Tween 80 has a special smell and a slightly bitter taste. It becomes gelatinous at low temperatures and recovers after being heated. Easily soluble in water, soluble in ethanol, vegetable oil, ethyl acetate, methanol, toluene, and insoluble in mineral oil. This product is used as a solubilizer or emulsifier for injections and oral liquids; a dispersant for capsules; and an emulsifier for ointments. Agents and bases; bases for suppositories, etc. Used as emulsifier in the food industry.
There are strict restrictions on the use and dosage of Tween 80:
Tween 80 is a hydrophilic surfactant that has a strong ability to rupture cell membranes and cause irritation, hemolysis and histamine release (sensitization). As a polymer, the purity of Tween 80 fluctuates greatly. High-purity Tween 80 is colorless and transparent, while most Tween products are yellow to brown and contain a large amount of impurities or degradation products. The lipophilic ingredients in Tween 80 include unsaturated fatty acids. These unsaturated fatty acids are easily oxidized and degraded to produce more toxic components. The resulting toxic and side effects will exceed the benefits of the product itself. The medical community has confirmed that Tween 80 used in injections can cause allergic reactions, including shock, dyspnea, hypotension, angioedema, rubella and other allergic-like reaction symptoms. These adverse reactions can be severe in human clinical trials. There were reports of deaths. Therefore, there are strict restrictions on the use of Tween 80. It is a potentially unsafe excipient and improper use will have a great impact on human health.
In view of the above situation, relevant standards have stipulated the safe use limit of Tween 80. In general drug preparation, the allowable dosage of Tween 80 is 0.5-5% according to the dosage of the drug. The dosage of Tween 80 for injection is limited to 100 micrograms/ml. GB2760-1996 stipulates that the limit of Tween 80 in ice cream and ice cream is 1‰, and the limit in milk is 1.5‰. The guidelines for the use of food additives (NY/T392-2000) clearly stipulate that Tween 80 and Span are food additives that are prohibited for use in the production of green foods.
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