Asthe standard for drafting standards,the Rules for Compiling National Standards for Pharmaceutical Excipients was first issued in the 2020 edition and then revised and re-issued in 2025.It has become an important technical specification for the pharmaceutical excipients standards in the Chinese Pharmacopoeia and for the phar-maceutical excipients standards formulated by pharmaceutical companies for associated review and approval.This article focuses on introducing the working background,main framework and main characteristics of the Rules for Compiling National Standards for Pharmaceutical Excipients,aiming to help the drafters,reviewers and implement-ers of pharmaceutical excipients standards better understand and master them,so as to further improve the standard-ization of writing pharmaceutical excipients standards and enhance the level of standards formulation and revision of pharmaceutical excipients.

Objective To establish a high-throughput HPLC method for the simultaneous determination of 11 common antibacterial agents in acyclovir eye drops and to evaluate the quality and safety of the antibacterial agents in 42 batches of national drug inspection samples.Methods Gradient elution was performed on a Kromasil 100-5-C18(4.6 mm×250 mm,5 μm)column with acetonitrile-5 mmol·L-1 ammonium acetate aqueous solution(containing 1%triethylamine,pH adjusted to 4.5 by acetic acid)as the mobile phase.The detection wavelength was 262 nm.Results Good linear relationships were obtained for 11 antibacterial agents(r≥0.999 9).The average recovery range was 98.2%-101.8%,and the RSD was 0.7%-2.7%(n=9).As revealed by the systematic analysis of 42 batches of national drug inspection samples,some batches of samples were detected with out-of-prescription antibacterial agents 4-hydroxybenzoic acid and ethylparaben,and the results were 0.02-49 μg·mL-1.This indicated that ethylparaben degradation and colinear production pollution were the two major risk sources.Conclusions The method is accurate,sensitive,and specific and can be used for the qualitative and quantitative detection of antibacterial agents in acyclovir eye drops.Besides,some products have degradation of antibacterial agents and incomplete cleaning during co-linear production.It is still essential to further reinforce product quality control.

Asthe standard for drafting standards,the Rules for Compiling National Standards for Pharmaceutical Excipients was first issued in the 2020 edition and then revised and re-issued in 2025.It has become an important technical specification for the pharmaceutical excipients standards in the Chinese Pharmacopoeia and for the phar-maceutical excipients standards formulated by pharmaceutical companies for associated review and approval.This article focuses on introducing the working background,main framework and main characteristics of the Rules for Compiling National Standards for Pharmaceutical Excipients,aiming to help the drafters,reviewers and implement-ers of pharmaceutical excipients standards better understand and master them,so as to further improve the standard-ization of writing pharmaceutical excipients standards and enhance the level of standards formulation and revision of pharmaceutical excipients.

Objective To establish a high-throughput HPLC method for the simultaneous determination of 11 common antibacterial agents in acyclovir eye drops and to evaluate the quality and safety of the antibacterial agents in 42 batches of national drug inspection samples.Methods Gradient elution was performed on a Kromasil 100-5-C18(4.6 mm×250 mm,5 μm)column with acetonitrile-5 mmol·L-1 ammonium acetate aqueous solution(containing 1%triethylamine,pH adjusted to 4.5 by acetic acid)as the mobile phase.The detection wavelength was 262 nm.Results Good linear relationships were obtained for 11 antibacterial agents(r≥0.999 9).The average recovery range was 98.2%-101.8%,and the RSD was 0.7%-2.7%(n=9).As revealed by the systematic analysis of 42 batches of national drug inspection samples,some batches of samples were detected with out-of-prescription antibacterial agents 4-hydroxybenzoic acid and ethylparaben,and the results were 0.02-49 μg·mL-1.This indicated that ethylparaben degradation and colinear production pollution were the two major risk sources.Conclusions The method is accurate,sensitive,and specific and can be used for the qualitative and quantitative detection of antibacterial agents in acyclovir eye drops.Besides,some products have degradation of antibacterial agents and incomplete cleaning during co-linear production.It is still essential to further reinforce product quality control.

