We wished to select a cold-adapted genotype G1P[8] ZTR-68 rotavirus (China southwest strain) in MA104 cells for possible use as a live vaccine. ZTR-68 was recovered originally from children with diarrhea. The virus was cultivated at 37 degrees C at the first passage. Then, the cultivation temperature was decreased stepwise by 3 degrees C per eight passages. In total, the virus was passaged 32 times, and cultivation was terminated at 28 degrees C. Biological characteristics of the virus were analyzed during serial passages. There was no difference between the migration patterns of genomic dsRNA segments according to polyacrylamide gel electrophoresis of original and cold-adapted viruses. Infectious and red cell-agglutination titers of cold-adapted virus were lower than those of the parent virus. Also, the virus formed small-size plaques with irregular shapes at 31 degrees C and 28 degrees C. These results suggested that a genetically stable attenuated virus can be obtained through serial cold-adapted passages. Thus, an alternative strategy is provided by cold-adaption for development of attenuated live rotavirus vaccines.
Adaptation, Physiological ; China ; Cold Temperature ; Diarrhea ; virology ; Female ; Genotype ; Humans ; Infant ; Male ; Rotavirus ; genetics ; growth & development ; isolation & purification ; physiology ; Serial Passage ; Virus Cultivation ; Virus Replication

Matteuccia struthiopteris is a nature plant, which contains a lot of potential active components. In the present study, we investigated the effect of polysaccharides extracted from Matteuccia struthiopteris on lupus-like syndrome induced by Campylobacter jejuni CJ-S131 in BALB/c mice. Mice were randomly divided into normal, model control, SLE model (vehicle treated), Matteuccia struthiopteris polysaccharides treated (30 and 15 mg x kg(-1)) groups and prednisone 5 mg x kg(-1) treated groups. The effect of Matteuccia struthiopteris polysaccharides (Ms) on weight and organ index of BALB/c mice was detected. Autoantibodies and total IgG production were measured by enzyme linked immunosorbent assay. Proteinuria was measured and kidneys were examined by light microscopy. Compared with SLE model group, treatment with Matteuccia struthiopteris polysaccharides 30 and 15 mg x kg(-1) reduced weight loss and Matteuccia struthiopteris polysaccharides 15 mg x kg(-1) reduced spleen swelling (P < 0.05). The increased production of autoantibodies and total immunoglobulin G (IgG) were also significantly inhibited. Matteuccia struthiopteris polysaccharides protected kidney against glomerular injury in BALB/c mice with reduced immunoglobulin deposition and lowered proteinuria (P < 0.01). Matteuccia struthiopteris polysaccharides had a protective effect on lupus-like syndrome induced by CJ-S131 in BALB/c mice.

OBJECTIVETo prepare the nasal thermosensible gels of Chinese medicine Xingbi and study the release mechanism.

METHODThe gels were prepared by using P407 as the gel matrix and P188 and PEG 6000 were used to adjust the gelatination temperature. The formulations were screened by the method of orthogonal test. Mathematic models were used to imitate the drug release.

RESULT20% poloxmar 407, 2% poloxmar 188 and 2% PEG 6000 were suitable to Chinese medicine Xingbi thermosensitive gel in situ. Nasal thermosensible gels of Chinese medicine Xingbi was gelated at the temperature between 32-34 degrees C and the dissolution curves in vitro showed that the drug release could be best described by the Higuchi equation.

CONCLUSIONThe formulation of the nasal thermosensible gels of Chinese medicine Xingbi is reasonable and it is worth doing further research.

Chemistry, Pharmaceutical ; methods ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Gels ; chemistry ; Humans ; Nose Diseases ; drug therapy ; Temperature

OBJECTIVETo develop an HPLC method for gradient elution determination of danshensu and protocatechuic aldehyde in Shengkangling granula.

METHODThe analysis was carried on a column of Hypersil ODS2-C18 with a mobile phase consisted of methanol-1% glacial acetic acid 0-8 min (5:95), 8-11 min (6:94-5:95), 11-20 min (5:95) gradient elution at the flow rate of 1 mL x min(-1). The detection wavelength was 280 nm.

RESULTThe linearity was obtained in the range of 0.0504-0.504 microg (r = 0.9998) for tanshinol and 0.1090-1.090 microg (r = 0.9999) for protocatechuic aldehyde, respectively. The average recoveries of tanshinol and protocatechuic aldehyde in Shenkangling granula were 98.40% and 98.85%, and the RSDs were all less than 2.0%.

