A toxic substance not to be ignored-ginkgolic acid
Ginkgolic acid is mainly an alkylphenolic acid compound, which has sensitization, cytotoxicity, embryotoxicity and neurotoxicity, etc. It is a component that needs to be strictly controlled in Ginkgo biloba leaf extract and its preparations. Both domestic and foreign standards adopt HPLC method to determine the content of total ginkgolic acid. At present, Chp2020 revised the ginkgo acid limit standard from 10mg/kg to 5mg/kg, which is consistent with foreign standards.
It is worth noting that Chp2020 has added a new fingerprint detection item. The GBE fingerprint is detected by HPLC in the acetonitrile-phosphoric acid system, the rutin is used for positioning, the 17 chromatographic peaks in the fingerprint of the control extract of Ginkgo biloba are compared. Full peak matching, calculated according to the similarity evaluation system of Chinese medicine chromatographic fingerprints, the similarity should be ≥0.90. the revision will help improve the quality of domestic Ginkgo biloba leaf extract products.
Ginkgo and its preparations are very popular in the international market, its quality control is becoming more and more important. At present, many Ginkgo biloba leaf extract manufacturers in my country follow the requirements of the Chinese Pharmacopoeia for product testing, few manufacturers perform quality control in accordance with the limits of the pharmacopoeias of Europe and the United States. As a result, although our country is rich in ginkgo resources, the quality of its products cannot meet the quality requirements of European and American countries , which rarely exports to these countries. Most of the domestic GBE can only be exported to countries with low quality standards, its international competitiveness is weak.
Therefore, in terms of raw materials and processes, domestic GBE manufacturers should strengthen the quality control of ginkgo biloba raw materials, adopt efficient extraction processes for production, and establish standardized production processes. In terms of quality control, currently, Chp2020 only specifies the lower limit of total flavonol glycosides and terpene lactones. It is recommended that domestic manufacturers should refer to the international pharmacopoeia standards to formulate a reasonable total flavonol glycosides and terpene lactones content range. In addition, consideration should be given to increasing the range of BB content and the total content range of GA+GB+GC in terpene lactones, formulating enterprise standards that are stricter than the Chinese Pharmacopoeia to improve product quality as a whole, which is of great significance to the development of European and American GBE markets.
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