ArchiveTo provide reference for improving the innovation efficiency of China's pharmaceutical industry and promoting high-quality development of China's pharmaceutical industry.
Data Envelopment Analysis (DEA) was used to measure the innovation (Technology) efficiency under constant scale (CRS) and variable scale (VRS) of pharmaceutical industry. The input and output data of 28 provinces (autonomous regions and municipalities) in China from 2014 to 2018 were selected from China Statistical Yearbook and China High-tech Industry Statistical Yearbook. On this basis, further comparative analysis was conducted from the perspective of industrial cluster to explore the change law of innovation efficiency of China's pharmaceutical industry, and corresponding suggestions were given.
There were great differences in the development of technological innovation efficiency among different regions in China; the innovation input and output of pharmaceutical industry was unbalanced and not directly proportional to the development level of the industry; the innovation efficiency in China was mainly affected by pure technical efficiency. through the analysis, it was found that there is a deviation between the evaluation of innovation efficiency of pharmaceutical industry by using DEA model alone and the actual situation of various regions. We conjectured that the deviation may be caused by the particularities of pharmaceutical industry and the impact of innovation spillover. It is suggested that when using DEA to evaluate the innovation efficiency of pharmaceutical industry, we should consider the factors such as the weak periodicity of pharmaceutical industry, the long output cycle of innovation achievements, and the existence of innovation efficiency spillover, so as to make the results more realistic.
Brexucabtagene autoleucel (Bre-cel) is an anti-CD19 chimeric antigen receptor (CAR)-T cell drug, developed by Kite Pharmaceuticals. Bre-cel (Tecartus) was approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) by the U.S. Food and Drug Administration on July 24th, 2020. Bre-cel is the first drug of CAR-T cell gene therapy for MCL. This review summarizes the pharmacological effect, pharmacokinetics, clinical trials and safety of Bre-cel.
In recent years, the economy of Chinese patent medicine industry has shown a downward trend, manifesting by the detailed problems of small-scaled pharmaceutical companies, low benefits, low achievements, and weak technological development and innovation capabilities. In order to reverse the current situation of inadequate technological innovation of Chinese patent medicines and improve the technological innovation level of Chinese patent medicine enterprises, this article preliminarily explores the construction of a set of scientific and technological innovation index evaluation systems with the Chinese patent medicine enterprises as the main body. Judging from the existing index evaluation status, there has not been any evaluation researches in the field of traditional Chinese medicine. Therefore, this paper takes 21 listed enterprises of Chinese patent medicine as the study object, combines with the “scale-efficiency-structure” index framework to screen out 10 indicators, including R&D funding investment and the number of R&D personnel, uses the entropy method out of objective weighting methods to determine the weight of each indicator, and initially constructs a comprehensive index evaluation method. The results show that during the years of 2015 to 2018, the scientific and technological innovation index of 21 listed Chinese patent medicine companies showed a peak, with the peak value appearing in 2016. This trend is consistent with that of sales revenue and profit of Chinese patent medicine industry in the same period. Compared with the net profit index of the company after deducting non-recurring gains and losses, the result is close to 70% after rank correlation analysis and comparison.
Taking the specific guiding principles of foreign regulations as reference, combined with the domestic situations, this paper analyzed the problems of good manufacturing practice for investigational medicinal products and give practical suggestions on the quality of investigational medicinal products, in addition to providing a reference for new drug researchers, this paper also aimed to promote the quality management level of drugs for clinical trials, protect the rights of clinical patients, and ensure the quality of clinical trials.
To explored the inhibitory effect as well as the mechanism of bicyclol on pulmonary fibrosis in silicotic rats.
A silicotic rat model was established by intratracheal drip of silicon dioxide (SiO2) suspension. Hematoxylin-eosin (HE) and Masson staining of rat lung tissues were performed for the exploration of the anti-fibrotic effect of bicyclol. Immunofluorescence (IF) and immunohistochemical (IHC) staining were used to observe macrophages aggregation and activation in rat lungs. Meanwhile, Western Blot assay was performed for further verification in cultured cells in vitro.
Both macrophage aggregation and nodule formation were observed in rat lungs by HE staining 28 days after intratracheal drip, indicating successful establishment of the silicotic rat model. Compared with the control group, both pulmonary fibrosis and macrophage aggregation in lungs of silicotic rats with bicyclol treatment were suppressed significantly using HE and Masson staining. IF and IHC staining showed downregulation of the expression of both arginase-1 (Arg1) and inducible nitric oxide synthase (iNOS) in macrophages of silicotic rat lungs by bicyclol. Furthermore, inhibition of the expression of Arg1 and iNOS by bicyclol in RAW264.7 cells stimulated with SiO2 was observed using Western blot assay.
Bicyclol suppresses macrophages aggregation and activation via down regulating Arg1 and iNOS, resulting in a slow-down of the process of pulmonary fibrosis in silicotic rats, which is likely to be a novel strategy for the treatment of silicosis.
Drug addiction is one of the most serious public health problems in the world. At present, drug addiction is considered as a chronic and recurrent brain disease. The exact mechanism of drug addiction has not been fully elucidated. The development of peddler imaging technology and the synthesis of various imaging agents have provided great help for people to understand the neuropharmacological mechanism of drug addiction. This paper reviews the application of positron emission tomography (PET) imaging in the study of drug addiction mechanism, focusing on the monitoring of neurotransmitter receptors, receptor transporters, regional cerebral blood flow and cerebral glucose metabolism in the process of drug addiction by using PET in vivo imaging technology, so as to understand the neurobiological basis of drug addiction and provide theoretical basis for effective treatment measures.
