ObjectiveTo statistically analyze the efficacy and application characteristics of animal-derived drugs in the 2020 edition of the Pharmacopoeia of the People's Republic of China （referred to as Chinese Pharmacopoeia）， and provide data references for the research and application of animal-derived drugs. MethodAnimal-derived drugs included in the 2020 edition of the Chinese Pharmacopoeia were selected and screened. Information such as the classification， nature and flavor， meridian tropism， usage， dosage， toxicity or contraindications of single animal-derived drugs were statistically analyzed. The efficacy and clinical application analysis of externally applicable Chinese medicinal preparations containing animal-derived drugs， the dosage forms of preparations containing animal-derived drugs， and the contraindications of their use were also analyzed. The above information was recorded in an Excel spreadsheet for statistical analysis. ResultThe 2020 edition of the Chinese Pharmacopoeia clearly records a total of 51 types of animal-derived drugs. Among them， liver-calming and wind-relieving drugs and deficiency-tonifying drugs are the most common in the efficacy classification of animal-derived drugs. The properties are mainly categorized as neutral and salty， with meridians including liver， kidney， heart， and lung meridians with a frequency of >10 times. Most animal-derived drugs are used in decoctions and pills， with the decoction method being the primary method for decoction. The common dosage of animal-derived drugs is 3-9 g， 5-10 g， or 3-6 g， and animal-derived drugs are used externally in appropriate amounts. In addition to mentioning the toxicity of drugs， the most common precautions for animal-derived drugs are caution and prohibition for pregnant women. Externally applicable Chinese medicinal preparations containing animal-derived in the Chinese Pharmacopoeia are widely used in various departments such as pediatrics， gynecology， orthopedics and traumatology， stomatology， internal medicine， surgery， dermatology， ophthalmology， and otorhinolaryngology， with extensive clinical applications. The dosage forms of preparations containing animal-derived drugs are mainly pills， capsules， tablets， and capsules. Animal-derived drugs are mainly in the form of fine powder before use. The precautions for use in preparations mainly focus on the contraindications for pregnant women and children. ConclusionThe clinical application of animal-derived drugs included in the 2020 edition of Chinese Pharmacopoeia is extensive and has unique efficacy. However， there are still problems such as imperfect quality standards and unclear mechanisms of action for animal-derived drugs， which require further research to better utilize the advantages of internal and external use of animal-derived drugs. In addition， non-medicinal parts of animals also have development and utilization value， which should be fully explored and utilized to achieve the green development of animal-derive drug resources.

Liquid chromatography-electrospray ionization tandem mass spectrometry(LC-ESI-MS)is a widely utilized technique for in vivo pharmaceutical analysis.Ionization interference within electrospray ion source,occurring between drugs and metabolites,can lead to signal variations,potentially compromising quantitative accuracy.Currently,method validation often overlooks this type of signal interference,which may result in systematic errors in quantitative results without matrix-matched calibration.In this study,we conducted an investigation using ten different groups of drugs and their corresponding me-tabolites across three LC-ESI-MS systems to assess the prevalence of signal interference.Such in-terferences can potentially cause or enhance nonlinearity in the calibration curves of drugs and metabolites,thereby altering the relationship between analyte response and concentration for quanti-fication.Finally,we established an evaluation scheme through a step-by-step dilution assay and employed three resolution methods:chromatographic separation,dilution,and stable labeled isotope internal standards correction.The above strategies were integrated into the method establishment process to improve quantitative accuracy.

