T/ZGKSL 003-2023 soluble microcrystalline patch

Scope

Scope: This document specifies the terms and definitions, classification, requirements, test methods, hygiene requirements for the production and processing process, inspection rules, marking, packaging, transportation, storage, and shelf life of soluble microcrystalline patches. This document applies to soluble microcrystalline patches that are applied to the human skin surface, removed after a period of residence, and used to beautify and modify the skin. Main technical content: Microcrystals have the ability to reversibly reduce the tightness of the stratum corneum, increase the percutaneous penetration of substances, and improve the absorption efficiency of substances in the skin. Their material properties depend on their special microstructures at the micron level. Therefore, the document specifies the requirements for the microstructure of soluble microcrystalline patches, including the shape of microcrystals, the range of microcrystal height, and the density of microcrystal arrays. Among them, the height of microcrystals is directly related to the depth of action of soluble microcrystalline patches on the skin. Therefore, the drafting group conducted in vitro skin staining experiments and in vivo percutaneous water loss experiments, and summarized the experimental results to define the range of microcrystal height in their microstructure. This part of the argument is described in detail in the drafting notes. It is worth noting that in addition to the height of microcrystals, the overall water content of microcrystalline patches and the flexibility of their forming materials are also related to the depth of action of microcrystalline patches. Due to the different production processes of different manufacturers and the involvement of trade secrets, it is difficult to make strict specifications. Therefore, the range of microcrystal height in the document is only for reference.

Development Information

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