Pub Date : 2023-06-21DOI: 10.25073/2588-1132/vnumps.4501
Dang Thuy Tien, Nguyễn Thi Thuy, Vu Manh Ha, Bui Thanh Tung
Zanthoxylum simulans Hance. is known in folklore as a spicy herb, commonly used to treat cold-induced diseases in the body. In this study, we evaluated the cytotoxic effects of Zanthoxylum simulans fruit bark extract. Samples of Zanthoxylum simulans were extracted with 70% ethanol and subsequently fractionated with n-Hexane, ethyl acetate (EtOAc), and n-butanol (n-BuOH) solvents. To evaluate the cytotoxic effect, we performed SRB (Sulforhodamine B) assay on the three cell lines human liver HepG2, lung SK-LU-1, and cervical carcinoma Hela. The results showed that the EtOH total extract had the strongest cytotoxicity effects on liver cancer cells with an IC50 of 63.68±3.97 mg/mL, but showed no toxicity to SK-LU-1 lung cancer or Hela cervical cancer cells. The results of cytotoxic effects on HepG2 liver cancer cells of these fractions showed that the n-Hexane and EtOAc fractions exhibited activity with IC50 values of 17.12±0.94 and 28.45±2.85 µg/mL, respectively, while the n-BuOH and H2O fractions showed no activity. Our results showed that Zanthoxylum simulans fruit bark extract has a strong cytotoxicity effect on liver cancer cells.
{"title":"Cytotoxicity Effects of Zanthoxylum simulans Hance. Fruit Bark Extract","authors":"Dang Thuy Tien, Nguyễn Thi Thuy, Vu Manh Ha, Bui Thanh Tung","doi":"10.25073/2588-1132/vnumps.4501","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4501","url":null,"abstract":"Zanthoxylum simulans Hance. is known in folklore as a spicy herb, commonly used to treat cold-induced diseases in the body. In this study, we evaluated the cytotoxic effects of Zanthoxylum simulans fruit bark extract. Samples of Zanthoxylum simulans were extracted with 70% ethanol and subsequently fractionated with n-Hexane, ethyl acetate (EtOAc), and n-butanol (n-BuOH) solvents. To evaluate the cytotoxic effect, we performed SRB (Sulforhodamine B) assay on the three cell lines human liver HepG2, lung SK-LU-1, and cervical carcinoma Hela. The results showed that the EtOH total extract had the strongest cytotoxicity effects on liver cancer cells with an IC50 of 63.68±3.97 mg/mL, but showed no toxicity to SK-LU-1 lung cancer or Hela cervical cancer cells. The results of cytotoxic effects on HepG2 liver cancer cells of these fractions showed that the n-Hexane and EtOAc fractions exhibited activity with IC50 values of 17.12±0.94 and 28.45±2.85 µg/mL, respectively, while the n-BuOH and H2O fractions showed no activity. Our results showed that Zanthoxylum simulans fruit bark extract has a strong cytotoxicity effect on liver cancer cells.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89904748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-21DOI: 10.25073/2588-1132/vnumps.4509
Ha Xuan Nghia, Nguyen Tuan Son, Dao Dinh Linh, Le Thi Nhung, Pham Duc Duy, Nguyen Trung Duy
Objectives: studying clinical and paraclinical characteristics of laryngeal cancer. Patients and methods: 31 laryngeal cancer patients were diagnosed and treated in the Oncology Department of the national otorhinolaryngology hospital of Vietnam from 11/2022 to 4/2023 by a cross-sectional descriptive study. The results: patients having the most common age range was 60-80 occupied 52.8%, and the mean age was 60.5 ± 9.4, ranging from 35 to 80. Males occupied 97.2% (35/36), females 2.8% (1/36). The most common functional symptom was hoarseness with 94.4%. The mean time of symptom onset was 5.9 ± 6.1, ranging from 1-36 months. The most common tumor site is the vocal cords, accounting for 97.2% of endoscopic and 80.6% of CT SCAN findings. Squamous cell carcinoma accounts for 100%. Tumors in stage I account for 50%. Surgery is the main treatment (75%). Conclusion: Laryngeal cancer is one of the cancers with a high rate in our country. The symptoms are usually non-specific, with hoarseness being the most common symptom. The common form of the disease is squamous cell carcinoma, and surgical treatment at an early stage is the main method.
