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The Draft Standards for Pharmaceutical Excipients of Cholesterol (for Injection) formulated by the Engineering Center was publicized by Chinese Pharmacopoeia Commission

Release Date:2021-12-31

       On Dcember 30, 2021, the Draft Standards for Pharmaceutical Excipients of Cholesterol (for Injection) formulated by the National Engineering Research Center for Chinese Pharmaceutical Manufacturing Technology and New Drug Development of Guangzhou Hanfang Pharmaceutical Co., Ltd. (“Engineering Center”) was publicized on the official website of Chinese Pharmacopoeia Commission.
     Cholesterol, as a special steroid, is widely used in cosmetics, emulsifiers, medicine and other fields. It can be used as a multi-functional cosmetic emulsifying agent to improve the properties of anionic emulsifiers and the stability of lotion. In addition, cholesterol is an ideal steroid prodrug.
         At present, the raw materials for cholesterol production by extraction in the world mainly come from pig, cattle, sheep and other animal tissues, including viscera, brain pulp, and lanolin. Due to the outbreak of bovine spongiform encephalopathy (BSE) in Western Europe and other countries, European and American countries are resistant to  finished cholesterol produced with animal brain as raw material, which makes it difficult for cerebral cholesterol and products produced with this material to enter European and American countries.
        The Engineering Center carried out independent R&D with the by-product of refined egg yolk lecithin (egg yolk crude oil) as the raw material, and produced cholesterol (for injection) products from a unique source. The product quality meets the quality standard of European Pharmacopoeia. Both high-purity cholesterol and egg yolk oil with low cholesterol content can be obtained. At the same time, cholesterol from egg yolk is safer than cholesterol from animals in the market. There is no potential safety hazard such as BSE, and the price advantage is obvious, which can reduce the production cost of domestic preparations and relieve the medical expenditure of patients.
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