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 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.

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 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 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 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.

The “Drug Administration Law of the People's Republic of China” has undergone two revisions and two amendments since its promulgation in 1984. The process of institutional evolution reflects the continuous deepening of understanding of drug administration courses, the continuous refinement of governance systems, the continuous improvement of governance mechanisms, the continuous enrichment of governance methods, and the continuous improvement of legal liability systems. The revision of the drug administration law in 2019 adheres to political guidance, problem-oriented approach, international perspective, national conditions, reform and innovation, and scientific development. The promulgation and successive revisions of the drug administration law reflect the changes in China's economic, social, and pharmaceutical industry development, fully reflecting the growing health needs of the people and clearly demonstrating the comprehensive progress of China's social governance. To advance drug safety on the track of modern rule of law, it is necessary to accurately grasp the historical position, improve the legal system, establish law enforcement authority, enhance legal literacy, and provide more solid legal system underpinnings for accelerating China's leap towards becoming a pharmaceutical manufacturing powerhouse.

To review the evolution and changes of the drug manufacturing supervision system since the promulgation of the “Drug Administration Law of the People's Republic of China” 40 years ago. The literature research method was used to retrieve laws, regulations, and supporting documents after 1985, and to review key institutional elements such as drug regulatory system, drug manufacturer license, GMP certification and inspection, inspector management, and commissioned production. The reform includes the drug production license simplified and optimized, and the system of drug supervisors and GMP inspectors has been upgraded to professional and specialized inspectors. GMP certification has been transformed into dynamic GMP inspection, and the scope of drug commissioned production management has gradually expanded. Over the past forty years, the drug manufacturing management system has adapted to and led the development of China's pharmaceutical industry, achieved institutional updates and iterations, and promoted high-quality development of the industry.

OBJECTIVE Pregnant women are at a high risk of severe/critical SARS-CoV-2 infection, which can cause serious harm to both mothers and fetuses. Therefore, safe and effective medications are urgently needed. The current circulating strain Omicron variant JN.1 has been observed to elicit immune escape, leading to a decline in the efficacy of vaccines and neutralizing antibody drugs. As a result, the importance of small molecule antiviral drugs has become increasingly apparent, but their safety in pregnant and lactating women are not clear. METHODS Through searching domestic and international literature and databases, this paper reviews the safety data and experience of the approved small molecule anti-SARS-CoV-2 drugs (including remdesivir, molnupiravir, azvudine, renmindevir, nirmatrelvir/ritonavir, simnotrelvir/ritonavir, and leritrelvir) during pregnancy and lactation. The paper also presents information on genetic toxicity, animal and human reproductive toxicity, placental transport, and milk secretion. RESULTS Among them, the research data on remdesivir and nirmatrelvir/ritonavir are relatively sufficient. Animal studies have not found obvious reproductive toxicity, and the use of these drugs during human pregnancy has not shown serious adverse effects on mothers and fetuses. However, remdesivir is not yet listed in our country. CONCLUSION Nirmatrelvir/ritonavir may be an option for anti-SARS-CoV-2 treatment during pregnancy, and breast-feeding should be done after the drug is cleared.

OBJECTIVE To evaluate and analyze real-world post-marketing adverse drug reactions(ADRs) of sindilizumab and provide critical reference for safe clinical medication. METHODS The data were sourced from the National Adverse Drug Reaction Monitoring System database, covering ADR reports related to sindilizumab in Beijing area in the past five years. These reports identified sindilizumab as the suspected drug to the ADRs. Statistical analysis was conducted using SPSS 22.0 software. RESULTS A total of 155 sindilizumab-related ADR reports were analyzed. In terms of gender distribution, the ratio of male to female patients was 1.77∶1. Skin reactions were the most common ADRs reported. Allergic reactions dominated ADR reports occurring within 24 hours. Severe ADRs accounted for 26.45% of the reports, with most severe reactions occurring after 24 hours of medication use (P=0.005). In patients with tumors not included in the approved indications, the risk of experiencing severe ADRs was significantly higher compared with those with indicated conditions (P=0.006). Nine patients experienced ADRs due to drug dosages exceeding the recommended dosage in the instructions. Additionally, the concomitant use of the drug with lenvatinib was associated with the emergence of new safety signals, including myocardial infarction and diabetic ketoacidosis, necessitating heightened vigilance in clinical practice. CONCLUSION This investigation has uncovered an augmented risk of severe ADRs in individuals receiving medications for non-indicated uses. Consequently, implementation of stricter surveillance measures is needed for patients with off-label conditions to facilitate timely medical interventions. Notably, a significant incidence of severe ADRs is observed to occur beyond the initial 24-hour period following treatment. Thus, individuals receiving the drug in day-care unit should be explicitly instructed to closely monitor their post-medication health status upon discharge and to seek immediate medical consultation in case of any arising discomfort. There exists noncompliance with the recommended dosage, thus attention should be paid to such cases. Moreover, concurrent use of sindilizumab with lenvatinib has been identified to induce myocardial infarction and diabetic ketoacidosis, representing a new safety signal that demands clinical caution.