{"title":"Research of Clinical and Paraclinical Characteristics of Laryngeal Cancer of National Otorhinolaryngology Hospital of Vietnam from 11/2022 to 4/2023","authors":"Ha Xuan Nghia, Nguyen Tuan Son, Dao Dinh Linh, Le Thi Nhung, Pham Duc Duy, Nguyen Trung Duy","doi":"10.25073/2588-1132/vnumps.4509","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4509","url":null,"abstract":"Objectives: studying clinical and paraclinical characteristics of laryngeal cancer. Patients and methods: 31 laryngeal cancer patients were diagnosed and treated in the Oncology Department of the national otorhinolaryngology hospital of Vietnam from 11/2022 to 4/2023 by a cross-sectional descriptive study. The results: patients having the most common age range was 60-80 occupied 52.8%, and the mean age was 60.5 ± 9.4, ranging from 35 to 80. Males occupied 97.2% (35/36), females 2.8% (1/36). The most common functional symptom was hoarseness with 94.4%. The mean time of symptom onset was 5.9 ± 6.1, ranging from 1-36 months. The most common tumor site is the vocal cords, accounting for 97.2% of endoscopic and 80.6% of CT SCAN findings. Squamous cell carcinoma accounts for 100%. Tumors in stage I account for 50%. Surgery is the main treatment (75%). Conclusion: Laryngeal cancer is one of the cancers with a high rate in our country. The symptoms are usually non-specific, with hoarseness being the most common symptom. The common form of the disease is squamous cell carcinoma, and surgical treatment at an early stage is the main method.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91542393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-21DOI: 10.25073/2588-1132/vnumps.4449
Vuong Dieu Linh, Chu Hoang Ha, Nguyen Ngoc Quang
This study aims to evaluate the mutation status of KRAS, BRAF, NRAS, PIK3CA, and AKT and analyze the association of gene mutations with clinicopathological characteristics of colorectal cancer. 151 colorectal cancer patients were diagnosed at Pathology and Molecular Biology Center in National Cancer Hospital K. The research was conducted as a cross-sectional study using methods such as genomic DNA extraction; mutation analysis by Real-time PCR. Mutation rates of KRAS, BRAF, NRAS, PIK3CA, and AKT were 37.1%, 7.3%, 2.6%, 12.6%, and 1.3%, respectively. KRAS mutation was significantly associated with the size tumor. Additionally, KRAS mutation was mutually exclusive against that of BRAF mutation and tended to coexist with PIK3CA mutation (p<0.05). In conclusion, the most popular mutation in colorectal cancer was KRAS. These were different in gene mutations with clinicopathological characteristics as well as each mutation with others.
{"title":"Analysis Characteristics of Genetic Alterations in Colorectal Cancer","authors":"Vuong Dieu Linh, Chu Hoang Ha, Nguyen Ngoc Quang","doi":"10.25073/2588-1132/vnumps.4449","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4449","url":null,"abstract":"This study aims to evaluate the mutation status of KRAS, BRAF, NRAS, PIK3CA, and AKT and analyze the association of gene mutations with clinicopathological characteristics of colorectal cancer. 151 colorectal cancer patients were diagnosed at Pathology and Molecular Biology Center in National Cancer Hospital K. The research was conducted as a cross-sectional study using methods such as genomic DNA extraction; mutation analysis by Real-time PCR. Mutation rates of KRAS, BRAF, NRAS, PIK3CA, and AKT were 37.1%, 7.3%, 2.6%, 12.6%, and 1.3%, respectively. KRAS mutation was significantly associated with the size tumor. Additionally, KRAS mutation was mutually exclusive against that of BRAF mutation and tended to coexist with PIK3CA mutation (p<0.05). In conclusion, the most popular mutation in colorectal cancer was KRAS. These were different in gene mutations with clinicopathological characteristics as well as each mutation with others.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"72 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88511743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-21DOI: 10.25073/2588-1132/vnumps.4389
Hoang Dinh Au, Doan Van Ngoc
A study of 100 patients with ureteral kidney stones, in which 66 cases of kidney stones and 68 cases of ureteral stones were taken with 128 slices of computerized tomography at Hanoi Medical University Hospital from September 2019 to the end of January 2020. Results: male/female ratio was 1.7/1. The mean age was 51.2 ± 11.7. The rate of renal function decline (creatinine increase) was 18%. The supersonic, X-ray, and Multi-slice Computer Tomography (MSCT) detected stones in 89%, 84%, and 100% of cases, respectively, including 32% of kidney stones, 34% of ureteral stones, 34% of stones in both kidneys and ureters, 63.6% kidney stones in many positions. Patients with two or more stones accounted for 78.8% and the average kidney stone size was 15.5 ± 10.9 mm. Ureteral stones in the upper third accounted for 54.4%, one stone accounted for 77.9%, and the average size of ureteral stones was 9.1 ± 3.6 mm. Complications of nephrolithiasis caused by stones account for 82%, and grades II and III are the most common. Complications of ureteral dilatation due to stones accounted for 51%, perirenal fat infiltration accounted for 24% and 32% of cases of drug excretion lasted more than 1 hour. Conclusion: MSCT plays an important role in diagnosing urinary stones and assessing renal function before treatment.
