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08 November 2014, Volume 11 Issue 11 Previous Issue    Next Issue

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Research of Extraction Process of Modified Xiongqiong Decoction Based on Material Basis and Effect of Anti-cerebral Ischemia FENG Qun, CHI Xue-jie, ZHANG Ya-nan, SUN Rong 2014, 11(11): 641-644.  Abstract ( 204 )   PDF (708KB) ( 123 )   Objective Extraction process of modified Xiongqiong decoction was researched and optimized on the basis of mice models of cerebral ischemia-reperfusion damages according to its material basis. Methods Six extraction processes of modified Xiongqiong decoction were explored according to modern references. Contents of active ingredients in the extracts were determined and protective effects of them on mice models of cerebral ischemia-reperfusion damages were observed. Optimum extraction process was selected according to determination of material basis and comparison of anti-cerebral ischemia. Results Active ingredients in the extract of the fifth extraction process is comprehensive relatively according to the integrated evaluation to volatile oil, walnut oil and ferulic acid. Extract of the fifth extraction process improved most obviously cerebral ischemia-reperfusion damages in all the extracts. Conclusion Model of "quality-efficacy" comprehensive assessment can guarantee effectiveness of Chinese medicine compound. The fifth extraction process has been confirmed to be optimum extraction process of modified Xiongqiong decoction preliminarily. However specific optimum parameters of the fifth extraction process need to be confirmed by a further study. References | Related Articles | Metrics

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Permeability of Cefpiramide through Blood-pancreatic Barrier in the Mice with Sever Acute Pancreatitis XU Hui, JIANG Jun, XIA Zong-ling, WANG Ming-li 2014, 11(11): 645-648.  Abstract ( 207 )   PDF (906KB) ( 127 )   Objective To investigate the permeability of cefpiramide (CPM) through blood-pancreatic barrier in the mice with sever acute pancreatitis(SAP). Methods CPM (42.5 mg·kg-1 body weight) was intravenous injected to mice after abdominally injecting L-arginine to induce sever acute pancreatitis while normal saline injection as control. At the given time points, the serum and pancreatic samples were collected. The concentrations of CPM in the samples were measured by HPLC. Results The disposition of CPM in two groups fitted one compartment model. The average penetration ratios (PR) of the drug through the blood-pancreas barrier in normal control group was (49.2±38.4)%. The parameters in plasma were as follows: t1/2 1.42 h, C0 59.93 mg·L-1, AUC0-∞ 122.73 mg·h·L-1, and those in tissue were as follows: t1/2 1.14 h, C0 22.58 mg·kg-1, AUC0-∞ 69.88 mg·h·kg-1. In SAP group, there was no significant difference in average PR、t1/2、C0 and AUC0-∞ of CPM in the tissue compared with the normal control group (P >0.05). Conclusion CPM was shown to have a fairly high distribution in the pancreas in the SAP mice. It is therefore proposed that CPM may be used clinically for the prevention and treatment of pancreatic infection. References | Related Articles | Metrics

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Research on the Acute and Mutagenic Toxic Effect of Huolianxiang Compound WU Yan, YANG Hong, ZHONG Ju-ying, LIU Zhao, GAO Er-ning, WANG Ping-juan, HUANG Dong-ye, TIAN Zhao-fu, BAI Jia-feng 2014, 11(11): 649-651.  Abstract ( 234 )   PDF (883KB) ( 121 )   Objective To further evaluate acute toxicity and mutagenicity of Huolianxiang-I on the basis of previous pharmacodynamics results in order to provide theory basis for its further application. Methods The acute toxicity and mutagenecity of Huolianxiang-I were examined by acute oral toxicity test, mouse bone marrow polychromatic erythrocyte micronucleus test,mouse bone marrow chromosome aberration test and Ames test. Results For acute oral toxicity, maximum tolerance doses of male and female mice are higher than 10g·kg-1 which are actually innocuity.For mutagenicity,negative results were seen in mouse bone marrow polychromatic erythrocyte micronucleus test,mouse bone marrow chromose aberration test and Ames test showing that Huolianxiang-I has no mutagenecity in this study. Conclusion No evident acute toxicity and mutagenicity are found in this study demonstrating that Chinese medicine compound Huolianxiang-I is safe. References | Related Articles | Metrics

