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1.
China Pharmacy ; (12): 661-665, 2022.
Article in Chinese | WPRIM | ID: wpr-922999

ABSTRACT

OBJECTIV E To in vestigate the situation ,achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation (GMPCE) published on the official website of the National Medical Products Administration. The basic information ,the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List (hereinafter refer to as “essential medicine list ”),Medicine List for National Basic Medical Insurance ,Industrial Injury Insurance and Maternity Insurance (hereinafter refer to as “medical insurance list ”)and the result of the successful selection of centralized medicine procurement organized by the state (hereinafter refer to as “centralized procurement list ”). RESULTS From 2017 to 2021,415 chemical generic drugs had passed consistency evaluation in China ,including 309 varieties,1 822 specifications, 6 dosage forms ,and 17 pharmacological mechanisms ,basically belonging to 30 provinces,and 492 drug manufacturers (except 12 products had not been found the manufacturers );the proportion of GMPCE in essential medicine list increased from 0.96% in 2012 edition to 25.40% in 2018 edition;that of GMPCE in medical insurance list increased f rom 2.13% in 2017 edition to 11.68% in 2021 edition;in the first 5 batches of centralized procurement list,GMPCE accounted for 81.65%,and the maximum price drop after entering the list was 97.52%. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever,total number of GMPCE is a little small,with the higher repetition rate of variety and the low proportion in the three lists ;the guarantee measures of those medicine supply need to be strengthened.

2.
Article in Chinese | WPRIM | ID: wpr-906499

ABSTRACT

In this paper, a comparative analysis is carried out on the policy of listed drugs in Australia, the policy of over-the-counter drugs in Japan, the policy related to the conversion of Chinese patent medicines to over-the-counter drugs, and the policy related to health food. The focus is on one of the possible situations for the registration of over-the-counter traditional Chinese medicines (TCMs), namely new prescription-composed over-the-counter TCMs. This paper discussed separately from the three parts of the scope of Chinese medicinal materials in the prescription medicines, the scope of indications, and the technical requirements, in order to provide references for the technical requirements related to the registration of over-the-counter TCMs. Recommendations on the marketing and registration of new prescription-composed over-the-counter TCMs:①It is recommended to formulate a list of medicinal materials for the use of Chinese herbal medicines, and consider including raw materials of health food. On this basis, a batch of safe Chinese medicinal materials/decoction pieces was added. And consider dynamic supervision, such as allowing the addition or recall of Chinese medicinal materials/decoction pieces in the list of medicinal materials. ②The scope of indications is recommended to consider the scope of indications for the conversion of Chinese patent medicines to over-the-counter TCMs in China, and the selection of medium-risk indications can reflect the characteristics and advantages of TCM treatment. ③Efficacy evaluation needs to provide high-quality scientific evidence, including clinical research data, and consider relaxing the requirements for non-clinical pharmacodynamic trials.

3.
Article in Chinese | WPRIM | ID: wpr-906315

ABSTRACT

With the publication of Registration and Classification of Traditional Chinese Medicine (TCM) and Application Data Requirements, the related management and technical documents of TCM with the same name and prescription need to be further studied and formulated. In this paper, the management mode and technical evaluation of TCM with the same name and prescription are discussed to provide reference for the formulation of management and technical documents of TCM with the same name and prescription. The issues to be discussed include which management mode to adopt, how to select the control drugs with the same name and prescription, whether the indication risk level should be divided, whether the indication should be limited to medium and low risk, and how to carry out the technical evaluation of similarity/consistency. From the perspective of technical document research and formulation, this paper mainly focuses on the technical level. However, there are still other theoretical possibilities in the management mode and technical evaluation of TCM with the same name and prescription. Therefore, this paper, as a preliminary summary of the management and technical evaluation of TCM with the same name and prescription, needs more scholars and industry experts to pay attention to and participate in this work.

