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08 September 2015, Volume 12 Issue 9 Previous Issue    Next Issue

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Experimental Study on Acute Toxicity of the Aconiti kusnezoffii Radix and Its Processed Products LIU Shuai, LIU Xiao-yan, LI Yan, YANG Chang, LIU Qiu-yu, LI Fei, DU Hong 2015, 12(9): 513-516.  Abstract ( 359 )   PDF (808KB) ( 544 )   Objective To discuss the principle of the processing method of raw Aconiti kusnezoffii Radix by comparing the acute toxicity of seven kinds of samples made with Aconiti kusnezoffii Radix or its processed products. Methods The median lethal dose (LD50) or the maximum dose of seven kinds of samples were measured by gavage method on mice. Results The LD50 of powder of raw Aconiti kusnezoffii Radix, powder of Aconiti kusnezoffii Radix processed with Chebulae Fructus, decoction of compatibility of Aconiti kusnezoffii Radix and Chebulae Fructus, decoction of Aconiti kusnezoffii Radix processed with Chebulae Fructus, decoction of raw Aconiti kusnezoffii Radix decoction was respectively 0.7009, 1.1690, 2.5600, 4.0000, 15.3 200 g·kg-1. The MTD of powder and decoction of Aconiti kusnezoffii Radix processed by pharmacopoeia method was respectively 20 g·kg-1 and 64 g·kg-1. Conclusion Powder of raw Aconiti kusnezoffii Radix had obvious toxicity, the acute toxicity of raw Aconiti kusnezoffii Radix was reduced to varying degrees. Powder and decoction of Aconiti kusnezoffii Radix processed by pharmacopoeia method had no obvious toxicity. References | Related Articles | Metrics

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Study on Antiinflammatory， Analgesic and Antipruritic Effects of Zijin Detoxicating Suppository GUO Shan-shan, GAO Ying-jie, BAO Lei, JIN Ya-hong, CUI Xiao-lan 2015, 12(9): 517-512.  Abstract ( 260 )   PDF (471KB) ( 188 )   Objective To evaluate the antiinflammatory, analgesic and antipruritic effects of Zijin detoxicating suppository (ZJDS). Methods To observe the antiinflammatory effect of ZJDS, the tests of ear swelling and skin capillary permeability induced by xylene and the test of rat granuloma were carried out. To investigate analgesic effect, hot plate and acetic acid induced writhing tests in mice were performed. To discover antipruritic effect of ZJDS, pruritus of guinea pig was induced by phosphoric acid histamine and pruritus of mice was induced by dextran. Results ZJDS showed obvious inhibition effect on mice ear swelling and abdominal skin capillary permeability increase, and significantly reduced the weight of cotton pellet granuloma. ZJDS can increase the pain and itch threshold of mice, and reduce the writhing times and the number of itching. Conclusion ZJDS possessed the pharmacological effects of antiinflammation, analgesia and antipruritus. References | Related Articles | Metrics

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Effects of Hyperbaric Oxygen on the Pharmacokinetics of Metformin Hydrochloride in Mice SONG Jin-bo, SONG Dan-dan, SHEN Jia-Wei, ZHOU Wei-li, CHU Fei-fei, SHI Hong, SHAO Gui-qiang, CAO Xiu-qin 2015, 12(9): 522-525.  Abstract ( 304 )   PDF (617KB) ( 224 )   Objective To investigate the effects of hyperbaric oxygen(HBO)on the pharmacokinetics of MET. Methods Two hundred mice were randomly divided into 2 groups, the HBO group and the control group. The 2 groups of animals received gavage of MET with a single-dose of 150 mg·kg-1. The animals in the HBO group were immediately put into the hyperbaric oxygen chamber and maintained at a pressure of 0.20 MPa for a duration of 20 min. The time used for compression and decompression was both 5 min. The animals in the control group were just given a single gavage of MET. Eight animals from each group were chosen at different time points both before and after drug administration, for collection of blood samples from the eyeballs. Concentrations of MET in serum were monitored with high performance liquid chromatography, and pharmacokinetic indices were calculated accordingly. Results The main pharmaeokinetic parameters of the HBO group were as follows: Cmax(9.64±2.94)μg·mL-1, tmax(0.42±0.12)h, t1/2 (5.28±0.78)h, AUC(29.76±5.21)μg·mL-1·h, CL/F (4.94±0.65)L·h-1·kg-1, Vd (12.46±3.17)L·kg-1, while the corresponding results of the control group were Cmax (18.68±4.26)μg·mL-1, tmax (0.10±0.04)h, t1/2 (7.41±1.06)h, AUC(44.12±7.15)μg·mL-1·h, CL/F (3.32±0.63)L·h-1·kg-1, Vd (7.62±1.97)L·kg-1. Conclusion HBO could obviously accelerate the elimination of MET and seemed to have significant effect on pharmacokinetic parameters. References | Related Articles | Metrics

