Re-evaluation of bioequivalence of generic drugs is one of the key research focus currently. As a means to ensure consistency of the therapeutic effectiveness of drug products, clinical bioequivalence has been widely accepted as a gold standard test. In vitro dissolution testing based on the theory of the BCS is the best alternative to in vivo bioequivalence study. In this article, the conventional dissolution method and flow-through cell method were used to investigate the dissolution profiles of domestic amoxicillin capsules in different dissolution media, and the absorption behavior of the drugs with different release rates (t85% = 15-180 min) in the gastrointestinal tract was predicted by Gastro Plus. The flow-through cell method was thought better to reflect the release characteristics in vivo, and amoxicillin capsules with regard to the release rates up to 45 min (t85% = 45 min) were having a satisfied bioequivalence with the oral solution according to the C(max) and AUC. Although two different dissolution profiles of domestic amoxicillin capsules were found by flow-through cell methods, prediction results revealed that domestic capsules were probably bioequivalent to each other.

At present,corresponding cell-free parasite DNA molecules (CFPD) has been detected in serum,plasma,urine,saliva and other bodily fluids of a variety of the patients with parasitic diseases.Due to its high specificity and sensitivity,the CFPD shows a strong advantage of noninvasive diagnosis and continuous monitoring,etc.in parasitic diseases.This article namely reviews the current research of CFPD in the patients with parasitic disease at home and abroad in recent years,so as to provide new ideas for the development direction of parasitic disease diagnosis in the future.The current related problems are discussed in the mean time.

Objective To observe the effect of Oxycontin combined with Gabapentin for treatment of malignant neuropathic pain.Methods Sixty-three cases of malignant neuropathic pain in Jinshan Hospital Affiliated to Fudan University were randomly divided into group A, B and C.Patients of which were given Oxycontin, Gabapentin, Oxycontin combined with Gabapentin respectively for pain treatment.The analgesic effects, toxic reaction side effects, quality of life, and immune function were all compared in three groups.Results Compared with pretherapy, the cancer pain score (NRS), quality of life (QOL) and karnofsky performance status(KPS) scores in all groups were changed significantly after drugs therapy(F=375.852,154.612, 151.838,P＜0.05).The levels of CD3,CD4, CD4/CD8 and NK cells in all groups were higher than before therapy(F=158.935,108.145,366.973,92.090,P＜0.05).After treatment,the NRS, QOL and KPS scores in group C were 2.00± 0.86,44.80± 6.07, 84.50± 6.05, in group A were 3.35 ± 0.67,37.35 ± 5.71,74.50 ±10.99,and in group B were 4.05±0.94,35.85±5.90,72.00±8.34, and the different were significant (F =3.250,10.499,3.465,P＜0.05).The levels of CD3, CD4, CD4/CD8and NK cells in group C were (72.94 ±5.63)％,(41.52±4.19)％, 1.86±0.30, (27.57±6.86)％,in group A were (62.84±5.27)％, (33.84 ±5.40)％,1.35±0.37, (20.49±6.67) ％,and in group B were (62.22±8.10)％, (33.19±6.90)％, 1.32 ± ±0.41, (20.32±5.63) ％, and the different were significant (F =3.377,3.344,3.352,3.386, P＜ 0.05).The patient in group C had less adverse effects than those in group A and B.Conclusion Oxycontin and Gabapentin in treatment of malignant neuropathic pain is effective.

Objective To investigate the clinical and pathological characteristics, diagnosis and differential diagnosis of uterine intravenous leiomyoma (IVL) , so as to improve the detection of the disease.Methods Five cases of IVL were retrospected, who were treated and diagnosed by clinical gross examination,morphologic features and immunohistochemical staining in Tumor Hospital of Anyang from 2011 to 2015.Results Symptoms of IVL were usually nonspecific, most patients experienced hypermenorrhea, abdominal pain or distension, and pelvic mass.Typical pathological changes were intravenous visible grey weblike or worm-formed nodules, which could be pulled out.Microscopically, the tumors were composed of mild spindle-shaped cells with rare mitotic figure and closely related to blood vessels.The tumors were positive for smooth muscle derived marker, progesterone receptor, estrogen receptor, and negative for S-100, HMB45 and CD34.However CD34 can displayed vascular endothelial cells around the tumor.Conclusion Uterine IVL is a benign tumor with malignant biological behavior, which has different clinical pathological features of leiomyoma ordinary.Surgery is the main treatment method.A satisfactory therapeutic effect can be achieved by selecting the appropriate extent of surgery.Long term follow up of iVL patients after operation is important.

