Shenyang Pharmaceutical University is a university in Shenyang, Liaoning, China. It is the first research institutes in pharmaceutical science in China.Shenyang Pharmaceutical University has historical traditions that have brought it to prominence as one of two comprehensive pharmaceutical universities in all of China. The university started at Ruijin in the Jiangxi in 1931 and moved to its present location on the banks of the Hun River in Shenyang, Liaoning in 1949. SPU has developed into a multidisciplinary, multilevel and multiform institute of higher learning, covering wide and diverse majors within the domain of pharmaceutical study. It consists of the schools of Pharmacy, Pharmaceutical engineering, Traditional Chinese Medicines, Business Administration, Basic Courses, and Adult Education. SPU has been authorized to confer master's and doctor's degrees and to enroll students from Hong Kong, Macau, Taiwan, as well as other countries. SPU has resources that facilitate learning: The Institute of Material Medicine; The Institute of Pharmaceutical Education of Higher Learning; The Computer Center; The Audio-visual Education Program Center; The Center of Instrumental Analysis; The Botanical Garden of Medicinal Herbs, and a subsidiary pharmaceutical factory. SPU has a staff of 1,111, among them there are 394 full-time teachers. The student population has grown to more than 7,000. There is one academician of the Chinese Academy of Engineering, over 182 professors and associate professors .More than 3,000 academic papers have been published by SPU academics on research toward recommended dosages of pharmaceutical preparations, polyphase liposomes and solid preparations, on chemical and active components of traditional Chinese medicines and natural drugs, on the distinction and properties of chemical models of traditional Chinese medicines and the study of their quality control. All of this scientific exploration is at the forefront of research in China. In recent years, numerous mutually beneficial collaborative efforts have come to fruition between the University's academics and all levels of government: city, province, and state. Wikipedia.
News Article | May 17, 2017
Those who submit faked clinical trial data might now go to jail — and in extreme circumstances, be executed — under a new interpretation of China’s criminal code, announced last month. The policy shift is one of a handful of measures that China is implementing both to speed up its notoriously slow drug-approval process and to keep dangerous and ineffective drugs off the market. This move “is the strongest signal yet, to all the drug developers, clinical-trial managers and principal investigators and physicians, that China is now very serious about clinical data”, says Dan Zhang, executive chairman of Beijing-based Fountain Medical Development, which helps companies to carry out clinical trials and itself stands to be held accountable by the policy change. A hint of the depth of the problem came after the China Food and Drug Administration (CFDA) in 2015 ordered companies to re-evaluate “the authenticity, integrity and compliance of clinical trial data” in pending applications for new drugs. The agency told them that if CFDA examiners later found violations, the companies would not be able to submit other drugs for approval. More than 80% of the applications were voluntarily withdrawn, according to CFDA documents. One-quarter of the remainder was subsequently rejected because of problems with authenticity. The new policy will broaden current laws to cover submissions of clinical-trial data, says Liu Ye, a lawyer dealing with medical issues at Haishang Law Firm in Shanghai. Manufacturing and selling counterfeit versions of drugs was already a crime, but the submission of fake data in the approval process was unregulated territory, says Su Ling, director of the Institute of Drug Regulatory Science at Shenyang Pharmaceutical University and a venture partner for the investment fund Lilly Asian Ventures. The new policy was approved by a court review committee on 10 April and will go into effect when published by the high court, expected within a few months. It will make those who submit faked clinical-trial data guilty under the same law as counterfeiting. Under that law, if the approved drug causes health problems, it can result in a 10-year prison term or the death penalty, in the case of severe or fatal consequences. Even if the drug is not approved and even if no one is harmed by an approved drug, those who break the law by submitting fake data may face three years in prison. The new policy also subjects those who submit fake clinical trial data to prosecution under a law that forbids bearing false testimony. The impact will depend on how the change is implemented, says Su. It still is not clear who among the large number of people involved in a trial would be held responsible for problematic data. Su also wonders how severe a judgment will be. “Will falsified data for one patient break the law, or would it have to be 10 or 100?” The first prosecution will clarify this, he says. “The government might make an example of someone.” Some doubt that anyone will be executed under the new policy, but others say it could happen. In 2007, China executed the former head of its drug agency for accepting bribes to approve medicines, some of which ended up killing people. “It’s a remote possibility, but if kids start taking bad vaccines, for example, and they die, I could see a real chance of this happening,” says Zhang. Liu, however, says that it might be difficult to enforce. “If intent cannot be proven, the crime will not hold. Proving intent is very challenging,” he says. Critics have long argued that the Chinese pharmaceutical industry is rife with problems. The flurry of application withdrawals last year happened for a variety of reasons, including poor documentation, “untruthful” data and neglect of standard protocols, according to a CFDA official. Publications from Chinese clinical hospitals tell a similar tale, says John Ioannidis, a researcher in health policy at Stanford University in California. They often fail to document whether trials are double-blinded, whether the study goals are achieved, whether informed consent and ethics approval had been given and whether the test and control groups had been randomly selected to decrease bias. Studies have also found that Chinese trials are much more likely to show a positive effect for a drug, even if the medicine had failed elsewhere. “Most of these problems are the result of people trying to cut corners in order to get papers published in better journals and reap the resulting benefits,” says Ioannidis. Su says the new policy will scare off many shams, whose applications clog up the approval process, and thus clear the way for valid drugs, which have been slow to get approval. There is typically a wait of four years or more for the CFDA to approve drugs that have already been approved in the United States or Europe. The CFDA has taken other steps to speed up the regulatory process and make it more rigorous. Between mid-2015 and the end of 2016, it quadrupled the number of staff by adding 450 new regulators, and it expects to add another 300 this year. And beginning in May, the Center for Drug Evaluation will be allowed to approve drugs to start clinical trials without getting a rubber stamp from the CFDA, its parent organization, which adds months to the process. Su even worries the efforts might “overheat”. People lacking drug development or regulatory experience could approve ineffective or even dangerous drugs, and that could be disastrous, he says.
