Latest ArticlesTo study the pharmacokinetics of berberine dernivative WZX20 in rats.
SD rats were intragastrically (ig) or intravenously (iv) given WZX20, and plasma were collected after injection. WZX20 components in plasma were determined by LC-MS. Pharmacokinetic parameters were determined from the plasma concentration-time data with DAS software package.
The pharmacokinetic parameters after gastric lavage were as follows: AUC0→t (596.46±22.22) ng·h·mL-1; AUC0-∞ (607.59±23.51) ng·h·mL-1; t1/2 (1.76±0.15) h; CL (32.96±1.3) L·h·kg-1; Vd (83.62±7.54) L·kg-1; Cmax (172.98±13.51) ng·mL-1; Tmax (0.5) h; F=33.19%. The intravenous pharmacokinetics parameters were as follows: AUC0→t (177.61±30.52) ng·h·mL-1; AUC0→∞(183.08±30.90) ng·h·mL-1; t1/2 (1.74±0.17) h; CL (11.23±2.18) L·h·kg-1; Vd (25.17±6.81) L·kg-1.
The established LC-Ms method is accurate, sensitive and rapid, and can be used for the blood concentration determination of WZX20. The pharmacokinetic parameters of WZX20 provide a good foundation for the study on the druggability of WZX20.
To investigate the hypolipidemic activity of Tibet medicine “Malus Fructus”.
The hypolipidemic activity of Malus Fructus was studied by using two kinds of hyperlipidemia models: in vitro (hyperlipidemia cell model induced by medical fat milk) and in vivo (hyperlipidemia mouse model induced by high fat feed). At the same time, by comparing the effects of same dose of Malus Fructus, Malus Folium, hawthorn on the body weight, viscera index, blood levels of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT), and glutamic oxaloacetic transaminase (AST) of high fat mice, the blood lipid-lowering effect of Malus Fructus was evaluated.
In the model of hyperlipidemia induced by medical fat milk, the levels of TC and TG in steato-degeneration cells were significantly decreased by the administration of Malus Fructus (50, 100 μg·mL-1), and it obviously improved the morphology of steato-degeneration cells. In the mouse model of hyperlipidemia induced by high-fat diet, the administration of Malus Fructus (0.75, 1.5 g·kg-1,ig) slowed down the weight gain of high-fat mice, significantly reduced the liver index and TC, TG, LDL-C, ALT, AST levels, and increased HDL-C levels. Under the same dose, the effects of reducing TC of different materials ranked in the following sequence: hawthorn > Malus Fructus > Malus Folium; the effects of lowering TG, LDL-C and ALT were as follows: Malus Fructus > hawthorn > Malus Folium; AST lowering effect: Malus Fructus > Malus Folium > hawthorn; HDL-C increasing effect: Malus Folium > Malus Fructus > hawthorn.
Malus Fructus has good activity of lowering blood lipid, which can significantly decrease blood lipid level, relieve obesity symptoms caused by high-fat diet, and alleviate liver injury. In addition, it is better than Malus Folium and hawthorn in lowering TG, LDL-C and ALT.
To optimize the spray drying process parameters of Yixintai compound concentrate.
The G1-entropy weight method was used to calculate the comprehensive score of the contents of astragaloside IV, salvianolic acid B and hydroxysafflor yellow A and the extraction rate, and the comprehensive score was used as the evaluation index. The effects of dextrin dosage, relative density of liquid medicine, peristaltic speed, air inlet temperature and air volume flow on spray drying process were investigated by single factor experiment. The spray drying parameters of Yixintai compound concentrate were optimized by Box-Behnken response surface design and BP neural network.
The optimum parameters of spray drying technology were as follows: relative density of liquid medicine 1.12, dextrin ratio 20%, air inlet temperature 150 degrees, air flow 35 m3·h-1 and peristaltic pump speed 15 r·min-1.
The optimized spray drying process of Yixintai compound concentrate is stable and feasible.
To evaluate the safety, efficacy and cost-effectiveness of Shugan Jieyu Capsules and analyze the prospect of its clinical application in China by rapid health technology assessment.
The CNKI, Wanfang, VIP, PubMed, Cochrane Library and other databases were searched and screened independently by two researchers according to the inclusion and exclusion criteria and then the qualitative analysis was performed.
Six Meta-analyses, one literature review and one economic evaluation were included. When Hamilton Depression Scale was used as the evaluation standard, the efficacy of Shugan Jieyu Capsules was the same as fluoxetine hydrochloride, and the incidence of adverse events was significantly lower than that of fluoxetine hydrochloride. In terms of cost-effectiveness, Shugan Jieyu Capsules showed lower cost and better effectiveness in the treatment of patients with primary and secondary depressive disorders.
Shugan Jieyu Capsules is superior to fluoxetine hydrochloride in the treatment of depression, and has less adverse events and superior cost-effectiveness. In order to meet the needs of patients, it should be further applied in clinic treatment.
