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2016 Vol. 13, No. 6
Published: 2016-07-25

 
321 Research on the Acute and Mutagenic Toxic Effects of Yinsongxiang Compound
WU Yan, DI Sha, LI Xian-yu, KONG Ran, AN Wan-LI, LI Zhi-hua, LIU Shao-hua, HUANG Dong-ye, TIAN Zhao-fu, YANG Hong
Objective To evaluate the acute and mutagenic toxic effects of Yinsongxiang compound. Chinese herbal active ingredient formula of Yinsongxiang compound was composed of Isatidis Radix, Lophatheri Herba, Chrysanthemi Flos, Lonicevae japonicae Flos extract and Glycyrrhizae Radix et Rhizoma extract. Methods Acute oral toxicity test, marrow cell micronucleus test锛圥CE锛�, marrow chromosomal aberration test of mice and Ames were tested. Results Mice acute oral MTD of the formula was higher than 15 g·kg-1, and the micronucleus rates in all doses were not significantly different from the control group. Negative Results were seen from chromosome aberration test, and no increase in the number of revertant colonies was found in the Ames test with and without S9 activation system. Conclusion The Chinese herbal active ingredient formula has no toxic substance and mutagenicity effects in this study锛�
2016 Vol. 13 (6): 321-324 [Abstract] ( 2670 ) HTML (1 KB)  PDF  (0 KB)  ( 531 )
325 Study on 28-day Repeated Oral Dose Toxicity of Arctigenin in Rats
LI Hui-en, LI Bi, n YAO Jing-chun, LI Xin
Objective To observe the toxicity of arctigenin in SD rats for 28 days by oral administration, and provide reference for clinical medication. Methods 120 healthy SD rats, half male and half female, were randomly divided into 4 groups: solvent control (0.5% sodium carboxymethylcellulose solution) group, arctigenin low-, mid-, and high-dose (12, 36, and 120 mg·kg-1) groups, 30 in each group. Dose volume was 10 mL·kg-1, with oral administration 1 time per day for 28 days, and observed for 4 weeks after the last administration. During the experiment, the general state of animals was observed daily, and food consumption was weighed weekly. Body mass was weighed twice per week in administration period and 1 time per week in recovery period. At the end of the administration period and 4 weeks after drug withdrawal, the related indexes including urine routine, blood routine, blood coagulation index, blood biochemistry and serum electrolyte were detected, then the rats were dissected and histopathologic examination was carried out. Results Oral administration for 28 days and 4 weeks after drug withdrawal, general state of the rats in arctigenin 12, 36, and 120 mg·kg-1 groups were normal, and no abnormal change in food consumption, urine routine, blood routine, blood coagulation index, or serum electrolyte (P>0.05) was found. In the first week of administration, the body mass of the female rats in 120 mg·kg-1 group increased slowly compared with the solvent control group (P<0.05); at the end of the recovery period, the value of CREA slightly elevated in 12 mg·kg-1 group, and the weight of brain of the male rats in 12 mg·kg-1 group increased (P<0.05). At the end of the administration and recovery period, a small number of mild pathological changes in heart, liver and other organs or tissues were observed in each group under an optical microscope, and there were no differences in the number or severity of lesions among the groups (P>0.05). Conclusion In this study, we haven’t found any abnormal changes related to the toxicity of arctigenin. So arctigenin by oral administration doesn’t have any obvious toxicity to SD rats.
2016 Vol. 13 (6): 325-329 [Abstract] ( 1354 ) HTML (1 KB)  PDF  (0 KB)  ( 174 )
330 Clinical Efficacy of Thioctic Acid Injection in Diabetic Patients with Cerebral Infarction and Its Influence on Serum Inflammatory Cytokines Level
FENG Jing, ZHENG Hu-lin
Objective To investigate the clinical effect of thioctic acid injection and the expression changes of the inflammatory cytokines soluble intercellular adhesion molecule-1 (sICAM-1) and interleukin-6 (IL-6) in patients with type 2 diabetes and cerebral infarction. Methods 138 cases of type 2 diabetes with cerebral infarction in our hospital from January 2012 to May 2014 were randomly divided into control group (conventional treatment) and treatment group (treated with thioctic acid injection). The total effective rates, neurological function, activity of daily living, expression levels of inflammatory cytokines of two groups were compared. Results The total effective rate of treatment group (91.30%) was significantly higher than that of control group (75.36%) (P<0.05). The values of activity of daily living were higher in treatement group compared with the control group (P<0.05), the neurological severity score was lower in treatment group compared with the control group (P<0.05). Compared with the control group, the concentration of sICAM-1 and IL-6 decreased significantly, the differences of them were statistically significant (P<0.01). Conclusion Thioctic acid injection for the treatment of type 2 diabetes with cerebral infarction has a significant clinical effect. It can improve patients’ neurological function, attenuate inflammatory response.
