How to make empty medicinal gelatin capsules
The production of empty medicinal gelatin capsules is a rigorous and multi-step process, involving raw material preparation, gelatin preparation, molding, drying, finishing and quality inspection. The following is the specific production method:
1. Raw material preparation and gelatin preparation
Raw material selection: Use medicinal gelatin that meets CP/USP standards as the base material, with plasticizers such as glycerin and food-grade pigments. The raw materials must pass 28 indicators such as viscosity, freezing force, and microbial limits. The moisture content is controlled in the range of 8%-12%.
Gel process: Accurately weigh each component according to the prescription ratio, use a sandwich gel tank to melt at 65±2℃, vacuum degassing for 30 minutes, control the viscosity in the range of 800-1200cps, and detect the transmittance (≥90%) and pH value (4.5-6.5) online.
2. Precision molding and gradient drying
Molding process: stainless steel pin-plate molding machine is used. Key parameters include glue temperature maintained at 60±1℃, mold preheating temperature at 45℃, dipping time at 4.5 seconds, and the molding workshop maintains ISO8 cleanliness.
Drying technology: implement a three-stage drying procedure, primary drying section (28℃/RH40%, 45 minutes), main drying section (32℃/RH25%, 3 hours), and balance section (25℃/RH35%, 2 hours), to ensure that the moisture content of the capsule is stable at 12%-18%.
3. Finished product finishing and packaging
Defect removal: photoelectric sorting machine is used to remove defective products such as deformation and bubbles to ensure product qualification rate.
Packaging specification: use aluminum-plastic composite film packaging, control water vapor permeability ≤0.5g/m²·24h, storage conditions are temperature 15-25℃, relative humidity ≤40%.
4. Quality inspection and standards
Key indicators: Inspection items include appearance (uniform color, no foreign matter), loss on drying (12.5%-17.5%), friability (broken number ≤15 grains), disintegration time (completely dissolved or disintegrated within 10 minutes), ignition residue (transparent ≤2.0%, translucent ≤3.0%, opaque ≤5.0%), heavy metals (≤40 parts per million), chromium content (≤2 parts per million).
Storage conditions: Store in a sealed container at a temperature of 10-25℃ and a relative humidity of 35%-65%.
