipated symptoms scores and proportion of FC subtypes at baseline were comparable.The rates of significant improvement,improvement and overall improvement in testa triticum tricum purif and PEG4000 groups at the end of 2,4 and 8 weeks were 37.70％ (23/61) vs 59.32％(35/59) (P=0.018),57.38％ (35/61)vs74.14％ (43/58) (P=0.054),and64.41％ (38/59)vs 79.31％ (46/58) (P =0.073) respectively.Testa triticum tricum purif therapy significantly improved the proportion of spontaneous bowel movement (SBM) ≥ 3 times/week from 43.55％ (27/62) to 80.33％ (49/61),83.61％ (51/61) and 93.22％ (55/59) at 2,4,and 8 weeks respectively (all P＜0.01),which were comparable with PEG4000 group (all P ＞ 0.05).The proportion of normalized stool forms in study group was significant higher than that of control group at the end of 8 weeks [86.44％ (51/59) vs 67.24％ (39/58),P =0.014].Only one patient complained mild abdominal distension during testa triticum tricum purif therapy.Conclusions The efficacy of testa triticum tricum purif for the treatment of FC in late middle-aged and older patients is comparable with osmotic laxatives PEG4000,which has significant effect on normalization of fecal forms and reliable safety.

OBJECTIVE： To establish a methaod for content determination of doxorubicin hydrochloride nano-liposomes， and to optimize its preparation technology. METHODS： The contents of doxorubicin hydrochloride nano-liposomes was determined by UV spectrophotometry. The membrane dispersion method was used to prepare doxorubicin hydrochloride nano-liposomes. Using particle size， encapsulation efficiency and drug-loading amount as indexes， the weight ratio of phospholipid to drug （mg/mg）， the weight ratio of phospholipid to cholesterol （mg/mg） and ultrasonic time （min） as factors， central composite design-response surface methodology was used to optimize the preparation technology. The photothermal conversion effect of doxorubicin hydrochloride nano-liposomes was investigated by near infrared irradiation. RESULTS： The linear range of doxorubicin hydrochloride were 1.01-16.16 μg/mL（r＝0.999 7）； precision， stability and reproducibility tests were all in line with the requirments of Chinese Pharmacopoeia. The optimal preparation technology included that the weight ratio of phospholipid to drug was 13.30 ∶ 1（mg/mg）； the weight ratio of phospholipid to cholesterol was 4.09 ∶ 1 （mg/mg）； the ultrasonic time was 10 min. Under this technology， the particle size and drug-loading amount of doxorubicin hydrochloride nano-liposomes were （200.5±25.1） nm and （11.02±0.20）％， relative errors of which to predicted value （196.3 nm， 10.68％） were 1.82％ and 1.63％. The consistency between measured value and predicted value was good. Doxorubicin hydrochloride nano-liposomes exhibited concentration- dependent and time-dependent photothermal conversion characteristics under near infrared irradiation at 808 nm. CONCLUSIONS： Established method is simple and good accuracy. The optimized preparation technology is simple and feasible.