1.Comprehensive evaluation of powder-liquid double-chamber bag products: a systematic review
Fei SHU ; Rui SUN ; Kai SONG ; Yuanlin ZHANG ; Jiaming YAN ; Lixin SHU
Journal of Pharmaceutical Practice and Service 2025;43(2):92-96
Objective To evaluate the advantages of powder-liquid double-chamber bag products compared with traditional powder injection. Methods The systematic review method was used to collect the literature on powder-liquid double-chamber bag, extract common evaluation indicators, evaluate the use value of powder-liquid double-chamber bag products, and conduct a comprehensive comparison with traditional powder injection products. Results A total of 23 articles were included in the literature. The effectiveness indicators used for evaluation were the stability of the liquid medicine, the accuracy of the preparation concentration, and the residual amount of the liquid medicine; the safety indicators were the incidence of insoluble particles and the incidence of punctures and scratches. The economic indicators were preparation cost, occupied volume of preparation supplies, waste weight, hospitalization cost and incidence of blood infection. The applicability indicators were preparation time, average occupation of medical staff, packaging weight and storage and transportation volume, environmental adaptability, and ease of waste disposal. Accessibility indicators are the number of manufacturers, raw material supply capacity, and patient affordability. Through the evaluation of literature evidence, it was found that the stability and concentration accuracy of the powder-liquid double-chamber bag were higher than those of the traditional powder injection, and the domestic supply had been achieved. The double-chamber bag method can reduce the infusion reaction and shorten the preparation time of the liquid medicine. Conclusion Compared with traditional powder injectabler products, powder-liquid double-chamber bags have advantages in the dimensions of effectiveness, safety, economy, suitability and innovation, and the accessibility dimension meets the requirements.
2.Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition
HONG Xiaoxu ; SONG Zonghua ; MA Shuangcheng ; LAN Fen ; SHU Rong
Drug Standards of China 2025;26(1):001-010
The Pharmacopoeia of the People’s Republic of China 2025 edition is to be issued in March 2025. Chinese Pharmacopoeia is the basic requirements on the drug manufacture, drug testing, drug use and drug administration. The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included, establishing the standards system, standards conversion and application of drug quality control for the new technology, new method & new tool, drug control on the safety and effectiveness as well as the drug standard international harmonization. It will take important role on improving the drug quality, ensuring the safety of drugs for public use, strengthen technical support for drug administration, promoting the high-quality development of China’s medical and pharmaceutical industry. This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.
3.The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
WANG Fei ; SONG Zonghua ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):011-016
Objective: Introduce and briefly describe the status, characteristics, and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition, providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.
Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.
Results:Compared with other pharmacopoeias of various countries, Chinese Pharmacopoeia includes standards for traditional Chinese medicine, chemical drugs, biological products and excipients, pharmaceutical packaging materials, etc. Each section of Chinese Pharmacopoeia has its own general notice, with 34 to 48 items arranged in 11 to 12 chapters. Depending on the type of products included and the development history, the general notice in each section present differences in format and content. Given the importance and significance of the standards in Chinese Pharmacopoeia, it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia. With the introduction and revision of regulations, changes in the content of pharmacopoeias, and the application of new technologies, methods, and concepts in drug quality control, considering the unique characteristics of various drugs in quality control and supervision, Chinese Pharmacopoeia has comprehensively standardized relevant requirements. While taking into account the characteristics of the first, second, third, and fourth parts of the pharmacopoeia, it retains the characteristics of relative uniformity and the content of each part, achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.
Conclusion: The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content. By introducing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition, pharmacopoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
4.Integration and innovation of wet granulation and continuous manufacturing technology: a review of on-line detection, modeling, and process scale-up.
