[Exploration of nanofiltration conditions for separation of alcohol precipitation liquid during preparation of Reduning Injection by Box-Behnken design combined with flux attenuation].

This study employed Box-Behnken design combined with flux attenuation to explore the nanofiltration conditions for separation of alcohol precipitation liquid during the preparation of Reduning Injection and discussed the applicability of nanofiltration in the separation of the liquid with high-concentration ethanol. The effects of nanofiltration molecular weight cut-off(MWCO) and pH on the rejection of chlorogenic acid, 3,5-dicaffeoylquinic acid, and 4,5-dicaffeoylquinic acid were consistent with the principles of pore size sieving and charge effect, respectively. The rejection of the three phenolic acids was reduced by concentration polarization effect caused by trans-membrane pressure(TMP). The swelling of membrane surface decreased the pore size and membrane flux for effective separation. Chlorogenic acid and 4,5-dicaffeoylquinic acid were more sensitive to pH and ethanol concentration than 3,5-dicaffeoylquinic acid. A certain correlation existed between the compound structure and the separation factors of nanofiltration, and the separation rules were associated with the comprehensive effect of charge effect, pore size sieving, concentration polarization, steric hindrance and so on.

[Comparison of activated carbon and ultrafiltration technique in the production process of huoxue tongluo injection].

OBJECTIVE: To research the applicability of activated carbon and ultrafiltration technique in the production process of Huoxue Tongluo Injection. METHODS: The kinetic-turbidimetric method was used to determine the content of bacterial endotoxins in Huoxue Tongluo solution. Particle size change in Huoxue Tongluo solution was determined by nanometer particle size instrument before and after the use of different concentration activated carbon and different molecular weight ultrafiltration membrane. RESULTS: The removal efficacy of bacterial endotoxins was 65.2%, 77.5%, 80.4% by using three concentrations of active carbon at 0.05%, 0.10%, 0.30% in Huoxue Tongluo Injection, respectively. It was above 95% by using cutoff molecular weight both 5 kDa and 10 kDa ultrafiltration membrane. Measure results by nanometer particle size instrument showed that particle size of filter liquor by 10 kDa cutoff molecular weight ultrafiltration membrane was much smaller than that of by use of different concentration activated carbon. CONCLUSION: Ultrafiltration method is more suitable to the removal of bacterial endotoxins. The solution is more clear after using ultrafiltration method, and large particles of solution is removed. The ultrafiltration method provides the basis for injection production.

Improving the clarity and sensitization of polysorbate 80 by ultrasonic-assisted ultrafiltration technology.

The safety problem of injections caused by clarity has lately become a widely shared concern. Due to the synthesis process, polysorbate 80 had a wide molecular weight distribution, which is also related to the clinical anaphylaxis. In this paper, ultrasonic-assisted ultrafiltration (UAU) technology was firstly applied to regulate colloidal structure and remove macromolecules from polysorbate 80 to improve injection clarity. In the separation process, ultrafiltration molecular weight cut off (MWCO), ultrasonic power and polysorbate 80 concentraion were selected as variables to adjust the separation efficiency. The ultrasonic frequency and power were provided by KQ-700DE ultrasonic system, based on the data analysis by response surface methodology (RSM), the optimal UAU parameters were as follows: ultrafiltration MWCO of 50,000, ultrasonic power of 900 W and polysorbate 80 concentration of 15.00 mg/mL. The experimental transmittance of polysorbate 80 was 87.6% and the qualification rate of clarity was 94.5%, which solved the separation contradiction among yield, clarity and safety. As an innovation in colloidal separation fields, UAU had a vast range of prospects for making use in pharmaceutical area.

[Speciation of inorganic elements in Chinese medicine and some factors influenced their biopharmceutical characteristics].

The paper reviews the speciation, process in vivo and biological effects of inorganic elements in Chinese medicine (CM) in the aspect of biopharmaceutics. We also summarize some factors influenced the biopharmceutical characteristics of drugs, including physical and chemical properties, formulation development, body's biological states and different actions. It is significant to safety, rationality of using of CM and modernization, internationalization of CM.