0.05). However, the scores of belief and attitude of experimental group were higher than those of control group (t=3.03～19.89, P0.05), while the score in control group displayed decreasing trend (t=5.75, P

Objective To observe the clinical effects of the homemade medicated and dietary compound granules in treating sub-health insomnia with deficient cultivation of heart-spirit. Methods Sixty qualified patients were randomly divided into treatment group and control group, 30 cases in each group. The treatment group was given homemade medicated and dietary compound granules(mainly composed of Semen Ziziphi Spinosae, Radix Codonopsis, Sclerotiium Poriae Circum Radicem Pini, Radix Polygalae, Flos Rosae Rugosae, Plumula Nelumbinis, Fructus Ziziphi Jugubae, and Arillus Longan). The control group was given Oryzanol powder. The course of treatment lasted for half a month. Before and after treatment, the scores of Pittsburgh Sleep Quality Index(PSQI) and the traditional Chinese medicine(TCM)symptom rating scale were observed, and the clinical efficacy of the two groups were also evaluated. Results After treatment for half a month and after suspension of medicine for half a month , (1) the total effective rate of the treatment group was higher than that of the control group (P<0.05);(2) the total PSQI scores , sleep quality scores , falling asleep time scores , and daytime function disorder scores were decreased in the treatment group (P < 0.01 compared with those before treatment) , but the scores of each PSQI item in the control group stayed unchanged (P > 0.05). The total PSQI scores , sleep quality scores , falling asleep time scores, and daytime function disorder scores of the treatment group were lower than those of the control group (P<0.01);(3) the total scores of TCM symptoms as well as the scores of dreaminess and susceptibility to awakening, palpitation and amnesia, lassitude and weakness, poor appetite, pale complexion, vertigo and dizziness, abdominal distension and loose stools were declined in the treatment group (P < 0.05 or P < 0.01 compared with those before treatment). Conclusion Medicated and dietary compound granules are effective on improving sleep quality, shortening time to fall asleep, improving sleep disorder, increasing the efficiency of daytime function, improving patients’ mental state entirely, and maintaining the short-term curative effect.

OBJECTIVE:To study the bioequiavailability of domestic roxithromycin tablets and imported ones.METH?ODS:20male healthy volunteers took single dose of150mg roxithromycin tablet orally in a random crossover design,blood concentrations were determined by LC-MS.RESULTS:The main pharmacokinetic parameters of domestic and imported tablets were determined respectively as follows,AUC 0～72 were(72.81?23.85)(mg?n)/L and(72.63?20.86)(mg?h)/L,AUC 0～∞ were(74.41?24.45)(mg?h)/L and(74.42?24.45)(mg?h)/L,C max were(6.46?1.51)mg/L and(6.58?1.55)mg/L,t max were(1.9?0.5)h and(1.8?0.5)h,t 1/2 were(13.56?1.35)h and(14.18?1.50)h,the relative bioavailability of the homemade tablet to imported one was(99.8?11.2)%.CONCLUSIONS:Domestic and imported roxithromycin are bioequivalent.

This study was aimed to establish a quantitative method for the determination of agarotetrol in agarwood to control its quality. The HPLC analysis was performed on a Diamonsil C18 column (4.6 mm í 250 mm, 5 μm), eluted with a mobile phase of water with 0.1% formic acid and acetonitrile in gradient mode with the flow rate of 0.7 mL·min-1. The detection wavelength was set at 252 nm. The column temperature was 30oC. The results showed that the separation of agarotetrol and adjacent peaks were more than 1.5, which achieved a baseline separation. A good lin-earity (r = 0.999 8) was observed in the range of 2.0-125.0 μg·mL-1, with the average recovery of 102.75%. The a-garotetrol cannot be less than 0.15% based on the data of Agarwood samples. It was concluded that the method was accurate and reliable to determine the content of agarotetrol, which can be used for the quality control of agarwood.

