Clinical Clerkship is the necessary stage from theory to clinical practice,As teaching hospital of Nanjing Medical University.we explore various kinds of methods of clinical practice quality improvement by emphasizing practice training,developing multiform teaching activities,highhghting autonomic learning and strengthening intemship management.

Objective To develop the method for determining the content of Schisandrin by HPLC. Method The Schisandrin in Hugan Pill was determinined by HPLC. The analytical column was Hanbon Lichrospher (250 mm?4.6 mm, 5 ?m) and mobile phase was methanol-water (67∶33), with wavelength was set at 251 nm. Result Schisandrin had good linear relationship with their peak area in the range of 0.105 1～2.102 ?g (r=0.999 9, n =7). The average recovery rate was 97.03%, RSD was 1.02% (n =5). Conclusion The method was rapid, simple and precise.

Objective: To analyze the compatibility rationality between the raw material and auxiliary material sodium bisulfite in Zhengqin Fengtongning injection.Methods: HPLC was applied to detect the contents of the impurity and the main component in Zhengqing Fengtongning injection, and ion chromatography was applied to determine the content of sodium bisulfite in Zhengqing Fengtongning injection.The changes of impurity, main component and sodium bisulfite among the samples were compared before and after the stress testing (high temperature at 40℃, 60℃ and illumination at 4 500 lx).LC-MS-MS was used to identify the structures of the impurities.Results: The impurity in Zhengqing Fengtongning injection was the combination of the raw material and sodium bisulfite.Conclusion: It is irrational for Zhengqing Fengtongning injection to use sodium bisulfite as the antioxidant.

Objective: To improve the quality standard for Zengguang tablets.Methods: Instead of the microscopic identification, Acorus tatarinowii rhizoma,Lycii Fructus and Polygalae radix were indentified by TLC.The content of schisandrin in Schisandrae Chinensis Fructus was determined by HPLC.The HPLC system consisted of a Hypersil BDS C18(250 mm×4.6 mm,5 μm)column, methanol-water (1∶1) was used as the mobile phase at a flow rate of 1.0 ml·min-1, and the detection wavelength was at 250 nm.The column temperature was 35℃ and the sample size was 10 μl.Results: The microscopic images were with strong specificity.The developed TLC spots were quite clear, and the method of TLC was simple with strong specificity and good reproducibility.The linear range of schisandrin was 21.17-423.40 ng(r=0.999 9).The average recovery was 99.7% and the RSD was 1.4%(n=6).Conclusion: The method for the quality control of Zengguang tablets is comprehensive and perfect.

Objective:To compare the quality differences in benzalkonium chloride samples from domestic and abroad to provide references for the quality standard revision for benzalkonium chloride in Chinese pharmacopoeia. Methods: The ratio of alkyl compo-nents was determined according to the method described in USP 38, and the total content of benzalkonium chloride was determined ac-cording to the method recorded in Chinese Pharmacopoeia (2015 edition) and USP 38, respectively. Results:According to the results of composition ratio of alkyl, the fraction defective of domestic samples and imported samples was 100% and 50%, respectively. The content difference between the values calculated by the methods in the two pharmacopoeias showed that the total content of domestic samples changed from 3. 86% to 4. 15%, and that of imported samples changed from 1. 15% to 3. 90%. Conclusion:There are sig-nificant differences in the quality of benzalkonium chloride between domestic samples and imported samples. It is recommended that the ratio of alkyl components should be supplemented in our pharmacopoeia referring to the method in USP 38 and the total content calcula-tion formula for benzalkonium chloride should be revised to improve the quality standard for benzalkonium chloride.

Objective: To determine the impurities in pharmaceutical adjuvant sodium bisulfite. Methods: An IC method was used with a Dionex IonPac AS17-C RFIC analytical column. ECD was used as the detector by gradient elution and the temperature of column was 30℃. Results:Sulfate radical was detected out in all samples. Conclusion:The method is simple and fast with high sensi-tivity, which is suitable for the determination of related substances in sodium bisulfite.

