Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.
Drug Evaluation ; methods ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional

Four primers against the genes encoding(cpa,cpb,etx,and iA) four major toxins(?,?,?,?) of Cl. perfringens were designed and the colony multiplex PCR of identification and genotyping of Cl. perfringens strains were developed. Cl. perfringens reference strains stored in china institute of veterinary drug control including A,B,C,D and E genotyping were genotyped using the colony muitiplex PCR assay. The expected sequences were obtained successfully by the colony multiplex PCR assay. But the sequences were not obtained from Cl. novyi,Cl. septicum and Cl. tetani. The expected sequences were obtained from Cl. perfringens individual colony diluted to 100 times with 0.85% saline solution.13 Cl. perfringens strains isolated from diferent animals were genotyped using the colony multiplex PCR assay,and the results were comparaed with the results of toxins neutranization test in mice. The two assays showed good accordance. These results showed that the development of the colony multiplex PCR is very important for early and fast identification and genotyping of Cl. perfringens in china.

Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.
China ; Drugs, Chinese Herbal ; adverse effects ; history ; History, Ancient ; Humans ; Medicine in Literature ; Medicine, Chinese Traditional ; history ; Polygonum ; adverse effects ; Risk Assessment

The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Animals ; Aristolochia ; adverse effects ; chemistry ; Aristolochic Acids ; analysis ; therapeutic use ; toxicity ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; analysis ; therapeutic use ; toxicity ; Humans

Objective To investigate the interaction of pullulan acetate nanoparticles (PANs) and bovine serum albumin (BSA),and to provide the basis for in vivo pharmacokinetic study of PANs.Methods Mixed solutions of different concentration of PANs and BSA solution was prepared,the interaction was studied by fluorescence quenching method and circular dichroism (CD) measurement.Apparent quenching constant (Kq) between the PANs and BSA was calculated,and the anti-stress effect induced by urea and heating of PANs-BSA solution was observed.Results The fluorescence spectrum of BSA was affected by PANs on density-related manner,and Kq calculated by the modified Stern-Volmer plot increased from 2.64×104 to 3.55 ×l05 with the concentration of PANs increased from 0.015 mg/ml to 0.25 mg/ml.With the denaturation of urea or heating,the CD spectrum of PANs-BSA and free BSA had the similar variation tendency.Conclusions The fluorescence spectrum display results show that interaction between PANs and BSA exists,but the interaction does not protect the BSA from degeneration by urea and heating.

The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.
China ; epidemiology ; Drug Evaluation ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Product Surveillance, Postmarketing

Abstract: Objective　To investigate the infection of Anisakis in marine fish sold in Fuxin, and conduct molecular identification and evolutionary tracing of third-stage larvae to determine Anisakis species. Methods　From 2018 to 2021, marine fish sold in the market were collected randomly, and the third stage larvae of Anisakis were detected in marine fish sold in the market by direct dissection, and the morphological characteristics were used to preliminarily identify species by microscopy; the total DNA was extracted, the internal transcribed spacer sequence of the ribosomal DNA of Anisakis was amplified, and the sequence alignment and evolution analysis were carried out. Results　A total of 289 market-sold sea fish samples of marine fish sold in the market were dissected and 84 samples of Anisakis were detected with a detection rate of 29.1%, of which the infection rates of hairtail and small yellow croaker were higher, at 41.4% and 41.2%, respectively. BLAST comparison of 28 sequences revealed eight species of anisakids, including Anisakis pegreffii, Anisakis simplex, Anisakis typical, Raphidascaris trichiurid, Contracaecum muraenesoxi, Hysterothylcaium zhoushanensis, Hysterothylacium amoyense and Hysterothylcaium fabri,belonging to the genera Anisakis and Hysterothylacium. The phylogenetic tree constructed from 28 sequences generally formed two topological branches, with Anisakis pegreffii, Anisakis simplex, and Anisakis typical forming three separate clusters as the topology branch of Anisakis genus. However, meanwhile, Hysterothylacium, Contracaecum, and Raphidascaris formed a separate topological branch. Conclusions　The marine fish sold in Fuxin City have severe anisakid infection, with a wide variety of anisakid species, the dominant species being Anisakis pegreffii.

