Herbal extracts are not to be given in i.V, due to particle size are not in the range, and before going for PK study for which compound u r going to calculate it, if u know then gave it in oral and check it
Yup crude herbal extracts cannot be given iv . Not acceptable because of suspended particles.
But it has been seen that herbal extract formulation, when administered intravenously, could potentially alter the pharmacokinetics of its active ingredients. There are studies where herbal extracts have been given iv. Here are the links below:
I woukd advise against it, Herbal extracts are not to be given in i.V, due to particle size as mentioned allready. However, since you are interested in PK, that means you have a specific compound you want to monitor. So you might consider i.v. of this compound and doing the PK or herbal extracts po.
Technically speaking, filtration will solve the problem of suspended particulates for herbal extract . However one should be apprehensive of the IV approach as its likely to cause RBC lysis or aggregation.
i think one option is to try and address the problems that could arise (e.g. problems dealing with particle size, impurity and toxicity) when considering iv administration of plant extracts before venturing into it. But I think it may be better to first do the pharmacokinetic studies via oral route of administration, since humans would normally take the extract orally anyway. By collecting blood, urine and stool samples of the rodents at certain time intervals, you should be able to get good pharmacokinetic data on the plant extract using methods such as hplc to assay for drugs and?/metabolite. This will however be extremely difficult for crude extract as they will normally contain lots of phytochemicals. The pharmacokinetic data would have helped if you were particular about a specific phytochemical and its metabolites. in the crude extract, and what such data would have done for you is to help you to some extent determine how much of the extract may be safely administered intravenously.
however if you must use the iv route, and cannot be guided by such pharmacokinetic studies, you must tread extremely cautiously. perhaps do an acute toxicity test, while closely monitoring your animals.
Herbal injection solutions are aqueous preparations of herbs (or herb combinations) and can be used in the clinic for a variety of diseases, but its serious adverse drug reactions have attracted attentions. It is not advisable in clinics if they are do not meet the requirements of safety (free of bacteria, pyrogen, allergen, toxicity), stablity and suitable pH rangle, osmosis pressure and clearness.
herbal extracts contain lot of molecules that even pass through finest filter paper, these will again agglomerate and generate bigger molecules and will not be suitable. purification of the target molecule by chromatographic technique may give you some clear solution, but smaller sugar molecules and organic acids again remain the problem
The administration of herbal extracts via intravenous injection in rodents is a subject that necessitates careful consideration, particularly with regard to the safety, ethical implications, and scientific validity of such procedures. Intravenous injection is a direct and efficient method to deliver substances into the bloodstream, allowing for immediate systemic distribution. However, when it comes to herbal extracts, several key factors must be meticulously evaluated:
Purity and Standardization of Herbal Extracts: Herbal extracts are complex mixtures containing multiple bioactive compounds, whose concentrations can vary significantly depending on the source, extraction method, and storage conditions. Prior to administration, it is essential to ensure the extract is of high purity and is standardized to contain consistent levels of the active constituents.
Safety and Toxicity: The safety profile of the herbal extract must be thoroughly assessed through in vitro and smaller scale in vivo studies before proceeding to intravenous administration in rodents. Many compounds safe for oral consumption may have different toxicity profiles when bypassing the digestive system's metabolic processes.
Solubility and Vehicle: The solubility of the herbal extract in the vehicle used for injection is critical. Insoluble particles can lead to embolism or acute inflammatory responses. The choice of vehicle should also be compatible with intravenous administration, not causing hemolysis or adverse reactions.
Dose Determination: Establishing the appropriate dosage is crucial to avoid toxic effects. Dose-finding studies should be conducted to determine the maximum tolerated dose and the therapeutic dose range.
Ethical Considerations: All experimental procedures involving animals should be designed with the utmost attention to ethical considerations. This includes minimizing pain and distress, using the minimum number of animals necessary to achieve scientific objectives, and ensuring that the study is scientifically justified and designed to produce valuable knowledge.
Regulatory Compliance: Compliance with institutional, national, and international guidelines and regulations governing animal research is mandatory. This often involves obtaining approval from an Institutional Animal Care and Use Committee (IACUC) or equivalent body, which evaluates the scientific and ethical aspects of the proposed research.
Monitoring and Welfare: Continuous monitoring of the animals for adverse effects following the injection is imperative to promptly address any health issues. Protocols should be in place for the management of unexpected reactions to ensure animal welfare.
In conclusion, while the intravenous injection of herbal extracts in rodents can be scientifically valuable, it requires rigorous preparation, safety assessment, and ethical considerations. The acceptability of such a method depends on the ability to meet these stringent criteria, ensuring that the research is conducted responsibly, safely, and with clear scientific merit.
Yours sincerely,
Check out this protocol list; it might provide additional insights for resolving the issue.