1.Analysis of Opportunities and Countermeasures of Drug Technology Transfer in China
Yue HAN ; Lanru LIU ; Hong ZHU ; Shuang XING
China Pharmacy 2017;28(19):2593-2596
OBJECTIVE:To investigate the risk,advantages and disadvantages and countermeasures of new drugs,generic drugs and imported drugs in different transfer opportunities,and to provide basis for improvement of development strategy for phar-maceutical enterprises. METHODS:The analysis was done in accordance with relevant regulations on transferable projects in the process of applying for registrations of new drugs,generic drugs and imported drugs. The transfer period and risk were explored and countermeasures were put forward. RESULTS & CONCLUSIONS:Transferable projects included intellectual property rights (patents,patent application,technical secrets,application information,non-disclosed data,etc.)and ownership rights(clinical tri-al approvals,new drug certificates,drug approval number,pharmaceutical product registration certificates,imported product regis-tration certificates,etc.)in the process of applying for registrations. There are 4 opportunities for drug technology transfer,opportu-nity 1 is before applying clinical trial approvals after the completion of non-clinical research such as pharmacology,toxicology;op-portunity 2 is ahead of clinical trial after the acquirement of clinical trial approvals;opportunity 3 is new drug technology transfer;opportunity 4 is production technology transfer. The new drugs have 4 transfer opportunities,generic drugs and imported drugs can transfer in opportunity 1,2,4. Different transfer opportunities present different risks and profits. The risk gradually decreases with the further promotion of drug registration process,while the innovation decreases at the same time. Pharmaceutical enterprises should combine with the policy,market and their own features to select a suitable transfer period.
2.Correlation between ultrasonic appearance and pathology of phyllodes tumors of the breast
Lanru HUO ; Peifang LIU ; Yilin XU ; Xiaokang LI ; Zhenzhen SHAO ; Ying ZHU
Chinese Journal of Clinical Oncology 2014;(9):571-575
Objective:This study aims to evaluate the sonographic features of phyllodes tumors of the breast (PTBs) and the cor-relation between sonographic and pathologic findings to improve the understanding of the disease. Methods:Sonographic findings of 85 PTBs from 83 patients were reviewed. The sonographic findings included the results of two-dimensional ultrasound and color Dop-pler flow imaging, elastographic features, and pathologic data. Results:Of the 85 lesions, 33 were the benign tumors, 28 were border-line, and 24 were malignant according to the pathologic diagnosis. Tumor morphology revealed that most masses were lobulated, with a clear-cut boundary, smooth verge, and inhomogeneous internal echo. Clear boundary was more common in the benign phyllodes tumors (χ2=12.721, P=0.002), and a cystic echo-free area was more commonly observed in these malignant tumors (χ2=9.677, P=0.046). LevelⅡandⅢsignals of the blood flow were observed in 75.3%of PTB cases. Of all lesions, only 26 were subjected to elasticity imaging, and the elastographic scores ranged from 2 to 3 in 88.5%of the cases (23/26). Conclusion:Conventional ultrasound and elastographic findings on PTBs exhibited definite characteristics. The border and cystic areas in the tumors can be used to differentiate between be-nign and malignant PTBs.
3.Practice of teaching reform in the pharmacy administration curriculums based on improvement of the student′s comprehensive abilities
Lanru LIU ; Hong ZHU ; Yining ZHANG
Journal of Pharmaceutical Practice 2014;(5):393-395
Objective To reform practice in the pharmacy administration courses for cultivating student′s comprehensive qual-ity.Method Reform practice was tried in the aspects of teaching methods , teaching contents , teaching means and evaluations based on theoretical teaching in the pharmacy administration courses .Results A teaching system was formed to enhance pharmacy under-graduate′s comprehensive abilities , including self-learning ability , language skills , communication and social skills , information pro-cessing skills , solving problem skills and ability to cooperate with others .Conclusion It is a workable and valuable teaching system which should be improved and innovated and kept up with the times in future .
4.Research on Historical Evolution and Clinical Application of Shengyutang
Yuning CAO ; Wenpan LIU ; Tianyu MA ; Lanru CHEN ; Jiahao HUANG ; Yonghai MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):235-243
Shengyutang is a famous classical formula of tonic, which is made from Siwutang with Ginseng Radix et Rhizoma and Astragali Radix. It is included in the Catalogue of Ancient Famous Classical Formulas(The First Batch). Based on the Principles of Key Information Research of Ancient Famous Classical Formulas, this paper used bibliometrics to sort out and research the key information of Shengyutang in the aspects of history, composition, origin and processing, dosage, decocting method, efficacy and indications. After research, it has been found that this formula was first recorded in Lanshi Micang written by LI Dongyuan during the Jin dynasty, composed of Rehmanniae Radix, Rehmanniae Radix Praeparata, Chuanxiong Rhizoma, Ginseng Radix et Rhizoma, Astragali Radix and Angelicae Sinensis taproot. The name of the formula passed down through generations was relatively unified, with clear origins and veins. In later generations, this formula was the mainstream, and adjustments were made to the dosage and composition according to the indication. In the formula, Astragalus membranaceus var. mongholicus was selected as the origin of Astragali Radix, and the origins of other medicinal materials were consistent with the 2020 edition of Chinese Pharmacopoeia. Except for Rehmanniae Radix Praeparata, the other medicinal materials were made from raw products, and the dosage form was boiled powder. According to the measurement standard in the Jin dynasty, the recommended usage and dosage were 1.24 g of Rehmanniae Radix, Rehmanniae Radix Praeparata, Chuanxiong Rhizoma, Ginseng Radix et Rhizoma each, 2.07 g of Astragali Radix and Angelicae Sinensis taproot each, crushed into coarse particles that pass through the 4 mesh sieve but can't pass through the 10 mesh sieve, added 1 200 mL of water and boiled to 300 mL, and removed the residue. Shengyutang has the functions of tonifying Qi and blood, and blood intake, treating various sores, and restlessness and insomnia caused by excessive blood flow. In ancient times, this formula was widely used in the treatment of surgical sores, gynecological diseases, deficiency syndrome, etc. In modern clinical practice, it is mostly used to treat gynecological, neurological, musculoskeletal, hematological diseases caused by Qi and blood deficiency. In this paper, the key information of Shengyutang was researched by reviewing relevant ancient literature, in order to provide reference for the modern application and development of this formula.