OBJECTIVE To establish a new derivatization headspace gas chromatography-flame ionization detection (HS-GC-FID) method to detect the residual amount of dimethyl sulfate in neostigmine methylsulfate bulk drug. METHODS Various derivatization methods were screened and then optimized. n-Butanol was used as the derivatization agent and methylated with dimethyl sulfate at the temperature of 50 ℃, producing the derivatization product methyl n-butyl ether. The analytical column was DB-624 (0.32 mm×30 m, 1.8 μm). The column temperature was maintained at 40 ℃, holding for 8 min, then was raised to 220 ℃ at the rate of 30 ℃·min^-1, holding for 2 min. The flow rate of carrier gas nitrogen was 2.0 mL·min^-1. The detection was achieved in FID with the injection port temperature of 200 ℃ and the detector temperature of 230 ℃. RESULTS Neostigmine methylsulfate showed no false positive interference with the detection of dimethyl sulfate. The calibration curve of dimethyl sulfate had good linearity over the range of 6.066 to 151.7 μg·mL^-1 (r²=0.999 9). The average recovery of dimethyl sulfate was 99.9%, and the RSD was 2.6%(n=9). CONCLUSION This method exhibits good specificity, simplicity, and high accuracy, and it can be used for the determination of genotoxic impurity dimethyl sulfate in neostigmine methylsulfate bulk drug.

OBJECTIVE To explore the mechanism of Shengqing Huazhuo (SQHZ) prescription in regulating simple obesity rats with spleen deficiency and dampness obstruction. METHODS The rat model of simple obesity with spleen deficiency and dampness obstruction was established, and the effects of SQHZ prescription on body weight, liver histomorphology and expression level of blood lipid metabolism in obesity rats were comprehensively evaluated. Ultra-high performance liquid chromatography-Q/Exactive mass spectrometry (UHPLC-QE-MS) was used to identify the blood components of SQHZ prescription, and the potential action pathways and targets were predicted by the network pharmacological platform. Non-targeted metabonomics was used to analyze the metabolomics of rat serum. The abundance of intestinal flora in rat faeces was detected by 16S rDNA amplicon sequencing technology. Finally, a multi-scale and multi-dimensional network was constructed by summarizing the KEGG pathways of the three, which can be used for overall visualization and deep analysis. RESULTS SQHZ prescription significantly reduced the body weight of obesity rats, and improved blood lipid levels and liver fat accumulation. Twenty-seven blood components of SQHZ prescription were identified by UHPLC-QE-MS technology. Network pharmacological analysis revealed the pathways related to metabolism of SQHZ prescription, mainly involving steroid hormone biosynthesis and ovarian steroidogenesis. Serum metabolomics analysis obtained 10 key differential metabolites, which involved metabolic pathways such as biosynthesis of unsaturated fatty acids and tryptophan metabolism. Intestinal microbiota sequencing results showed that SQHZ prescription could regulate the composition and improve the structure of intestinal microbiota in obesity rats, and the metabolic pathways involved are the biosynthesis of steroid hormones and unsaturated fatty acids. CONCLUSION SQHZ prescription not only shows significant therapeutic effects in treating simple obesity rats with spleen deficiency and dampness obstruction, but also has the ability to regulate serum metabolism and intestinal microbial community structure.

