Latest ArticlesObjective: To establish a quantitative proton nuclear magnetic resonance method for the determination of vemurafenib.Methods:The structure of vemurafenib was confirmed by MS and NMR. The spectra of proton nuclear magnetic resonance spectroscopy were obtained in dimethylsulfoxide-d6 by using Bruker ANANCE NEO 600, the parameters of which were set up as follows: 90° pulse sequences, the relaxation delay time was 15 s, the number for scanning was 32, the experiment temperature was controlled at 25 ℃, and hydroquinone were selected as internal standard. The quantitative study was conducted on vemurafenib.Results:The 1H and 13C NMR spectra of vemurafenib was assigned. The content of vemurafenib determined by qHNMR were 98.78%, which was basically consistent with the results of mass balance method (98.91%).Conclusion:The method is simple, rapid and accurate, and can be used for the determination of vemurafenib.
Objective: To establish thin layer chromatography (TLC) and high performance liquid chromatography (HPLC) characteristic chromatography methods of 70% ethanol extract from seeds of fenugreek, and to investigate the similarities and differences among eleven batches of fenugreek extract.Methods:① G and HF254 silica gel plates were used for TLC, using a mixture of n-butanol-ethanol-water (2∶6∶2) as developer, bismuth potassium iodide-ferric chlorideand and 10% sulphuric acid-ethanol as color developing reagents. The sunlight and ultraviolet wavelength at 254 nm and 365 nm were used to identify the spots on TLC plats. ② A Supersil ODS-B column (250 mm×4.6 mm, 5 μm) was used for HPLC chromatography. The mobile phase was 0.1% phosphoric acid-acetonitrile with a gradient elution. The flow rate was 0.7 mL·min-1, the column temperature was 30 ℃, and the detection wavelength was 203 nm.Results:The TLC chromatogram of 70% ethanol extract from fenugreek indicated that there were eight spots containing trigonelline and dioscin as anti-diabetic active components. In HPLC chromatogram, there were twenty-nine common peaks in eleven batches of fenugreek, and fourteen components were identified. The similarity of the eleven batches of 70% ethanol extract were more than 0.9. The cluster analysis showed that there was variability among the samples of fenugreek from different origins. However, there are high similarity between Anhui and Henan provinces.Conclusion:These developed methods are reproducible and reliable. The two chromatograms showed strong characteristics, which can be used to control the quality of 70% ethanol-extract of fenugreek.
Based on the patent data of Scutellariae Barbatae Herba, this paper analyzed the current research situation of its industrial chain, aiming to provide relevant suggestions for its patent application and product development. The patent application of Scutellariae Barbatae Herba in China mainly experienced three stages: the slow development period, rapid development period and recession period. The number of patents is large, but the authorization rate is low. Individuals and enterprises are the main innovation entities of patent applications, and product development basically surrounded Scutellariae Barbatae Herba's efficacy, mainly focusing on downstream drugs, health food and other aspects, with less development in the middle and upper streams. Under such status, China should strengthen technical innovation of the whole industry chain and encourage collaborative innovation of industry, university and research, promote the combination of basic research and market application, provide theoretical support for the short board products, promote the transformation of scientific and technological achievements, and contribute to the innovation and upgrading of Scutellariae Barbatae Herba industry chain.
New cancer cases are increasing year by year, which has become the focus of drug research and development. Based on the summary of clinical trials of programmed cell death-1 (PD-1)/programmed death ligand-1 (PD-L1) antibody drugs in China, combining with the status of clinical trial registration, this paper analyzes the significance and problems of data disclosure.
Drug licensing transactions are constrained by many legal provisions and face many uncertainties, which confuse investors to make decisions. A reasonable risk assessment system for drug licensing transactions will help licensors grasp risks more comprehensively and carry out corresponding prevention and control.
The authors identified the risk factors through expert consultation, case analysis and other methods, and further split the risks of drug licensing transactions using the risk breakdown structure (RBS) method to obtain the risk assessment indicators of drug licensing transactions.
Eight secondary assessment indicators of drug licensing transaction risk, including strategic risk, patent and intellectual property risk, clause negotiation risk, R&D risk, cooperation risk with third parties, policy supervision risk, supply chain risk, and market risk, and 37 tertiary assessment indicators of drug licensing transaction risk were identified, and a diversified drug investment risk assessment system was constructed.
