[Research progress and maturity assessment of continuous manufacturing of traditional Chinese medicine].

The pharmaceutical manufacturing model is gradually changing from intermittent manufacturing to continuous manufacturing and intelligent manufacturing. This paper briefly reviewed the supervision and research progress in continuous pharmaceutical manufacturing in China and abroad and described the definition and advantages of continuous pharmaceutical manufacturing. The continuous manufacturing of traditional Chinese medicine(TCM) at the current stage was summarized in the following three terms: the enhancement of the continuity of intermittent manufacturing operations, the integration of continuous equipment to improve physical continuity between units, and the application of advanced process control strategies to improve process continuity. To achieve continuous manufacturing of TCM, the corresponding key technologies, such as material property characterization, process modeling and simulation, process analysis technology, and system integration, were analyzed from the process and equipment, respectively. It was proposed that the continuous manufacturing equipment system should have the characteristics of high speed, high response, and high reliability, "three high(H~3)" for short. Considering the characteristics and current situation of TCM manufacturing, based on the two dimensions of product quality control and production efficiency, a maturity assessment model for continuous manufacturing of TCM, consisting of operation continuity, equipment continuity, process continuity, and quality control continuity, was proposed to provide references for the application of continuous manufacturing technology for TCM. The implementation of continuous manufacturing or the application of key continuous manufacturing technologies in TCM can help to systematically integrate advanced pharmaceutical technology elements and promote the uniformity of TCM quality and the improvement of production efficiency.

[Effect of Root Iron Plaque on Norfloxacin Uptake by Rice].

In anaerobic condition, release of oxygen by roots to rhyzosphere caused the formation of red plaque of iron oxides or hydroxides on the root surface of rice. The effect of iron plaque on norfloxacin uptake was investigated with solution culture in greenhouse, and the results are showed in the following. The content of iron plaque increased with the increase of Fe2+ concentration in medium. After the addition of norfloxacin in nutrient solution, the content of iron plaques on the root surface decreased to different degree, and the reduction of iron plaques was increasing with the increase of norfloxacin mass concentration. Significant relationships were found between the iron plaques and norfloxacin on the root surface, and the correlation coefficients were 0.959 (norfloxacin mass concentration was 10 mg x L(-1)) and 0.987 (norfloxacin mass concentration was 50 mg x L(-1)), respectively, however, the norfloxacin contents in roots and shoots had no significant correlation with the iron plaques. After addition of different mass concentrations of norfloxacin, the quality distribution percentages of norfloxacin on the root surface and in roots and shoots were 87.7%-97.6%, 0.8%-4.8%, 1.5%-7.5%, respectively, the norfloxacin content on the root surface was far greater than those in roots and shoots. It was therefore concluded that iron plaque on roots was a norfloxacin reservoir for rice plant but had no significant effect on the transfer of norfloxacin to roots and shoots of the rice plant.

[Degradation pathways and main degradation products of tetracycline antibiotics: research progress].

Tetracycline antibiotics (TCs) can produce a series of abiotic degradation reactions in the process of production and storage, and some of the degradation products have lower antibacterial activity but higher toxicity, as compared to the parent antibiotics. TCs can enter the environment via the disposal of livestock and poultry wastes, and then degrade in one or more ways according to the external conditions. Besides abiotic degradation, bio-degradation also happens. This paper reviewed the degradation pathways and main degradation products of TCs in different ecological environments, and discussed the future research directions, aimed to provide valuable reference for the ecological risk assessment of the antibiotics.

[Effect of soil organic matter and cadmium (II) on adsorption and desorption of chlortetracycline in soil].

Chlortetracycline (CTC) has been widely used in veterinary medicines and disease treatment. Heavy metals and antibiotics often coexist in soil due to land application of animal wastes and other sources of inputs. On the basis of the OECD Guideline 106, the batch equilibrium experimental method was employed to investigate sorption and desorption processes of CTC in cinnamon soil with and without soil organic matter (SOM) and examine the effect of Cd2+ on these processes. Results showed that the Freundlich model was the best isotherm to describe the experimental data for adsorption and desorption of CTC in soil on single and combined pollution conditions. In these a single chlortetracycline pollution and chlortetracycline-Cd combined pollution conditions, removal of SOM could increase the CTC adsorption capacity (K(f)) and adsorption intensity (1/n). The apparent adsorption-desorption hysteresis was found in cinnamon soil with and without SOM. In single pollution condition, the removal of SOM could significantly increase HI in cinnamon soil from 0.81 to 1.06. In all cases of CTC combined with Cd desorption studies, it had been known that HI of CTC in soils with SOM (1.11) were higher than those without SOM (0.84). This study was provided available data and parameters to set a more complete model to predict environmental concentration of CTC and evaluation their environmental risk.

[Influences of cation species on adsorption and desorption of oxytetracycline in two typical soils of China].

On the basis of the OECD Guideline 106, batch sorption methods were employed to reveal the effect of different cations (0.01 mol x L(-1) Ca2+, K+ and Na+) on oxytetracycline (OTC) adsorption and desorption process in two tested soils (cinnamon soil and red soil). Results show that the Freundlich model is the best isotherm to describe the experimental data of adsorption and desorption, and the average fitting correlation coefficient is 0.989. Except for the adsorption isotherm of cinnamon soil on OTC in 0.01 mol x L(-1) KCl, the other isotherms resemble the L-type curves. To the same cation, OTC adsorption capacity (lgKf) in the red soil (ranging from 2.907 to 3.173) is always higher than in the cinnamon soil (ranging from 2.577 to 2.885), and the adsorption strength (1/n) in the red soil (ranging from 0.672 to 0.825) is always lower than the cinnamon (ranging from 0.713 to 1.005). The dominant mechanism is physical adsorption in two soils. To the same soil, cation species don't affect OTC adsorption capacity (lgKf) (p > 0.05). And Ca2+ can reduce significantly the adsorption strength (p < 0.05), comparing with K+ and Na+. The apparent adsorption-desorption hysteresis is found, and the average hysteresis index (HI) in all soils are from 0.015 to 0.053. To the same cation, OTC HI is significantly higher than that of red soil (p < 0.05). In cinnamon soil, there is significantly HI difference (p < 0.01) between K+ and Ca2+, Na+. However, three cations have no significantly difference effect on HI in red soil.

[Dynamic changes of nitrogen forms in livestock manure during composting and relevant evaluation indices of compost maturity].

In this paper, the dynamic changes of nitrogen (N) forms in different livestock manures were investigated during composting, and the relevant N evaluation indices of compost maturity were approached. The results indicated that during composting, the total nitrogen (TN) concentration in dairy cattle manure increased first and became steady then, but in other five test manures, it decreased first and became steady then. For all test manures, their hydrolizable nitrogen (HN) decreased after an initial increase, NH4(+)-N decreased first and became steady then, while NO3(-)-N had a persistent increase. Among the N indices of compost maturity, HN/TN and NH4(+)-N/TN could be selected as the adaptable parameters to evaluate the maturity, while NO3(-)-N/TN could be only used as a universal one. According to the required standard of compost maturity based on the comprehensive index GI (seed germination index), i.e., GI > 0.50, it was suggested that for the livestock manures except young pig manure, the basic requirements of their compost maturity were HN/TN < 20.77%, NH4(+)-N/TN < 10.06%, and NO3(-)-N/TN > 0.38%.