The pharmacokinetic study of Saussurea involucrata liquid tonic, a traditional Chinese patent for inflammatory pain, in female rats in breastfeeding period

Abstract

Saussurea involucrata liquid tonic is an oral liquid preparation indicated for postpartum pain. However, ensuring the safety of postpartum medication is a crucial concern for both mothers and infants. Therefore, this study aimed to evaluate the pharmacokinetic characteristics and milk distribution of Saussurea involucrata liquid tonic. The main components of the Saussurea involucrata liquid tonic, rutin, and chlorogenic acid, were profiled using fingerprint analysis. A quantitative method was then established and validated using LC-MS/MS to determine the main components and corresponding metabolites (quercetin, ferulic acid, and caffeic acid) by the gastroenteric tract enzymes and gut microbiota in plasma and milk. After administering single and multiple doses of Saussurea involucrata liquid tonic to female SD rats during breastfeeding, the above-mentioned components appeared in the plasma without accumulation in the body. Additionally, they did not distribute in the milk. These findings indicate that the five components may be the effective substances of Saussurea involucrata liquid tonic, and that it is safe for postpartum medication. This study provides new insights into understanding the effective substances of Saussurea involucrata liquid tonic and the safety study of postpartum medication for natural products and traditional Chinese patent medicines.