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Clinical Study of Qiangguyin for Treating Postmenopausal Osteoporosis LIU Guo-tai, WANG Jian-hui, ZHOU Li, WU He-hua, GUI Shun, DENG Yi-wen 2014, 11(11): 652-656.  Abstract ( 244 )   PDF (816KB) ( 158 )   Objective To observe and evaluate the clinical efficacy and safety of the Qiangguyin on postmenopausal osteoporosis(PMOP), and to explore its mechanism. Methods All 90 patients who meet the inclusion criteria were randomly divided into three groups, namely Qiangguyin group, basic medication group and Xianlinggubao group with 30 cases for each one. Basic medication group was given calcium carbonate D3 tablets and alfacalcidol capsules. Xianlinggubao group was based on basic medication group to plus Xianlinggubao capsules. Qiangguyin group was based on basic medication group to plus Qiangguyin granules. All groups were treated for 6 months. Outcome measures included bone mineral density(BMD), bone metabolic markers, visual analogue scales(VAS) and SF-36 score. Results After 6 months of treatment, VAS and SF-36 scores of all groups had changes, the difference was statistically significant(P <0.05). BMD and bone metabolic markers of Qiangguyin group and Xianlinggubao group after treatment changed, both the groups had advantages over basic medication group (P<0.05). Conclusion Qiangguyin is not only able to effectively relieve pain of PMOP, but also promote the bone mineral density. It may improve the quality of life and reduce the bone metabolic markers (PINP and S-CTX). References | Related Articles | Metrics

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Determination of Eight Impurities of Rosuvastatin Calcium Tablets by HPLC CAI Yin, WU Li, MIAO Yan, ZHOU Zhi-liang, ZHU Jin-lian, XIA Xiao-qin 2014, 11(11): 657-660.  Abstract ( 243 )   PDF (857KB) ( 100 )   Objective To establish the related substance method of rosuvastatin calcium tablets. Methods Prepared eight impurities of rosuvastatin calcium tablets first, Column: Agilent extend-C18(4.6 mm×250 mm, 5 μm) with mobile phase consisted of 0.05 M sodium dihydrogen phosphate buffer (adjusted to pH 2.0 with phosphoric acid): acetonitrile: methanol=46:20:34 at a flow rate of 0.7 mL·min-1 when the detective wavelength was set at 242 nm, used external standard method to calculate the content of impurities. Results The contents of (3S, 5S)-rosuvastatin calcium, 5-oxo-rosuvastatin and rosuvastatin-5S-lactone are more than others in three batches of rosuvastatin calcium tablets. Conclusion The contents of impurity A, B, C should not be more than 0.5% and impurity D, E, F, G, H should not exceed 0.2%, for each unspecified impurities not more than 0.2% and not more than 1.5% for total. References | Related Articles | Metrics

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Determination of Chlorogenic Acid in Fufang Shengdi Mixture by HPLC XU Wei-ying, ZHENG Xin-ying, GU Xiao-ying, REN Shi-he 2014, 11(11): 661-663.  Abstract ( 180 )   PDF (916KB) ( 126 )   Objective To establish a HPLC method for the determination of chlorogenic acid in Fufang Shengdi mixture. Methods A SHISEIDO MG C18 column(250 mm×4.6 mm, 5μm) was used with the mobile phase of 0.4% phosphoric acid and acetonitrile for isocratic elution (10:90) at the wavelength of 327 nm, with the flow rate of 1mL·min-1 and the column temperature was 30℃. Results The calibration curves for chlorogenic acid were linear in the concentration ranges of 0.0624～4.68 μg, and the correlation coefficient was 0.999999. The average recovery was 100.7%,(RSD=1.7%,n=6). Conclusion This method is simple and reproducible,and is suitable for the quality control of the Fufang Shengdi mixture. References | Related Articles | Metrics

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Management Research of EU Drug Standard and Reference Material LIU Si-qi, GAO Jing, YANG Yue 2014, 11(11): 664-668.  Abstract ( 213 )   PDF (1146KB) ( 217 )   Objective To study the management pattern of drug standard and reference material in European Union, and put forward suggestions on developing scientific management system of drug standard in China. Methods Analyze management processes and advantages in European Union by consulting EDQM website, and compare them with current situation of China. Results The elaboration of European pharmacopoeia fully demonstrated its standardization, authority, timeliness and transparency, and all parties had specific responsibilities. Conclusion The management pattern and features are useful references for China to improve drug standard. References | Related Articles | Metrics