Shenyang Pharmaceutical University and Deliwei Beijing Biological Technology Co. | Date: 2015-06-05
The invention relates to fat emulsions, particularly to a use of high-concentration glycerol in freeze-thaw resistant emulsions and a free-thaw resistant emulsion thereof. The said high-concentration glycerol is the glycerol that is greater than or equal to 3 w/v % in the emulsion composition. The maximum percentage of the glycerol in the emulsion is 50 w/v %. When the percentage of the oil in the emulsion is 2%-30 w/v %, the glycerol is more than or equal to of the oil in the emulsion. The invention comprises a drug-contained emulsion through including drugs. Compared with prior arts, the invention provides a freeze-thaw resistant emulsion which tolerates the low-temperature freeze-thaw experiments, avoiding the pharmaceutical stability issues due to the temperature changes during the emulsion transport, storage and utilization, ensuring medicine quality, meanwhile it drastically reduces the requirements of the transport and storage conditions as well as the medicine costs.
Shenyang Pharmaceutical University and Deliwei Beijing Biological Technology Co. | Date: 2017-04-19
The invention relates to fat emulsions, particularly to a use of high-concentrationglycerol in freeze-thaw resistant emulsions and a free-thaw resistant emulsion thereof. The said high-concentrationglycerol is the glycerol that is greater than or equal to 3 w/v % in the emulsion composition. The maximum percentage of the glycerol in the emulsion is 50 w/v %. When the percentage of the oil in the emulsion is 2%-30 w/v %, the glycerol is more than or equal to 1/3 of the oil in the emulsion. The invention comprises adrug-contained emulsion through including drugs. Compared with prior arts, the invention provides a freeze-thaw resistant emulsion which tolerates the low-temperature freeze-thaw experiments, avoiding the pharmaceutical stability issues due to the temperature changes during the emulsion transport, storage and utilization, ensuring medicine quality, meanwhile it drastically reduces the requirements of the transport and storage conditions as well as the medicine costs.
Mao S.,Shenyang Pharmaceutical University |
Sun W.,Shenyang Pharmaceutical University |
Kissel T.,University of Marburg
Advanced Drug Delivery Reviews | Year: 2010
Among non-viral vectors, chitosan and chitosan derivatives have been developed in vitro and in vivo for DNA and siRNA delivery systems because of their cationic charge, biodegradability and biocompatibility, as well as their mucoadhesive and permeability-enhancing properties. However, the transfection efficiency of chitosan is too low for clinical application. Studies indicated that the transfection efficiency depends on a series of chitosan-based formulation parameters, such as the Mw of chitosan, its degree of deacetylation, the charge ratio of chitosan to DNA/siRNA (N/P ratio), the chitosan salt form used, the DNA/siRNA concentration, pH, serum, additives, preparation techniques of chitosan/nucleic acid particles and routes of administration. In this paper, chitosan-based formulations for the delivery of DNA and siRNA were reviewed to facilitate the process of chitosan vector development for clinical application. In addition to formulation optimization, chitosan structure modification or additive incorporation is an effective way to improve the stability of the polyplex in biological fluids, enhance targeted cell delivery and facilitate endo-lysosomal release of the complex. In summary, the transfection efficiency of chitosan-based delivery systems can be adjusted by changing formulation-related parameters. © 2009 Elsevier B.V. All rights reserved.
Chen W.,Shenyang Pharmaceutical University
AAPS PharmSciTech | Year: 2011
Berberine chloride (BBR) is a natural isoquinoline alkaloid extracted from medicinal herbs. It has been reported that the intestinal absorption of BBR is very low. In this study, the absolute bioavailability of BBR was studied, and the enhancing effects of D-α-tocopheryl polyethylene glycol 1000 succinate (TPGS) on intestinal absorption were investigated in rats. BBR injection was administrated via the femoral vein at a dose of 1.0 mg kg(-1) in intravenous group, and BBR oral formulations were administrated by oral gavage at a dose of 100 mg kg(-1) in BBR control (control) group and BBR-TPGS (test) group, respectively. The result showed that BBR had a very low absolute bioavailability of 0.68%, and TPGS could enhance intestinal absorption of BBR significantly. TPGS at a concentration of 2.5% could improve peak concentration (C(max)) and area under the curve (AUC(0-36)) of BBR by 2.9 and 1.9 times, respectively. The absorption enhancing ability of TPGS may be due to its ability to affect the biological activity of P-glycoprotein and thereby reduce the excretion of absorbed BBR into the intestinal lumen. This study indicated that absolute bioavailability of BBR was 0.68% in rats, and TPGS was a good absorption enhancer capable of enhancing intestinal absorption of BBR significantly.
