1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
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.
2.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
3.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
4.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
5.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
6.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
7.Differentiation and Treatment of Pediatric Allergic Rhinitis Based on the Theory of "Spleen Fuctions as Wei Qi"
Haoyu DU ; Yongbin YAN ; Ying DING ; Wenbo LIU ; Yudi LI
Journal of Traditional Chinese Medicine 2025;66(15):1610-1613
Based on the theory of "spleen functions as wei qi", this paper believes that the disease mechanism of allergic rhinitis (AR) in children is the nasal dysfunction caused by the loss of spleen's wei qi. The root cause of AR is the failure of splenic transportation as well as its inability to properly distribute nutrients. The inducement of AR is the invasion of pathogenic qi coupled with insecurity of the wei exterior. The key to AR recurrence lies in the deficiency of healthy qi and lingering of pathogenic qi, with pathogenic qi lodging inside the body. The treatment should adhere to the principle of helping the spleen restore wei qi. During the acute phase, the treatment should dispel wind, conso-lidate the wei qi, and relieve stuffy orifices, and the modified Qufeng Tongqiao Decoction (祛风通窍汤) is used. During the remission phase, the treatment should fortify the spleen, raise the clear, and harmonize the wei qi, and the modified Yuhan Decoction (御寒汤) is applied. During the recovery phase, the treatment should reinforce the healthy qi, consolidate the constitution, and strengthen the wei qi, and the modified Huangqi Jianzhong Decoction (黄芪建中汤) is employed.
8.Effectiveness analysis of channel-assisted minimally invasive repair technique combined with flexor hallucis longus tendon transfer for Achilles tendon sleeve avulsion.
Lingtong KONG ; Zhonghe WANG ; Haoyu LIU ; Nazhi ZHAN ; Hongzhe QI ; Hua CHEN
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(3):264-270
OBJECTIVE:
To evaluate the effectiveness of the channel-assisted minimally invasive repair (CAMIR) technique combined with flexor hallucis longus (FHL) tendon transfer in the treatment of Achilles tendon sleeve avulsion.
METHODS:
A retrospective analysis was conducted on 17 patients with Achilles tendon sleeve avulsion who underwent CAMIR technique combined with FHL transfer between January 2019 and January 2023. The cohort comprised 13 males and 4 females, aged 32 to 65 years (mean, 49.7 years). Etiologies included sports-related injuries in 15 cases and blunt trauma in 2 cases. The interval from injury to surgery ranged from 4 to 368 days (median, 15 days). All patients exhibited calcification at the Achilles tendon insertion site, with 7 cases complicated by Haglund deformity. Postoperative complications were meticulously monitored, and tendon healing was assessed via MRI. Clinical outcome were evaluated using the visual analogue scale (VAS) score for pain, Tegner activity level rating scale, ankle activity score (AAS), American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score, Victorian Institute of Sport Assessment-Achilles (VISA-A) score, and subjective clinical scoring systems preoperatively and at last follow-up.
RESULTS:
The operation time was 50-62 minutes (mean, 56 minutes), and the intraoperative blood loss was 5-50 mL (mean, 19.7 mL). All patients were followed up 12-67 months (mean, 38 months). No postoperative complication, such as Achilles tendon re-rupture, incision infection, deep vein thrombosis, heel raise insufficiency, or sural nerve injury, was observed. At last follow-up, MRI examination confirmed satisfactory tendon healing in all cases. Significant improvements were noted in VAS scores, Tegner activity level rating scale, AAS scores, AOFAS ankle-hindfoot scores, and VISA-A scores compared to preoperative ones ( P<0.05). At last follow-up, the subjective clinical score ranged from 6 to 10 (median, 9).
CONCLUSION
The CAMIR technique combined with FHL tendon transfer is a good treatment for repair of Achilles tendon sleeve avulsion, with good recovery of ankle function and few complications.
Humans
;
Achilles Tendon/diagnostic imaging*
;
Middle Aged
;
Male
;
Female
;
Tendon Transfer/methods*
;
Minimally Invasive Surgical Procedures/methods*
;
Adult
;
Retrospective Studies
;
Aged
;
Treatment Outcome
;
Tendon Injuries/surgery*
9.Silencing PTPN2 with nanoparticle-delivered small interfering RNA remodels tumor microenvironment to sensitize immunotherapy in hepatocellular carcinoma.
Fu WANG ; Haoyu YOU ; Huahua LIU ; Zhuoran QI ; Xuan SHI ; Zhiping JIN ; Qingyang ZHONG ; Taotao LIU ; Xizhong SHEN ; Sergii RUDIUK ; Jimin ZHU ; Tao SUN ; Chen JIANG
Acta Pharmaceutica Sinica B 2025;15(6):2915-2929
Protein tyrosine phosphatase nonreceptor type 2 (PTPN2) is a promising target for sensitizing solid tumors to immune checkpoint blockades. However, the highly polar active sites of PTPN2 hinder drug discovery efforts. Leveraging small interfering RNA (siRNA) technology, we developed a novel glutathione-responsive nano-platform HPssPT (HA/PEIss@siPtpn2) to silence PTPN2 and enhance immunotherapy efficacy in hepatocellular carcinoma (HCC). HPssPT showed potent transfection and favorable safety profiles. PTPN2 deficiency induced by HPssPT amplified the interferon γ signaling in HCC cells by increasing the phosphorylation of Janus-activated kinase 1 and signal transducer and activator of transcription 1, resulting in enhanced antigen presentation and T cell activation. The nano-platform was also able to promote the M1-like polarization of macrophages in vitro. The unique tropism of HPssPT towards tumor-associated macrophages, facilitated by hyaluronic acid coating and CD44 receptor targeting, allowed for simultaneous reprogramming of both tumor cells and tumor-associated macrophages, thereby synergistically reshaping tumor microenvironment to an immunostimulatory state. In HCC, colorectal cancer, and melanoma animal models, HPssPT monotherapy provoked robust antitumor immunity, thereby sensitizing tumors to PD-1 blockade, which provided new inspiration for siRNA-based drug discovery and tumor immunotherapy.
10.Morphological characteristics analysis for deposition sequencing of overlapping bloodstain patterns
Zunlei QIAN ; Lindi ZHANG ; Mengqi WU ; Haoyu WANG ; Zhao LIU ; Zhenjun JIA
Chinese Journal of Forensic Medicine 2024;39(3):299-303
Objective To explore the morphological characteristics of overlapping bloodstains and judge the deposition sequence of bloodstain patterns.Methods The overlapping bloodstains formed by drip stains and bloody shoe prints were simulated on ceramic tiles,and the morphological characteristic differences of 6 group overlapping bloodstain patterns were analyzed to screen effective indicative characteristics.A survey was held to measure the accuracy of the participants in judging the blood deposition sequence without and with information about the morphological characteristic guidance.Results After participants mastered morphological characteristics,the accuracy of judging deposition sequence increased from 59.5%to 89.0%,and the accuracy of judging dry and wet conditions of the primary bloodstains increased from 45.6%to 65.3%.Conclusion According to the morphological characteristics of bloodstains,not only the deposition sequence of bloodstains can be effectively judged,but also the dry and wet conditions of bloodstains can be judged,so as to infer the time interval of bloodstains deposition,which can provide technical support for the analysis and reconstruction of crime scene.

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