Preparation and performance test of vegetable enteric hollow capsules by one-line molding process / 中国药学杂志

ABSTRACT

OBJECTIVE: To develop vegetable enteric hollow capsules with sodium alginate (Alg-Na), starch and excipients by one-line molding process and investigate their properties. METHODS: The influence of the ratio of raw materials on capsule shape index was analyzed by multiple factors trials. The light transmittance and mechanical properties were evaluated, and DSC, FT-IR, and SEM analysis were conducted. RESULTS: The optimal formula composed of medium viscosity Alg-Na 0.6%, ultralow viscosity Alg-Na 2.5%, starch 10%, gellan gum 0.6%, and glycerin 2% could produce vegetable enteric hollow capsules with good performance. The main property indexes were as follows liquid viscosity 434 mPa·s, capsule thickness 0.11-0.12 mm, water content 10.09%, disintegration time 8-15 min in simulated intestinal fluid (not disintegrated within 2 h in simulated gastric fluid), light transmittance of capsule film 85.5%, tensile strength 27.97 MPa, and elongation at break 2.0%. CONCLUSION: This study lays theoretical foundation for replacing gelatin capsules with vegetable enteric hollow capsules.