ArchiveChinese patent medicine is one of important parts in Chinese drug market. It is imperative for new drug development and drug policy-making to establish a drug value assessment framework of Chinese patent medicine embodying the characteristics of traditional Chinese medicine. In this study, PubMed, CNKI and other domestic and foreign literature databases as well as the major international government and academic websites were searched to collect literature, policies, standards, guidelines and expert opinions related to drug value assessment at home and abroad. The methods of literature analysis, content analysis and expert consultation were comprehensively adopted to interpret, compare and analyze the relevant laws and regulations. We obtained the core elements and index system of drug value assessment in the world. According to the characteristics of Chinese medicine and the extensive expert consensus, a set of value assessment framework of Chinese patent medicine covering the whole life cycle from the establishment of the R&D project, pre-clinical application, new drug certificate application and post-marketing use is established, providing strong support for the research and development of new Chinese medicine, post marketing re-evaluation, establishment of clinical medication guidelines, drugs pricing, medical insurance compensation and medication choice of patients.
Results from large-sample double-blind randomized controlled trial (RCT) have always represented the highest level of evidence-based medicine clinical evidence, but it cannot solve all the clinical research problems, thus real-world evidence (RWE) based on the perspective of real-world research (RWS) has developed rapidly. This paper aims to provide reference for the further application and development of RWE by comparing the differences between RWE and randomized controlled trial evidence in data source, internal and external effectiveness, evidence level, application scope, experiment design, implementation elements and implementation cost.
This paper is expected to provide reference for China to establish appropriate standards to evaluate the adaptability of real-world data, and facilitate the establishment of related systems for medical device approval and supervision. Finding appraised standard to evaluate the suitability of real-world data by analyzing the series of factors in the “Use of Real-world Evidence to Support Regulatory Decision-Making for Medical Devices”, in order to turn real-world data (RWD) into a truly practical real-word evidence (RWE). The adaptability assessment of China's RWD can be carried out from 2 aspects such as relevance and reliability. In the aspect of RWD relevance assessment, evaluation criteria can be designed from 5 aspects: data source and selection, data validity, regulatory requirements, ethical issues as well as operability. In the aspect of real world data reliability assessment, evaluation criteria can be designed from 3 aspects: management process standardization, data standardization and quality control.
This article aims to provide reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. The main content of “Real-World Evidence Program” issued by US FDA was summarized by literature research method, and the construction of related systems in China were analyzed. To promote the application of real-world research for drug regulatory decisions, China should publish guidelines related to real-world research, promote the construction of data standards and shared database, extensively introduce the demonstration projects as well as strengthen the guidance for real-world research of enterprises. And at the same time, the relationship between stakeholders should be paid attention to deal with.
To establish an evaluation system of drug market value and to provide reasonable reference opinions for drug R&D and industrialization investment.
Based on literature research and expert interviews, 18 measurement indicators were selected to construct an evaluation system, and factor analysis was adopted. The common factor was extracted by dimensionality reduction and the comprehensive score was calculated accordingly.
The factors of development team, drug evaluation, market pattern, and social policy environment are the 4 key factors obtained after dimensionality reduction.
The development team is the most important part of market value evaluation. It will greatly enhance the competitiveness of pharmaceutical companies to built a development team in appropriate level. Investors are suggested to fully consider the development team factors when making investment decisions.
At different stages after establishment of the new China, with the constant change of narcotic drugs and psychotropic substance types, as well as drug abuse situation in domestic and overseas, the policy and system of the narcotic drugs and psychotropic substances in China constantly adapt to the complex situation under the inheritance and adjustment, and followed up to adjust the catalogues of narcotic drugs and psychotropic substances, as far as possible to adapt to the requirement and the situation of the drug regulation and anti-drug struggle. Based on a series of laws and other normative documents successively issued by Chinese government about the narcotic drugs and psychotropic substances, according to the major changes of the catalogues or the listed control system of the narcotic drugs and psychotropic substances, the catalogue changing process (1949—2019) of the narcotic drugs and psychotropic substances in China can be divided into five periods, and then this paper systematically analyzes the main contents, characteristics, causes, significance of the catalogue changes of narcotic drugs and psychotropic substances. This paper also provides a retrospective research in response to the current increasingly complex control problem of the narcotic drugs and psychotropic substances, in order to improve the listing management system.
The aim of bio-distribution study is to investigate the performance of medicine reaching the target organs after it was administrated to the human body, as well as its metabolism and clearance process with the time extending. Bio-distribution is a particular and feature research area specific for gene therapy medicines. It could lead severe hazards when human body exposing exogenous gene segments, thus it's necessary to adopt appropriate methods to monitor the state of gene segments of medicines inside the human body to predict potential safety risks. Currently, many regulatory authorities request to carry out bio-distribution research in preclinical study and provide relevant data and information before application in clinical trials. This article mainly generalizes the testing items, types and features of samples, analytical methods and detective strategy of bio-distribution study to provide the industry and regulatory agency with detailed and practical guidance for these kinds of researches and consequently prompt the regulation science in China in the field of preclinical evaluation and assessment.
