The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.

Objective:To construct and validate a predictive model for the risk of excessive blood loss in pa-tients with ruptured tubal pregnancy,and to provide a basis and tool for the assessment of changes in the condi-tion of patients with ruptured tubal pregnancy.Methods:Clinical data of inpatients with ruptured tubal pregnancy from January 2014 to July 2021 were retrospectively analyzed,who underwent surgical treatment in the Depart-ment of Gynecology,Dongguan Maternal and Child Health Hospital.The pelvic blood volume was categorized into excessive blood loss and non-excessive blood loss groups based on whether the amount of pelvic blood was found to be≥750 ml intraoperatively.Factors influencing the occurrence of excessive blood loss were screened and modeled by univariate analysis,Lasso regression,and multi-factor Logistic stepwise regression.The area un-der the subject working characteristic curve(AUC)was used to evaluate the discrimination of the predictive mod-el,the model's consistency was evaluated by calibration curve and goodness-of-fit test,and the clinical utility of the model was evaluated and validated by the decision analysis curve.Finally,column line plots were drawn.Results:①A total of 386 patients with ruptured tubal pregnancy were included,of whom 124(32.12%)had blood loss≥750 ml.②The optimal predictors for predicting concomitant blood loss in patients with ruptured tubal preg-nancy were screened,including:days of abdominal pain,dizziness,pallor,fatigue,the maximum diameter of para-metrial mass,human chorionic gonadotropin(β-hCG),and hemoglobin(Hb)and the model and the column line graphswere constructed accordingly.③The prediction model AUC was 0.827(95%CI 0.781-0.873);the cut-off value was 0.391,at which point the specificity and sensitivity were 68.55%and 84.35%,respectively,and the AUC validated within the model by resampling was 0.804.Clinical decision curves showed that the threshold probability intervals for the maximum net benefit values ranged from 8.5%-97%,respectively.Conclusions:The constructed prediction model was validated to suggest good discriminatory efficacy and degree of consistency.As a tool,it has clinical application value in predicting the risk of hemorrhage in patients with ruptured tubal pregnan-cy.It can help to determine the occurrence of adverse events such as hemorrhagic shock at an early stage and improve the success rate of rescue treatment.

Objective:To investigate the post-traumatic growth status of tumor patients receiving radiotherapy and analyze its influencing factors, aiming to provide theoretical basis for clinical doctors and nurses to formulate targeted intervention strategies.Methods:A cross-sectional survey of 170 tumor patients receiving radiotherapy admitted to Department of Radiotherapy of Sun Yat-sen Memorial Hospital was conducted by convenience sampling method, general information questionnaire and a post-traumatic growth inventory (PTGI).Results:The average PTGI score of 170 patients was 83.11±16.74, and 141 cases of them had significant post-traumatic growth, accounting for 82.9%(score ≥71). Logistic regression analysis showed that personality type, work status, and the times of hospitalization were the influencing factors of post-traumatic growth (all P<0.05). Conclusions:Tumor patients undergoing radiotherapy obtain a high level of post-traumatic growth. Medical staff should make full use of the patients’ potential for post-traumatic growth and implement interventions as soon as possible to promote the physical and mental health of tumor patients undergoing radiotherapy.

Objective To establish a UPLC-MS/MS method for the determination of dexmedetomidine in human plasma and investigate the effect of obstructive jaundice on pharmacokinetics of dexmedetomidine in vivo. Methods Samples were obtained by liquid-liquid extraction. Agilent Eclipse Plus C₁₈ column was used for chromatograph with methanol and 0.1% formic acid-water solution as mobile phase. Flow rate was 0.2 ml/min. The column temperature was 35 ℃, and the MS detection was selected in MRM mode. Results The calibration curves of dexmedetomidine showed good linearity in the ranges of 0.01−10.00 ng/ml. The results of intra and inter-day precisions were both within 15%. The recovery rate was 85.5%−93.1%. Matrix effect was 91.2%−95.6%. Samples remained stable during analysis. Compared with the control group, c_max、AUC_(0−t)、AUC_(0−∞) and V_z of dexmedetomidine in the patients with obstructive jaundice were increased by 63.4%, 78.9, 66.4%, 82.5%, respectively (P<0.01). CLz was decreased by 42.1%. Conclusion This method is accurate, sensitive and reproducible. It is suitable for dexmedetomidine assay in human plasma. The elimination rate of dexmedetomidine is slower in obstructive jaundice.