Recently traditional Chinese medicine (TCM)-induced liver injury has been an unresolved critical issue which impacts TCM clinical safety. The premise and key step to reduce or avoid drug-induced liver injury (DILI) is to identify the drug source of liver injury in early stage. Then the timely withdrawal of drug and treatment can be done. However, the current diagnosis of DILI is primarily governed by exclusive method relying on administering history supplied by patients and experience judgment from doctors, which lacks objective and reliable diagnostic indices. It is obvious that diagnosis of TCM-induced liver injury is especially difficult due to the complicated composition of TCM medication, as well the frequent combination of Chinese and Western drugs in clinic. In this paper, we proposed construction of research pattern and method for objective identification of TCM-related DILI based on translational toxicology, which utilizes clinical specimen to find specific biomarkers and characteristic blood-entering constituents, as well the clinical biochemistry and liver biopsy. With integration of diagnosis marker database, bibliographic database, medical record database and clinical specimen database, an integrative diagnosis database for TCM-related DILI can be established, which would make a transformation of clinical identification pattern for TCM-induced liver injury from subjective and exclusive to objective and index-supporting mode. This would be helpful to improve rational uses of TCM and promote sustainable development of TCM industry.
Animals ; Biomarkers, Pharmacological ; metabolism ; Biopsy ; methods ; Chemical and Drug Induced Liver Injury ; diagnosis ; metabolism ; pathology ; Early Diagnosis ; Humans ; Liver ; drug effects ; pathology ; Medicine, Chinese Traditional ; adverse effects ; Rats

OBJECTIVE Liver cancer is one of the most common causes of cancer related deaths worldwide, specially, in China. Hinesol, extracted from Atractylodeslance a(Thunb.) DC. has been proved that has anti-cancer effect in leukemia in vitro and in vivo.However,it has been not well under-stood in liver cancer cells.METHODS Cell proliferation,apoptosis,cell cycle and invasion were performed to investigate the anti-liver cancer effect of hinesol in SMMC-7721 and LM3 by MTT assay,flow cytometry and scratch assay.Western blot was used to research the potential mechanism.RESULTS We revealed that hinesol suppresses cell proliferation and invasion,prompts population of G1 phase,induces apop-tosis in dose-dependent manner in SMMC-7721 and LM3 cells.Western blot data showed that hinesol could inhibits the expression of cyclin-D1, Bcl-2 and Bax, and inhibited phosphorylation of MEK and ERK, down-regulated the expressions of NF-κB p65 and phosphor-p65 in nucleus. The results indicated that hinesol reduces cell proliferation via arresting cell cycle at G1 phase and induces apoptosis.Further-more,western blot showed that hinesol inhibited phosphorylation of MEK and ERK,down-regulated the expressions of NF-κB p65 and phosphor-p65 in nucleus.CONCLUSION Our results demonstrate that hinesolreduces cell proliferation via arresting cell cycle at G1 phase and induces apoptosis, it has potent anti-cancer effect against liver cancer cells via down-regulation of MEK/ERK and NF-κB pathway,and indicate that hinesol is a potential liver cancer drug for further research.

Objective To investigate the expression of vascular endothelial growth factor(VEGF)in synovium of rats with adjuvant arthritis and the relationship between the histopathologic score and the expression of VEGF.Methods Adjuvant arthritis was established in Wistar rats by inoculating complete Freund's adjuvant(CFA). We calculated the arthropathologic score and the expression of VEGF mRNA and protein at different stages after CFA inoculation.Results In model group the arthropathologic score and expression of VEGF protein in synovium increased significantly all the time (P