Latest ArticlesTo establish the HPLC-PDA fingerprint of Folium Photiniae combined with chemometrics to identify and screen the quality markers of Folium Photiniae, in order to provide a scientific basis for the quality of Folium Photiniae.
The fingerprint was obtained by an Agilent Eclipse XDB-C18 (250 mm×4.6 mm,5 μm) chromatographic column with a mobile phase of acetonitrile (A)-0.1% formic acid aqueous solution (B) in a gradient elution. The volume flow rate was set at 1.0 mL·min-1, the wavelength was 350 nm and the column temperature was 35 ℃. The fingerprints of 15 batches of Folium Photiniae were established using the developed method and the similarity was evaluated. The common peaks were analyzed by chemical identification pattern to distinguish Folium Photiniae from different origins, and the quality markers of Folium Photiniae were screened.
The similarity of the 15 batches of Folium Photiniae were all above 0.996, and a total of 10 common peaks were calibrated. Cluster analysis, principal component analysis and partial least squares analysis screened out chromatographic peak No.1 (neochlorogenic acid), No.2 (chlorogenic acid), No.4 (rutin), No.5 (hyricoside), and No.6 (isoquercitrin) as the quality markers of Folium Photiniae. The contents of neochlorogenic acid and chlorogenic acid is positively correlated with the quality of Folium Photiniae. The contents of rutin, hypericin and isoquercitrin may be negatively correlated with the quality of Folium Photiniae, indicating that the contents of these three components in Folium Photiniae should be limited at a low level. Further quantitative analysis of the above five components indicated the linear ranges of 0.135 3~2.706 0, 0.134 0~2.680 0, 0.008 5~0.170 5, 0.015 6~0.312 8, 0.005 9~0.118 9 μg, respectively. The linear relationship of each component is good (R2≥0.999 0), and the average recovery rate is 99.30% to 101.90%.
The established HPLC fingerprint and multi-component determination method are proved to be stable and reliable, which can provide a basis for the quality evaluation of Folium Photiniae.
3CL protease is an ideal target for the research and development of anti-new coronavirus drugs. In this paper, the patent application situation of 3CL protease inhibitors in the field of anti-SARS-CoV-2 was analyzed. The focuses were put on the application time distribution, profile of patent applicants, and status of key products related to 3CL protease inhibitors, to reflect the global patent application trend, reveal the patent barriers faced by our country in the research and development of the drug, and provide support for the drug research and development. Combined with the results of patent analysis, this paper suggested that Chinese applicants expand their research and development ideas based on traditional Chinese medicine resources, and at the same time pay attention to the layout of overseas patents, and accelerate the in-depth integration of production, education, and research.
To study and analyze the development and vaccination of corona virus disease 2019 (COVID-19) vaccines in four major countries represented by China to understand the current situation of COVID-19 vaccine availability.
The policies and plans of vaccine development in each stage were refined and summarized and then classified and counted according to the approval types and time, and descriptive statistical analysis was carried out on the relevant data from development to vaccination.
Up to March 31, 2022, the effectiveness of 13 COVID-19 vaccines developed by China, the United Kingdom, the United States and Russia were all higher than the minimum standard of the WHO (50%). China had made the largest contribution in terms of supply. In terms of vaccination volume, China had exceeded 3.27 billion doses, ranking the leading position.
Vaccine purchase funds, distribution plan defects, vaccine nationalism, COVID-19 strain variation and other obstacles to effective vaccine access can be ensured and achieved by accelerating research and development, increasing production, fair distribution and expanding vaccination.
Mobocertinib succinate is a novel and potent tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). On September 15, 2021, it was approved by U.S. FDA for the first time, and the brand name is Exkivity. It is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy. This article introduces the drug's mechanism of action, pharmacokinetics, pharmacodynamics, clinical evaluation studies, and safety.
The research and development data is the important evidence to prove the safety, effectiveness and quality control of drugs, which also is the important content in pre-approval inspection．New changes have taken place in drug pre-approval inspection after Drug Registration Administration came into force on 1 July 2020. Based on study and analysis of the observations of pre-approval inspection of chemical drugs in the past 2 years, the common problems and changes were put forward. The study provides references for registration applicants and pharmaceutical researchers to improve their quality management.
Primary brain cancer is a heterogeneous group of tumors arising from cells within the central nervous system. The cure rate and survival period of patients with common malignant primary brain cancers are low, and their treatment methods and therapeutic effects are also quite limited. Therefore, it is necessary to construct appropriate tumor models to study the molecular biology of the disease, preclinical pharmacodynamic and safety evaluation of new anti-tumor drugs and/or the therapeutic methods. This review summarizes the research progress of in vitro and in vivo models of primary brain cancer. In vitro models mainly include the culture of brain cancer cell line, organoids and the brain slices. In vivo models mainly include the rodent models and other model organisms such as the fruit fly and zebrafish. At present, lots of primary brain cancer disease models with their own advantages and disadvantages have been developed, but these models cannot fully simulate the complexities of brain tumors in humans. Therefore, researchers are developing more complex disease models based on the existing models to study the primary brain tumor treatment methods, screen and evaluate therapeutic drugs.
