Objective To explore achillis tendon-sliding procedure and subtalar joint capsula release by the same cut and individualization treatment used in the correction of congenital clubfoot.Methods Forty eight cases (76 feet) of congenital clubfoot who were first visit were treated by achillis tendon-sliding procedure and subtalar joint capsula release by the same cut,meantime,footplate fascia release and transfer of the anterior tibial tenden were made by individualization.Results All cases were followed-up,the average time follow-up was 1 year and 6 months,excellent were 71% and good were 15.7%.Five cases were recurrence and its rate was 6.94%.Conclusions Achillis tendon-sliding procedure and subtalar joint capsula release by the same cut can solve rotation of displacement between calcaneus and talus and individualization treatment can also solve high arch deformity and adduction of foot.This technique is a simple,safe and effective treatment for congenital clubfoot.

Objective To review the study of noninvasive imaging methods for evaluating liver fibrosis.Meth- ods The current literatures on the use of the ultrasonography,CT and MRI for the evaluation of liver fibrosis were reviewed.The principles,applications and advancement of each imaging methods were described and summarized re- spectively.The features of the newly developed imaging techniques were also discussed.Results In addition to the morphologic information,the imaging examinations can also provide functional information about the circulation sta- tus,diffusion and metabolism features of liver.The potential diagnostic value of MR elastography for liver fibrosis has been addressed.Conclusion The imaging examinations,especially the functional MRI techniques,are reliable noninvasive alternatives for the evaluation of hepatic fibrosis,with bright potentiality for clinical application.

Objective To investigate the clinical value of the combination of hysterescope and laparoecope in the treatment of tubal obstruction infertility.Methods Two hundred and sixty-slx infertile women managed by the combination of hysteroscope and laparoecope from August 2003 to December 2006 were enrolled.The postoperation tubal recapalization extent and pregnancy rate were analyzed.Results The recanalization rate of the umbrella and ampulla portion was higher (86.9%) than that of other sites (interstitial portion was 33.8%,isthmic portion was 35.5% ),and the pregnancy rote of patients with one tubal recavalization was signifieenfly higher than that of patients with bilateral tubal obstruction.The pregnancy rate was 48.0% in 12 months,little higher than 41.0% in 6 months after operation.Conclusion The combination of hysterecope and laparescope in treatment of tubal obstruction infertility has ideal effect and clinical application value.

This study was to investigate the role of urethral catheter balloon dilatation(F16)in the treatment of intrauterine adhesion after hysteroscopic surgery.A total of 523 patients with severe intrauterine adhesion(IUA)following hysteroscopic surgery underwent urethral catheter balloon dilatation during April 2000 and December 2005.During 3～15 months'follow-up,normal menses were seen in 340 patients (65.0％),nearly normal menses in 165 patients(31.5％),and menoschesis in 18 patients(3.4％).302 patients showed normal uterine cavity with no recurrent endometrial adhesion,203 patients(38.8％)were found slight IUA,and only 18 patients(3.4％)still presented with severe adhesion.No operative complication was reposed.and the pregnant rate was 47.6％.In summary.urethral catheter balloon dilatation.based therapeutic strategies is safe.effective and beneficial.

Strong inhibition of Bacillus subtilis strain NJ-18 on mycelia growth of Alternaria solani was observed in the antagonistic tests by cylinder plate methods, and the inhibition width was 21.5 mm. Observation under microscope found that the supernatant of fermentation from NJ-18 could make the pathogen hyphae cells malformed and swelled, and consequently the growth of the pathogen was inhibited. Determining of the colonization in potato plants by the signed rifampicin-resistance in NJ-18 showed that it could colonize well in the plants, the colonization quantity of NJ-18 in the root and stem of the potato detected 30 days after fermentation irrigation was 103 CFU/g plant’s fresh weight. In pot experiment, we inoculated the tomato plants with the spore suspensions of Alternaria solani after spraying the fermentation of NJ-18, the results were investigated in 14 days and the efficacy in controlling the disease was 72.9%, which was significantly higher than 45.7%, the efficacy resulted from spray treatment of 2000 fold dilution of 50% iprodione wetable powder.

·AIM: To investigate whether Erigeron Breviscapus (vant) Hand-Mazz (EBHM) EBHM has neuroprotective effect against N-methyl-D-aspartate (NMDA)-induced neuron death in retinal ganglion cell layer (RGCL).· METHODS: 60 healthy SD rats were randomly divided into four groups. 6 animals were normal control group (group A). The others were divided as group B (EBHM group), group C (normal saline+NMDA group) and group D (EBHM + NMDA group). Each group had 18 rats.10nmol NMDA was intravitreally injected to induce partial damage of the neurons in RGCL in the right eyes of Groups C and D. Same volume PBS was intravitreally injected into the left eyes as self-control. Groups B and D were pre-treated intraperitoneally with 6g/L EBHM solution at a dose of 150mg/kg body weight/day seven days before and after NMDA treatment. Group C were administrated intraperitoneally with 9g/L normal saline at the same time of EBHM injection. Rats were sacrificed at 4,7,14d after NMDA treatment. Flat whole retinas were stained with 5g/L cresyl violet and neuron counting in RGCL from both eyes were observed. Each subgroup had 6 rats.· RESULTS: There was no significant difference of neuron counting in RGCL between the right eye and the left eye in group A (P=0.200). There was no significant difference between normal control group and EBHM group either in the right eyes or in the left eyes at 4, 7 and 14 d respectively after intravitreal injection of 10nmol NMDA in group C and group D. (P=0.636, P=0.193). Neuron counting of RGCL in group C and D was significantly decreased in the NMDA-treated eyes at 4, 7 and 14d after intravitreal injection (P＜0.001). There was no significant difference between self-control eyes group and normai control group(P＞0.05). However, neuron counting was significantly higher in the EBHM+NMDA group than normal saline +NMDA group at 14days after intravitreal injection (P=0.044), but was lowered than normal control group (P＜0.05).· CONCLUSION: EBHM has no effect on neuron counting of RGCL when administered alone in normal rats.The results indicates that EBHM plays a partial protective role in NMDA-induced neuron loss in RGCL in the rats.