2016 Vol. 13 (6): 330-332 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
333 Study on Determination Method of Related Substances of Calcipotriol and Stability of Raw Materials
YOU Ya-ning, GENG Qing-guang, WANG Chang-he
Objective To establish the determination Methods of related substances and to investigate the stabilitiy of calcipotriol raw materials. Methods High performance liquid chromatography (HPLC) was used for the determination of related substances in calcipotriol. The column was Kromasil 100-5 C18 and the column temperature was 35 鈩�. The mobile phase was acetonitrile- methanol - 0.01 mol·L-1 phosphate buffer solution (pH 6.0 ± 0.1) (20:50:30) with the flow rate of 1.0 mL·min-1. The detection wavelength was 264 nm. Moreover, the effects of light, heat, acid, alkali and oxidation on calcipotriol were investigated. Results The resolution and reproducibility of the principal component peak and impurity peaks of calcipotriol is good. It showed a good linear relationship in the concentration range of 0.138 5~37.221 8 µg·mL-1, and the linear equation was Y=120 000X+2 969.5, R=0.999 4. The limit of quantitation of the method was 0.14 µg·mL-1. Destructive test Results showed that calcipotriol was sensitive to light, heat, acid, alkali and oxidation. Conclusion The method is simple, accurate, with high sensitivity, high precision and good reproducibility, which can be used for the separation and analysis of the related substances in calcipotriol raw materials. Light, heat, acid, alkali, as well as the impact of oxidation should be avoided in the process of production and storage of the calcipotriol raw materials and its preparations.
2016 Vol. 13 (6): 333-337 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
338 Determination of Saikosaponin a, Paeoniflorin and Baicalin in Chaigeqingre Granula by HPLC
ZENG Jun-fen, LU Jian-wu, SONG Jin-chun
Objective To establish a method for the determination of saikosaponin a, paeoniflorin and baicalin in Chaigeqingre granula by HPLC. Methods The chromatographic column was Agilent-C18(150 mm×4.6 mm, 5 μm), using the gradient mobile phase composed of 0.1% H3PO4 (A) -acetonitrile (B), (0~12 min, 15~20% B; 12~30 min, 20~25% B), the flow rate was 1.0 mL·min-1 and the detection wavelength was 210 nm. The temperature of column was 30鈩�, and the injection volume was 20 μL锛�Results The linear range of saikosaponin a, paeoniflorin and baicalin was 1.96~31.36 μg·mL-1, 9.4~150.4 μg·mL-1 and 1.52~24.32 μg·mL-1 with average recovery of 97.65% (RSD=1.29%), 103.56% (RSD=1.14%), 102.83% (RSD=1.20%). Conclusion The method is convenient, accurate and reproducible for the determination of saikosaponin a, paeoniflorin and baicalin in Chaigeqingre granula.
2016 Vol. 13 (6): 338-340 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
341 Problems and Countermeasures of Labeling Contents of Using in the Elderly in Medicine Instructions in China
FAN Yan, XIA Dong-sheng
Objective To provide reference for labeling contents of using in the elderly in medicine instructions in China. Methods The regulations about labeling contents of using in the elderly in medicine instructions in China were summarized and the related literatures were searched. The current status and problems of labeling contents of using in the elderly were comprehensively analyzed. Then the recommendations were proposed. Results Some medicine instructions were insufficient or imprecise in our country, which might be related to many factors, such as insufficient studies of medication for the elderly, lacking of the sense of responsibility among drug manufacturers, etc. Conclusion It is necessary to strengthen the responsibility of drug manufacturers based on studies of medicines used for the elderly, and constantly standardize the labeling contents of using in the elderly in medicine instructions, so as to enhance the medication safety of the elderly.
2016 Vol. 13 (6): 341-343 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
344 Status Analysis of the Adverse Drug Reaction Monitoring Work Basing on the Quantity and Quality of ADR Reports
BAN Bing-kun, WEI Jing-tu, LI Er-ping, ZHOU Li, SUN Rong
Objective To investigate the status of adverse drug reaction (ADR) at the grass-roots, so as to provide data reference for improving the level of monitoring work. Methods By adopting the method of retrospective study, the quantity and quality of ADR reports in 2015 from Miao and Buyi Autonomous Prefecture of Guizhou province were analyzed to find the problems in the monitoring work. Results The amount of ADR increased year by year, at the same time, the proportion of new and severe report has also increased, there are 2 800 reports per million population, the proportionality of monthly reports, the timeliness of general adverse reaction reports and evaluation of ADR are good, but the structure of the source of ADR is poor, the time of new and serious report did not conform to the regulations, the accuracy rate of the type of new report is not high in general. Conclusion The monitoring work of the region has made great progress and the monitoring system is basically sound, but the quality of report has many problems, so the adverse drug reaction monitoring work should be promoted.
