| dc.description.abstract | Background : Propolis is known for a number of pharmacological effects, such as
antioxidant, immunomodulatory, and anti-inflammatory. One of the drug formulation
technologies is the Self Nano Emulsifying Drug Delivery System (SNEDDS), which
has the potential to overcome drug solubility and absorption. However, the nano-size
drug particle may potentially cause toxicity.
Aim : To determine the acute and subchronic toxicity profile of the SNEDDS (Self
Nano Emulsifying Drug Delivery System) propolis extract on Wistar rats (Rattus
norvegicus).
Method : The SNEDDS propolis was tested for toxicity with acute OECD 425 and
subchronic toxicity OECD 408 method using test animals. Acute test were carried out
limit test on 2000 mg/kgBW and main test based on regression factor 3.2 (175; 550 and
2000 mg/kgBW). Treatment group for subchronic given graduated dose from 250;500
and 1000 mg/kgBW. Observations were carried out intensive for 14 days in acute,
while in the subchronic for 90 days and follow-up observations for 28 days for the
satellite group. Observation were made to clinical toxicity symptoms, body weight,
hematology and clinical biochemistry examinations and macropathology.
Result : The LD50 value of SNEDDS propolis was greater than 2000 mg/kgBW after
acute toxicity test and classified to low toxicity category 4. The symptoms experienced
by the test animals were lethargy, locomotor decrease, increase in defecation and
symptoms refers to respiratory illness, but there were no died case until the end of the
study both in acute and subchronic test. The body weight observation shows increase
compared to the day 0. Meanwhile in visual observation of organ not indicates to
toxicity.
Conclusion : SNEDDS propolis did not cause toxicity both in acute or subchronic test. | en_US |