Guang-di YANG ; Ge AO ; Yang CHEN ; Yu-Fang HUANG ; Shu CHEN ; Dong-Xun LI ; Wen-Liu ZHANG ; Tian-Tian WANG ; Guo-Song ZHANG
China Journal of Chinese Materia Medica 2025;50(6):1484-1495
Continuous manufacturing, as an innovative pharmaceutical production model, offers advantages such as high production efficiency and ease of control compared to traditional batch production, aligning with the future trend of drug production moving toward greater efficiency and intelligence. However, the development of continuous manufacturing technology in wet granulation has been slow. On one hand, this is closely related to its high technical complexity, substantial equipment investment costs, and stringent process control requirements. On the other hand, the long-term use of the traditional batch production model has created strong path dependence, and the lack of mature standardized processes further increases the difficulty of technological transformation. To promote the deep integration of wet granulation technology with continuous manufacturing, this review systematically outlines the current application of wet granulation in continuous manufacturing. It focuses on the development of key technologies such as online detection, process modeling, and process scale-up, with the aim of providing a reference for process innovation and application in wet granulation.
Drug Compounding/instrumentation*
;
Technology, Pharmaceutical/methods*
;
Drugs, Chinese Herbal/chemistry*
;
Models, Theoretical
5.Zhiwei Fuwei Pills regulate miRNA-21/Bcl-2 pathway to improve mitochondrial apoptosis in rats with precancerous lesions of gastric cancer.
Jiao-Jiao ZUO ; Rui-Ping SONG ; Peng-Cheng DOU ; Xin-Yi CHEN ; Zhuang-Zhuang FENG ; Jin SHU
China Journal of Chinese Materia Medica 2025;50(15):4342-4351
This study aimed to investigate the effects of Zhiwei Fuwei Pills on mitochondrial apoptosis in the rat model of precancerous lesions of gastric cancer(PLGC) based on the microRNA-21(miRNA-21)/B-cell lymphoma-2(Bcl-2) signaling pathway. Eighty-five 5-week-old male SPF-grade SD rats were selected, of which 75 were fed with N-methyl-N'-nitro-N-nitrosoguanidine(MNNG) for multifactorial modeling, and the PLGC model was established after 26 weeks. The rats were randomly grouped as follows: model, folic acid(0.002 g·kg~(-1)), low-dose(0.42 g·kg~(-1)) Zhiwei Fuwei Pills, medium-dose(0.84 g·kg~(-1)) Zhiwei Fuwei Pills, and high-dose(1.67 g·kg~(-1)) Zhiwei Fuwei Pills, with 15 rats in each group. Additionally, 10 rats were assigned to a blank group and administrated with an equivalent volume of normal saline by gavage. After four weeks of continuous drug administration, the gastric mucosal tissue was collected. Hematoxylin-eosin(HE) staining was performed to reveal the pathological changes in the gastric mucosa. Terminal deoxynucleotidyl transferase dUTP nick end labeling(TUNEL) was employed to detect apoptosis in gastric mucosal epithelial cells. RT-PCR was adopted to determine the mRNA levels of miRNA-21, phosphatase and tensin homolog(PTEN), Bcl-2, Bcl-2-associated X protein(Bax), and cysteinyl aspartate-specific protease 3(caspase-3). Western blot was employed to determine the protein levels of PTEN, Bcl-2, Bax, and caspase-3. Immunohistochemistry(IHC) was used to detect the positive expression of PTEN, Bcl-2, and Bax in the gastric mucosal tissue. Transmission electron microscopy(TEM) was employed to observe the morphological and structural changes in mitochondria. The results showed that compared with model group, the drug administration groups showed alleviated pathological changes, with increased apoptotic cells, down-regulated mRNA levels of miRNA-21 and Bcl-2, up-regulated mRNA and protein levels of PTEN, Bax, and caspase-3, and down-regulated protein level of Bcl-2. In addition, the drug administration groups exhibited mitochondrial swelling and rupture and reduction of cristae, which indicated mitochondrial apoptosis. These findings suggest that Zhiwei Fuwei Pills can effectively improve mitochondrial apoptosis in PLGC cells by regulating the miRNA-21/Bcl-2 signaling pathway.
Animals
;
MicroRNAs/metabolism*
;
Male
;
Apoptosis/drug effects*
;
Stomach Neoplasms/physiopathology*
;
Proto-Oncogene Proteins c-bcl-2/genetics*
;
Rats
;
Rats, Sprague-Dawley
;
Drugs, Chinese Herbal/administration & dosage*
;
Mitochondria/genetics*
;
Signal Transduction/drug effects*
;
Precancerous Conditions/drug therapy*
;
Humans
;
PTEN Phosphohydrolase/genetics*
6.Mechanism of traditional Chinese medicine treatment of hepatic fibrosis by restoring circadian rhythms.
