OBJECTIVE To establish a high-performance liquid chromatography method for the simultaneous determination of 14 components including geniposide, mangiferin, baicalin, berberine hydrochloride, wogonoside, baicalein, aloe-emodin, rhein, wogonin, emodin, praeruptorin A, chrysophanol, physcion and praeruptorin B in Qingfei Yihuo tablets. METHODS Titank C18 (250 mm×4.6 mm, 5 μm) column was used; 0.1% phosphoric acid solution(A)-acetonitrile(B) was used as the mobile phase with gradient elution; detection wavelengths: geniposide at 238 nm, aloe-emodin, rhein, emodin, chrysophanol, physcion and mangiferin at 254 nm, berberine hydrochloride at 265 nm, baicalin, wogonoside, baicalein, and wogonin at 280 nm, praeruptorin A and praeruptorin B at 321 nm. The flow rate was 1.0 mL·min−1 and the column temperature was 35 ℃; the injection volume was 10 μL. RESULTS The linear ranges of geniposide, mangiferin, baicalin, berberine hydrochloride, wogonoside, baicalein,aloe-emodin, rhein, wogonin, emodin, praeruptorin A, chrysophanol, physcion and, praeruptorin B were 4.96−223.17, 0.84−42.22, 18.76−938.16, 4.46−223.17, 4.86−243.10, 1.59−79.32, 0.76−38.17, 1.03−51.49, 1.59−79.40, 1.21−60.72, 1.80−90.06, 0.91−45.48, 1.04−51.83 and 0.86−43.23 μg·mL−1, with r all ≥ 0.999 9. The RSDs of instrument precision, stability and reproducibility tests were <3%, and the average recoveries in sample(n=6) were >90%, with the RSDs <3%. CONCLUSION The method is simple and reproducible and can provide a scientific basis for improving the quality standard of Qingfei Yihuo tablets.

OBJECTIVE To establish a rapid and accurate PCR method for detecting 24 strains of Burkholderia cepacia complex(Bcc) by comparing three detection methods of loop-mediated isothermal amplification(LAMP), SYTO 9 dye method based on polymerase chain reaction(PCR) and TaqMan probe real-time fluorescent quantitative PCR method( TaqMan probe method). METHODS According to the molecular biological information of 24 strains of Bcc in the NCBI database, multiple candidate sequence fragments unique to Bcc were screened out, and specific primer and probe that could simultaneously detect 24 strains of Bcc were designed. At the same time, the detection methods of LAMP, SYTO 9 dye method based on PCR and Taqman probe were explored, and the optimal annealing temperature was optimized and screened. The 39 experimental strains were used to verify the Bcc detection method. RESULTS LAMP method could not effectively detect Bcc, SYTO 9 dye method and TaqMan probe method could effectively detect more than 20 strains of Bcc, while TaqMan probe method had higher amplification effect, better detection sensitivity, repeatability and stability, which could meet the requirements of this study. CONCLUSION In this study, a TaqMan probe method for rapid detection of Bcc was established. Compared with LAMP method and SYTO 9 dye method, this method has the advantages of fast, simple and high sensitivity, and provides technical support for the rapid detectionof Bcc.

OBJECTIVE To analyze the use and distribution characteristics of toxic traditional Chinese medicine decoction pieces in oncology outpatient department, and to provide data reference for the safe and rational use of toxic traditional Chinese medicine decoction pieces in clinical applications. METHODS The 838 prescriptions data of toxic traditional Chinese medicine from the Oncology Outpatient Department of The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine in 2022 were collected and made retrospective statistical analysis of patient gender, age, clinical diagnosis, variety of toxic traditional Chinese medicine, frequency of use, frequency of overdose, and combination use of toxic traditional Chinese medicine. RESULTS Among the 838 prescriptions of toxic Chinese herbal medicines, 22 toxic Chinese herbal medicines were involved, accounting for 81.48% of the hospital's toxic Chinese herbal medicines. The majority of prescriptions (217 cases, accounting for 25.89%) aged 50 to 60 years old. Most of the single prescriptions were concentrated in 11 to 15, and the toxic Chinese herbal decoction pieces were mainly used in various tumor diseases, digestive system diseases and gynecological diseases, etc. In addition to golden larch bank, ginkgo and centipede, the other toxic traditional Chinese medicines all had the overdose problem. 231 prescriptions of toxic traditional Chinese medicine were used in combination with≥2 , with 190 prescriptions of 2 ingredients being the most commonly used (accounting for 22.67%). There were 78 incompatibilities, most of which were the combination of Aconiti Lateralis Radix Praeparata and Pinelliae Rhizoma. It was used to treat chronic Atrophic gastritis, insomnia and depression. CONCLUSION Toxic traditional Chinese medicine decoction pieces are widely used in oncology department. However, the overdose phenomenon is serious, it is necessary to be aware of the potential risks of overdose and combination of toxic traditional Chinese medicine. Therefore, it is necessary to further strengthen drug management, promote rational application, and ensure patient medication safety.