{"title":"Evaluation of the Role of MSCT in the Diagnosis of Ureteral Kidney Stones","authors":"Hoang Dinh Au, Doan Van Ngoc","doi":"10.25073/2588-1132/vnumps.4389","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4389","url":null,"abstract":"A study of 100 patients with ureteral kidney stones, in which 66 cases of kidney stones and 68 cases of ureteral stones were taken with 128 slices of computerized tomography at Hanoi Medical University Hospital from September 2019 to the end of January 2020. Results: male/female ratio was 1.7/1. The mean age was 51.2 ± 11.7. The rate of renal function decline (creatinine increase) was 18%. The supersonic, X-ray, and Multi-slice Computer Tomography (MSCT) detected stones in 89%, 84%, and 100% of cases, respectively, including 32% of kidney stones, 34% of ureteral stones, 34% of stones in both kidneys and ureters, 63.6% kidney stones in many positions. Patients with two or more stones accounted for 78.8% and the average kidney stone size was 15.5 ± 10.9 mm. Ureteral stones in the upper third accounted for 54.4%, one stone accounted for 77.9%, and the average size of ureteral stones was 9.1 ± 3.6 mm. Complications of nephrolithiasis caused by stones account for 82%, and grades II and III are the most common. Complications of ureteral dilatation due to stones accounted for 51%, perirenal fat infiltration accounted for 24% and 32% of cases of drug excretion lasted more than 1 hour. Conclusion: MSCT plays an important role in diagnosing urinary stones and assessing renal function before treatment.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86939989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-21DOI: 10.25073/2588-1132/vnumps.4503
Nguyen Thanh Hai, Pham Thi Thuy Van, Ly Cong Thanh, Luong Thi Lap, Can Khanh Linh, Nguyen Xuan Bach
Drug-drug interaction is one of the drug-related problems that can reduce therapeutic efficacy or increase the risk of undesirable effects. Subjects and methods: interventional study design with before-after comparison. In the pre-intervention period, we retrospectively carried out all electronic prescriptions and medical records of inpatients treated from 01/11/2021 to 31/01/2022. In the post-intervention period, we prospectively performed monitoring reports on the drug-drug interaction warning system and medical records of inpatients from 01/02/2022 to 31/03/2022. Results: The proportion of patients exposed to drug-drug interactions (DDIs) decreased significantly from 4.27% in the pre-intervention period to 3.56% in the post-intervention period (p<0.05). There were no medical records with contraindicated DDIs in the post-intervention period. The percentage of patients for contraindication DDIs with conditions determined to patients with the condition was 39.33% and 27.59%, respectively, in the pre-and post-intervention phases. Medical records rate with major DDIs decreased significantly in the post-intervention period (2.95% vs 3.68%; p<0.05). Conclusion: Clinical decision support systems with drug-drug interaction warnings and clinical pharmacy activities help to reduce the frequency of DDIs. The results show that the combination of these two measures initially brings about effective DDIs management in hospitals.