4.
Acta Pharmaceutica Sinica ; (12): 1749-1756, 2021.
Article in Chinese | WPRIM | ID: wpr-887019

ABSTRACT

This paper reviews modern science and technology with regard to traditional Chinese medicine (TCM) research methods, quality control, and discusses the establishment and improvement of the evaluation system for TCM, focusing on the following issues: 1) How to incorporate the efficacy of TCM in the overall evaluation of TCM quality; 2) how to quantify the efficacy and properties of TCM; 3) how to understand the correlation between the efficacy and properties of TCM and its application; 4) how to reflect the specificity of the effective components in the overall evaluation of TCM quality; and 5) how to reflect the quality value transfer of effective components in the whole process of production and metabolism in vivo to the overall evaluation of TCM quality. The overall quality evaluation of TCM needs to better reflect its clinically safety and effectiveness. It is suggested to establish a clinical quality assessment method based on the content of the chemical components of TCM to explore and establish an overall evaluation method of TCM quality that reflects the efficacy of TCM and conforms with clinical practice.

5.
China Pharmacy ; (12): 769-775, 2021.
Article in Chinese | WPRIM | ID: wpr-875806

ABSTRACT

OBJECTIVE:To provide su ggestions for perfecting drug electronic commerce regulatory policy and online drug sale supervision mechanism in China. METHODS :The evolution of online drug sale policy in China were sorted out. The related regulations of online drug sale supervision mechanism stated in newly revised Drug Administration Law in 2019 and Measures for Online Drug Sale Supervision (Exposure Draft )in Nov. 2020(hereinafter referred to as New Exposure Draft )were analyzed on the basis of regulatory science to put forward the opinion. RESULTS & CONCLUSIONS :Drug e-commerce in China has experienced 4 stages of development ,and is now in a new stage of encouraging innovation ,inclusiveness and prudence. The newly revised Drug Administration Law and New Exposure Draft catch up with the trend of “Internet plus ”development in the new era ,and conditionally liberate the network prescription drug operation ,and build new advantages and new kinetic energy for the development of pharmaceutical business. The new network drug supervision mechanism is an important embodiment of the regulatory department ’s active adaptation to social development ,a specific practice of the innovation of scientific drug regulatory concept,and also provides legal guarantee and policy space for new business forms of innovation drug circulation. However ,the author thinks that the relationship between prescription drug information and drug advertising ,network prescription transmission and authenticity ,legitimacy audit ,as well as the concept definition of sales behavior and service behavior are still questionable. Relevant concepts and terms should be adjusted and redefined. It is suggested that online drug sellers should be defined as “drug e-commerce operators ”or“online drug operators ”. The third party platform of online drug trading is defined as “drug e-commerce platform operator ”or“online drug trading platform operator ”.

6.
China Pharmacy ; (12): 721-724, 2019.
Article in Chinese | WPRIM | ID: wpr-817031

ABSTRACT

OBJECTIVE: To provide reference and basis for our country to formulate policies for online prescription drug sales. METHODS: SWOT analysis was adopted to analyze the Strengths (S), Weaknesses (W), opportunities (O), threats (T) and other factors of prescription drug online sale so as to put forward policy reform suggestions. RESULTS & CONCLUSIONS: The online prescription drug sales had the advantages of better drug availability, improving cost affordability, promote information disclosure and break the monopoly, caught up with the country to vigorously promote the “Internet+” era opportunities. But online prescription drug sales also had disadvantages and threats such as inappropriate management mode, incomplete credit system and inadequate supervision. Conditional release of online prescription drug sales would be favorable to the internal and external environment and the overall development situation. It is suggested that under the condition of improving the ability of intelligent supervision, promote the adjustment of online prescription drug policy, allow Internet e-commerce to carry out prescription drug dispensing by prescription, and orderly release online prescription drug sales.

