Objective: To establish a GC method for the determination of content and content uniformity of memantine hydrochloride dispersible tablets.Methods: The sample was dissolved in water, alkalified by sodium hydroxide solution and extracted by methylene chloride.An HP-5 gas chromatography column (50 m×0.32 mm, 1.05 μm) was used.The column temperature was programming increased, and the initial temperature maintained at 120 ℃ for 3 min, and then raised to 220 ℃ at a rate of 10℃·min-1 and maintained for 7 min.A hydrogen flame ionization detector (FID) was used and the split ratio was 1∶1.The inlet temperature was 230 ℃ and the detector temperature was 260 ℃.The injection volume was 1 μl and the carrier gas was nitrogen with high purity at a flow rate of 3.0 ml·min-1.Adamantane was used as the internal standard, and the internal standard method was used for the calculation.Results: The calibration curve was linear over the range of 0.05-1.0 mg·ml -1 (r=0.999 7).The detection limit and the limit of quantification was 1.1 ng and 3.3 ng, respectively.The average recovery was 100.2% (RSD =0.73%, n=9).Conclusion: The method has the advantages of simple operation, small extraction process toxicity, little environmental pollution, high accuracy and high specificity, and can be used for the determination of content and content uniformity of memantine hydrochloride dispersible tablets.

Background and purpose:Pathogenic gene polymorphism may affect the function of gene, leading to the difference of individual tumor susceptibility and heterogeneity of bioactive substances in individuals. The purpose of this study was to investigate the interrelationship betweenHER-2 gene polymorphism and its protein expression, and to evaluate their association with the clinicopathological characteristics of breast cancer.Methods:The data from a total number of 303 female breast cancer patients of Han ethnicity were collected. The MassARRAY platform was used to examineHER-2 gene rs2517954 and rs2517955 single nucleotide polymorphisms. Meanwhile immunohistochemistry was used to detect HER-2 protein expression and corresponding estrogen receptor (ER), progesterone receptor (PR), P53 and Ki-67 expressions in breast cancer tissues. Pearson chi-square test was used to study the relationship of the two loci and the protein expression, and their correlation with clinicopathological features of breast cancer was analyzed.Results:Under the codominant model,HER-2 gene rs2517954 and rs2517955 loci polymorphisms were associated with its protein expression (χ2=9.613,P=0.008;χ2=9.613,P=0.008). And under the dominant model,HER-2 gene rs2517955 loci TT homozygous and CT heterozygous mutant was associated with its protein expression (χ2=8.894,P=0.003). There were no signiifcant correlations betweenHER-2 gene rs2517954, and rs2517955 loci polymorphisms, and breast cancer patients’ clinical stage, tumor size, histological grade, lymph node metastasis, ER, PR, Ki-67 and P53 expressions (P>0.05).Conclusion:HER-2 gene rs2517955 loci polymorphism is correlated with its protein expression. Further studies may be helpful to elucidate the mechanism of HER-2 protein expression in breast cancer.

Objective:To evaluate the measurement uncertainty in the determination of sodium valproate tablets by GC with an in -ternal standard method , and determine the main sources of uncertainty .Methods:A GC internal standard method was selected to sys-tematically analyze the uncertainty in the determination of sodium valproate tablets , including the sample quantity , dilution ratio, purity and area repeatability of chromatographic peaks .Results: The expanded uncertainty of sodium valproate tablets was 2.7%, and the determination range of sodium valproate tablets was (96.3 ±2.7)%(k=2).Conclusion:The established GC internal standard meth-od for the uncertainty evaluation is reliable , which is helpful to improving the quality evaluation and control of sodium valproate tablets .

OBJECTIVE:To investigate the similarity of dissolution curves between generic preparations and reference prepara-tions of Bisacodyl enteric-coated tablets in various dissolution mediums,and to provide reference for improving production technolo-gy and internal quality of generic preparations. METHODS:Paddle method was adopted with rotation speed of 75 r/min. The disso-lution test was performed using 1000 mL pH 6.0 phosphate buffer solution,pH 6.8 phosphate buffer solution,water containing 2% sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor(f2)meth-od was used to the similarity of dissolution curves. RESULTS:Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50,namely the similarity. CONCLUSIONS:The quality of generic Bisacodyl enteric-coat-ed tablets produced by different manufacturers is obviously different;the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation,it is necessary to strengthen the real-time monitoring of its dissolution curve,to ensure the drug quality.