药物-药物相互作用是药物相关问题之一，可降低治疗效果或增加不良反应的风险。研究对象和方法:介入研究设计，前后比较。在干预前，我们回顾性分析了2021年11月1日至2022年1月31日住院患者的所有电子处方和病历。干预后，我们前瞻性地对2022年2月1日至2022年3月31日住院患者的药物-药物相互作用预警系统和病历进行监测报告。结果:出现药物-药物相互作用(ddi)的患者比例由干预前的4.27%下降至干预后的3.56% (p < 0.05)。干预后无ddi禁忌的医疗记录。在干预前和干预后两阶段，确定病情的患者使用禁忌症ddi的比例分别为39.33%和27.59%。重度ddi患者的医疗记录率在干预后显著下降(2.95% vs 3.68%;术中,0.05)。结论:具有药物相互作用警示和临床药学活动的临床决策支持系统有助于减少ddi的发生。结果表明，这两种措施的结合初步实现了医院ddi管理的有效实施。
{"title":"Effect of Clinical Decision Support System and Clinical Pharmacists’ Practice in Preventing Drug-drug Interactions among Inpatients in Bac Ninh General Hospital","authors":"Nguyen Thanh Hai, Pham Thi Thuy Van, Ly Cong Thanh, Luong Thi Lap, Can Khanh Linh, Nguyen Xuan Bach","doi":"10.25073/2588-1132/vnumps.4503","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4503","url":null,"abstract":"Drug-drug interaction is one of the drug-related problems that can reduce therapeutic efficacy or increase the risk of undesirable effects. Subjects and methods: interventional study design with before-after comparison. In the pre-intervention period, we retrospectively carried out all electronic prescriptions and medical records of inpatients treated from 01/11/2021 to 31/01/2022. In the post-intervention period, we prospectively performed monitoring reports on the drug-drug interaction warning system and medical records of inpatients from 01/02/2022 to 31/03/2022. Results: The proportion of patients exposed to drug-drug interactions (DDIs) decreased significantly from 4.27% in the pre-intervention period to 3.56% in the post-intervention period (p<0.05). There were no medical records with contraindicated DDIs in the post-intervention period. The percentage of patients for contraindication DDIs with conditions determined to patients with the condition was 39.33% and 27.59%, respectively, in the pre-and post-intervention phases. Medical records rate with major DDIs decreased significantly in the post-intervention period (2.95% vs 3.68%; p<0.05). Conclusion: Clinical decision support systems with drug-drug interaction warnings and clinical pharmacy activities help to reduce the frequency of DDIs. The results show that the combination of these two measures initially brings about effective DDIs management in hospitals.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136355468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-20DOI: 10.25073/2588-1132/vnumps.4526
Nguyen Hue Linh, Pham Thi Minh Hue, Nguyen Thi Mai Anh, Bui Thi Thuong, N. Van Khanh, Nguyen Thi Thanh Binh, Nguyen Thi Hai Yen, Dang Kim Thu, Bui Thanh Tung, Tu Minh Koong, Nguyen Thi Thanh Hai
The group of protein drugs has been developing very strongly, promising great advances in diagnosis, treatment, prevention, and human health improvement. Protein drug production is a large area of research, requiring advanced scientific and technological expertise, and integration of multi-disciplinary technology from fields such as biology, genetics, biotechnology, protein extraction and purification, and pharmaceutical manufacturing. As protein drug manufacture involves biosynthesis processes using different cell lines, biopharmaceuticals have some distinct characteristics from small-molecule synthetic drugs, such as variability of biological processes, diversity of synthetic proteins, therefore leading to some differences in research and development, approval procedures, bioactivity testing, quality control and quality assurance and the production of “generic” biopharmaceuticals - biosimilars. This article provides an overview of protein drug production from the initial stage to the finished product process, to identify and promote training activities, research and development, and knowledge transfer, contributing to the development of the biopharmaceutical industry in Vietnam, as well as effectively applying the drugs in clinical practice. Protein drug production is a valuable industrial field, with the goal of not only protecting and taking care of people's health but also developing national research, manufacturing, scientific and technological capacity, and bringing economic value. Keywords: Protein drug, biopharmaceuticals, formulation, biosimilars.
