Objective:To establish a gas chromatography-mass spectrometry method(GC-MS-MS)for determining the content of methyl p-toluenesulfonate(MTS),ethyl p-toluenesulfonate(ETS),and isopropyl p-toluenesulfonate(IPTS)in tosufloxacin tosylate hydrate.Methods:The HP-1MS(0.250 mm ×30 m,0.50 μm)column was used at progamming temperature,the injection temperature was 250 ℃.The MS conditions were as follow:the ionization mode was EI,the electron voltage was 70 V,the ion source temperature was 250 ℃,the scanning method was MRM,the quantitative ion pairs for MTS,ETS and IPTS were m/z 91 →65,m/z 155→91 and m/z 91→65.Results:The linearity ranges of MTS,ETS and IPTS were 48.779-975.59 ng·mL-1(r=0.998 5),54.586-1 091.7 ng·mL-1(r=0.998 4)and 46.241-924.82 ng·mL-1(r=0.999 8).The average recoveries were 99.47％,99.15％,98.83％(n=9).The MTS,ETS and IPTS were not detected in the 7 batches of tosufloxacin tosylate hydrate.Conclusion:The established method can be used for the determination of MTS,ETS,and IPTS content in tosufloxacin tosylate hydrate.

Objective To provide valuable references and insights for improving the excipient standard system of the Chinese Pharmacopeia and promoting its harmonization with ICH Q3D.By analyzing the harmonization strategies and implementation of excipient standards in the pharmacopoeias of Europe,the United States,and Japan.Methods Through a combination of literature review and case study analysis,this paper introduces the policies and strategies adopted by the pharmacopoeias of three major regions(Europe,the United States,and Japan)in implementing the ICH Q3D guidelines in the field of pharmaceutical excipients.Additionally,it reviews the updates on excipient standards in these regions and analyzes the characteristics of their alignment with ICH Q3D.Results The strategies for implementing ICH Q3D in pharmacopeial excipient standards vary across different regions,with each following distinct approaches and progressing at different rates.Notably,there are significant differences in the establishment of standards for elemental impurities.Conclusion Promoting the harmonization of pharmacopeial excipient standards with ICH Q3D is a challenging and long-term endeavor.It is essential to develop a harmonization strategy that is tailored to China's national context.

This article summarizes the rapid rehabilitation nursing experience for one pediatric pa-tient with pancreatic divisum who underwent en bloc pancreatoduodenectomy preserving the duodenum,common bile duct,and Oddi's sphincter(DCOPPHTR).The nursing care encompassed preoperative prehabilitation to enhance physical and psychological preparation,postoperative precise volume and dynamic blood glucose management,early mobilization to facilitate recovery,personalized nutritional support to improve nutritional status,psychological nursing to bolster confidence,and family involve-ment to enhance quality of life.The pediatric patient experienced rapid recovery and was discharged from the hospital.A six-month follow-up indicated a significant improvement in quality of life.

To reduce the dependency on high-carbon-load chromatographic columns,a new method has been established for the determination of the content of docusate sodium using ion-pair high-performance liquid chromatography(IP-HPLC).Tetrapropylammonium chloride was used as the ion-pair reagent with a mobile phase,composition of acetonitrile:10 mmol/L tetrapropylammonium chloride solution=66∶34,adjusting pH to 6.5 with 0.1%phosphoric acid solution,flow rate of 1.5 mL/min,detection wavelength of 214 nm,column temperature of 35℃,and an injection volume of 25 μL,and quantified by an external standard method.The main peak of docusate sodium exhibited a tailing factor of 1.34.The method showed good linearity within the range of 0.02 mg/mL to 0.40 mg/mL,with a correlation coefficient(r)of 0.999 9.It also demonstrated good repeatability,with recovery ranging from 97.0%to 98.2%(n=6).The quantification limit was 3.31 μg/mL,and the detection limit was 2.76 μg/mL.In summary,the new method shows good durability,a wide linear range,and high sensitivity,it is suitable for the determination of docusate sodium.

Objective To analyze and evaluate the differences between the standards for elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"and ICH Q3D,and to explore strategies for harmonization between them.Methods This study summarizes and reviews the main differences between the general chapters and specific monographs of pharmaceutical excipients in the 2020 edition of the"Chinese Pharmacopoeia"and its first supplement,compared with ICH Q3D.Results By integrating the harmonization strategies for elemental impurities in foreign pharmacopoeias and the risk assessment results for pharmaceutical excipients,this study proposes harmonization strategies and pathways for the standards of pharmaceutical excipients in the"Chinese Pharmacopoeia."Conclusions A systematic risk assessment of elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"should be conducted based on their risk levels.The revision methods should be determined and continuously updated according to the assessment results.