Objective:To investigate the safety and efficacy of FOLFOX (5-fluorouracil + calcium folinate + oxaliplatin) hepatic arterial infusion chemotherapy (FOLFOX-HAIC) combined with immune and targeted therapy as triple combination therapy for patients with single China Liver Cancer Staging (CNLC) Ⅰb hepatocellular carcinoma.Methods:A total of 20 patients with single CNLC Ⅰb hepatocellular carcinoma who received FOLFOX-HAIC combined with immune and targeted therapy as triple combination therapy in the First Affiliated Hospital of Guangxi Medical University from October 2021 to August 2022 were included. The clinical data of all patients was retrospectively analyzed. There were 18 males and 2 females, with the age of (55.1±9.9) years. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) were used to evaluate the efficacy of FOLFOX-HAIC combined with immune and targeted therapy, and the clinical safety of triple combination therapy was evaluated by common terminology criteria for adverse events 4.0.Results:According to RECIST 1.1, objective response rate of 20 patients was 70.0% (14/20) and disease control rate was 100.0% (20/20) after 2 cycles of treatment (one cycle of FOLFOX-HAIC plus programmed death-1 antibody). According to mRECIST, objective response rate was 90.0% (18/20) and the disease control rate was 100.0% (20/20) after 2 cycles of treatment. Following the treatment, 12 patients (60.0%) received liver tumor resection, and all of them achieved R 0 resection, 2 patients (10.0%) received radiotherapy, 3 patients (15.0%) stopped drug treatment for surgery, 2 patients (10.0%) refused surgery, and 1 patient (5.0%) died of multiple organ failure caused by immune hepatitis. According to pathological results, 3 patients (25.0%, 3/12) achieved pathological complete response, and 4 patients (33.3%, 4/12) achieved major pathological response. In the safety evaluation, the overall incidence of adverse events was 100.0% (20/20). Seven patients (35.0%) had grade 3 adverse events and 1 patient (5.0%) died of multiple organ failure due to immune hepatitis (grade 5). Grade 1-3 adverse events could be relieved after symptomatic treatment. Conclusion:The triple combination therapy of FOLFOX-HAIC combined with immune and targeted therapy is safe and has high objective response rate and disease control rate, which could be a new strategy for the neoadjuvant treatment of hepatocellular carcinoma.

Objective:To investigate the efficacy and safety of bronchoscopic lavage in children with severe adenoviral pneumonia.Methods:Patients with severe adenovirus pneumonia who were admitted to ICU department of Hunan Children′s Hospital for bronchoscopy were collected from February to June 2019 and divided into lavage group( n=36) and non-lavage group( n=15) in line with whether lavage was performed.Their results, namely, bronchoscopic diagnosis, blood gas analysis before and 2 hours, 24 hours and 48 hours after bronchoscopy, improvement time of clinical symptoms(fever and pulmonary moist rales), the positive rate of pathogen detection and mortality rate, main vital signs such as heart rate, respiratory rate, mean arterial pressure and bronchoscopy-related complications were recorded before and 1 hour, 2 hours and 24 hours after bronchoscopy. Results:A total of 51 children were collected, all of whom suffered from endobronchitis.More secretions were observed in the airways of 36 patients in the lavage group, and only a little or no secretions were observed in 15 patients in the non-lavage group.P/F value and PCO 2 at 2 hours, 24 hours and 48 hours after treatment in the lavage group were improved comparing to those before treatment and were superior to those in the non-lavage group( P<0.05). P/F values at 24 hours and 48 hours after treatment in the non-lavage group increased and PCO 2 decreased at 48 hours after treatment( P<0.05). The thermal duration, time to resolution of moist rales in the lungs in the lavage group were shorter than those in the non-lavage group( P<0.05). The mortality rate in the lavage group was lower than that in the non-lavage group[2.8%(1/36) vs.26.7%(4/15), P<0.05]. The positive rate of pathogen detection in lavage group was higher than that in non-lavage group[55.6%(20/36) vs. 20.0%(3/15), P<0.05]. There was no significant difference in heart rate, respiratory rate, and mean arterial pressure at each time point before and after bronchoscopic treatment( P>0.05). Associated complications were 11 cases of intraoperative transient hypoxemia, four cases of bronchial mucosal bleeding, and one case each of postoperative hypoxemia, intraoperative hypertension and hypotension.There was no significant difference in the incidence of complications between the two groups( P>0.05). Conclusion:Bronchoscopic lavage, in treating children with severe adenovirus pneumonia, may improve clinical symptoms, respiratory function, and rate of pathogen detection, reduce mortality, and is effective and safe.

