2.Improvement of the Determination Method of Content and Related Substances of Molsidomine Tablet
China Pharmacy 2016;27(12):1674-1677
OBJECTIVE:To improve the method for the determination of content and related substances of Molsidomine tablet. METHODS:HPLC was adopted to determine the content and related substances,HPLC-MS was adopted for the qualitative degra-dation impurities in destruction test. The column was Waters Symmetry-C18 with mobile phase of 0.05% formic acid- methanol (gradient elution) at a flow rate 1.0 ml/min and 0.2 ml/min (respectively for content and related substances determination,mass spectrometry),the detection wavelength was 210 nm,column temperature was 30℃,the injection volume was 20μl and 5μl(re-spectively for content and related substances determination,mass spectrometry). RESULTS:Each component was well separated un-der chromatographic conditions;degradation impurities were confirmed;the linear range of molsidomine was 4. 0-28.0 μg/ml(r=0.9997);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 97.74%-100.70%(RSD=0.49%,n=9). CONCLUSIONS:The method is simple,accurate with good specific and high precision,and can improve the quali-ty control of Molsidomine tablet.
3.Analysis of gefitinib on brain metastases in 50 patients with non-small cell lung cancer
China Oncology 2010;20(2):134-139
Background and purpose: Brain metastases are common occurrences in patients with non-small cell lung cancer (NSCLC). Gefitinib is a specific inhibitor of epidermal growth factor receptor-associated tyrosine kinase, which has been commonly used in the treatment for advanced NSCLC. The aim of this study was to evaluate the antitumor efficacy of gefitinib in NSCLC patients with brain metastases. Methods: Fifty NSCLC patients with brain metastases were reviewed retrospectively. All of them were treated with gefitinib, given orally at a daily dose of 250 mg. These patients discontinued administration of gefitinib when disease progression, death or intolerable side effects appeared. X~2 test was applied in response analysis. Survival analysis was compared with Kaplan-Meier method and Log-rank test respectively. The multivariate analysis was perfonned with Cox's proportion risk model. Statistical significance was defined as P<0.05. Results: In terms of intracranial lesions, partial response (PR) was observed in 5 patients (10%), stable disease (SD) in 37 patients (74%) and progressive disease (PD) in 8 patients (16%), objective response rate (ORR) and disease control rate (DCR) were 10% and 84%, respectively. As for systemic disease, PR was observed in 5 patients (10%), SD in 30 patients (60%) and PD in 15 patients (30%), overall ORR and DCR were 10% and 70%, respectively. Overall DCR was related to the patients' PS score and the number of brain metastases (P=0.004, P=0.022), but there was no statistical difference in overall DCR among different subtypes of age, gender, smoking history, histology, the onset of brain metastases, chemotherapy, brain radiotherapy and side effects (P>0.05). The median time to disease progression (MTTP) was 7.0 months, which was related to the patients' PS score and smoking history (P=0.000, P=0.045). The median survival time (MST) was 10.8 months, and 1-and 2-year survival rates were 44% and 6% respectively. The univariate analysis showed that the survival time was related to the patients' PS score. smoking history and the number of brain metastases (P=0.011, P=0.028, P=0.044). The multivariate analysis indicated that both the patients' PS score and smoking history were two independent prognostic factors (P=0.005, P=0.006) and the relationship of the survival time and the number of brain metastases was near to statistical significance (P=0.075). Conclusion: The patients with non-smoking history and favorable performance status(PS 0-1) may have better survival benefit and those with single brain metastasis have a trend to survive longer. Gefitinib may be effective on brain metastases in NSCLC patients and appears to be a possible new treatment option.
