OBJECTIVE To develop a novel gastric retention drug delivery system incorporating curcumin(Cur), based on the shape memory polypropylene carbonate-polyethylene glycol (PPC-PEG), with the objective of enhancing the in vivo bioavailability of Cur. METHODS The curcumin-cyclodextrin inclusion complex (Cur_β-CD) was prepared and loaded onto the shape memory polypropylene carbonate-polyethylene glycol composite film (PPC-PEG) to create the expanded gastric retention drug delivery system (Cur_β-CD_PPC-PEG); multiple characterization, proliferation inhibition analysis of human gastric cancer cells (SGC-7901) in vitro, and pharmacokinetics analysis in rats were then performed. RESULTS After cyclodextrin inclusion, the water solubility of Cur_β-CD was 35.85 times higher than that of Cur. The deformation recovery rate of the composite film PPC-PEG(7.5∶2.5) is 88.6% at 37 ℃. The Cur was physically incorporated into the composite film of Cur_β-CD_PPC-PEG, and the loaded Cur exhibited excellent thermal stability. The loaded Cur has a certain effect on the shape memory performance of PPC-PEG; however, it still satisfies the requirement for deformation recovery rate as a deformable gastric retention formulation. The in vitro cumulative release rate of Cur_β-CD_PPC-PEG over a 48-hour period was determined to be 71.42%. The Cur_β-CD_PPC-PEG exhibits significant efficacy in vitro against the proliferation of gastric cancer SGC-7901 cells, with a remarkable inhibitory rate of 86.64% observed after 48 h of treatment. The pharmacokinetic results showed that the area under the curve (AUC_0-24) and the retention time in vivo (MRT_0-24) of Cur_β-CD_PPC-PEG were 9.73 times and 2.95 times higher than those of Cur. CONCLUSION In this study, a novel shape memory gastric retention drug delivery system of Cur_β-CD_PPC-PEG is successfully prepared. The system exhibits a favorable drug controlled release effect within 48 h, characterized by rapid onset, prolonged duration of efficacy, and high bioavailability.

OBJECTIVE To indentify and analyze Bacillus species and their characteristics contaminating traditional Chinese medicine. METHODS Screening for a reaction system more suitable for gyrB gene amplification conditions and sequencing Bacillus species in contaminated traditional Chinese medicine preparations, medicinal herbal, herbal pieces and extracts. Analyzing the types and homogeneity of contaminating bacteria through comparing gene sequences and constructing a phylogenetic tree. RESULTS The results indicate that the prevalence of Bacillus subtilis as the most common contaminating bacterium across various sample types, followed by Bacillus velezensis, Bacillus megaterium, Bacillus licheniformis and Bacillus amyloliquefaciens. Additionally, pathogenic bacterium Bacillus cereus was also detected in this analysis. The gyrB gene demonstrates good discriminatory power for various Bacillus species and subspecies, effectively distinguishing same contaminating strains relationships among diverse production enterprises, showing relevance of sources. CONCLUSION To ensure the quality and safety of traditional Chinese medicine products, production enterprises must enhance control measures at the source during the production process and select appropriate sterilization processes tailored to the characteristics of traditional Chinese medicine varieties.

