Rationing of iodine content in kelp layers and products based on them. Changing approaches within the framework of a risk-based strategyin drug quality control

The State Pharmacopoeia of the Russian Federation regulates the lower level of iodine content in Laminaria thalli. However, an excess of iodine is as harmful to the human body as its deficiency.

The aim. To determine the range of permissible iodine content in the medicinal plant raw material "Laminaria thalli" and products based on it within the framework of a risk-oriented strategy in medicine quality control.

Materials and methods. Samples of medicinal herbal preparations, biologically active additives, food products based on Laminaria thalli of various origins, samples of algae collected by the authors on the coast of the White Sea and the Pacific Ocean, as well as literature data on the iodine content in pharmacopoeial species were studied. The iodine content was determined by inductively coupled plasma mass spectrometry after extraction according to GOST EN 15111-2015. The non-carcinogenic risk was calculated in accordance with Guidance R 2.1.10.1920-04.

Results. The average (0.14%) and maximum (0.46%) iodine content in pharmacopoeial species of Laminaria thalli was determined, which correlates with the iodine content norm in Laminaria algae proposed by the U.S. Food and Drug Administration (FDA) — 0.1–0.5%. It was found that at the maximum therapeutic dose and course of treatment with laxative herbal preparations, containing 0.5% of iodine, the level of non-carcinogenic risk falls into the category of maximum permissible. Under similar conditions, treatment, for example, of mastopathy with preparations based on Laminaria thalli with 0.5% of iodine leads to an unacceptable impact of iodine on human health.

Conclusion. The authors recommend, instead of the existing norm of iodine content (not less than 0.1%), to take into account the permissible amount of this element (0.1–0.5%), which corresponds to its real content in pharmacopoeial species of Laminaria thalli.

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