4.Analysis of treatment and prognosis of 352 lung cancer patients with brain metastases
Journal of Shanghai Jiaotong University(Medical Science) 2006;0(11):-
Objective To analyze the treatment and prognosis of lung cancer patients with brain metastases.Methods The clinical data of 352 lung cancer patients with brain metastases were retrospectively reviewed.According to the treatment modalities,patients were divided into palliative therapy group(n=28),simple whole brain radiotherapy(WBRT)or chemotherapy group(n=49)and comprehensive treatment group(n=275).Comprehensive treatment group was subdivided into WBRT plus chemotherapy group(n=192),stereotactic radiosurgery(?knife)plus chemotherapy/WBRT group(n=72,n=16 for?knife plus chemotherapy and n=56 for?knife plus WBRT and chemotherapy)and neurosurgical resection plus chemotherapy/WBRT group(n=11).In comprehensive treatment group,111 patients received chemotherapy≤3 cycles,and the other 164≥4 cycles.Survival curves of each group were drawn respectively,and both survival time and survival rates were compared among groups.Results The median survival time of palliative therapy group,simple WBRT or chemotherapy group,WBRT plus chemotherapy group,?knife plus chemotherapy/WBRT group and neurosurgical resection plus chemotherapy/WBRT group was 1.7,3.2,9.0,11.6 and 17.1 months,respectively.It was revealed by survival analysis that WBRT plus chemotherapy group was better than simple WBRT or chemotherapy group (P=0.0000),?knife plus chemotherapy/WBRT group was better than simple WBRT or chemotherapy group(P=0.0000),and neurosurgical resection plus chemotherapy/WBRT group was better than simple WBRT or chemotherapy group and WBRT plus chemotherapy group(P=0.0001,P=0.0229).There was no significant difference in survival rates between neurosurgical resection plus chemotherapy/WBRT group and?knife plus chemotherapy/WBRT group(P=0.2543),and there was no significant difference in survival rates between those with?knife plus chemotherapy and those with?knife plus WBRT and chemotherapy(P=0.3804).In comprehensive treatment group,the survival rates of those with chemotherapy≥4 cycles was significantly higher than that of those with chemotherapy≤3 cycles(P=0.0000). Conclusion Both WBRT plus chemotherapy and?knife plus chemotherapy and WBRT are effective modalities for the treatment of lung cancer patients with brain metastases,and the latter has the tendency to gain more survival benefit.There is no significant difference in the survival time between patients receiving?knife with WBRT and those without.It is proper for the patients to have no less than 4 cycles of chemotherapy.
5.Level of intestinal endotoxemia in Alzheimer disease rats
Feng WANG ; Bai HAN ; Dewu HAN
Chinese Journal of Pathophysiology 1989;0(05):-
AIM:The objective of the study was to explore whether intestinal endotoxemia participate in the development of Alzheimer disease.METHODS:Adult Wistar rats were subjected to 90 days intraperitoneal injection with D-galactose and aluminum trichloride(AlCl3) to establish the model of Alzheimer disease.After the administration,the study and memory ability in the rats were observed by Morris water maze.The level of lipopolysaccharide(LPS) in the sera of Alzheimer disease's rats was determined by tachypleus amebocyte lysate method.The level of tumor necrosis factor-?(TNF-?) and interleukin-1(IL-1) in the sera were determined by radioimmunoassay.The expressions of amyloid ?-protein precursor(APP),presenilin 1(PS1) and ?-site APP-cleaving enzyme(BACE) in hippocampus were detected by RT-PCR.RESULTS:Compared with the normal control,the level of LPS in the sera and the expressions of APP,PSI,BACE mRNA in the hippocampus were markedly increased(P
6.Study on the relationship between the efficacy of IFN and ribavirin on chronic hepatitis C and the anti-IFN antibodies.
