In this work, a rapid analysis method basing on ultraviolet spectroscopy was established for the determination of danshensu, protocatechuic aldehyde, rosmarinci acid, lithospermic acid and salvianolic acid B in the extraction process of Danhong injection. In the extraction process of Danshen and Honghua crude drugs, 44 extraction solution samples were collected and the contents of the five components were determined by HPLC analysis. The ultraviolet spectra of the samples were collected. Partial least square regression was used to establish the multivariate calibration models between the ultraviolet spectra and the contents of the five components. The results showed that the established models could predict the contents of the five components in the extraction solution accurately. The ultraviolet spectroscopy method established in this work can be used for rapid analysis of the intermediates of Danhong injection, which may be applied for the quality control in the manufacturing process.
Chemistry, Pharmaceutical ; standards ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; analysis ; isolation & purification ; Quality Control ; Salvia miltiorrhiza ; chemistry ; Spectrophotometry, Ultraviolet ; methods

OBJECTIVETo establish a method integrating multi-targets for determining critical process parameters of the manufacturing process of traditional Chinese medicine.

METHODThe ethanol precipitation process of Danhong injection was taken as an application case of the method established. Fractional factorial design of experiments were conducted. Mathematical models relating seven process parameters to ten targets in the ethanol precipitation process were established. Then the sums of the absolute values of the regression coefficients in the models were used to evaluate the criticality of process parameters.

RESULTWater content in the concentrate, ethanol concentration and ethanol consumption were identified as the critical process parameters.

CONCLUSIONThe method established can integrate multi-targets effectively for the evaluation of critical process parameters.

Chemical Precipitation ; Chemistry, Pharmaceutical ; methods ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Salvia miltiorrhiza ; chemistry

In this work, a feedforward control strategy basing on the concept of quality by design was established for the manufacturing process of traditional Chinese medicine to reduce the impact of the quality variation of raw materials on drug. In the research, the ethanol precipitation process of Danhong injection was taken as an application case of the method established. Box-Behnken design of experiments was conducted. Mathematical models relating the attributes of the concentrate, the process parameters and the quality of the supernatants produced were established. Then an optimization model for calculating the best process parameters basing on the attributes of the concentrate was built. The quality of the supernatants produced by ethanol precipitation with optimized and non-optimized process parameters were compared. The results showed that using the feedforward control strategy for process parameters optimization can control the quality of the supernatants effectively. The feedforward control strategy proposed can enhance the batch-to-batch consistency of the supernatants produced by ethanol precipitation.
Chemical Precipitation ; Chemistry, Pharmaceutical ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Quality Improvement ; Salvia miltiorrhiza ; chemistry

OBJECTIVETo develop an HPLC method to determine the contents of danshensu, hydroxysafflor yellow A, rosmarinic acid, lithospermic acid, salvianolic acid B in the water extract of mixed Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos simultaneously.

METHODThe separation were carried out at 30 degrees C on a ZORBAX Eclipse Plus C18 column (4.6 mm x 100 mm, 1.8 microm) with formic acid-500 mmol x L(-1) ammonium formate-water solution (0.5:10:90) as mobile phase A and acetonitrile-formic acid solution (100: 0.5) as mobile phase B in gradient mode at a flow rate of 0.5 mL x min(-1). Detection wavelengths were 280 nm for danshensu, rosmarinic acid, lithospermic acid, salvianolic acid B, and 380 nm for hydroxysafflor yellow A.

RESULTThe 5 components were separated well with a good linearity (R2 > 0.999 3) in the range of the test concentration. The average recoveries of danshensu, hydroxysafflor yellow A, rosmarinic acid, lithospermic acid, and salvianolic acid B were 99.1%, 102%, 102%, 98.5% and 101%, respectively.

CONCLUSIONThis method is simple, accurate, and repeatable.

Benzofurans ; analysis ; Chalcone ; analogs & derivatives ; analysis ; Chromatography, High Pressure Liquid ; methods ; Cinnamates ; analysis ; Depsides ; analysis ; Lactates ; analysis ; Quinones ; analysis ; Rhizome ; chemistry ; Salvia miltiorrhiza ; chemistry

OBJECTIVETo study the selective isolation of a single chemical component from volatile oil of Fructus foeniculi by inclucion method.

METHODThe host molecule was selected and a single chemical component isolated from volatile oil by the host-guest recognition.

RESULTX-ray single crystal analysis showed that 1,1,6,6-tetraphenylhexa-2, 4-diyne-1, 6-diol could successfully include 4-[1-propenyl] benzaldehyde from volatile oil of Fructus foeniculi.

CONCLUSIONThe host-guest inclusion technology can be used to isolate a single component selectively from mixture.

Crystallization ; Crystallography, X-Ray ; methods ; Foeniculum ; chemistry ; Molecular Conformation ; Oils, Volatile ; chemistry ; isolation & purification ; Plants, Medicinal ; chemistry ; Seeds ; chemistry

OBJECTIVETo examine the nephrotoxicity induced caused by combined effect of arsenic and cadmium in exposed workers.

METHODSUrinary cadmium and arsenic were used as the exposure biomarkers of cadmium and arsenic. Urinary beta2-microglobulin (Ubeta2-MG), albumin (UALB) and N-acetyl-beta-D-glucosaminidase (UNAG) were measured as the effective biomarkers of tubular and glomerular dysfunction induced by cadmium and arsenic.