{"title":"Protein Drug Production","authors":"Nguyen Hue Linh, Pham Thi Minh Hue, Nguyen Thi Mai Anh, Bui Thi Thuong, N. Van Khanh, Nguyen Thi Thanh Binh, Nguyen Thi Hai Yen, Dang Kim Thu, Bui Thanh Tung, Tu Minh Koong, Nguyen Thi Thanh Hai","doi":"10.25073/2588-1132/vnumps.4526","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4526","url":null,"abstract":"The group of protein drugs has been developing very strongly, promising great advances in diagnosis, treatment, prevention, and human health improvement. Protein drug production is a large area of research, requiring advanced scientific and technological expertise, and integration of multi-disciplinary technology from fields such as biology, genetics, biotechnology, protein extraction and purification, and pharmaceutical manufacturing. \u0000As protein drug manufacture involves biosynthesis processes using different cell lines, biopharmaceuticals have some distinct characteristics from small-molecule synthetic drugs, such as variability of biological processes, diversity of synthetic proteins, therefore leading to some differences in research and development, approval procedures, bioactivity testing, quality control and quality assurance and the production of “generic” biopharmaceuticals - biosimilars. \u0000This article provides an overview of protein drug production from the initial stage to the finished product process, to identify and promote training activities, research and development, and knowledge transfer, contributing to the development of the biopharmaceutical industry in Vietnam, as well as effectively applying the drugs in clinical practice. Protein drug production is a valuable industrial field, with the goal of not only protecting and taking care of people's health but also developing national research, manufacturing, scientific and technological capacity, and bringing economic value. \u0000Keywords: Protein drug, biopharmaceuticals, formulation, biosimilars. \u0000 \u0000 ","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85080469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-20DOI: 10.25073/2588-1132/vnumps.4485
Nguyen Thanh Hai, Tang Quoc Hung, Tran Bich Ngoc
After more than 10 years of implementation of in vivo Bioequivalence study, there are 835 Bioequivalence drugs licensed to manufacture in Vietnam, accounting for 77.89% of Bioequivalence drugs licensed to circulate on the Vietnamese pharmaceutical market in the period 2012-2022, a worthwhile result. An achievement in the development of In vivo Bioequivalence study in recent years is that the state management agency (Ministry of Health) has increased the required active ingredients to submit bioequivalence study reports for drug registration in Vietnam from 12 active pharmaceutical ingredients to 26 active pharmaceutical ingredients. In the next few years, this number will gradually increase. Therefore, the Government should introduce promotion, development, and preferential policies for enterprises to invest in these ingredients. This paper aims at providing Vietnam pharmaceutical enterprises with an overview of information on the current state of bioequivalence drugs license in Vietnam; supporting the implementation of these studies in practice.
Keywords: Bioequivalence, BABE, BE, Regulations, Registration.
{"title":"In Vivo Bioequivalence Study of Drug: An Analysis of Registration in Vietnam Period 2012-2022","authors":"Nguyen Thanh Hai, Tang Quoc Hung, Tran Bich Ngoc","doi":"10.25073/2588-1132/vnumps.4485","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4485","url":null,"abstract":"After more than 10 years of implementation of in vivo Bioequivalence study, there are 835 Bioequivalence drugs licensed to manufacture in Vietnam, accounting for 77.89% of Bioequivalence drugs licensed to circulate on the Vietnamese pharmaceutical market in the period 2012-2022, a worthwhile result. An achievement in the development of In vivo Bioequivalence study in recent years is that the state management agency (Ministry of Health) has increased the required active ingredients to submit bioequivalence study reports for drug registration in Vietnam from 12 active pharmaceutical ingredients to 26 active pharmaceutical ingredients. In the next few years, this number will gradually increase. Therefore, the Government should introduce promotion, development, and preferential policies for enterprises to invest in these ingredients. This paper aims at providing Vietnam pharmaceutical enterprises with an overview of information on the current state of bioequivalence drugs license in Vietnam; supporting the implementation of these studies in practice.
