Latest ArticlesInflammation is a self-defense mechanism which is started when the body is infected or injured. As a common defense mechanism, inflammation is very common in clinic. If not treated in time, it may lead to a variety of more serious diseases. At present, most of the anti-inflammatory drugs used in clinic are chemically synthesized, but their side effects cannot be ignored, which has become an urgent clinical problem to be solved. Plant essential oil is extracted from aromatic plants, which has anti-inflammatory effect. This paper expounds the effective components, mechanism of action, synergy, and safety of plant essential oil for inflammatory pathogens, which can be used for reference for the future direction of scientific research on plant essential oil.
Taste masking is one of the key issues to improve drug compliance in children during the development of oral liquid preparations of traditional Chinese medicine (TCM). Because different families of TCM contain different odors, and TCMs are generally used as compound preparations in clinical practice, the taste usually presents a complex blend phenomenon. At present, the main methods to improve the taste of TCM oral liquids are medicinal materials processing, pre-treatment, preparation technology modification, adding auxiliary materials and so on. but the masking effect and application range of various masking methods are different. In practical application, the masking methods should be selected according to the drug type, dosage form and equipment needs. This paper summarizes the classification, application and new taste masking technology of TCM oral liquid preparations for children by sorting and analyzing relevant journals and patents, so as to provide reference for the research on this kind of pharmaceutical preparations.
To establish a method for determining the biological activity of adalimumab based on tumor necrosis factor-α (TNF-α) neutralization activity to provide technical means for parallel comparison of biological activities of similar biotherapeutic products of adalimumab.
The mouse fibroblast cell line L929 was used as target cell and the key reagents such as TNF-α and actinomycin D (Act-D) were standardized, then the experiment parameters including cell inoculation density, concentrations of key reagents, dilution gradient of adalimumab and incubation time were optimized. Then, the optimized method was validated by the methodology verification in the laboratory and the joint validation between laboratories to evaluate the performance of the method and its applicability to adalimumab reference products and similar biotherapeutic products.
There was a dose-response relationship between adalimumab concentrations and signal values in this method. The optimized concentrations of TNF-α and Act-D were 1 ng·mL-1 and 400 ng·mL-1 respectively, the optimized seeded cell number was 2×104 cells per well, the optimized initial antibody concentration was 1 000 ng·mL-1, the dilution ratio was 1∶2.5, and the optimized seeding time and incubation time were 18 h and 24 h. Methodological validation showed that this method was specific, reproducible and accurate. The results of joint validation were satisfactory.
This method is applicable to the five listed adalimumab products and can be used as a platform quality control method for the biological activity of adalimumab, which is convenient for the national sampling work and the parallel comparison between the products. It also provides an optional evaluation method for the establishment of national adalimumab standards and technical support for the inclusion of adalimumab monograph in Chinese Pharmacopoeia in the future.
Patient engagement in drug development is a vital part of patient-centered drug development, and its value and implementation have been recognized and actively explored by leading countries or regions in the field of medicine all over the world. Since November 2021, the Center for Drug Evaluation has issued six guidelines or drafts for patient-centered drug development. Patients provide suggestions and feedback in time through deep participating in the drug development, while collecting and analyzing the information require scientific research methods to ensure the quality of patient data and the rigor and transparency of reports. Qualitative or mixed-methods research is a scientific research method suitable for patients open information collection, analysis, and reporting. However, these two methods may not be widely recognized in the field of drug development. Therefore, this paper briefly introduces these two methods and their application in patient involvement in drug development, aiming to improve the quality of related research.
To establish an 1H quantitative nuclear magnetic resonance (1H qNMR) method for determination of noracetildenafil.
1H qNMR spectra were obtained in CDCL3 by using Bruker Ascend 600 spectrometer with noesyigld1d pulse sequence, the relaxation delay time was 30 s, and 32 scans were recorded.
The signals δ8.15 and 9.14 of noracetildenafil and δ6.09 of 1,3,5-Trimethoxybenzene were used for quantitation. Linear regression of areas ratio (As/Ar) versus mass ratio (Ws/Wr) of δ8.15 and 6.09 yielded a correlation coefficient of 0.999 1 and regression equation of y=0.119 7x+0.003 4, the replicability RSD was 1.66% (n=5), the repeatability RSD was 0.76% (n=5), and the determined content was 97.48%. Linear regression of areas ratio (As/Ar) versus mass ratio (Ws/Wr) at δ9.14 and 6.09 yielded a correlation coefficient of 0.999 1 and regression equation of y=0.116 8x+0.004 5, the replicability RSD was 1.69% (n=5), the repeatability RSD was 0.43% (n=5), and the content of noracetildenafil was 95.35%. The result determined by 1H qNMR method (96.42%) was consistent with the results by mass balance method (96.54%) and HPLC assay method (97.07%).
The established 1H qNMR method can be used for the quantitative determination of noracetildenafil. It is accurate and rapid and could be complementary with the mass balance method for the assay of reference substances.
