To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines； further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

Objective:To establish a detection method for fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.Methods:The detection of fatty acid composition involves pre-test of the sam-ple using the methanol sodium methylation method,followed by direct injection analysis using gas chromatography,and finally calculating the content of each fatty acid composition using the area normalization method with correction factors.The detection of methoxylaniline value is achieved by dissolving and diluting the sample with isooctane:isopropanol(8∶2,volume ratio),reacting with 4-methoxylaniline,measuring the absorbance at a wavelength of 350 nm,and calculating the methoxylaniline value.Results:Under the composition of fatty acids,the 8 kinds of fatty acids have good separation degree.The methyl ricinoleate and methyl stearate have good linear relationship in the range of 0.1-5.0 mg·mL-1.The repeatabilityand intermediate precision(RSD)ofthe determination results of each fatty acid in the sample are all less than 5%.It is also found that only α-type of linolenic acid is present in castor oil,without γ-type.In the determination of methoxyaniline value,the blank solvent does not interfere with the determination of the sample,and the repeatability RSD is 3.6%.Conclusion:The detection method for fatty acid composition and meth-oxylaniline value established in this article is accurate and reliable,and can be used for the detection of fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.

Objective:To establish a detection method for fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.Methods:The detection of fatty acid composition involves pre-test of the sam-ple using the methanol sodium methylation method,followed by direct injection analysis using gas chromatography,and finally calculating the content of each fatty acid composition using the area normalization method with correction factors.The detection of methoxylaniline value is achieved by dissolving and diluting the sample with isooctane:isopropanol(8∶2,volume ratio),reacting with 4-methoxylaniline,measuring the absorbance at a wavelength of 350 nm,and calculating the methoxylaniline value.Results:Under the composition of fatty acids,the 8 kinds of fatty acids have good separation degree.The methyl ricinoleate and methyl stearate have good linear relationship in the range of 0.1-5.0 mg·mL-1.The repeatabilityand intermediate precision(RSD)ofthe determination results of each fatty acid in the sample are all less than 5%.It is also found that only α-type of linolenic acid is present in castor oil,without γ-type.In the determination of methoxyaniline value,the blank solvent does not interfere with the determination of the sample,and the repeatability RSD is 3.6%.Conclusion:The detection method for fatty acid composition and meth-oxylaniline value established in this article is accurate and reliable,and can be used for the detection of fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.

Objective:To investigate the application value of fluorescence imaging in single-port thoracoscopic anatomic segmentectomy.Methods:The clinical data of 280 patients (145 patients with fluorescence method and 135 patients with modified inflation-deflation method) who underwent thoracoscopic anatomic segmentectomy were retrospectively studied in the Anhui Chest Hospital from June 2020 to June 2021. There were 113 patients in the simple segmentectomy group and 167 patients in the complex segmentectomy group. The baseline data of the fluorescence method and the modified inflation-deflation method in the complex segmentectomy group were corrected by propensity score matching, and the perioperative results were compared between the groups.Results:There were no significant differences in segmental resection time, intraoperative blood loss, postoperative drainage, postoperative pain, postoperative extubation time, length of hospital stay, incidence of complications and cost of hand-holding between the fluorescence method and the modified method of the simple segmentectomy group.In the complex segmentectomy group, the time of segmental resection with the fluorescence method was significantly shorter than that with the modified inflation-deflation method( P<0.05), and other indexes had no significant difference. Conclusion:Fluorescence method single-port thoracoscopic anatomic segmentectomy has the same perioperative safety and short-term efficacy as modified inflation-deflation method, which can significantly shorten the operative time and improve the operative efficiency in complex anatomic segmentectomy.

In this paper, the uncertainties of correction factors of fluconazole impurities determined by HPLC standard curve method were evaluated, and the main common factors affecting the accuracy of standard curve method were found, so as to improve the accuracy of the method.In this study, the corresponding fitting lines of fluconazole and its impurities A, B, C, D, F and I were established respectively, and the ratio of the slope of fitting lines of each impurity and its corresponding principal component was calculated as the correction factor of the impurity.Then on the basis of GUM method, the uncertainty of each impurity correction factor determined by standard curve method was evaluated according to the established uncertainty evaluation scheme of correction factor determination process.The correction factor and uncertainty of fluconazole impurities A, B, C, D, F and I were 1.068 ± 0.046, 0.102 ± 0.005, 0.0582 ± 0.0031, 1.382 ± 0.121, 0.802 ± 0.067 and 1.383 ± 0.119, respectively, and the coverage factor k was 2.Finally, the contribution rate of each uncertainty component was calculated.In the relative combined standard uncertainties urel(f) of fluconazole impurities A, B, C, D, F and I correction factors, the sum of contribution rate of slope uncertainty urel(K) of the linear equation of principal component and its impurity is more than 85%; in the slope uncertainties urel(K) of linear equation, the contribution rates of uncertainties of solution concentration in 8 of 12 data groups are more than 80%, and the contribution rates of uncertainties introduced by reference substance content in solution concentration are about 80%.It can be seen that the preparation of linear solution concentration is the most influential factor in the determination of impurity correction factor by standard curve method, followed by the linear fitting process.In the preparation process of linear solution concentration, the purity of reference substance is the most influential factor, followed by weighing and pipetting times.The conclusion can help the experimenters to better formulate experimental plans and ensure the accuracy of the results when doing similar work.

