Chinese Journal of Pharmacovigilance

Determination of Oxazepam in Human Plasma by NP-HPLC

ZHANG Tao, LING Yi

2012, 9(5): 257-258.

Abstract ( 227 )

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Objective To establish a method for determination of the concentration of oxazepam in human plasma by HPLC. Methods The plasma samples were extracted with ether. The ether extraction was evaporated under nitrogen stream at 55℃ in water bath, and the residue was dissolved in methanol. Shim-pack CLC-CN(150 mm×6.0 mm, 5 m) was used as the analytical column. Mobile phase consists of n-hexane:methanol: ethanol(80:17:3, V/V/V), with a flow rate of 1.10 mL·min-1. The temperature of chromatographic separation was 30℃, and the drug was detected at 230 nm by an ultraviolet detector. Results A good linearity was obtained from 0.02 to 5.0 mg·L-1 with a correlation of 0.9996. The recovery of oxazepam was nearly 100%. Intraday RSD and interday RSD were both less than 5%(n=5). Conclusion The method is suitable for monitoring oxazepam in human plasma.

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A 26 Weeks Oral Toxicity of Extracts of Phyllanthus urinaria L. in Beagle Dogs

JIA Qing-Wen, XIN Ju-yun, DAI Xue-dong

2012, 9(5): 259-262.

Abstract ( 308 )

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Objective To observe the long-term toxicity of the extracts of Phyllanthus urinaria L. in dogs by repeated oral administration. MethodDaily doses of extracts at 125 mg·kg-1, 250 mg·kg-1 and 500 mg·kg-1 for 26 weeks were used for low, mid, and high dose group, respectively. Examinations including haematological indexes, biochemical indexes, urinalysis and histopathology were performed at 26 weeks during the administration, and 6 weeks after the withdrawal, respectively. ResultsThe dogs in the high group showed a reduction in the food consumption and appeared interval disgorging during the administration. The levels of ALT, AST, ALP, T-Bil, BUN and γ-GT in high group were significantly higher than those in control group at 26 weeks after administration(P<0.05). Those changed blood biochemistery indexes regained normal at 6 weeks after withdrawal. Hematology data did not show treatment related change in all of the dogs. The high group dogs showed positive protein and bilirubin in the urine at terminal sacrifice. The liver and kidney of dogs in high and mid group appeared reversible pathological changes. ConclusionRepeated oral administration of the extracts of Phyllanthus urinaria L. at high dose could lead to reversible damage to liver and kidney function and pathology in dogs.

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The Effect of Different Extracting Methods on the "Quality - Toxicity" Combined Evaluation Mode of Cortex Periplocae

BAO Zhi-ye, CHI Xue-jie,SUN Rong

2012, 9(5): 263-265.

Abstract ( 212 )

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Objective By comparing the 2-Hydroxy-4-methoxybenzaldehyde's content and the acute toxicity of different extracts in Cortex Periplocae, to explore the effect of different extraction solvents on the quality and toxicity of Cortex Periplocae. Methods By using HPLC and the classic acute toxicity experiment method, to determine the content of 2-Hydroxy-4-methoxybenzaldehyde and compare the acute toxicity of different extracts. Results The 2-Hydroxy-4-methoxybenzaldehyde's content of different composition from the biggest to the smallest is all components, alcohol extraction components and water extraction components. The acute toxicity of different extracts from the biggest to the smallest is alcohol extraction components,water extraction components and all components. The LD50 of water extraction components and alcohol extraction components in Cortex Periplocae are 93.578 g·kg-1·d-1 and the 95% confidence limit is 89.149～98.484 g·kg-1·d-1 which is equal to 1091.8 times of 70kg people's daily dried medicinal herb expenses and 61.388 g·kg-1·d-1 and the 95% confidence limit is 57.466～65.521 g·kg-1·d-1 which is equal to 716.2 times of 70kg people's daily dried medicinal herb expenses. The all-components in Cortex Periplocae is unable to make LD50, while MTD results calculated in accordance with crude drug content is respectively 16.0 g·kg-1·d-1, which is equal to 186.6 times of 70kg people's daily dried medicinal herb expenses. Conclusion There are significant differences on the content of 2- Hydroxy-4-methoxybenzaldehyde and the toxicity. There are the biggest content of 2-Hydroxy 4 methoxybenzaldehyde in the all-components while the toxicity of alcohol extraction components are the biggest. We need do further study to corroborate whether 2-Hydroxy-4-methoxybenzaldehyde is also one of the toxic substance in Cortex Periplocae.

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The Effeet of Extracting Methods on "Quality-Toxicity" Comprehensive Evaluation Model of Rhizoma Menispermi

LUO Dong, ZHENG Li-na, SUN Rong

2012, 9(5): 266-268.