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Study on Procoagulant Activity of Living Rhino Horn and Rhino Horn FENG Run-dong, CAO Lei, LIU Rui, SONG Bing-xue, LIU Jing, CAO Yong-xiao 2015, 12(9): 526-527.  Abstract ( 255 )   PDF (481KB) ( 122 )   Objective To observe the difference in procoagulant activity between living rhino horn and rhino horn by the comparative research method. Methods The procoagulant activity of the living rhino horn and traditional rhino horn was evaluated in DIC model mice by intravenous thrombin and amino caproic acid. Results The living rhino horn of 100, 200 mg·kg-1 significantly increased the number of platelets and shorten TT, PT and APTT of DIC model mice. There was no difference in procoagulant activity of traditional rhino horn and the living rhino horn at the same dose. Conclusion The procoagulant activity of living rhino horn is equal to that of the traditional rhino horn,and the living rhino horn can be used as a substitute of rhino horn. References | Related Articles | Metrics

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Research on Lung protection effects of Ambroxol in Children with Tetralogy of Fallot after Operation LUO Hui-li, HUANG Hai-ying, MAI Hui-juan 2015, 12(9): 528-530.  Abstract ( 242 )   PDF (559KB) ( 140 )   Objective To investigate the lung protective effects of ambroxol in children with tetralogy of fallot undergoing radical surgery. Methods From March 2012 to August 2014, a total of 61 children with tetralogy of fallot undergoing radical surgery were divided into normal observation group (n=34) and control group (n=34) randomly according to obscura envelope method. Ambroxol was applied in observation group at the end of operation, and normal saline was given in control group. The surgical case and breathing were recorded at each time point after operation. Results Compared with control group, the time of ICU, mechanical ventilation and hospitalization in observation group showed significant change after operation (P <0.05). Compared with control group, observation group showed significantly increased level of arterial partial pressure of oxygen on the third, fourth day after surgery(P <0.05). Compared with control group, observation group showed significant change of the arterial partial pressure of oxygen and oxygenation index in the first week after surgery (P <0.05). The incidence of infection in newborn in observation group showed obviously lower than those in the control group(P <0.05). Conclusion Ambroxol has a significant curative effect for lung protection in the patients after tetralogy of fallot surgery while avoiding respiratory complications, and it can be used widely in clinical work. References | Related Articles | Metrics

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Review on Chinese Adverse Drug Reaction Information Bulletin and Its Problems TIAN Chun-hua, XIA Dong-sheng, LIU Cui-li, GAO Jian-chao 2015, 12(9): 531-533.  Abstract ( 283 )   PDF (1175KB) ( 284 )   Chinese Adverse Drug Reaction Information Bulletin is one of the earliest risk control measures established in our country. From 2001 to 2014, a total of 65 issues were released which has played a positive role in promoting China's adverse drug reaction monitoring and protecting public safety. In this paper, the comprehensive review and analysis of the existing problems were conducted about Chinese Adverse Drug Reaction Information Bulletin , in order to make medical professionals learn more about the work and promote the development of adverse drug reaction monitoring. References | Related Articles | Metrics

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Discussion on the Key Drug Monitoring in China WANG Dan, DONG Duo 2015, 12(9): 534-537.  Abstract ( 595 )   PDF (673KB) ( 332 )   The key drug monitoring is a new task introduced by the approach of adverse drug reaction reporting and monitoring revised in 2011. As of now, the approach has been implemented for more than four years. Experience in the key drug monitoring has been accumulated. The article, in the point of technical supervision view, tries to re-examine the meaning and content of the key drug monitoring, summarizes the methods as well as its advantages and disadvantages, combings the existing problems, and provides ideas in order to promote the work to carry out in deep and effective way. References | Related Articles | Metrics