ObjectiveEsophageal cancer is a common malignant tumor of the upper gastrointestinal tract， and has high incidence and mortality in China. Its incidence is increasing year by year， and survival rate is low， thus seriously threatening human life and health. To further explore the pathogenesis of esophageal cancer and its systematic and efficient diagnosis and treatment methods， the animal models of esophageal cancer was evaluated according to the animal model evaluation method previously established by our team based on the characteristics of its clinical symptoms of traditional Chinese and western medicine， and suggestions for model improvement were proposed. MethodThe existing animal models of esophageal cancer were summarized through China National Knowledge Infrastructure （CNKI） and Wanfang Data. The relevant indexes of the models were assigned， and their coincidence with the clinical diagnostic guidelines of traditional Chinese and western medicine for esophageal cancer was evaluated. ResultExcept the spontaneous animal model of esophageal cancer with high clinical coincidence adopted in few studies， the animal model induced by methylbenzylnitrosamine was in good agreement with the clinical data， which simulated the etiology and pathogenesis of esophageal cancer to a certain extent. The model partially reflected some indicators of clinical diagnosis in western medicine， and also indicated the body weight loss， purple nail and increased number of drinking in traditional Chinese medicine （TCM）. However， there was still a lack of differentiation of TCM syndromes. ConclusionOn the basis of the original model， the animal model induced by methylbenzylnitrosamine and the mouse model of xenogeneic gastric wall transplantation of human esophageal cancer cells were applied， which were intervened with the factors of phlegm and qi mutual obstruction syndrome， blood stasis and phlegm stagnation syndrome， Yin deficiency and internal heat syndrome and Qi deficiency and yang weakness syndrome， and were distinguished to reflect the performance of TCM syndrome. The animal model of esophageal cancer combined with TCM syndrome was thus obtained， which embodied the clinical symptoms of esophageal cancer in TCM， and the characteristics of the animal model combined with TCM syndrome， and simulated the clinical practice of traditional Chinese and western medicine， providing an accurate pathological model carrier for basic research.

Objective:To establish a rapid HPLC testing method for chloroquine phosphate,hydroxychloroquine sulfate and amodiaquine hydrochloride.Methods:The chromatographic separation was performed on a GRACE prevail C18(53 mm×7 mm,3 μm)column,and the column temperature was maintained at 30℃.Acetonitrile-0.3% triethylamine acetonitrile solution (adjusting pH to 3.0 with phosphoric acid) (12∶88) was used as the mobile phase,the flow rate was 1.0 ml· min-1 and the UV detection wavelength was 254 nm.The qualitative research was performed using relative retention time and spectral similarity as the double indicators.The relative correction factor in the quantification analysis was used for the content determination.Results:Three anti-malarial drugs showed good behavior in one chromatographic system.The rapid HPLC testing analysis could be achieved.The qualitative research was more accurate by using the double indicators (UV spectral similarity and relative capacity factor).The HPLC qualitative accuracy was increased.The relative correction factor method for the quantification could effectively reduce the use of reference substances and speed up the analysis of HPLC.Conclusion:The method is rapid and simple,and suitable for the rapid determination of drugs.

Objective To explore the correlation between ATF5 protein expression level and drug sensitivity of gastric cancer AGS cells.Methods We established the high,middle and low ATF5 expression groups by transfecting the AGS cells with ATF5 pcDNA3.1 plasmid,ATF5 siRNA and empty plasmid using the liposome transfection technique.Then we detected the expression of the ATF5 protein of the 3 groups using the Western Blot.The drug sensitivity of AGS cells in 3 groups to paclitaxel and cisplatin was detected using the MTT experiments and plate clone formation experiments then the correlation between ATF5 protein expression level and drug sensitivity of gastric cancer AGS cells was analyzed.Results With the effect of paclitaxel or cisplatin on AGS cells in 3 groups,the surviving fraction and the IC50 of high ATF5 expression group were higher than those of control group,which indicated statistical significance (all P ＜ 0.05);while the surviving fraction and the IC50 of low ATF5 expression group were lower than those of control group (all P ＜ 0.05,P cisplatin =0.00,P paclitaxel =0.002).We found that cell clone formation of AGS cells to paclitaxel and cisplatin was significantly increased after the transfection with ATF5 protein plasmid and decreased after transfection with ATF5 siRNA plasmid (all P ＜ 0.05).Conclusion The expression of ATF5 protein is related to the drug sensitivity of gastric cancer AGS cells that upregulation of ATF5 protein expression can decrease the drug sensitivity of AGS cells to paclitaxel and cisplatin in gastric cancer.

