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 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.

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.

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.

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

The establishment of quality evaluation of traditional Chinese medicine system that not only accords with Chinese medicine function characteristics but also is recognized as international medical circles, is an arduous task in urgent need of solving the current modernization of traditional Chinese medicine in the process of internationalization. It is difficult to evaluate atraditional Chinese medicine by detection of single active components in traditional Chinesemedicinewiththe western medicine quality controlmethod due to the overall effects of traditional Chinese drugs, the components of the overall diversity, targets, and the complexity of the interaction between components of unpredictable make the Long-term since, domestic and foreign scholars continue to explore and put forward a series of quality evaluation of traditional Chinese medicine to promote the development of traditional Chinese medicine. This article summarized the related academic ideas and developments to, providea new thought and perspective for the quality control of traditional Chinese medicine.
Drug Evaluation ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; Humans ; Medicine, Chinese Traditional ; standards ; Quality Control

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.

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.

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:To research the number and function of monocyte-macrophages in patients with chronic active hepatitis B. Methods:The 51 chronic viral hepatitis B( CHB) patients were selected randomly,which consisted of 20 cases of mild-moderate,31 cases of severe group and 13 cases of healthy controls. PBMCs were separated by percoll. Monocytes were tagged by CD14,the molecules CD80,CD86,HLA-DR and CD163 were detected by flow cytometry which expressed on the surface of PBMCs. Serum cytokine were detected for IL-10, IL-12 and IL-23 by ELISA. The distribution of CD68 was detected in the liver by immunohistochemical staining. Results:The expressions of CD80 for all chronic hepatitis B patients were lower than the controls respectively,no matter mild-moderate or even severe group. Similarly,the HBV patients expressed lower level of CD86 in the peripheral blood mononuclear cells when compared with the control group. Furthermore, there was statistically difference between the levels of CD86 in severe group compared with control group (P<0. 01). As the expression of CD80 and CD86,the levels of HLA-DR in the patents had also declined when compared with controls. While the HLA-DR levels in both the mild-moderate HBV hepatitis groups were statistically significant higher than the severe group (P<0. 01). Different from the above all,the expression of CD163 in all chronic HBV hepatitis was higher than the control group. The CD68 positive cells in chronic HBV patients were observed and infiltrated increasingly in portal area and hepatic lobules (P<0. 05). There were statistically significant differences of IL-10 levels between the mild-moderate group,severe group and the control group,respectively (P<0. 01). Conclusion:Macrophages have participated in the pathological lesions of liver in CHB patients,among peripheral blood mononuclear cells,the phenomena of imbalance between type M1/M2 and polarization to type M2 have been observed,which participated in the development of the chronicity of CHB.