Traditional Chinese medicine formula granules are a new way of medication. For this method, many patients still have doubts: Are the raw materials pure? Is it adulterated? Is the effect the same as traditional decoction? These questions must have reassuring answers.
In February 2021, the State Food and Drug Administration and other four departments jointly issued the "Announcement on Ending the Pilot Work of Traditional Chinese Medicine Formula Granules", and also issued the "Technical Requirements for Quality Control and Standard Research of Traditional Chinese Medicine Formula Granules". The reference quality control system and process optimization strategy of traditional Chinese medicine formula granules provided a scientific basis for establishing the whole process quality control in line with the characteristics of traditional Chinese medicine.
As early as 2016, Tianjiang Pharmaceutical launched the national standard research plan for traditional Chinese medicine formula granules. From collection, production, to quality, technology, and research and development, multiple departments formed a national standard research team and invested hundreds of millions of funds.
Tianjiang Pharmaceutical took the lead in establishing a "cross-regional, whole-industry-chain, and digital" Chinese medicine quality control model in the field of traditional Chinese medicine, and continued to drive the standardized and healthy development of the upstream medicinal materials and decoction pieces industry. Through advanced pharmaceutical technology and precise quality control, it continuously improved product quality. , continue to innovate the clinical service model, and provide more safe, effective, stable and controllable traditional Chinese medicine formula granule products and clinical overall solutions for the clinic.
At present, the State Food and Drug Administration has promulgated 201 national standards for traditional Chinese medicine formula granules commonly used in clinical practice. The construction of this standard system solves the problem of no national standard for traditional Chinese medicine formula granules for more than 20 years, and ensures the safety and effectiveness of clinical medication. Among the 196 national standards, 102 of them were completed by Tianjiang Pharmaceutical and Yifang Pharmaceutical, two subsidiary of Chinese Medicine Holding, ranking first among the 15 standard providers.
