S. E. Nugraha, J. M. Keliat, R. A. Syahputra, Sony Eka, Nugraha
{"title":"研究甜菜红素化合物的毒性:对标准化β-庸俗草提取物的硅学分析和体内预测","authors":"S. E. Nugraha, J. M. Keliat, R. A. Syahputra, Sony Eka, Nugraha","doi":"10.22159/ijap.2024v16i1.49189","DOIUrl":null,"url":null,"abstract":"Objective: Extensive research has been conducted on beetroot's antioxidant, hematoprotective, and cardioprotective properties. However, there currently needs to be more available evidence pertaining to the toxicity assessment of the extract. The toxicity assessment was conducted using both in silico and in vivo methods. Prior to testing, the extracts were standardized in accordance with the guidelines set by the Indonesian Food Drug Authority (BPOM), which is the regulatory authority for food and drugs in Indonesia.\nMethods: The experimental subjects consisted of 25 male Wistar rats in good health, weighing between 150 and 170 grams. These rats were separated into five groups, each including five rats. Group 1 will serve as the control group, while groups 2 through 5 will be designated as the treatment groups. The analysis of chemical toxicity was conducted using pK-CSM, SwissADME, and Pro-Tox II methodologies.\nResults: The results indicated that the standardized ethanol extract contained 4.341% water, 3.67 % total ash, and 1.53 % acid-insoluble ash. Lead (Pb) and cadmium (Cd) were absent at a concentration of 0 parts per million (ppm). Subsequently, the total plate count and yeast mould count were 0.47 5 x 10-4 (CFU/g) and a of 0.382 x 10-4 (CFU/g) respectively. This finding implies that the extract meets BPOM requirement. This study also measured the betalain content of red beetroot, yielding a total concentration of 11.34 0.37 mg/100 gram of sample. Haematological experiments showed that beetroot extract affected rat blood haematology. Compared to the control group, rats given the extract had higher red blood cell and platelet counts. Additionally, the Insilico toxicity test conducted on the active component derived from beetroot revealed LD50 of the compounds ranged from 305 mg/kg so that were categorized into classes IV and presence of hepatotoxic potential. During the in vivo experiment, there has been a notable rise in hepatic and renal parameters. Furthermore, one mortality event occurred in the test subject at a 5,000 mg/kg body weight dosage.\nConclusion: Single oral administration of the extract at a dose larger than 5,000 mg per kilogram of body weight does not result in lethal effects, however showed potential toxicity to the liver.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"12 12","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"INVESTIGATING THE TOXICITY OF BETALAIN COMPOUNDS: IN SILICO ANALYSIS AND IN VIVO PREDICTIONS FOR STANDARDIZED BETA VULGARIS L. EXTRACT\",\"authors\":\"S. E. Nugraha, J. M. Keliat, R. A. Syahputra, Sony Eka, Nugraha\",\"doi\":\"10.22159/ijap.2024v16i1.49189\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective: Extensive research has been conducted on beetroot's antioxidant, hematoprotective, and cardioprotective properties. However, there currently needs to be more available evidence pertaining to the toxicity assessment of the extract. The toxicity assessment was conducted using both in silico and in vivo methods. Prior to testing, the extracts were standardized in accordance with the guidelines set by the Indonesian Food Drug Authority (BPOM), which is the regulatory authority for food and drugs in Indonesia.\\nMethods: The experimental subjects consisted of 25 male Wistar rats in good health, weighing between 150 and 170 grams. These rats were separated into five groups, each including five rats. Group 1 will serve as the control group, while groups 2 through 5 will be designated as the treatment groups. The analysis of chemical toxicity was conducted using pK-CSM, SwissADME, and Pro-Tox II methodologies.\\nResults: The results indicated that the standardized ethanol extract contained 4.341% water, 3.67 % total ash, and 1.53 % acid-insoluble ash. Lead (Pb) and cadmium (Cd) were absent at a concentration of 0 parts per million (ppm). Subsequently, the total plate count and yeast mould count were 0.47 5 x 10-4 (CFU/g) and a of 0.382 x 10-4 (CFU/g) respectively. This finding implies that the extract meets BPOM requirement. This study also measured the betalain content of red beetroot, yielding a total concentration of 11.34 0.37 mg/100 gram of sample. Haematological experiments showed that beetroot extract affected rat blood haematology. Compared to the control group, rats given the extract had higher red blood cell and platelet counts. Additionally, the Insilico toxicity test conducted on the active component derived from beetroot revealed LD50 of the compounds ranged from 305 mg/kg so that were categorized into classes IV and presence of hepatotoxic potential. During the in vivo experiment, there has been a notable rise in hepatic and renal parameters. Furthermore, one mortality event occurred in the test subject at a 5,000 mg/kg body weight dosage.