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Aims: To carry out phytochemical screening and acute oral toxicity test to validate their safety and efficacy. Study Design: Standard phytochemical screening tests were used to highlight phytochemical compounds of roots of the plants. The evaluation of acute toxicity of the root extracts of the plants followed the model of Acute Toxicity Class based on OECD 423 Guideline, 2001. Place and Duration of the Study: The study was undertaken at the Department of Chemistry & Biochemistry for the extraction for samples extraction and phytochemical screening. Acute oral toxicity studies were done at the Department of Biological Sciences for acute toxicity study, University of Eldoret, Between June and September 2022. Methodology: Phytochemical screening for presence of Tannins, saponins, flavonoids, glycosides, alkaloids, anthocyanin, terpenoids, steroids, coumarins, lipids, proteins and carbohydrates were carried out. Acute oral toxicity studies were done using the fixed dose method at a dose of 2000mg/kg body weights of rats. Three groups were used: control and test groups for each of the respective plant root extracts. Signs of toxicity and/or mortality were monitored daily for 14 days. Weekly fasting body weights were also recorded. Results: The phytochemical screening results showed the presence of tannins, saponins, flavonoids, glycosides, alkaloids, anthocyanin, terpenoids, steroids, lipids, proteins and carbohydrates present in the root extract of Combretum hereroense. Tannins, saponins, flavonoids, glycosides, terpenoids, steroids, and carbohydrates were present in root extracts of Balanites aegyptiaca. Following the acute oral toxicity study, there were no abnormalities observed in physiological parameters. In addition, no deaths were recorded during the study period. The LD50 was therefore greater than 2000 mg/kg. The fasting body weights of extract treated rats increased stably compared to the control [p = .05]. Conclusion: The results showed C. hereroense and B. aegyptiaca methanol root extracts were considered safe in acute oral exposure. Long-term toxicity studies are needed for further toxicological profile elicitation of the plant, and a possible reinforcement of clinical relevance of the results of laboratory studies.
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OBJECTIVE： To compare the quality of original preparations of Thioctic acid injection and generic preparations from 2 domestic manufacturers， discuss the acute toxicity test of mice and to investigate the project of consistency evaluation methods. METHODS： According to the quality standard that stated in Chinese Pharmacopeia， physicochemical properties （characters， pH， osmotic pressure， etc.， contents and related substances of samples of Thioctic acid injection as well as LD50 in acute toxicity test （n＝10）， and mortality of mice after administration of injection solution （n＝30） were compared among 3 manufacturers. RESULTS： The physicochemical properties as and related substances of the original drug and 2 generic drugs were all in line with the quality standard； the contents of 3 samples ranged 95％-105％. The acute toxicity test results showed that the LD50 values of 2 generic drugs （LD50： 247.911 mg/kg， 95％ confidence interval： 222.209-277.999 mg/kg；LD50： 215.291 mg/kg， 95％ confidence interval： 196.637-235.053 mg/kg） were smaller than that of original drug （LD50： 266.534 mg/kg， 95％ confidence interval： 250.597-283.418 mg/kg）， but there was no statistical difference （P＞0.05）. The results of 3 repeated experiments showed that there was statistical significance in the number of animal death caused by the 2 generic drugs （26， 28） was more than that of the original drug （19） （all P＜0.05）， when injection solution was injected into mice in a single dose. After administration of the original drug， mice showed excitatory reactions such as movement and squeal， while 2 generic drugs showed inhibitory reactions. CONCLUSIONS： 2 generic drugs of Thioctic acid injection and the original drug all conform to the relevant regulations of Chinese Pharmacopoeia in terms of preparation quality standards， but the results of acute toxicity test are quite different， so it is difficult to prove the consistency between the 2 generic drugs and the original drug. Therefore， acute toxicity test is necessary for the consistency evaluation of injections.
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Purpose@#To study the effect of Three roots granule medicine with compound medicines ingredient of Asparagus cohinchinensis, Polygonatum odoratum and Polygonatum sibiricum on acute toxicity test and genotoxicity tests. @*Methods@#In toxicity study of Three roots granule medicine, by acute toxicity test were observed general status of animals, body weight changes, signs of poisoning and death for 14 day and determined the maximum tolerated dose, by Ames test, mouse bone marrow polychromatic erythrocyte micronucleus test and mouse sperm deformity test were determined genotoxicity effect. The data were analyzed through SPSS 19.0.@*Results and Conclusions@#In the result of toxicity study, three roots granule medicine was MTD>15g/kg, no acute toxic activity, did not induce mutagenic effect in Ames test and was negative in mouse bone marrow polychromatic erythrocyte micronucleus test and mouse sperm deformity test. Three roots granule medicine has no acute toxicity effect, no genotoxicity effect and safety. We as regard as in future can continuously study to the other pharmacology study of three roots granule medicine.