Objective To develop a high-performance liquid chromatography-diode array detector (HPLC-DAD) method for determination of cinnamic acid in the decoction of cinnamon, and investigate the effect of different storage temperature and time for the stability of cinnamic acid. Methods An HPLC- DAD method was established. Separation was performed on an Agilent Zorbax C₁₈ column (4.6 mm×250 mm, 5 μm) with 0.1% formic-acetonitrile acid water solution (60:40) as the mobile phase by isocratic elution. The flow rate was 1.0 ml/min, the temperature of column was 25 ℃, the injection volume was 5 μl, the detective UV wave length was 275 nm. The decoction were stored under refrigerated temperature (4 ℃) ambient temperature (25 ℃) and high temperature (40 ℃). The cinnamic acid was detected after 0, 1, 3, 7, 14, 21, 30 d. Results Cinnamic acid was successfully separated by this method, with good linear relationship between 10.21-204.20 μg/ml. The precision, repeatability, stability and recovery were good. Compared with the zero day, the content of cinnamic acid in the decoction of cinnamon decreased significantly (P<0.01) after 21 days and 30 days of ambient temperature storage and after 14 days, 21 days and 30 days of high temperature storage, but no significant change was found in the other groups (P>0.05). Conclusion This HPLC-DAD method had good stability and repeatability. Cinnamic acid was stable in the decoction of cinnamon for 30 days under refrigerated temperature.

Objective To establish a method for the determination of propylthiouracil in human plasma by UPLC-MS/MS and provide methodological basis for therapeutic drug monitoring (TDM) and bioequivalence test (BE) in clinical. Methods The chromatographic separation was performed on an Agilent SB-C₁₈ column (4.6 mm×150 mm, 5 μm), the mobile phase was methanol and water containing 0.1% formic acid (80∶20, V/V), isocratic elution. MS condition was optimized in the positive ion detection mode by multiple reaction monitoring (MRM), along with the Agilent JetStream electrospray source interface (AJS-ESI). The precursors to the product ion transitions were m/z 171.1→112.1 for propylthiouracil and m/z 176.1→117.0 for the internal standard (IS). Results The calibration curve was linear in the range of 10−5 000 ng/ml for propylthiouracil in human plasma, r=0.999 3. The intra-day and inter-day precision and accuracy were good (RSD<10%，RE<±10%). The matrix effect of different concentrations was less than 110% and the coefficient of variation was less than 5%. The average recovery of different concentrations was 101.60%−113.56%, which conformed with the requirement of methodological validation. Conclusion The method is rapid, sensitive and accurate, which can be used for the determination of propylthiouracil in human plasma.

Objective:To evaluate the oncologic outcomes of different laparoscopic radical hysterectomy.Methods:From January 2011 to December 2014, the laparoscopic operation cases of cervical cancer at stage Ⅰb1, Ⅰb2, Ⅱa1 and Ⅱa2, including the histologic subtypes of squamous-cell carcinoma, adenocarcinoma and adenosquamous carcinoma, were collected in five clinical centers. The data were divided into two groups according to the surgical procedures, that is, modified laparoscopic-vaginal radical hysterectomy (mLVRH) and total laparoscopic radical hysterectomy (TLRH). The overall survival rate (OS), disease-free survival rate (DFS) at 5 years were retrospectively analyzed in this study.Results:There were 674 cases in total, including 377 cases of mLVRH, 297 cases of TLRH. (1) The OS at 5 years: the mLVRH was 96.1% and the TLRH was 92.0%, and the mLVRH was higher than that of TLRH （ P=0.010）. Stratify analysis， including stage of disease （Ⅰb1 and Ⅱa1）， histologic subtypes （squamous-cell carcinoma, adenocarcinoma）， lymph node metastasis， revealed that, ① Stage of disease: in stage Ⅰb1, the OS at five years of mLVRH was higher than that in TLRH group （98.6% vs 93.6%, P=0.012）. In stage Ⅱa1, there was significant difference between the two groups, the OS at five years of mLVRH and TLRH were 93.6% and 77.6% （ P=0.007）. ② Histologic subtypes: for the OS at five years of squamous-cell carcinoma, mLVRH and TLRH were 96.1% and 92.3%, and there was significant difference （ P=0.046）； for adenocarcinoma, the OS at five years were 91.0% and 88.6%， and there was no difference between two groups （ P=0.230）. ③ Lymph node metastasis： the mLVRH and TLRH with lymph node metastasis, the OS at five years were 98.6% and 96.4%; the mLVRH and TLRH without lymph node metastasis, the OS at five years were 89.3% and 80.8%. There were no significant differences between the two groups,respectively ( P=0.156， P=0.093）. (2) The DFS at 5 years: there was no significant difference between mLVRH and TLRH (94.1% vs 90.9%, P=0.220). Stratify analysis for stage of disease, the mLVRH group was higher than that in the TLRH group in stage Ⅰb1 (97.0% vs 92.8%, P=0.039). However, for stage Ⅱa1, there was no significant difference between mLVRH and TLRH group （88.2% vs 75.8%, P=0.074）. Conclusions:The results of this retrospective study indicated that different laparoscopy surgical procedures had diverse oncologic outcomes. The OS at 5 years of the mLVRH is superior to the TLRH. The DFS at 5 years in Ⅰb1 stage, the mLVRH is higher than the TLRH. Therefore, the modified laparoscopy is still an alternative surgery for early cervical cancer patients when following the principle of no-tumor-exposure.

