Producing and quality control of fecal-derived microbiota enteric capsules

Objective To initially explore the feasibility and quality control of producing fecal-derived microbiota enteric capsules. Methods Fecal-derived microbiota was put into double layered enteric capsules. The bacteria colony numbers of fresh prepared glycerol containing fecal-derived microbiota liquid, glycerol containing and glycerol free fecal-derived microbiota after stored at -80 ℃ for 72 h were counted with standard plate count methods in order to investigate the stability after frozen. Methylene blue was taken as the standard, resistance to acid and release rate of capsules was evaluated. Thet test was performed for statistical analysis. Results The preparation process of double layered microbiota capsules was simple and practicable. The data of 12 plates of each microbiota were acquired. The number of bacteria colony of fresh prepared glycerol containing fecal-derived microbiota ((5.08±1.37)×107colony-forming units (cfu)/mL) was significantly more than that of the group without glycerin ((1.73±0.64)×107cfu/mL) at -80 ℃ for 72 h (t=7.621, P<0.01). There was no significant difference in the number of bacteria colony between glycerin containing frozen fecal-derived microbiota ((4.67±1.56)×107cfu/mL) and fresh fecal-derived microbiota (t=0.694, P=0.495). Regression equations were achieved with fecal-derived microbiota containing methylene blue, and there was a good linear relation between 0.5 μg/mL and 8.0 μg/mL. Three fecal-derived microbiota enteric capsules containing methylene blue were prepared. Their resistance to acid was 96.0%, 99.1%, and 95.5%, while the release rate was 88.6%, 95.1% and 86.5%, respectively. All met the requirement of Chinese Pharmacopoeia to enteric capsules. Conclusion The preparation of double layered fecal-derived microbiota enteric capsules had feasible technology and stable quality, which could provide reference in prevention and treatment of diseases related with colonic microbiota imbalance. Key words: Gut microbiota; Fecal microbiota transplantation; Capsules, enteric-coated; Quality control