We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in that it enhances the pharmaceutical manufactures the ability to control enterprise risk and eliminate the negative impact on traditional Chinese medicine. With the widely used and ADR report concentrated Radix Bupleuri injection as an example, the author provide a new approach to post-marketing clinical research.
Bupleurum ; chemistry ; Drug Compounding ; Drug-Related Side Effects and Adverse Reactions ; etiology ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Product Surveillance, Postmarketing ; methods ; Safety

This article summarized the toxic components, toxication faeature and mechanism and clinical poisoning reports of Senecio spp. The distribution of major toxic components pyrrolizidine alkaloids (PAs) in Chinese medicinal herbs and the application of Senecio spp. in China were also recapitulated. The proposals for the application and development of Senecio spp. were put forward.
Animals ; Chemical and Drug Induced Liver Injury ; Humans ; Plant Poisoning ; etiology ; veterinary ; Plants, Medicinal ; chemistry ; poisoning ; toxicity ; Plants, Toxic ; chemistry ; poisoning ; toxicity ; Pyrrolizidine Alkaloids ; isolation & purification ; poisoning ; toxicity ; Senecio ; chemistry ; classification ; poisoning ; toxicity

Animals ; Anticonvulsants ; pharmacology ; Arsenicals ; Cerebrovascular Disorders ; drug therapy ; Drug Combinations ; Drugs, Chinese Herbal ; isolation & purification ; pharmacology ; therapeutic use ; Fever ; drug therapy ; Humans ; Hypnotics and Sedatives ; pharmacology ; Materia Medica ; isolation & purification ; pharmacology ; therapeutic use ; Mercury Compounds ; Plants, Medicinal ; chemistry ; Stroke ; drug therapy ; Sulfides

OBJECTIVETo investigate the clinical effects of sialoendoscopically-assisted sialolithectomy for the sialolithiasis in the hilum of the submandibular glands.

METHODSBetween December 2005 and March 2011, treated 80 cases of radiography-verified sialiolithiasis in the hilum of the submandibular glands, The patients included 42 males and 38 females aged from 13 to 68 years. All these patients underwent sialoendoscopic observation and sialoendoscopically-assisted sialolithectomy and were followed up periodically for 3 - 6 months after operation. The success rate of stone removal, postoperative complications and clinical effects were analysed.

RESULTSThe stones were completely removed in 71 cases, and almost completely removed in 5 cases, with a successful rate of 95% (76/80). Among 76 successful cases, 8 were treated by basket entrapment, 59 by intraoral open surgery and 9 by both of these two techniques. Within 3 - 6 months' follow-up, 1 case suffered temporary lingual nerve parenthesis and two suffered ranula formation.

CONCLUSIONSSialoendoscopically-assisted sialolithectomy is a safe and effective gland-preservation technique for the patients with the hilum of the submandibular glands.

Adolescent ; Adult ; Aged ; Endoscopy ; methods ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Natural Orifice Endoscopic Surgery ; adverse effects ; Ranula ; etiology ; Salivary Duct Calculi ; surgery ; Salivary Ducts ; pathology ; Submandibular Gland ; surgery ; Young Adult

OBJECTIVETo establish a RP-HPLC method for the determination of swertiamarin, sweroside, gentiopicrin and oleanolic acid in different parts of Swertia pseudochinesis.

METHODA Zorbax SB-C18 (4.6 mm x 250 mm, 5 microm) column was used with acetonitrile-water (10:90) and methnol-water(86:14) at detection wavelengths of 238 nm, 246 nm, 274 nm and 207 nm for swertiamarin, sweroside, gentiopicrin and oleanolic acid respectively. The flow rate was 1.0 mL x min(-1) and the column temperature was 25 degrees C.

RESULTAll of the compounds were based--isolated. The linear ranges of swertiamarin, sweroside, gentiopicrin and oleanolic acid were 0.068 9-0.344 4(r = 0.999 2) , 0.001 1-0.014 0 (r2 = 0. 999 8), 0.001 1-0.013 4 (r2 = 0.999 9) and 0.001 1-0.008 8 mg x mL(-1) (r2 = 0. 999 6), respectively.