To examine the effect of Shuganning Zhusheye on the growth of human hepatic stellate cells LX2 (HSC-LX2), and to explore its anti-fibrosis mechanism.
The HSC-LX2 cells were treated with Shuganning Zhusheye and the absorbance of the cells was measured by the CCK8 assay to calculate the cell proliferation rate. The expression levels of mRNA and protein such as collagen Ⅰ, collagen Ⅲ and TGF-β were detected by fluorescence quantitative PCR and Western Blot. The effect of Shuganning Zhusheye on the cell cycle distribution and apoptotic rate of HSC-LX2 cell was detected by flow cytometry.
Compared to the untreated group, the inhibition rates of the low, medium and high concentrations of Shuganning Zhusheye on HSC-LX2 cells for 120 h were 14.27%, 16.37% and 18.67% respectively (P<0.05). The quantitative results showed that the mRNA levels and the protein expression levels of collagen Ⅰ and collagen Ⅲ in HSC-LX2 cells were lower than those in the untreated group (P<0.05). Shuganning Zhusheye blocked the cycle of HSC-LX2 cells in G2/M phase and induced the early and late apoptosis of the cells with a maximum apoptosis rate of 2.69%. And the effect of inducing apoptosis was concentration-dependent (P<0.05).
Shuganning Zhusheye inhibited cell proliferation by blocking the cell cycle, and promoted the early and late cell apoptosis. At the same time, it downregulated the expression levels of mRNA and protein regarding collagen Ⅰ and collagen Ⅲ, so as to play an anti-fibrosis effect.
Minodronic acid is a third-generation nitrogen-containing heterocyclic bisphosphonate drug mainly used for the treatment of osteoporosis and hypercalcemia caused by osteoporosis and malignant tumors. Through summary of the existing literature, it was found that the research on the synthesis of minodronic acid is mainly concentrated on the synthesis of the key intermediate 2-(imidazo[1,2-a]pyridin-3-yl) acetic acid, and the preparation of this intermediate is mainly based on the fact that the 3-position of the imidazo[1,2-a]pyridine's structure contains a substituent group which is susceptible to functional group conversion. The synthesis technology of minodronic acid by phosphorylation of this intermediate is relatively simple. The synthesis strategy of the key intermediate 2-(imidazo[1,2-a]pyridin-3-yl) acetic acid is reviewed in this article.
Phase Ⅰ clinical trial is a preliminary clinical pharmacology and safety evaluation trial in human body to observe human tolerance to new drugs and its pharmacokinetics, providing basis for the drug administration strategy. The subjects are mainly healthy volunteers. Phase Ⅰ clinical trials are usually non-therapeutic, thus whether the drug can be successfully administered is the key of the trial. Oral administration is the most commonly used and the easiest way for administration in phase Ⅰ clinical trials; however, it is usually overlooked due to the most facility when application. To prevent errors in administration and ensure effective, smooth and correct administration, this article discusses how to deal with the risk of oral medicine, take measures, formulate the response system, and then to strengthen the management of oral administration, in order to effectively control the risk of oral medicine and guarantee the success through subject, researcher, drug administrator, quality control personnel before, during and after the drug administration.
To design and synthesize novel vanillin derivatives and evaluate their anti-proliferation effect against HeLa cells.
Taking vanillin derivative SBE-13 as lead, 2-chloroquinoline fragment were introduced into the new compounds by the methods of electronic isosteric and skeleton transition. 2-Chloro-3-chloromethylquinoline and vanillin were used as raw materials to obtain the target compounds 4a~4k by etherification and reductive amination.
A total of 11 novel vanillin derivatives were designed and synthesized, and their structures were confirmed by 1H NMR and ESI-MS. Most of the compounds exhibited good antiproliferative activities against HeLa cells. Notably, compound 4b potently inhibited HeLa cells with an IC50=9.79 μmol·L-1, a 10-fold improvement over SBE-13 (IC50=78.30 μmol·L-1).
Compound 4b displayed significant antiproliferative effect in vitro, which is worthy of further study.
To systematically study the polymorphism of compound CP0119.
Totally 100 conditions such as volatile crystallization, slurry crystallization, anti-solvent crystallization, cooling crystallization, diffusion crystallization and water vapor stress crystallization were used to select the crystal types. Different crystal types were characterized by X-ray powder diffraction analysis (XRPD), differential scanning thermal analysis (DSC), thermogravimetric analysis (TGA) and Fourier infrared spectroscopy (FT-IR). Dynamic water adsorption test (DVS) was used to determine the wettability of anhydrous crystal. The stability and translatability of the crystal samples were studied by stress testing. The most stable crystal in the corresponding solvent at room temperature was determined by crystal competition test and its stability was investigated.