OBJECTIVE:To establish a method for simultaneous residual determination of dichloromethane and ethyl acetate in bisacodyl raw material. METHODS:Head-space GC was performed on the capillary column of 6% cyanopropyl phenyl-94% di-methyl polysiloxane(DB-624)by temperature programming,the temperature of injector was 220 ℃,detector was flame ionization detector with temperature of 250 ℃,carrier gas was high purity nitrogen with the flow rate of 3.0 ml/min,split ration was 1∶10, headspace heating temperature was 70 ℃,equilibration time was 30 min,volume of headspace vial was 5 ml,and the injection volume was 1 ml. RESULTS:The linear range was 6-120μg/ml for dichloromethane(r=0.999 9)and 50-1 000μg/ml for ethyl ac-etate(r=0.999 9);the limit of quantitation was 0.2,1.7 μg,limit of detection was 0.06,0.5 μg;RSDs of precision,stability and reproducibility tests were no higher than 3%;recoveries were 100.30%-102.00%(RSD=0.63%,n=9) and 100.10 %-101.30%(RSD=0.44%,n=9). CONCLUSIONS:The method is simple and accurate,and can be used for the simultaneous residual deter-mination of dichloromethane and ethyl acetate in bisacodyl raw material.

OBJECTIVE:To establish a method for the determination of content and content uniformity in Bisacodyl enter-ic-coated tablet. METHODS:HPLC method was performed on the column of Agilent ZORBAX C18 with mobile phase of acetoni-trile-20 mmol/L ammonium acetate(adjusted pH to 5.0 with acetic acid)(55∶45,V/V),the detection wavelength was 265 nm,col-umn temperature was 30℃,flow rate was 1.0 ml/min,and the volume injection was 20 μl. RESULTS:The linear range of bisaco-dyl was 50-1 000 μg/ml(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.50%-101.17%(RSD=0.5%,n=9). CONCLUSIONS:The method is reproducible with high accuracy,and suitable for the quali-ty control of Bisacodyl enteric-coated tablet.

ObjectiveTo evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH ) with overactive bladder ( OAB ).Methods82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n = 38 ) and combination group ( n = 44). The ages were from 50 to 75 y ( averaged, 56.8 ± 8.6). Inclusion criteria: the mean frequency of micturition ≥8 times per day, the frequency of nocturia ≥2 times per day, voiding volume ＜200 ml each time; for the overactive bladder symptom score ( OA BSS), the 3 rd score ＞ 2, total score ＞ 3. The tamsulosin group accepted tamsulosin 0.2 mg once daily, the combination group accepted tansulouxin 0.2 mg and solifenacin 0.2 mg once daily. Both groups were maintained the corresponding therapy for 12 weeks.The international prostate symptom score (IPSS), Qmax, residual urine volume, OAB score and adverse reactions were recorded.ResultsThe values of IPSS ( 19.5 ±2.2 vs 15.6 ±2.4, P =0.027), the voiding symptom score ( 15.6 ± 2.4 vs 3.4 ± 1. 7, P = 0. 022) and Qmax ( 13.7 ± 3.8 vs 16.6 ± 4.1, P = 0. 034 )improved significantly after treatment in tamsulosin group ( P ＜ 0. 05 ). The values of IPSS ( 19.7 ± 2.3 vs 9.7 ± 3.0, P ＜0. 001), the storage symptom score (13.8 ± 1.9 vs 5.6 ± 1.6, P ＜0. 001 ), OABSS (10.3 ±1.8 vs 5.3 ±1.3, P ＜0.001) and Qmax(14.1 ±4.1 vs 17.2 ±3.5, P=0.027) also improved significantly after treatment in combination group ( P ＜ 0. 05 ). The values of IPSS ( 9.7 ± 3.0 vs 15.6 ±2.4, P ＜ 0.001 ), the storage symptom score (5.6 ± 1.6 vs 12.0 ± 1.6, P ＜ 0.001 ) and OABSS ( 5.3 ±1.3 vs 9.7 ± 2.7, P ＜ 0. 001 ) improved significantly in combination group than those in tamsulosin group ( P ＜0.001 ). There were no difference between two groups in values of the voiding symptom score, Qmax and residual urine volume ( P ＞ 0.05 ). The incidences of adverse reactions in tamsulosin group and combination group were 7.9％ (3/38) and 20.5％ (9/44) without significant difference. There was no acute urinary retention in both groups.ConclusionsIt is effective and safe for patients with BPH and OAB to accept combination therapy of tamsulosin and solifenacin.

