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OBJECTIVE： To investigate the effects of rosuvastatin on in-stent restenosis in middle-aged patients with acute coronary syndrome（ACS）after percutaneous coronary intervention （PCI）. METHODS： Totally 400 middle-aged ACS patients underwent PCI were selected from Xuchang Central Hospital during Mar. 2016 to Apr. 2017， and then divided into control group and observation group according to random number table， with 200 patients in each group. Both groups were given conventional drugs for secondary prevention of coronary heart disease. Control group were given Clopidogrel hydrogen sulfate tablets 75 mg， once a day+Aspirin enteric-coated tablets 100 mg， once a day+Atorvastatin calcium tablets 20 mg， once at bed time every day orally after PCI. Observation group was given Clopidogrel hydrogen sulfate tablets 75 mg， once a day+Aspirin enteric-coated tablets 100 mg， once a day+Rosuvastatin calcium tablets 10 mg， once at bed time every day orally after PCI. Both groups were treated for consecutive 12 months. The serum levels of TG， TC， LDL-C， hs-CRP and IL-35 were recorded in 2 groups before surgery， 1， 3， 6 and 12 months after surgery； in-stent minimum lumen diameter （MLD） was observed immediately after surgery and 12 months after surgery. The occurrence of in-stent restenosis， major adverse cardiovascular events （MACE） and adverse drug reaction （ADR） were recorded. RESULTS： Totally 14 patients dropped out from control group and 18 from observation group， and 368 patients completed the study. Before surgery and immediately after surgery， there was no statistical significance in the serum levels of TG， TC， LDL-C， hs-CRP IL-35 or MLD （P＞0.05）. One day after surgery， the levels of hs-CRP were increased significantly in 2 groups， compared with before surgery （P＜0.05）. One， three， six and twelve months after surgery， the serum levels of TG， TC， LDL-C and hs-CRP were decreased significantly in 2 groups， while the levels of IL-35 were increased significantly， compared with before surgery； and the serum levels of TG and TC （1 and 3 months after surgery）， LDL-C （3 and 6 months after surgery） and hs-CRP （1 month after surgery） in observation group were significantly lower than control group； the level of IL-35 in observation group （1 month after surgery） was significantly higher than control group （P＜0.05）. Twelve months after surgery， MLDs of 2 groups were decreased significantly， and observation group was significantly higher than control group （P＜0.05）. There was no statistical significance in the incidence of in-stent restenosis or the total incidence of MACE and ADR between 2 groups after surgery （P＞0.05）. CONCLUSIONS： Rosuvastatin can effectively improve the levels of blood lipid and inflammatory factor in meddle-aged patients with ACS after PCI， and its effect is better than that of atorvastatin. The drug can delay in-stent restenosis after PCI in these patients， which is better than the effect of atorvastatin. At the same time， rosuvastatin can not increase the risk of MACE and ADR with good safety.
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Objective: To provide reference and suggestions for improving the in-use period information of sterile products after first opening or reconstitution in China. Methods: The package inserts of sterile products in our hospital were investigated. The sterile products needed to be reconstituted before use and with multiple-dose package were selected. The in-use period information of European imported sterile products and domestic sterile products were comparatively analyzed. Results: The presentation rate of in-use period in the package inserts of domestic sterile products was 32. 25% , which was less than 55. 56% of the other imported sterile products, and significantly less than 93. 55% of European imported sterile products. Conclusion: The relevant content of in-use period of sterile products after first opening or reconstitution is supplemented relatively late in China's stability testing guidance for drug substances and products, moreover, the specific technical proposals are absent. It is suggested that the drug administrative department and its techni-cal supportive agencies should improve the relevant guidance and guide pharmaceutical research enterprises and manufacturing enterpri-ses to carry out in-use stability studies, furthermore, gradually improve the relevant in-use period information in package inserts.
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OBJECTIVE:To provide references and suggestions for expiration date management of dismounted drugs in China.METHODS:The main contents about compliance policy for expiration date of repackaged drugs in America were summarized.The current situation and problems of expiration date management of dismounted drugs in China were analyzed to provide suggestions for standardizing expiration date management of dismounted drugs in China.RESULTS & CONCLUSIONS:The compliance policy for expiration date of repackaged drugs in America contain determination principle of expiration date of repackaged drugs,repackaged container standard,etc.In contrast,the expiration date management of dismounted drugs in China is lack of specific standards and requirements;major issues are as follows as the concept of expiration date of dismounted drugs is ambiguous and container management is not standardized.It is suggested that relevant departments can refer to compliance policy for expiration date of repackaged drugs in America,define the method of determining the expiration date of the dismounted drugs,and standardize the standards and management of packaging containers so as to standardize expiration date management of dismounted drugs in China practically.
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OBJECTIVE:To determine the concentration of AstragalosideⅣin Yishenkangshuai tablet.METHODS:The sample was separated by using chloroform-ethyl acetatemethanol-water(15∶40∶22∶10)on the silica gel plates.The plate was scanned at510nm by camagⅡTLC scanner.RESULTS:The rate of recovery was99.28%and RSD was2.5%.CONCL_ USION:The method is simple,quick and repeatable.
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OBJECTIVE:To determine the concentration of ranitidine in serum METHODS:To use the method of multipled ultraviolet coefficient,the concentration of ranitidine in serum was scanned with detective wavelengths from 200nm to 400nm,and the work-curve was made with detective wavelengths at 324nm and 358nm RESULTS:Ranitidine taken orally resulted in an obvious double-peak in blood concentration CONCLUSION:The method is simple and quick,and is fit for the determination of serum concentration of ranitidine in basic units