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.

Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.

OBJECTIVE: To compare the effectiveness of a zero-profile three-dimensiaonal (3D)-printed microporous titanium alloy Cage and a conventional titanium plate combined with a polyether-ether-ketone (PEEK)-Cage in the treatment of single-segment cervical spondylotic myelopathy (CSM) by anterior cervical discectomy and fusion (ACDF). METHODS: The clinical data of 83 patients with single-segment CSM treated with ACDF between January 2022 and January 2023 were retrospectively analyzed, and they were divided into 3D-ZP group (35 cases, using zero-profile 3D-printed microporous titanium alloy Cage) and CP group (48 cases, using titanium plate in combination with PEEK-Cage). There was no significant difference in gender, age, disease duration, surgical intervertebral space, and preoperative Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) score, neck disability index (NDI), vertebral height at the fusion segment, Cobb angle, and other baseline data between the two groups (P>0.05). The operation time, intraoperative blood loss, hospital stay, complications, interbody fusion, and prosthesis subsidence were recorded and compared between the two groups. VAS score, NDI, and JOA score were used to evaluate the improvement of pain and function before operation, at 3 months after operation, and at last follow-up, and the vertebral height at the fusion segment and Cobb angle were measured by imaging. The degree of dysphagia was assessed by the Bazaz dysphagia scale at 1 week and at last follow-up. RESULTS: The operation was successfully completed in all the 83 patients. There was no significant difference in intraoperative blood loss and hospital stay between the two groups (P>0.05), but the operation time in the 3D-ZP group was significantly shorter than that in the CP group (P<0.05). Patients in both groups were followed up 24-35 months, with an average of 25.3 months, and there was no significant difference in the follow-up time between the two groups (P>0.05). The incidence and grade of dysphagia in CP group were significantly higher than those in 3D-ZP group at 1 week after operation and at last follow-up (P<0.05). There was no dysphagia in 3D-ZP group at last follow-up. There was no complication such as implant breakage or displacement in both groups. The intervertebral fusion rates of 3D-ZP group and CP group were 65.71% (23/35) and 60.42% (29/48) respectively at 3 months after operation, and there was no significant difference between the two groups [OR (95%CI)=1.256 (0.507, 3.109), P=0.622]. The JOA score, VAS score, and NDI significantly improved in the 3D-ZP group at 3 months and at last follow-up when compared with preoperative ones (P<0.05), but there was no significant difference between the two groups (P>0.05). There was no significant difference in the improvement rate of JOA between the two groups at last follow-up (P>0.05). At 3 months after operation and at last follow-up, the vertebral height at the fusion segment and Cobb angle significantly improved in both groups, and the two indexes in 3D-ZP group were significantly better than those in CP group (P<0.05). At last follow-up, the incidence of prosthesis subsidence in 3D-ZP group (8.57%) was significantly lower than that in CP group (29.16%) (P<0.05). CONCLUSION The application of zero-profile 3D-printed Cage and titanium plate combined with PEEK-Cage in single-segment ACDF can both reconstruct the stability of cervical spine and achieve good effectiveness. Compared with the latter, the application of the former in ACDF can shorten the operation time, reduce the incidence of prosthesis subsidence, and reduce the incidence of dysphagia.
Humans ; Spinal Fusion/instrumentation* ; Titanium ; Cervical Vertebrae/surgery* ; Diskectomy/instrumentation* ; Bone Plates ; Male ; Printing, Three-Dimensional ; Female ; Retrospective Studies ; Middle Aged ; Treatment Outcome ; Benzophenones ; Adult ; Spondylosis/surgery* ; Aged ; Polymers ; Ketones ; Polyethylene Glycols

Objective:To evaluate the clinical application effects of a domestic bone-level implant system for restoring single tooth loss, and provide clinical evidence for the promotion and application of domestic implants.Methods:A prospective, multicenter clinical trial was conducted from April 2018 to January 2020 in three institutions: Department of Oral Implantology, School & Hospital of Stomatology, Wuhan University, Department of Stomatology, The First Affiliated Hospital of Zhejiang University School of Medicine, and Department of Stomatology, The Third Hospital of Hebei Medical University. The trial planned to include 100 patients for single tooth implantation and restoration, followed up for 1 year, to evaluate the implantation success rate and other related outcomes.Results:This study screened a total of 142 patients and ultimately included 100, comprising 43 males and 57 females with age of (47.0±12.2) years. Ninety-eight out of 100 patients completed a one-year follow-up (98.0%), while 2 patients terminated the trial early due to implant loosening (2.0%). After a one-year follow-up, the implants of the 98 patients were all functioning successfully, with a success rate of 98.0% (98/100). The patients were satisfied with the overall restoration effect.Conclusions:This study indicates that the domestic bone-level implant system has achieved favorable short-term clinical outcomes for single-tooth implantation and restoration.