OBJECTIVE：To study the protection ef fects of mulberry anthocyanin- 3-glucoside on epilepsy model mice and the effect of hippocampal brain derived neurotrophic factor （BDNF）/tyrosine kinase B （TrkB）pathway. METHODS ：Totally 120 C57BL/6 mice were randomly divided into normal group ，model group ，single medication group （mulberry anthocyanin- 3- glucoside），agonist combination group（mulberry anthocyanin- 3-glucoside+TrkB agonist LM 22B-10），with 30 mice in each group. single medication group and agonist combination group were given mulberry anthocyanin- 3-glucoside 600 μg/kg intragastrically once a day ，for consecutive 6 weeks. The agonist combination group was given LM22B-10（5 mg/kg）via the lateral ventricle once a day at 6th week. Normal group and model group were given constant volume of normal saline intragastrically. After last medication，except for normal group ，other groups were given lithium chloride-pilocarpine to establish epilepsy model. After modeling，10 mice in each group were taken to record the latency ，frequency and duration of spontaneous recurrent epilepsy ， observed for 6 hours a day for 4 weeks；EEG was recorded on the 14th，28th and 36th day after modeling ，and the abnormal frequency of EEG in 1 h was counted . On the 6th day of modeling ，other 10 mice in each group were taken to detect the serum calcium level ，and the remaining 10 mice in each group were taken to detect the expressions of BDNF mRNA and protein in the hippocampus. RESULTS ：Compared with normal group ，latency，frequency and duration of spontaneous recurrent epilepsy and the times of abnormal brain wave on the 14th，28th and 36th day after modeling were increased significantly in model group （P＜ 0.05）. The serum calcium level ， mRNA and proteinexpression of BDNF in hippocampus were increased E-mail：wangfang7699@126.com significantly （P＜0.05）. Compared with model group ，the latency，frequency，duration of spontaneous recurrent epilepsy and the times of abnormal brain wave on the 28th and 36th day after modeling were decreased significantly in single medication group（P＜0.05），while serum calcium level ，mRNA and protein expression of BDNF in hippocampus were decreased significantly （P＜0.05）. Compared with single medication group ，the latency，frequency and duration of spontaneous recurrent epilepsy and the times of abnormal brain wave on the 28th and 36th day after modeling were increased significantly in agonist combination group （P＜0.05），while serum calcium level ，mRNA and protein expressions of BDNF in hippocampus were increased significantly （P＜0.05）. CONCLUSIONS ：Mulberry anthocyanin- 3- glucoside has a good protection effect on epilepsy model mice ，the mechanism of which may be associated with inhibiting the activation of hippocampal BDNF/TrkB pathway.

