Herbal Mixtures: Aspects Related to the Quality of Chinese Medicine Formulas and Perspectives for Products Registration in Brazil

Abstract

Traditional medicine products are easily found in different regions of the world. Given this scenario, the World Health Organization (WHO) is very interested in the rational insertion of these resources, especially in primary pharmaceutical care in emerging countries. One of the main concerns of the WHO is with the population's access to traditional medicine products without quality guaranteed by regulatory and health control agencies in the country of origin. In ancient Chinese Pharmacology and Medicine, products based on associated drugs, used by boiling in water (decoction), successfully contribute to maintaining the health of Chinese people. In Brazil, the sanitary legislation of herbal mixtures for medicinal teas allows the sanitary notification of these products as traditional herbal medicines. On the other hand, the lack of clinical services to monitor consumption and the scarcity of evidence to ensure safety and efficacy, add to the inadequacy of the products to sanitary standards, the lack of inspection, and the definition of quality parameters for the evaluation of mixtures. Due to the chemical complexity of herbal mixtures, the correct identification of drugs through conventional techniques is usually possible for individual species, making it necessary to develop more comprehensive approaches. These testes allow to investigate the presence and/or absence of multiple pre-established markers, through the concept of fingerprint similarity and evaluation by chemometric tools. Liquid chromatography integrated with mass spectrometry and multivariate data analysis proved to be the most used method. Among the objectives of this critical and prospective review are: to describe the probable origin of medicinal teas, the theoretical foundation of the compositions in pharmacology and traditional Chinese medicine, the modern techniques developed in the quality control of herbal mixtures, and the perspectives for rational and safe insertion of traditional herbal medicines in Brazilian pharmaceutical care.