Objective:To analyze the risk factors of intracranial hemorrhage after implanting 125-iodine seeds for brain tumors.Methods:A total of 234 patients with intracranial tumors receiving treatment of 125-iodine seeds from March, 2013 to November, 2020 were retrospectively analyzed. Patients were divided into bleeding group and non-bleeding group according to whether postoperative intracranial hemorrhage was reported. Univariate and multivariate analysis was performed by logistic regression to determine the independent risk factors of intracranial hemorrhage.Result:A total of 22 cases (9.4%) reported postoperative intracranial hemorrhage in 234 patients treated with 125-iodine seeds. Univariate analysis showed that the type of tumor and the history of anti-angiogenic drug within one month were possible risk factors ( P<0.1). Multivariate logistic regression analysis showed that anti-angiogenic drug within one month was the independent risk factor for intracranial hemorrhage ( P<0.05). Conclusions:The application of anti-angiogenic drugs within one month is the independent risk factor of intracranial hemorrhage with 125-iodine seeds for the treatment of brain tumors.

The laccase (PpLAC) gene family members in peach fruit were identified and the relationship between their expression pattern and chilling induced browning were investigated. The study was performed using two varieties of peaches with different chilling tolerance, treated with or without exogenous γ-aminobutyric acid (GABA) during cold storage. Twenty-six genes were screened from the peach fruit genome. These genes were distributed on 6 chromosomes and each contained 5-7 exons. The PpLAC gene family members shared relatively similar gene structure and conserved motifs, and they were classified into 7 subgroups based on the cluster analysis. Transcriptome sequencing revealed that the expression levels of PpLAC7 and PpLAC9 exhibited an increasing pattern under low temperature storage, and displayed a similar trend with the browning index of peach fruit. Notably, GABA treatment reduced the degree of browning and inhibited the expression of PpLAC7 and PpLAC9. These results suggested that PpLAC7 and PpLAC9 might be involved in the browning of peach fruit during cold storage.
Food Storage ; Fruit/genetics* ; Laccase/genetics* ; Prunus persica/genetics*

Objective To investigate a new clinical classification of hepatolithiasis based on biliary anatomy and pathology in order to guide clinical decision-making.Methods The cases of hepatolithiasis admitted to our hospital from Mar 2015 to Aug 2018 were classified into six types and an additional type according to biliary anatomy,stone site and extent,liver pathological changes,and Oddi sphincter function.Results Of the214 cases of hepatolithiasis,5 cases (2.3％) were type Ⅰ;41 cases (19.2％) were type Ⅱ;76 cases (35.5％) were type Ⅲ;17 cases (7.9％) were type Ⅳ;29 cases (13.5％) were type Ⅴ;46 cases (21.5％) of type Ⅵ.The most common complication was incision infection (28 cases,13.1％),liver failure 0,and perioperative death 0.During the follow-up from 3 months to 3 years,there were 14cases of stone recurrence,the recurrence rate was 7.6％.Conclusion This classification scheme and the "individualized precise anatomical combined hepatectomy or segmental hepatectomy" based on this classification is safe and effective while enhancing the cure rate.

Fifty three HIC/AIDS patients with acute appendicitis treated in our hospital from January 2016 to June 2017 were retrospectively analyzed.The anesthesia and surgery were successfully completed in all patients,and there were no serious intraoperative complications.The postoperative complications occurred in 18 cases (34.0 ％),including 13 cases (24.5 ％) of incision infections and 3 cases (5.7 ％) of lung infections,1 case of adhesion obstruction (1.9 ％) and 1 case (1.9 ％) of new opportunistic infections.All patients were clinically cured after treatment and discharged from the hospital without perioperative death.The characteristics of acute appendicitis in HIV/AIDS patients are emergent onset,poor body condition,lower immunity,more comorbities,rapid condition changes,and high frequency of special infections;the patients with lower CD4 count may have higher postoperative infection,the slower recovery and the poorer outcomes.

