RESUMEN
Strengthening the standard formulation and quality management of traditional Chinese medicine（TCM） dispensing granules is an important part of the strategic planning for the development of TCM in China. In order to examine the clinical application and overall quality control of the existing national standards for TCM dispensing granules， this study classified and summarized the varieties in the existing standards， analyzed their clinical applicability， and discussed the characteristics of the test methods for identification， content determination and specific chromatogram/fingerprint. It was found that the coverage of the existing standards was inadequate in terms of quantity， and it was even weaker in the aspects of therapeutic efficacy， herb family， processing method and preparation method of TCM dispensing granules. It was concluded that the characteristics of national standards in test methods were summarized as follows：guided by clinical application， based on the reference system， taking specific chromatogram as a breakthrough， so as to improve the overall quality control of TCM dispensing granules. It is suggested that the coverage of national standards should be subsequently expanded to meet the needs of market development. In order to enhance clinical applicability， the content of national quality standards should be increased， including increasing variety diversity to meet the needs of clinical application， raising the standard requirements to improve the clinical medication experience， and strengthening effectiveness research to highlight clinical efficacy. At the same time， the accessibility of regulatory inspection is enhanced， the rules for the management of varieties without national standards are promulgated to lay the foundation for the healthy and orderly development of TCM dispening granule industry.
RESUMEN
In the context of the national strategy of promoting the research and development of food and drug homologous substances, it is necessary to study the regulatory model of food and drug homologous substances as food. Medicinal and food homologous substances are regulated as "Chinese medicinal materials" or "Chinese decoction pieces" in the drug category, and as "food and drug homologous substances", "agricultural products" or "traditional Chinese medicine healthy food" in the food category. Drug supervision focuses on quality, while food supervision focuses on safety, and it is worth exploring whether there is a blind spot in the supervision of food and drug substances completely based on the food concept. In this paper, Lonicerae Japonicae Flos, as drug and food homologous substance, is selected as the research object, and its quality regulation status is investigated by reviewing the relevant laws and regulations and standards on food, analyzing the quality information and test results of the samples, and analyzing the necessity of quality regulation when serving as food, in order to provide a basis and reference for the way food substances are regulated.