Objective To identify the clinical profile and neuro-imaging findings of the right temporal lobe variant of semantic dementia (RTLV),and to understand the relationship between anatomic and function by comparison to the left temporal lobe atrophy.Methods Of 70 patients with diagnosis of frontotemporal dementia in our memory clinic,three patients with right temporal lobe atrophy were identified based on the MRI scans.We obtained the profile of cognitive function,behavior and personality changes in these 3 patients and compared them with those in 5 semantic dementia (SD) patients with predominant leftsided temporal lobe atrophy.We also underwent 18F-fluoro-2-deoxy-D-glucose positron emission tomography (18F-FDG-PET) with statistical parametric mapping analysis in these 3 patients.Results In RTLV patients,the most prominent cognitive deficits were impairment of prosopagnosia,and getting lost.Variety behavioral symptoms including apathy,social disinhibition,stereotypy,compulsive behaviors were more prevalent in early course for patients with RTLV,which were different from SD patients with semantic loss began with anomia or single-word comprehension.18F-FDG-PET scan showed decreased metabolism mainly in right temporal lobe and in other brain regions with varying degrees.Conclusions The RTLV is clinical heterogeneous.Prosopagnosia,behavioral changes and getting lost are the main features in the early course.It therefore,might be proposed a separate clinical entity.

ObjectiveTo investigate the relationship between tumor-infiltrating mast cell (TIM) and the clinicopathological and prognostic factors of patients with colorectal cancer.MethodsA total of 282 cases of paraffin-embedded colorectal cancer specimens were obtained from the First Affiliated Hospital of Sun Yat-sen University from January 2002 to December 2005.The density of TIM was determined by immunohistochemical staining.According to the mean TIM density detected [ ( 8.4 + 6.5 )/HPF ],all the patients were divided into low-TIM density group (mean TIM density ＜8.4/HPF) and high-TIM density group (mean TIM density ＞8.4/HPF).The clinicopathological factors and the prognosis of patients between high-TIM density group and low-TIM density group were compared.All data were analyzed using the t test or chi-square test.The survival curve was drawn using the Kaplan-Meier method,and the survival of the patients was analyzed by the Log-rank test.The clinicopathological factors were analyzed retrospectively with the univariate and multivariate COX regression model.ResultsTIM was detected in all the patients with colorectal cancer.Significant differences were observed in the number of patients in N stage and TNM stage between patients in the high-TIM density group and those in the lowTIM density group (x2 =6.025,7.410,P ＜ 0.05 ).All patients were followed up till September 2010,the 5-year overall and tumor-free survival rates of patients were 82.9％ and 63.1％ in the low-TIM density group,79.0％ and 59.3％ in the high-TIM density group,with significant difference between the 2 groups (P ＜ 0.05 ).COX proportional hazard regression model revealed that high density of TIM was associated with short overall survival time and tumor-free survival time of colorectal cancer patients ( RR =2.119,95 ％ CI 1.326- 3.386; RR =2.084,95 ％ CI 1.357-3.199,P ＜0.05).The resuhs of multivariate analysis showed that high density of TIM was the independent factor influencing the overall survival time and tumor-free survival time (RR =1.651,95％ CI 1.009-2.702; RR =1.680,95％ CI 1.074-2.629,P ＜ 0.05 ).ConclusionHigh density of TIM is correlated with the N stage and TNM stage of colorectal cancer,and it is an independent predictor of poor survival for patients with colorectal cancer.

Objective To analyze the clinicopathological factors on the prognosis and investigate the necessity of adjuvant chemotherapy for patients with stage Ⅱ colorectal cancer.Methods The clinical data of 255 patients with stage Ⅱ colorectal cancer who were admitted to the First Affiliated Hospital of Sun Yat-Sen University from January 2000 to December 2005 were collected.The survival curve was drawn by Kaplan-Meier method,and the survival rate of the patients were analyzed by Log-rank test.Factors influencing the survival were analyzed by Cox regression model.Results All patients were followed up till April 23,2010,and the mean time of follow-up was (63 ± 22)months.The median survival time was 63 months.The 5-year and tumor-free survival rates were 85.3％ and 83.7％,respectively.The 5-year overall and tumor-free survival rates of patients without preoperative bowel obstruction or perforation were 86.9％ and 85.6％,which were sigaificantly higher than 72.7％and 68.4％ of patients with preoperative bowel obstruction or perforation(x2 =4.546,4.573,P ＜ 0.05 ).The 5-year overall and tumor-free survival rates of patients with negative resection margin were 85.5％ and 83.9％,which were significantly higher than 75.0％ and 75.0％ of patients with positive resection margin(x2 =7.020,6.009,P ＜ 0.05 ).The result of multivariate analysis revealed that preoperative bowel obstruction or perforation were the independent risk factors for patients with stage Ⅱ colorectal cancer(Wald =4.477,relative risk =2.371,95 ％ confidence interval:1.066-5.275,P ＜ 0.05 ).The 5-year overall and tumor-free survival rates were 87.3％ and 86.0％ for patients who received adjuvant chemotherapy,and were 82.2％ and 80.3％ for patients who did not receive adjuvant chemotherapy (P ＞ 0.05 ).Conclusions Preoperative bowel obstruction or perforation are independent risk factors for the survival of patients with stage Ⅱ colorectal cancer.Adjuvant chemotherapy could not improve the prognosis of patients with stage Ⅱ colorectal cancer.

