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.

Research and Development of New Traditional Chinese Medicine Based on Experienced Prescriptions of Prestigious Chinese Physicians / 中国实验方剂学杂志

The experienced prescriptions of famous prestigious Chinese physicians are effective prescriptions developed by prestigious Chinese doctors during their long-time clinical practice, which reflect the traditional Chinese medicine (TCM) understanding of the disease development regularity and core pathogenesis. These experienced prescriptions provide valuable experience for medication and prescription regularities, and represent the highest level of TCM treatment and the major sources of new drug research, development and technology innovation. It is of great significance to inherit academic thoughts and clinical experiences of prestigious Chinese physicians, explore and summarize experienced prescriptions, and develop new Chinese drugs. The researches of new drugs based on experienced prescriptions are the major direction encouraged by the government, with the maximum amount of new TCM drug applications but a low approval rate in recent years. The main reason for the low number of approved new TCM drug applications is that researchers know less about evaluation concepts and relevant techniques, leading to problems in research and development strategy. To facilitate a smooth advance of the new drug research and development and take full advantage of the experienced prescriptions, in this paper, we focus on the problems about new drug development of experienced prescriptions, lay emphasis on the new TCM drug research and development concepts of clinical value, history of human application and whole-process quality control, and deeply and systematically analyze concerns in such links as pharmacy, pharmacodynamics, toxicology and clinic application. The purpose of this article is to provide the reference in solving actual problems, the reliable basis of further researches on experienced prescriptions, and the important guarantee for developing more safe, effective and high-quality controllable drugs to meets clinical requirements, so as to achieve the strategy of a healthy China.

Matrix formulation of chaizhi cataplasma optimized by D-optimal mixture design combined with multiple mechanical indicators and its in vitro evaluation / 中国中药杂志

To optimize the matrix formulation of Chaizhi cataplasma (CC) and investigate its release and transdermal absorption properties in vitro. The optimized matrix formulation of cataplasma containing liquid herbal extract is determined by using D-optimal mixture design, with initial bonding strength, endurance bonding strength and gel strength as the evaluating indicators. Modified Franz diffusion cells were used to study the in vitro release and transdermal absorption of geniposide in CC. The optimized matrix formulation of CC contained NP700, aluminum glycinate, tartaric acid, glycerin, PVPK90 and water (9∶0.7∶0.8∶30∶5∶30.5). Cumulative release rate of geniposide in CC was (77.02±3.73)% in 24 h. The percutaneous penetration rate of geniposide was 7.25 μg•cm⁻²•h⁻¹ and the 24 h permeated amount was (156.22±4.90) μg•cm⁻². The optimized CC prepared by the D-optimal mixture design showed a good adhesion and formability. The in vitro release of the geniposide in CC was in accordance with the first order equation, while its in vitro transdermal absorption was close to the zero order equation.

Construction of prokaryotic expression vector, expression and purification of ginseng Cu/Zn superoxide dismutase / 中国中药杂志

The total RNA was extracted from ginseng leaves of Panax ginseng. The Cu/Zn-SOD gene was amplified via RT-PCR and the pET-28(a)-Cu/Zn-SOD expression vector was constructed. The pET-28 (a)-Cu/Zn-SOD recombinant plasmid was transformed into Escherichia coli BL21 (DE3) competent cells and was induced by IPTG in order to select optimal induction of expression conditions. The target protein was purified by the nickel ions (Ni ) affinity chromatography and the target protein enzyme activity was determinated by the xanthine oxidase method. The similarity of the Cu/Zn-SOD gene sequences and the Cu/Zn-SOD gene sequences of Korean ginseng in NCBI was 99. 00%. The target protein expression level was about 44.42%, and the molecular weight was 16.30 kDa after the pET-28(a)-Cu/Zn-SOD recombinants were induced by IPTG. The purified Cu/Zn-SOD protease activity reached 10,596.69 U x mg(-1). The P. ginseng pET-28(a)-Cu/Zn-SOD prokaryotic expression vector was built by the method of molecular biology, which provided the foundation for studying the Cu/Zn-SOD biology function.

Correlation study on lignin contents of Schisandra chinensis and ecological factors / 中国中药杂志

The contents of schisandrin, schizandrin A, B and C were determined by HPLC, and the effects of the climate factors and altitude on lignin contents were analyzed in order to select the optimal cultivation area of S. chinensis. The lignin contents were analyzed by HPLC using a ZORBAX SB-C18 column (4.6 mm x 250 mm, 5 microm). The column temperature and detection wave length were set at 35 degrees C and 254 nm, respectively. Methanol-water was used as the mobile phase in gradient elution mode and the flow-rate was 1.0 mL min(-1). The method had a good repeatability, stability and accuracy. The correlation of climate factors and lignins contents was analyzed by SPSS software. The results showed that the schizandrin A content in S. chinensis fruits were higher than 0.4% in Ji'an, Liuhe, Antu and Fusong in Jilin province, which met the quality requirement. It had significant linear negative correlation relationship between schisandrin, schizandrin A, B and altitude, the contents decreased with the increase of altitude. The significant negative linear fitting coefficient was 0.844 1 between schisandrin and altitude; but it had not significant correlation between schizandrin C and altitude. A significant positive correlation of climate factors and the contents of S. chinensis lignins were mainly the temperature factors (the average annual temperature, the highest temperature in July, the average temperature in July, the highest temperature in January, the average temperature in January) and precipitation factor (average annual precipitation), which reveals that higher temperature and precipitation were helpful to the formation and accumulation of lignins of S. chinensis. So the cultivation area of S. chinensis should be in the low elevations region with warm and rainy climate.