ABSTRACT
Based on the concept of quality by design( QbD),the design space of Meiyan Shuqi Prescription extraction process was established,and its granules forming process was optimized. The content of total flavonoids was the critical quality attribute( CQA).The amount of water,extraction time and frequency were used as the critical process parameters( CPPs). Box-Behnken experimental design was used to optimize the extraction process. The design space of Meiyan Shuqi Prescription extraction process was established and verified. The results of variance analysis showed that the P value of the quadratic regression model was less than 0. 01,which indicated that the model had a statistical significance,and the relationship between each factor and response value could be functionalized by the established model. Through further optimization of design space,the optimal extraction process of Meiyan Shuqi prescription was13-fold volume of water,extraction for 3 times and each extraction time of 1. 4 hours. Furthermore,the forming process optimized by single factor was as follows: the excipient was dextrin; the ratio of extract powder to excipient was 1 ∶1; the wetting agent was 70% ethanol; and the amount of wetting agent was 0. 3 m L·g-1. The Meiyan Shuqi Prescription extraction process and the forming process based on QbD concept provide reference for the study of other traditional Chinese medicine prescriptions.
Subject(s)
Drugs, Chinese Herbal , Ethanol , Flavonoids , Medicine, Chinese Traditional , Research DesignABSTRACT
In the processes of planting, harvest, transport and storage, improper treatment of Chinese materia medica (CMM) and foodstuffs and agricultural products will result in fungal growth and mycotoxins contamination, which will not only directly affect the quality, safety and efficacy of these complex matrices, but also seriously threaten the consumers' health and lives. Therefore, the establishment of high-throughout analytical methods with high sensitivity for the determination of mycotoxins in CMM and foodstuffs and agricultural products at trace levels will provide reliable references for reducing the risk of mycotoxin exposure in humans. Due to the matrix complexity of CMM and foodstuffs and agricultural products, highly-effective pretreatment technologies are necessary for the establishment of such analytical techniques. In this review, the current extraction and purification methods commonly used for the detection of mycotoxins were summarized, the importance of pretreatment techniques for the precise quantification of mycotoxins in complex matrices such as Chinese herbal medicines was highlighted, as well as the development tendency about the pretreatment techniques for mycotoxins in complex matrices in the future was proposed.
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of three antithrombotic agents on venous thromboembolism (VTE) after unilateral total knee arthroplasty.</p><p><b>METHODS</b>From November 2011 to March 2014, 149 patients undergoing unilateral total knee arthroplasty for knee osteoarthritis were reviewed. Among them, there were 66 males and 83 females, ranging in age from 48 to 76 years old. All the cases were randomly divided into three groups including Aspirin group, low-molecular-weight heparin (LMWH) group, and rivaroxaban group, according to antithrombotic agents. Deep vein thrombosis (DVT), pulmonary embolism (PE) and bleeding complication (including wound ecchymosis, hematoma and other local complications, gastrointestinal, cardiovascular, urinary hemorrhage and other major bleeding events) of antithrombotic agents were observed and analyzed statistically at the 6 week, 8 week, and 12 week after operation.</p><p><b>RESULTS</b>Among patients who received Aspirin (48 cases), 4 patients had DVT, in 1 patient had PE, and 2 patients had bleeding complication. Among 54 patients in low-molecular-weight heparin group, 3 patients had DVT, 1 patient had PE, and 3 patients had bleeding complication. While among those patients received the rivaroxaban (47 cases), 3 patients had DVT, 0 patient had PE, and 11 patients had bleeding complication. There were no statistically differences among three groups on DVT, and PE (P>0.05). The incidence of bleeding complication in rivaroxaban group was higher than the other two antithrombotic agents, and the difference among the three groups was statistically significant (P<0.05).</p><p><b>CONCLUSION</b>Aspirin, low-molecular-weight heparin, and rivaroxaban could effectively reduce the incidence of VTE after total knee arthroplasty, and their efficacy was similar. Rivaroxaban has a higher incidence of bleeding complication and further clinical trials are required to be conducted to assess the safety of rivaroxaban in clinical.</p>
