Latest ArticlesTo establish a "three-in-one" traditional Chinese medicine registration review evidence system, the formation of a traditional Chinese medicine theoretical evidence evaluation system is crucial. The existing traditional Chinese medicine theory evidence system is still immature, lack of standardized retrieval steps for the retrieval of ancient documents, and the evaluation elements of the evidence are not comprehensive enough. So the retrieval process of ancient documents was standardized in this study. Propose six elements of DSPMRE to clarify retrieval issues and needs, and the integrity of the documents, the source and consensus of literature were innovatively proposed to be the three elements of evidence evaluation. Recommendations were made on the level of traditional Chinese medicine theoretical evidence to improve the three key links, i.e., literature retrieval, analysis and evaluation, and classified recommendation, thus to build a traditional Chinese medicine theoretical evidence system that supports the research and development and registration approval of new Chinese medicines under the triple-combination system.
It has been nearly 40 years since the Hatch-Waxman Act was enacted in 1984. Generics have developed tremendously during this period, which shows the importance of promoting the development of generics. The Hatch-Waxman Act is important, but it is not the whole story of how generics develop in the United States. After the promulgate of Hatch-Waxman Act, the development mechanism of generic drugs in the United States did not stick to the original state, but continuously made dynamic adjustments in many aspects, including combating misconduct in abbreviated new drug application (ANDA) to standardize the procedures, greatly improving the time efficiency for ANDA, establishing a generic drug replacement mechanism, establishing two patent invalidation procedures [inter parte review (IPR) and post grant review (PGR)], revising the Orange Book, exclusivity period, containment period, etc. to improve patent links system, and establishing a drug price negotiation system and a drug inflation penalty system. China should shorten the period of drug patent reexamination and invalidation examination. The first generic drug exclusivity period system should be coordinated with anti-monopoly. A user payment system should be established in China, but innovative drugs can be exempted. The drug approval and review mechanism, patent law, anti-monopoly law and other fields need to work together to continuously track and improve relevant systems.
Since joining the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 2017, China has gradually strengthened the research on the extrapolation of overseas clinical trial data. Standardization of bridging studies and international multi-center clinical trials will become the trend of the times. Extrapolation of overseas clinical trial data is particularly important in the registration process of drugs that have been listed overseas and not listed in China. Usually, the Center for Drug Evaluation of NMPA needs to consider the completeness of clinical trial packages to determine whether a drug is racially sensitive and whether bridging studies are needed. At present, to investigate the influence of ethnic factors on the acceptability of overseas clinical trials, the ICH E5 (R1) Guidelines are generally followed internationally. In addition, the United States, Japan, the European Union, and other ICH member states have issued their own relevant regulations or guidelines. This article introduces the basis and key points of current review of overseas clinical trial data in China, summarizes and analyzes the design of bridging studies based on international experience, and finally puts forward reasonable suggestions for extrapolation of overseas clinical trial data in China.
Vascular cognitive impairment (VCI) refers to a group of cognitive disorders caused by cerebrovascular disease or its related risk factors. The main clinical characteristics include cognitive dysfunction, with reduction of attention, memory and executive ability, and in severe cases, vascular dementia. DL-3-N-butylphthalein (NBP) is used to improve vascular cognitive impairment. It can increase the survival number of hippocampal neurons, promote synaptic formation, facilitate cerebrovascular regeneration, regulate cell apoptosis, thus exert a therapeutic effect of nerve function improvement. In recent years, more and more literatures was reported on the mechanism of NBP in the treatment of vascular cognitive impairment. This article will systematically elaborate the signal pathway and mechanism involved in the treatment of NBP that have been found so far, so as to provide reference and support for the further research on the prevention and treatment of vascular cognitive impairment.
To investigate the anti-neuroinflammatory effect of Aucubin extracted from Rehmannia glutinosa in lipopolysaccharide (LPS)-induced neuroinflammation model in vitro.
N9 cells were activated by 10 μg·mL-1 LPS to establish an in vitro neuroinflammatory model. After treatment with Aucubin for 24 h, NO content was detected by Griess method, cell viability was detected by MTT method, cell morphology was photographed by microscopy, the level of Iba-1 (a specific marker of microglia) was detected by immunofluorescence, CD11b level and CD86/CD206 ratio were determined by flowsight assay, and the levels of IL-6, IL-1β, IL-4 and IL-10 were detected by kits.
