OBJECTIVE To study the extraction method, quality, transdermal permeability, and transdermal promoting effects of Chuanxiong Rhizoma Hort. volatile oil (LVO) and Angelicase Sinensis Radix volatile oil (AVO) combined with the characteristic advantages of “unification of drugs and excipients” of traditional Chinese medicine volatile oil. METHODS The orthogonal design was used to screen and optimize extraction process of LVO and AVO. Quality control was carried out by detecting the physical parameters and indicator component content of LVO and AVO. Franz diffusion cells were used to conduct the studies of skin permeation in vitro. The contents of ligustilide and resveratrol(RSV) were determined by HPLC, and the steady-state transdermal rate(Jss) and enhancement factor (EF) compared with blank were used as evaluation indicators. And the transdermal permeability and transdermal promoting effects of different concentrations of LVO, AVO and mixed were investigated respectively. RESULTS The extraction process for LVO and AVO involves 8 times the amount of water, heating and refluxing for 8 h, collecting with ethyl acetate, dehydrating anhydrous sodium sulfate, and then volatilizing under reduced pressure. Perfect quality control methods were established for LVO and AVO, including the properties, relative density, pH, optical rotation, viscosity and ligustilide content. LVO and AVO have good permeability and promote RSV transdermal effect in vitro, and the maximum Jss values within 10 h were (48.23±6.53) and (27.84±3.03), respectively, and the maximum EF values were 4.51 and 19.34, respectively. CONCLUSION LVO and AVO have good transdermal permeability and transdermal promoting effects of RSV when used alone or in combination. The transdermal permeability of LVO was significantly higher than that of AVO, while the transdermal promoting effects of AVO was higher than that of LVO. The combination of LVO and AVO's own pharmacological effects and good transdermal absorption promoting effect plays a role of “unification of drugs and excipients”, which has a good advantage in clinical use, and lays a foundation for their development and application in transdermal drug delivery preparations of traditional Chinese medicine.

OBJECTIVE To establish an evaluation method for the release of mupirocin ointment in vitro, according to the quality research of ointment preparations at home and abroad and the technical guidelines for generic drugs. METHODS The diffusion cell method was adopted, the release membrane was polyethersulfone membrane, the receiving medium was sodium dihydrogen phosphate buffer solution with pH 7.4, the rotation speed was 600 r·min^-1, and the sample size was 300 mg. The concentration of mupirocin in the receiving solution at different time points was determined by HPLC method, and the cumulative release and release rate were calculated. The particle size morphology and particle size distribution of mupirocin ointment from different manufacturers were determined by particle size analyzer. The viscosity of preparations from different manufacturers was determined by rheometer. RESULTS The determination method for the release of mupirocin ointment in vitro was established, and the precision, durability and discrimination of this method were good, and the consistency evaluation was made for preparations from different manufacturers. There were great differences in particle size distribution and viscosity between different manufacturers. CONCLUSION The differences in particle size distribution between different manufacturers reflect the differences in preparation production process, and the differences in viscosity reflect the differences in preparation prescription, both of them can affect the release rate of mupirocin ointment in vitro.

Polyporus umbellatus, a traditional medicinal fungus in China, is used medicinally for its sclerotium. It is commonly categorized into two types, Zhushiling and Jishiling, based on the morphology of the sclerotia. Cultivation of Polyporus umbellatus heavily relies on the asexual reproduction of its sclerotia and the absence of clear distinction between Zhushiling and Jishiling often results in the confusion and intermixing of seed sclerotia. This can lead to the instability in quality and yield of Polyporus umbellatus medicinal materials, thereby adversely affecting the robust development of the Polyporus umbellatus industry. This article provides a comparative overview of Zhushiling and Jishiling in 4 aspects: morphology, quality, genetics and spawn cultivation. The results indicate that although the differentiation between Zhushiling and Jishiling based on morphological features such as sclerotium branches and surface characteristics holds certain significance, there remains a necessity to develop more scientific and precise criteria for this classification. The traditional perspective that Zhushiling is of superior quality compared with Jishiling is often based on empirical observations rather than rigorous scientific evidence. It is imperative to conduct comprehensive and systematic studies to objectively evaluate the quality and medicinal properties of both types. The variation in the sclerotial morphology of Polyporus umbellatus may be the result of a complex interplay among genetic, geographic, environmental factors, as well as other factors that have yet to be identified. Key technological breakthroughs in cultivation of the Polyporus umbellatus spawn leading to the formation of the sclerotia have not yet been achieved. However, the strains of Jishiling may possess greater potential for the development of spawn cultivation techniques. Zhushiling and Jishiling exhibit differences across 4 distinct aspects. Conducting the systematic analysis of Polyporus umbellatus from various perspectives is significantly important for the evaluation of its resources and for maximizing its potential value.

