Hwang Ji Hye, Jung Chul
Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.
Namsangcheon Korean Medicine Clinic, Seoul, Republic of Korea.
J Pharmacopuncture. 2023 Mar 31;26(1):86-93. doi: 10.3831/KPI.2023.26.1.86.
This study aimed to evaluate the potential toxicity of a recently developed and clinically used No-Pain pharmacopuncture (NPP) solution. We also assessed the lethal dose of the NPP agent following a single intramuscular injection in Sprague-Dawley (SD) rats.
Animals were divided into two groups the NPP test material group and the normal saline control group. A single intramuscular injection of the NPP agent (1.0 mL/animal) was administered to rats of the NPP test material group. The control group rats received the same volume of normal saline. Both female and male rats were included in each group. All rats were monitored for clinical signs and body weight changes for 14 days after administration of the test substance or saline. At the end of the observation period, a gross necropsy was conducted and localized tolerance at the injection site was analyzed.
No mortality was observed in the NPP test material and control groups. Moreover, no test substance-related effects were observed on clinical signs, body weight, necropsy findings, and localized tolerance at the injection site.
The approximate lethal dose of the NPP agent is greater than 1.0 mL/animal under the conditions used in this study. Additional toxicity evaluations and clinical studies are needed to confirm the safety of NPP use in clinical practice.
本研究旨在评估一种最近开发并临床应用的无痛药针（NPP）溶液的潜在毒性。我们还评估了在Sprague-Dawley（SD）大鼠单次肌肉注射NPP制剂后的致死剂量。
将动物分为两组，即NPP测试材料组和生理盐水对照组。给NPP测试材料组的大鼠单次肌肉注射NPP制剂（1.0 mL/只动物）。对照组大鼠注射相同体积的生理盐水。每组均包括雌性和雄性大鼠。在给予测试物质或生理盐水后，对所有大鼠进行14天的临床体征和体重变化监测。在观察期结束时，进行大体尸检并分析注射部位的局部耐受性。
NPP测试材料组和对照组均未观察到死亡。此外，在临床体征、体重、尸检结果以及注射部位的局部耐受性方面，未观察到与测试物质相关的影响。
在本研究使用的条件下，NPP制剂的近似致死剂量大于1.0 mL/只动物。需要进行额外的毒性评估和临床研究，以确认NPP在临床实践中使用的安全性。
