1-Dotriacontanol

1. Pharmacological action: Policosanol is a mixture of eight higher fatty alcohols extracted from cane wax. Animal experiments have found that Policosanol can reduce the levels of cholesterol and low-density lipoprotein (1D1-C) in the serum of normal and endogenous high-cholesterol animals. Studies on various animal models have shown that Policosanol can reduce cholesterol in the liver, adipose tissue, and heart. Non-clinical models have shown that Policosanol exerts its effects by inhibiting the biosynthesis of cholesterol. In addition, Policosanol increases the binding and internalization of 1D1 to receptors, promotes the catabolism of 1D1-C, and thus reduces the level of 1D1-C in plasma. Policosanol can also increase the level of high-density lipoprotein (HD1-C) and reduce the levels of triglycerides and very low-density lipoprotein (V1D1-C). 2. Toxicological studies: Preclinical studies have shown that oral administration of Policosanol has almost no acute toxicity. The 1D50 of rats, mice, and rabbits is higher than 5000 mg/kg. The tolerance study of multiple administration of Macaca arctoides monkeys showed that the highest dose (500 mg/kg) did not cause any changes in clinical, hematological and blood biochemical indicators. 3. Genotoxicity: The results of the Ames test, mouse micronucleus test and dominant lethality test of policosanol were all negative. 4. Reproductive toxicity: No teratogenic effect was found in rats and rabbits at a dose of 1000 mg/kg of policosanol. Two-generation fertility and reproductive toxicity studies did not show any effect of policosanol on fertility and fetal development. 5. Carcinogenicity: In the carcinogenicity test of rats (50-500 mg/kg) and mice, no increase in the incidence of tumors was found after continuous administration for 24 months and 18 months. Similarly, Macaca arctoides monkeys were orally administered (0.25, 2.5 and 25 mg/kg) for 54 weeks, and no biochemical and tissue physiological changes related to drug toxicity were found. Similar results were obtained when Beagle dogs were given 30 or 180 mg of policosanol daily.