7.
China Pharmacy ; (12): 4613-4617, 2017.
Article in Chinese | WPRIM | ID: wpr-668667

ABSTRACT

OBJECTIVE:To provide reference for the perfection of relevant system of licensed pharmacist qualification exami-nation in China. METHODS:Using the self-made network questionnaire,the survey was conducted among the candidates who par-ticipated in the National Licensed Pharmacist Qualification Examination in 2016 about their evaluation on relevant system of li-censed pharmacist qualification examination. The survey data was analyzed statistically so as to put forward suggestions. RE-SULTS:A total of 4209 questionnaires were collected,including 4205 valid questionnaires with effective rate of 99.90%. 41.90%of the interviewed candidates thought that the examination paper was a good reflection of"to determine the content of the examina-tion according to the need"principle;nearly half of them thought the paper content was reasonable;69.25% thought that the prac-tice of examination paper for the overall promotion of candidates'professional skills and practice level of performance were not sat-isfactory. 80.10% and 68.94% of the interviewed candidates thought that the outline and guidelines of the new national licensed pharmacist qualification examination could guide the preparation of examination. More than half of the interviewed candidates be-lieved that pharmaceutical services and practical experience should be added in examination outline. 49.51% of the candidates thought the persons majoring in pharmacy and TCM should be allowed to participate in this examination. 39.52% of the candidates thought that the requirements of education degree for applicants should be increase to college or bachelor degree or above. 57.18%of the respondents considered that the validity of qualified branch scores should be extended. CONCLUSIONS:The vast majority of the candidates give a high evaluation on the new version of the national licensed pharmacist qualification examination outline and guideline,while some people think that the outline of the examination,the form of examination and entry criteria and other aspects need to be improved. It is recommended that the state attach importance to the cultivation of pharmacy service personnel,raise the threshold of entry and examination,improve the quality of examination quality and improve the form of examination and focus on requirements according to the different areas of practice examination.

8.
China Pharmacist ; (12): 714-716, 2017.
Article in Chinese | WPRIM | ID: wpr-512612

ABSTRACT

The 7th version (2015) of national examination syllabus for licensed pharmacists has been put into effect for more than two years,which has caused extensive concern of all sectors of society.This article summarized and evaluated thinking of the revision,content of the new version and the situation implementation to provide reference for further improving the system of licensed pharmacists.

9.
China Pharmacy ; (12): 4762-4765, 2015.
Article in Chinese | WPRIM | ID: wpr-502660

ABSTRACT

OBJECTIVE:To evaluate the value and social effect of the regulation by the indicator of drug proportion. METH-ODS:The scientificity and rationality of pharmaceutical proportion and the regulation activity by the indicator of drug proportion was analyzed by analyzing the connotation and influential factors of drug proportion and the method of comparative study,qualita-tive analysis and quantitative analysis. RESULTS:There was great difference in connotation and value between international drug proportion and domestic one. Indicator of drug proportion had no direct relation to pharmaceuticals consumption control and rational drug use;the value and effect of the regulation activity in a hospital by the indicator of drug proportion were far from complete and required further research. CONCLUSIONS:Health administrative department and policy decisions department should further re-search and objectively evaluate the value and effect of the regulation activity in a hospital by the indicator of drug proportion. Whether the regulation activity in a hospital by the indicator of drug proportion carry out based on scientific verification;if neces-sary,the indicator of drug proportion should be cancelled or adjusted in hospital management and evaluation indicator system.

