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.

Triptolide (TP), also known as triptolide alcohol, is an epoxidised diterpene lactone compound extracted from the xylem of Tripterygium wilfordii Hook. f., a plant of the Weseraceae family. As the main active ingredient in Tripterygium wilfordii Hook. f. extracts, it has been proved to have immunosuppression, anti-tumor, anti-inflammation and other pharmacological effects. However, the development of triptolide has been limited due to its poor water solubility, high toxicity, obvious adverse reactions and low bioavailability. Therefore, researchers have optimised the structure of triptolide with the hope to improve its physicochemical properties. By now, the structure optimization has mainly been focused on sites like C-5,6, C-14, C-16, C-20, epoxy groups, unsaturated five-membered lactone ring. This paper summarizes the researches related to the structure optimization and their biological activity of the above reactive sites, which provides new thoughts for the structure-activity relationship and clinical application of triptolide.

OBJECTIVE To investigate the terpenoid constituents from the fresh-used leaves of Artemisia argyi Levl. et Vant. and their anti-inflammatory activities. METHODS Modern phytochemical separation techniques such as high performance preparative liquid chromatography (HPLC) were used to isolate the 95% ethanol extract of the fresh leaves from A. argyi and to identify the structure by combining physicochemical properties with MS and NMR data. The anti-inflammatory activity of terpenoids was evaluated by the inhibitory ability of nitric oxide (NO) release from LPS-induced RAW264.7 macrophages. RESULTS Fifteen terpenoids were isolated from the fresh leaves of A. argyi and identified as artanomaloide (1), dehydroleucodin (2), tamaulipin-B acetate (3), moxartenolide (4), yomogin (5), costic acid (6), costic acid methyl ester(7), PBI(8), (-)-3-hydroxy-β-ionone(9), pubinernoid A(10), subamone(11), artefrigin(12), cassipourol(13), 3β-acetoxy-24-oxo-dammara-20, 25-diene (14), dammara-20,24-dien-3β-ol acetate (15). The IC₅₀ values of the anti-inflammatory activity of compounds 1-12 ranged from (1.27±0.02) to (17.55±0.13) μmol·L^-1. CONCLUSION The fresh leaves from A. argyi are more abundant in terpenoids with anti-inflammatory activity, among which compounds 3 and 7-14 are isolated for the first time, and this kind of components can be applied in the development of pharmaceutical and health products.

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.

OBJECTIVE To prepare cepharanthine(CEP) polymer micelles and characterize them. METHODS The CEP polymer micelles were prepared by solvent evaporation method. Based on the single factor investigation, the preparation process was optimized by Box-Behnken response surface method with the entrapment efficiency and drug loading as indicators, and the particle size distribution, potential and in vitro release of the micelles were characterized. RESULTS The optimum process of CEP polymer micelle was as follows: 50 mg of MA-PEG-PLGA and 17.82 mg of CEP were dissolved in 0.25 mL of acetone, added dropwise into 14 mL of PBS solution at 60 ℃ and stirred on a magnetic stirrer at a speed of 1 000 r·min^-1 for 4 hours to obtain a clear CEP polymer micelle. The optimized CEP polymer micelles are spherical, with an average particle size of (111.37±3.51) nm, a PDI of (0.21±0.01) and a Zeta potential of (-9.78±2.15) mV. In vitro release results showed that CEP was released rapidly within 10 h, and its micelles released (79.99±4.96)% and (71.66±2.62)% respectively within 72 h, indicating that CEP could be released slowly after being made into micelles. The results of freeze-drying agent investigation showed that 0.5% poloxamer 188 had the smallest change in complex particle size after freeze-drying. The results of hemolysis test showed that the hemolysis rate was obviously reduced after CEP was made into micelles. CONCLUSION The optimized formulation and technology in this study can be used for the preparation of CEP-MA-PEG-PLGA polymer micelles, which lays a foundation for the subsequent development of CEP targeted preparations.

OBJECTIVE To prepare liposome formulations encapsulating isovaleryl shikonin, to optimise the preparation process. METHODS The isovalerylshikonin-liposome (IsoSHK-lip) were prepared by the thin film dispersion method. The UV absorption, standard curve, precision, stability and recovery of IsoSHK-lip were investigated. A response surface optimization method was used to optimize a 3-factor, 3-level preparation scheme with A: lecithin-cholesterol mass ratio, B: lecithin-isovalerylshikonin mass ratio and C: volume of hydrated solvent as the three factors. The particle size, polymer dispersity index (PDI), Zeta potential, morphological characterisation and stability of IsoSHK-lip were also investigated for the optimal solution. RESULTS The response surface optimization predicted that the optimal preparation conditions for IsoSHK-lip were: lecithin-cholesterol mass ratio of 8.82∶1, lecithin-isovalerylshikonin mass ratio of 30.65∶1, and volume of hydrated solvent of 29.22 mL. Repeated preparation of the optimal IsoSHK-lip resulted in an average encapsulation rate of 90.03%, a mean particle size of 117.48 nm, a mean PDI of 0.246, and a mean Zeta potential of -13.59 mV. The stability experiments showed that the particle size, PDI and Zeta potential of IsoSHK-lip did not change significantly after 7 d at 4 ℃. Transmission electron microscopy showed that the IsoSHK-lip was subspherical with particle sizes in the range of 100-200 nm. CONCLUSION IsoSHK-lip is prepared by repeating the optimal results obtained by response surface methodology three times, resulting in a near spherical shape, smaller particle size, uniform particle size distribution and better stability of IsoSHK-lip, which provides the basis for subsequent pharmacological studies of dosage forms.

OBJECTIVE To investigate and analyze the quality status of lysozyme oral preparations, and study the key quality control technologies for common problems in current standards, so as to provide technical support for drug supervision. METHODS The 28 batches of lysozyme lozenges and 47 batches of lysozyme enteric-coated tablets obtained by medicine post market quality surveillance were tested according to the current legal standards, and several analytical methods were established for exploratory research. RESULTS According to the legal standard test, although the qualified rate of 75 batches of lysozyme oral preparations was 100%, it was still found that there were problems in the legal standard such as the potency determination has significant errors and lacks key quality control items such as dissolution and content uniformity. The results of exploratory study on potency differed greatly from those of statutory test, the results of dissolution study showed that some enteric-coated tablets were not easy to dissolve, and the results of content uniformity study showed that some large size enteric-coated tablets did not meet the requirements. CONCLUSION As a traditional biological extraction type of biochemical drugs, lysozyme oral preparations are marketed early, so some quality standards can no longer reflect the current situation of the products. The enterprises should optimize the production processes and improve current standards.

OBJECTIVE To establish content determination method of polyethylene glycol (PEG) in mupirocin ointment. METHODS The content determination method of PEG was performed on TSKgel G2000SW_XL column at 35 ℃ using refractive index detector at 35 ℃, 0.1 mol·L^-1 NaNO₃(pH 3.0) was used as mobile phase and the flow rate was 1.0 mL·min^-1,and the injection volume was 20 μL. RESULTS The content determination method of three different PEG in mupirocin ointment was established. The type and content of PEG in mupirocin ointment from different manufacturers were determined. In this method, the limits of detection (LOD) for PEG400, PEG3350, and PEG4000 were all 0.01 mg·mL^-1. The limits of quantitation(LOQ) were all 0.02 mg·mL^-1, and the ranges of linearity were all 0.2 to 5.0 mg·mL^-1. The average recoveries were 99.3%、99.8% and 100.2%, respectively (n=3). CONCLUSION The established method is efficient, rapid, accurate and sensitive, which can be used as the content determination method of PEG in mupirocin ointment.

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 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.