Meng-Ru ZHANG ; Ruo-Nan JIANG ; Shu-Hua XIONG ; Hong-Yan WU ; De-Song KONG ; Li CHEN
China Journal of Chinese Materia Medica 2025;50(16):4407-4414
Hepatic fibrosis is a key pathological process in the development of chronic liver disease to cirrhosis, and its core mechanism involves the activation of hepatic stellate cells(HSC) and abnormal deposition of extracellular matrix(ECM). Although existing treatments, such as antiviral drugs, can delay disease progression, they have the problem of single therapeutic targets and cannot reverse fibrosis. Accordingly, multidimensional intervention strategies are urgently needed. Recent studies have shown that circadian rhythm disorders aggravate hepatic fibrosis by regulating metabolism, immunity, and inflammation. Traditional Chinese medicine(TCM) plays a unique role in restoring the circadian clock via multi-target and holistic regulation. This paper establishes a three-dimensional network by systematically integrating biological clock, metabolism, and immunity for the first time to elucidate the scientific connotation of the theory of time-concerned treatment of TCM, and proposes a new strategy for the development of time-targeted compound prescriptions, providing innovative ideas for the treatment of hepatic fibrosis.
Humans
;
Liver Cirrhosis/metabolism*
;
Drugs, Chinese Herbal/therapeutic use*
;
Circadian Rhythm/drug effects*
;
Animals
;
Medicine, Chinese Traditional
;
Hepatic Stellate Cells/drug effects*
7.Mechanism of Chaijin Jieyu Anshen Formula in regulating synaptic damage in nucleus accumbens neurons of rats with insomnia complicated with depression through TREM2/C1q axis.
Ying-Juan TANG ; Jia-Cheng DAI ; Song YANG ; Xiao-Shi YU ; Yao ZHANG ; Hai-Long SU ; Zhi-Yuan LIU ; Zi-Xuan XIANG ; Jun-Cheng LIU ; Hai-Xia HE ; Jian LIU ; Yuan-Shan HAN ; Yu-Hong WANG ; Man-Shu ZOU
China Journal of Chinese Materia Medica 2025;50(16):4538-4545
This study aims to investigate the effect of Chaijin Jieyu Anshen Formula on the neuroinflammation of rats with insomnia complicated with depression through the regulation of triggering receptor expressed on myeloid cells 2(TREM2)/complement protein C1q signaling pathway. Rats were randomly divided into a normal group, a model group, a positive drug group, as well as a high, medium, and low-dose groups of Chaijin Jieyu Anshen Formula, with 10 rats in each group. Except for the normal group, the other groups were injected with p-chlorophenylalanine and exposed to chronic unpredictable mild stress to establish the rat model of insomnia complicated with depression. The sucrose preference experiment, open field experiment, and water maze test were performed to evaluate the depression in rats. Enzyme-linked immunosorbent assay was employed to detect serum 5-hydroxytryptamine(5-HT), dopamine(DA), and norepinephrine(NE) levels. Hematoxylin and eosin staining and Nissl staining were used to observe the damage in nucleus accumbens neurons. Western blot and immunofluorescence were performed to detect TREM2, C1q, postsynaptic density 95(PSD-95), and synaptophysin 1(SYN1) expressions in rat nucleus accumbens, respectively. Golgi-Cox staining was utilized to observe the synaptic spine density of nucleus accumbens neurons. The results show that, compared with the model group, Chaijin Jieyu Anshen Formula can significantly increase the sucrose preference as well as the distance and number of voluntary activities, shorten the immobility time in forced swimming test and the successful incubation period of positioning navigation, and prolong the stay time of space exploration in the target quadrant test. The serum 5-HT, DA, and NE contents in the model group are significantly lower than those in the normal group, with the above contents significantly increased after the intervention of Chaijin Jieyu Anshen Formula. In addition, Chaijin Jieyu Anshen Formula can alleviate pathological damages such as swelling and loose arrangement of tissue cells in the nucleus accumbens, while increasing the Nissl body numbers. Chaijin Jieyu Anshen Formula can improve synaptic damage in the nucleus accumbens and increase the synaptic spine density. Compared to the normal group, the expression of C1q protein was significantly higher in the model group, while the expression of TREM2 protein was significantly lower. Compared to the model group, the intervention with Chaijin Jieyu Anshen Formula significantly downregulated the expression of C1q protein and significantly upregulated the expression of TREM2. Compared with the model group, the PSD-95 and SYN1 fluorescence intensity is significantly increased in the groups receiving different doses of Chaijin Jieyu Anshen Formula. In summary, Chaijin Jieyu Anshen Formula can reduce the C1q protein expression, relieve the TREM2 inhibition, and promote the synapse-related proteins PSD-95 and SNY1 expression. Chaijin Jieyu Anshen Formula improves synaptic injury of the nucleus accumbens neurons, thereby treating insomnia complicated with depression.
