Latest ArticlesThe article was to carry out visualized analysis of Chinese and English literatures of regulatory science, and compare the current research status and hot spots around the world. Using "regulatory science" as the search term, Chinese literature was searched in CNKI, Wanfang and VIP from January 1, 2016 to December 26, 2021. English literature was searched in the Web of Science core collection and PubMed from January 1, 2001 to December 26, 2021. After excluding duplicate or irrelevant literature, the VOSviewer 1.6.17 was used for social network analysis and time series, including countries, organizations, authors and keywords. A total of 264 Chinese and 3 307 English literatures were included in the analysis. The research hotspots of Chinese literature were drugs, medical devices and discipline construction. While the research hotspots of English literature were biomarkers, nano medicine and other specific technologies. China's regulatory science has preliminarily established the framework and system of drug regulatory scientific research by carrying out the first batch of key projects and collaboration with universities. With the further deepening of research in the future, China will be completely in line with the world's level in this area.
To improve the relatively backward condition and level of clinical trial institutions in Northwest China by relying on advanced clinical research management concepts and adopting information technology, and explore solutions for the uneven development of clinical trial institutions in China.
Based on the daily work requirements and management experience of the clinical trial institution in the First Affiliated Hospital of Xi'an Jiaotong University, we developed the Clinical Trial Institution Management System (CTIMS) meeting the regulatory requirements in the new period and provided solutions for the improvement of research ability and management level of clinical trial institutions in Northwest China.
By using the CTIMS, the clinical trial institutions in Northwest China can obtain standardized, digital, and intelligent clinical trial management methods, so that they can enter the "fast lane" of clinical research and achieve the goal of narrowing the capacity gap with clinical trial institutions in developed areas.
Through the application of the CTIMS, the clinical research capacity, management efficiency and level of clinical trial institutions, as well as the relatively backward situation of clinical trial development in Northwest China will be improved.
Huangqi (Astragali Radix) is the dry root of Mongol Milkvetch (Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao) and Membranous Milkvetch (Astragalus membranaceus (Fisch.) Bge.), which is a major medicinal material in Gansu Province. It mainly contains Astragali Radix polysaccharides, flavonoids, saponins, alkaloids, amino acids, trace elements, organic acids and other chemical components. The pharmacological effects of Huangqi mainly focus on improving immunity, anti-oxidation, anti-tumor, protecting cardiovascular, promoting body metabolism, lowering blood sugar, diuresis and decreasing swelling. Based on literature retrieval, the distribution of resources, chemical components and pharmacological effects of Astragalus are reviewed and summarized. The quality markers (Q-Marker) of Astragali Radix are predicted based on traditional medicinal properties, efficacy, chemical components and different compatibility. The chemical components of Astragali Radix polysaccharide, ononin, calycosin, formononetin, astragaloside Ⅰ, astragaloside Ⅱ, and astragaloside Ⅳ were predicted by the analysis, providing a scientific basis for the quality control of Astragali Radix.
Charged aerosol detector (CAD) is a new universal liquid chromatography detector rapidly developed in recent years. It has the advantages of high sensitivity, broad linear range, the signal response consistency independent of chemical structures, as well as the feature of simple operation. It is especially suitable for detecting substances without ultraviolet absorption. This paper briefly summarizes the working principle and detection characteristics of CAD detector and its application in the analysis fields of traditional Chinese medicine and natural products, chemical drugs, sugars, biochemical drugs, pharmaceutic adjuvant and surfactants, so as to provide reference for its better application in the liquid chromatographic analysis.
Natural medicines are becoming more and more popular in clinical applications because of their remarkable efficacy with few side effects. Natural pharmaceutical compounds have been shown to be effective against many human diseases, especially cancer. Sulforaphane (1-isothiocyanate-4-(methylsulfonyl) butane) is a natural drug, which widely exists in cruciferous plants and is abundant in broccoli, Chinese kale, broccoli and other vegetables. There is growing evidence that sulforaphane is effective in the prevention and treatment of various cancers, including prostate, breast, colon, skin, bladder and oral cancers. In addition, researchers have found that sulforaphane is highly effective in fighting neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease and multiple sclerosis. Moreover, sulforaphane has great potential in preventing oxidative stress, anti-inflammation and anti-fatigue. In this paper, the biological activity and mechanism of sulforaphane are reviewed, and the bioavailability and toxicity of sulforaphane are discussed.
To study the pharmacokinetics of metformin hydrochloride tablets (manufactured by Beijing Zhongxin Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride tablets (trade name: Glycoran®, manufactured by Nippon Shinyaku Co., Ltd., Japan) in healthy subjects after single-dose administration under postprandial state, evaluate their bioequivalence, and observe the safety.
Thirty-six healthy subjects were randomly divided into two groups, 18 in each group. After having high-fat meal, the subjects took the test or reference preparations. Blood samples were collected at 0 h (after meal and before administration) and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12 and 24 h after administration. Plasma levels of metformin were measured. The trial consisted of two periods of cross administration and 7-day washout period. PhoenixTM WinNonlin® 8.1 software was used to estimate the non-compartmental pharmacokinetic parameters, and SAS9.4 software was used for statistical description and bioequivalence analysis. If the 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters (Cmax, AUC0-T, AUC0-∞) of T/R were within 80.00%~125.00% equivalent interval, it was safely proved that the two preparations were bioequivalent.
One out of 36 subjects dropped-out due to adverse events. The main pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were (418.42±94.72) and (399.52±79.49) ng·mL-1, AUC0-t were (3 402.04±803.32) and (3 219.06±704.13) ng·h·mL-1; AUC0-∞ (3 458.50±815.42) and (3 276.11±715.12) ng·h·mL-1. The geometric mean ratios of Cmax, AUC0-t, AUC0-∝, and their 90% confidence intervals were 103.11% (98.69%~107.72%), 104.73 (100.11%~109.57%), and 104.63% (100.03%~109.44%), respectively. All were within the bioequivalent range of 80.00%~125.00%. No serious adverse events and unexpected adverse events occurred during the trial.
The test preparation is bioequivalent to the reference preparation after a single-dose oral administration under postprandial condition in healthy Chinese subjects. The two preparations have good safety and tolerability.
There are many unmet clinical needs of antidepressants, such as slow onset of action and low remission rate. The high degree of difficulty in its research and development is related to the high cost of research and the limitations of current understanding of the pathogenesis of major depressive disorder. To facilitate pharmaceutical research and development practitioners and to keep abreast of the frontiers of antidepressant research and expand research ideas, this paper summarizes the clinical research status and pipeline analysis of antidepressants, and sorts out the current global antidepressant clinical research trends and clinical research direction of antidepressants in China.
This paper combs and analyzes the drug patent infringement cases in China from 1995 to October 2020. The empirical analysis was carried out from the dimensions of the year of case acceptance, the subject of litigation, the type of drug involved, the level of adjudication and the case conclusion. According to the above statistical analysis, the number of patent infringement cases of chemical drugs in China is the largest, accounting for 53.3%, followed by that of traditional Chinese drugs and biological drugs in China, accounting for 30.7% and 16%, respectively. In drug patents in China, the "basic patents" of drugs are mostly held by foreign companies that own the original patented drugs. They build patent portfolio around the "basic patents" and actively use patent litigation strategy. Combined with empirical research, this paper discusses the specific strategies of patent work of pharmaceutical companies in China.
The curative effect is the vitality of Traditional Chinese Medicine (TCM). The evaluation of curative effect is the main bottleneck restricting the development of TCM, and syndrome curative effect is the characteristic of TCM's curative effect. However, there is still a lack of scientific and feasible clinical efficacy evaluation system of TCM for the treatment of migraine. Based on accurate positioning and combining the characteristics of TCM with the evidence-based evaluation system, we can construct a reasonable clinical efficacy evaluation system and promote the transformation of TCM from experience to evidence. By summarizing the previous clinical research of our team, the author preliminarily constructed a set of clinical efficacy evaluation system of TCM for treating migraine with TCM connotation, in order to break down the barrier of TCM clinical efficacy evaluation for migraine and promote the development of TCM clinical research.
In order to implement the new regulatory policy for radiopharmaceuticals and adapt to the new trend of industry and development of nuclear medicine, this research combining with the working experience of radiopharmaceutical inspection proposes, suggests on the development of inspection institutions and the effective connection between supervision and inspection using review of regulations and literature, expert interviews. It is recommended that the provincial drug inspection agencies should accelerate to expand the qualification of radiopharmaceutical inspection in order to meet the requirement of territorial supervision and solve the problems that do not match the current industrial development. It is also recommended to clarify the requirements for the initiation of production license inspection and medical institution filing inspection, further improve the working procedures for the connection between supervision and inspection, and effectively play the supporting role of inspection technology.
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