Chinese Journal of Practical Internal Medicine 2001;0(07):-
Objective In order to study the relationship between the efficacy of IFN and ribavirin in treating the patients with chronic hepatitis C and the anti-IFN antibodies.Methods 20 patients received 3MU rIFN ?-2b three times a week and ribavirim 1?050mg once a day for 24 weeks;32 patients were treated with 3MU rIFN ?-2b and without ribavin.These patients were all followed up 24weeks after stopping treatment,meanwhile the anti-IFN antibodies were detected.Results In first group,50% of the patients had complete response,which was higher obviously than 18.7% in the second group;25%relapse developed in the first group,which was lower than 56.3% in the second group.25% of the patients had no response in each groups.The relapse was related to the anti-IFN antibodies,especially neutralizing antibodies.Conclusion The efficacy of combined treatment with IFN?-2b and ribavirin is superior to the treatment with only rIFN?-2b.The relapse is related to anti-IFN antibodies,especially neutralizing antibodies.
7.The Research of Qualitative and Quantitative Method for the Determination of Hesperidin,Magnolol from "He-Wei-Yin" Mixture
Nan LI ; Guozhu HAN ; Changchuan BAI
Journal of Medical Research 2006;0(07):-
Objective To develop a method for the determination of Hesperidin,magnolol from "He-Wei-Yin" Mixture,and for its quality control,high-performance liquid chromatography (HPLC) is used.Method After plenty of study about the condition,the final result choosed was as following:an analytical column of HypersiC18(200mm?4.6mm,5?m ) maked by HP was utilized. The column number was 13164421196.The mobile phase was adapted gradient with methanol-1% acetum solution,according to the following profile:0~30min,methanol concentration from 30% to 70%;30~40min,from 70% to 80%;40~50min,from 80% to 30%. The flow rate was 1.0ml/min with the column kept at ambient temperature. All the components had come out in 45 min with the detection wavelength at 294nm. It followed the order of Heperidin,Magnolol according to the retention times in the chromatography.Results In the result,the regression equations were as following:Hesperidin was Y=139.718X+4.511 with a good linearity (r=0.99994). Magnolol was Y=1456.342X+106.506 with a good linearity (r=0.99957) between the peak area and the mass of the standard.The recoveries of the method were as following:in the "He-Wei-Yin" Mixture,for hesperidin,precision of the method RSD=1.87%(n=5),recovery of the method 96.53%(RSD=3.36%,n=3);for Magnolol,precision of the method RSD = 0.34% (n=5); recovery of themethod 93.17%(RSD=4.69%,n=3).At the same condition as above,the determination of content was carried out for six different dose and batch No.Conclusion The method is simple and reliable,easy to operate,suitable for the quality control of Hesperidin and Magnolol in "He-Wei-Yin" Mixture.
8.Relationship of the prognosis of lung cancer with brain metastases and the expressions of p53,nm23 and VEGF
Hao BAI ; Weizhong HE ; Baohui HAN
China Oncology 2006;0(10):-
Background and purpose:Brain is one of the most common sites for distant metastasis in patients with non-small cell lung cancer,and the prognosis of patients with brain metastasis is usually dismal.The purpose of this retrospective study is to document the relationship between the prognosis of lung cancer patients with brain metastasis and the expressions of p53,nm23 and VEGF in resected lung cancer tissues.Methods:Ninety-two patients who were definitively treated with surgery for non-small cell lung cancer but lately developed brain metastasis between 1997 and 2005 were identified in our institution.Their clinical data were retrieved and retrospectively reviewed.All pathological specimens of their resected lung cancer were examined for the expressions of p53,nm23 and VEGF by immunohistochemical staining.The association between the treatment outcome and the expression of the above mentioned biomarkers were analyzed.Results:The median survival time(MST) of patients with p53(+) versus p53(-) was 11.0 versus 11.9 month,respectively.The 1,2,and 3-year overall survival rates were 45.71%,22.86%,and 18.29% respectively for p53(+) patients,and 49.55%,16.12%,and 8.89% respectively for p53(-) patients(P=0.5179);The MST of patients with nm23(+) versus nm23(-) was 13.0 versus 10.1 month,respectively.The 1,2,and 3-year overall survival rates were 54.20%,21.51%,and 16.45% respectively for nm23(+) patients,and 32.0%,12.0%,and 4.0% respectively for nm23(-) patients(P=0.1075);The MST of patients with VEGF(+) versus VEGF(-) was 10.5 versus 12.2 months,respectively.The 1,2,and 3 year overall survival rates were 42.20%,0,and 0 respectively for VEGF(+) patients,and 50.0%,25.41%,and 16.57% respectively for VEGF(-) patients(P=0.0231).Conclusions:VEGF was a significant adverse prognostic factor for patients with non-small cell lung cancer who developed brain metastasis.Lung cancer patients whose tumor tissue demonstrated positive VEGF expression had reduced overall survival rates at 1,2,and 3 years after surgery.The expression of p53 and nm23 are not significantly associated to the prognosis of this group of patients.
