OBJECTIVE:To establish the method for identification of Changyanling tablet and determination the content of berberine in the tablet METHODS:Rhizoma coptidis,Radix paeoniae alba and Rhizoma corydalis in Changyanling tablet were qualitatively identified by thin layer chromatography method The content of berberine was determined by the TLC-scanning RESULTS:The average recovery of berberine was 98 19% with a RSD of 0 93% CONCLUSION:This method is simple,accurate and reliable,and can be used for the quality control of this preparation

In order to protect the trial subjects' rights and benefits in drug clinical trials,we must pay special attention to the risk and benefit of the trial subjects(striving to minimize the risk and maximize the benefit),ensure the trial subjects' complete realization of the clinical trials and the successive informed consent,pay special attention to the protection of the specific trial subjects,and avoid the conflict of interests.

Objective To evaluate prognostic significance of c-kit and PDGFR-α gene mutation in extragastrointestinal stromal tumors(EGIST). Methods Paraffin embedded tissue specimens from 23 EGISTs were tested for CD117,CD34 and Ki-67 expression by immunohistochemical method.EGIST cases were also tested for the presence of c-kit exons 9,11,13,17 mutations and PDGFR-α exons 12,18 mutations.Kaplan-meier survival rate was used to evaluate the prognostic factors. Results Of 23 cases of EGIST,23(100%)were positive for CD117,17(74%)were positive for CD34.For Ki-67 labeling index(Ki-67 LI):30%were＜1%,44%were between 1%-5%,26%were＞5%.C-kit mutations were detected in 44% of EGIST patients and all were of exon 11 mutations.PDGFR-α mutations were found in 13%of all the 23 cases and all were of exon 18 mutations(The commonest type of mutation D842V).Survival analysis indicated that mitotic count and Ki-67 index were significant predictors for survival.Conclusion The pattern of c-kit and PDGFR-α mutation in EGIST was essentially similar to that in GIST.But the mutation frequency of PDGFR-α was slightly higher in EGIST than in GIST.EGIST could be a special subtype of GIST.The results of this study also show combination of mitotic counts and Ki-67 labeling index may be useful for predicting the prognosis of EGIST.

Objective To establish the fingerprint chromatogram of Buzhong Yiqi Decoction(BYD) by multiple wavelength method,and to analyze the substance of formulas as a whole.Methods HPLC-PDA method was adopted.The chromatographic conditions were as follows:Hypersil ODS2 analytical column,the mobile phase consisting of 0.05 %phosphate acid and acetonitrile with gradient elution,detecting wavelength at 254 and 280 nm,the flow rate being 1.0 mL/min and the temperature of the column at 30 ℃.Results The methodological results were good.The results of dual-wavelength fingerprint chromatogram showed the all-around information of the fingerprints at 254 and 280 nm.The similarity of 10 batches of BuzhongYiqi Decoction was over 0.98.Conclusion Dual-wavelength fingerprint chromatogram can realize the analysis of a formulas as a whole,which supplies references for improving the quality control of BuzhongYiqi Decoction.

Objective To evaluate the clinical effect and safety of Yinao Capsul es for neurasthenia with the syndrome of liver-kidney deficiency and Qi-yin de ficiency. Methods A multi-center,randomized,single-blind and positive drug p arallel controlled trial was adopted. Three hundred and forty-two cases in the treatment group were treated with Yinao Capsules,and 111 cases in the control g roup were treated with Naolinsu Capsules. Results Yinao Capsules had a total eff ective rate of 93.6 %and the markedly effective rate of 52.1 %. Compared with Naolinsu Capsules,Yinao Capsules showed a better clinical effect (P

Objective To establish the HPLC fingerprint of amino acids compounds from Buzhong Yiqi Pill.Methods A pre-column derivatization HPLC method was adopted with praline as a reference.Separation was performed on a AccQ? TagTM C18(3.9? 150 mm)analytical column with mobile phase consisting of 0.15 mol/L sodium acetate buffer solution and 60 % acetonitrile,gradient elution with the flow rate of 1.0 mL/min.The column temperature was at 37 ℃.The Fluorescence detecting wavelength was set at 250 nm(excitation wavelength)and 395 nm(emission wavelength),the analysis time was 35 min.Results Twelve common peaks on the HPLC fingerprints of Buzhong Yiqi Pill were presented.The similarity was determined by the correlation coefficient,included angle cosine coefficient and evaluation software of chromatogram fingerprint similarity.The results showed the similarity for 10 bathes of samples was in 0.97～ 1.00.Conclusion Good fingerprints were obtained,which can be used for the quality control of Buzhong Yiqi Pill.

Objective To investigate the effect of Buzhong Yiqi Decoction for allergic rhinitis(AR)with spleen -qi de-ficiency in guinea pigs.Methods AR guinea -pig model was established by intraperitoneal injection of ovalbumin for general sensitization and then by nasal drip of ovalbumin for local sensitization.Spleen -qi deficiency mod el was induced by gastric infusion of cold -maceration extract of Radix et Rhizoma Rhei.Fifty -four guinea pigs were randoml y allocated to four groups:AR group(Group A),AR model with spleen -qi deficiency group(Group B),AR model with spleen -qi deficiency treated by Buzhong Yiqi group(Group C)and blank control group(Group D).Nasal symptoms were observed.The number of eosinophils(EOS )in nasal secretion was detected by sm ear cytologic examination and the number of EOS and mastocyte in nasal mucosa was exa mined by pathological section.Results Before local sensitization,nasal s ymp-toms such as nose scratching,sneezing and nasal discharge in Group A,Gro up B and Group C were severer than those in Group D and were improved in Group C in the late stage.Positive rate of EOS i n nasal secretion and nasal mucosa of Group C and Group D was lower than that in Group A and Group B and the differen ce was insignificant between Group C and Group D.The number of mastocyte i n Group C was lower than that in Group A and Group B.Conclusion Buzhong Yiqi Decoction can relieve nasal symptom s in AR Guinea pigs with spleen -qi deficiency by counteracting the infiltration of EOS and the increase of nastocytes in nasal mucosa.

Objective:To optimize the extraction technology of Qige granule. Methods:An HPLC method was established to de-termine the contents of astragaloside IV and puerarin in the extract of Qige granules. Based on the orthogonal design of L9(34),three factors including the water amount,decocting duration and extracting times were evaluated. Results:The best extraction process was as follows:adding 12-fold amount of water and extracting 3 times with 30 min for each time. Conclusion:The extraction technology opti-mized by the components evaluation is reasonable and practicable.