1.Analysis and reflection on the filing management of traditional Chinese medicine preparations in medical institu- tions
Yatian WANG ; Chao LI ; Zhimei GUAN
China Pharmacy 2022;33(3):263-270
OBJECTIVE To compare and study the supporting policies for the filing man agement system of traditional Chinese medicine preparation prepared by traditional technology (hereinafter referred to as “TCM preparation ”)in medical institutions issued by the state and various provinces ,and their development ,so as to provide reference for the improvement of the follow-up supervision and management of the filing works. METHODS According to Announcement on the Filing Management of TCM Preparations Prepared by Medical Institutions Using Traditional Processes issued by former National Food and Drug Administration (hereinafter referred to as the Announcement)as well as notices and specific implementation rules issued by provincial bureaus ,the filing work data of 10 provinces in recent 3 years were selected for comparison ,sorting,statistics,classification and induction. The policy characteristics and progress of filing work were studied. RESULTS & CONCLUSIONS According to the local actual situation,some provinces had refined or expanded the contents of several parts of the Announcement,such as the scope of TCM preparations,the situation not allowed to record ,the filing process and working time requirements ,the disclosure ,change and cancellation of filing information ,and the implementation of supervision and management. The statistical results of filing data in 10 provinces showed that compared with 2019,the number of TCM preparation declared for filing and medical institutions declared for filing had increased with growth rate of 91.0% and 48.8% respectively in 2020. There is still room for improvement in the supporting policies for the filing of TCM preparations ,which can be optimized by referring to the features of some provinces ’ implementation policies ,refining the construction of norms and standards ,and strengthening the construction of regulatory system platform. It is necessary to optimize policy and strengthen the capacity building of reporting institutions in advance ;carry out daily supervision and control risk based on risk during the filing management ;emphasize follow-up supervision ,strengthen the construction of ADR monitoring system in medical institutions ,and carry out life cycle supervision and management constructively afterwards,in order to promote the further development of TCM preparations in medical institutions.
2.AKT inhibitor Hu7691 induces differentiation of neuroblastoma cells.
Shaowei BING ; Senfeng XIANG ; Zhimei XIA ; Yilong WANG ; Zhonghai GUAN ; Jinxin CHE ; Aixiao XU ; Xiaowu DONG ; Ji CAO ; Bo YANG ; Jinhu WANG ; Qiaojun HE ; Meidan YING
Acta Pharmaceutica Sinica B 2023;13(4):1522-1536
While neuroblastoma accounts for 15% of childhood tumor-related deaths, treatments against neuroblastoma remain scarce and mainly consist of cytotoxic chemotherapeutic drugs. Currently, maintenance therapy of differentiation induction is the standard of care for neuroblastoma patients in clinical, especially high-risk patients. However, differentiation therapy is not used as a first-line treatment for neuroblastoma due to low efficacy, unclear mechanism, and few drug options. Through compound library screening, we accidently found the potential differentiation-inducing effect of AKT inhibitor Hu7691. The protein kinase B (AKT) pathway is an important signaling pathway for regulating tumorigenesis and neural differentiation, yet the relation between the AKT pathway and neuroblastoma differentiation remains unclear. Here, we reveal the anti-proliferation and neurogenesis effect of Hu7691 on multiple neuroblastoma cell lines. Further evidence including neurites outgrowth, cell cycle arrest, and differentiation mRNA marker clarified the differentiation-inducing effect of Hu7691. Meanwhile, with the introduction of other AKT inhibitors, it is now clear that multiple AKT inhibitors can induce neuroblastoma differentiation. Furthermore, silencing AKT was found to have the effect of inducing neuroblastoma differentiation. Finally, confirmation of the therapeutic effects of Hu7691 is dependent on inducing differentiation in vivo, suggesting that Hu7691 is a potential molecule against neuroblastoma. Through this study, we not only define the key role of AKT in the progression of neuroblastoma differentiation but also provide potential drugs and key targets for the application of differentiation therapies for neuroblastoma clinically.