With the increased requirements of medical healthcare,traditional Chinese medicine (TCM)has received more and more attention from the whole world.
The development of analysis technique has significantly promoted the TCM analysis level, but it also gradually brings about quality issues. National post-market drug surveillance results over the years have shown that through exploratory studies, potential quality issues may also be found in the products which have been tested qualified based on mandatory drug standards,such as adulteration,weight increment and staining of the active pharmaceutical ingredients (APIs)and prepared decoction pieces,improper processing,use of non-medicinal parts,relatively high level of exogenous poisonous and harmful residues. Moreover, there are also other issues including feeding not as prescribed during the production process,no or less charging of expensive and fine medicines,cross contamination, process changes and inconsistency of excipients and quality. Other industry hidden rules, such as APIs of Chinese patent medicine which may be shoddy, doped, adulterated and feeding at an amount lower than the prescribed amount, and processed using an arbitrarily modified process, emerge persistently regardless of the prohibition. Bad money drives out good,which results in varied TCM quality,is difficult to embody the high quality and high price of the products,and triggers the impact on market equity and justice,thus influencing the healthy development of TCM industry. Above phenomena indicate that the mandatory test standards are only the lowest standards needed to be met by the TCM. Quality control item missing is reflected in some standards,so that some illegal enterprises have taken the opportunity to cheat on workmanship and materials. Although test items are set up for all medicines in order to judge the medicines' authenticity,they cannot reflect the medicines' quality. In China,under the overall background of economic transformation and upgrading and supply-side reform,it is of important and urgent practical significance in studying innovative models for TCM quality evaluation,proposing and implementing nationally recognized and industry-used quality level standards as well as scientific quality evaluation and strict control,so as to specify the market order, strike against hidden industry rules, guide the healthy and ordered development of TCM industry, practice "the Four Most Strict Requirements "proposed by General Secretary Xi Jinping,prevent medicine monitoring systemic risks and ensure the people's safe and effective medications.
Currently, the study on quality level of TCM has become a leading hotspot and new field for TCM quality evaluation. The study on quality level of Chinese patent medicine is still in the primary exploratory stage. Hence, National Institutes for Food and Drug Control has approved the project through Academic Leader Foundation, supported the "Study on Innovative Model for Quality Evaluation of Chinese Patent Medicine", and established a research group to study the new models for Chinese patent medicine quality evaluation using model medicines including Niuhuang Qingwei Pills specific to the current situation that most standards of Chinese patent medicine cannot reflect the medicine's actual quality resulting in products' cost overhang and inconsistent quality. To provide scientific scale for the level evaluation,Guideline principle and technical requirement for preparing traditional Chinese medicine reference drug has been proposed and published by the research group. TCM reference drug,as a new form of national drug standard substance, is defined as the physical control prepared with authentic, high-quality and standardly processed raw medicinal materials (pieces) and excipients, in strict accordance with the preparation method and manufacturing process, and in compliance with the quality management practices of pharmaceutical production,and is mainly used for quality control of Chinese patent medicine to evaluate the authenticity of product dosing (whether the right raw material is dosed)and the reliability of dosing quantity (whether it is dosed according to formula). Meanwhile,multiple combination techniques are used to establish the new models for quality evaluation during the research and development of reference drug, with contents in the reference drug and critical ingredient transformation rate as the references, and to establish level limit standards, so as to distinguish the "medicines manufactured based on GMP" and "eligible medicines manufactured only for standard tests".
To enhance the study on the innovative models for Chinese patent medicine quality evaluation,National Institutes for Food and Drug Control have carried out a series of studies together with drug test institutions in some provinces and cities,with some achievements obtained. This journal specially sets up "a column of Study on Innovative Model for Quality Evaluation of Chinese Patent Medicine",reports the relevant study achievements in 6 papers,summarizes "Research progress on evaluation of quality grade of traditional Chinese medicine",and introduces the "Establishment of Niuhuang Qingwei pills reference drug", "Discussion on a novel quality evaluation model for compound Danshen tablets based on reference drug", "Discussion on a novel model for quality evaluation of Kanggongyan tablets based on reference drug",and "Study on multi-component determination of Chenxiang Huaqi pills based on reference drug", aiming to provide new thoughts, reference and consultation for Chinese patent medicine quality level system study. TCM quality level evaluation is still in the exploratory stage,which needs more innovative methods and more systemic and profound studies to form mature theory and application.
