OBJECTIVE:To establish an RP-HPLC method for the determination of Berberine hydrochloride in Keyang-min tincture.METHODS:The sample separation was performed on Agilent Eclipse XDB C18(250 mm?4.6 mm,5 ?m),and the mobile phase was acetonitrile-5 mmol?L-1 perfluorooctane sulfonate(32∶68) at flow rate of 1 mL?min-1.The detection wavelength was 346 nm and the temperature of column was 35 ℃.RESULTS:The linear range of Berberine hydrochloride was 0.059 2～0.888 3 ?g(r=0.999 9).The average recovery rate was 99.71%(RSD=1.18%,n=6).CONCLUSION:The met-hod is sensitive,accurate,and reproducible,and suitable for the determination of Berberine hydrochloride in Keyangmin tincture.

OBJECTIVE:To study the effect of Hordeum vulgare on hormone level in male mice.METHODS:Male mature mice(5～6 months) were treated with Hordeum vulgare decoction 1 mL(equivalent to 0.5 g?mL-1 crude drug) bid for 14 consecutive days.Follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) and testosterone(T) in blood were monitored.RESULTS:In Hordeum vulgare group compared normal control,serum E2 increased significantly,serum level of testosterone decreased significantly,while FSH and LH levels remained stable.CONCLUSION:Hordeum vulgare can influence the hormone level in male mice by influencing the gonad axis of the mice.

0.05); the effective rates in rest pain in the two groups were 41.25% and 57.97%,respectively(P

In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.

Aim To establish and evaluate a mouse model of my-ocardial fibrosis by hypodermic injection of isoprenaline. Meth-ods Kunming mice were randomly divided into 2 groups, namely, the myocardial fibrosis model group and the control group, 10 mice in each group. The mice in the model group were given isoprenaline 5 mg · kg-1 by hypodermic injection. From the following day, the dose of isoprenaline was reduced to 2. 5 mg·kg-1 , and lasted for 30 days. The mice in the control group were treated with the physiological saline in the same way. Final-ly, heart weight was then weighed and the cardiac weight index (CWI) was calculated. Hydroxyproline (Hydro) level in myo-cardium was determined by a colorimetric method. HE and Mas-son’s trichrome staining were used to estimate the extent of myo-cardial fibrosis and calculate the collagen volume fraction ( CVF) . RT-PCR was used to measure the myocardial Collagen I mRNA expression. Results Compared with the control group, the CWI and Hydro content in the myocardial tissues in the model group were increased(P<0.01). The content of col-lagen in the myocardial tissues and the CVF were increased obvi-ously(P<0.01). The RT-PCR results showed that the left ven-tricle Collagen I mRNA expression in the model group increased obviously( P<0.01 ) . Conclusion Isoprenaline-induced myo-cardial fibrosis model has been established and the method is very simple, economic and reliable.

Objective To investigate the therapeutic effects, duration of hematopeietic depression and side effects of FLAG regimen for refractory and relapsed acute myeloid leukemia(AML). Methods 13 cases for 5 days, and granulocyte colony stimulating factor G-CSF 300 μg/d from day 0 till neutruphil recovery (ANC≥1x109/L). 13 patients were 8 males and 5 females. The median age was 41.8 years(range 28-67). It includes 5 relapsed AML patients and 8 refractory AML patients. Results Of the 17 times, 11 showed response to therapy; the rate of complete remission was 35.3 %(6/17); the rate of partial remission was 29.4 % (5/17) and the overall response rate was 64.7 %. Main toxicities were gastrointestinal side effects, myelosupression and the function of liver was lightly damaged. Neutropenia at lowest number began at the time of 5-12 days after regimen initiating and last 7-34 days, thrombocytopenia began at the time of 5-13 days and last 8-30 days. Conclusion FLAG regimen showed obvious effects for refractory and relapsed AML Most patients gained chance for hematopoietic stem cell transplantation. Hemotological and nonhemotological toxicities are acceptable.

Objective: To probe into the relationship between changes of sex hormone levels and TCM syndrome differentiation in climacteric women.Methods: According to TCM syndrome differentiation,55 cases of women in menopause were divided into three groups: kidney yang deficiency,kidney yin deficiency and the normal;the correlation between the three types and E2,FSH and LH was explored by statistical methods,and then they were compared with procreative women.Results: In all the 55 cases,kidney yin deficiency covered 70.90%,kidney yang deficiency covered 16.36%,the normal covered 12.72%;changes of E2 correlated positively with symptom scores of kidney yang deficiency and kidney yin deficiency;changes of FSH and LH correlate negatively with that of kidney yang deficiency and kidney yin deficiency.And they all correlated closely with menopause.Conclusion: the main syndrome type of climacteric women was kidney yin deficiency;E2↓,FSH↑ and LH↑ was expression of physiological kidney deficiency of climacteric women.

Objective To study the influence of pine-seed oil upon body weight,blood lipid and lipid peroxidation of mice fed on high fat feed.Method The mice were fed by high fat feed(80% basal feed added 20% lard,HF) and HF added pine-seed oil(80% high fat feed added 20% pine-seed oil,SHF).At 45 d and 90 d,the body fat content,blood lipid level,and malonyldehyde(MDA),lipofusin(LP),catalase(CAT),superoxide dismutase(SOD) and glutathione peroxidase(GSH-Px) of brain and liver homogenate were measured respectively.Results Pine-seed oil could reduce the body weight serum triglyceride(TG),total cholesterol(TC),low density lipoprotein-cholesterol(LDL-C) content,but increase high density lipoprotein-cholesterol(HDL-C) of the mice fed by HF.It suggested that pine-seed oil had definite effect on regulating blood lipid.Compared with normal control(NC) group,the activities of CAT、T-SOD、GSH-Px of brain and liver in HF group were remarkably lower,but MDA and LP remarkably higher.It suggested that HF could promote lipid peroxidation in brain and liver of mice.Compared with HF group,the activites of CAT,T-SOD and GSH-Px of brain and liver in SHF group were remarkably higher,but MDA remarkably lower.Conclusion Pine-seed oil can reduce the body weight,blood lipid,and lipid peroxidation of mice fed by HF.

Purpose To study the spiral CT (SCT) appearances of pleural plaques,to improve the accuracy of diagnosis and differential diagnosis,and to evaluate clinic application.Materials and Methods The SCT appearances in 42 cases with pleural plaques were analysed retrospectively,which closed met with asbestos dust.Results SCT showed 407 pleural plaques in 42 cases,of which there were hyline / uncalcified pleural plaques (n=250),calcified pleural plaques(n= 36),mixed pleural plaques(n=121);unilateral pleural plaques (n=10),bilateral pleural plaques (n=32);single pleural plaque in 5 cases,multiple pleural plaques in 37 cases.The largest pleural plaque was 4.2cm×1.2cm.There were a lot of shapes of the pleural plaques.Various shapes of calcifications could be showed in the calcified or mixed type pleural plaques.The pleural plaques distributed in the middle-inferior part,anterior / posterior-lateral chest wall,underlying the ribs in 28 cases (66.6 %),both bilateral domes of diaphragm in 10 cases and mediastinal pericardium in 4 cases.The pleural plaques associated with pulmonary intertitial fibrosis in 4 cases.No cases in the apices / costophrenic angles.No enhancement of pleural plaques in 6 cases which were administrated contrast scan.Conclusion SCT can clearly show the distribution,extention,shape,size,density and relation to adjacent tissues of the pleural plaques,and with asbestos exposure history,can make a diagnosis and differential diagnosis from other pleural thickened lesions.SCT is the best choice of imaging methods for asbestosis and pleural plaque.