 Keywords: Bioequivalence, BABE, BE, Regulations, Registration.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"141 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135187211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-20DOI: 10.25073/2588-1132/vnumps.4522
Tran Thi Van Anh, Pham Quoc Tuan, N. Van Khanh, Dao Viet Hung, Nguyen Thi Thanh Hai, Tran Van Thao, Nguyen Thi Hong Nhung, Ngo Thi Xuan Thinh, Ha Thanh Hoa, Nguyen Xuan Truong
Herba Siegesbeckiae is a medicinal material derived from the aerial part of Siegesbeckia orientalis, which is used to treat various types of pain such as back, knees, bones, joints, and numbness of limbs. This plant contains several phenolic compounds, including chlorogenic acid (1), caffeic acid (2), and rutin (3). They were chosen as marker compounds to develop a quantification method. In this study, a high-performance liquid chromatography (HPLC) method with a DAD detector was used to simultaneously quantify these three compounds (1-3). The Agilent C18 column (250 x 4.6 mm; 5 µm) was used for the separation of the analytes, and the mobile phase consisted of MeCN - 0.1% phosphoric acid in water with gradient elution. The flow rate was 1.0 ml/min, and the detection wavelength was 320 nm for 1 and 2, and 360 nm for 3. The injection volume was 20 µl. The method was validated according to the guidelines of ICH and AOAC on system suitability, specificity, linearity, precision, and accuracy. The established quantification method was applied to determine the content of compounds 1, 2, and 3 in samples of Herba Siegesbeckiae, which were found to be 0.09-0.82 mg/g, 0.02-0.21 mg/g, 0.07-0.52 mg/g, respectively. This quantification method can be used to assess the quality of Herba Siegesbeckiae and related products.
{"title":"Simultaneous Quantification of Acid chlorogenic, Acid caffeic and Rutin in Herba Siegesbeckiae orientalis by HLPC Method","authors":"Tran Thi Van Anh, Pham Quoc Tuan, N. Van Khanh, Dao Viet Hung, Nguyen Thi Thanh Hai, Tran Van Thao, Nguyen Thi Hong Nhung, Ngo Thi Xuan Thinh, Ha Thanh Hoa, Nguyen Xuan Truong","doi":"10.25073/2588-1132/vnumps.4522","DOIUrl":"https://doi.org/10.25073/2588-1132/vnumps.4522","url":null,"abstract":"Herba Siegesbeckiae is a medicinal material derived from the aerial part of Siegesbeckia orientalis, which is used to treat various types of pain such as back, knees, bones, joints, and numbness of limbs. This plant contains several phenolic compounds, including chlorogenic acid (1), caffeic acid (2), and rutin (3). They were chosen as marker compounds to develop a quantification method. In this study, a high-performance liquid chromatography (HPLC) method with a DAD detector was used to simultaneously quantify these three compounds (1-3). The Agilent C18 column (250 x 4.6 mm; 5 µm) was used for the separation of the analytes, and the mobile phase consisted of MeCN - 0.1% phosphoric acid in water with gradient elution. The flow rate was 1.0 ml/min, and the detection wavelength was 320 nm for 1 and 2, and 360 nm for 3. The injection volume was 20 µl. The method was validated according to the guidelines of ICH and AOAC on system suitability, specificity, linearity, precision, and accuracy. The established quantification method was applied to determine the content of compounds 1, 2, and 3 in samples of Herba Siegesbeckiae, which were found to be 0.09-0.82 mg/g, 0.02-0.21 mg/g, 0.07-0.52 mg/g, respectively. This quantification method can be used to assess the quality of Herba Siegesbeckiae and related products.","PeriodicalId":23520,"journal":{"name":"VNU Journal of Science: Medical and Pharmaceutical Sciences","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87656879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-06DOI: 10.25073/2588-1132/vnumps.4523
Nguyễn Văn Sơn, Nguyen Phuong Anh
Abstract: Abdominal aortic aneurysm is a swelling (aneurysm) of the aorta. Abdominal aortic aneurysms often grow slowly without noticeable symptoms, so screening by clinical examination combined with imaging methods to detect disease early helps to reduce morbidity and mortality. Computed tomography (CT) is becoming increasingly common and has become a good method for detecting abdominal aortic aneurysms. This study aims to describe the imaging characteristics of aortic aneurysm of computed tomography scanner at E Hospital. A retrospective and prospective descriptive study on 34 patients with abdominal aortic aneurysm on CTscanner at E Hospital from June 2022 to May 2023. The results indicated that past 60 age: 94.1%. Male: 61.8%, female: 38.2%. Aneurysm of under renal artery: 100%. Lozenge aneurysm: 97.1%, Bag shape aneurysm: 2.9%. Calcify of vessel wall: 61.8%. Thrombosis of vessel wall: 58.8%. Diameter of aneurysm ≤ 50mm: 82.4% and length of aneurysm ≤50mm: 61.8%. Injury of lateral artery: 35.3%, include of iliac artery: 41.7%. Conclusion: Computed tomography helps to identify and evaluate the characteristics of the aneurysm, thereby contributing an important part to making treatment methods for patients Keywords: Abdominal aorta aneurysm, imaging characteristics, CT.
