Domestic generic drug registration has a large proportion in chemical drugs with outstanding repeated registration phe-nomenon and low level innovation of enterprises. Under the above background, chemical drug registration reform kicked off. The imple-mentation of new drug registration classification, marketing authorization holder and the changes of listed drug registration documents have a huge impact on China' s pharmaceutical industry, which can promote the reformulation of domestic pharmaceutical market, en-courage R&D and innovation in enterprises and accelerate the pace towards the international market.

OBJECTIVE:To provide reference for cultivating high-level comprehensive medical talents with high quality. METHODS:Based on the market and social needs,the teaching reform was conducted from the concepts of educational ideas, modes,curriculum system,contents,management and other aspects. RESULTS:In order to adapt to the needs of society and era, it should establish large education educational ideas to cultivate student's independent ability to obtain knowledge and self-develop-ment to make people change into community basic services and service and dedicate society with modes of cultivating inter-disci-plinary talents,including combination of prduction and study,foundation strengthening,professional expanding,penetration of sci-ence and technology and combination of arts and science;generally optimize curriculum system with theprinciple of precise defini-tion,clear classification,and optimized combination based on market and social needs;and update contents timely and teaching materials;the teaching management should be changed from closed off management of the past to the external management which dominated by the market assessment. CONCLUSIONS:Reform of medical higher education based on the market and social needs can cultivate the talents with high quality and comprehensive medical knowledge for the social needs,which is conductive to the de-velopment of medical industry.

Objective:To construct a risk prediction and assessment system for incisional infection after spinal surgery.Methods:Based on the failure mode and effect analysis (FMEA), risk factors and assessment indicators of postoperative incisional infection in spinal surgery were sorted out through literature search followed by expert consultation using the Delphi expert consultation method. After three-level assessment indicators were selected according to their importance and expert opinions and assigned by different scores, a risk prediction and evaluation system was constructed for postoperative incisional infection after spinal surgery.Results:The 2 rounds of expert consultation questionnaire resulted in an effective response rate of 100%. The degree of expert consultation authority was 0.85, showing high reliability; the Kendall coordination coefficients of expert consultation ranged from 0.525 to 0.686, showing good coordination ( P<0.05). The three-level assessment indicators consisted of 3 primary, 18 secondary and 54 tertiary ones. After statistical analyses of the important risk indicators selected which consisted of 6 preoperative evaluation ones and 18 postoperative evaluation ones, 6 preoperative and 12 postoperative predictive indicators were obtained. The values of risk priority number (RPN) were calculated for high, medium and low risks for postoperative incisional infection using a semi-quantitative method. Conclusion:A self-designed system has been constructed for risk prediction and assessment of incisional infection after spinal surgery based on expert consultation and FMEA method.

The α-amino acid ester acyltransferase (SAET) from Sphingobacterium siyangensis is one of the enzymes with the highest catalytic ability for the biosynthesis of l-alanyl-l-glutamine (Ala-Gln) with unprotected l-alanine methylester and l-glutamine. To improve the catalytic performance of SAET, a one-step method was used to rapidly prepare the immobilized cells (SAET@ZIF-8) in the aqueous system. The engineered Escherichia coli (E. coli) expressing SAET was encapsulated into the imidazole framework structure of metal organic zeolite (ZIF-8). Subsequently, the obtained SAET@ZIF-8 was characterized, and the catalytic activity, reusability and storage stability were also investigated. Results showed that the morphology of the prepared SAET@ZIF-8 nanoparticles was basically the same as that of the standard ZIF-8 materials reported in literature, and the introduction of cells did not significantly change the morphology of ZIF-8. After repeated use for 7 times, SAET@ZIF-8 could still retain 67% of the initial catalytic activity. Maintained at room temperature for 4 days, 50% of the original catalytic activity of SAET@ZIF-8 could be retained, indicating that SAET@ZIF-8 has good stability for reuse and storage. When used in the biosynthesis of Ala-Gln, the final concentration of Ala-Gln reached 62.83 mmol/L (13.65 g/L) after 30 min, the yield reached 0.455 g/(L·min), and the conversion rate relative to glutamine was 62.83%. All these results suggested that the preparation of SAET@ZIF-8 is an efficient strategy for the biosynthesis of Ala-Gln.
Escherichia coli/genetics* ; Glutamine ; Zeolites/chemistry* ; Amino Acids