[Rationality of formula composition of ammonium glycyrrhizinate in Yanlishuang Oral Dripping Pills based on pharmacodynamics and pharmacokinetics].

This study explored the rationality of incorporating ammonium glycyrrhizinate in Yanlishuang Oral Dripping Pills from the perspectives of pharmacodynamics and pharmacokinetics. An acute pharyngitis rat model was established using 10% ammonia solution. From the pharmacodynamic perspective, the rationality of ammonium glycyrrhizinate in the formulation was evaluated by detecting routine blood indices, serum levels of inflammatory factors tumor necrosis factor-α(TNF-α) and interleukin-6(IL-6), and pathological changes of pharyngeal tissue. A two-preparation, two-period, self-crossover design was adopted to conduct a bioequivalence study between Yanlishuang Oral Dripping Pills(R) and a preparation without ammonium glycyrrhizinate(T). Rabbits were divided into two groups, namely the T/R group and the R/T group. Gas chromatography-tandem mass spectrometry(GC-MS/MS) was used to investigate the pharmacokinetic characteristics of menthol, borneol, and camphor, thereby exploring the rationality of ammonium glycyrrhizinate in the formulation from the pharmacokinetic perspective. Pharmacodynamic results showed that both Yanlishuang Oral Dripping Pills and ammonium glycyrrhizinate alone reduced serum IL-6 and TNF-α levels, decreased white blood cell counts in rats with pharyngitis, and improved pathological injury of pharyngeal tissue. However, when ammonium glycyrrhizinate was absent, the therapeutic effect of Yanlishuang Oral Dripping Pills on acute pharyngitis was weakened, indicating that ammonium glycyrrhizinate enhances the anti-inflammatory effect and plays a synergistic role in the formulation. Pharmacokinetic results showed that, compared with the ammonium glycyrrhizinate-deficient preparation, Yanlishuang Oral Dripping Pills accelerated the absorption of menthol, borneol, and camphor and increased their systemic exposure, suggesting that ammonium glycyrrhizinate promotes the absorption of other components and increases their exposure in vivo. This reveals, from the pharmacokinetic perspective, the reason why ammonium glycyrrhizinate enhances the efficacy of Yanlishuang Oral Dripping Pills and further supports the rationality of its formulation. In conclusion, ammonium glycyrrhizinate significantly enhances the anti-inflammatory effect of Yanlishuang Oral Dripping Pills, promotes the absorption of active components, and increases bioavailability. The rationality of its formulation was explored through pharmacodynamic and pharmacokinetic experiments, providing a theoretical basis for the further development and clinical application of Yanlishuang Oral Dripping Pills.