Objective To analyze the historical and current inclusion of heavy metals and specific elemental impurity tests in the monographs of pharmaceutical excipients in the Pharmacopeias of the US(USP),Europe(EP)and Japan(JP)pharmacopeias.By examining the characteristics and trends in these pharmacopeias,the study seeks to provide insights that can inform the strategy for incorporating elemental impurity tests in the Chinese Pharmacopoeia and offer guidance for the industry to enhance control over elemental impurities in drugs and excipients.Methods The study reviews the inclusion and revision processes of heavy metals and specific elemental impurity tests in the pharmacopeias of the US,Europe and Japan,focusing on aspects such as the number of excipient monographs,the proportion of heavy metal tests,professional categories,and treatment methods.A comparative analysis with the Chinese Pharmacopoeia was conducted to explore the reasons behind the observed differences and to identify potential future developments.Results The USP contains the largest number of excipient monographs,the EP has the fastest progress in the evaluation of elemental impurities in excipients,the JP relies most heavily on wet chemical methods for testing.Conclusion The strategies of the US,European,and Japanese pharmacopeias can serve as valuable references for the development of elemental impurity testing strategies in the Chinese Pharmacopoeia.It is recommended to classify pharmaceutical excipients by risk level,removing heavy metal tests for low-risk categories and conducting elemental impurity risk assessments for higher-risk mineral-based excipients.The inclusion of specific elemental impurity tests should be determined based on these risk assessments,with specific limits or methods established as needed according to excipient category or individual monographs.

To reduce the dependency on high-carbon-load chromatographic columns,a new method has been established for the determination of the content of docusate sodium using ion-pair high-performance liquid chromatography (IP-HPLC). Tetrapropylammonium chloride was used as the ion-pair reagent with a mobile phase, composition of acetonitrile:10 mmol/L tetrapropylammonium chloride solution = 66∶34, adjusting pH to 6.5 with 0.1% phosphoric acid solution,flow rate of 1.5 mL/min, detection wavelength of 214 nm,column temperature of 35 °C, and an injection volume of 25 μL,and quantified by an external standard method. The main peak of docusate sodium exhibited a tailing factor of 1.34. The method showed good linearity within the range of 0.02 mg/mL to 0.40 mg/mL, with a correlation coefficient (r) of 0.999 9. It also demonstrated good repeatability, with recovery ranging from 97.0% to 98.2% (n=6). The quantification limit was 3.31 μg/mL, and the detection limit was 2.76 μg/mL.In summary,the new method shows good durability, a wide linear range, and high sensitivity, it is suitable for the determination of docusate sodium.

Objective To investigate the awareness of female patients with pelvic floor dysfunction regarding minimally invasive laser treatment of the reproductive tract and analyze the factors influencing their decision-making intentions,this study aims to provide a foundation for early treatment of pelvic floor dysfunction and further development in reproductive health management.Methods A convenience sampling method was employed to select 164 female patients with pelvic floor dysfunction who sought treatment at the Pelvic Rehabilitation Center of Dongguan Maternal and Child Health Care Hospital between June 2023 and August 2024.The study utilized the Female Sexual Function Index,Incontinence Quality of Life Questionnaire,and Family Support Self-Assessment Scale to conduct a survey.Binary logistic stepwise regression analysis was conducted to investigate the factors influ-encing patients'inclination towards undergoing genital laser minimally invasive treatment.Results Among the 164 female patients,143(87.2%)expressed an intention to receive treatment,with 22.6%demonstrating a rela-tively clear understanding of genital laser minimally invasive treatment.Logistic regression analysis revealed that occupation significantly influenced treatment intention(P<0.05).Compared to healthcare professionals,individuals in the teaching profession(OR=10.81,95%CI:1.04～112.21),self-employed individuals(OR=20.34,95%CI:3.46～119.43),and those in other professions(OR=16.26,95%CI:4.05～65.29)were more inclined to express willingness for undergoing treatment.Furthermore,a lower score on the Incontinence Quality of Life scale was found to positively correlate with treatment intention(OR=0.96,95%CI:0.93～0.99).Conclusion Although patients express a high intention to undergo minimally invasive genital laser treatment,their overall awareness of the procedure remains insufficient.

Objective:To establish a gas chromatography-mass spectrometry method(GC-MS-MS)for determining the content of methyl p-toluenesulfonate(MTS),ethyl p-toluenesulfonate(ETS),and isopropyl p-toluenesulfonate(IPTS)in tosufloxacin tosylate hydrate.Methods:The HP-1MS(0.250 mm ×30 m,0.50 μm)column was used at progamming temperature,the injection temperature was 250 ℃.The MS conditions were as follow:the ionization mode was EI,the electron voltage was 70 V,the ion source temperature was 250 ℃,the scanning method was MRM,the quantitative ion pairs for MTS,ETS and IPTS were m/z 91 →65,m/z 155→91 and m/z 91→65.Results:The linearity ranges of MTS,ETS and IPTS were 48.779-975.59 ng·mL-1(r=0.998 5),54.586-1 091.7 ng·mL-1(r=0.998 4)and 46.241-924.82 ng·mL-1(r=0.999 8).The average recoveries were 99.47％,99.15％,98.83％(n=9).The MTS,ETS and IPTS were not detected in the 7 batches of tosufloxacin tosylate hydrate.Conclusion:The established method can be used for the determination of MTS,ETS,and IPTS content in tosufloxacin tosylate hydrate.