How to make enteric hollow capsules
The production process of enteric hollow capsules involves multiple steps. The following is a typical method for preparing enteric hollow capsules:
1. Preparation of materials
The preparation of enteric hollow capsules requires a variety of materials, including gelatin, enteric coating materials, plasticizers, sunscreens (if necessary), water, and other possible excipients.
2. Preparation steps
Sol:
Heat a certain amount of purified water to a certain temperature (such as 88°C), and then stir it in a sol tank at a certain stirring speed (such as 60 revolutions per minute).
Add granular bone gelatin while stirring. After adding the materials, the sol tank is kept at a certain temperature (such as 65°C) and a certain vacuum degree (such as 0.08Mpa) is maintained. Continue stirring for a certain time (such as 30 minutes) to dissolve the gelatin.
After dissolution, a transparent glue solution is obtained. Different pigments and excipients can be added to the glue solution according to the different requirements for preparing the capsule cap and the capsule body.
Preparation of capsule cap and capsule body glue:
For the capsule cap glue, lemon yellow food coloring and brilliant blue food coloring can be added to the dissolved gelatin solution, and the temperature and specific gravity of the glue solution can be adjusted to obtain red opaque capsule cap glue.
For the capsule body glue, medicinal titanium dioxide can be added to the dissolved gelatin solution, and the temperature and specific gravity of the glue solution can be adjusted to obtain white opaque capsule body glue.
Molding and drying:
Under certain ambient temperature and humidity conditions, the capsule cap glue and capsule body glue are dipped into the mold for molding.
After molding, it is dried under certain temperature and humidity conditions to obtain a gelatin blank.
Coating:
Anhydrous ethanol and acetone solution are mixed as coating solvents.
Enteric coating materials are slowly added to the coating solvent and completely dissolved to obtain a coating solution.
The coating solution is dipped on the outer surface of the gelatin blank several times, and dried under certain temperature and humidity conditions to obtain an enteric gel blank.
Cutting and fitting:
The demolded gel blank is cut according to the designed size.
The cap and body are fitted on the fitting machine to obtain enteric hollow capsules.
3. Quality inspection and packaging
Quality inspection: The prepared enteric hollow capsules are subjected to multiple quality inspections such as disintegration time, friability, drying loss, tightness, microbial limit, etc. to ensure that the products meet the relevant standards and requirements.
Packaging: The qualified products are counted and packaged, and sealed and stored under appropriate temperature and humidity conditions.
It should be noted that the preparation method of enteric hollow capsules may vary depending on the process. The above method is only a typical preparation process, and the specific steps and materials may vary depending on actual needs. In actual production, preparation and quality inspection should be carried out in strict accordance with relevant standards and requirements to ensure the quality and safety of the product.