Objective : To investigate the behavior problems and influencing factors of school-age students from the third to the sixth grade in Zhongshan,and to provide evidence for early intervention of behavior problems in children. Methods : According to the proportion of population in urban area and township in Zhongshan,students of Grade Three to Six from eight primary schools（three in urban area and five in township）were recruited by stratified sampling method. The behavior problems in children were assessed by the Conners Parent Symptom Questionnaire（PSQ）. Sociodemographic information,family discipline and so on was investigated by a general questionnaire. The influencing factors for behavior problems were analyzed by a logistic regression model. Results : A total of 2 292 questionnaires were issued,and 2 236 valid questionnaires were recycled,with an effective rate of 97.56%. The positive rate of behavioral problems was 11.72%. The results of multivariate logistic regression analysis showed that the risk factors for behavior problems were females（OR=1.594,95%CI：1.170-2.171）,birth asphyxia（OR=2.372,95%CI：1.320-4.261）,main family discipline（laissez-faire：OR=3.326,95%CI：1.450-7.630;doting：OR=3.244,95%CI：1.867-5.638;autocratic：OR=2.609,95%CI：1.584-4.296,mixed：OR=2.313,95%CI：1.669- 3.207）,less than four hours per week for father-child communication（OR=1.551,95%CI：1.052-2.286）,negative life events（OR=2.188,95%CI：1.448-3.308）,living in township（OR=2.031,95%CI：1.330-3.102）,academic performance （average：OR=2.786,95%CI：1.868-4.156;poor：OR=6.665,95%CI：3.236-13.727;very poor：OR=25.068,95%CI：5.786-108.617）;the protective factors were occupation of mother as civil servants or professional personnel（OR=0.449,95%CI：0.238-0.844）and higher grades（Grade Five：OR=0.496,95%CI：0.339-0.727;Grade Six：OR=0.468,95%CI：0.309-0.710）. Conclusion Females,birth asphyxia,main family discipline,less communication between father and child,occupation of mother,negative life events,place of residence,academic performance and grade were the influencing factors for behavior problems.

Objective To explore the relationship between the immune function of cellin peripheral blood with the virureplication and hepatitiviru(HCV)-cAg expression in the patientwith chronihepatiti(CHC) .MethodPeripheral blood lymphocytesubpopulation ,HCV-Rnand HCV core antigen (HCV-cAg) in 63 healthy people undergoing the physical exami-nation (control group) and 85 caseof CHC(Chgroup) were analyzed by the flow cytometry ,real-time Pcand ELIS,respec-tively .ResultThe percentageof total cell,T4 cell,T8 cell,double negative cell(DN) and double positive cell(DP) in the Chgroup were (67 .37 ± 10 .43)% ,(37 .11 ± 10 .28)% ,(21 .63 ± 8 .87)% ,(7 .80 ± 4 .57)% and (0 .20 ± 0 .29)% , respectively ,the absolute contentwere in turn (0 .70 ± 0 .44) × 109/L ,(0 .37 ± 0 .22) × 109/L ,(0 .22 ± 0 .17) × 109/L ,(0 .08 ± 0.06)×109/Land(0.19±0.68)×107/L,respectively.TheratioofT4/T8was(2.18±1.26)% .Theresultsindicatedthatthe percentage of T8 cellin the Chpatientwadecreased obviously (P＜0 .01) ,which resulted in the ratio of T4/T8 raising(P＜0 .05);meanwhile ,the absolute contentof the total cell,T4 cell,T8 celland Dnwere all decreased obviously (P＜0 .05);moreove,the percentage of T4 celland Dnin the patientwith HCV-Rnpositive and HCV-cAg positive wasignificantly in-creased (P＜0 .05) .Conclusion When HCV replicating in the patientwith CHC,the T lymphocyte subpopulation haobviouab-normity .The low immune function or immune tolerance ofT cells may be the important cause of recurrence and uncurability of CHC.

Objective To explore the clinical effect of percutaneous osteoplasty with SKy bone expander system in the treatment of calcaneal fracture.Methods 63 feet of 55 patients with calcaneal fractures were involved in this study.According to Sanders fracture classification including 38 feet of Sanders Ⅱ,18 feet of Sanders Ⅲ,7 feet of Sanders Ⅳ.There were 6 to 16 days interval between the injuries and the surgeries.The patients were treated by percutaneous osteoplasty with the SKy bone expander system.The standard of operation was the satisfaction of reduction and Bohler's and Gissane's angles under X-ray.Results All of 63 feet of 55 patients were followed up for average 22 months.According to the criterion of therapeutic effect,the results were as follows:excellent in 30 cases,good in 26 cases,fair in 7cases,and no poor case.The excellent and good rate was 88.9％.Conclusion Percutaneous osteoplasty with SKy bone expander system in the treatment of calcaneal fracture,especially in reduction and fixation of Sanders type Ⅱ and Sanders type Ⅲ,can recover Bohler's and Gissane's angles,significantly shorten the duration of illness,and has fast recovery and can possess satisfactory curative effect,and it is worth popularizing.