This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.
Equipment and Supplies ; economics ; standards ; India

The concept and classification of Korean medical device were introduced. The phases for Korea to import medical device include selecting Korean certification holder, hospital admittance, device marketing and supervision after marketing. China and other countries can find references to export medical devices into Korea.

Objective To explore the clinical effects of enema combined with massage therapy on jaundice in premature infants.Methods Seventy-five premature infants with jaundice were randomly divided into 3 groups,enema combined message therapy group(group A),abdominal massage therapy group(group B),and double-side phototherapy group(group C).All 3 groups were received the same formula fee-ding,intravenous nutrition and identical drug treatment.Group A was given enema with mixed kaiselu and normal saline together with 60 times clockwise abdominal massage once a day for 2 weeks.Group B only received abdominal massage twice per day for 2 weeks.Transcutaneous bilirubin(TB) indexes of all the premature infants in the 3 groups were detected and transformed into total TB concentrations every morning,through version of MINOLTA JM-102 transcutaneous bilirubin radiometer made in Japan.When TB index counted more than 196.58 ?mol/L,group A and B were given single-side phototherapy for 24 hours.Neither enema nor abdominal massage was given to group C,and double-side phototherapy was applied when TB indexes were above 196.58 ?mol/L.Daily TB indexes,duration of jaundice and phototherapy,time of meconium exhaustion,defecation times in each day,incidence of constipation and feeding intolerance were recorded.Results Duration of jaunhospitalized and phototherapy were significantly shortened in group A compared with those of the other groups.In 34 premature infants who were hospital for at least 2 weeks,TB indexes in group C were lower than those in group B on the 9th day.On the 12th day and the 14th day,TB indexes in group A and C were lower than those in group B(Pa

Objective To explore the effect of traditional Chinese massage on upper limbs spasticity in stroke patients who accepted Botulinum toxin type A (BTX-A) injection. Methods 74 stroke patients with upper limbs spasticity were divided into treatment group (n=36)and control group (n=38). The control group received BTX-A injection, and the treatment group received massage after injection. Both groups received rehabilitation training after injection and were assessed with modified Ashworth scale, Fugl-Meyer assessment and modified Barthel index before and 2 weeks, 4 weeks, 8 weeks and 12 weeks after treatment. Results All the scores of assessments improved in both groups after treatment (P<0.001), and there was no significant difference between them (P>0.05). Conclusion Addition of traditional Chinese massage doesn't work more on spasticity of upper limbs after stroke when accepted BTX-A injection.

OBJECTIVETo develop a pulsed field gel electrophoresis (PFGE) method for molecular typing of Lactobacillus and Streptococcus thermophilus (S. thermophilus) and to apply it in identification and characterization of both bacteria isolated from yoghurt collected from Beijing supermarket.

METHODSThe five most useful restriction enzymes including Apa I, Not I, Sfi I, Xba I and Sma I were chosen to cut DNA of 52 strains of Lactobacillus, S. thermophilus as well as associated standard bacteria strains. The endonucleases and electrophoresis conditions for PFGE analysis were optimized and applied in molecular typing of Lactobacillus and S.thermophilus isolates. Cluster analysis based on the PFGE data was conducted. The identification results of PFGE were compared with those obtained in biochemical and 16s ribosomal RNA PCR identification tests.

RESULTSNot I was suitable for L. bulgaricus, L. fermentum and L. delbrueckii digestion. While Apa I was an appropriate endonuclease for S. thermophilus, L. acidophilus and L. casei digestion. The results of molecular typing indicated that 24 strains of L.bulgaricus and 15 strains of S. thermophilus were grouped into 8 types by PFGE method, respectively. While 7 strains of L.acidophilus were grouped into 3 types and 2 strains of L. delbrueckii were grouped into 2 different PFGE types.

CONCLUSIONThe results of PFGE analysis are in compliance with those of 16s rRNA PCR and biochemical identification. The PFGE method developed in this study is suitable for molecular characterization of both Lactobacillus and S. thermophilus.

Bacterial Typing Techniques ; methods ; Electrophoresis, Gel, Pulsed-Field ; methods ; Lactobacillus ; classification ; isolation & purification ; Streptococcus thermophilus ; classification ; isolation & purification

Congresses as Topic ; Humans ; Rhinitis ; Rhinitis, Allergic, Perennial

Reproductive toxicity research takes an important place in traditional Chinese medicine pre-clinical safety evaluation. Modern reproductive toxicity experiment includes drug-related miscarriage, fetal death, teratism, and adverse effects on fertility, genital system, embryonic development and fetus, which is different from contraindicated in pregnancy in traditional Chinese medicine theory. Now the three-phases reproductive toxicity study is the method mainly applied in traditional Chinese medicine reproductive toxicity evaluation. Besides that, alternative methods of whole embryos culture and embryonic stem cell test are also used in traditional Chinese medicine embryo toxicity evaluation. This article reviews research progress and pre-clinical evaluation on reproductive toxicity of traditional Chinese medicine.
Animals ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; toxicity ; Embryonic Development ; drug effects ; Embryonic Stem Cells ; drug effects ; Female ; Humans ; Medicine, Chinese Traditional ; Pregnancy ; Reproduction ; drug effects ; Toxicity Tests

OBJECTIVETo examine the association between CLOCK gene T3111C polymorphism with attention deficit hyperactivity disorder (ADHD) and ADHD related sleep disturbances in children.

