Chemistry Reference
In-Depth Information
diet. Bifidogenic responses are not always found when oligosaccharides are
added to the diet of humans. This occurs when the populations of bifidobac-
teria in the colon are already relatively high (Alander et al., 2001).
5.10.2.
Lactulose
Most preparations of lactulose contain substantial concentrations of
lactose, epi-lactose and galactose. Thus, the use of lactulose is contraindicated
in those who require low lactose or low galactose diets. In some countries, such
as the USA, lactulose is a prescription drug and its use is limited to prescribed
medical use. Those who develop gastrointestinal disturbances, such as bloat-
ing, discomfort, flatulence and diarrhoea, with dietary fibre should exercise
caution in using lactulose. Acute and sub-acute toxicity data for lactulose have
been summarized by Mizota et al. (1987) and are similar to that for sucrose. In
1992, the Ministry of Health and Welfare in Japan approved lactulose as a
useful ingredient in specified foods currently being sold for health use
(FOSHU). Thus, in 1995, a soft drink, ''Mai-asa Sohkai'', containing 4 g
lactulose per carton, was approved as ''a beverage made from lactulose which
properly supports the proliferation of Bifidobacterium in the intestines to
maintain good condition of the bowels'' (Anon., 1997).
As an anti-constipation drug, the normal daily dose for adults is 20 g
lactulose. It is also established that ingestion of lactulose at higher doses can
result in diarrhoea.
5.10.2.1.
Toxicological Data
Canlac, a subsidiary of Solvay Pharmaceuticals, has measured toxic
effects of Lactulose USP concentrate (693 g/L). The results of these studies
can be summarized as:
Acute toxicity - by oral route, LD
50
in rats, 30-45 mg/kg
Chronic toxicity
-
oral route (diet), after prolonged exposure, in rats, 15 ml/kg, no
observed effect.
-
oral route (diet), after prolonged exposure, in dogs, target organ:
gastrointestine, 4 ml/kg, no observed effect
-
no effect on fertility
-
no teratogenic effect.
The lactulose concentrate was not hazardous under normal conditions
of handling and use. Ecotoxicity tests were also measured. In summary, no
adverse environmental effects were found, and it was not regarded as hazar-
dous for the aquatic environment (Anon., 2003).