OBJECTIVE To explore the role of NLRP3 inflammasome-mediated ferroptosis in sevoflurane (Sev) induced postoperative cognitive dysfunction (POCD) in rats. METHODS The POCD rat model was established by 4% Sev inhalation anesthesia and abdominal exploration. Firstly, 18-20-month-old SD rats were randomly divided into control group and Sev anesthesia group, with 10 rats in each group. Secondly, SD rats were randomly divided into control group, NLRP3 inflammasome inhibitor group (MCC950), Sev group, and Sev+MCC950 group, with 10 rats in each group. The rats in MCC950 group and Sev+MCC950 group were intraperitoneally injected with 3 mg·kg^-1 MCC950 at 1 h before anesthesia. The rats in the control group and Sev group were intraperitoneally injected with the same amount of normal saline. The learning and memory function of the rats was detected by Morris water maze test, the histopathological changes of hippocampus was observed by HE staining, the apoptosis of hippocampal neurons was detected by TUNEL, Prussian blue staining was used to detect iron deposits in the hippocampus, and the expressions of NLRP3 inflammasome-related proteins and ferroptosis-related proteins in hippocampus were detected by Western blot. Detection of oxidative stress levels in hippocampal tissue by ELISA, the content of Fe²⁺ was detected by colorimetry, and reactive oxygen species (ROS) levels were detected by DHE staining. RESULTS Compared with the control group, there were no significant differences in learning and memory function, hippocampal tissue structure, oxidative stress, ROS and Fe²⁺ levels, NLRP3 inflammasome-related proteins and ferroptosis-related proteins expression in MCC950 group (P>0.05). In the Sev group and Sev+MCC950 group of rats, there were significant learning and memory dysfunction and pathological injury of hippocampus, the activities of SOD and GSH in hippocampus were significantly decreased, the levels of MDA, ROS and Fe²⁺ were significantly increased, and the expressions of NLRP3 inflammasome related proteins and ACSL4 proteins were significantly increased, the protein expressions of SLC7A11 and GPX4 were significantly decreased (P<0.05). Compared with the Sev group, the learning and memory function of rats and the degree of pathological damage of hippocampal tissue were significantly alleviated, the activities of SOD and GSH in hippocampal tissue were significantly increased, the levels of MDA, ROS and Fe²⁺ were significantly decreased, and the expressions of NLRP3 inflammasome-related proteins and ACSL4 proteins were significantly decreased, the protein expressions of SLC7A11 and GPX4 were significantly increased in the Sev+MCC950 (P<0.05). CONCLUSION Sev induces POCD in rats, and its mechanism may be related to the activation of NLRP3 inflammasome-induced neuronal ferroptosis in the hippocampus.

As an innovative diseases treatment strategy, bionic nano-decoy system which can neutralize a variety of pathogenic substances has attracted extensive attention in the biomedical field in recent years. Compared with traditional diseases treatment methods, bionic nano-decoy system shows the characteristics of high-efficiency pathogenic molecule clearance, excellent biocompatibility and sustainable or repeated drug delivery, which make it have great application potential in the field of diseases neutralization and treatment. In this paper, the concept, characteristics, preparation technology and application scope of bionic nano-decoy system are reviewed, aiming to provide important reference for researchers and medical professionals in the design and development of new bionic nano-decoy system, in order to promote the development of this field and ultimately achieve clinical application.

Pediatric medicines are the hot topic in the pharmaceutical industry currently, and the safe and reasonable application of pharmaceutical excipients for pediatric medicines plays a decisive role in the quality control of products. This article provides an overview of the current application status and existing problems of pharmaceutical excipients for pediatric medicines in China. In-depth research was conducted on the application and collection of standards of pharmaceutical excipients for pediatric medicines in China, and suggestions were put forward for improving the quality standard system. A scientific standard system of pharmaceutical excipients for pediatric medicines can ensure the safety and standardization of products, technically support the evaluation and approval process, and have important significance for the quality control of pediatric medicines.

OBJECTIVE To interpret Guidance on Quality Control for Nanomedicines (interim) issued by center for drug evaluation, NMPA, and provide reference for the development of nanomedicines. METHODS By conducting a systematic review of domestic and international literature and combining background of the guidance, this paper discussed the definition and classification of nanomedicines, quality research and control strategies, process control and stability research. It also proposes points of attention in the quality control studies of nanomedicines with cases. RESULTS and CONCLUSION The special nano-size, structure and surface properties of nanomedicines may significantly change the physicochemical properties and behaviors of active pharmaceutical ingredients in vitro and in vivo, which in turn affect their safety and efficacy. Quality research spans the entire lifecycle of nanomedicines. Critical quality attributes related to nano-characteristics should be evaluated based on the type, composition and structure of nanomedicines, manufacturing process, as well as their clinical use. Risk assessment strategy based on drug evaluation should focus on the impact of the quality attributes of nanomedicines on their safety and efficacy.