OBJECTIVE To summarize the research progress and beneficiary population of immune re challenge in the treatment of non-small cell lung cancer (NSCLC), and provide reference for the treatment of NSCLC in clinical practice. METHODS Using keywords such as “non- small cell lung cancer”, “immune checkpoint inhibitor”, “rechallenge”, etc., a combination of topic words and free words was used to search relevant literature from PubMed、Cochrane Library、embase、self-built databases such as China National Knowledge Infrastructure until February 1, 2024. RESULTS A total of 526 relevant literature were retrieved, with over 40 valid articles. Among them, there are 6 systematic reviews/Meta analyses on NSCLC rechallenge, 5 clinical studies, and most of the rest are retrospective real-world studies. CONCLUSION The effectiveness and controllable irAEs of immune rechallenge therapy for NSCLC were analyzed, and it was preliminarily believed that patients with high programmed cell death ligand 1 (PD-L1) expression (TPS ≥ 50%), good performance status (PS) score in the Eastern Cooperative Oncology Group (ECOG) in the United States (ECOG-PS≤1) and longer initial immunotherapy time were more likely to benefit from ICIs rechallenge.

OBJECTIVE To evaluate the testing capability of the vaccine quality control laboratories and vaccine manufacturer laboratories which participated in the proficiency testing of pH, osmotic pressure molar concentration and aluminum content of inactivated COVID-19 vaccine. METHODS Samples of inactivated COVID-19 vaccine were tested for uniformity and stability by F-test and t-test, and then distributed to participating laboratories by cold chain transportation. The abilities of the participating laboratories for determination of pH, osmotic pressure molar concentration, and aluminum content were evaluated by Z ratio. RESULTS A total of 30 laboratories across the country participated in this proficiency testing, and the pH and aluminum content assessment results were all satisfactory, while the osmotic pressure molar concentration results of two laboratories were unsatisfactory. After participating in measurement audits, satisfactory results were obtained. CONCLUSION The provincial vaccine quality control laboratories, and vaccine production enterprises participating in this proficiency testing have good testing capabilities and quality control levels.

OBJECTIVE To provide reference and suggestions for the quality control of this variety, evaluate the quality of xiaojianzhong preparations and preparations analyze the existing problems based on the national drug sampling. METHODS A total of 160 batches of samples were tested according to the statutory standard. In the exploratory study, ochratoxin A and zearalenone residues were detected by liquid chromatography-tandem mass spectrometry; paeoniflorin sulfite in xiaojianzhong preparation was detected by ultra performance liquid chromatography-tandem high resolution mass spectrometry; cinnamaldehyde was determined by high performance liquid chromatography; the overall quality of Xiaojianzhong preparation was evaluated by fingerprint analysis. The pH value of the mixture was investigated. RESULTS The qualified rate of 160 batches of samples was 100% according to statutory standard. Exploratory studies showed that ochratoxin A or zearalenone was detected in 33.1% of the samples, and paeoniflorin sulfite was detected in 83.5% of the samples.The pH value of 9% mixture was beyond the range of benzoic acid inhibitory effect. Cinnamaldehyde in 95.4% of the samples was below the proposed limit. Fingerprint analysis showed that the similarity of 14.6% of samples was lower than the proposed limit. CONCLUSION It is suggested to unify the quality control items of the four dosage forms, increase the pH limit, monitor the quality of the raw materials of licorice and dextrin, standardize the use of cerealose, and strengthen the system specification for the development of ancient classic prescriptions.