\\nConclusion: Single oral administration of the extract at a dose larger than 5,000 mg per kilogram of body weight does not result in lethal effects, however showed potential toxicity to the liver.\",\"PeriodicalId\":13737,\"journal\":{\"name\":\"International Journal of Applied Pharmaceutics\",\"volume\":\"12 12\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-01-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Applied Pharmaceutics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22159/ijap.2024v16i1.49189\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Applied Pharmaceutics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22159/ijap.2024v16i1.49189","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
INVESTIGATING THE TOXICITY OF BETALAIN COMPOUNDS: IN SILICO ANALYSIS AND IN VIVO PREDICTIONS FOR STANDARDIZED BETA VULGARIS L. EXTRACT
Objective: Extensive research has been conducted on beetroot's antioxidant, hematoprotective, and cardioprotective properties. However, there currently needs to be more available evidence pertaining to the toxicity assessment of the extract. The toxicity assessment was conducted using both in silico and in vivo methods. Prior to testing, the extracts were standardized in accordance with the guidelines set by the Indonesian Food Drug Authority (BPOM), which is the regulatory authority for food and drugs in Indonesia.
Methods: The experimental subjects consisted of 25 male Wistar rats in good health, weighing between 150 and 170 grams. These rats were separated into five groups, each including five rats. Group 1 will serve as the control group, while groups 2 through 5 will be designated as the treatment groups. The analysis of chemical toxicity was conducted using pK-CSM, SwissADME, and Pro-Tox II methodologies.
Results: The results indicated that the standardized ethanol extract contained 4.341% water, 3.67 % total ash, and 1.53 % acid-insoluble ash. Lead (Pb) and cadmium (Cd) were absent at a concentration of 0 parts per million (ppm). Subsequently, the total plate count and yeast mould count were 0.47 5 x 10-4 (CFU/g) and a of 0.382 x 10-4 (CFU/g) respectively. This finding implies that the extract meets BPOM requirement. This study also measured the betalain content of red beetroot, yielding a total concentration of 11.34 0.37 mg/100 gram of sample. Haematological experiments showed that beetroot extract affected rat blood haematology. Compared to the control group, rats given the extract had higher red blood cell and platelet counts. Additionally, the Insilico toxicity test conducted on the active component derived from beetroot revealed LD50 of the compounds ranged from 305 mg/kg so that were categorized into classes IV and presence of hepatotoxic potential. During the in vivo experiment, there has been a notable rise in hepatic and renal parameters. Furthermore, one mortality event occurred in the test subject at a 5,000 mg/kg body weight dosage.
Conclusion: Single oral administration of the extract at a dose larger than 5,000 mg per kilogram of body weight does not result in lethal effects, however showed potential toxicity to the liver.
期刊介绍:
International Journal of Applied Pharmaceutics (Int J App Pharm) is a peer-reviewed, bimonthly (onward March 2017) open access journal devoted to the excellence and research in the pure pharmaceutics. This Journal publishes original research work that contributes significantly to further the scientific knowledge in conventional dosage forms, formulation development and characterization, controlled and novel drug delivery, biopharmaceutics, pharmacokinetics, molecular drug design, polymer-based drug delivery, nanotechnology, nanocarrier based drug delivery, novel routes and modes of delivery; responsive delivery systems, prodrug design, development and characterization of the targeted drug delivery systems, ligand carrier interactions etc. However, the other areas which are related to the pharmaceutics are also entertained includes physical pharmacy and API (active pharmaceutical ingredients) analysis. The Journal publishes original research work either as a Original Article or as a Short Communication. Review Articles on a current topic in the said fields are also considered for publication in the Journal.