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Objective To evaluate the safety of the Eucommia folium and to provide the basis of the rational use ofEucommia folium resource.Methods According to < Technical Standards for Testing & Assessment of Health Food>,version 2003, acute safety test/micronucleus test of born marrow in mice/sperm shape abnormality test in mice/Ames test andthirty-day feeding test were all performed after water extract concentrations of Eucommia folium treatment (1 mLconcentrations equal to 1.5 g Eucommia folium) . Results On the acute toxicity test, the MTD of rats and mice were both40.0 mL/kgbw. The results of genetic toxicity test were all negative in the dosage of 10 g/kg bw(according to the dosage ofEucommia folium) .The results of thirty-day feeding test indicated that there have no significant differences in body weight,blood cytology indexes, blood biochemical indexes, organ/body ratio and pathematology examination in the rats in all thegroups (0.83, 1.67, 3.30 mL/kg) as compared to the control group(P>0.05) . Conclusion Under this experimentalcondition, no obvious abnormity and toxic reaction were observed.
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Objective: To prepare Bruceae Fructus oil (BFO) β-cyclodextrin polymer (CDP) inclusion complexes (BFO-CDP-IC), and investigate its safety by acute toxicity test. Methods: BFO was extracted and CDP was prepared according to the literature, the IC of BFO with CDP (BFO-CDP) was prepared by homogenizing method and characterized by SEM, 1H-NMR, and FT-IR. The optimum preparation process was determined by single factor test and L9(34) orthogonal test. Entrapment efficiency (EE) was determined by HPLC. Acute toxicity of BFO-CDP-IC was assessed by determining the number of deaths of ICR mice over gavage treatment for 2 weeks. The commercial emulsion of BFO (BFOE) was used as a reference. Results: The extraction rate of BFO was 17.3%, the yield of CDP was 49.26%, and the degree of crosslinking was 8.47. The optimal conditions for preparation were as follows, ratio of BFO and CDP was 1:10, preparation temperature and time was 20℃ and 6 min, the amount of ether was 0.5 g. Additionally, the HPLC data showed that drug loading of complexes was 7.1%, and EE was 80%. In the acute toxicity test, the median lethal dose (LD50) of BFOE was 9.78 g/kg. In contrast, all mice treated with IC survived even at the highest dosage (15.36 g/kg). Conclusion: The prepared BFO-IC has high EE compared with commercially available BFOE, BFO-CDP polymer significantly decreased toxicity of BFO.
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OBJECTIVE:To investigate the safety of Polyisobutylene (PIB) Gutong plaster by transdermal administration. METHODS:66 rabbits were randomly divided into a normal group,a group with intact skin and a group with damaged skin. The latter two groups were respectively re-divided into PIB group,the groups of low,medium and high-dose PIB Gutong plaster and Gutong plaster group. An acute toxicity test was conducted on the rabbits,which 14 d of continuous observation was made 24 h af-ter transdermal administration. Another 60 rabbits were divided into several groups as above except for a normal group. A single pri-mary skin irritation test was conducted on them,where skin irritation reactions were recorded 6 h after a single administration based on intra-individual left/right self comparison method. 70 guinea pigs were randomized into a negative control group (vase-line),a PIB group,a positive control group(2,4-dinitrochlorobenzene),a Gutong plaster group and the groups of low,medium and high-dose PIB Gutong plaster,which were dosed for sensitization,followed by a skin sensitization test. RESULTS:No obvi-ous toxicity symptoms could be seen after administration of PIB Gutong plaster. The rabbits’intact or damaged skin had no irrita-tion response to PIB and low and medium-dose PIB Gutong plaster. PIB Gutong plaster caused no irritation response in the rabbits’ intact skin,but slight irritation in damaged skin 1 h after administration. The allergic reaction incidence of the positive control group of guinea pigs was 100% while that of any other groups was 0. CONCLUSIONS:The PIB Gutong plaster is safe for trans-dermal administration.
