Single-Dose Intramuscular Toxicity Study of SU-Eohyeol Pharmacopuncture in Rats

Abstract

Objectives This toxicological study was performed to assess for potential toxicity and to determine the approximate lethal dose of SU-Eohyeol pharmacopuncture (SUEP) following a single intramuscular injection of SUEP into male and female Sprague-Dawley (SD) rats. Methods The groups in our experiment consisted of an experimental group treated with SUEP at a dose of 1.0 mL/animal and a control group injected with a normal saline solution, and five male and female rats were placed in each group. Each animal was administered a single intramuscular injection. We monitored all rats for clinical signs and body weight changes for 14 days after administration. At the end of the observation period, the rats were euthanized and autopsied, and localized tolerance examinations were conducted at the site of administration of the test substance. Results There were no deaths in either sex in the SUEP-treated group. There was no significant difference between the SUEP-treated group and the control group in the clinical signs and weight changes among the rats. In addition, no significant SUEP-related changes were observed on autopsy findings or local tolerance examinations at the injection site by histopathological examination. Conclusion Our results suggest that the approximate lethal dose of a single intramuscular administration of SUEP in female and male rats under the conditions of this study is greater than 1.0 mL/animal. To determine the safety of the use of SUEP in Korean medical clinical practice, additional toxicity studies will be needed.

Single-Dose Toxicity Study of Intramuscular Neuralgia-Pharmacopuncture Injection in Rats

“…CSP is an oil-based pharmacopuncture, the main ingredient of which is Taxus cuspidate. CSP is a directional pharmacopuncture, with excellent analgesic effects owing to its ability to induce a strong sense of qi; as such, CSP has been widely used in KM clinical practice [1,17]. However, owing to difficulties in the stable supply of Taxus cuspidata, a modified CSP consisting of CF, PS, RS, and SS was developed and has been used since 2015.…”

“…Pharmacopuncture is a modern form of acupuncture therapy used in traditional medicines, such as Korean medicine (KM) and traditional Chinese medicine (TCM), to deliver herbal medicine to acupoints to regulate body function and improve pathological conditions [1,2]. Various types of pharmacopuncture agents are used clinically, and new types of pharmacopuncture agents are continuously being developed based on evidence from the literature and clinical experiences in KM and TCM [3,4]. It is crucial to verify the safety and effectiveness of pharmacopuncture prior to clinical use, which can be obtained through non-clinical toxicity tests on medicinal plants and herbal medicines [5][6][7].…”

“…Moreover, a component of amygdalin has pain and inflammation relief properties [13]. NP comprises the extracts of these herbal medicines and functions to dispel wind-cold-dampness, moves qi to relieve pain, has anti-inflammatory and analgesic effects, and is used to treat neuropathy and pain [1]. NP was inspired by care special pain (CS) pharmacopuncture (CSP) and has the same drug composition as CSP; however, the solvent and extraction methods differ from those of CSP, which is an oil-based pharmacopuncture of the cold-pressed oil extraction method.…”

“…NP was inspired by care special pain (CS) pharmacopuncture (CSP) and has the same drug composition as CSP; however, the solvent and extraction methods differ from those of CSP, which is an oil-based pharmacopuncture of the cold-pressed oil extraction method. Given the difference in extraction methods, it is believed to be easier to operate and absorb into the body, can be used in larger amounts, and can reproduce a sense of qi similar to that of CSP [1].…”

Single-Dose Intramuscular Toxicity Test Using No-Pain Pharmacopuncture in Sprague–Dawley Rats

“…Moreover, in KM and TCM, several pharmacopuncture agents are used [13,14]. Furthermore, in KM, based on the literature and clinical experience, the development of new herbal pharmacopuncture agents is being actively pursued [15]. To promote the development and utilization of pharmacopuncture, the most important concern is to expand the scope of health insurance coverage and to verify its safety and therapeutic efficacy.…”