Objective To compare the detection performance of the modified serum test (TRUST) method and the traditional method in syphilis screening.Methods A series of TRUST high titer syphilis serum was diluted,and the positive rate of each method was calculated by using the improved method and the traditional method.Comparison of two detection methods of C50,C5 ～ C95 interval,as well as the accuracy of the density curve,and the consistency of the two methods were compared,and diagnostic performance were compared.Results The improved method of C50 was less than the traditional method of C50,and the improved method of C5 ～ C95 range was narrower than the traditional method,compared with the traditional method.The improved method of the non precision density curve was steeper than the traditional method,and the two confidence interval of the consistency degree of the 95％ methods was 73.4％ to 95.8％.The diagnostic sensitivity (SEN),diagnostic specificity (SPE),positive predictive value (PPV),negative predictive value (NPV) and diagnostic efficiency(DF) of the improved method were 64.29 ％,99.1％,85.71％,97.05 ％ and 96.39 ％,respectively.The SEN,SPE,PPV,NPV and DF of the traditional methods were 3.75 ％,98.49 ％,75 ％,96.18 ％ and 95 ％,respectively.The improved method was superior to the traditional methods in the two aspects of SEN and PPV (x2 =8.25,10.03,all P＜0.05),with the statistically significant difference.The improved method was slightly higher than the traditional method in SPE,NPV and DF (x2 =2.39,3.45,4.03,all P＞0.05),with the no statistically significant difference.Conclusion The precision,diagnostic sensitivity and diagnostic specificity of the improved method was higher than that of the traditional method,and it can be applied to the detection of large batch samples with the aid of the full automatic enzyme immunoassay instrument.The improved method can be used to replace the traditional method for syphilis screening.

This study was aimed to investigate the chemical constituents from the leaves of Vitex negundovar. cannabifolia. Column chromatography including silica gel, Sephadex LH-20, ODS, and semi-preparative HPLC were used to separate and purify the chemical constituents, and the structures were elucidated on the basis of physicochemical properties, MS and NMR spectroscopic data. As a result, 11 compounds were isolated from the ethyl acetate extract of V. negundo var. cannabifolia, and identified as apigenin (1), penduletin (2), chrysosplenol-D (3), quercetin (4), 1,4-dihydroxy-3R,5R-dicaffeoyloxy cyclohexane carboxylic acid (5), maeranthoin F (6), capsidiol (7), caryolandiol (8), β-sitosterol (9), p-hydroxybenzonic acid (10), and β-daucosterin (11). It was concluded that compounds 5 8were firstly isolated from the plants of Vitex genus, and compounds 1 and 4 were isolated from V. negundovar. cannabifolia for the first time.

AIM: To compare the pharmacokinetics and relative bioavailability of the domestic and imported sustained-release tablets of gliclazide in healthy volunteers. METHODS:The study was performed by an four-period crossover design with singledose and multiple-dose administration. The plasmadrug concentrations of twenty male healthy volunteers were determined by liquid chromatography with mass spectrum detector method (LC-MS). RESULTS:The pharmacokinetic parameters after a single oral dose of the domestic and imported gliclazide tablets were (7.2+s 1.5) h and (6.9 +1.4) h for tmax, (13.4 ±1.2) h and (13.7 +1.3) h for t1/2, (2.4 +0.8) mg ·L-1and (2.3 ±0.6) mg· L-1 forcmax, (48 ±14)mg · h · L-1 and (48 +14) mg· h · L-1 forAUC0-60,(51+15) mg· h· L-1 and (50±14) mg· h· L-1for AUC0-∞, (22.4 ± 1.9 ) h and (22.8 ± 1.9 ) h for MRT, respectively. The steady state pharmacokinetic parameters after multiple doses of the domestic and imported gliclazide tablets were (6. 1 ± 1.4) h and (6.5+1.4) h for tmax, (4.6±0.9) mg· L-1 and (4.7±1.1) mg· L-1 for cmax, (0.23 ±0.08) mg ·L-1and (0.26±0.08) mg· L-1 forcmin, (1.6±0.3) mg·L-1 and (1.6±0.3) mg · L-1 for mean value of steady plasma-drug concentration (cav),(94±19) mg· h · L-1 and (95 ±20) mg · h · L-1forAUCss, (282 ±33)% and (283 ±43)% for degree of fluctuation DF ), respectively. The relative bioavailability of the domestic gliclazide tablet to the imported gliclazide tablet following a single and multiple dose were ( 102 ± 9) % and (99 ± 10 ) %, respectively. Main pharmacokinetic parameters between the two formulations in both single and multiples dose studies showed no statistical difference ( P >0.05 ). CONCLUSION: The result of two one side t-test shows that the two formulations are bioequivalent.

