Journal of pharmacopuncture · 2026
Safety Evaluation of Spray-Dried Curcuma longa L. Extract for Pharmacopuncture: acute toxicity and neurobehavioral assessment in zebrafish.
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Rullyansyah Subhan, Kusumawati Idha, Ismail Intan Safinar, Purwanto Djoko Agus, Isadiartuti Dewi, Bustaman Muhammad Safwan Bin Ahamad, Ngadni Muhammad Afiq Bin, Rahmawan Rizky Rafi, Fitri Ananda Permata, Pattymahu Charlyna Veronika Puspitasari
Аннотация
OBJECTIVES: Curcuma longa L. (CL) exhibits potent anti-inflammatory and analgesic properties suitable for pharmacopuncture; however, the clinical application of CL is severely hindered by poor aqueous solubility. Moreover, traditional ethanol-based extracts are unsuitable for safe parenteral administration due to the risk of tissue necrosis and neurotoxicity at sensitive acupoint sites. Thus, no systematic safety evaluation of water-soluble CL extract (CLE) formulations for injection has yet been conducted.
METHODS: Spray-dried CLE (SDCLE) was prepared by spray-drying CLE with lactose (19 w/w) as the microencapsulation agent. The curcuminoid composition was quantified using a validated high-performance thin-layer chromatography (HP-TLC) method. The solubility of SDCLE was compared with that of native CLE (NCLE). Acute toxicity (LC50), survival, and locomotor behavior were determined using probit regression and automated EthoVision XT tracking following a 96-hour exposure of adult zebrafish to SDCLE (0-500 mg/L).
RESULTS: SDCLE, formulated to contain 10% (w/w) NCLE, exhibited a curcumin content of 0.148 ± 0.02 mg/g. This formulation showed markedly enhanced aqueous solubility (91.30% at a 130 dilution) compared with NCLE alone (55.78% at the same dilution), yielding clear, homogeneous solutions suitable for parenteral administration. Post-exposure acute toxicity assessment in zebrafish revealed a time-dependent decrease in LC50 values, from 469.96 mg/L at 24 h to 288.13 mg/L at 96 h. Acute toxicity analysis identified a no-observed-effect concentration (NOEC) of 144.07 mg/L and a lowest-observed-effect concentration (LOEC) of 187.28 mg/L. Exposure to concentrations ≤ 200 mg/L resulted in > 95% survival and preserved normal locomotor activity, whereas concentrations ≥ 300 mg/L induced pronounced neurobehavioral suppression, characterized by a 35% reduction in swimming distance and a six-fold increase in inactivity.
CONCLUSION: Spray-drying overcame the solubility limitations of CLE, enabling aqueous reconstitution for pharmacopuncture applications. A 96-hour LC50 of 288.13 mg/L was employed to define mortality, while neurobehavioral endpoints indicated toxicity at sublethal concentrations, supporting the safety of concentrations ≤ 200 mg/L for rational SDCLE dose selection.
METHODS: Spray-dried CLE (SDCLE) was prepared by spray-drying CLE with lactose (19 w/w) as the microencapsulation agent. The curcuminoid composition was quantified using a validated high-performance thin-layer chromatography (HP-TLC) method. The solubility of SDCLE was compared with that of native CLE (NCLE). Acute toxicity (LC50), survival, and locomotor behavior were determined using probit regression and automated EthoVision XT tracking following a 96-hour exposure of adult zebrafish to SDCLE (0-500 mg/L).
RESULTS: SDCLE, formulated to contain 10% (w/w) NCLE, exhibited a curcumin content of 0.148 ± 0.02 mg/g. This formulation showed markedly enhanced aqueous solubility (91.30% at a 130 dilution) compared with NCLE alone (55.78% at the same dilution), yielding clear, homogeneous solutions suitable for parenteral administration. Post-exposure acute toxicity assessment in zebrafish revealed a time-dependent decrease in LC50 values, from 469.96 mg/L at 24 h to 288.13 mg/L at 96 h. Acute toxicity analysis identified a no-observed-effect concentration (NOEC) of 144.07 mg/L and a lowest-observed-effect concentration (LOEC) of 187.28 mg/L. Exposure to concentrations ≤ 200 mg/L resulted in > 95% survival and preserved normal locomotor activity, whereas concentrations ≥ 300 mg/L induced pronounced neurobehavioral suppression, characterized by a 35% reduction in swimming distance and a six-fold increase in inactivity.
CONCLUSION: Spray-drying overcame the solubility limitations of CLE, enabling aqueous reconstitution for pharmacopuncture applications. A 96-hour LC50 of 288.13 mg/L was employed to define mortality, while neurobehavioral endpoints indicated toxicity at sublethal concentrations, supporting the safety of concentrations ≤ 200 mg/L for rational SDCLE dose selection.