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STUDY DESIGN: Prospective in vivo toxicity study. PURPOSE: To evaluate the conducted acute toxicity study of Escherichia coli (E. coli)-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) with 6-weeks old Sprague-Dawley rats. OVERVIEW OF LITERATURE: rhBMP-2 has well-known osteoinductivity and it is used as a bone graft substitute. E. coli-derived rhBMP-2 can be mass-produced with relatively low costs. E. coli-derived rhBMP-2 facilitates osteoblastic differentiation and bone formation in vitro and in vivo. However, studies regarding side effects or toxicity of E. coli-derived rhBMP-2 have not been published. Thus, we conducted the acute toxicity study of E. coli-derived rhBMP-2 on 6-weeks old Sprague-Dawley rats. METHODS: One mg of BMP-2 was diluted in 0.285 mL of glycine buffer to prepare high BMP-2 concentrations (3.5 mg/mL). Intermediate (0.9 mg/mL) or low (0.35 mg/mL) concentrations of BMP-2 solution was prepared by serial dilutions. The compound was administrated at a dose of 0, 0.7, 1.8, 7 mg/kg by single intravenous injection to five of male and female rats. After the injection, the gross general observations including changes of body weight and histopathological analysis was performed for 14 days. RESULTS: No animal was found dead during the experiment and the body weight changes were both statistically insignificant in the control and experimental groups. No abnormal sign was shown in general observations and autopsy examinations. CONCLUSIONS: Thus, the lethal dose of E. coli-derived rhBMP-2 should be higher than 7 mg/kg with a single intravenous injection.
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Animals , Female , Humans , Male , Rats , Autopsy , Body Weight , Body Weight Changes , Escherichia coli , Escherichia , Glycine , Injections, Intravenous , Mortality , Osteoblasts , Osteogenesis , Prospective Studies , Rats, Sprague-Dawley , Toxicity Tests, Acute , TransplantsABSTRACT
OBJECTIVES: Tricalcium phosphate and calcium hydrogenorthophosphate are high production volume chemicals, mainly used as foodstuff additives, pharmaceuticals, lubricants, synthetic resin, and disinfectants. Phosphate has the potential to cause increased algal growth leading to eutrophication in the aquatic environment. However, there is no adequate information available on risk assessment or acute and chronic toxicity. The aim of this research is to evaluate the toxic potential of phosphate compounds in the aquatic environment. METHODS: An aquatic toxicity test of phosphate was conducted, and its physico-chemical properties were obtained from a database recommended in the Organization for Economic Cooperation and Development (OECD) guidance manual. An ecotoxicity test using fish, Daphnia, and algae was conducted by the good laboratory practice facility according to the OECD TG guidelines for testing of chemicals, to secure reliable data. RESULTS: The results of the ecotoxicity tests of tricalcium phosphate and calcium hydrogenorthophosphate are as follows: In an acute toxicity test with Oryzias latipes, 96 hr 50% lethal concentration (LC50) was >100 (measured:>2.14) mg/L and >100 (measured: >13.5) mg/L, respectively. In the Daphnia test, 48 hr 50% effective concentration (EC50) was >100 (measured: >5.35) mg/L and >100 (measured: >2.9) mg/L, respectively. In a growth inhibition test with Pseudokirchneriella subcapitata, 72 hr EC50 was >100 (measured: >1.56) mg/L and >100 (measured: >4.4) mg/L, respectively. CONCLUSIONS: Based on the results of the ecotoxicity test of phosphate using fish, Daphnia, and algae, L(E)C50 was above 100 mg/L (nominal), indicating no toxicity. In general, the total phosphorus concentration including phosphate in rivers and lakes reaches levels of several ppm, suggesting that phosphate has no toxic effects. However, excessive inflow of phosphate into aquatic ecosystems has the potential to cause eutrophication due to algal growth.