Aim To evaluate the short-term biocompatibility of a newkind of prosthetic nucleus-Evergel, which is made from the modifiedpolyvinyl alcohol hydrogel. Methods According to China national standardGB/T16886 documents, the toxicity of Evergel prosthetic nucleus materialwas investigated by the cytotoxicity test, sensitization test, haemolysis test,Ames test, mice marrow micronucleus test and chromosome aberration test ofmammalian cell in vitro. Results This material had no cytoxicity, no sen-sitivity, no obvious haemolysis, and no mutagencity in Ames test, micemarrow micronucleus test and chromosome aberration test of mammalian cellin vitro. Conclusion The Evergel prosthetic nucleus has a good biocom-patibility and can be used clinically.

This assay was aimed to evaluate the influence of different contact ways and extracting conditions on the hemolytic effect of biomaterials. Using direct contact method and extract contact method, we assessed the hemolytic effect of PDLLA and PVC. The extracting conditions included: 37 degrees C 24 h, 37 degrees C 72 h, 37 degrees C 120 h, 50 degrees C 72 h, and 70 degrees C 24 h. After the material or extract had been in contact with the diluted blood of rabbit for certain times, the hemolysis rate was calculated. The results for PDLLA showed there were some differences between direct contact and extract contact at 37 degrees C for different extraction time (P < 0.05), but the hemolysis rates, lower than 5%, were in accord with the requirements of medical devices. However, under the condition of 50 degrees C and 70 degrees C, there were significant differences when extract contact method was compared with direct method (P < 0.01). For PVC, there was no statistically significant difference under all conditions (P > 0.05). Our conclusions: (1) Under the extracting condition of 37 degrees C from 24 h to 120 h, the soluble part of PDLLA and PVC that might influence erythrocyte did not dissolve considerably. (2) Under the extracting condition of 50 degrees C and 70 degrees C, the hemolysis rate may remarkably vary with the chemical characteristics of tested materials; (3) As to an unknown material, it is advisable to adopt two methods at the same time, one for direct contact and the other for extracontact. Thus the hemolytic effect of biomaterials can be evaluated from physical and chemical angles. (4) In case that the chemical property of the sample can endure the test, the extracting condition at 50 degrees C and 70 degrees C may be of benefit to assessing the hemolytic effect of biomaterials. (5) The extract contact method as a supplemental test of direct contact method is of realistic significance.
Animals ; Biocompatible Materials ; toxicity ; Hydrolysis ; drug effects ; In Vitro Techniques ; Materials Testing ; methods ; Rabbits ; Temperature ; Time Factors

Objective:To investigate the risk factors of diabetic kidney disease (DKD) in type 2 diabetes mellitus (T2DM) patients in plain-sand areas and loess hilly areas of Gansu province.Methods:A total of 1 599 T2DM patients who participated in chronic disease and risk factors monitoring and basic public health service management were selected by multi-stage stratified random sampling method in the sandy plain areas and loess hilly areas of Gansu province. Questionnaire survey, physical measurement and laboratory tests were performed. Multivariate binary logistic model was used to analyze the influencing factors.Results:The prevalence of DKD was 22.1% (174/787) among T2DM patients in the sandy plain areas and 19.1%(155/812) in the loess hilly area, respectively. Hypertension ( OR=3.022), hyperuricemia ( OR=2.114) and HbA1c≥7%( OR=2.231) were the risk factors for DKD in the plain-sand areas, and the risk of DKD increased with age. In the loess hilly areas, female sex ( OR=0.379) was the protective factor for DKD; while duration of disease≥10 years ( OR=2.476), hyperuricemia ( OR=1.907), HbA1c≥7% ( OR=1.927) were the risk factors for DKD; and the risk of DKD increased with the increase of age, and decreased with the increase of per capita monthly income. Conclusions:The prevalence of DKD and its influencing factors are different between sandy plain areas and loess hilly areas in Gansu province. The prevention and treatment of hypertension should be given more attention in sandy plain areas. In addition, the screening of DKD should be conducted among T2DM patients, particularly for those with old age, hyperuricemia and HbA1c≥7% in both areas of the province.