There are many complex risks in the process of drug licensing transactions. The construction of a comprehensive and reasonable drug investment risk assessment system can help investors better identify and evaluate the risks of licensing projects before making decisions.
To establish the first batch of national reference standard of rivaroxaban.
The structure of rivaroxaban was confirmed by IR, NMR and LC-MS spectroscopy. The purity of rivaroxaban was determined by HPLC. Moreover, moisture and residual ignition were determined. The content of rivaroxaban was calculated by mass balance method.
The structure of rivaroxaban was confirmed. The content of the first batch of national reference standard of rivaroxaban was assigned as 99.6%.
The first batch of national reference standard of rivaroxaban can be applied for the identification and content determination of rivaroxaban and its related preparations.
To explore the feasibility of multivariate data analysis (MVDA) in formulation robustness study of biopharmaceutical drug products by taking an antibody-drug conjugate (ADC) HS630 as example.
A two-level fractional factorial design with five factors was used to investigate the effects of protein content, contents of three excipients and pH on critical quality attributes. After preparation, the samples of each group were exposed to high temperature for 28 d and light for 10 d, respectively. The contents of polymers and free DM1 were detected and analyzed.
Partial least squares (PLS) method was used for model fitting and data analysis, and the model seemed good with an acceptable predictive capability. All the excipients and pH had no significant effect on the contents of polymers and free DM1. Although it was not significant, a higher free DM1 content was noticed with higher protein content and higher pH conditions. Light and high temperature had significant effects on the attributes of drug product with a similar trend but small ranges. The formulation in the studied range was regarded as robust.
Taking MVDA method into formulation robustness study of drug products can analyze the multi-dimensional data obtained under different treatment conditions. The critical components of the formulation can be identified, and the influence of treatment conditions on the critical quality attributes can be investigated.
With the rapid research and development of cellular therapy products, new stem cell-derived cellular therapy products are constantly being developed, but only few relevant guidance documents to assist the design of studies for non-clinical safety evaluation have been published. Stem cell-derived cellular therapy products not only come from different sources, but also have different safety factors and potential risks of ectopic tissue formation, uncontrolled biological distribution, immunogenicity and tumorigenicity, etc. Different stem cell-derived cellular therapy products bring great challenges to non-clinical studies. The paper gives a brief overview of the types of stem cells and general principles for the non-clinical safety evaluation of stem cell-derived cellular therapy products, focusing on the animal selection, experimental design and tumorigenicity study, in order to provide some references for non-clinical safety evaluation of stem cell-derived cellular therapy products in China.
Glucagon-like peptide-1 (GLP-1) analogues have been widely used in the treatment of diabetes and obesity, and multi-receptor agonists that combine GLP-1 analogues with other intestinal hormones such as glucose-dependent insulin-stimulating peptide (GIP) and glucagon (GCG) are in clinical development. Compared with GLP-1 analogues, multi-receptor agonists can exert multiple physiological effects and have better effects in controlling blood glucose and reducing body weight with fewer side effects, which are expected to be a new therapy for diabetes and obesity. In this paper, we reviewed the development of intestinal hormone multi-receptor agonists, summarized their design ideas and clinical manifestations, and provided reference for the development of multi-receptor agonists.
Toxicologic pathology is one of the most valuable disciplines contributing to the advancement of animal and human health. The gold standard of the toxicologic pathology evaluation in toxicity studies during nonclinical safety evaluation of drugs is considered to be the histopathological examination of paraffin-embedded, hematoxylin and eosin-stained tissue sections. Digital toxicologic pathology, artificial intelligence (AI), and in particular machine learning (ML) are globally disruptive, rapidly growing sectors of technology whose impact on the field of histopathology is quickly being realized. The development and application of increasing numbers of algorithms in the histopathological field have demonstrated that AI pathology platforms are now poised to truly impact the future of digital toxicologic pathology, precision medicine, and personalized medicine. However, as with all great technological advances, there are implementation and adoption challenges. The development of AI and ML, application of AI in toxicologic pathology, application of ML in digital toxicologic pathology, and impact of AI on digital toxicologic pathology were reviewed in the paper, in order to provide some references for applying AI and ML in toxicologic pathology in China.
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