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Calcium , Daphnia , Disinfectants , Ecosystem , Eutrophication , Lakes , Lubricants , Oryzias , Phosphorus , Resins, Synthetic , Risk Assessment , Rivers , Toxicity Tests , Toxicity Tests, AcuteABSTRACT
Objective To observe the safety of the compound Tiaoshi-plaster's use to skin,providing the scientific foundation for its use to the treatment for the younth's short sight.Methods Experiment 1,acute toxicity test for skin of rabbits:rabbits were randomly divided into two groups:a integrated skin group and a damaged skin group,in addition,every group further divide into high and low dosage group and vehicle control group,totally 5 groups.All above groups received the plaster or vehicle for 24 hours,then take away the drug,and after lh,24 h,48 h,72 h since the 7th day,observe each group's reaction separately everyday,to see whether there is a acute toxicity reaction or not.Experiment 2,self control group,use onerabbit's left and right sides' skin to observe stimulus toxicity via skin:divide the rabbits into a integrated skin group and a damaged skin group,in addition,every group further divide into high,low dosage group and vehicle control group,totally 6 groups.Observe the reaction after multiple doses,after 7 days' successive doses,take the drug-used tissues to do pathological examination.Experiment 3,cavy's skin irritation test:cavies were divide into vehicle group,plaster group,positive group,totally 3 groups,at the 6h,7th day,14th day,take off right side's skin of every group to do the provocative test respectively.On the 28th day,take off the left side's skin to do the provocative test.To see if the skin or the whole body is allergic to the plaster.Results In experiment 1,toxic response could not be found in any group; In experiment 2,rabbits in the integrated skin group didn't show redness or edema,rabbits in the damaged skin group all had redness and edema,but the differences were not statistically significant,compared with the corresponding time of vehicle group (P＞0.05).Such skin damage was not caused by plaster usage but inflammatory reaction of skin damage.In experiment 3,the vehicle group and the study group didn't show any abnormal anaphylactic reaction.Conclusion The compound Tiaoshiplaster is safe to skin.
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Objective To investigate the acute toxicity, subacute toxicity, nasal membrane local toxicity of the Magnolia biondii Pamp volatile oil nanometer bangosome. Methods Kunming mice and SD rats were selected as experimental material. Kunming mice were used in the acute and subacute toxicity tests by intragastric administration of Magnolia biondii Pamp volatile oil nanometer bangosome with different dosage and different time, and SD rats were used in the nasal membrane local toxicity test by nose dropping, while the control group was treated with intragastric administration of or nose dropping with normal saline for the same dosage. The treatment course lasted fifteen days. At the end of the tests, the general condition, routine blood test, function index of live and kidney, organ humid weight index, histological changes of liver and kidney and ultra microstructure change of rat nasal membrane were obtained and compared with the control group. Results In the acute toxicity test, the daily maximum tolerant dosage by intragastric administration was equal to 222.7 times of the clinical routine, with no marked toxic reaction. In the subacute toxicity test, the general condition, blood test, organ humid weight index and histological changes of live and kidney in different dosage groups were similar to the control group. While in the function index of live and kidney, uric acid was stepped down in the middle and large dose groups, and total bilirubin was decreased in the large dose group. The nasal membrane local toxicity test revealed that there was little change in the ultra microstructure of rat nasal membrane.Conclusion The Magnolia biondii Pamp volatile oil nanometer bangosome may have little toxicity by intragastric administration and nose dropping.
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[Objective]Modify Xuejiejiawei Granule judgment toxic particles to guide its clinical drug safety.[Method]Make different dosages,give the mouse to fill stomach,from the observing mouse's physiological condition to judging the medicine toxic.[Result]36 mice after given the medicine observation period do not have an example to die,after the dissection the internal organs have non-pathological changes.[Conclusion] Looking at Xuejiejiawei Granule from the medicine toxic effect,the Xuejie adding the taste pellet is a safe medicine.
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OBJECTIVE:To evaluate the derma safety of miconazole and chloramphenicol cream (MCC) for Guinea pigs.METHODS:Blank matrix,positive sensitizing agent (2,4-dinitro-chlorobenzene) and MCC (high dose and low dose) were applied on normal or damaged areas of the unhairing backs of Guinea pigs to conduct acute toxicity test,sensitivity test and irritation test,respectively.RESULTS:MCC caused no acute toxicity when applied on the skin of Guinea pigs,nor skin/systemic hypersensitive reaction was noted after repeated sensitization.Single or multiple dosing of MCC caused no irritation on normal skin of Guinea pigs but caused mild irritation on damaged skin which disappeared after 48 h or 72 h.CONCLUSION:MCC has good dermo safety for Guinea pigs.
