Varieties systematization and standards status analysis of fermented Chinese medicine / 中国中药杂志

Fermented Chinese medicine has long been used. Amid the advance for preservation of experience, the connotation of fermented Chinese medicine has been enriched and improved. However, fermented Chinese medicine prescriptions generally contain a lot of medicinals. The fermentation process is complicated and the conventional fermentation conditions fail to be strictly controlled. In addition, the judgment of the fermentation end point is highly subjective. As a result, quality of fermented Chinese medicine is of great difference among regions and unstable. At the moment, the quality standards of fermented Chinese medicine are generally outdated and different among regions, with simple quality control methods and lacking objective safe fermentation-specific evaluation indictors. It is difficult to comprehensively evaluate and control the quality of fermented medicine. These problems have aroused concern in the industry and also affected the clinical application of fermented Chinese medicine. This article summarized and analyzed the application, quality standards, and the modernization of fermentation technology and quality control methods of fermented Chinese medicine and proposed suggestions for improving the quality standards of the medicine, with a view to improving the overall quality of it.

Thoughts on path of R&D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions" / 中国中药杂志

Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.

Current situation and problems of national standards for Chinese medicinal materials / 中国中药杂志

To learn the current situation and strengthen the management of national standards for Chinese medicinal materials, we sorted out the relevant national standards. According to incomplete statistics, there are 1 185 kinds of Chinese medicinal materials, including 1 024 kinds of plant medicines, 106 kinds of animal medicines, and 54 kinds of mineral medicines, in addition to ethnic medicinal materials with different functions. The relevant standards include 819 Pharmacopoeia standards, 342 standards issued by the Ministry of Health or National Medicinal Products Administration, 7 standards for new medicinal materials, and 17 standards for imported medicinal materials. In this paper, the sources of standards as well as the distribution of families and genera and the distribution of medicinal parts of medicinal materials are analyzed. The suggestions are as follows:(1)to improve the coordination among different national standards of Chinese medicinal materials;(2)to improve the standardization and controllability of relevant standards;(3)to revise the issued standards for Chinese medicinal materials(including Tibetan, Uygur, and Mongolian medicinal materials).

Research and development strategies of new Chinese medicines based on new regulations / 中国中药杂志

In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.

Discussion of range and relevant issue of highly toxic Chinese medicinal materials / 中草药

The range of highly toxic Chinese medicinal materials was summarized according to the Appendix of Measures for the Management of Toxic Drugs and the records in Quality Standards of Chinese Medicinal Materials. As a result, there are 51 kinds of highly toxic Chinese medicinal materials in all. The significance of determining the list of highly toxic medicinal materials is as follows: providing reference to the amendments of the appendix of Measures for the Management of Toxic Drugs, to the management of highly toxic Chinese medicinal materials and promoting the safety of drug usage in our hospitals, and to the research of new traditional Chinese medicine containing highly toxic Chinese medicinal materials.

Investigation of alcohol concentration in alcohol precipitation process in compound preparation of Chinese materia medica / 中草药

The data of the alcohol concentration in alcohol precipitation process of 22 Chinese materia medica (CMM) were investigated and analyzed. The result showed that the real alcohol concentration in the alcohol precipitation process was higher than the expected generally, and the real alcohol concentration in the alcohol precipitation process in the same product was different in different batches. The gap between the real alcohol concentration in the alcohol precipitation process and the expected maybe related to the product and the method to determine how much alcohol to be added and the way of operation. The data above were analyzed, and some suggestions were presented as follows: (1) Meaning of the expected alcohol concentration in the alcohol precipitation process described in the drug quality specification should be explained clearly; (2) The method used to determine how much alcohol should be added and the indicator of on-line control should be studied and determined; (3) During the process validation, the real alcohol concentration in the alcohol precipitation process should be detected according to the procedure in China Pharmacopeia (2010 edition) and make sure whether the real alcohol concentration in the alcohol precipitation process was the same as the expected; (4) The alcohol precipitation process of new CMM should be systematically studied, and the method used to determine how much alcohol should be added must be on record in `Production Process for Oon-site Inspection'.