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Discussion on the Responsibility of Provincial Center for ADR Monitoring during Key Drug Monitoring SUN Jun, WEI Zhen, LI Ming, YU Dan-dan 2015, 12(9): 538-541.  Abstract ( 436 )   PDF (698KB) ( 347 )   Objective To discuss the responsibility of provincial center for ADR monitoring during key drug monitoring. Methods The data from official website of FDA, EMA and our country, and the related literatures are collected and analyzed. Results The purpose and method of key drug monitoring at the present stage in China are similar to the Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment of FDA, and the Guideline on Good Pharmacovigilance Practices (GVP) Module VIII-Post-Authorisation Safety studies of EMA, we may design the responsibility of provincial center for ADR monitoring during key drug monitoring referring to the above document. Conclusion Provincial center is a technical center rather than a contract research organization, be authorized to keep the study protocol of key drug monitoring on record rather than approval, supervise the implementation of key drug monitoring program rather than monitor or audit, check the study protocol and the final study report rather than provide a final conclusion References | Related Articles | Metrics

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Study on Refining Process Optimization of Shuxuening Injection ZHAO Yu-xin, GAO Hui-qin, ZHANG Hao-jun, LI Xiang-ming, WANG Wen-peng, SUN Sheng-bin, JIANG Guo-zhi, LI Zhen-jiang 2015, 12(9): 542-546.  Abstract ( 231 )   PDF (817KB) ( 237 )   Objective To optimize the refining process of Shuxuening injection by polyamide chromatography column. Methods Through the orthogonal experiment design method in the polyamide chromatography column, observing velocity, alcohol elution volume and ethanol concentration which can change the transfer rate of component of Shuxuening injection. Results The polyamide chromatography velocity, alcohol elution volume and ethanol concentration are the main factors that can affect the component of Shuxuening injection. Conclusion The parameters of optimal refining process parameters are that, the flow rate is 0.2 times the volume of polyamide column chromatography column per hour, alcohol elution volume is 9 times extract's weight, ethanol concentration is 75%. References | Related Articles | Metrics

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Research of How Traditional Chinese Medicine Can Be Registered as OTC Drug in USA SONG Yang, YOU Xiao-min, ZONG Mao-mao, YANG Yue 2015, 12(9): 547-551.  Abstract ( 420 )   PDF (704KB) ( 714 )   Objective According to the introduction of American OTC Drug Monograph, practical advice and help were put forward to provide the example and reference for our traditional Chinese medicine enterprises. Methods Literature study was used to analyze the foreign and domestic materials. Results The applicants can bring new active ingredients which are contained in their products into the existing monographs or make new monographs for them. Conclusion Our traditional Chinese medicine enterprises should choose products whose active ingredients have been contained in the existing monographs and have knowledge of all the discussion papers related to the targeted monographs. In Addition, the applicants should also pay attention to standardizing the labellings of botanical drugs, especially the readability requirements. References | Related Articles | Metrics

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Study on Drospirenone and Ethinylestradiol Tablets Using FDA Public Data Program SHI Wen-hui, CHEN Ying, YAO Jie, SUN Zhi-ming, XU Hao-qin 2015, 12(9): 552-555.  Abstract ( 423 )   PDF (647KB) ( 265 )   Objective To understand the drug adverse reaction of drospirenone and ethinylestradiol tablets and discuss the characteristics and feasibility of FDA public data program (openFDA) through analyzing adverse reactions reports from the openFDA. Methods The openFDA database was searched with term"drospirenone and ethinylestradiol" from January 1, 2001 to December 31, 2014, and the data was transformed and analyzed by R software with jsonlite package. Results 38617 reports were retrieved, and the distribution of received date showed a curve of rises first and then fall with the turning point occurred in May,2011 when FDA published safety review of possibly increased risk of blood clots with birth control pills containing drospirenone. The mean age of patients was 30.02 years, the top three drugs use indications were contraception, acne and premenstrual syndrome, and the top three adverse reactions were pain, injury and pulmonary embolism. Conclusion Compared with the FAERS database, openFDA simplifies the data cleaning procedure, which is a more convenient way to get to know adverse reactions of certain drug, however, problems on the quality of raw data still exist, which would affect the accuracy of analysis result , therefore, the mining of adverse reaction signals using openFDA comparatively has better potential applications. References | Related Articles | Metrics

