Understanding The Importance of Oral Toxicity Testing in The Development of High-Quality Herbal Medicine
Indonesian society has long been using herbal remedies, which are empirically useful for treating various diseases. The number of studies on herbal medicine is increasing. Herbal medicine must be standardized, safe, and profitable. Traditional medicine usually consists of more than one type of simple medicine designed to improve therapeutic outcomes so that faster healing can be achieved.
Important toxicity tests are carried out to determine how damaged a compound is against biological and non-biological materials. General testing is carried out on a product to meet the regulatory and state licensing requirements. It’s important to develop new drugs and to know the potential of molecular therapy drugs. Oral acute toxicity tests are one of many types.
What is an Acute Oral Toxicity Test?
An acute oral toxicity test is a crucial method in toxicology to assess the potential toxic effects of a substance or chemical product. An acute oral toxicity test is performed to determine the effect of a single dose of a compound on an animal. It is generally recommended that these tests be carried out on two types of animals. (rodensia dan non-rodensia).
Rodensia is an animal that has a pair of serial teeth that continue to grow throughout their lives and need to be constantly nurtured to maintain their length. This series of teeth is very strong and sharp and is used to scratch food like grains, wood, and other hard materials. For example, a rat, a hamster, or a marmot A non-rodensia is an animal that has no serial teeth and keeps growing like a rodensia. Their teeth have more normal growth patterns and do not need to be constantly polished. For example, cats, dogs, rabbits, horses, cows, lions, and many other mammals do not belong to the group of rodents.
Testing of herbal medicines with the Organization for Economic Co-operation and Development Method (OECD)
The OECD Guidelines for the Testing of Chemicals are an internationally accepted standard for testing the safety of products, including chemicals, pesticides, treatments, and so on. The primary objective of this trial is to determine a 50% lethal dose (LD50), which is the dose that is expected to cause death in 50% of the animal population.
Determination of toxic doses and lethal doses using OECD methods has advantages over other toxicity testing methods because it uses fewer test animals as well as easy test techniques. Regulation of test toxicities with test animals should take into account animal welfare, using as few test animals as possible, and the beneficial test results are later applied to humans.
The results of this test are an evaluation of the effect of the drug on tissues and organs, the dose-response relationship, the effect on the patient, and the various complications that may arise during the test. Toxicity tests generally use at least three doses (low, moderate, and high) as well as controls to compare the effects of the treatment group.
Like the usual medicinal compounds, herbal medicines also have adverse effects if not accompanied by an understanding of the rules of dosage and proper use. Unwanted effects generally occur due to unstandardized ingredients, inappropriate injections, combination effects of composite compounds, hygroscopic and voluminous properties, or possible contamination by other microbes. There may also be unwanted effects arising due to additional compounds in herbs. Mistaken effects and use can also cause losses. For example, turmeric is either consumed for uterine defecation or is well consumed during menstruation, but it can cause miscarriage in young pregnancies.
In an acute oral toxicity test, LD50 is determined because it is necessary to give a dose that causes the death of more than 50% of the test animals. If LD50 cannot be determined, then it is given until the maximum dose that is still possible is given to the test animal. The volume of the drug given for oral administration should not exceed 2–3 percent of the weight of the trial animal.
After receiving intensive, carefully observed scab treatment for a certain period of time, usually 7–14 days, it may even be longer, especially in relation to the recovery of toxic symptoms. In addition to observing the occurrence of the death of the experimental animal, another thing to bear in mind is the emergence of toxic effects mainly associated with the functioning of vital organs of the body, among others kidneys, liver, and hemopoetic.
The LD50 value is useful for:
1. Classification of chemicals based on relative toxicity.
2. Consideration of the dangers of overdose.
3. Planning short-term toxicity studies in animals.
4. Providing information on the reactivity of certain animal populations.
5. Providing comprehensive information needed in human drug trials.
6. Quality control.
7. Mechanism of toxicity.
8. Effects of age, sex, other hosts, and environmental factors.
9. Differential responses among species and strains.
Acute oral toxicity testing should be carried out in a laboratory that provides high-quality test results (comprehensive, accurate, and reliable) as well as superior consulting services. IML Testing and Research is a product testing laboratory that can perform oral toxicity tests on your herbal medicinal products.
You can test your product at IML Testing and Research and get an EXCLUSIVE FREE CONSULTATION related to testing your herbal medicine products with our team of experts!
