Teratogenic effect of unregistered traditional Chinese medicine containing Atractylodis lancea radix, Glycyrrhiza glabra radix, Rheum officinale rhizome, and Angelica dahurica radix on fetal morphology of BALB/c mice.

OBJECTIVES: In Indonesia, several unregistered traditional Chinese medicines (UTCM) are still used to treat gastritis in pregnancy. On the other hand, the safety of medications during pregnancy remains unresolved. This study aims to investigate the teratogenic effect of UTCM containing Atractylodis lancea radix, Glycyrrhizae glabra radix, Rheum officinale rhizome, and Angelica dahurica radix on fetal morphology.

METHODS: A total of 80 pregnant mice were divided into four groups including the negative control (N), given vehicle, as well as treatment groups D1, D2, and D3 given a dose of 35.2 mg/kg BW, 70.5 mg/kg BW and 105.65 mg/kg BW daily respectively. The drugs were administered between the 6th and 15th days of organogenesis. On the 18th day of pregnancy, a laparotomy was conducted. The teratogenic effects were determined by measuring maternal and fetal body weight, the number of fetuses, and skeletal abnormalities in mouse fetuses, visualised with Alizarin solution. All data were analysed using ANOVA.

RESULTS: The results showed that in all treatment groups, there was a substantial difference in maternal body weight, fetal number, and fetal body weight (p<0.05). There were open eyelids and clubfoot abnormalities observed in all groups, while 27 fetuses with haemorrhages were found in D3. All treatment groups had sternal, sacral, caudal, phalanges and metacarpal abnormalities.

CONCLUSIONS: UTCM administration showed fetal development effects at the early stage of pregnancy in mice. The dose (D3) 105.65 mg/kg BW affected maternal weight gain and fetal skeletal ossification. UTCM administration D1 (35.2 mg/kg BW), D2 0.5 mg/kg BW), and D3 (105.65 mg/kg BW) had no maternal toxicity and fetal teratogenesis.