T/CEMA 046-2025 Technical Specification for Production of Tibetan Medicine Zuotai

Scope

Zota is a representative Tibetan medicine preparation, which plays an important role in the production of Tibetan medicine and is directly related to the safety and effectiveness of Tibetan traditional medicines. Due to the fact that the main raw materials for Zota production are mercury and sulfur, the preparation process is complex, and there are no unified production technical standards. Therefore, its quality and safety have drawn widespread attention from society. As a core technology in the preparation of Tibetan medicine, Zota has a complex preparation process, high technical difficulty, and high production costs. It also imposes strict requirements on the plant facilities, personnel structure, process technology, material guarantee, and quality control of production units. However, at present, due to the pursuit of profit and benefits by practitioners and the influence of the historical background of Tibetan medicine inheritance, large pharmaceutical companies, medium-sized medical institutions, and small individual businesses are all producing Zota, leading to a chaotic situation with problems such as lack of supervision, poor standardization, unstable quality, prominent safety hazards, and high medication risks. Therefore, it is urgent to formulate technical standards that meet the professional characteristics of Zota production in Tibetan medicine. In view of this, the main drafters invited experts from disciplines such as Tibetan medicine, Tibetan medicine, pharmacy, and chemistry across the country to study and draft this document, aiming to provide a common technical guidance for the standardized production of Zota in Tibetan medicine, improve the standardization, stability, and safety of Zota production, and ultimately enhance the safety and effectiveness of Tibetan traditional medicines containing Zota.

Development Information

Related Standards