1.Research and Development Status Quo of Respiratory Inhalation Preparations :A Systematic Review
Zhe CHEN ; Wenyan LI ; Xiaofeng NI ; Xiangcheng PAN ; Lingli ZHANG
China Pharmacy 2021;32(14):1671-1677
		                        		
		                        			
		                        			OBJECTIVE:To systematically evaluate the research and development status quo of respiratory inhalation preparations. METHODS :Related literatures or data about R&D status quo of domestic and foreign respiratory inhalation preparations were retrieved from 5 databases(PubMed,Embase,CNKI,Wanfang database and VIP ),4 clinical trial registration platforms,15 national/regional drug administration platforms and yaozhi.com . The status quo of related studies was analyzed by descriptive analysis. RESULTS & CONCLUSIONS :A total of 27 second literatures were included. The information of respiratory inhalation preparations approved by European Union ,the United States ,Canada,Japan and China was collected ,and the information of related drugs under registration and approval in China was also collected. The market situation of respiratory inhalation preparations was analyzed from the perspective of dosage form :powder aerosols accounted for 46%,aerosols account ed for 32%,and atomized inhalation solutions accounted for 22% in the global consumption sum of each dosage form. From the perspective of market share ,companies such as AstraZeneca in the UK ,Boehringer Ingelheim in Germany and GlaxoSmithKline in the UK had a total market share of about 70%. At present ,there were 39 kinds of respiratory inhalation preparations on the market in European Union ,121 kinds in the United States ,111 kinds in Canada ,37 kinds in Japan ,69 kinds of domestic inhalation preparations and 80 kinds of imported inhalation preparations in China. Respiratory inhalation preparations were undergoing clinical trials with 511 cases abroad and 69 cases in China. The barriers to the imitation of respiratory inhalation preparations mainly included research and development ,clinical trial ,approval  and production barriers. At present ,the support is provided for 0035) domestic drug innovation and localization of medical devices  in China through a series of policies ,which is helpful to promote the localization research and development of inha led  preparations. Future research and development can pay more cn attention to combination ,indication,dosage and device of  inhalation preparation.
		                        		
		                        		
		                        		
		                        	
2.Compatibility Stability Investigation of Fat-soluble Vitamin (Ⅱ)/Water-soluble Vitamin for Injection with Common Electrolytes
Jing FAN ; Xiangcheng LI ; Fei LI ; Dong PAN ; Lijie LIU ; Jing LI ; Wei SUN
China Pharmacy 2017;28(11):1478-1482
		                        		
		                        			
		                        			OBJECTIVE:To investigate the compatibility stability of Fat-soluble vitamin (Ⅱ)/Water-soluble vitamin for in-jection with common electrolytes. METHODS:Referring to clinical common dose,Fat-soluble vitamin (Ⅱ) for injection/Wa-ter-soluble vitamin for injection collective packing [containing Fat-soluble vitamin(Ⅱ) for injection 2 ampoules and Water-soluble for injection 1 ampoule] were respectively mixed with Glucose injection,Potassium chloride injection,Concentrated sodium chlo-ride injection,Sodium bicarbonate injection,Potassium aspartate injection,Potassium aspartate and magnesium aspartate injection, Sodium glycerophosphate injection,Multi-trace elements injection (Ⅱ) to obtain mixture A-H. At room temperature (25 ℃),these mixtures were investigated in terms of appearance,pH value,osmotic pressure molar concentration and the number of insolu-ble particles at 0,1,2,3,4 h. The contents of bacterial endotoxin were tested at 0,4 h. RESULTS:Within 4 h after mixing, there was no significant change in appearance of those mixtures;pH value of mixture H changed greatly (RSD=5.13%,n=5), and that of mixture D and G increased significantly. The osmotic pressure molar concentration of those mixtures had no significantly change(RSD<2%,n=5)and lower than 600 mOsmol/kg. The bacterial endotoxin tests of those mixtures were negative. Two and four hours after mixing,the number of insoluble particles ≥10 μm in mixture B was increased significantly;2,3,4 h after mix-ing,the number of insoluble particles ≥10 μm in mixture E,F,H were increased significantly;0 ,1,2,3,4 h after mixing,the number of insoluble particles ≥10 μm in mixture G was increased significantly. There was statistical significance in the number of insoluble particle ≥10 μm in above mixtures compared to mixture A at the same time point(P<0.05),but it was in line with the standard of 2015 pharmacopeia. One,two,three and four hours after mixing,the number of insoluble particle ≥10 μm in mixture D was increased significantly,there was statistical significance compared to mixture A at the same time point(P<0.05);the num-ber of insoluble particle ≥10 μm in mixture D was beyond prescribed scope of pharmacopeia at 2,3,4 h after mixing. Within 4 h after mixing,both the number of insoluble particle ≥10 μm in mixture C and the number of insoluble particle ≥25 μm in edch mixture had no significant change,in accordance with pharmacopeia standard. CONCLUSIONS:Fat-soluble vitamin (Ⅱ)/Wa-ter-soluble vitamin for injection is not suitable for mixing with Multi-trace elements injection(Ⅱ),Sodium glycerophosphate injec-tion or Sodium bicarbonate injection due to great change of pH value and the number of insoluble particles.
		                        		
		                        		
		                        		
		                        	
            
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