Objective To evaluate the diagnostic efficiency and prognostic value of 18F-fluorodeoxyglucose (FDG) PET/CT for response assessment after treatment in patients with diffuse large B-cell lymphoma (DLBCL) when using the Deauville criteria and International Harmonization Project (IHP) criteria.Methods A total of 212 patients (119 males,93 males,average age:59.6(10-88) years) with DLBCL from February 2010 to June 2018 were analyzed.All subjects underwent restaging PET/CT after treatment.Images were evaluated with the IHP criteria,Deauville score of 3-5 (DC3) and Deauville score of 4-5 (DC4).The diagnostic efficiency of the 3 criteria for treatment effect was assessed and follow-up results were used as the gold standard.Spearman rank correlation analysis was used.Progression-free survival (PFS) and overall survival (OS) were analyzed by Kaplan-Meier analysis and Cox proportional hazards model.Results The positive predictive value and accuracy of DC4 for treatment effect evaluation were 96.8％(61/63) and 94.3％(200/212),those of IHP criteria were 75.3％(67/89) and 87.7％(186/212)respectively,and those of DC3 were 82.9％ (68/82) and 92.0％ (195/212) respectively.IHP criteria results and Deauville scores were correlated(rs =0.926,P＜0.05).The 2-year PFS rates in IHP-,DC3-and CD4-positive groups were 78.7％,76.5％ and 69.8％,respectively,and those in IHP-,DC3-and CD4-negative groups were significantly higher (95.6％,94.7％,97.2％;x2=14.415,18.293 and 26.920,all P＜0.05).The similar results were found for OS rates (x2 =9.597,11.149 and 17.416,all P＜0.05).The 2-year PFS rates in Deauville score of 1,2,3,4,5 groups were 95.3％,91.7％,93.3％,88.9％ and 55.6％ respectively (x2 =48.199,P＜0.05).Cox-regression analysis showed significant correlation between Deauville criteria and 2-year PFS rate (P＜0.05).Conclusions PET/CT with DC4,DC3 and IHP criteria have high predictive values for treatment outcome,and DC4 is the best.Cox regression analysis shows significant risk of progression by Deauville criteria.

Objective To compare the diagnostic efficiency of superb microvascular imaging (SMI) and contrast-enhanced ultrasonographic microvascular imaging (MVI) for differentiating breast lesions.Methods One hundred and sixteen patients with 116 breast lesions were first examined by grayscale ultrasound.Then SMI and MVI were performed on all patients.Microvascular architectures of breast lesions were depicted by both methods.The lesions were evaluated based on their microvascular architectures.The diagnostic efficacy of both methods were compared.Results The diagnostic sensitivity,specificity,and accuracy of SMI and MVI were 79.24％,90.48 ％,85.35％ and 88.68％,87.30％,87.93％,respectively.The areas under the curve of SMI and MVI were 0.888 and 0.926.The diagnostic values of SMI and MVI were not statistically different (P =0.212).Conclusions SMI can detect tiny vessels and depict microvascular architecture of breast lesions as MVI do,which is beneficial for breast tumor differentiation.The diagnostic efficacy of SMI is almost the same as MVI.

Pancreatic cancer is one malignancy with high aggressive and extremely poor prognosis,its incidence and mortality rates are increasing gradually in our country.Although surgical techniques and adjuvant drug therapy are improving,survival of patients with pancreatic cancer still has not been significantly improved.Long non-coding RNA are a class of non-coding transcripts longer than 200 nucleotides.Recent studies show long non-coding RNA is closely related to pancreatic cancer cells,apoptosis,metastasis and drug resistance.LncRNA plays an important role in the diagnosis,treatment and prognosis of pancreatic cancer.In this article we reviewed the role of long noncoding RNA and their significance in pancreatic carcinoma.

Objective To develop a rapid and reliable method for determination of 210Po using large-area grid ionization chamber α spectrometry.Methods Samples were digested using a microwave digestion system.After preparation of sample source,the concentration of 210Po in clam was detected by large-area grid ionization chamber (φ 25 cm).209Po tracer was used to obtain the recovery.Results Large-area grid ionization chamber could achieve better counting and α spectrum resolution when the optimized thickness was 250 μg/cm2.By spiking 209Po tracer in clam,the minimum detectable activity was 9.870 × 10 4 Bq and the recovery of 210Po was 98％.Conclusions Compared with the traditional method,the developed method can avoid separation process,using less quantity of sample (0.2-0.5 g dry) and simplify the measurement process.This method may be has broad application prospects.