OBJECTIVE To study the general situation and characteristics of the adverse drug reactions(ADRs) associated with polatuzumab vedotin(combined with bendamustine and rituximab), so as to provide reference for clinical rational drug use. METHODS The clinical data of all patients who were hospitalized at Tianjin Cancer Hospital Airport Hospital and treated with polatuzumab vedotin during hospitalization from January 2021 to August 2022 were collected by searching Hospital Information System. The basic patient information, medication status, incidence of adverse reactions, etc, were collected and analyzed. RESULTS A total of 7 patients were enrolled in the analysis, which there were 4 males(57.1%) and 3 females(42.8%). The toxicity profile of polatuzumab vedotin consisted mainly of neutropenia and leukopenia. ADRs mainly occured within 3 months after administration, and it could be recovered after symptomatic treatment or observation, and there was no death due to ADRs. CONCLUSION During the rational use of polatuzumab vedotin in clinical practice, clinicians and pharmacists should reinforce the monitoring on its using to ensure the safe and effective of polatuzumab vedotin clinical application.

OBJECTIVE To provide reference for improving the construction of China's emergency drugs supply guarantee mechanism. METHODS Based on the 4R model, the literature research method was used to carry out a systematic analysis of the management measures and operation of emergency drugs in China and the United States in four stages: reduction, readiness, response and recovery, and to make a side-by-side comparison. RESULTS The flexibility of the United States in its legal system had contributed to the maturity of strategic national stockpile, with a dedicated Administration for Strategic Preparedness and Response responsible for the implementation and management of the entire supply process, focusing on the development of information systems and the maintenance of physical stockpiles. In contrast, China's national pharmaceutical reserve emphasized its respective roles and responsibilities, with joint management of institutions, and the reserve tasks and transportation and distribution were mainly undertaken by enterprises, which provided more room for operation in the overall supply process, but the regulatory rules for enterprises had yet to be further improved. CONCLUSION It is recommended that China, on the basis of its own national conditions, draw on the characteristics and experience of the United States strategic national stockpile, improve and perfect the relevant laws and regulations as soon as possible, build a management system with an efficient management organization at its core, supplemented by an information management system, and at the same time, assist in promoting the virtuous cycle of rotational stockpiling by enterprises, and actively carry out summary and assessment work, in order to promote the optimization and development of the mechanism of guaranteeing the supply of emergency drugs in the long term.

OBJECTIVE To analyse current availability of pediatric drugs in China quantitatively and provide fundamental data support for optimizing the incentive policy. METHODS Based on national drug coding database issued by National Medical Products Administration, the marketed drugs were classified into children's only drug, adult-children's drug, children's inferred drug and non-children's drug by consulting the drug instructions through the approval number. Taking children's only drug and adult-children's drug as the key subjects, this paper carried out statistics and analysis on the marketing status of pediatric drugs in China from the perspectives of approval, variety, dosage form, specification, distribution of treatment fields, enterprise and so on. RESULTS Among the marketed drugs, there were 4 229 approvals for pediatric drugs and 44 112 approvals for adult-children's drugs, accounting for 2.99% and 31.19% respectively. children's only drug had 625 varieties, accounting for 18.83% of the total pediatric drug varieties. Analgesic, antipyretic, anti-inflammatory, anti-rheumatic and anti-gout drugs accounted for 55.71% of the total approvals for children's only drug(chemicals and biologics, excluding vaccines), and expectorant, antitussive and antiasthmatic agents accounted for 26.71% of total approvals for children's only drug (traditional Chinese medicine), but there were 16 and 19 treatment fields respectively were <1.00%; among the oral dosage forms, oral liquid accounted for 21.46%, while tablet, capsule, pill and other oral solid accounted for 37.51%. In the last 10 years of domestic drugs on the market, the number of approvals for regulation of water, electrolytes and acid-base balance drugs, analgesic, antipyretic, anti-inflammatory, anti-rheumatic, anti-gout drugs and respiratory drugs accounted for 64.29% of children's only drug(chemicals and biologics, excluding vaccines), the number of approvals for internal medicine-expectorant, antitussive, antiasthmatic agent, exterior-relieving agent and heat-clearing agent accounted for 61.70% of children's only drug(traditional Chinese medicine). CONCLUSION There has been a certain basis for the marketing of pediatric drugs in China, but children's only drugs are few overall. The availability of pediatric drugs varies significantly among treatment fields. Some fields are in short supply, while others are in excess supply. Most fields are difficult to meet the drug demand of children, and the R&D and production of children's only drug is still concentrated on traditionally strong fields.