Objective:To investigate the association between oxygen desaturation rate and blood pressure (BP) among severe obstructive sleep apnea syndrome (OSAS) and the possible mechanism.Methods:Patients with snoring were enrolled from the Department of Sleep Medicine Center, the Affiliated Huaian No.1 People′s Hospital of Nanjing Medical University form March 2018 to January 2019 and underwent polysomnography (PSG). Noninvasive BP and Heart rate variability were full-night monitored continuously and synchronized with PSG. Based on the PSG results and exclusion criteria, a total of 86 severe OSAS patients were enrolled in this study and divided into two groups according to the ambulatory BP measurements: hypertensive group ( n=44) and normotensive group ( n=42). Oxygen desaturation rate was expressed as the change in the percentage of pulse oxyhemoglobin saturation (SpO 2) per second during desaturation events after the obstructive apnea events occurred. The PSG parameters were compared between the two group and the multiple regression analyses were used to explore the association between oxygen desaturation rate and BP and its possible mechanism. Results:The apnea-hyperpnoea index (AHI) and respiratory event-related arousals (RERAs) were significantly higher in hypertensive group than those in normotensive group [(69.8±18.2) vs. (56.5±13.9) event/h; (40.5±17.4) vs. (30.2±14.6) event/h, both P<0.01]. In addition, hypoxia exposure conditions in the hypertensive group were more severe than those in the normotensive group, especially oxygen desaturation rate [(0.45±0.14)%/s vs. (0.33±0.10)%/s, P<0.001]. After adjusting for age, sex, neck circumference, waist circumference, smoking, drinking, the regression analyses showed that only the oxygen desaturation rate was significantly associated with both awake and asleep BP in OSAS patients ( β=0.473, 0.478, both P<0.01) and the correlation analyses suggested that the oxygen desaturation rate was related to the both awake and asleep sympathetic-parasympathetic imbalance ( r=0.367, 0.337, both P<0.01). Conclusion:Oxygen desaturation rate is closely related to BP levels in patients with severe OSAS, and the underlying mechanism is associated with the increased sympathetic activity.

Objective:To investigate the effect of segmental Le FortⅠosteotomy and bilateral sagittal split ramus osteotomy ( BSSRO ) on the condyle position in skeletal class Ⅲ malocclusion patients . Methods:In this retrospective study , 19 patients with skeletal class Ⅲmalocclusion who met the inclu-sion criteria were enrolled .All the patients underwent the segmental Le FortⅠ osteotomy and BSSRO . Cone beam computed tomography ( CBCT) scans were performed in the following phases:T1:within one week before the surgeries;T2:within one week post-surgery;T3:three months post-surgery;T4:6 to 14 months post-surgery .The posterior spaces , anterior spaces and the superior spaces of the bilateral tem-poromandibular joints were measured according to the Kamelchuk method respectively .The fossa ratios of the condyle and the distribution of the condyle positions related to the glenoid fossa ( anterior , concentric and posterior position ) were calculated .The results were analyzed statistically .Results:The posterior space , the anterior space and the superior space of bilateral temporomandibular joints in T 2 phase [ right:(2.78 ±1.23) mm, (2.47 ±0.89) mm, (3.07 ±0.85) mm; left: (2.93 ±0.83) mm, (2.69 ± 1.14) mm, (3.44 ±1.16) mm] showed significantly larger spaces than those in T 1 phase [right:(1.81 ±0.95) mm, (1.65 ±0.55) mm, (2.13 ±0.52) mm;left:(2.12 ±1.05) mm, (1.79 ±0.59) mm, (2.15 ±0.93) mm],in T3 phase [right:(2.08 ±1.25) mm, (1.79 ±0.68) mm, (1.80 ±0.76) mm;left: (2.05 ±0.75) mm, (1.99 ±0.94) mm, (2.14 ±0.71) mm] and in T4 phase [right:(1.94 ±0.77) mm, (1.81 ±0.69) mm, (2.05 ±0.69) mm;left:(1.89 ±0.69) mm, (1.80 ±0.61) mm, (2.19 ±0.75) mm], P<0.05.No significant differences were observed among T 1,T3 and T4 pha-ses in the terms of the joint spaces of both sides ( P >0.05).The fossa ratio and the condyle position related to the glenoid fossa had no significant difference in all the four phases (P>0.05).The results suggested that the condyle moved downward in T 2 phase and changed to the original pre-surgery position in T3 phase, then keot stable in T4 phase.Conclusion:Segmental Le FortⅠ osteotomy and BSSRO caused significant and transient changes of the condyle position in skeletal class Ⅲmalocclusion patients . However , the condyle tended to move back to the original pre-surgery position and might keep stable .