Animals
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Male
;
Rats
;
Nucleus Accumbens/metabolism*
;
Drugs, Chinese Herbal/administration & dosage*
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Depression/complications*
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Membrane Glycoproteins/genetics*
;
Rats, Sprague-Dawley
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Sleep Initiation and Maintenance Disorders/complications*
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Neurons/metabolism*
;
Receptors, Immunologic/genetics*
;
Signal Transduction/drug effects*
;
Synapses/metabolism*
8.Electrical stimulation based on triboelectric nanogenerator promotes osteogenesis of MC3T3-E1 cells on titanium surfaces.
Bo PANG ; Shu YANG ; Hongyang HAN ; Xingwei ZHANG ; Tao SONG
Journal of Biomedical Engineering 2025;42(2):366-373
This paper aims to explore the effect of electrical stimulation of triboelectric nanogenerators (TENGs) on the osteogenic and other biological behaviors of mouse embryonic osteoblast precursor cells (MC3T3-E1 cells) on titanium surfaces. First, an origami-type TENG was fabricated, and its electrical output performance was tested. The optimal current of the generator and the feasibility of the experiment were verified by the CCK-8 assay and scratch assay. At the optimal current, the osteogenic conditions of the cells in each group were determined by quantitative analysis of the total protein content, alkaline phosphatase (ALP) activity, and alizarin red staining (ARS) on the titanium surface. Finally, the adhesion and spreading of cells on the titanium surface after electrical stimulation were observed. The results showed that the TENG had good electrical output performance, with an open-circuit voltage of 65 V and a short-circuit current of 42 μA. Compared with the rest of the current, a current strength of 30 μA significantly improved cell proliferation and migration, osteogenesis, and adhesion and spreading capabilities. The above results confirm the safety and operability of TENG in biomedical applications, laying the foundation for future TENG applications in reducing the time of bone integration around titanium implants after surgery.
Titanium/chemistry*
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Osteogenesis
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Animals
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Mice
;
Osteoblasts/cytology*
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Electric Stimulation/instrumentation*
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Cell Adhesion
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Cell Proliferation
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Surface Properties
;
Cell Differentiation
;
Nanotechnology
9.Clinical study on the efficacy of unicompartmental knee arthroplasty in elderly patients with medial osteoarthritis and anterior cruciate ligament deficiency.
Hai-Song LIANG ; Dong SHENG ; Xiao-Su HUI ; Xin-Wen BAI ; Yu DENG ; Cong-Ke SHU ; Fa-Song XIANG
China Journal of Orthopaedics and Traumatology 2025;38(4):336-342
OBJECTIVE:
To investigate the short-and med-term clinical efficacy of unicompartmental knee arthroplasty(UKA)for the treatment of medial knee osteoarthritis (OA) in elderly patients with anterior cruciate ligament deficiency(ACLD).
METHODS:
A retrospective analysis was conducted on 31 patients aged over 75 years old with primary medial knee OA and ACLD who underwent UKA between January 2018 and December 2022. The cohort included 12 males and 19 females, aged from 75 to 91 years with an average age of (79.56±4.54) years, with 13 left knee, 16 right knee, and 2 bilateral knees. Clinical outcomes were assessed preoperatively and at final follow-up using the visual analogue scale (VAS), Hospital for Special Surgery(HSS) score, range of motion (ROM), hip-knee-ankle angle (HKA), and tibial component posterior slope angle (TCPSA). Complications such as infection, prosthesis wear, prosthesis loosening, and dislocation were also recorded.