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Literature Analysis of 264 Cases of Adverse Drug Reactions Induced by Azlocillin Sodium LIU Xin-xin, FENG Ya-nan, LI Yong-hui, GUO Rui-feng 2015, 12(9): 556-559.  Abstract ( 254 )   PDF (1313KB) ( 302 )   Objective To probe into the status, characterstics and influencing factors of ADR cases induced by azlocillin sodium, so as to provide a reference for clinical treatment. Methods Datas were collected from domestic published literatures from China Journal Full-text Database before 2014, and 264 case reports of adverse drug reactions induced by azlocillin sodium were analyzed retrospectively. Results Younger patients appeared to be with a high rate of ADR, which mainly involved skin and its appendages (48.43%), systemic damage(20.24), gastrointestinal system(13.01%), and the serious ones showed anaphylactic shock and anaphylactoid reaction.Conclusion Azlocillin sodium should be used reasonably, and the monitoring of clinical use should be strengthened to ensure the safety of medication. References | Related Articles | Metrics

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Retrospective Analysis on 365 Cases of Adverse Drug Reactions in a Psychiatric Hospital WANG Jun, SU Ming-jie, ZHAO Xiao-yan, LIU Xiu-ping 2015, 12(9): 560-563.  Abstract ( 250 )   PDF (712KB) ( 302 )   Objective To investigate the characteristics and general pattern of the adverse drug reactions (ADR) occurred in a psychiatric hospital. Methods A total of 365 ADR cases collected in Beijing Huilongguan Hospital from 2010 to 2014 were analyzed statistically in terms of patients' age,sex,drug category,causality assessment, degree evaluation, drug combination, ADR involved organs or systems and clinical manifestations,ect. Results Among 365 cases of ADR reports, most patients were form 21 to 30 years old, accounting for 111 cases (30.41%). ADR caused by antipsychotics in 14 varieties were in the first place, accounting for 345 cases (74.35%). Systems or organs involved in ADR cases were most frequently reported as central and peripheral nervous system disorders (30.25%) and gastrointestinal system disorders(18.86%). Conclusion Attention should be paid to the ADR monitoring and reporting work, especially serious adverse reaction reporting and monitoring for the rational use of drugs,strengthen the ADR analysis,evaluation, timely intervention and persuation. It is better for patients to use drugs according to themselves so as to reduce the ADR and ensure safe drug use. References | Related Articles | Metrics

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Clinical Analysis of 22 Cases of Acute Poisoning of Clozapine in Children HE Li-mei YANG Zhi, ZHANG Hai-xia, HE Zhou-kang, LONG Rong 2015, 12(9): 564-566.  Abstract ( 265 )   PDF (747KB) ( 327 )   Objective To study the clinical manifestation of clozapine poisoning and discuss the relationship of clozapine blood concentration and hemoperfusion, so as to reduce clozapine poisoning and provide better rescue measures. Methods Clinical data of 22 patients who took clozapine were collected and analyzed in terms of patients' age, dosage, medical test results and hemoperfusion effect. Results After treatment, 13.6% patients were cured, 86.4% patients were improved. After hemoperfusion, the blood concentration of clozapine declined(280.8±180.2) ng·mL-1, and there is a significant difference before and after hemoperfusion(P<0.05). Besides, the time needed for waking of perfusion group and non-perfusion group was (25.8±1.5) h and (34.8±4.1)h respectively(P<0.05). Conclusion All the children poisoned were accidental, clinical pharmacist should explain and publicize the safety way to preserve drugs, and avoid poisoning accidents. In this study, clinical doctors can make a decision to take hemoperfusion measures timely according to blood concentration of clozapine and clinical manifestation, reduce the time needed for waking of patients. References | Related Articles | Metrics

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Anticoagulation Effect and Association Analysis in Patients on Routine Warfarin Dosage ZHANG Ya-tong, FU Chun-yi, LI Zheng, DONG Fan, HU Xin 2015, 12(9): 567-569.  Abstract ( 305 )   PDF (798KB) ( 246 )   Objective To Explore the anticoagulant effect and related factors under conventional warfarin dosing regimen. Methods Patients under 3 mg per day without dosage change more than 5 days were included, the coagulation effect of warfarin was analyzed, and the patients' blood samples were collected and tested in VKORCl and CYP2C9 genotypes, and clinical data of them were also collected. Genetic factors and non-genetic factors were statistically analyzed on the effect of warfarin's anticoagulation. Results 52 patients had INR values below 1.8, 22 patients higher than 2.5, only 21 patients had INR values between 1.8 and 2.5 which accounted for 22.11%. Genetic factors and non-genetic factors had no impact on warfarin anticoagulation effect, and only the age was associated with INR values of the patients. Conclusion Most patients under routine warfarin dosage had not reached into the target INR values, and the age was still the important factor on the warfarin anticoagulation effect . References | Related Articles | Metrics