Objective To study the clinical efficacy of external fixator and combined screwing at iliac crests and pubic symphysis for the treatment of unstable pelvic fractures.Methods From January 2013 to February 2014,12 cases of unstable pelvic fracture were treated at our department.They were 8 men and 4 women,from 32 to 57 years of age (average,42.5 years).Seven cases were caused by a traffic accident,and 5 by falling from a height.By Tile classification,8 cases were type B (including type B1 in 3 cases,type B2 in 3 and type B3 in 2),and 4 cases type C1.Associated injury included shock in 7 cases,bladder injury in one,limb long bone fracture in 6,joint injury in 3,and thoracic and lumbar injury in 4.The interval from injury to operation averaged 4 days,ranging from 12 hours to 7 days.The type B fractures were treated with an external fixator and combined screwing at iliac crests and pubic symphysis while the type C1 fractures with internal fixation with percutaneous S1 sacroiliac screws in addition to what was used for the type B fractures.Results The 12 patients were followed up for 5 to 12 months(average,9 months).No one died in this group.The fractures healed after 8 to 13 weeks (average,11.3 weeks).All the patients recovered normal walking.Superficial infection at the pin hole occurred in 7 cases,but there was no deep infection.Screw loosening was observed in only one case,and no reduction loss,injury to nerves or urinary canal was observed.According to the Majeed criteria,the efficacy was evaluated as excellent in 10 cases,good in one,and moderate in one.Conclusion External fixator and combined screwing at iliac crests and pubic symphysis can restore the stability of anterior pelvic ring,leading to good clinical outcomes.

Objective To investigate the effect of electroacupuncture at points Xiaohai and Xiajuxu on the expressions of tumour necrosis factor-α (TNF-α) and choline acetyltransferase (ChAT) in serum and nicotinic acetylcholine receptorα 7 (α 7 nAchR) in duodenal tissues in a rat model of duodenal ulcer (DU) and preliminarily explore the relative specificity of He-Sea point in “treating visceral diseases with He-Sea point”.Methods Forty healthy SD rats were randomized into blank (A), model (B), Xiaohai (C) and Xiajuxu (D) groups, 10 rats each. A rat model of DU was made by subcutaneous injection of 10% cysteamine hydrochloride at the right buttock. After successful model making, group C was given electroacupuncture at point Xiaohai and group D, at point Xiajuxu. Duodenal tissue ulcer was macroscopically observed and scored in every group of rats. Rat serum expression of TNF-α was determined by double antibody sandwich enzyme-linked immunosorbent assay (ELISA); rat serum expression of ChAT, by ultraviolet spectrophotometry & colorimetry; rat duodenal expression ofα7 nAchR, by Western blot.Results After model making, the duodenal ulcer score was significantly higher in groups B, C and D than in group A (allP<0.01) and significantly lower in groups C and D than in group B (bothP<0.01) and in group D than in group C (P<0.01). TNF-α expression was significantly higher in group B than in group A (P<0.01) and significantly lower in groups C and D than in group B (bothP<0.01) and in group D than in group C (P<0.01). ChAT expression tended to increase in group C compared with group B but there was no statistically significant difference (P>0.05) and was significantly higher in group D than in group B (P<0.01) or C (P<0.05).α7 nAchR expression was significantly higher in groups C and D than in group B (bothP<0.01). There was a positive correlation between ChAT andα7 nAchR expressions in every group (r=0.444,P=0.007).Conclusions Electroacupuncture at both points Xiaohai and Xiajuxu can reduce the duodenal ulcer score and serum TNF-α expression and increase serum ChAT and duodenalα7 nAchR expressions in DU rats. The results show that the therapeutic effect of electroacupuncture on duodenal ulcer may be produced by regulating TNF-α. Its mechanism may be activating cholinergic anti-inflammatory pathway to produce an anti-inflammatory effect. The effect being better in group D than in group C suggests that Xiajuxu has the relative specificity.