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Management Research on Emergency Inspection of Chromium Exceeding the Standard in Drug Capsule GAO Zhi-feng, YANG Rui 2014, 11(11): 669-671.  Abstract ( 203 )   PDF (767KB) ( 117 )   Objective To enhance the level of drug emergency inspection management. Methods The inspecting procedures of some typical drug incidents such as chromium exceeding the standard in drug capsule were analyzed, and then we summed the difficulties and solutions. At last we extracted the management characteristics of drug emergency inspections. Results and Conclusion The key to complete the drug emergency inspection successfully included four aspects, namely maintaining the real data steadily, keeping the rigorous style from beginning to the end, innovating work methods frequently and necessary systems to ensure. References | Related Articles | Metrics

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Discussion on Licensed Pharmacists' role in Protection of the Public Rational Drug Use LI Zhao-hui 2014, 11(11): 672-674.  Abstract ( 220 )   PDF (679KB) ( 174 )   Objective To exert licensed pharmacists' role in protection of the public rational drug use. Methods The data of rational drug use importance and domestic licensed pharmacist career development were collected and analyzed, initiatives were proposed to play the role of licensed pharmacist in China and protect the public reasonably safe and effective use of drugs. Results There is a big gap between China and foreign countries in licensed pharmacist qualification, practice management and continuing education, licensed pharmacists may play a greater role in the protection of public rational drug use, through perfecting the system, improving qualily, providing pharmacy services and other initiatives. Conclusion licensed pharmacists should constantly improve the quality and deliver high-quality pharmacy services for patients. Licensed pharmacists are the protectors of the public rational drug use. References | Related Articles | Metrics

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Literature Review of 582 Adverse Reaction Cases Induced by Potassium Sodium Dehydroandrographolide Succinate Injection DING Wei, CHENG Gang, DONG Duo, Han WEN-min, WU Gui-zhi 2014, 11(11): 675-678.  Abstract ( 264 )   PDF (828KB) ( 371 )   Objective Through investigating the characteristics and mechanism of adverse reactions induced by potassium sodium dehydroandrographolide succinate injection to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using "potassium sodium dehydroandrographolide succinate" and "adverse reaction" as key words to retrieve the CNKI database. Fifty-three articles which met the inclusion and exclusion criteria were extracted and analyzed. Results Pediatric patients appear to have higher ADR occurrence rate by using succinate injection. Systems and organs mainly involved in adverse reactions are skin and its appendages, systemic damage, respiratory damage, and etc. Rash, fever, and allergic reaction are the most common reported adverse reactions. Anaphylactic shock which is life threatening is also reported in several cases. Conclusion It is important to pay attention to the adverse reactions caused by potassium sodium dehydroandrographolidesuccinate injection, specially to strengthen pediatric postmarketing surveillance, in order to prevent adverse drug reactions and ensure the safe drug use in clinic. References | Related Articles | Metrics

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Analysis of 189 Reports of Adverse Drug Reaction Caused by Intravenous Amiodarone GAO Guan-nan LIU Yu-qing LI Yi-shi JIANG Jun ZHANG Xiao-Ji ZHANG Li-ming 2014, 11(11): 679-682.  Abstract ( 235 )   PDF (782KB) ( 166 )   Objective To analyze the features related factors, prevention and treatment methods of amiodarone induced adverse drug reaction (ADR). Methods Acquiring ADR case information from Beijing Adverse Drug Reaction Monitoring Center during 2005～2012 to observe the clinical manifestations of amiodarone ADR. And using statistical methods to analyze the relationship between amiodarone ADR severity and the impacts from the patient's gender, age, method of administration, dose.Also the processing of ADRand prognosis outcome were evaluated. Results A total of 189 cases of ADR reports were collected, 116 cases were male, mean age 67±15 years old, 73 cases were female, mean age 60±15 years old. There are 174 cases of circulatory system diseases, 4 cases of respiratory diseases, 4 cases of cancer, 2 cases of surgical diseases and 5 other cases. Administration includes load administered 37 cases, no load administered 152 cases. A total of 30 cases of serious adverse reactions were observed. Among them, liver damage is the most, accounting for 74.19%, and followed by anaphylactic shock and blood pressure drop, 6.45% respectively. Torsades de pointes ventricular tachycardia, renal insufficiency, palpitations, hypotension, respectively, accounted for 3.23%. ADR treatments include medication reduction, discontinuation and active clinical treatment. A total of 183 cases were followed up (6 cases failed to follow-up), of which 67 cases were cured, 106 cases were improved, 7 cases with sequelae, 3 deaths (original disease deaths).Serious ADRs induced by intravenous amiodarone account for 15.87%.There was no significant correlation between ADR occurrence and gender (P =0.061,> 0.05), age (P =0.140,>0.05), dose (P =0.857,>0.05), with or without use of a loading dose (P =0.572,>0.05). Conclusion In clinical applications, amiodarone is a relatively safe antiarrhythmic drug, but its ADRs diverse. Early symptomatic treatment will lead to good outcomes. In clinical work, clinicians should pay attention to individual amiodarone application, monitor ADR and reduce serious adverse events. References | Related Articles | Metrics

