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.

Effect of Yishen Jianpi Yangxue Tongli Fang on IGF-1 mRNA Expression of PCOS Rat / 中国中医药信息杂志

Objective To investigate the effects of Yishen dianpi Yangxue Tongli Fang (YSJP) on IGF-1 mRNA expression in the ovary of PCOS rat, and study its mechanism on the molecular level. Methods Seventy two female SD rats were randomly divided into normal control group, model group, clomifene group and low-, mid-, high-dose Chinese medicine group. The animal model established by capsulae levonorgestreli silasticus was used to observe the IGF-1 mRNA expression in ovary by hybridization in situ. Results IGF-1 mRNA expression of PCOS model group was higher than the normal control group obviously. The semi-quantitative image analysis showed that TCM treatment could decrease IGF-1 mRNA expression. Conclusion Yishen Jianpi Yangnue Tongli Fang could decrease the IGF-1 mRNA expression in ovary and improve the insulin resistance of PCOS rats.