OBJECTIVE To investigate the effect of saikosaponin A (SA) on inflammatory injury in rats with reflux esophagitis (RE) by regulating the interleukin (IL)-6/tyrosine kinase 2 (JAK2)/signal transducer and activator of transcription 3 (STAT3) pathway. METHODS SD rats were randomly divided into RE group, normal group, SA low-dose group (gavage of 12.5 mg·kg^-1 SA), SA high-dose group (gavage of 50 mg·kg^-1 SA), omeprazole group (gavage of 2 mg·kg^-1 omeprazole), SA high-dose+IL-6 activator recombinant rat IL-6 protein (rRIL-6) group (gavage of 50 mg·kg^-1 SA+intraperitoneal injection of 0.05 mg·kg^-1 rRIL-6), with 12 rats in each group. Except for the normal group, rats in all other groups were required to undergo RE model construction through fore-stomach ligation combined with partial ligation of the external pylorus. After successful modeling, the drug was administered once a day for 2 weeks. The damage rate of esophageal mucosa was detected. Hematoxylin-eosin staining(HE) was applied to detect pathological changes in esophageal tissue. Enzyme-linked immunosorbent assay (ELISA) was applied to detect levels of tumor necrosis factor-α (TNF-α), cyclooxygenase-2 (COX-2), and IL-8 in esophageal tissue. Terminal dexynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) staining was applied to detect cell apoptosis in esophageal tissue. Immunohistochemical staining was applied to detect the expression of claudin-5 in esophageal tissue. Western blot was applied to detect IL-6, p-JAK2, and p-STAT3 proteins in esophageal tissue. RESULTS Compared with the normal group, the esophageal tissue compactness of rats in the RE group decreased, and there was a large amount of inflammatory cell infiltration, the incidence of esophageal mucosal injury, levels of TNF-α, COX-2, IL-8 in esophageal tissue, apoptosis rate, and the expression of IL-6, p-JAK2, and p-STAT3 proteins increased, while the average optical density of claudin-5 in esophageal tissue decreased (P<0.05). Compared with the RE group, the pathological damage to the esophageal tissue of rats in the SA low-dose group, SA high-dose group, and omeprazole group was reduced, the incidence of esophageal mucosal injury, levels of TNF-α, COX-2, IL-8 in esophageal tissue, apoptosis rate, and the expression of IL-6, p-JAK2, and p-STAT3 proteins decreased, while the average optical density of claudin-5 in esophageal tissue increased (P<0.05). Compared with the SA high-dose group, the SA high-dose+rRIL-6 group had severe pathological damage to the esophageal tissue, the incidence of esophageal mucosal injury, levels of TNF-α, COX-2, IL-8 in esophageal tissue, apoptosis rate, and the expression of IL-6, p-JAK2, and p-STAT3 proteins increased, while the average optical density of claudin-5 in esophageal tissue decreased (P<0.05). CONCLUSION SA may improve inflammatory injury in RE rats by inhibiting the IL-6/JAK2/STAT3 signaling pathway.

With the rapid development of science and technology, the application of 3D printing technology in personalized drug manufacturing is becoming increasingly mature, providing innovative solutions for patients and the pharmaceutical industry. Due to the integration of the 3D printing process, there are more adjustable parameters, and the printing process needs to be analyzed and monitored so as to optimize the printing process and reduce the risk thus to ensure the quality of the product. Process analytical technology (PAT) can ensure the consistency between product quality and intended use through systematic control measures, solving the limitations, contingencies and lags associated with pharmaceutical batch sampling, so the pharmaceutical industry has begun to introduce PAT technology to co-manage the production process. Based on the above background, this paper aims to integrate current research findings, dentify the challenges and opportunities associated with the application of PAT, and provide references for industry practices and future research. This paper briefly introduces PAT-related regulations, model building methods, lists commonly used PAT tools, and summarizes the application of PAT in the process of drug 3D printing. Combined with the advantages of PAT and the current status of domestic and international applications, we also evaluates the current regulatory environment and analyzes the current challenges faced by 3D printed drugs and PAT.

OBJECTIVE To explain the main content of the Special Regulations on the Management of Traditional Chinese Medicine Standards and propose suggestions on management of traditional Chinese medicine standards. METHODS The main content and key features of the Special Regulations on the Management of Traditional Chinese Medicine Standards was analyzed, and the suggestions were proposed to strengthen the management of traditional Chinese medicine standards. RESULTS The Special Regulations on the Management of Traditional Chinese Medicine Standards was focused on the reform of mechanism of management of Chinese medicine standards, such as building standard system that conforms to the key characteristics of traditional Chinese medicine, optimizing the management program of traditional Chinese medicine standards, clarifying the responsibilities of interested parties, and improving the technical system of traditional Chinese medicine standards. CONCLUSION The mechanism for traditional Chinese medicine standards should be optimized, the technical requirements related to traditional Chinese medicine standards should be improved, and all kinds of standards should be coordinated.

"Osteoimmunology" is a field that emphasizes the interaction between the immune system and skeletal system cells. Specifically, it explores how dysregulation of the immune system can result in inflammatory stimulation and the release of inflammatory factors, which significantly impact bone metabolism. Periodontitis is an inflammatory destructive disease of periodontal tissue, triggered initially by dental plaque and influenced by host immune inflammatory responses, genetic factors, and environmental factors. Inflammatory response and alveolar bone resorption stand out as prominent features of periodontitis, with immune system imbalance disrupting bone homeostasis, resulting in alveolar bone loss due to the imbalance of bone formation and resorption. Flavonoid natural products exhibit biological activities such as anti-inflammatory, antioxidant, osteogenic promotion, and antimicrobial effects, effectively ameliorating inflammatory damage to periodontal tissues. This paper provides an overview of nine classical inflammatory signaling pathways potentially involved in alveolar bone inflammatory resorption and reviews advancements in the mechanisms of action of 20 flavonoids reported for inhibiting periodontal tissue destruction associated with periodontitis by suppressing inflammatory responses and modulating inflammatory signaling pathways. The aim is to offer theoretical foundations and novel insights to enhance the treatment strategy of periodontitis.

