Hwang Ji Hye
Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.
J Pharmacopuncture. 2023 Dec 31;26(4):348-356. doi: 10.3831/KPI.2023.26.4.348.
Neuralgia-pharmacopuncture (NP) was recently developed as a water-soluble type of pharmacopuncture inspired by CS (care special pain)-pharmacopuncture. I aimed to evaluate the toxic response and approximate lethal dose of when NP when administered intramuscularly to Sprague Dawley rats.
The experimental group was divided into the NP test substance group and the saline control group and administered at a dose of 1.0 mL/animal to the posterior thigh muscles on both sides using a 1 mL syringe; each group consisted of five males and five females. Each rat was monitored for clinical signs and changes in body weight for 14 days after a single intramuscular injection. After completing observation, necropsy findings and localized tolerance at the injection site were assessed via gross necropsy and histopathological examination.
No deaths occurred in the NP or control group, regardless of sex. During the observation period, no changes (such as general symptoms, weight change, or visual observation results at the time of autopsy) were judged to be due to the test substance. Histopathological examination showed no changes at the administration site judged to be caused by the test substance in either the male or female test substance administration groups. In addition, mononuclear cell infiltration of the outer membrane of the femoris muscle at the administration site was observed at the same frequency and extent in the control and NP groups, and was judged to be caused by physical stimulation by the injection needle; therefore, it had no toxicological significance.
Based on the above results, the approximate lethal dose for a single intramuscular administration of the test substance NP in Sprague-Dawley rats was judged to be > 1.0 mL/animal, and there were no findings that were judged to be due to the test substance at the administration site.
神经痛药物穴位注射法（NP）是最近受特殊疼痛护理（CS）药物穴位注射法启发而研发的一种水溶性药物穴位注射法。我的目的是评估NP肌肉注射给斯普拉格-道利大鼠时的毒性反应和近似致死剂量。
将实验组分为NP受试物组和生理盐水对照组，用1毫升注射器以1.0毫升/只动物的剂量注射到双侧后大腿肌肉；每组由5只雄性和5只雌性组成。单次肌肉注射后，对每只大鼠进行14天的临床症状和体重变化监测。观察结束后，通过大体尸检和组织病理学检查评估尸检结果和注射部位的局部耐受性。
NP组和对照组均未发生死亡，无论性别如何。在观察期内，未判断出任何变化（如一般症状、体重变化或尸检时的肉眼观察结果）是由受试物引起的。组织病理学检查显示，在雄性和雌性受试物给药组中，给药部位均未发现被判断为由受试物引起的变化。此外，在对照组和NP组中，给药部位股四头肌外膜的单核细胞浸润频率和程度相同，被判断为由注射针的物理刺激引起；因此，它没有毒理学意义。
基于上述结果，判断斯普拉格-道利大鼠单次肌肉注射受试物NP的近似致死剂量>1.0毫升/只动物，且在给药部位未发现被判断为由受试物引起的结果。