To establish a GC method to determine the related substances in pharmaceutical excipient benzyl alcohol. Methods:A GC method was used with an Agilent DB-wax eapillary column(0. 32 mm × 30 m,1. 8 μm)and programming temperature. The initial temperature was 50℃, and then raised to 220℃ with a rate of 5℃·min-1 and maintained for 35min. The detector was FID. The temperature of the injection port was 200℃,and the detector temperature was 310℃. The results were confirmed by GC-MS. Results:Within a certain range,the peak area and concentration of every impurity had a good linear relationship (r≥0. 999 9). The recovery was between 96. 1% and 102. 7%. The quantitative limit was between 1. 37-3. 63 ng. Toluene, benzyl chloride, benzalde-hyde and benzyl ether were found out in the samples. Conclusion:The method is accurate and convenient, and suitable for the quanti-tative determination of related substances in pharmaceutical excipient benzyl alcohol.

Objective:To determine the related substances in benzalkonium chloride used as a pharmaceutical adjuvant, and com-pare the quality at home and abroad. Methods:An HPLC method was used with an ODS-HYPERSIL C18 column(250 mm × 4. 6 mm, 5 μm). The detection wavelength was 210 nm and 257 nm. The flow rate was 1. 0 ml· min-1 and the column temperature was 30℃. The injection volume was 20 ml. The mobile phase was A ( dissolving 1. 09 g sodium1-hexanesulfonate and 6. 9 g sodium dihydrogen phosphate in water, adjusting pH to 3. 5 with phosphoric acid and diluting to 1 000. 0 ml) and B ( methanol) with gradient elution. Results:The content of benzaldehyde in the samples at home and abroad was low. The content of benzyl alcohol in the samples from a-broad was qualified, which was significantly higher than that in the domestic samples. The content of benzyl chloride in the domestic samples was higher than that in the samples from abroad. Conclusion:The method is simple and fast, which is suitable for comparing the related substances of domastic and imported samples. At the same time, the study provides basis for enterprises to choose benzalko-nium chloride rationally.

OBJECTIVE:To establish a method to determine and compare the contents of sodium benzoate in medicinal(phar-maceutical excipients and active pharmaceutical ingredients) and non-medicinal (chemical reagents and food additives) grade. METHODS:HPLC was conducted for content determination,SPSS 18.0 software was adopted to compare the results. The column was Purospher STAR LP RP-18 endcapped with mobile phase of acetotrile-0.02% formic acid(adjusted pH to 4.0 with aqua ammo-nia)(30∶70,V/V)at a flow rate was 1.0 ml/min,the detection wavelength was 230 nm,column temperature was 35 ℃,and vol-ume injection was 20 μl. RESULTS:The linear range of sodium benzoate was 10.5-525.3 μg/ml(r=0.999 9);RSDs of precision, stability,reproducibility and durability tests were lower than 0.5%;recovery was 99.38%-101.26%(RSD=0.56%,n=9). The av-erage contents of sodium benzoate in medicinal and non-medicinal grade were between 99.400%-99.875%,but the average content of non-medicinal grade is lower than the medical grade. CONCLUSIONS:The method is accurate and simple with high specificity and good reproducibility,and can be used to determine and compare the content of sodium benzoate in medicinal and non-medici-nal grade.

Objective To evaluate the therapeutic value of minimally invasive excision of benign breast lesions using stereotactic mammotome minimally invasive surgery system.Methods Under ultrasonographic image monitoring,1160 breast masses of 310 patients were excised using mammotome minimally invasive stereotactic excision system and sent for pathologic examinations immediatly.Patients′condition was follow-ed up and recorded post-operative.Their clinical data were retrospectively analysed.Results Accurate and complete resection of all of the 1160 breast masses was achieved.The resected tissues were large enough to make pathologic diagnosis.The pathologic diagnoses were all found to be benign,and included: fibroadenoma(n=672),fibroadenosis(n=451),intraductal papilloma(n=12),cyst(n=6),cystic hyperplasia(n=17) and tubular adenoma(n=17).Regular follow up every 6-12 months was done.Postoperative surgical scars were unremarkable,the skin incisions were small and concealed,breast appearance and skin sensation were normal and ultrasonography did not reveal residual lesions or recurrences.Conclusions Complete resection of benign breast lesions can be done with mammotome technique.This technique is safe,accurate and effective.Moreover,there is little trauma,low complication rate,and the breast appearance is not affected.This minimally invasive excision technique for benign breast lesions is suitable for wide use.