Gelatin comes from the Latin word "gelatus" which means "stiff" or "frozen". It comes from the collagen that takes the body parts of the animal. Now this kind of substance is used in food, medicine, photography, cosmetics and other industries.

As the main raw material, gelatin is easy to cause microbial contamination in the production process. In order to prevent microbial contamination problems, oxidizing substances such as hydrogen peroxide are added to the production process.

Bubbles are one of the defects that may occur in the production process of gelatin capsules, because it not only affects the appearance of medicines or health care products, but may also break the capsule filling process, resulting in leakage of contents.

Capsule drugs are used frequently in life. However, in actual production, the problem of softening of the capsule is often encountered, which is usually happened in spring and summer. The main reason is that the gel cap is not properly stored, which is affected by the temperature or adsorbs moisture in the air.

This standard specifies the specifications, technical indicators and requirements, test methods, inspection rules, criterion rule and requirements of product packaging, labeling, transportation and storage of empty gelatin capsules. This standard is applicable to empty hard gelatin capsules made of gelatin and auxiliary materials. Gelatin for capsules should meet the standard.

Gelatin is a versatile natural polymer. It has low immunogenicity, antibacterial property, anti-oxidation performance, etc. It can be applied to capsules, blood substitutes, hemostatic excipients, tissue engineering scaffold materials, and the like.

Gelatin is obtained by purifying the collagen of the animal skin, bone, tendon and ligament after incomplete acid hydrolysis, alkaline hydrolysis or enzymatic degradation.

Medicinal gelatin has a unique structure - its anion and cation dissociation on the molecular chain, making it have a good solubility and water retention. Gelatin solutions with concentrations up to 50% can be obtained by different dissolution methods. To completely dissolve gelatin in a short time, you can use hot water at 50~60°C or even 90~95°C. In addition, gelatin is insoluble in organic solvents.

There are many types of capsules, and they are generally classified by their raw materials. However, even gelatin capsules of the same raw material can be further subdivided. For example, they can be classified according to their quality.

The cross-linking reaction refers to a reaction in which two or more molecules (generally linear molecules) are bonded to each other to form a relatively stable molecule (body-shaped molecule) of a network structure. The cross-linking phenomenon of gelatin capsules indicates that the gel capsules change with time, and a film is formed on both inner and outer sides of the capsule shell.