OBJECTIVE To establish a method for determining the entrapment efficiency of alprostadil injection, compare the differences between ultrafiltration centrifugation and microcolumn centrifugation methods for determining the entrapment efficiency of alprostadil injection, and select the optimal method. METHODS High pressure homogenization method was used to prepare alprostadil injection. Ultrafiltration membrane with different molecular weights were used to establish the ultrafiltration centrifugation method by selecting the centrifugation speed and time. The micro column was prepared with Sephadex G-50, and the encapsulated and free drugs were separated by centrifugal elution. The separation effect was evaluated by establishing the elution curve of soybean oil and free alprostadil. At the same time, the difference between different elution solvents was investigated, the optimal elution solvent was screened, and the microcolumn centrifugation method was established. The drug content was determined by high-performance liquid chromatography and post column derivatization device, and the entrapment efficiency was calculated. RESULTS The entrapment efficiency of three batches of alprostadil injection measured by ultrafiltration centrifugation method ranged from 98.6% to 99.5%, while the entrapment efficiency measured by microcolumn centrifugation method ranged from 89.5% to 91.3%. CONCLUSION The results of the ultrafiltration centrifugation method for determining the entrapment efficiency are too high and not suitable for the determination of the entrapment efficiency of this product. The microcolumn centrifugation method using glycerol aqueous solution as the eluting solvent is suitable for the determination of the entrapment efficiency of this product.

Ganoderma lucidum is a fungus belonging to the genus Ganoderma in the family of Polyporaceae. As a precious medicinal herb which can be used for both medicine and food, it has various biological activities such as antioxidant, antibacterial, anti-tumor, anti-inflammatory, and neuroprotective properties. However, due to the difficulty in dissolution, low bioavailability, difficulty in absorption by the human body, and the increased burden on liver injury patients caused by direct use, the application of Ganoderma lucidum is greatly limited. In recent years, in order to improve the application efficiency of Ganoderma lucidum and expand its scope of application, the research on its nanoparticle size has received widespread attention from researchers. The article introduces the preparation of Ganoderma lucidum nanoparticles (including biological, chemical and physical methods) and their applications and mechanisms of action in different fields such as biomedicine, health care, environment and agriculture. It points out the shortcomings of existing related research and future development directions, and provides reference for in-depth research on Ganoderma lucidum nanoparticles.

With the continuous progress of biotechnology and drug research and development, small molecule drugs play an increasingly important role in the treatment of nervous system diseases because of their unique physical and chemical properties and biological effects. However, most of the previous studies tried to increase the brain exposure and retention time of the subjects, while ignoring the brain transport and efflux clearance pathways. In this paper, the recent research progress on the efflux clearance pathway of small molecule drugs in the brain was reviewed, focusing on the involvement of blood-brain barrier transport, metabolic enzymes in the brain, and aquaporin-4(AQP4) pathway, in order to further understand the efflux clearance pathway of small molecule drugs in the brain, which will not only help optimize the efficacy of existing drugs and reduce the adverse reactions caused by drug accumulation. It can also provide new ideas and directions for the research and development of drugs for neurological diseases in the future.

OBJECTIVE To develop a quantitative proton nuclear magnetic resonance (qHNMR) method for the determination of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC). METHODS A Bruker AVANCE Ⅱ 600 MHz NMR resonance spectra was utilized to acquire the NMR spectra of DOPC. The compound 1,3,5-trimethoxybenzene served as the internal standard, deuterated chloroform as the solvent, with 30° pulses, 16 scans, a test temperature of 25 ℃, and an acquisition time (AQ) of 5 s. The relaxation delay time (D1) was set at 35 s for quantitative analysis of DOPC. RESULTS The sample's ¹H-NMR spectra displayed a methyl proton signal at chemical shift δ 0.87; the quantitative peak signals of DOPC and internal standard were well resolved on the ¹H-NMR spectra with good linear relationship for DOPC (r>0.9996). The method demonstrated accuracy and repeatability with DOPC content ranging from 96.7% to 98.7%, consistent with results obtained from phosphomolybdic acid colorimetry. CONCLUSION The established qHNMR method accurately quantifies DOPC, is faster than the classical phosphomolybdate colometry method, requires no complex pretreatment operations.