Cannabinoid is a kind of special compound in Cannabis sativa L., with a variety of biological activities, which have been widely used in medicine, food, cosmetics, textile, and other industries. However, Cannabis sativa contains the addictive ingredient Δ9-tetrahydrocannabinol, which also makes the application of Cannabis sativa subject to legal constraints. To prevent the abuse of Cannabis sativa related products and ensure the safety and effectiveness of products, it is very important to establish convenient, efficient, environmentally friendly, and inexpensive analytical methods that can be applied to the cannabinoid components in various matrices. Because of the high structural similarity, the poor stability of cannabinoid structure and the matrix effect in different matrices, the analysis becomes more complicated. At present, there is no unified standard for the quality control of cannabinoids, and there are various analytical methods. Based on the above questions, this paper introduces the classification of cannabinoids, expounds on the analysis methods of cannabinoids in Cannabis sativa plants, biological samples, food, cosmetics, and textiles, and looks forward to the future development direction of cannabinoid analysis methods, to provide useful help for the further development and rational application of Cannabis sativa .

Permeability is one of the determinants of intestinal absorption and oral bioavailability. The non-cell-based permeation model is a kind of in vitro permeability measurement tool, which has the advantages of high efficiency, low cost, stable property, easy to use and customizable. According to the barrier type, non-cell-based permeation model can be divided into biomimetic barriers containing (phosphate) lipids and non-biomimetic barriers without lipids. Biomimetic permeation models include parallel artificial membrane permeability assay, vesicle-based permeation assay and PermeaPad®. Non biomimetic permeation models include Hollow fiber membrane models based on polyether sulfone materials. In foreign countries, the application of these four barriers for different purposes is gradually becoming a hot spot in drug absorption research. However, in China, there are only more applied studies on PMAPM and few published applied studies on the other three barriers. In order to meet the development needs of insoluble drug formulations, the author summarized the permeability devices and permeability calculation methods, searched the application of non-cell-based permeation model in the permeability of BSCⅡ drugs in recent years, and summarized the characteristic applications of three Biomimetic permeation models and hollow fiber membranes.

Atractylodes macrocephala, a plant of the Asteraceae family, as a commonly used traditional Chinses medicine in clinic, has the efficacy of invigorating spleen and supplementing qi, eliminating dampness and inducing diuresis, and expelling wind and dispersing cold. Moreover, it was proved that it has many pharmacological effects such as anti-inflammation, anti-tumor, and improving immunical ability based on the scientific researches. Atractyloside is one of its active ingredients and characteristic ingredients. In this paper, using the search terms of Baizhu lactone, sesquiterpene lactone, quality evaluation, quality control, and chemical composition, the CNKI, Weipu and PubMed literature database were searched. And relevant literature results were compared and summarized. The catagories, structural formula of atractyloside and their transformation mechanism were summarized. It was found that the content of lactone components could be affected by different processing methods, different producing locations, different harvesting season, and different growth years. It was found that for the quality evaluation of Atractylodes macrocephala, the multivariate statistical analysis combined with content determination or fingerprint establishment could be more accurate, reliable and comprehensive, among which the supervised PLS-DA with OPLS-DA analysis was better than the unsupervised PCA analysis. This literature summary could provide a beneficial reference for the quality evaluation and utilization of Atractylodes macrocephala.

Gel materials have advantages such as comfortable touch, good air permeability, high viscoelasticity, etc., so they are widely used in modern transdermal drug delivery preparations such as patches, gel agents and film agents. With the innovative development of medical materials, many new gel materials with excellent functions have emerged, which has expanded the application scope of transdermal drug delivery preparations and optimized their properties. The classification, properties and application of gel materials in transdermal drug delivery system were reviewed, and the latest research progress was summarized, so as to provide reference for the innovative application of gel materials in transdermal drug delivery system.m.