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.
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.
Capsules are used extensively in the pharmaceutical industry. It has the advantages of convenient and easy to take, reducing the stimulation of the ingredients on the stomach and masking the bad smell of the drug.
Capsules have become one of the main dosage forms of oral solid preparations other than tablets. Medicinal gelatin empty capsule is a special kind of medicinal excipient, which enters the digestive system of the human body together with the medicine and is finally absorbed by the human body. Therefore, the quality is directly related to the safety of the medicine. The quality of gelatin and the standardization of its production process are the main factors affecting the safety of empty capsules.
Although industrial gelatin and medicinal gelatin are not fundamentally different, industrial gelatin is definitely not used in the pharmaceutical industry. So how do we distinguish between these two gelatins?
Gelatin is a product obtained by partially hydrolyzing collagen obtained from the skin of an animal, connecting tissues and bone. Its main ingredient is protein. It has many excellent physical and chemical properties, such as adhesion, surface activity and the like. Depending on the application, gelatin can be divided into edible gelatin, medicinal gelatin, lighting gelatin and industrial gelatin.