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Objective:To discuss and analyze the current situation of the application and approval of new Chinese medicine in China; To provide a reference for the research and development of new Chinese medicines in the future.Methods:The drug registration data were retrieved from Xanda database from January 1, 2016 to December 31, 2022, and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties, registration categories, therapeutic areas, prescription sources, dosage form distribution, development cycle, clinical research and control drugs.Results:From 2016 to 2022, the total number of application for new Chinese medicines was 265. The number of registration classification 1.1 of new compound drugs was the largest. The dosage forms of new drugs were mainly granules, capsules, and tablets. Indications mainly focused on respiratory, neuropsychiatric, digestion and cardio-cerebrovascular diseases, etc. From 2016 to 2022, the total number of approval for new Chinese medicines was 29, of these, 19 from 2021 to 2022. The number of registration classification 1.1 of new Chinese medicines was the largest. The treatment fields are mainly respiratory system, gynecology and neuropsychiatric diseases, etc. The dosage forms of new drugs were mainly granules, capsules, and tablets. The number of drugs in prescriptions was 6-15. High-frequency drugs included Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Scutellariae Radix, Pinelliae Rhizoma, Poria and Gypsum Fibrosum. Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number. The development period was approximately between 10-20 years. The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion:The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines, helping to develop more high-quality Chinese medicines.
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OBJECTIVE：To study the mecha nism of Bambuterol hydrochloride in the improvement of chronic obstructive pulmonary disease （COPD）model rats ，and to find the potential biomarker. METHODS ：Totally 30 rats were randomly divided into normal group ，model group and bambuterol hydrochloride group （3.3 mg/kg），with 10 rats in each group ；COPD model was established by lipopolysaccharide （LPS）infusion combined with smoking in model group and bambuterol hydrochloride group. After modeling ，bambuterol hydrochloride group was given relevant medicine intragastrically ，normal group and model group were given constant volume of normal saline intragastrically ，once a day ，for consecutive 45 d. After last medication ，the serum sample and alveolar lavage fluid of rats were collected. The levels of interleukin- 6（IL-6）and tumor necrosis factor-α（TNF-α）in alveolar lavage fluid were detected by ELISA. The serum metabolites were detected by LC-MS and analyzed by metabolomics. Orthogonal partial least squares discriminant analysis （OPLS-DA）was used to screen out the differential metabolites. The potential biomarkers were identified based on the related literature ，and the metabolic pathway enrichment analysis was carried out by MetPA analysis platform. RESULTS ：Compared with normal group ，the levels of IL- 6 and TNF-α in alveolar lavage fluid of rats were increased significantly in model group （P＜0.05）. Compared with model group ，the levels of IL- 6 and TNF-α in alveolar lavage fluid of rats were decreased significantly in bambuterol hydrochloride group （P＜0.05）. Results of metabolomics and OPLS-DA showed that 21 differential metabolites and 12 potential biomarkers were found （including maleylpyruvate ， hydroxypyruvate， tartronate semialdehyde，etc.）. Bambuterol hydrochloride can significantly reduce the levels of maleylpyruvate ，methylselenocysteine and 5-deoxy-D-glucuronic acid （P＜0.05）， while increase the levels of hydroxypyruvate ， tartronate semialdehyde and. These biomarkers were mainly @163.com concentrated in pentose phosphoric acid pathway ，glyoxyli acid and tricarboxylic acid metabolism pathway ，followed by 开发。E-mail：pn333@163.com inositol phosphoric acid metabolism pathway ，arginine and tyrosine metabolism pathway ，glycine，serine and threonine metabolism pathway. CONCLUSIONS ：The mechanism of bambuterol hydrochloride improving COPD may be associated with the decrease of the levels of TNF-α and IL-6，as well as the pathway of amino acid metabolism ，energy metabolism and lipid metabolism.
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OBJECTIVE:To provide reference for the realization of normalization and standardization of quality control and management of Pharmacy intravenous admixture service(PIVAS). METHODS:The management and effectiveness of PIVAS quali-ty control in our hospital were introduced from aspects of the establishment of internal quality control system,the key indicators and effects of quality control. RESULTS:According to checking items from aspects of examining once in a month,on prescription checking,preparation,infection control,equipments,drugs,consumable materials,sanitation;holding 1 monthly quality control reviews;and analyzing unqualified indexes and existing security risks,the quality control of PIVAS had achieved good results. The qualified percentage of quality control index was increased from 84%(Jan. 2016)to 90%(Jun. 2016),error rate in the same peri-od was decreased from 0.579‰ to 0.099‰. CONCLUSIONS:Developing quality control of the implementation of detailed quality control key indexes for the whole process of intravenous infusion in PIVAS can effectively regulate the position working process,re-duce preparation error and ensure the quality of infusion preparation.