In addition to the original crystal type (crystal type 1), 9 new crystal types were screened and prepared. Many kinds of methods could be used to identify the crystal samples in different material states. The competitive test showed that the crystal type 1 was the most stable crystal type, and the stability test showed that the crystal form and melting point crystal of type 1 were not changed when it was placed in long-term and accelerated conditions for 10 d.
By systematically studying the polycrystalline form of compound CP0119, the preparation method, material composition, crystal form stability and crystal form transformation rule of the 9 crystal forms were clarified, which provided scientific basis for the subsequent preparation process and preparation research.
To optimize the extraction conditions of Scutellaria baicalensis by ultrasound-assisted ionic liquid and evaluate the anti-inflammatory activity.
The extraction method of scutellarin, baicalin, baicalein, wogonoside, wogonin and oroxylin A by high performance liquid chromatography was established. The extraction process was optimized by Box-Behnken response surface method, with the index of comprehensive score such as weight coefficient and the anti-inflammatory activity was evaluated.
The optimal extraction conditions were as follows: the concentration of ionic liquid was 20%, the ratio of material to liquid was 1∶60 mL·g-1, the extraction temperature was 35 ℃, the extraction time was 15 min. The contents of six chemicals were obtained as 0.73%, 10.05%, 2.61%, 1.30%, 0.45%, and 0.22% by the validation experiment. MTT assay showed that the cell viability significantly decreased as the concentration exceeded 50 μg·mL-1. Compared with LPS group, the extraction at different concentrations significantly inhibited the release of NO (P<0.01), and the IC50 value was 17.07 μg·mL-1.
The extraction process is simple, feasible, green, high efficiency and highly reproducible and the total flavonoids of Scutellaria baicalensis have obvious anti-inflammatory activity.
To establish a determination method of polymer impurities in cefoxitin sodium injection.
Cefoxitin sodium was dissolved in water to prepare stock solution of cefoxitin sodium polymer. High performance size exclusion chromatography (HPSEC, TSK-gel G2000SWxl) and column switching-LC/MSn were applied to separate and deduce the poor retention impurities in the stock solution and to evaluate the specificity of HPSEC method. A new RP-HPLC method for polymer analysis was established with a Shimadzu Inertsil Ph-3 column, using a gradient elution by phosphate buffer solution (pH 3.2)-acetonitrile-methanol, and the method was validated.
Several cefoxitin sodium polymers were identified in stock solution of cefoxitin sodium polymer, 4 small molecular impurities were also detected. Polymer impurities were liable to co-elute with small molecular impurities by HPSEC method, making a poor quantification accuracy and specificity. Two indicative polymer impurities were detected by RP-HPLC method with an effective specificity.
HPSEC method was not suitable for the quality control of polymer impurities in cefoxitin sodium injection, while the new established RP-HPLC method was specific, which could effectively control the polymer impurities. Cefoxitin sodium polymer stock solution could be used to identify polymer peaks as the system suitability solution.
To evaluate the effectiveness, safety and economy of Binkgo biloba extract injection in ischemic stroke patients using rapid health technology assessment and to help efficiently and quickly provide evidence-based basis for clinical drug selection and decision makers.
Databases in Chinese and English, and HTA organization websites were searched. Studies were selected according to the inclusion and exclusion criteria, and the data were extracted and the quality of included literature was evaluated and analyzed.
At last, 7 systematic reviews and 4 pharmacoeconomic studies were included in this study. In patients with ischemic stroke, Ginkgo biloba extract injection improved clinical efficacy, neurological deficit scores and activity of daily living, ameliorated plasma viscosity and reduced fibrinogen, as well as improved the deterioration rate of the disease. There was no statistically significant difference in mortality compared with the control group. Few adverse reactions and no serious adverse reactions were observed. The quality of the included economics research literature was relatively low. Drug efficacy in experimental group and control group was equal. The cost-effectiveness analysis method was adopted in the economic evaluation, in which only the drug cost out of direct cost was included. The year of research is relatively early, which cannot match the current drug price, and results of the researches are difficult to be used as reference.
Ginkgo biloba extract injection is an efficacious and safe choice for ischemic stroke treatment. The evaluation of its economics still requires further high-quality pharmacoeconomic analysis.
To investigate the influence factors of blood concentration of tacrolimus, and to provide reference for clinical use of tacrolimus (FK506).
66 patients with nephrotic syndrome, who received hospitalized treatment in nephrology department of our hospital were enrolled in this study. The blood concentration of FK506, general data and laboratory testing values and so on, were recorded and analyzed using multiple linear regression method by SPSS 17.0 software.
Among the 66 patients, 40.91% patients' FK506 concentration fell in the effective range, 54.55% below the effective range, and 4.55% above the effective range. Correlations were found in unit dose of blood concentration for tacrolimus with total cholesterol (CHO) combination with drugs that increase the FK506 blood concentration, and serum creatinine (P<0.01).
The FK506 blood concentration in patients with nephrotic syndrome patients is greatly varied between individuals, and CHO, drugs that increase FK506 concentration and CK are main factors affecting FK506 blood concentration in nephrotic syndrome patients.
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