CONCLUSIONThe method is simple and accurate, which can be used for quality control of S. pseudochinesis.

Chromatography, High Pressure Liquid ; methods ; Flowers ; chemistry ; Glucosides ; analysis ; Iridoid Glucosides ; Iridoids ; analysis ; Oleanolic Acid ; analysis ; Plant Leaves ; chemistry ; Plant Roots ; chemistry ; Plant Stems ; chemistry ; Plants, Medicinal ; chemistry ; Pyrones ; analysis ; Reproducibility of Results ; Swertia ; chemistry ; Triterpenes ; analysis

OBJECTIVETo study the bone state with ultimate stress by examining biomechanical distribution of upper femur in Chinese, in order to accumulate more experiences for clinical work.

METHODSTotally 60 Chinese femurs from fresh cadavers were randomly divided into two groups. All the femurs were cleaned, and the body age ranged from 36 to 72 years old, averaged 56.4 years, including 41 from males, and 19 from females. These two groups underwent mechanical stress and bending stress tests. Special mechanical laboratory and machines were used to get the information. Results about the loading value at each testing point under stress were collected.

RESULTSThe four faces of the upper femur suffered different stress under external forces. The bone on upper femur can tolerate more mechanical stress than bending stress. Medial and lateral region of the femur neck and the rear side of the small tuberosity section were themain position enduring the vertical stress. The rear position of the base femur neck and the small tuberosity section were the main regions enduring the bending stress. Those main positions had strong cancellous bones. The intertrochanteric fracture fixation and artificial femoral stems were designed depending on this biomechanical basis.

CONCLUSIONAccording to our experiment result, doctors need to chose more effective fixations for upper femur fracture, and femoral stems for the patients. More information should be collected by further researches.

Adult ; Aged ; Biomechanical Phenomena ; Female ; Femur ; chemistry ; Humans ; Male ; Middle Aged ; Stress, Mechanical

Danggui, Agelicae Sinensis Radix, is a widely used Chinese herb to enrich blood, but its quality cannot be effectively assessed by the known chemical markers such as ferulic acid, ligustilide, polysaccharides, etc. A new bioassay was therefore developed to quantify the Enrich-Blood Bioactivity (EBB) for the quality assessment of Danggui raw materials. Danggui sample was first extracted with ethanol and water, respectively. Then the ethanolic extract and water extract were mixed as a test sample to quantify the amount of EBB by mice experiment. The blood deficiency mode in mice was developed by intraperitoneal injecting cyclophospharmide and phenylhdrazine hydrochloride. The quantity of red blood cell was chosen as EBB marker. Cyclosporine A was chosen as a control substance. EBB in analytes was quantified by the amount reaction of parallel line analysis (3, 3') method. The results indicated that the reliability test for quantifying EBB was passed through and the measured value was valid. The analytes showed the significant EBB (P < 0.05). The correlation coefficient was 0.9984 (n=5) between the amount of cyclosporine A (0.035-0.56 g x kg(-1)) and the increased number of red blood cell. The relative standard deviation (RSY) on the amount of EBB was estimated to be 6.15% (n = 6) by six replicated tests, and the confidence limit rate was 26.68% (n = 6). Five Danggui samples, which were collected from different cultivation areas with various morphological characters, showed the variety of EBB in the range of 21.95-44.16 U x g(-1). It is concluded that the developed method is accurate to quantify the EBB of Danggui raw materials, and is therefore suitable to assess its quality.
Angelica sinensis ; chemistry ; Animals ; Biological Assay ; methods ; Drugs, Chinese Herbal ; pharmacology ; Erythrocyte Count ; Erythrocytes ; drug effects ; Male ; Mice ; Mice, Inbred BALB C ; Plant Roots ; chemistry