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Literature Analysis of 30 Adverse Drug Reaction/Event Cases Induced by Xingnaojing Injection ZOU Zhen-lei, YANG Le, GUO Xiao-xin 2014, 11(11): 683-686.  Abstract ( 1370 )   PDF (890KB) ( 376 )   Objective To analyze the causes and characteristics of the adverse drug reaction/event (ADR/ADE) cases induced by Xingnaojing injection provide references for clinical rational drug use. Methods 30 ADR/ADE cases induced by Xingnaojing injection were analyzed retrospectively. Results The middle-aged and the old patients accounted for 56.67%. The use of Xingnaojing injection in 43.33% cases is beyond the indications of the drug instructions. The dosage of Xingnaojing injection in 13.33% cases is more than the dosage of the drug instructions. 70.00% of ADR/ADE occurred within 30 minutes after administration. The ADR/ADE can occur in the first time medication or continuous administration process. 33.33% of the patients had combined medication. The ADR/ADE involved six systems-organs. Systemic damage in which allergic reactions and anaphylactic shock is majority accounted for 60.00%. Conclusion Clinicians should pay attention to allergies of patients. The instruction should be adhered to. The combined medication should be cautious. The monitoring of adverse drug reactions should been strengthened. The drug manufacturing enterprise should strengthen the quality control and drug safety research, and improve the drug instructions of Xingnaojing injection. References | Related Articles | Metrics

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Analysis and Discussion on Skin Allergy Caused by Disposable Electrocardiogram Electrode LU Yi-yan , CUI Wen-bo 2014, 11(11): 687-692.  Abstract ( 355 )   PDF (902KB) ( 107 )   Objective Combined by the risk management principle, some advices are given to ensure safe and effective clinical use of disposable ECG electrode and also in order to improve level of medical device adverse event monitoring and its risk management. Methods Based on the investigation of 10 cases of skin allergic damage caused by disposable ECG electrode, combined by both foreign and domestic clinical researches as well as such MDAE recorded in FDA MAUDE database, brief risk factor analysis was carried out from four risk aspects according to MDAE legal definition. Results Risk factors related to skin allergic damage caused by disposable ECG electrode include objective factors such as patient's own factor and product intrinsic property factor, as well as erasable factors such as medical factor and product quality factor. Conclusion A full time control involving preventive measurement, process control and timely disposal should be taken to reduce the incidence and extent of damage caused by disposable ECG adverse event. References | Related Articles | Metrics

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Analysis On Common Risk of Venous Indwelling Needle CHEN Jie SUN Li-na, JIANG Jin-yan 2014, 11(11): 693-695.  Abstract ( 237 )   PDF (767KB) ( 611 )   Objective To discuss common risk and its influencing factors of venous indwelling needle,and put forward the risk control suggestions. Methods The suspected adverse events of venous indwelling needle collected from Center for ADR Monitoring of Fujian from 2008 to 2013 and the relevant literature were classified and counted, and then the possible causes of the events were analyzed. Results The common device failures were weeping and blocking. The common injures were the infusion site reactions, such as swelling, scleroma, pain, infection etc, and phlebophlogosis. Conclusion After analyzing the risk of vein detained needle and possible factors of adverse events, the risk control suggestions are put forward to avoid the risk of venous indwelling needle, as well as to improve the safety of such prducts. References | Related Articles | Metrics