Analytical Method Validation of Gamijakyakgamchobuja-Tang (KCHO-1, Mecasin) Preparation

Area of Science:

• Pharmacology
• Analytical Chemistry
• Neuroscience

Background:

• Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease.
• KCHO-1 (Mecasin) is a complex herbal medicine developed to alleviate ALS symptoms.
• Prior research confirmed Mecasin's development and conducted toxicity testing.

Purpose of the Study:

• To validate and assess the stability of the concentration analysis method for Mecasin preparations.
• To ensure reliable quality control for Mecasin as a potential treatment for ALS.
• To support the development of standardized manufacturing processes for complex herbal medicines.

Main Methods:

• High-Performance Liquid Chromatography (HPLC) was employed for concentration analysis.
• Homogeneity of Mecasin preparations at 50mg/ml and 200mg/ml in sterile distilled water was assessed.
• Stability studies were conducted at room temperature (4 hours) and under refrigeration (2-8°C for 7 days).

Main Results:

• Mecasin preparations at tested concentrations were found to be homogeneous.
• The preparations exhibited stability for up to 4 hours at room temperature.
• Mecasin preparations remained stable for 7 days when refrigerated at 2-8°C.

Conclusions:

• The HPLC method is suitable for analyzing Mecasin preparation concentrations.
• The validated method ensures definitive quality control for Mecasin.
• This research facilitates the development of reliable manufacturing practices for Mecasin in ALS treatment.