Ocular pharmacokinetics is the process of absorption, distribution, metabolism and excretion of drugs in eye tissues, and can be quantitatively described by mathematical models, which is more sophisticated and complex than the overall pharmacokinetics. Ocular pharmacokinetics research is the key to the development of ophthalmic drugs and to guide the rational use of ophthalmic drugs. Therefore, a comprehensive understanding of the research content of ocular pharmacokinetics is very important for ophthalmic drugs developers and users. This article outlines the key content of ocular pharmacokinetic research, so that relevant ophthalmologists can have an overall understanding of the pharmacokinetics of ophthalmic drugs, and improve the safety and rationality of ophthalmic drugs.
Gegenqinlian decoction is from Treatise on Febrile Diseases, which is composed of Puerariae lobatae Radix, Scutellariae Radix, Coptidis Rhizoma and Glycyrrhizae Radix et Rhizoma, and has the effect of solution of muscle heat and check flow field of diarrhoea. This research summarized the progress in research of the chemical component, pharmacological action and clinical application of Gegenqinlian decoction. Based on the ‘Five Principles’ of quality marker (Q-marker) of traditional Chinese medicine, the Q-marker of Gegenqinlian decoction was predicted, which showed that puerarin, daidzin, baicalin, baicalein, berberine hydrochloride, palmatine, epiberberine, coptisine, liquiritin and glycyrrhizic acid could be used as the Q-markers of Gegenqinlian decoction. These chemical components will be selected as index compounds to provide reference for the quality control research of Gegenqinlian decoction.
Zeolitic imidazolate framework-8 (ZIF-8) is a metal organic framework composed of zinc ions and 2-methylimidazole (MIM). It exhibits unique advantages, such as easiness to synthesize, large surface area, high porosity, pH responsiveness, as well as excellent thermal stability and biocompatibility, due to all these properties, it is widely used in gas adsorption, catalysis and sensing. In recent years, research on ZIF-8 as a drug carrier has gradually increased, and it has been applied in anticancer drugs, antibacterial drugs, and hypoglycemic drugs, etc. This review focuses on the recent development of ZIF-8 synthesis methods and its application in chemical drugs, natural drugs, and biotechnology drug delivery systems, and analyzes the advantages and application characteristics of ZIF-8 in different types of drug delivery systems, in order to provide a reference for further research of ZIF-8 to deliver drugs.
With the development of modern Chinese medicine, sensory evaluation has been paid more attention to. As an effective supplement of chemical composition and physical parameters, sensory indexes are widely used in many fields such as quality control and process research of traditional Chinese medicine. As an important tool for process optimization, experimental design can obtain optimized process parameters and the law of interaction between different parameters through few experiments, which plays an important role in process research. This paper reviews the application of sensory evaluation technology in the preparation process research of traditional Chinese medicine in recent years, taking experimental design as context and sensory index as detection objects, determining the weight coefficients of evaluation indexes by weighting method, combined with data processing of sensory evaluation results.
To evaluate the efficacy and safety of Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (36%) Injection in nutritional therapy for patients receiving moderate or major abdominal surgery.
Totally 240 cases of parenteral nutrition support patients receiving moderate or major abdominal surgery were enrolled in the randomized, double blind, multi-center, controlled study. The patients were randomized to be given Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (36%) Injection (n=122) or hospital-prepared all-in-one parenteral nutrient solution (n=118; nitrogen content, heat and liquid quantity as equal as the former) for 5 d. During the treatment process, the curative effect was observed, such as serum prealbumin (PA), retinol binding protein (RBP), hypersensitive C-reactive protein (hs-CRP) and IL-6; safety indicators such as weight, blood routine, blood biochemistry, urine routine, coagulation function, vital signs, electrocardiogram and adverse reactions of each system were monitored; the time spent for preparing the nutrient solution was calculated and the clinical efficacy was compared by statistical analysis.
There was no significant difference in efficacy and safety indicators between the two groups (P>0.05). However, the time spent for preparing the nutrient solution in the experimental group was significantly shorter than that in the control group (P<0.000 1).
There is no significant difference in the curative effect and safety between the Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (36%) triple-chamber bag and the hospital-prepared all-in-one parenteral nutrient solution, but the former is more convenient to be prepared, which can save 13 minutes on average compared with the latter.
To explore and evaluate the application of electronic informed consent and electronic payment of subject compensation (2E) in clinical trials of innovative drugs.
We conducted 2E in two clinical trials of innovative drugs. The electronic informed consent process was conducted as: the investigators registered trial information on PC, the subjects completed registration via mobile phone, the investigator selected certain subject to finish electronic informed consent process, the subject and the investigator signed their electronic signatures, then the signed informed consent was archived in the system. The e-payment of subject compensation process was conducted as: the subjects uploaded their bank card information via official account of Wechat, the CRC submitted application, the investigator confirmed the compensation, then the system dispatched the compensation after re-verification. The 2E technology was evaluated by the staffs and subjects respectively.
The compensation time has been shortened to a minimum of 3 minutes and a maximum of 24 hours. The staffs and the investigators all praised 2E technology.
2E technology can improve the efficiency and quality of clinical trials and benefit more subjects.
To 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.
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