10.
Article in Chinese | WPRIM | ID: wpr-355785

ABSTRACT

<p><b>OBJECTIVE</b>To observe the chronic combined effects of sodium fluoride and sodium arsenite on the Runx2 and downstream related factors of bone metabolism in SD rats.</p><p><b>METHODS</b>SD rats were divided randomly into nine groups of 6 each by factorial experimental design (half female and half male) , and supplied with the different doses of fluoride, arsenite and fluoride plus arsenite containing in deionized water (untreated control containing 0 mg/kg fluoride and 0 mg/kg arsenite, and low-fluoride and high supplemented with 5 and 20 mg/kg fluoride, and low-arsenite and high supplemented with 2.5 and 10 mg/kg arsenite, and low-fluoride plus low-arsenite, and low-fluoride plus high-arsenite, and high-fluoride plus low-arsenite, and high-fluoride plus high-arsenite, respectively) . After 6 months exposure, the concentration of Runx2, matrix metallopeptidase 9 (MMP-9) ,Osterix, Receptor activator for nuclear factor-κ β ligand (RANKL) were detected by enzyme-linked immunosorbent assay method, respectively.</p><p><b>RESULTS</b>There were no dental fluorosis found in the control group, low-arsenic group and high-arsenic group. There were significant differences in the constituent ratio of dental fluorosis among the rats from low-fluoride and high-fluoride (that is 5 rats out of 6 and 6 rats out of 6) compared with the control group (0 rat out of 6) (χ(2) = 8.57, 12.00, P < 0.05). The bone fluorine level increased with the increase of fluoride dose, the groups without fluoride supply (control group, low-arsenite and high-arsenite group's geometric mean (minimum-maximum) were 0.005 (0.003-0.009), 0.006 (0.003-0.021), 0.003 (0.002-0.100) mg/g, respectively), low-fluorine groups (low-fluoride group, low-fluoride plus low-arsenite, and low-fluoride plus high-arsenite group were 3.395 (2.416-5.871), 3.809 (1.471-7.799), 1.471 (1.473-6.732)mg/g, respectively) , the high-fluorine groups (high-fluoride, high-fluoride plus low-arsenite, and high-fluoride plus high-arsenite group were 70.086 (46.183-131.927), 69.925 (40.503-96.183), 40.503 (52.622-89.487) mg/g, respectively) and the differences between groups was significant (P < 0.05). The bone arsenic level increased with the increase of arsenite dose. The low-arsenic groups (low-arsenite group, low-arsenite plus low-fluoride, and low-arsenite plus high-fluoride group were 7.195 (5.060-9.860), 6.518 (2.960-12.130), 6.970 (3.400-9.730) µg/g, respectively), the high-arsenic groups (high-arsenite, high-arsenite plus low-fluoride, and high-fluoride plus high-arsenite group's geometric mean(minimum-maximum) were 8.823 (5.760-10.840), 9.470 (7.230-12.860), 8.321 (2.420-17.540) µg/g, respectively) were significantly higher than that in the groups without arsenic supply (control group, low-fluoride and high-fluoride group were 1.785 (0.300-3.750), 2.226 (1.410-3.980), 2.030 (1.040-3.850)µg/g, respectively) (P < 0.05). There was no significant difference of the bone arsenic concentration between low-arsenic and high arsenic group. There was significant positive correlation between fluoride concentration and Runx2, MMP-9, Osterix, RANKL level (the correlation coefficient was 0.647, 0.354, 0.582, 0.613 between fluorine gavage concentration and protein level, the correlation coefficient was 0.559,0.387, 0.487, 0.525 between bone fluorine concentration and protein level, respectively, P < 0.01). There was negative correlation between arsenite gavage concentration with Runx2 level (r = -0.527, P < 0.05) and was no correlation between arsenite gavage concentration with MMP-9, RANKL,Osterix level (P > 0.05). There was interaction between fluoride and arsenite to Runx2, MMP-9, RANKL,Osterix (F = 3.88, 15.66, 2.92, 6.42, respectively, P = 0.01, <0.01, 0.031, <0.01, respectively).</p><p><b>CONCLUSION</b>The combined effects of fluoride and arsenic on the Runx2, MMP-9, RANKL, Osterix of bone metabolism showed antagonistic effects.</p>


Subject(s)
Animals , Arsenites , Toxicity , Bone and Bones , Metabolism , Core Binding Factor Alpha 1 Subunit , Metabolism , Environmental Exposure , Female , Fluorides , Toxicity , Fluorosis, Dental , Pathology , Male , Matrix Metalloproteinase 9 , Metabolism , RANK Ligand , Metabolism , Rats , Rats, Sprague-Dawley , Transcription Factors , Metabolism
11.
Article in Chinese | WPRIM | ID: wpr-643004

