Toxicity and neuroprotective effect of Suhexiang pills: A preclinical study of a traditional compound preparation for ischemic stroke treatment.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE: Suhexiang pills (SHXP), a classic "orifice-opening formula" in traditional Chinese medicine, comprise 15 herbal ingredients and possess aromatic properties that open orifices, regulate qi, and alleviate pain. It has been approved by China's National Medical Products Administration for the treatment of phlegm-induced coma caused by obstruction of the heart orifice and hemiplegia following stroke. AIM OF THE STUDY: The present study aimed to evaluate the potential therapeutic effects of SHXP on cerebral ischemia-reperfusion injury in rats using a transient middle cerebral artery occlusion (tMCAO) model. Additionally, adult Sprague-Dawley (SD) rats were intragastrically administered SHXP for 91 days to assess potential toxicities. MATERIALS AND METHODS: In a tMCAO model, the neuroprotective effects of SHXP were assessed. Male rats received SHXP (320, 640, and 1280 mg/kg/day) starting 7 days before ischemia and continuing until 48 h post-ischemia. Infarct volume was then measured by 2,3,5-triphenyltetrazolium chloride (TTC) staining. Concurrently, a 91-day repeated-dose toxicity experiment of SHXP was conducted in rats. Rats were orally administered SHXP (0.6, 1.5, and 4.5 g/kg/day), and the assessment included in vivo observations (survival, body weight, food consumption) as well as hematological, biochemical, urinalysis, and histopathological analyses. RESULTS: The results indicated that SHXP exerted therapeutic efficacy against ischemic stroke. Additionally, no significant systemic toxicity was observed after 91 days of repeated SHXP administration. The data established the no-observed-adverse-effect level (NOAEL) of SHXP at 4.5 g/kg. CONCLUSIONS: This study demonstrates that SHXP is an effective therapeutic agent for ischemic stroke with a favorable safety profile for long-term use.