Squalene CDE registration number has been publicized

Recently, squalene of Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd. has been publicized on the CDE platform with the registration numberF20210000392.

Product Introduction

Squalene is a kind of polyunsaturated hydrocarbon produced in the process of human cholesterol synthesis and other metabolic processes. It contains 6 isoprene double bonds and belongs to terpenoids. Many foods contain squalene, among which the content of shark liver oil is relatively high, and squalene is also contained in many vegetable oils, which generally contain 0.002~0.03 in vegetable oils. The content of squalene in olive oil, rice bran oil and tea seed oil is relatively high, especially in olive oil, where the content of squalene is as high as 0.2~0.7.

Product activity

Squalene is combined with low-density protein in the body, transported through the blood and distributed to various tissues, which can enhance the ability of body tissues to utilize oxygen, resist various diseases caused by hypoxia, and improve the body's tolerance. Improve heart function, enhance physical fitness, purify body garbage, protect liver, anti-aging, prevent diabetes, repair cells and enhance resistance. Since 1906 by the Japanese chemist Dr. Ben Manwan found, because of its good biological activity and in food, medicine, cosmetics and other fields have been widely used.

Product use

As a pharmaceutical excipient, squalene is mainly used as a vaccine adjuvant. Due to its low viscosity, high activity and good stability and tolerance, it can significantly accelerate the onset time of adjuvant inactivated vaccine while ensuring the immune effect. Squalene is used in oil-in-water MF59 adjuvant, which is widely used in clinical trials of various subunit vaccines such as influenza, hepatitis B, hepatitis C and HIV vaccines, and has been approved by the US FDA as the second listed human adjuvant in addition to aluminum adjuvant.

Quality Control

The squalene of Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd. has formulated internal control quality standards in accordance with the European Pharmacopoeia (EP). The finished products are light in color, low in acid value, low in peroxide value, solvent-free in the refining process, and good in inter-batch stability. Different specifications of packaging can be provided as required to meet the needs of different customers.