2016 Vol. 13 (6): 344-346 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
347 Research Progress on Pharmacology and Toxicology of Xuezhining
SHI Liang, HUANG Na-na, SUN Rong
Objective To provid references for further rational drug use through summarizing and analyzing the research progress of the related pharmacology of Xuezhining related preparations in recent 10 years. Methods References in the last decades at home and abroad about Xuezhining related preparations were collated, analyzed and summarized. Results Xuezhining has been used for the treatment of hyperlipidemia, atherosclerosis and angina. In addition, it still has a certain effect in coronary heart disease and arrhythmia which caused by atherosclerosis. Its pharmacological effects are enhancing coronary blood circulation, softening blood vessels, improving myocardial sensitivity to cardiac glycoside action, against arrhythmia and hyperlipidemia. Its lipid-lowering mechanism is lowering plasma total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) levels and increasing high-density lipoprotein cholesterol (HDL-C) levels. There was no clinical toxicity and side effects reported. Conclusion Xuezhining affects the metabolism of lipids and reduces blood viscosity in patients with hyperlipidemia by inhibiting the body’s absorption, decomposition, excretion and deposition in the vascular wall of cholesterol and triglycerides in different ways. There were no toxic side effects reported yet.
2016 Vol. 13 (6): 347-350 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
351 Meta-analysis of Adverse Drug Reactions of Ceftriaxone Sodium for Injection
WEI Fen-fang, SUN Yi-Yuan, YANG Yue
Objective To preliminarily evaluate the safety of ceftriaxone sodium for injection in clinical practice. Methods Medline, EBsco, Cochrane Library and Chinese Biomedical Literature Database, China National Knowledge Database, VIP database were retrieved, and randomized controlled trials (RCTs) related to ceftriaxone were included. Meta-analysis for adverse drug reaction (ADR) rates of ceftriaxone sodium was performed by RevMan 5.1. In addition, subgroup analyses including different countries, different indications and different doses were performed according to PRISAM guidelines. Results A total of 21 RCTs were included, involving 5417 cases. The result of Meta-analysis showed that the rate of adverse reactions in ceftriaxone sodium for injection group was significantly higher than that in the control group [OR=1.18, 95% CI (1.02, 1.35), Z=2.26, P=0.002]. Heterogeneity of several studies was statistically significant. Subgroup analyses showed that heterogeneity of several studies in foreign group was statistically significant [OR=1.20, 95% CI (1.03, 1.41), Z = 2.33, P=0.02]. The ADR incidence of the conventional dose group was higher than that in the control group, and its heterogeneity was statistically significant (Z=2.17, P=0.03). Conclusion Treatment with ceftriaxone sodium for injection has higher adverse reaction incidence than other treatments. The Results need more high-quality randomized controlled trials to testify.
2016 Vol. 13 (6): 351-358 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
359 Literature Review on 89 Cases of Adverse Reactions Induced by Niuhuangjiedu Tablets/Pills
GU Bing
Objective hrough investigating the characteristics and mechanism of adverse reactions induced by Niuhuangjiedu tablets/pills to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using “Niuhuangjiedu pills”, “Niuhuangjiedu tablets”, “adverse reaction” and “to” as key words to search and retrieve articles in the CNKI database. Forty-four references which met the inclusion and exclusion criteria were extracted and analyzed. Results Systems-organs mainly involved in adverse reactions are skin and its appendages, systemic damage, gastrointestinal system damage, etc. Rash, fever, allergic reaction, and diarrhea 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 Niuhuangjiedu tablets/pills, strengthen clinical rational use of drugs, in order to prevent adverse drug reactions and ensure the safe drug use in clinic.
2016 Vol. 13 (6): 359-363 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
364 Analysis on 137 Cases of Adverse Drug Reactions of Mannitol Injection
ZHANG Xin, QIN Wen-ming, ZAI Shu-yue
Objective To analyze the common characteristics and rules of adverse drug reactions (ADRs) induced by mannitol injection, propose effective preventive measures of ADRs, and ensure medication safety of patients. Methods 137 cases of ADRs induced by mannitol injection from our center from July 1st, 2015 to September 30th, 2015 were analyzed in terms of genders and ages, symptoms, system-organs, time of occurring, new or serious ADRs. Results Most ADRs induced by mannitol injection occurred in patients over 46 years old, which happened equally between the male and the female. ADRs often occurred in patients with high doses. The main clinical manifestations of ADRs induced by mannitol injection involved urinary system disorders, skin and appendages disorders, nervous system disorders, and general disorders. ADRs mostly occurred within 30 min. Conclusion The usage and dosage in drug instructions for middle-old aged patients should be further improved, the medication of special groups should be paid more attention, clinical medication should be standardized and monitoring should be strengthened.