9.Effects of Metformin on Serum Sex Hormone and Leptin in Ovariectormized Female Rats
Zhaozhen YIN ; Huirong HAN ; Bai KANG
China Pharmacy 1991;0(04):-
OBJECTIVE:To study the effects of metformin (MF)on serum sex hormone and leptin contents in ovariectormized female rats. METHODS: 40 SD rats were randomly divided into four groups: control group(normal saline 5 mL? kg-1?d-1,NS group),OVX group(normal saline 5 mL?kg-1?d-1),OVX+low and high dosage MF group(135,270 mg? kg-1?d-1,MFlow and MFhigh group),all group were ig drugs for 30 days on end.The serum sex hormone indexes including E2,P,LH,LSH and leptin content were measured with RIA. RESULTS:Compared with NS group,the serum E2 and P content were significantly lower(P0.05). CONCLUSIONS: MF can significantly improve sex hormone secretion and lower serum content of LEP in OVX rats.
10.Association of single nucleotide polymorphisms in the IL2RA-RBM17 region with vitiligo in the Chinese Mongolian population
Jianwen HAN ; Jia LIU ; Yunhua BAI
Chinese Journal of Dermatology 2016;49(6):406-410
Objective To investigate the association between single nucleotide polymorphisms (SNPs) in the IL2RA-RBM17 region and vitiligo in the Chinese Mongolian population.Methods Five milliliters of venous blood samples were collected from 425 patients with vitiligo (patient group) and 503 healthy human controls (control group) of Mongolian nationality after informed consent,and genomic DNA was extracted with the AxyPrep DNA extraction kit (AP-MX-BL-GDNA-25).Nine SNPs were selected across the IL2RA-RBM17 region,including rs706779,rs3134883,rs7090530,rs12251307,rs4750005,rs3920615,rs4747887,rs4750012 and rs7099083.Ligase detection reaction (LDR) was performed for SNP genotyping.With the PLINK 1.07 and SPSS 11.0 packages,statistical analysis was carried out by the chi-square test for comparisons of allele and genotype frequencies between the patient group and control group.Linkage disequilibrium analysis was performed for 5 SNPs by calculating the r2 and D' values.Haplotype analysis of 5 related SNPs was conducted to investigate differences in haplotype frequencies between the patient group and control group.Results There were significant differences in allele frequencies of 5 SNPs,including rs4750005,rs3920615,rs4747887,rs4750012 and rs7099083,between the patient group and control group (all P < 0.05).Under a dominant mode of inheritance,a significant decrease was observed in the frequencies of GG/GC genotypes of rs3920615,CT/CC genotypes of rs4747887,CT/CC genotypes of rs4750005,TC/TT genotypes of rs4750012 and AG/AA genotypes of rs7099083 in the patient group compared with the control group (all P < 0.005 6).Moderate to strong linkage disequilibrium was observed between the 5 SNPs (D' =0.424-1,r2=0.137-0.985).Haplotype analysis showed that the frequency of a haplotype (H2:CGCTA) was significantly lower in the patient group than in the control group,and the difference reached statistical significance after Bonferroni adjustment (P=0.001 6,OR =0.674).Conclusion SNPs in the IL2RA-RBM17 region are associated with vitiligo in the Chinese Mongolian population.