Objective To evaluate the prognostic accuracy of the score of toxic epidermal necrolysis (SCORTEN) scoring system in patients with toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (SJS).Methods Clinical data were collected from 39 patients with SJS/TEN hospitalized in Peking Union Medical College Hospital during April 1992 and March 2014,and retrospectively analyzed.Among the 39 patients,13 had died,and the other 26 patients,who were matched to the dead patients in a ratio of 2:1 for age,all had a definite diagnosis and were discharged with improved conditions.The SCORTEN scoring system was used to evaluate the 39 patients with SJS/TEN and calculate expected mortality.The expected mortality and actual mortality were compared between different groups stratified by age in the 39 patients.The receiver operating characteristic (ROC) curve was drawn to assess the prognostic accuracy of the SCORTEN scoring system.Results According to the SCORTEN scoring system,15 out of the 39 patients scored 1 point,14 scored 2 points,6 scored 3 points,and 4 scored 4 points.The total number of expected deaths was 6.808,while that of actual deaths was 13.There was no significant difference between the expected mortality and actual mortality in every SCORTEN score-based group.The area under curve (AUC) was 0.832 8,indicating a good predictive ability of the SCORTEN scoring system.Conclusion The SCORTEN scoring system can predict mortality in TEN/SJS patients at early stage.

Objective:To establish a method to determine ferrous succinate in ferrous succinate tablets .Methods:Ion chromatog-raphy was performed on an IonPac AG19(4 mm ×250 mm)anion exchange chromatography column with a guard column of Ion Pac TM AG19( 4 mm ×50 mm);30.00 mmol· L-1 KOH was used as the isocratic eluent at a flow rate of 1.00 ml· min-1 with suppressed conductivity detection ( Curb:75 mA) at the temperature of 30℃.The sample size was 25 μl .Results:The linear range of succinic acid was 2.005 1-25.064 0μg· ml-1(r=0.999 5).The detection limit and quantitation limit was 0.12ng and 0.42ng, respectively. The recovery was 101.45%(RSD=0.43%, n=6).Conclusion:The method is simple, rapid, accurate, reproducible and sensitive , and can be used to determine the ferrous succinate content in ferrous succinate tablets .

Bullous pemphigoid (BP) is a group of autoimmune blistering skin diseases.There are special measures for the assessment of disease severity and therapeutic response in autoimmune bullous skin diseases.Common scoring indexes include autoimmune bullous skin disorder intensity score (ABSIS),bullous pemphigoid disease area index (BPDAI),and so on.ABSIS has been validated,and is widely applied in evaluation of pemphigus vulgaris and other autoimmune blistering diseases.BPDAI is still in the process of verification,and has been applied in only a few clinical trials.The evaluation of diseases by ABSIS and BPDAI is both based on a global assessment of skin and mucosal lesions,and degree of subjective pruritus.