Objective To determine the effect of endomorphin (EM) on colonic electromyography activity and investigate the pathogenesis of slow transit constipation (STC). Methods An experimental rat model of slow transit constipation was constructed by contract laxatives mixed with the feed. The changes of colonic electromyography and reaction to endomorphin 1 and endomorphin 2 were examined. Results Compared with the control group, the frequency and amplitude of slow wave in cathartic colon rats were decreased significantly. Endomorphin 1 and endomorphin 2 significantly decreased the amplitudes of slow wave, but did not change the frequencies of slow wave. The effect of endomorphin 1 was more pronounced than that of endomorphin 2, which could be reversed by the morphine antagonist Naloxone in concentration-dependent manner. Endomorphin could not block the stimulating effect of acetylcholine. Conclusions Endomorphin can influence the colonic electromyography activity and intestine motility of cathartic colon rats, and may be involved in the pathologic mechanism of slow transit constipation.

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

OBJECTIVETo explore the feasibility of preparing novel gypenosides long-circulating liposomes with PEG grafted on beta-sitosterol (PEG-Sito).

METHODSuccinicanhydride was adopted to connect beta-sitosterol and PEG 2000. Sphingomyelin and PEG-Sito was used as material to prepare gypenosides long-circulating liposomes by using ethanol injection method. Encapsulation efficiency was determined by using protamine precipitation method. H-NMR was used to verify the synthesis of PEG-Sito, the novel gypenosides long-circulating liposomes were characterized by particle size, zeta potential and atomic force microscope.

RESULTThe synthesis of PEG-Sito was verified by 1H-NMR. Encapsulation efficiency of long-circulating liposomes prepared by ethanol injection method was 74.3%, particle size was 288.1 nm, zeta potential was -20.25 mV, the morphology were round observed by AFM.

CONCLUSIONThe novel gypenosides long-circulating liposomes prepared with PEG-Sito was feasible, it had a high encapsulation efficiency and good morphology.

Drug Compounding ; methods ; Feasibility Studies ; Gynostemma ; chemistry ; Liposomes ; blood ; chemistry ; Plant Extracts ; chemistry ; Polyethylene Glycols ; chemistry ; Reproducibility of Results ; Sitosterols ; chemistry ; Sphingomyelins ; chemistry

OBJECTIVE Topreparealipidderivativeofgemcitabine(Gem)anditspolymericmi-celles to overcome the disadvantages of Gem.METHODS N-benzyl-3′-acetyl-gemcitabine(BAG)was synthesized.A BAG-loaded poloxamer polymeric micelle (BAG∶poloxamer 188 =10∶1 ,mol/mol)was prepared using an injection method.The micelles were characterized with a laser particle size and elec-tric charge instru ment and negatively-stained trans mission electron microscopy.Hu man breast cancer cells MCF-7 were cultured with Gem or BAG polymeric micelles of 5,10,20,30,50,70,90 μmol·L-1 for 24,48 and 72 h,respectively.The inhibitory rate of cells was measured with an MTT method.The MCF-7 cytotoxicity of BAG polymeric micelles was investigated.A pharmacodynamic study was per-formed on the mice bearing mouse hepatocellular cancer cells H22.Intravenous (iv)and oral (ig)ad-ministration was used at the dose of Ge m 40 mg·kg -1 or BAG polymeric micelles 62 mg·kg -1 .The mice were administered on the 1 st,4th and 7th day and sacrificed on the 8th day.Tumor inhibitory rates were measured.RESULTS TheBAGstructurewasidentifiedbythinlayerchromatograph,1Hand13C NMR,infrared ray chromatograph and mass spectrum.The appearance of BAG micelles was a slightly blue suspension.The micelles were spheres according to the electron microscopic observation.Their size was 62.82 nm and the zeta potential was -18.8 mV.The half inhibition concentration (IC50)of Gem and BAG polymeric micelles was 40.6 and 90.0 μmol·L-1 ,5.0 and 14.9 μmol·L-1 ,5.0 and 1 3.6 μmol·L-1 at 24,48 and 72 h,respectively according to the MTT results.According to the in vivo results,compared with the tumor model group,Gem (ig),Gem (iv)and BAG polymeric micelles (iv and ig)had significant effect on the tumor weight of H22 cell xenograft mice (P<0.01 ).As for anti-tumor efficiency,BAG polymeric micelles (ig)were better than Gem (ig)(P<0.05);BAG polymeric micelles (iv)were better than BAG polymeric micelles (ig)(P<0.05),and BAG polymeric micelles (iv)were almostequaltoGem(iv).CONCLUSION ThelipidderivativeofGemcanbeloadedinthepoloxamer 1 88 polymeric micelles.BAG polymeric micelles show in vitro MCF-7 cell inhibition and in vivo inhibition of mouse H22 xerografts;iv or ig.BAG polymeric micelles (ig)show better anti-tumor effect than Gem (ig),indicating that BAG polymeric micelles are a promising novel anti-tumor oral preparation.