Tumor vaccines have great potential in tumor immunotherapy. Effective, controllable and long-acting tumor vaccine therapy will play a greater role in treating tumors, preventing tumor recurrence, prolonging patient survival and tumor prevention. This research analyzes the applications and grants of invention patents in the global tumor vaccine field, from the technology birthplaces, target markets, technology innovation entities, technology innovation topics and other aspects, to reveal the technology innovation trend. There are 5 635 invention patent applications in the global tumor vaccine field, with 1 839 having been granted, close to one third, indication that technological innovation is active. The United States and China are both the main technology birthplaces and also the target market. In addition, the markets in Europe and Japan are also attracting much attention. The global technological innovation entities in the field of tumor vaccines are mainly enterprises and universities/institutes. Immatics Biotechnologies in Germany, Oncotherapy Science in Japan, and Glaxo Smith Kline in the United Kingdom are leading the research and development of global tumor vaccines. The technological innovation entities in China are mainly universities/institutes, but enterprises are also beginning to play an important role. The technology innovation topics focus on antigens related to tumor vaccines, tumor immune activity, polypeptide modification, and vaccine-related biotechnology. This research analyzes the global invention patents in the field of tumor vaccines, reveals the trend and direction of technological innovation, and provides information support for tumor immunotherapy research. At the same time, it provides a new research perspective for technology development from the angle of information science.
Adaptive licensing (AL) is a prospectively planned, flexible approach for the regulation of drugs and biologics. AL is based on the stakeholder model of patients, health-care providers, payers, and regulators, seeking maximizing the positive impact of new drugs on public health by balancing timely access for patients with the need to assess and provide adequate evolving information on benefits and harms, so that better-informed patient-care decisions can be made. This paper reviews the emergence and development of AL, deeply analyzed the principles and design ideas of AL, and discussed the risk management and safeguard measures in AL. This paper will provide theoretical and practical reference for the construction of AL pathway in China.
The aim of this article is to make some suggestions for the regulations on interchangeability and clinical drug switching of biosimilar in China. Literature and relevant policies were reviewed. The development status of biosimilars in China was summarized, the regulatory experiences on the interchangeability of biosimilars in the United State and European Union were combed, and research findings on clinical drug switching were analyzed as well. Biosimilars have developed rapidly in China, but the related regulatory system has not been completely established. The United States and European Union have already initially established the management of biosimilar interchangeability, while the practical experience and clinical evidence are limited, and expert consensus has not been reached. There are still potential risks and concerns on switching from an originator biologic to a biosimilar or from one biosimilar to another. Drug regulatory authority should pay more attention to drug safety, clinical data information transparency, and technical guidelines on interchangeability, drug traceability, and incentive system.
With the optimization of drug evaluation and approval system in China, an increasing number of “global new” innovative drugs, especially those with conditional approval, are being marketed in China. For such drugs that have not yet accumulated sufficient evidence in real world, urgent problems, such as how to balance clinical needs with the risks of medical insurance funds and scientific designing of medical insurance access plans, are yet to be solved by China medical insurance departments. While in the United Kingdom (UK), the Cancer Drugs Fund (CDF) has been set up since 2011, which specializes in compensation for anticancer drugs. Through the managed access agreements (MAAs) signed with drug manufacturers, CDF regularly collects and evaluates the real-world therapeutic data, and decides whether to include or withdraw this anticancer drug in the reimbursement scope of the National Health Service (NHS), solving the “uncertainty of drug therapeutic effect” potently. This paper analyzes the operation mode, drug types, and agreement elements of the MAAs implemented by the CDF in recent years in order to provide a reference for the medical insurance management of high-value innovative drugs reimbursement accessing in China.
Based on the analysis using big data, the medication rules of Tazi prescriptions for Chuangyang were summarizedto provide inheritance basis for the development of modern Chinese medicines for external use, and to explore the development of new Chinese medicines for external use.
The ancient Tazi prescriptions of Chuangyang was screened in Traditional Chinese Medicine Classic Database since the Spring and Autumn Period and the Warring States Period. The data mining technology, such as frequency and correlation analysis were used to analyze the characteristics and regularity of high frequency single-drug, drug groups, and new prescriptions from the view of clinical application combined with the existing commercially available external proprietary Chinese medicines for Chuangyang.
A total of 423 ancient prescriptions were collected, involving 280 traditional Chinese medicines. Spicy, bitter and sweet taste were the main medicinal properties. The high frequency single-drugs meridians enter the spleen, liver and kidney meridians, and their main effects were relieving pain, detoxification, clearing heat, and eliminating dampness. In the results of correlation analysis, high-frequency drug groups include Scutellaria baicalensis-Coptis chinensis, Angelica-Licorice, and Scutellaria baicalensis-Licorice. There are 6 new prescriptions, including Scutellaria-Phellodendron-Sophora-Sophora-Honeysuckle-Dandelion-White Peony-Centipede-Forsythia, Angelica-Asarum-Nepeta-Honeysuckle-Dew Hive-Angelica and so on.
The ancient prescriptions for the treatment of Chuangyang are mainly used to relieving pain and detoxification, clearing heat and drying dampness, promoting blood circulation, as well as removing rot and pus. Combined with the current marketed external medicines for the treatment of Chuangyang, new drugs still need further research and development.
Radioisotope tracer technology, as a method to analyze labeled drugs using radioisotopes as tracers, is internationally recognized as the “gold standard” in human mass balance and metabolism study. The first [14C]-radiolabeled drug clinical trial regarding human radiolabeled mass balance and metabolism study was completed in Phase I clinical trial unit of our hospital. Up to now, we have completed six trials, and several trials are in progress. The Standard Operating Procedures for clinical trial of [14C]-radiolabeled drug have been established, and the construction of isotope tracer technology platform for new drug clinical trails in human have been explored. This paper introduces the key points of technology platform operation, such as protocol design and consideration, project establishment and ethical review, management of subjects, study drug, biological sample, and environment, requirement of investigator, project training and other contents. The objective of this paper is to provide information for the application of isotope labeling technique in mass balance, metabolism and other clinical trials of innovative drugs.
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