OBJECTIVE To investigate accurate identification methods for the Yi medicine Cyathulae Capitatae Radix, and provide scientific basis for its accurate application. METHODS A camera imaging system was used to identify original plant differences based on plant taxonomy. A trait identification method was established through the comprehensive application of cameras,stereomicroscopes, and fluorescence microscopy imaging systems. Optical microscopy, fluorescence microscopy, and polarizing microscopy imaging systems were used to identify the differences in microscopic identification ( cross section and powder ), and a thin layer identification method was established for the unique components of Cyathulae Capitatae Radix. RESULTS A key table for the origin and characteristics of the Cyathulae Capitatae Radix and its four adulterants is established, the main differences of the origin are the type and mode of inflorescence, the shape of stamens, the color of leaves, and the color and taste of the root epidermis. The differences in characters identification include color, lenticels, cross-section, texture, odor, and the location and intensity of fluorescence response under different colored light conditions. In microscopic identification, the transverse section of the root can be distinguished by the number of circles in the three vascular bundles, the number of strands in the central vascular bundle, and fluorescence reaction, but the difference in powder microscopic characteristics is not significant. The thin layer chromatography established with reference materials of saponin components such as cyaonoside A, cyaonoside B and chikusetsu saponin Ⅳa, in thin layer chromatography can effectively distinguish Cyathulae Capitatae Radix and its four adulterants, the thin layer chromatography established with the reference substance of sterol component amaranthone can effectively distinguish the other three adulterants except Cyathulae Radix. CONCLUSION Cyathulae Capitatae Radix and its four adulterants can be identified through their original plants, characteristics, microscopic cross-sections, and thin layer chromatography, and the five medicinal materials have significant differences in composition and should not be mixed.

Helicobacter pylori (H. pylori) is a microaerophilic, Gram-negative bacterium that colonizes the gastric mucosa and exhibits a distinctive spiral morphology. It was found to be involved in the development of diseases such as gastritis, peptic ulcers, and gastric cancer in 1982. Currently, H. pylori infection affects more than half of the global population, and the emergence of antibiotic resistance poses a significant challenge. Consequently, there is an urgent need for novel therapeutic agents capable of overcoming H. pylori resistance. This review provides a concise overview of the pathogenic mechanisms associated with H. pylori while summarizing and discussing both approved pharmaceuticals and investigational drugs targeting this bacterium, with the aim of facilitating the advancement of subsequent therapeutic agents targeting H. pylori.

OBJECTIVE To establish an experimental method using ICP-MS to study the compatibility between pantoprazole sodium for injection and neutral borosilicate glass injection bottle-coated stopper composite packaging materials. METHODS By conducting extraction experiments, simulated acceleration experiments, and migration experiments under long-term experimental conditions, the changes in elemental impurities of pantoprazole sodium for injection at different times were investigated. The simulated solution after erosion was analyzed to predict the tendency of detachment on the inner surface of boron tube bottles, and its migration amount was evaluated for safety. RESULTS The linear relationship of each element by ICP-MS method was good, and the correlation coefficient (r) was greater than 0.999 0. The quantitative limit was less than its corresponding limit of 10%. The average recovery rate was 97.5%-108.8%. In the extraction experiment, the elements with higher detected level in each sample were Si, B, and Al, but all were below the safety limits. The detected levels of other elements were relatively low, even below the detection limits. Under intermediate and long-term conditions of 6 and 12 months, the detection results of elemental impurities in various added components in the packaging materials were all lower than the AET values. CONCLUSION This method can effectively determine the content of various impurity elements in the sample and reveal their migration trends. The compatibility between the composite packaging components and pantoprazole sodium for injection is good, and the safety of the product meets the requirements. It provided a scientific basis for selecting boron tube bottle and film-covered stopper as the inner packaging material.

OBJECTIVE To study and evaluate the formulation and preparation process of ozone oil inclusion compound gel. METHODS Hydroxypropyl- β-cyclodextrin (HP-β-CD) was the inclusion material and Carbome-940 was the matrix to prepare the ozone oil inclusion compound gel, and its appearance, pH value, viscosity, peroxide value, moisture retention rate, rheological properties, stability, bacteriostatic performance and biological safety were evaluated. RESULTS Finally, the semi solid gel with clear appearance, no particle feeling, uniform, fine, shiny, moderate viscosity and no greasy property was obtained. The pH value was (5.48±0.01), the viscosity was (46.78±0.18) Pa·s, and the moisture retention rates were (96.69±0.75)%, (95.84±0.44)%, and (94.12±0.89)% after 24, 36, and 48 hours of storage, respectively, with good rheological properties. The stability test showed that ozone oil gel should not be stored at high temperature. The bacteriostatic results showed that the ozone oil gel had bacteriostatic effects on Staphylococcus aureus, Candida albicans and Escherichia coli. The bacteriostatic rate of Staphylococcus aureus and Escherichia coli reached more than 95%, and the bacteriostatic rate of Candida albicans reached more than 80%. The biosafety evaluation test showed that the ozone oil gel had no vaginal mucosa irritation, skin sensitization and acute systemic toxicity. CONCLUSION The process of preparing ozone oil inclusion compound gel by this method is simple, feasible and easy to operate. It has certain promotion value and application prospect in drugs and cosmetics, which lays an experimental foundation for further industrial application of ozone oil.