ABSTRACT

Objective To determine whether arsenic has estrogen-like effects,the cell proliferation was measured iil human eervical cancer line(HeLa)in vitro.Methods The HeLa cells were grown in improved RPMI 1640 supplemented respectively with β-estradiol(E2,1 nmol/L),Arsenic trioxide(As2O3,0.5,1.0,5.0 μmol/L),ICI (500 nmol/L),E2(1 nmol/L)+ICI(500 nmol/L),As2O3(1.0 μmol/L)+ICI(500 nmol/L)and control.The growth morphology of HeLa cell was observed under microscope after 72 h.The method of M1Tr was used to study the cell proliferation after 24.48 and 72 h.The technique of flow eytometry was used to measure cell cycle after 48 h. Results HeLa cells in E2 and 0.5 μmoL/L As2O3 treatment were more better growth in morphology than control group.Percentage of HeLa cells proliferation at 24,48,72 h in E2 and 0.5 μmol/L As2O3 treatment were 6.35%, 11.56%,38.33%and 6.35%,8.50%,20.26%respectively.The proliferation effect of HeLa cells was similar in two treatments.The proliferation of HeLa cells were inhibited in other treatments.Compared with control[(41.68± 1.05)%],HeLa cells were promoted go to S phases in E2[(55.72±2.31)%]and 0.5 μmol/L As2O3[(47.82± 1.41)%]treatment.But in other treatments HeLa cells were hold back to S phases.Compared with control,there was a significant differenee(P<0.05)of cell percentage in S phases in 5.0 μmol/L As2O3[(21.11±4.99)%]and ICI[(20.16±4.76)%]treatments.Conclusion Small amounts of As2O3 impose estrogen.1ike effects and stimulate the proliferation of HeLa cells.

12.
Article in English | WPRIM | ID: wpr-269711

ABSTRACT

<p><b>AIM</b>There is an increasing evidence for the role of high risk human papillomavirus (HPV) in the pathogenesis of oral squamous cell carcinoma (OSCC). The purpose of this study is to evaluate the relevance of HPV infection to the survival and prognosis of OSCC.</p><p><b>METHODOLOGY</b>Fifty-two patients with OSCC were followed from 4 to 88 months with a median of 50.7 months. HPV DNA was identified in formalin-fixed, paraffin-embedded tumor specimens by nested PCR with MY09/MY11 and GP5+/GP6+ primer pairs and the HPV genotype was determined by direct DNA sequencing. Association between the HPV status and risk factors for cancer as well as tumor-host characteristics were analyzed. Survival curves were calculated by the Kaplan-Meier method and analyzed using the log-rank test.</p><p><b>RESULTS</b>HPV was found in 40.4% of the tumors with HPV16 accounting for 63.5%, HPV18 for 30.8%, HPV6 for 3.9% and HPV11 for 1.8%. No infection with more than one HPV genotype was detected. HPV infection was significantly associated with poor histological grade, TNM stage I-II, alcohol usage and no smoking status. Multivariate analysis showed that HPV had an independent prognostic effect on the overall survival after adjusting other confounding factors such as histological grade, TNM stage and tobacco usage. The presence of HPV was significantly correlated with a better survival in patients with OSCC.</p><p><b>CONCLUSION</b>HPV infection can act as an independent predictor for the survival and prognosis of OSCC.</p>


Subject(s)
Alcohol Drinking , Alphapapillomavirus , Classification , Physiology , Carcinoma, Squamous Cell , Virology , Cause of Death , DNA, Viral , Female , Follow-Up Studies , Forecasting , Genotype , Human papillomavirus 11 , Physiology , Human papillomavirus 16 , Physiology , Human papillomavirus 18 , Physiology , Human papillomavirus 6 , Physiology , Humans , Male , Middle Aged , Mouth Neoplasms , Virology , Neoplasm Staging , Papillomavirus Infections , Virology , Prognosis , Risk Factors , Sequence Analysis, DNA , Smoking , Survival Rate
13.
Article in Chinese | WPRIM | ID: wpr-382143