METHODSOne hundred and sixty-six unrelated children with ADHD diagnosed according to DSM-IV criteria and a control group of 150 normal children were enrolled in this study. Parents filled out the Sleep Disturbance Scale for Children (SDSC). Genotype and allele frequencies of T3111C of the CLOCK gene were examined by PCR-restriction fragment length polymorphisms (PCR-RFLP).

RESULTSThere were significant differences in the genotype and allele frequencies of T3111C of the CLOCK gene between the ADHD and control groups (P<0.05). C allele frequency in the ADHD group was significantly higher than in the control group (χ2=7.254, P=0.007, OR=1.740, 95%CI=1.160-2.612). The ADHD children with sleep disturbances were found to have higher C allele frequency than those without sleep disturbances (χ2=13.052, P<0.001, OR=2.766, 95%CI=1.573-4.865).

CONCLUSIONSThere is an association between CLOCK gene T3111C polymorphism and both ADHD and related sleep disturbances in children. The individuals with C allele are susceptible to ADHD as well as ADHD related sleep disturbances.

Adolescent ; Attention Deficit Disorder with Hyperactivity ; complications ; genetics ; CLOCK Proteins ; genetics ; Child ; Child, Preschool ; Female ; Humans ; Male ; Polymorphism, Genetic ; Sleep Wake Disorders ; etiology ; genetics

OBJECTIVETo investigate the effects of garlic oil (GO) on n-hexane metabolized to 2, 5-hexanedione (2, 5-HD) in mice.

METHODSAdult healthy Kunming-mice were treated with n-hexane and GO. The serum was obtained and extracted with ethyl acetate, and the levels of the serum 2, 5-HD were determined by gas chromatography.

RESULTS(1) The concentration of 2, 5-HD in serum increased firstly after a single exposure to n-hexane (4 000 mg/kg). The peak value occurred at 10 hours after n-hexane treatment, but could hardly be detected at 20 h. (2) There was no 2, 5-HD in serum of control mice. The content of 2, 5-HD in serum increased along with the exposure dose of n-hexane. The serum 2, 5-HD contents of the 2000, 4000 and 6000 mg/kg groups mice were 8.04, 16.68 and 22.38 microg/ml at 8 h in pretreated mice, respectively, and showed significant dose-effect relationship. (3) When the different age mice were exposed to the same dose of n-hexane, the contents of 2, 5-HD in serum were significantly different after 8 hours (P<0.05). The serum 2, 5-HD level of the 5 weeks old mice (22.83 microg/ml) was much higher than the 4 (19.59 microg/ml) and 6 (16.42 microg/ml) weeks old mice. (4) When the different gender mice were exposed to the same dose of n-hexane, the concentration of 2, 5-HD in serum of female mice (13.22 microg/ml) was higher than that of the female mice (10.34 microg/ml, P<0.05). (5) GO significantly inhibited the increase of the serum 2, 5-HD levels of both the pretreatment and post-treatment groups treated with 80 mg/kg n-hexane respectively, but the pretreatment with GO exhibited the more suppressive effects than the post-treatment (P>0.05). Compared with the n-hexane group, the concentrations of serum 2, 5-HD in GO-pretreated groups mice decreased by 16.2%, 20.8%, 22.8% (P<0.05) and 32.1% (P<0.01), respectively, and showed significant dose-effect relationship.

CONCLUSIONThe serum content of 2, 5-HD, the metabolite of n-hexane, is different in different genders and age mice after exposed to the same dose of n-hexane. GO can effectively inhibit the production of n-hexane metabolized to 2, 5-HD in mice serum.

Allyl Compounds ; chemistry ; Animals ; Biotransformation ; drug effects ; Female ; Hexanes ; pharmacokinetics ; Hexanones ; blood ; Male ; Mice ; Sulfides ; chemistry

OBJECTIVETo search for the difference of protein molecules expression of HBV infection.

METHODSSpecimens taken from human normal liver tissues (group A), HBV infected human liver tissues which were HBsAg positive, and HBsAg, anti-HBe, and anti-HBc positive in serum (group B) were analysed through the methods of 2-dimensional electrophoresis (2-DE) and matrix-assisted laser-desorption/ionization time of flight mass spectrometry (MALDI-TOF-MS/MS).

RESULTSTotally 1125 plus/minus 56 (n=3) spots were detected in the sample of group A, 1203 plus/minus 42 (n=3) in group B samples. The percent volume of the protein spots was compared to show the proteome alteration in HBV infected human liver tissues. Forty proteins were found to present variations of two or more than two fold in quantity and 22 differentially expressed protein sports were finally identified by MALDI-TOF-MS/MS, including human mitochondrial aldehyde dehydrogenase, haptoglobin Hp2, peroxiredoxin 2, etc.

CONCLUSIONThe protein profile of human normal liver tissue and HBV infected liver tissues showed obviously difference.

Electrophoresis, Gel, Two-Dimensional ; Hepatitis B ; complications ; metabolism ; Humans ; Liver ; chemistry ; Liver Neoplasms ; etiology ; Proteomics ; methods ; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization