Latest ArticlesWith the emergence of new biological agents as more effective drugs for the treatment of ulcerative colitis and Crohn's disease, it is critical to understand their mechanisms, pharmacological characteristics and related clinical efficacy, safety and economic characteristics for the optimal treatment of inflammatory bowel disease (IBP). Vedolizumab is a new type of gut-selective monoclonal antibody that can specifically bind to α4β7 integrin, prevent inflammatory cells from migrating to the intestine, inhibit intestinal inflammation, and has demonstrated satisfactory clinical efficacy and safety profiles. This article reviewed the mechanisms of action, pharmacokinetic/pharmacodynamic characteristics, clinical efficacy, safety and economy of vedolizumab, in order to provide guidance for clinical practice.
In order to monitor the progress and safety of clinical trials of drugs for COVID-19 (including vaccines), ways to set up efficient working mechanism and working mode for expedited reporting were explored, technical requirements were improved, in depth risk evaluation and management during drug clinical trials were carried out, measures were made to ensure that the applicants implemented risk minimization measures as well as protected the safety of subjects. Meanwhile, by providing comprehensive and reliable real-time research data, the joint prevention and control was promoted as well as research and evaluation linkage, which promoted the overall research and development process of COVID-19 vaccines in China.
To establish a rapid, convenient and robust method for detecting the infection titer of Sendai virus (Sev) vectors.
With transmission-defective Sendai virus vector as the research target and flow cytometry as the detection method, a mathematic model based on Poisson's distribution was established, and the infection titer was determined by one parameter of the mathematic model after curve-fitting.
An innovative method for detecting the infection titer of Sendai virus vector was successfully established. There were no significant differences between the results obtained from the flow cytometry method and traditional immunofluorescence method, and the flow cytometry method displayed good reproducibility [infection titer is (2.13±0.05)×109 IU·mL-1, RSD is 2.34%].
The infection titer detection is an important quality control item of viral vector gene therapy products and the traditional methods such as plaque method, TCID50 method and immunofluorescence method have the disadvantages of long experiment cycle, bad reproducibility and poor objectivity. This study is of significance to be a representative quality control reference for infection titer detecting of other viral vectors.
Apoliprotein B mRNA-editing enzyme catalytic polypetide protein (A3G) is a member of the innate immune family. It has cytosine deaminase activity and can be packaged into progeny viruses through interaction with Gag protein or the nucleocapsid domain of viral RNA. In the process of HIV-1 reverse transcription, A3G deaminates cytosine and introduces uracil into the minus strand of DNA, resulting in excessive mutation of the virus and exerting antiviral effects. In addition, A3G plays an anti-HIV-1 role by packaging itself into virions. HIV-1 co-regulatory protein Vif can antagonize A3G inhibition of HIV-1 through the ubiquitin-proteasome system. Therefore, up-regulating the expression of A3G or inhibiting the antagonistic effect of Vif on A3G may become a new effective method for the treatment of HIV-1 infection.
High content technology is a kind of cell imaging technology, which can obtain many parameters of cells simultaneously by using its automatic microscope, fluorescence probe and image analysis system. It has the advantages of high efficiency, high speed and multi index, and has been gradually used in the analysis and screening of various drug cytotoxicity. This paper reviews the application of high content technology in the study of mitochondrial damage mechanism of liver, kidney, nerve and other tissues in recent years, aiming to provide reference for further drug toxicity research and safe drug use.
To observe the efficacy and safety of clindamycin hydrochloride palmitate dispersion tablets for the treatment of chronic periodontitis.
One hundred and fifty patients diagnosed with chronic periodontitis in our hospital from May 2020 to May 2021 were randomly divided into observation group (75 cases) and control group (75 cases). After the initial therapy of periodontal diseases, the two groups were administered with clindamycin hydrochloride palmitate dispersion tablets or cefaclor sustained-release capsules combined with metronidazole tablets for one week, respectively. Periodontal indexes, such as bleeding on probing (BOP), bleeding index (BI), periodontal probe depth (PD) and adhesion level (AL), as well as the total effective rate, incidence of adverse events and patient compliance, were observed and compared between the two groups.
Compared with the control group, the incidences of BOP and BI were significantly lower in the observation group after treatment (P<0.01), but PD and AL had no significant difference (P>0.05). The total effective rate of treatment in the observation group was lower than that of the control group, but the difference was not statistically significant (P>0.05). The incidence of adverse events in the observation group was lower than the control group and the patients had good compliance.
Clindamycin hydrochloride palmitate dispersion tablets was effective in the treatment of chronic periodontitis, with low incidence of adverse events, good safety and patient compliance.
Phase Ⅰ clinical trial is the most important course in the clinical stage of new drug discovery and development. The accuracy, authenticity, and traceability of clinical data in each step are of crucial importance. The administration of injectable medicines in phase Ⅰ clinical trial is different from routine practice, and its particularity requires researchers to control all the details related to medicines more accurately, which include accurate calculation and dispensing of dosage, accurate infusion speed and observation, calculation of actual dosage, etc. We have completed several phase Ⅰ clinical trials of injectable drugs. This paper summarized our experience in each aspect above-mentioned. This not only provides experience for the implementation of injectable medicine clinical trials, but also fully help protect the safety of subjects and ensures the quality of clinical trials.
To compare the lipid-regulating effects of long gypenosides and gypenosides.
Ninety male rats were randomly divided into control group, model group, positive group (1 mg·kg-1), gypenosides groups (60, 30 and 15 mg·kg-1) and long gypenosides groups (60, 30 and 15 mg·kg-1). The hyperlipidemia model was established by feeding high-fat diets, then all rats were intervened with corresponding medicines for 6 weeks. The body weight, liver index, levels of blood lipid, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were determined. HE staining was conducted to evaluate the histopathological changes of livers.
Compared with the control group, the body weight, liver index, total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), ALT and AST in the model group were significantly increased. The high-density lipoprotein cholesterol (HDL-C) level was significantly decreased. Fatty degeneration was obviously observed in liver tissue. Compared with the model group, gypenosides significantly decreased TC and ALT levels in serum. Long gypenosides significantly reduced the levels of TC, TG, AST and ALT, increased the level of HDL-C. High dose long gypenosides and gypenosides relieved the fatty degeneration. The results of correlation analysis showed that the levels of TC, TG and AST in serum correlated with plant origin.
Long gypenosides and gypenosides can reduce blood lipid and have positive effect on liver tissue of hyperlipidemia rats, especially long gypenosides.
To comprehensively evaluate the quality of Centella asiatica by combining the sensory characteristics and gray relational analysis to improve the reliability and scientificity of the quality evaluation of Centella asiatica.
The characteristics, microscopic structure and thin layer chromatography of Centella asiatica were identified by pharmacognosy methods; the impurity, moisture, total ash and extract content were determined with reference to the fourth general rule of the Chinese Pharmacopoeia; HPLC method was used to determine the contents of impurities, moisture, total ash and extracts of Centella asiatica. The contents of asiaticoside and madecassoside were determined; the gray relational analysis was used to construct the quality evaluation model of Centella asiatica, and the relative degree of correlation was calculated.
There were no significant differences in the characteristics and microscopic structure of Centella asiatica from different producing areas; thin layer chromatography could detect both asiaticoside and madecassoside; the impurity content was 0.500%~8.837%; the moisture content was 4.899%~6.423%; the total ash content was 10.103%~16.368%; the extract content was 28.100%~38.311%; the asiaticoside content was 0.383%~1.019%; the madecassoside content was 0.541%~1.915%. Combined with various factors such as impurities, moisture, total ash, extract, asiaticoside and madecassoside, it was indicated that the 29 batches of Centella asiatica from different producing areas had quality differences and their relative correlations degree values were in the range of 0.437~0.556. The top 3 samples are S15, S8, and S9, Centella asiatica produced in Xiajiang county, Ji'an city, Jiangxi province, the measured relative degree of correlation is larger, and the quality ranking is higher, indicating that the quality of Centella asiatica produced in Xiajiang county, Ji'an city, Jiangxi province is better.
The quality evaluation model established by the sensory characteristics combined with gray relational analysis can be used for the quality evaluation of Centella asiatica from different producing areas.
To evaluate the purification process of Weixuening mixture extract by alcohol precipitation method and membrane separation method.
In this study, the Weixuening mixture extract was used as the research object, and physicochemical parameters, solid removal rate, and the transfer rates of indicative components were used as the indexes to evaluate the two different refining processes of Weixuening mixture extract, i.e., alcohol precipitation method and membrane separation method. By investigating the influences of different molecular weight cut-offs, operating pressure, and extracting solution concentration on membrane separation index and membrane flux, the best purification process was selected.
The physicochemical parameters of the membrane separation method were significantly better than those of the alcohol precipitation method. The transfer rates of the indicative components of the alcohol precipitation solution such as catechin, epicatechin, polydatin, resveratrol, and quercetin, respectively, were 82.34%, 83.31%, 79.06%, 77.51%, and 80.16%, respectively. The solid removal rate was 64.75%. The best process for membrane separation was as follows: the membrane pressure was 0.5 MPa; the extract concentration was 0.11 g·mL-1; the molecular weight cutoff was 30 kDa. The transfer rates of the indicative components such as catechin, epicatechin, polydatin, resveratrol, and quercetin in the membrane separated solution were 83.44%, 84.32%, 80.42%, 83.36%, and 83.58%, respectively. The membrane flux was 10.57 mL·m-2·min-1 and the solid removal rate was 65.96%.
Compared with the alcohol precipitation method, the membrane separation method is more conducive to the refining of the extract of Weixuening mixture, which lays the foundation for the industrial production of Weixuening mixture.