Sorbitol, also known as sorbitol. It is white hygroscopic powder or crystalline powder, flakes or granules, odorless. Depending on the crystallization conditions, the melting point changes in the range of 88~102℃, and the relative density is about 1.49. Easily soluble in water (1g dissolves in about 0.45mL water), slightly soluble in ethanol and acetic acid. It has a refreshing sweetness, the sweetness is about half that of sucrose, and its caloric value is similar to that of sucrose. In the food industry, it is mostly sorbitol liquid with a content of 69~71%. Sorbitol liquid is a clear, colorless, syrupy liquid with a sweet taste, neutral to litmus, and miscible with water, glycerin and propylene glycol. Can be used as nutritive sweetener, humectant, chelating agent and stabilizer.
When used as pharmaceutical excipients, sorbitol can be compatible with a variety of auxiliary agents and is widely used as solid dispersants, fillers, wetting agents, diluents, Capsule plasticizers, sweeteners, ointment bases, etc. The following will help you understand the role of sorbitol in four pharmaceutical excipients:
1. Anti-crystallization agent
Both sorbitol and mannitol have the ability to expand cells. A hypertonic dehydrating diuretic acting as an external fluid solvent. The Chinese Pharmacopoeia stipulates that mannitol infusion for clinical use is a 20% supersaturated solution. Mannitol infusion tends to crystallize and precipitate below 20°C, and the room temperature in most areas of my country is lower than 20°C in winter. It needs to be preheated to dissolve before use. This not only causes difficulties in clinical medication, especially emergency medication, but also easily arouses suspicion among patients, resulting in Conflict between doctors and patients. Adding an appropriate amount of sorbitol during the production of mannitol infusion to formulate compound mannitol infusion can prevent the mannitol from crystallizing out and achieve the same therapeutic effect.
2. Cryoprotectant
The new dosage form of Neupogen (human granulocyte colony-stimulating factor) approved by the United States uses sorbitol instead of mannitol as a protective agent in its preparation. The agent allows Neupogen to maintain its biological activity in a frozen environment.
3. Stabilizers for traditional Chinese medicine preparations
Chinese patent medicine products have been successfully developed in recent years, such as Shuanghuanglian oral liquid, Shuanghuanglian powder injection, Angong Niuhuang pills, Qingkailing infusion, etc. It has the characteristics of convenient use of western medicine. Adding a small amount of sorbitol can stabilize the medicinal effect and prevent precipitation.
4. Pharmaceutical sweeteners
Since sorbitol has a pure sweetness, stable properties and is not easy to deteriorate, many solid or liquid pharmaceutical preparations use sorbitol as the main sweetener. Agent to replace saccharin sodium that leaves a bitter taste after eating.
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