To investigate the physical and biological stability of PEG-modified liposome influenza vaccine lyophilized powder by influencing factor experiment and accelerated experiment and predict the validity period.
High temperature influencing factor test was carried out at (40±2) ℃, and accelerated test was carried out at 4 ℃ and (25±2) ℃. Physical stability was evaluated by appearance, particle size, encapsulation rate and stability coefficient. Spleen lymphocyte proliferation test and hemagglutination inhibition test were used to evaluate the biological stability, in which the stimulation index (SI) and antibody titer ratio (HI) were used as indexes. The validity period was calculated by using the classical constant temperature method and Arrhenius formula.
In the influencing factor experiment, the particle size and stability coefficient increased and the encapsulation rate decreased gradually after placing PEG2000 (3000/6000)-modified liposome influenza vaccine freeze-dried powder at (40±2) ℃ for 20 days. On the 10th day, the SI value of each PEG group was significantly bigger than that of the original solution group (P<0.05). The titer ratio of antibody before and after immunization was >4 for all PEG groups; on the 20th day, the SI value of each PEG group was significantly smaller than that of the original solution group (P<0.05); the antibody titer ratio of each PEG group after and before immunization was less than 4. In the accelerated experiment, three batches of PEG6000-modified liposome influenza vaccine lyophilized powder were placed at 4 ℃ and (25±2) ℃ for 3 months, the sample was stable at 4 ℃ with minor changing in particle size, encapsulation rate and stability coefficient, while at (25±2) ℃ the particle size and stability coefficient gradually increased, the encapsulation rate gradually decreased. There was significant difference in SI value between PEG6000 group and stock solution group under 4 ℃ storage condition (P<0.05), and no significant difference under (25±2) ℃ storage condition. For PEG6000 group, the ratio of antibody titer after and before immunization were ≥4 under both storage condition of 4 ℃ and (25±2) ℃. For the validity period prediction, the values of decomposition velocity constants K at 25 ℃, 30 ℃, 35 ℃ and 40 ℃ were 1.039×10-3, 2.649×10-3, 3.574×10-3, and 4.868×10-3 d-1, respectively. The regression equation of lnK to 1/T was as following: lnK=20.195-8 148.5/T (r=0.917 9).
PEG-modified liposome influenza vaccine freeze-dried powder has good stability at (40±2) ℃ for 10 days, PEG6000-modified liposome influenza vaccine freeze-dried powder has good stability at 4 ℃ and (25±2) ℃ for 3 months. It is estimated that PEG6000-modified liposome influenza vaccine can be stored for 2.2 years, 3.3 months and 24 days at 4 ℃, 25 ℃ and 37 ℃ respectively.
Dictamni cortex is the dried root bark of the Dictamnus L. in the Rutaceae family. It contains alkaloids, limonoids, phenylpropanoids, flavonoids, et al. Based on summarization of its chemical components, pharmacological effects and toxicity, and according to the concept of traditional Chinese medicine quality marker (Q-marker), the Q-markers of Dictamni cortex were predicted from the aspects of genetic relationship and measurability of components, traditional efficacy, traditional property, different producing areas and collecting periods, and component contents under different ultraviolet radiation intensities. γ-fagarine, limonin, dictamnine, obacunone and fraxinellone can be used as Q-markers of Dictamni cortex, which provide a scientific reference for the establishment of quality standards.
As the "sacred product for nourishing blood" and "sacred medicine for gynecology", Colla corii asini has a long history, wide application, and the effect of nourishing blood and nourishing. The chemical components of Colla corii asini are mainly protein and its degradation products, carbohydrates, trace elements, volatile substances, and fatty acids. It has various pharmacological effects, such as nourishing the blood and activating blood circulation, optimizing immune response, improving Alzheimer's disease, anti-oxidation, anti-fatigue, protecting lung injury, delaying aging, and treating gynecological diseases. Due to the nourishing blood and nourishing effect of Colla corii asini, its annual output is soaring year by year, and it enjoys a high reputation in domestic and foreign markets. In this paper, Colla corii asini is reviewed from three aspects: chemical composition, pharmacological action, and quality control by consulting relevant literature at home and abroad, in order to provide reference and inspiration for the further development and utilization of Colla corii asini.
2-anilinoquinoline is a characteristic structure of anticancer drugs, which can regulate various molecular targets related to tumor proliferation, differentiation, migration and apoptosis. Studies found that modifying the C-3, C-4, C-5 positions on the 2-anilinoquinoline ring and the aminobenzene ring to connect them with different groups, such as alkoxy, amide, carbonyl etc., can improve the targeting effect of drugs and enhance cytotoxicity. This review focuses on the structural modification and research progress of 2-anilinoquinoline derivatives as antitumor drugs in recent years to provide reference for future research.
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