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Pub Date : 2023-05-15DOI: 10.25073/2588-1132/vnumps.4512
Dinh Thi Huyen Trang, Bui Van Trung, Ngo Quoc Anh, Duong Hong Anh, Pham Hung Viet
According to the traditional know-how, the Northern wild pineapple (Pandanus tonkinensis) has been used efficiently as a major component of oriental remedies for liver protection. Based on the experimentally found chemical composition of Pandanus tonkinensis and their obtained biological activities in terms of the hepatoprotection purpose, two structure-elucidated compounds pinoresinol 4-O-beta-D-glucopyranoside and vladinol F were selected as potential markers for this medical plant. This paper is aiming to present the validation of proposed HPLC method for simultaneous quantification of the both pinoresinol 4-O-beta-D-glucopyranoside and vladinol F in the fruits of Pandanus tonkinensis with the following conditions: using RP-C18 (250 mm × 4.6 mm; 5 μm) column, detection wavelength measured at 228 nm, the mobile phases consisting of acetonitrile and 0.1% acetic acid in gradient mode with a flow rate of 1mL/min and injection volume was 10 mL. Method validation showed a high specificity, linear calibration ranging from 25.5 to 76.4 mg/ml (r= 0.9991) and from 26.0 to 77.9 mg/ml (r= 0.9987) for two markers, respectively. Besides, a good repeatability and intermediate precisions (RSD < 2%), a reliable accuracy (recovery efficiency between 99.4 and 101.5%, RSD < 1.73%) as well as the obtained limits of quantification in values of 2.55 m/g and 2.60 mg/g for the two mentioned markers were received. Using the above validated method, the content of two markers - pinoresinol 4-O-beta-D-glucopyranoside and vladinol F in Pandanus tonkinensis fruits collected from different locations (Thanh Hoa, Hoa Binh, Thai Nguyen) had been determined falling in the range of 0.0250 - 0.0435 mg/g and 0.0243 - 0.0371 mg/g, respectively. Keywords: pinoresinol 4-O-beta-D-glucopyranoside, vladinol F, markers, Pandanus tonkinensis, HPLC
根据传统的技术诀窍，北方野生菠萝(Pandanus tonkinensis)被有效地用作东方护肝疗法的主要成分。根据实验发现的东金熊猫的化学成分及所获得的保肝生物学活性，选择两种结构已明确的化合物松脂醇4- o - β - d -葡萄糖吡喃苷和椰油醇F作为该药用植物的潜在标记物。建立了以RP-C18 (250 mm × 4.6 mm)为高效液相色谱(HPLC)同时定量测定东金兔果实中松脂醇4- o - β - d -葡萄糖苷和松脂醇F的方法。色谱柱为5 μm)，检测波长为228 nm，流动相为乙腈- 0.1%乙酸，梯度流动，流速为1mL/min，进样量为10 mL。方法验证表明，两种标记物的线性定标范围分别为25.5 ~ 76.4 mg/ mL (r= 0.9991)和26.0 ~ 77.9 mg/ mL (r= 0.9987)。该方法重复性好，中间精密度(RSD < 2%)，准确度可靠(回收率在99.4 ~ 101.5%之间，RSD < 1.73%)，定量限分别为2.55 m/g和2.60 mg/g。采用该方法测定了不同产地(清化、和平、太原)冬香果中松脂醇4- o - β - d -葡萄糖苷和缬草酚F的含量，测定范围分别为0.0250 ~ 0.0435 mg/g和0.0243 ~ 0.0371 mg/g。关键词:松脂醇4- o - β - d -glucopyranoside, vladi酚F，标记物，熊猫，HPLC
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