The aim of this study is to explore the tissue distribution of PEGylated puerarin in acute myocardial ischemia model rats. Healthy male SD rats were randomly divided into two groups (30 each). Both were given PEGylated puerarin at a dose of 488 mg x kg(-1). After 5 min of medication, one group was normal rats, another group with acute myocardial ischemia was established by peritoneal injection of 50 mg x kg(-1) isoprenaline. After administration, the animals were executed at 30, 60, 90, 120, 150 and 180 min, then heart, liver, spleen, lung, kidney were extracted. The content of puerarin in organ tissue was determined by HPLC. The results showed that the AUC of tissue distribution of PEGylated puerarin in normal rats was liver > kidney > heart ≈ spleen > lung > brain. While the AUC of tissue distribution of PEGylated puerarin in acute myocardial ischemia model rats was liver ≈ heart > kidney > lung ≈ spleen > brain. AUC(heart) of PEGylated puerarin in acute myocardial ischemia model rats was 1.7 times than that of the normal rats, and there was significant difference (P < 0.05). Thus, PEGylated puerarin had a good heart-targeting property in early myocardial infarction area, drugs could accumulate in the ischemic myocardium. It provided important information for further study and clinic use of PEGylated puerarin.
Animals ; Brain ; metabolism ; Isoflavones ; pharmacokinetics ; Kidney ; metabolism ; Liver ; metabolism ; Lung ; metabolism ; Male ; Myocardial Ischemia ; metabolism ; Myocardium ; metabolism ; Rats ; Rats, Sprague-Dawley ; Spleen ; metabolism ; Tissue Distribution

OBJECTIVETo observe the effects of Tianma Gouteng Fang (TGF) on the transmitter amino acids in the hippocampus extracellular liquids in freely moving rats subjected to incomplete brain ischemia.

METHODHippocampus extracellular liquids was collected continuously by the microdialysis sampling technology in freely moving rats during pre-ischemia, incomplete ischemia and reperfusion periods induced by the occlusion and loose of both common carotid arteries. Each dialysate sample was assayed for GABA, Tau, Glu, Cys and Arg with HPLC-electrochemical detector.

RESULTTGF increased the concentrations of GABA and Tau in the extracellular liquids of rat hippocampus. Compared with the model group, the concentration of Glu in the middle and large dosage groups of TGF, during the 120 min of ischemia, reduced by 38.64% and 31.35%, Tau increased by 13.99% and 12.86%, GABA advanced 25.89% and 33.99%, Cys decreased by 40.93% and 42.08%, Arg raised to 116.95% and 108.96%, respectively. After 120 min of reperfusion, the concentration of Glu decreased by 14.55% and 11.48%, Tau increased by 16.13% and 14.03%, GABA increased by 24.41% and 26.22%, respectively.

CONCLUSIONTGF can increase the concentration of inhibitory amino acids in hippocampus extracellular liquids of rats and inhibit the excessive release of excitatory amino acids and raise the concentration of the inhibitory amino acids and Arg during the ischemia-reperfusion periods. Therefore, TGF can play the neuroprotective role.

Animals ; Arginine ; metabolism ; Brain Ischemia ; complications ; metabolism ; Drug Combinations ; Drugs, Chinese Herbal ; isolation & purification ; pharmacology ; Excitatory Amino Acids ; metabolism ; Extracellular Space ; metabolism ; Gastrodia ; chemistry ; Hippocampus ; metabolism ; Male ; Neuroprotective Agents ; pharmacology ; Plants, Medicinal ; chemistry ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; etiology ; metabolism ; Taurine ; metabolism ; Uncaria ; chemistry ; gamma-Aminobutyric Acid ; metabolism

OBJECTIVETo examine the in vitro dissolution of forsythin in Forsythia suspensa powder of different particle diameter, in order to give guidance to the grinding process.

METHODHPLC was used to determine the in vitro dissolution quantity and dissolution velocity of forsythin coarse powder, fine powder and ultramicroscopic powder.

RESULTThe dissolution curves of Forsythia suspensa coarse powder, fine powder and ultramicroscopic powder were basically inconformity to Weibull distribution. Specifically, T50 was 11.8, 10.5 and 6.8 min, respectively, and Q45 was 78.22%, 81.91% and 90.76%, respectively.

CONCLUSIONThe superfine milling process can significantly increase the dissolution quantity and dissolution velocity of forsythin.

Bridged Bicyclo Compounds, Heterocyclic ; chemistry ; Chromatography, High Pressure Liquid ; Forsythia ; chemistry ; Furans ; chemistry ; Particle Size ; Powders