Objective To explore the clinical value of enhanced recovery after surgery (ERAS) in the perioperative period of biliary surgery.Methods The prospective study was adopted.The clinical data of 800 patients diagnosed as benign biliary tract diseases who were admitted to the Cangzhou's Central Hospital from March 2011 to January 2015 were collected.Patients were randomly divided into the case and control groups by random sequence method.The patients of case group received the ERAS management and patients of the control group received traditional perioperative management.(1) Stress state evaluation:the insulin resistance (IR) index and level of serum C-reactive protein (CRP) were calculated.(2) Levels of inflammatory cytokines:levels of IL-6 and TNF-α in the 2 groups were detected by enzyme-linked immunosorbent assay (ELISA).(3)Nutritional status:level of serum prealbumin (PA) was detected.(4) Postoperative status:time to anal exsufflation,time of defecation,duration of hospital stay and treatment expenses were recorded.(5) Postoperative complications were observed.Measurement data with normal distribution were represented as x ± s and comparison between groups was analyzed using t test.Repeated measurement data were analyzed by the repeated measures ANOVA.Count data were represented as ratio and analyzed using the chi-square test.Results The 800 patients were screened for eligibility,including 400 in each group.(1) Stress state evaluation:the levels of IR and CRP from pre-operation to 7 days after operation were from 3.8 ± 0.8 to 3.7 ± 0.7 and from (18 ± 5) μg/L to (27 ±8) μg/L in the case group,from 3.9 ±0.9 to 3.8 ±1.0 and from (18 ±5) μg/L to (38 ±9) μg/L in the control group,respectively,with statistically significant differences in the changing trends (F =12.38,17.85,P ＜0.05).(2) Comparisons of levels of inflammatory cytokines:levels of IL-6 and TNF-α from pre-operation to 7 days after operation were from (9.3 ± 3.1) ng/L to (12.5 ± 2.8) ng/L and from (10.2 ± 3.5) ng/L to (12.8 ±3.3)ng/L in the case group,from (8.9 ±3.3)ng/L to (17.3 ±6.5)ng/L and from (9.9 ±2.8) ng/L to (14.3 ±4.2)ng/L in the control group,with statistically significant differences in the changing trends (F =19.93,15.74,P ＜ 0.05).(3) Comparison of nutritional status:level of PA from pre-operation to 7 days after operation was from (335 ± 53)mg/L to (332 ±50)mg/L in the case group and from (330 ± 49)mg/L to (331 ± 45)mg/L in the control group,with a statistically significant difference in the changing trends (F =4.46,P ＜ 0.05).(4)Comparisons of postoperative status:time to anal exsufflation,time of defecation,duration of hospital stay and treatment expenses were (30 ± 10)hours,(51 ± 13) hours,(7.7 ± 2.5) days,(10.2 ±2.3) × 103 yuan in the case group and (54 ± 8) hours,(70 ± 16) hours,(15.4 ± 3.1) days,(15.6 ± 4.7) × 103 yuan in the control group,with statistically significant differences (t =37.73,18.62,38.67,20.64,P ＜0.05).(5) Comparisons of postoperative complications:incidence of complications was 15.00％ (60/400)in the case group and 22.50％(90/400) in the control group,and the numbers of patients with incision infection,nausea and vomiting,abdominal infection,intra-abdominal infection,urinary tract infection,intro-abdominal hemorrhage and bile leakage were 23,15,8,5,4,3,2 in the case group and 30,20,13,10,7,5,5 in the control group,respectively,showing statistically significant differences in the incidence of complications (x2=7.39,P ＜ 0.05).Conclusion ERAS management in the perioperative period of biliary surgery is beneficial to postoperative recovery of patients,and it can also relieve postoperative stress state and inflammatory response,reduce the duration of hospital stay,treatment expenses and incidence of postoperative complications.

Objective To evaluate the safety and efficacy of one-stage endoscopic sphincterotomy plus laparoscopic cholecystectomy for the treatment of patients who have concurrent gallstones and CBD stones.Methods We conducted a prospective study from Mar 2008 to Nov 2011 in our department.A total of 63 consecutive patients of concurrent gallstones and CBD stones were included and divided into two groups:31 patients in test group first underwent ERCP and EST to remove CBD stones,and then during the same general anesthesia underwent laparoscopic cholecystectomy (LC) ; while 32 patients in control group first underwent ERCP and ES,and then LC 3-5 days later.Results The stone clearance rate in test group and control group were 96.9％ and 96.7％ (P ＞ 0.05),respectively.The postoperative lung infection rate in the test group and the control group were 7.1％ and 16.1％ (P ＜0.05),respectively.The length of hospital stay (LOS) of the two groups was (7.5 ± 1.7) days and (12.6 ±2.5) days,respectively (P ＜ 0.05).The total expense of hospitalization was (￥) (2 356 ± 126) and (￥) (37 056 ± 152),respectively (P ＜ 0.05).Conclusions One-stage laparoendoscopic management of patients with concurrent gallstones and CBD stones is safe,effective and more economic approach than two-stage treatment for patients suffering from concurrent gall stone and choledocholithiasis.