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AIM: To investigate the effect of glycyrrhizin(GZ) and glycyrrhefinic acid(GA) on reducing the toxicity of Radix Aconiti Laterlis(RAL) and its mechanisms of action. METHODS: Radix Aconiti Laterlis(RAL),RAL with Radix Glycyrrhizae(RG),RAL with GZ,RAL with GA were boiled for 30 min,respectively.HPLC was used to measure the concentrations of aconitine and hypaconitine in the different decoctions.Meanwhile,the acute toxicity of the above decoctions was determined by oral and intraperitoneal administration in mice respectively. RESULTS: By oral administration,the acute toxicity of the decoctions of RG with RAL and GE with RAL was obviously lower than that of RAL.The acute toxicity of the decoction of GA with RAL was slightly reduced when compared with that of RAL.By intraperitoneal administration,the acute toxicity of GA with RAL was obviously higher than that of RAL.RG significantly restrained the dissolution of alkalines contained in RAL into the decoction.But GA and GZ increased the dissolution of the alkalines. CONCLUSION: By oral administration,RG could reduce the acute toxieity of RAL.Restraint on the dissolution of the toxic alkalines contained in RAL into the decoction may be in part the reasons.But GA and GZ are not the effective components reducing the dissolution of the toxic alkalines.They may combine with the toxic alkalines,postpone the absorption of the combined compounds through gastrointestinal tract,and reduce the acute toxicity of RAL by oral administration.
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Objective: To probe and reveal the brain tomic and the wise sharpening action of Fuyuanbunao Granules and Its toxicity and side effect. Methods: The effects of Fuyuanbunao Granules on the memory acquisition disturbance induced by pentobarbital sodium or anisodine, the memory consolidation disturbance induced by sodium nitrite, and the memory repetition disturbance induced by alcohol were observed. Meanwhile, the acute toxicity test was done. Results: The granules could obriously improve the memory disturbance induced by the factors obove, and the improvement effect varied with the dose. The effects of larger dose groups were more obvious. There were no death of animals or toxicity and sile effect in test. Conclusion:Fuyuanbunao Granules maybe have the cholinergic acction. It can promote the aerobic metabolism, improve the cerebral anoxia and the inhibited state of center nervous system. It has low toxicity and can be used in clinical application.
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This paper reported the acute toxicity test and the long-term toxicity test of Tongbi Tablets in rats and dogs. The LD_(50) of mice was 5.29g/kg. For dogs following oral administration (0.513g/kg/day, which was a tenth part of mice'LD_(50)) for 6 months running, the toxic symptom of strychnine-like and an increase in BUN could be-observed after 4-month administration. Both recoveried after breaking off the administration. For 0.051g/kg/day dosage group of dogs(administered for 6 months running)and all dosage groups of rats, no toxic symptom was observed, suggesting that the clinical dosage of this medicine was safe.
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Objective To understand the acute toxicity of a plant-derived molluscicide Eomecon Chionantha Hance alkaloids ECA to fish. Methods The conventional tests of acute toxicity to fish were carried out at the laboratory. Results The Hypophthalmichthys molitrix mortality was zero under the concentration of 1. 25 mg/L for 96 hours, and 100% under the concentration of 20. 0 mg/ L. for 2 hours. LC50 of ECA to Hypophthalmichthys molitrix was 6. 457 mg/L for 2 h and the 95% confidence interval was 5. 289-7. 882 mg/L. The Cyprinus carpio mortality was zero under the con centration of 2. 5 mg/L for 96 hours, and 100% under the concentration of 20. 0 mg/L for 2 hours. LC50 of ECA to the Cyprinus carpio was 7. 244 mg/L for 2 hours and the 95% confidence interval was 5. 278-9. 954 mg/L. The Carassius auratus mortality was zero under the concentration of 1. 25 mg/L for 96 hours, and 100 % under the concentration of 20. 0 mg/L for 5 hours. LC50 of EGA to the Carassius auratus was 7. 080 mg/L for 5 hours and the 95% confidence interval was 5. 202 -9. 635 mg/L. Conclusion Toxicity of ECA to fish is lower than that of niclosamide. The EGA thus represents a promising plant-derived molluscicide which is worthy of further investigation.
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Objective To study the action of chromatogram retention index in forecasting the LC50 of chlorinated phenols and chlorinated benzenes for the Guppy.Methods Chromatogram retention time of chlorinated phenols and chlorinated benzenes were determined,and the LC50 for Guppy was from the published data.Results A regression model was established,for chlorinated phenols,it was lg(LC50)=1.599-2.64?10-3I,r=0.970,P