알레르기 반응을 감소시킨 봉독약침의 조제법 및 안정성에 관한 연구

Study on the Preparation Method and Stability of Bee Venom Pharmacopuncture with Reduced Allergenicity

Objectives Bee venom pharmacopuncture, despite its high risk of hypersensitivity and compound instability, has been widely used due to its potent therapeutic effects. Therefore, this study aimed to develop a pharmacopuncture formulation with reduced hypersensitivity and improved compound stability. Methods Dried bee venom powder was fractionated by molecular weight using Sephadex, and the high-molec-ular-weight enzyme fraction was removed. All procedures were verified by high-performance liquid chromatography (HPLC). For stability testing, pH, insoluble particle count, and melittin content (by HPLC) were measured every two weeks. The pharmacopuncture samples were refrigerated, stored at 35°C for two days, and then re-refrigerated to assess stability during transport. Results The high-molecular-weight enzyme fraction was successfully removed. No significant changes were ob-served in pH. In the control group, both the number of insoluble particles and the melittin content gradually changed. Storage at 35°C reduced melittin content, whereas it remained stable under refrigeration. Short-term exposure to room temperature during refrigerated storage resulted in a maximum decrease of 2.91%, after which the content re-mained stable. Conclusions Melittin is the main active compound in bee venom pharmacopuncture, and both its stability in aqueous solution and hypersensitivity potential are critical factors. Further clinical validation is warranted based on these findings.