Objective To study the correlation between the expressions of Bcl-2 and Caspase-3 in intestinal epithe-lial and inflammatory cells of lamina propria and the staging and pathogenesis of ulcerative colitis (UC). Methods The pathomorphological changes of 25 samples of UC in the active phase and remission phase and 25 samples of control were ob-served under microscope. The expressions of Bcl-2 and Caspase-3 were detected by immunohistochemistry SP method. The correlations between expressions of Bcl-2, Caspase-3 and UC staging were analyzed. Results There were no significant dif-ferences in expressions of Bcl-2 and Caspase-3 in intestinal epithelial cells between three groups (P>0.05). The expression of Bcl-2 in inflammatory cells of lamina propria was significantly higher in active UC group than that of normal control group (P＜0.05), no significant difference between UC remission group and normal control group (P>0.05). There was a higher positive expression of Caspase-3 in inflammatory cells of lamina propria in UC remission group. There was correlation be-tween Bcl-2, Caspase-3 and UC staging (r=0.371 and 0.4453 respectively). Conclusion The expression levels of Bcl-2 and Caspase-3 were related with pathogenesis of UC. The detection of expression levels of Bcl-2 and Caspase-3 has a cer-tain application value in UC staging.

Objective To study the correlation between TCM differentiation of syndromes typing for ulcerative colitis (UC) and expressions of Bax and Caspase-3.Methods 50 patients with UC were divided into 2 groups according to TCM syndrome differentiation including dampness-heat internal accumulation syndrome group (25cases),deficiency of spleen and stomach syndrome group (25cases).Immunohistochemistry was used to study expression of Bax and Caspase-3 in colonic mucosas and compare with the normal group (25cases).Results The expressions of Bax were highest in dampness-heat internal accumulation syndrome group (4.56±1.58).The expressions of Bax of deficiency of spleen and stomach syndrome group were lower than dampness-heat internal accumulation syndrome group(3.28± 1.14)scores.There were significant differences between the three groups (P＜0.05).However,There were no significant difference between dampness-heat internal accumulation syndrome group and deficiency of spleen and stomach syndrome group in terms of the Caspase-3expressions (P＞0.05).In addition,Caspase-3 and Bax were positively related in each group(r=0.23and 0.21).Conclusion The high expressions of Bax,Caspase-3 in ulcerative colitis were closely related to TCM typing according to syndrome differentiation.Caspase-3 and Bax were adjustment in apoptosis.The detection of expression of Bax,Caspase-3 is helpful to the TCM syndrome differentiation and to the selection of treatment plan.At the same time,it can provide more important experiment basses for the pathogenesis of ulcerative colitis.

Objective To explore TCM syndrome and treatment regular for AIDS dementia complex (ADC). Methods Through literature retrieval, the review of medical records and clinical investigation, expert questionnaires survey was carried out. Results The recovery rate of complete questionnaires in the 1st survey was 88.89%. The agreement rate, the arithmetical mean, the weight coefficient, the mean level and the rank sum of the concept, clinical features, diagnostic criteria, syndrome differentiation and treatment of insufficiency of kidney essence, nursing, period of treatment and curative effect standard were more than others, CV<0.076. The agreement rate, the arithmetical mean, the weight coefficient, the mean level and the rank sum of the etiology and pathogenesis, syndrome differentiation and treatment of deficiency of heart and liver yin were smaller, and CV was within 0.168–0.234. The recovery rate of complete questionnaires in the 2nd survey was 96.00%. The agreement rate, the arithmetical mean, the weight coefficient, the mean level and the rank sum of the etiology and pathogenesis, syndrome differentiation and treatment of deficiency of kidney and liver were more than the 1st survey, and CV was within 0.065–0.106, which was smaller than the 1st survey. The agreement rate, the arithmetical mean, the weight coefficient, the mean level and the rank sum of syndrome differentiation and treatment of deficiency of kidney and liver were smaller, and CV was 0.156. The weight coefficient of the 1st and 2nd survey were within 0.072–0.087, 0.071–0.089. The questionnaire reliability of the 1st and 2nd survey were 0.916 and 0.886 respectively. The half reliability of the 1st and 2nd survey were 0.81 and 0.79 respectively. Conclusion TCM syndrome and treatment regular for ADC is preliminarily formed.