Objective: To investigate vitamin D levels among primary and middle school students in Xicheng District, Beijing Municipality, and to examine the association of vitamin D levels with hemoglobin (Hb) and serum ferritin (SF) levels, so as to provide insights into the prevention of anemia among primary and middle school students. Methods: The first, third and fifth grade primary school students and the first grade junior high school students were sampled from Xicheng District in 2019, using the multistage stratified cluster sampling method, and students' gender, age, height, weight and Hb levels were collected. The 25-hydroxyvitamin D [25-( OH )D] was measured using electrochemiluminescence assay, and SF was detected using immunoturbidimetry. The vitamin D deficiency was determined according to the American College of Endocrinology guidelines. The associations of 25-( OH) D levels with Hb and SF levels were examined using Pearson correlation analysis and Spearman rank correlation analysis. Results: Totally 403 primary and junior high school students were investigated, including 196 boys ( 48.64% ) and 207 girls ( 51.36% ). There were 179, 114 and 110 students at ages of 6 to 8 years ( 44.41% ), 9 to 11 years ( 28.29% ) and 12 to 13 years ( 27.30% ), respectively. The mean 25-( OH )D level was ( 14.80±5.96 ) ng/mL among the study students, and there were 90 students ( 22.33% ) with severe vitamin D deficiency, 243 students ( 60.30% ) with vitamin D deficiency, 63 students ( 15.63% ) with vitamin D inadequacy and 7 students ( 1.74% ) with vitamin D sufficiency. The mean Hb level was ( 136.28±8.33 ) g/L and the median SF level (interquartile range) was 56.80 (14.36) ng/mL among the study students, respectively. The 25-( OH )D level positively correlated with Hb ( r=0.364, P<0.001 ) and SF levels ( rs=0.374, P<0.001 ), and after adjustment for age and body mass index, the 25-( OH )D still correlated positively with Hb ( r=0.157, P=0.048 ) and SF levels ( rs=0.174, P=0.022 ) . Conclusions Vitamin D deficiency is prevalent among primary and middle school students in Xicheng District, and the 25-(OH)-D levels correlate positively with Hb and SF levels. 25-( OH )-D deficiency may contribute to the development of anemia.
vitamin D ; hemoglobin ; serum ferritin ; primary and middle school student

Odor and taste are characteristic properties of traditional Chinese medicine (TCM). They are closely related to the chemical compositions in TCM. They are also the outer reflection of TCM quality and an important part of the character identification. This article reviewed the current research on odor and taste identification of TCM, which indicated that odor and taste identification had not been paid enough attention to and its research lagged behind modern social development. Based on current analytical techniques and methods, this article proposed a new idea for odor and taste identification of TCM. The idea emphasized the objectification of odor and taste and TCM identification research should be combined with chemical components analysis.

Deoxyglycychloxazol (TY501) is a glycyrrhetinic acid derivative which exhibits high anti-inflammatory activity and reduced pseudoaldosteronism compared to glycyrrhetinic acid. In this study, a sensitive and rapid liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was established for the quantitation of TY501 in rat plasma. Plasma samples were treated by precipitating protein with methanol and supernatants were separated by a Symmetry C8 column with the mobile phase consisting of me-thanol and 10 mM ammonium formate (containing 0.1%of formic acid) (90:10, v/v). The selected reaction monitoring (SRM) transitions were performed at m/z 647.4-191.2 for TY501 and m/z 473.3-143.3 for astragaloside aglycone (IS) in the positive ion mode with atmospheric pressure chemical ionization (APCI) source. Calibration curve was linear over the concentration range of 5–5000 ng/mL. The lower limit of quantification was 5 ng/mL. The mean recovery was over 88%. The intra-and inter-day precisions were lower than 6.0% and 12.8%, respectively, and the accuracy was within 71.3%. TY501 was stable under usual storage conditions and handling procedure. The validated method has been successfully applied to a pharmacokinetic study after oral administration of TY501 to rats at a dosage of 10 mg/kg.