2016 Vol. 13 (6): 364-366 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
367 Analysis of Utilization Rationality of Proton Pump Inhibitors in Prescriptions of Outpatients in a Hospital
JIANG Jun, XIA Zong-ling, WANG Qiu-chun
Objective To investgate the rationality of proton pump inhibitors (PPIs) use for outpatients in our hospital so as to regulate the rational clinical use of PPIs. Methods 4 392 outpatient prescriptions of PPIs were selected on the 10th and 20th of each month in 2015. The rationality of PPIs use was analyzed and evaluated in terms of indications, route of administration, solvent, usage, dosage, and combination of drugs by the standard of outpatient prescriptions for PPIs in our hospital. Results 1 074 irrational prescriptions were analyzed in 4 392 prescriptions, with irrationality ration of 24.39%. There are 1 145 unreasonable situations, including 856 cases of non-indicated use of drugs (accounting for 74.46%), 191 cases of improper combined use of drugs (accounting for 16.68%), 49 cases of inappropriate route of administration (accounting for 0.17%), 49 cases of solvent (accounting for 4.10%) and 2 cases of incorrect usage(accounting for 4.10%). Conclusion There exists an irrational situation of PPIs use in outpatients to a certain degree. Clinicians should master the indications of drug use seriously, pharmacists ought to pay more attention to censoring the prescriptions and contact with clinicians in time when discovering the irrational use of drugs.
2016 Vol. 13 (6): 367-370 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
371 Retrospective Analysis of Antibacterials Use of Patients in Hospital
LU Bin
Objective The using situation of antibacterials for patients in our hospital was retrospectively analyzed, in order to provide evidence for the rational use of antibacterials. Methods Distribution of pathogens, drug resistance rate and drug frequency (DDDs) of Gram-positive cocci and Gram-negative bacilli, the antibacterials use density (AUD) of patients from 2010 to 2012 in our hospital were retrospectively analyzed. Results 2 300 strains of bacteria were recorded in medical records, with 1 575 strains of Gram-negative bacilli (68.47%), 640 strains of Gram-positive cocci (27.83%), 85 strains of fungi (3.70%). Drug resistant rate of Gram-positive cocci was highly correlated with DDDs (R=0.827, P<0.05). Drug resistance rates of Gram-negative bacilli showed moderate correlation with DDDs, but the differences were not significant (R=0.568, P>0.05). The AUD of ceftriaxone, erythromycin and cefazolin between 2010~2012 ranked the top five consistently (2010: 5.03, 7.32, 2.33; 2011: 6.55, 4.01, 2.41; 2012: 5.13, 3.33, 3.01), the top five order of AUD for antibacterials had a few changes, and the AUD values declined in the three years. Conclusion The higher DDDs, the higher antibacterials resistance of pathogens, the antibacterials usage in our hospital was generally reasonable, but the rational use still needs to be further strengthened.
2016 Vol. 13 (6): 371-373 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
374 Literature Analysis of 38 Cases of Allergic Reactions Induced by Copper Containing Intrauterine Devices
YANG Yue-hua, XU Hao-qin, SUN Zhi-ming, ZHANG Min
Objective To explore the clinic features and regularity of allergic reactions caused by copper containing intrauterine devices(IUD), so as to provide a reference for clinical diagnosis and treatment. Methods Allergic reactions caused by IUD reported in CNKI, VIP, Wanfang databases were collected and analyzed statistically. Results Copper containing IUD related allergic reactions generally occurred in women who first use it especially in those who have a history of allergy in clinics, but it was not related to the copper surface or the shape of IUD. The allergic reactions mostly occurred in maternity care or family planning institutions, and involved multiple organs and systems. The clinical manifestations were various. There were also some symptoms of the reproductive system specifically. If allergic reactions were diagnosed, to take out the IUD and all symptoms would disappear in a short time. Conclusion Doctors should be careful to ask the women about the history of allergy before placing IUD, and to prepare first aid and to master the technology of treating acute allergy. In addition, if a similar allergic reaction was encountered in the clinic, the possibility for IUD allergic reaction should be considered.
2016 Vol. 13 (6): 374-377 [Abstract] ( 0 ) HTML (1 KB)  PDF  (0 KB)  ( 0 )
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