ABSTRACT

Objective To observe the effect of local mild hypothermia and Naloxone in the treatment of acute intracerebral hemorrhage. Methods Forty-five patients with acute intracerebral hemorrhage were randomly divided into 4 groups:a control group(12 patients),a hypothermia group(11 patients),a Naloxone group(11 patients)and a hypothemrmia plus Naloxone group(11 patients).The patients in the control group were managed with conventional interventions including the administration of 6-aminocaproic acid within 24 hours and dehydrant when intracranial pressure was high.Those in the hypothermia and Naloxone groups were treated with local hypothermia at 33~34 ℃ for 3 days or intravenous transfusion of Naloxone at 4 mg/d in addition to the conventional intervention.Those in the combination group were treated with local hypothermia and intravenous Naloxone in addition to the conventional intervention.Immediately after admission and 2 weeks after treatment,head CT scans were conducted to observe the volume of cerebral hematoma and edema.The patients' neurological function was scored according to the European Stroke Standards(ESS)before and after treatment. Results There was no significant difference among the 4 groups in terms of the volume of hematoma and edema or in their ESS scores before treatment.After treatment,any differences among the 4 groups with regard to hematoma volume were not significant.The volume of edema in the hypothermia group was similar to that in the combination group and significantly lower than that in the Naloxone andcontrol groups.Hematoma volume in the Naloxone group was significantly lower than that in the control group.After treatment,the ESS scores were significantly higher in the combination group than that in hypothermia group,and scores in the hypothermia group were significantly higher than in the Naloxone group.ESS scores in the Naloxone group were significantly higher that in the control group. Conclusion Local mild hypothermia and Naloxone treatment can inhibit cerebral edema and enhance recovery of neurological function in patients with intracerebral hemorrhage.Local mild hypothermia has advantages over Naloxone in inhibiting the development of cerebral edema and in promoting recovery of neurological function.Local mild hypothermia in combination with Naloxone further inhibits edema,and it can enhance neurological function to a greater extent.

14.
Article in Chinese | WPRIM | ID: wpr-267914

ABSTRACT

This study was purposed to investigate the angiogenin (ANG) expression in COS-7 cells and its biological activity. The gene of angiogenin was obtained from mononuclear cells of peripheral blood by using RT-PCR and inserted into eukaryotic expression vector of pcDNA3.1. After being transfected into COS-7 cells, the recombinant ANG was identified by Western blot assay. The function of promoting proliferation of ANG to ECV304 cells was detected by MTT method, and its activity of vascularization was analyzed by chick embryo chorioallantois treated by the culture supernatant after transfection with pcDNA3.1-ang. The result showed that recombinant ANG was expressed in COS-7 cells after transfection for 24 to 36 hours. It could specifically react with monoclonal antibody against ANG. The recombinant ANG could obviously promote the proliferation of ECV304 cells. In contrast with the control group, the culture supernatant of pcDNA3.1-ang transfected group could stimulate the angiogenesis in embryo chorioallantois. It is concluded that the ang transiently expresses in COS-7 cells, and its expression product obviously stimulates the cell proliferation and angiogenesis.


Subject(s)
Angiogenesis Inducing Agents , Pharmacology , Animals , COS Cells , Metabolism , Cell Line , Cell Proliferation , Chlorocebus aethiops , Endothelial Cells , Cell Biology , Genetic Vectors , Genetics , Humans , Recombinant Fusion Proteins , Genetics , Pharmacology , Ribonuclease, Pancreatic , Genetics , Pharmacology , Transfection
15.
China Pharmacy ; (12)1991.
Article in Chinese | WPRIM | ID: wpr-529874

ABSTRACT

OBJECTIVE:To provide suggestions for the documentation and management of drug records.METHODS:To analysis the related legal problems of relationships between drug records and medical records,medication records and patient rights,drug records' role as evidence,legal responsibility and risk,countermeasures and recommendations will be presented.RESULTS & CONCLUSIONS:From the legal perspective,the drug record can be used as evidence as medical record and the inappropriate documentation of medication record may lead to legal responsibility.It is important to have a good understanding of the legal meaning of drug records,improve the documentation of drug records and enhance the management of drug records.

16.
Article in Chinese | WPRIM | ID: wpr-553736

ABSTRACT

To study the changes in serum immunosuppressive acidic protein (IAP) and T lymphocytes rDNA transcription activity in peripheral blood of patients with pancreatic cancer before and after operation. The level of IAP and T lymphocytes rDNA transcription activity in peripheral blood of 58 patients with pancreatic cancer were measured before and after opreration by one directional immunodiffusion test and a cell image analysis of Ag NORs, respectively, and the results were compared with that of healthy controls. The level of IAP was higher while T lymphocytes rDNA transcription activity was lower before operation compared with healthy controls( P 0 05). The levels of IAP and T lymphocytes rDNA transcription activity were closely related to tumor invasion, metastasis and clinical stages (TNM). Serial determination of the levels of IAP and T lymphocytes rDNA transcription activity might serve as an important index for evalution of tumor invasion and metatasis, and also prognosis for the patients with pancreatic cancer

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