As the name implies, gelatin can be used in the production of pharmaceutical products. Some pharmaceutical products are produced directly, such as cod liver oil; while some are produced indirectly, such as capsules and packaging for drugs. Gelatin is made from the skins, bones and tendons of animals through a complex physical and chemical process. It is fat free, high in protein and easily absorbed by the body. It has physical properties such as high viscosity, high freezing power and easy freezing.
Pharmaceutical gelatin should be dry, clean, uniform and free of inclusions. It looks like a light yellow to yellow fine particle. It should pass the standard sieve with an aperture of 4 mm and its solution is odorless. It is mainly used as plasma substitutes, hemostatic sponges, soft and hard capsules, raw material for tablet sugar coating, capsule material for microspheres and microcapsules, and other slow release materials and biofilm materials.
Succinyl gelatin for injection is prepared by spray drying and freeze-drying processes and made into solid formulations to improve its stability and ease of transport and storage, and to compensate for the unstable nature of peptide biologics infusions and the inconvenience of transport and storage.
Gelatin is an important chemical ingredient with a wide range of applications. However, there is no official standard for gelatin except for the technical specifications of “gelatin” listed in the pharmacopoeia. In addition, the pharmacopoeia only specifies requirements for a single variety of gelatin, and the technical items and indicators are incomplete and cannot reflect the actual scope of application.
In order to standardize the production of hard capsules, the Ministry of Health developed the “Gelatin Capsule Standard” for the main raw material gelatin in 1988, but this standard only applied to the manufacture of hard capsules. Since there is no formal standard for gelatine, both gelatine manufacturers and gelatine users are based on either the edible gelatine standard or the “gelatine capsule” standard. Therefore, there was an urgent need for a unified gelatin standard to regulate the then inconsistent production and use requirements.
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