Li X.,Shenyang Pharmaceutical University
International journal of nanomedicine | Year: 2011
The purpose of this study was to develop folate-poly (PEG-cyanoacrylate-co-cholesteryl cyanoacrylate) (FA-PEG-PCHL)-modified freeze-dried liposomes for targeted chemotherapy using docetaxel as a model drug. FA-PEG-PCHL was synthesized and its cytotoxicity was evaluated by CCK-8 assay in L929. Docetaxel-loaded liposomes modified by FA-PEG-PCHL were prepared by an organic solvent injection method and lyophilized to obtain freeze-dried FA-PEG-PCHL-docetaxel liposomes (FA-PDCT-L). Two carcinoma cell lines (MCF-7 and A-549 cells) were cultured with docetaxel solution, conventional docetaxel-loaded liposomes, or FA-PDCT-L, and the cytotoxicity and apoptosis was evaluated for each preparation. The uptake of the docetaxel preparations into MCF-7 cells was studied by confocal laser scanning microscopy. Liquid chromatography-mass spectrometry was used to study the pharmacokinetics and tissue distribution characteristics of the preparations. The existence of an enlarged fixed aqueous layer on the surface of the liposomes was affirmed by zeta potential analysis. The entrapment efficiency and particle size distribution were almost the same as those of docetaxel-loaded liposomes. The drug release profile showed that the release rate was faster at higher molecular weight of the polymer. Compared with docetaxel solution and docetaxel-loaded liposomes, FA-PDCT-L demonstrated the strongest cytotoxicity against two carcinoma cell lines, the greatest intracellular uptake especially in the nucleus, as well as the most powerful apoptotic efficacy. In pharmacokinetic studies, the area under the plasma concentration-time curve of FA-PDCT-L was increased 3.82 and 6.23 times in comparison with the values for the docetaxel-loaded liposomes and docetaxel solution, respectively. Meanwhile, a lower concentration of docetaxel was observed for FA-PDCT-L in the liver and spleen, and a significantly higher concentration of FA-PDCT-L in tumors suggested that the presence of FA-PEG-PCHL on the liposomes resulted in greater accumulation of the drug in tumor tissue. Liposomes modified by FA-PEG-PCHL could be one of the promising suspensions for the delivery of antitumor drugs in cancer.
Shenyang Pharmaceutical University | Date: 2014-11-05
The present invention relates to a series of quinoline and cinnoline derivatives of general formula I, pharmaceutically acceptable salts, hydrates, solvates or prodrugs thereof. And the compounds of general formula I show potent inhibitory activity gainst c-Met kinase. The present invention further relates to the uses of the compounds, pharmaceutically acceptable salts and hydrates for the preparation of medicaments for the treatment and/or prevention of diseases caused by abnormal expression of c-Met kinase, especially for treatment and/or prevention of cancer.
Shenyang Pharmaceutical University | Date: 2015-09-09
The invention relates to a series of quinoline derivatives of general formula I, pharmaceutically acceptable salts, hydrates, solvates or prodrugs. Thereof M, R_(1), R_(2), X, Y and n are defined as claims. And the compounds of general formula I show potent inhibitory activity gainst c-Met kinase. The present invention further relates to the uses of the compounds, pharmaceutically acceptable salts and hydrates for the preparation of medicaments for the treatment and/or prevention of diseases caused by abnormal expression of c-Met kinase, especially for treatment and/or prevention of cancer.
Shenyang Pharmaceutical University | Date: 2015-05-04
The invention relates to a series of quinoline derivatives of general formula I, pharmaceutically acceptable salts, hydrates, solvates or prodrugs. Thereof M, R_(1), R_(2), X, Y and n are defined as claims. And the compounds of general formula I show potent inhibitory activity against c-Met kinase. The present invention further relates to the uses of the compounds, pharmaceutically acceptable salts and hydrates for the preparation of medicaments for the treatment and/or prevention of diseases caused by abnormal expression of c-Met kinase, especially for treatment and/or prevention of cancer.
Shenyang Pharmaceutical University | Date: 2014-02-20
The present invention belongs to the field of medicinal technique, specifically relates to nitrogen-containing heterocyclic ring-substituted dihydroartemisinin derivatives and their optical isomers according to formula I or II; wherein substituent X, Y, r, R_(1), R_(2), R_(3 )and R_(4 )are as defined in the Description. The derivatives and compositions thereof can be prepared into clinically acceptable tablets, capsules, injections, ointments, etc., and thus have pharmaceutical uses in the treatment and/or prevention of cancers.