RESULTSThe combination of cadmium and arsenic induced more severe renal injury than that caused by either of the chemicals given alone. There were positive correlations and significant dose-effect among the concentrations of urinary cadmium, arsenic and levels of Ubeta2-MG, UALB, UNAG (P<0.05, P<0.01).

CONCLUSIONCadmium combined with arsenic may have additive effect on renal dysfunction in workers exposed to arsenic and cadmium.

Adult ; Albuminuria ; chemically induced ; Arsenic ; toxicity ; urine ; Cadmium ; toxicity ; urine ; Dose-Response Relationship, Drug ; Female ; Humans ; Kidney ; drug effects ; Male ; Middle Aged ; Occupational Exposure ; beta 2-Microglobulin ; urine

OBJECTIVETo investigate the clinicopathological features of nonalcoholic steatohepatitis (NASH) and elucidate its diagnosis and differential diagnosis.

METHODSLiver biopsy tissues and clinical data of 32 patients with NASH were collected and the clinicopathological findings by HE and Masson staining were evaluated for NASH grading.

RESULTSBallooning degeneration of the liver cells and fibrosis around hepatic sinusoid was scarce in mild NASH cases and increased in moderate to severe cases. Steatotic and inflammatory cells in the liver lobes decrease in liver cirrhosis related to seatohepatitis.

CONCLUSIONBallooning degeneration of the liver cells and fibrosis around the hepatic sinusoid have important value in differential diagnosis of mild from moderate to severe NASH, and correct histological grading benefits clinical intervention and prognostic evaluation of NASH.

Adult ; Biopsy, Needle ; Diagnosis, Differential ; Fatty Liver ; diagnosis ; pathology ; Female ; Humans ; Image Interpretation, Computer-Assisted ; Liver ; pathology ; Male ; Middle Aged ; Prognosis

Objective: To analyze associations of MRI-lesions and clinical features with disability in patients with multiple sclerosis (MS) in Shanghai, China. Methods: We studied patients with MS, identified from a survey in Shanghai, whose sites of lesions in the CNS was based on the MRI examinations. Associations between MRI-lesions, various clinical variables and the severity of disability were analyzed with univariate and multivariate logistic regression analysis. Results: There were 210 patients in this study. The disability of the patients with lesions confined to the spinal cord was significantly more severe than those with lesions in the brain (p < 0.008). Current age (OR: 1.041, 95% CI: 1.007~1.077), MS duration (OR: 1.082, 95% CI: 1.011~1.159) and MRI-lesions in the spinal cord (OR: 2.441, 95% CI: 1.039~5.737) were significantly associated with severity of disability on multivariate logistic regression analysis. Conclusion: MRI-lesions in the spinal cord, older age, a longer MS duration were significantly associated with a more severe disability in this MS study in Shanghai China.

BACKGROUNDCD4(+) T cell counts have been used as the indicator of human immunodeficiency virus type 1 (HIV-1) disease progression and thereby to determine when to start highly active antiretroviral therapy (HAART). Whether and how the baseline CD4(+) T cell count affects the immunological and viral responses or adverse reactions to nevirapine (NVP)-containing HAART in Chinese HIV-1 infected adults remain to be characterized.

METHODSOne hundred and ninety-eight HIV-seropositive antiretroviral therapy (ART)-naive subjects were enrolled into a prospective study from 2005 to 2007. Data were analyzed by groups based on baseline CD4(+) T cell counts either between 100 - 200 cells/microl or 201 - 350 cells/microl. Viral responses, immunologic responses and adverse events were monitored at baseline and at weeks 4, 12, 24, 36, 52, 68, 84, 100.

RESULTSEighty-six and 112 subjects ranged their CD4(+) T cell counts 100 - 200 cells/microl and 201 - 350 cells/microl, respectively. The pre-HAART viral load in CD4 201 - 350 cells/microl group was significantly lower than that in CD4 100 - 200 cells/microl group (P = 0.000). After treatment, no significant differences were observed between these two groups either in the plasma viral load (pVL) or in the viral response rate calculated as the percentage of pVL less than 50 copies/ml or less than 400 copies/ml. The CD4(+) T cell counts were statistically higher in the 201 - 350 group during the entire follow-ups (P < 0.01) though CD4(+) T cell count increases were similar in these two groups. After 100-week treatment, the median of CD4(+) T cell counts were increased to 331 cells/microl for CD4 100 - 200 cells/microl group and to 462 cells/microl for CD4 201 - 350 cells/microl group. Only a slightly higher incidence of nausea was observed in CD4 201 - 350 cells/microl group (P = 0.05) among all adverse reactions, including rash and liver function abnormality.

CONCLUSIONSThe pVLs and viral response rates are unlikely to be associated with the baseline CD4(+) T cell counts. Initiating HAART in Chinese HIV-1 infected patients with higher baseline CD4(+) T cell counts could result in higher total CD4(+) T cell counts thereby achieve a better immune recovery. These results support current guidelines to start HAART at a threshold of 350 cells/microl.

Acquired Immunodeficiency Syndrome ; drug therapy ; immunology ; Adult ; Antiretroviral Therapy, Highly Active ; adverse effects ; methods ; Blotting, Western ; CD4-Positive T-Lymphocytes ; immunology ; Enzyme-Linked Immunosorbent Assay ; Female ; Flow Cytometry ; HIV Infections ; drug therapy ; immunology ; Humans ; Male ; Middle Aged ; Nevirapine ; adverse effects ; immunology ; therapeutic use ; Prospective Studies

Bacillus megaterium ; pathogenicity ; Brain Abscess ; diagnosis ; microbiology ; Female ; Humans ; Middle Aged