CONCLUSIONThe method is simple, accurate and rapid. It may be suitable for the usual quality control of tanshinol and protocatechuic aldehyde in Shengkangling granula.

Benzaldehydes ; analysis ; Catechols ; analysis ; Chromatography, High Pressure Liquid ; methods ; Dosage Forms ; Drugs, Chinese Herbal ; analysis

OBJECTIVETo study the effect and safety of Kudiezi injection on patients with acute ischemic stroke.

METHODSeven hundreds patients were divided into two groups by central randomization system. The study group, 346 cases, was treated with kudiezi injection plus traditional Chinese medicine (TCM) synthesis rehabilitation project, and the control group, 354 cases, was treated with synthetic rehabilitation project. The patients were treated for 10 to 21 days. Before treatment and at the 7th, 14th and 21th day of treatment, the indexes include NIHSS used for evaluating the neurological deficit degree and the motor function score (Fugl-Meyer) for evaluating motor function were observed. The safety index is defined by adverse observation event and laboratory test. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time.

RESULTApplication of generalized estimating equation model, we found that as the treatment time, NIHSS score and FMI score of the two groups showed a trend of improvement. And at the 14th days and 21th days of treatment, compared to the control group the treatment group showed significant statistical difference on the impact of NIHSS and FMI (P<0.05). No serious adverse events were observed.

CONCLUSIONKudiezi injection plus TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the neurological deficit and motor function. Kudiezi injection is safe and effective in the treatment of acute ischemic stroke.

Aged ; Brain Ischemia ; drug therapy ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Injections ; Male ; Medicine, Chinese Traditional ; adverse effects ; Middle Aged ; Product Surveillance, Postmarketing ; Stroke ; drug therapy

OBJECTIVETo verify the efficacy and safety of post-marketed fleabane injection combined with Dengzhan Shengmai capsules in the treatment of ischemic stroke (IS).

METHODA multicentre, prospective, practical, randomized controlled study was carried out to compare the efficacy and safety of Dengzhan group (n = 343) and western medicine group (n = 335), appling "clinical study central stochastic system". The treatment of Dengzhan group is using fleabane injection in acute stage and Dengzhan Shengmai capsules in convalescence. The primary indexes of effect evaluation are the important outcome events in 360 days' follow-up, including mortality, recurrence, disability and quality of life to reflect the effect of clinical study. The indexes of safety evaluation involve laboratory examination results and incidence of adverse events.

RESULTAfter 360 days' follow-up, 4 people died of IS in Dengzhan group, and the mortality rate of which is 1.17%, while 16 died in Western medicine group (WM group), and the mortality rate is 4.78%, suggesting that the mortality rate of Dengzhan group is significantly lower than WM group (P<0.05). Eleven cases recurred in Dengzhan group, and the recurrence rate of which is 3.21%, while 12 recurred in WM group, and the recurrence rate is 3.59%, indicating that the recurrence rate of Dengzhan group is slightly lower than WM group. The disability rate of Dengzhan group is 39.53%, among which the rate of severely disabled cases are 1.49%, while the disability rate of WM group is 40.13%, among which the rate of severely disabled cases are 3.13%, suggesting that the disability rate of Dengzhan group is lower and the severity of disability is also lighter than WM group. In the field of quality of life, the activity ability and the upper limb function store of stroke patients in Dengzhan group improved far much better than WM group (P<0.05). Analysis of safety suggested that, adverse events occurred in 11 cases in Dengzhan group, among which 4 cases is related with the drug treatment, the incidence of adverse events of which is 1.17%, and the main manifestations involve fever and chilling, rash, nausea, dizziness, palpitation, etc. which were all appeared after the treatment of fleabane injection, and disappeared 1 to 2 days after drug withdrawal. 13 cases occurred abnormal liver function and 2 cases abnormal kidney function in Dengzhan group. According to the judgment of clinical physicians, 3 case of ALT abnormality is possibly related to the treatment, the others are all unrelated with the treatment.

CONCLUSIONFleabane injection and Dengzhan Shengmai capsules are all safe and effective TCM in the treatment of ischemic stroke.

Adult ; Aged ; Brain Ischemia ; drug therapy ; Capsules ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Erigeron ; adverse effects ; Female ; Humans ; Injections ; Male ; Middle Aged ; Product Surveillance, Postmarketing ; Prospective Studies ; Stroke ; drug therapy