Pain management remains as a global public health issue, with 20% of the adult population worldwide impacted and many patients still suffer from unrelieved or undertreated pain. Classic opioids exert antinociceptive effects by activating μ opioid receptor (MOR), but they are associated with many side effects (including respiratory depression, addiction, and constipation) which have aggravated the ongoing and escalating opioid crisis in worldwide. Therefore, there is an urgent need for the development of novel analgesics free of MOR-mediated unwanted adverse effects. Multi-target therapeutics target two or more related targets in a disease network system simultaneously, which can potentially provide greater efficacy and improve treatment outcomes compared with single-target therapies. Due to the key role of MOR in regulating pain signal transmission, MOR-based multi-target ligands have been accepted as one of the mainstream strategies for designing new potent analgesics without side effects. In this review, recent advances in multitarget-directed drugs toward MOR are summarized, which may provide references for the development of potent and safer analgesics.

OBJECTIVE To analyze the common pharmaceutical issues in application of generic nifedipine controlled-release tablets, in order to provide reference for the research and manufacture of this formulation. METHODS Based on some references and review experience, the common issues in the application documents of generic nifedipine controlled-release tablets about prescription research, production process research, and quality control, etc., were analyzed. RESULTS and CONCLUSION Nifedipine controlled-release tablets have certain technical difficulties and individual drug characteristics. A comprehensive study should be conducted on the basis of osmotic pump controlled-release technology, combined with the characteristics of the reference formulation and nifedipine controlled-release tablets, to ensure that the quality of the generic formulation is equivalent to that of the reference formulation.

OBJECTIVE To accurately distinguish deer-derived medicinal materials from four different position: Cervi Cornu Pantotrichum, Cervi Cornu, Cervi Cornu Degelatinatum and Deer hide. METHODS The extraction efficiency of two extraction solvent systems for four different kinds of deer-derived medicinal materials was compared, and the optimum enzymatic hydrolysis conditions of the samples were optimized to form an efficient and simple sample pretreatment process. A specific analysis method, combining chemical markers and characteristic polypeptides was established to identify four different position of deer-derived medicinal materials by using liquid chromatography-triple quadrupole mass spectrometry and mass spectrometry multi-reaction monitoring technology (MRM). And methodological experiments were conducted as part of this analysis method. RESULTS The optimized sample pretreatment method with high extraction efficiency and good enzymatic effect was successfully applied, and the corresponding characteristic polypeptide ion pairs were successfully detected in 24 batches of samples. CONCLUSION The distinction and identification method with high-level specificity, sensitivity and robustness of deer-derived medicinal materials were established. The innovative analysis method can be effectively used to evaluate the quality of deer-derived medicinal materials, which provides a reference for ensuring and improving the quality of deer-derived medicinal materials.

OBJECTIVE To understand the overall situation of Tibetan medicines on the market, and to explore the method of comprehensive evaluation of Tibetan medicines. METHODS Data were extracted from the drug information network of the State Drug Administration and analyzed from the dimensions of manufacturers and varieties of Tibetan medicines. RESULTS The 373 items of proprietary Tibetan medicine were included, 80 items (proprietary Chinese medicine) were excluded, 19 manufacturers were involved, and 182 different dosage forms of proprietary Tibetan medicine were involved. The protection level of Tibetan patent medicine protection varieties includes 16 varieties, and the provincial standard document number involves 16 varieties. The classification of systemic treatment diseases is mainly concentrated in the treatment of gastrointestinal diseases, the treatment of skin, yellow water and rheumatic drugs, the treatment of liver diseases. CONCLUSION The preliminary comprehensive evaluation catalogue of proprietary Tibetan medicines can be conducted in steps according to the existing evaluation methods of proprietary Chinese medicines in terms of protected varieties, multi-varieties of manufacturers and classification of major diseases.The first batch of varieties include 25 Flavor Song shi pills, 25 Flavor Coral pills, 25 Flavor Pearl pills, 25 Flavor Guijiu pills, Zhituo Jiebai pills, 15 Flavor Black pills, 70 Flavor Pearl pills, Renqing Changjue, Coral 70 Flavor pills, Pain Relieving patch, and Nodikon capsules.