To investigate the effect and mechanism of Qianggu Tongbi capsules on oxidative stress in rats with osteoarthritis.
Twenty-four SD rats were randomly divided into two groups, 6 of which were used for control group and 18 were used for modeling. After modeling, the 18 rats were randomly divided into model group, Qianggutongbi capsules group, and glucosamine group. Hematoxylin eosin staining (HE) was used to observe the changes of cartilage. Superoxide dismutase (SOD) kit, malondialdehyde (MDA) kit, and nitric oxide (NO) kit were applied to detect the levels of SOD, MDA and NO in serum, respectively. Real time-polymerase chain reaction (RT-PCR) was applied to detect the expressions of nuclear factorerythroid 2-relaxed factor (Nrf2), Kelch-like ECH-associated protein 1 (Keap1), macrophage activation factor (Maf), heme oxygenase-1 (HO-1), and NADPH quinone oxidoreductase 1 (NQO1) in each group. Western blot was used to detect the expressions of Nrf2, Keap1, Maf, HO-1, and NQO1 in each group.
HE staining results showed that there was obvious infiltration of dense inflammatory cells in the cartilage tissue of the model group, while the inflammatory cells in the Qianggu Tongbi capsules group and glucosamine group were significantly reduced compared with the blank control group. Compared with the model group, the levels of antioxidant indexes of Qianggu Tongbi capsules group and glucosamine group increased significantly, while the free radical concentrations decreased significantly (P<0.05). Compared with the model group, the mRNA and protein expression levels of Nrf2, Maf, HO-1, and NQO1 in Qianggu Tongbi capsules group and glucosamine group were significantly up-regulated (P<0.05), while the mRNA and protein expression levels of Keap1 were down-regulated (P<0.05).
Qianggu Tongbi capsules can change the antioxidant indexes in serum by activating the expression of Nrf2-Keap1/ARE pathway-related proteins and mRNA, so as to restore the function of antioxidant stress in rats with osteoarthritis.
Since the first anti-monopoly review case was completed, public authorities are starting to pay more attention to reverse payment settlement agreements. However, it is extremely problematic for any single mode of analysis to accurately identify the illegality of reverse payment settlement agreements, not excluding the rule of reason. On the contrary, the hybrid modes of analysis applied by the Supreme Court in this case is both flexible and definitive, which is expected to become a new paradigm in China. In view of this, this article analyzes the trial thinking of the Supreme Court, and summarizes the difficulties of the case in terms of the effect analysis, validity review and exemption clause. Finally, based on the characteristics of reverse payment settlement agreements and the antitrust rules in intellectual property field of China, this article makes suggestions to improve the mode of analysis.
The health decision will be impacted by the selection of different comparators that influence the results of the comparative effectiveness and incremental cost-effectiveness analysis. With the application of health technology assessment in assistent of health decision-making, the selection of comparators has gradually received stakeholders' attention. Focusing on the comparators selection, this study systematically reviews the health technology assessment guidelines and comparator selection guidelines published by seven countries and regions including China Taiwan, Japan, the United Kingdom, Germany, Canada, Australia, the United States and international organizations based on a literature review. Meanwhile, taking the selection of comparators as an example in the health technology evaluation report of chimeric antigen receptor T-cell (CAR-T) immunotherapy therapies when applying for medical insurance access in different countries, the international experience is summarized from the selection process, criteria, methods, usage and other dimensions. To deal with the current issues discussed in this study, the decision-making departments and stakeholders need to determine the comparators before the beginning of the evaluation, establish a two-way communication and feedback mechanism, determine the selection criteria and methods based on different decision-making purposes and uses, and select flexible response options for special circumstances, so as to provide reference for optimizing the selection of comparators in drug value evaluation.
Corydalis saxicola Bunting mainly distributes in Guangxi, Guizhou and Yunnan, etc., and it is a genuine folk medicine in Guangxi Province. The chemical composition of Corydalis saxicola Bunting mainly contains alkaloids, flavonoids, steroids and so on. It has activities of liver protection, anti-tumor, and anti-oxidation, thus often used in the treatment of sore boils, hepatitis, liver cirrhosis, and liver cancer. The chemical constituents and pharmacological effects of Corydalis saxicola Bunting are summarized in this article, and the quality markers (Q-Marker) of Corydalis saxicola Bunting were predicted and analyzed based on the concept of quality marker, providing scientific basis for the establishment of quality evaluation system of Corydalis saxicola Bunting and reference for the development of its medicinal value.
Lazertinib is a highly effective, oral and irreversible third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (EGFR-TKI). On January 18, 2021, the Korea Ministry of Food and Drug Safety (MFDS) first approved lazertinib for the treatment of patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer, who previously received EGFR-TKI treatment. This article introduces lazertinib's mechanism of action, pharmacokinetics, pharmacodynamics, clinical research, safety evaluation, etc.
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