Quality control of ethanol extraction process of Corydalis Rhizoma based on quality by design (QbD) / 中草药

Objective: To improve the quality control level of ethanol extraction process of Corydalis Rhizoma (CR) by using quality by design (QbD), so as to meet the extraction requirements of Kedaling Tablets. Methods: The critical process parameters were solvent multiple, extraction time and soaking time, and the critical quality attributes were dry extract rate, content and transfer rate of dehydrocorydaline. The response surface methodology was used to establish the mathematical model between the critical process parameters and the critical quality attributes. The overlapping design space of multiple index design spaces was established to select the optimal operation space, where the process verification was carried out. Results: The operating space parameters of ethanol extraction of CR was 14-24 h of the immersion time, 3.0-4.0 times of the first time solvent multiple, 1.5-2.0 times of the second and third time solvent multiple, and 1.5-2.5 h of the extraction time. Under this operating space, the extraction yield of CR was ranged from 6%-8%, the content of dehydrocorydaline was more than 2.8%, and the transfer rate was not less than 85%. Conclusion: The concept of QbD is helpful to improve the ethanol extraction process of CR, and to obtain a reliable and suitable extraction operation space for the production of Kedaling Tablets.

New strategies of laparoscopic cholecystectomy from left upper abdomen under massive adhesion of right upper abdomen / 中国内镜杂志

Objective Seen from the laparoscope, there is massive adhesion after the peritonitis, an operation with a large incision or radiation treatment in right upper abdomen. After failing to dissociate the adhesion and create e-nough space with the help of laparoscope, the laparoscopic cholecystectomy from the left upper abdomen is adopted depending on the specific situation to explore the possibility and practicability of creating instrument channel and operating space. Methods From May 2001 to May 2015, 13 patients (with a medical history of peritonitis, an opera-tion with a large incision, serious peritonitis or radiation treatment in right upper abdomen) were received operations of laparoscopic cholecystectomy, adhesion was serious near the trauma or otherwise. During the operation, massive adhesion was found in the right upper abdomen. The conventional LC did not work. Instrument channel and operat-ing space were created from the left upper abdomen through facies inferior hepatis and falciform ligament. LC cost 70 minutes to 155 minutes with an average of 117 minutes. Results LC of 13 patients (with a massive adhesion) from left upper abdomen was successful. In this way, it was easy to create instrument channel and operating space and avoid the massive adhesion. The operations took a longer time without injuring stomach intestines and bile vessel. Conclusion Acquired adhesion's peculiarity is negative correlation with distance, LC from the left upper abdomen through facies inferior hepatis and falciform ligament can be avoided the disassociation of massive adhesion and be created the instrument channel and operating space. The two ways are proved to be effective.