Compared with the model group, the aucubin group effectively improved cell morphology, reduced cell supernatant NO level, decreased cell marker CD11b level and CD86/CD206 value, and regulated the release of inflammatory factors.
Aucubin inhibited the activation of microglia to M1 phenotype and promoted the transformation of M2 phenotype. It also regulated the release of inflammatory factors, thus inhibited the activation of N9 microglia and finally suppressed LPS-induced neuroinflammation.
To establish the quality standard of Xianqian Granules.
According to the relevant methods presented in the fourth general rules of Pharmacopoeia of the People's Republic of China (2020), TLC method for identifying 4 Chinese medicinal materials in Xianqian Granules, including Agrimoniae Herba, Rubiae Radix et Rhizoma, Paeoniae Radix Rubra, and Notoginseng Radix et Rhizoma, was established, as well as the HPLC method for determining the index components of purpurin and paeoniflorin in Xianqian Granules.
The TLC method was specific to identify the 4 medicinal materials effectively. In the quantitative analysis method, the mass concentrations of purpurin and paeoniflorin were linear in the ranges of 2.47~53.00 μg·mL-1 and 18.29~392.0 μg·mL-1, respectively. The average recoveries were 97.37% (RSD 1.44%) and 99.04% (RSD 0.82%), respectively.
The established methods for quality evaluation of Xianqian Granules are simple, accurate, and specific, which can be used for the quality control for Xianqian Granules.
To 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.
To establish a detection method for exogenous DNA in neomycin sulfate drugs based on the concept of analytical quality by design (AQbD).
The MODDE Pro11 software was used to design the experiment, investigate the key influencing factors and optimize the parameters. Qubit® DNA detection kit based on fluorescence staining method was employed for the determination of exogenous DNA.
The universal detection method of exogenous DNA in neomycin sulfate was established. The key effect factors are solvent type, solvent concentration and sample concentration. When NaCl was used as solvent, the optimal analysis conditions were solvent concentration at 1.4 mol·L-1 and sample concentration at 1.8 mg·mL-1. The linear range of DNA standard was 20~100 ng·mL-1 (r=0.995 7, n=2). The accuracy was above 81.0%. The recoveries in ruggedness tests were 80%~120%.
The established method is accurate, robust and universal. This study provides reference for the development of determination of exogenous DNA in aminoglycoside antibiotics.
This article reviews and analyzes the process of pharmaceutical innovation research in China to understand the frontier and hot spots of pharmaceutical innovation research, in order to provide reference for future research and practice. The relevant documents were searched in database CNKI, and CiteSpace visualization software was used to visually analyze and compare the selected documents, such as organization and author, keyword co-occurrence and clustering, keyword timeline and burst detection. A total of 2 255 literatures were included in this study. The results showed that the articles published on pharmaceutical innovation research has increased in volatility in the past 3 decades, and intuitively showed that the main affiliations, authors and major journals in this research field have not formed research clusters, and the institutional cooperation of scholars is limited. There are 10 clusters of high-frequency keywords, which are consistent with the development trend of pharmaceutical innovation. The emergence of 23 high-frequency keywords represents the research frontier in the field of pharmaceutical innovation. The cooperation density between institutions and authors remains a relatively low level, and a stable cooperative network relationship has not been formed between authors and institutions. In terms of research content, the development stage of China's pharmaceutical innovation research is consistent with the development of medicine, and the research content and field need to go further. The management performance and efficiency of pharmaceutical innovation and the cultivation of pharmaceutical innovation talents are more important research contents in recent years. There is still a large development space in pharmaceutical innovation research.
In recent years, molecular targeted drugs involved in the pathogenesis and progression of cancer are being extensively investigated. Anlotinib, a novel multi-target tyrosine kinase inhibitor, is the first third-line treatment approved for patients with advanced non-small cell lung cancer in China, and has been approved for the treatment of soft tissue sarcoma, small cell lung cancer, medullary thyroid cancer and differentiated thyroid cancer. Numerous studies in China and abroad have found that this drug has three major functions, which are anti-tumor angiogenesis, inhibition of tumor growth and remodelling of the tumor microenvironment, and it can inhibit the development of solid tumours through various mechanisms. In this review, we summarize the role of anlotinib in various malignancies and research progress of related mechanism, to provide reference for its clinical application in oncology treatment.
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