RESULTS:
All 31 patients were followed up from 12 to 63 months with an average of (28.34±10.56) months. The average postoperative TCPSA was (4.83±1.31)° ranged from 2.5° to 6.8°. At the final follow-up, there was significant improvement in VAS (3.24±0.53) vs. (6.59±0.69), HSS score (85.19±4.45) vs. (64.38±5.94), ROM (118.83±5.38)° vs. (98.85±4.08)°, and HKA (176.83±5.16)° vs. (169.57±6.28)° compared to preoperative values (P<0.05). No cases of infection, prosthesis loosening, or dislocation were reported.
CONCLUSION
UKA provides favorable short-and mid-term outcomes for elderly patients with medial knee OA and ACLD . However, long-term clinical efficacy needs further investigation through extended follow-up.
Humans
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Male
;
Female
;
Arthroplasty, Replacement, Knee/methods*
;
Aged
;
Osteoarthritis, Knee/physiopathology*
;
Retrospective Studies
;
Aged, 80 and over
;
Range of Motion, Articular
;
Anterior Cruciate Ligament Injuries/surgery*
10.Preliminary application of modified interposed jejunal anastomosis in digestive tract reconstruction following total laparoscopic proximal gastrectomy.
Wusiman LAIBIJIANG ; Abudukelimu ABULAJIANG ; Yilihamu YILIYAER ; D D SONG ; Y SHU ; W B ZHANG
Chinese Journal of Gastrointestinal Surgery 2025;28(11):1314-1317
Objective: To investigate the feasibility and safety of modified interposed jejunal anastomosis following total laparoscopic proximal gastrectomy. Methods: The modification in the digestive tract reconstruction involves transecting the small intestine 2-3 cm below the gastrojejunostomy site and relocating the enteroenterostomy cranially, based on the double-tract anastomosis technique. Specifically, the jejunum and its mesenteric vessels are transected 20-25 cm from the ligament of Treitz. An overlap anastomosis is performed between the esophagus and the distal jejunum, with the common opening closed using a 15 cm barbed suture in a buried manner. A side-to-side gastrojejunostomy is completed under natural anatomical alignment, and the common opening is closed similarly. A side-to-side anastomosis is then created between the small intestine approximately 10 cm below the gastrojejunal anastomosis and the small intestine distal to the ligament of Treitz. Finally, the small intestine is transected 2-3 cm below the gastrojejunal anastomosis without dividing the mesenteric vessels. Results: From April to December 2024, a total of five patients with adenocarcinoma of the esophagogastric junction underwent modified interposed jejunum anastomosis following totally laparoscopic proximal gastrectomy at the Affiliated Tumor Hospital of Xinjiang Medical University. The median age of the group was 56 (53-74) years, including four males and one female, with a median body mass index of 24 (21-29) kg/m². Three cases were classified as Siewert type II and two as type III. All five patients successfully completed the totally laparoscopic proximal gastrectomy with modified interposed jejunum anastomosis. The median operative time was 215 (165-240) minutes, the digestive tract reconstruction time was 75 (65-93) minutes, and the intraoperative blood loss was 50 (30-100) ml. The median time to postoperative flatus was 71 (68-88) hours, with no severe complications occurring in any case. The median postoperative hospital stay was 8 (8-9) days. Within three months after surgery, none of the patients reported reflux symptoms such as acid regurgitation or heartburn. Conclusions: Total laparoscopic modified interposed jejunal anastomosis is safe and feasible, with relatively simple operative steps. It effectively prevents reflux while ensuring the passage of food through the remnant stomach and duodenal loop.
Humans
;
Gastrectomy/methods*
;
Jejunum/surgery*
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Laparoscopy/methods*
;
Anastomosis, Surgical/methods*
;
Male
;
Female
;
Middle Aged
;
Aged
;
Stomach Neoplasms/surgery*
;
Plastic Surgery Procedures/methods*

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