Good news has recently arrived. The pharmaceutical excipient kaolin (F20220000303) of Jiudian Hongyang has successfully passed review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. Its registration status has been formally changed from "I" to "A", and it has been successfully approved for marketing.

Pharmaceutical-grade kaolin is derived from a natural aluminosilicate mineral. With its distinctive porous layered structure and stable physicochemical properties, it combines several functions, including adsorption and removal of impurities, filling and dilution, and suspension aid and reinforcement. It is a multifunctional pharmaceutical mineral excipient with wide use in the pharmaceutical field.

Pharmaceutical-grade kaolin has a wide range of topical uses. Kaolin modified by high-temperature calcination can, in cataplasms, work with the polymeric matrix to build a stable network structure. Relying on its high specific surface area, it optimizes the cohesive strength of the paste and regulates consistency and spreadability, giving a comfortable wear feel and leaving no paste residue on removal. Fine powder of pharmaceutical-grade kaolin produced under strict control of hygienic specifications can also be used to prepare topical mud plasters and topical dusting powders, meeting the needs of various dermatological preparations.

In oral preparations, kaolin is used in oral liquids and suspensions as a suspending excipient to slow the settling of poorly soluble drug particles. Its pore adsorption capacity can take up volatile oils, odoriferous impurities, and free moisture in the materials, improving formulation stability. In addition, because calcined kaolin has a low water content and more stable physicochemical properties, it can also be used as a filler in formulations.

The successful change of kaolin to status A further enriches Jiudian Hongyang's line of functional pharmaceutical excipients and demonstrates Jiudian Hongyang's research and development strength and quality-control standard in high-end pharmaceutical excipients. Going forward, Jiudian Hongyang will deepen process improvement and technical upgrading of natural mineral excipients, continue to expand its range of compliant excipients, and improve its end-to-end capability to support excipient supply.