Abstract ( 221 )

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Objective Explore the effeet of extracting methods on "quality toxicity" comprehensive evaluation model by comparing the content of alkaloid and acute toxicity from Rhizoma Menispermi extracted by different methods. MethodsWith 0.5% sulfuric acid as solvent, thermal circumfluence method, ultrasonic method, percolation method, warm immersion method were used to extract total alkaloids from Rhizoma Menispermi, the acid-base titration to determinate the content of the total alkaloid, high performance liquid chromatography to determinate the content of Menispermine, the classical method of acute toxicity to compare acute toxicity. ResultsIn the determination of Menispermine in different components of Rhizoma Menispermi,it was found that the size order of the content of total alkaloids was: ultrasonic method>percolation method, and the content of the total alkaloid extracted by thermal circumfluence method and warm immersion method could not be measured. the size order of the content of Menispermine was: thermal circumfluence method>warm immersion method, but the content of Menispermine extracted by the ultrasonic method and percolation method could not be measured. Different extraction methods on the size of the acute toxicity in mice the maximum administered dose(MLD): percolation method>ultrasonic method>thermal circumfluence method>warm immersion method. The acute toxicity of warm immersion method was maximum. ConclusionUnder different extracting methods, the content of main chemical composition and toxicity was different, and there was a certain relationship between its toxicity and the content of total alkaloids and Menispermine, but not completely consistent. There was certain effect of extracting methods on "quality toxicity" comprehensive evaluation model. It was more comprehensive, Objective and reasonable to determine extraction methods of toxic Chinese medicine through the comprehensive evaluation model.

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The Effect of Extracting Methods on "Quality Toxicity" Comprehensive Evaluation Model of Fructus Bruce.

ZHU Lan-lan, SUN Rong

2012, 9(5): 269-271.

Abstract ( 230 )

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Objective Explore the effect of extracting methods on "quality toxicity" comprehensive evaluation model by comparing the content of alkaloid and acute toxicity from Brucea javanica(L.)Merr. extracted by different methods. MethodsGC was used to determine the content of oleic acid in water extract and alcohol extract of Brucea javanica(L.)Merr.; the classical method of acute toxicity was used to determine the acute toxicity of Brucea javanica(L.)Merr. at different extraction, and compare the acute toxicity. ResultsThe content of oleic acid which included water extract and ethanol extract was separately1.83%、10.35%. The LD50 of water extract and alcohol extract of Fructus Brucea to ice were 4.023g·kg-1, 3.320g·kg-1. Diarrhea and cyanosis are main acute toxic symptoms. ConclusionThe content of oleic acid and acute toxicity of the Fructus Brucea by different extracting methods were different, and death occurred in each sample, the LD50 showed that the different extracts which extracted from the Fructus Brucea at different extracting methods had certainly toxicity in mice. The acute toxicity of different extracts on mice is: alcohol extraction group>water extraction group, the content of oleic acid in different extracts is: alcohol extraction group>water extraction group. Suggesting that it was certain effect of extracting methods on "quality toxicity" comprehensive evaluation model. It was more comprehensive, Objective and reasonable to determine extraction methods of toxic Chinese medicine through the comprehensive evaluation model.

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The Effect of Different Extracting Methods on the "Quality-Toxicity" Combined Evaluation Mode of Folium Artemisiae Argyi

CHI Xue-jie, SUN Rong

2012, 9(5): 272-274.

Abstract ( 206 )

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Objective By comparing the volatile oil, total flavonoids content and the acute toxicity of different extracts in Folium Artemisiae Argyi, to explore the effect of different extraction solvents on the quality and toxicity of Folium Artemisiae Argyi. MethodsBy using pharmacopeial determination of volatile oil method, UV and the classic acute toxicity experiment method, to determine the content of volatile oil and total flavonoids, as well as compare the acute toxicity of different extracts. ResultsThe content of volatile oil is 0.76%, while the total flavonoids content of different extracts from the biggest to the smallest is alcohol extraction components, water extraction components and all components. The acute toxicity of different extracts from the biggest to the smallest is volatile oil, water extraction components, alcohol extraction components and all components. The LD₅₀ of volatile oil and water extraction components in Folium Artemisiae Argyi are 1.673 mL·kg^-1 and 80.228 g·kg^-1 while the 95% confidence limit are 1.5538 ~1.7954mL·

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The Effeet of Extracting Methods on "Quality Toxicity" Comprehensive Evaluation Model of Rhizome et Rhizome Sophorae Tonkinensis

ZHENG Li-na, SUN Rong

2012, 9(5): 275-278.

Abstract ( 198 )

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Objective Explore the effeet of extracting methods on "quality-toxicity" comprehensive evaluation model by comparing the content of alkaloid and acute toxicity from Radix et Rhizome Sophorae Tonkinensis extracted by different methods. the quality control methodology of alkaloid substance from Radix et Rhizome Sophorae Tonkinensis was studied. MethodsHPLC was used to determine the content of matrine and oxymatrine in water extract and alcohol extract of Radix et Rhizome Sophorae Tonkinensis. ResultsIn the determination of matrine and oxymatrine in different components of Radix et Rhizome Sophorae Tonkinensis, it was found that the size order of the content of matrine is water extract>alcohol extract, and the content of oxymatrine is alcohol extract>water extract. ConclusionThere is a certain relationship between the content of matrine and oxymatrine and acute toxicity in different components of Radix et Rhizome Sophorae Tonkinensis, but not completely consistent. There was certain effeet of extracting methods on "quality toxicity" comprehensive evaluation model. It was more comprehensive, Objective and reasonable to determine extraction methods of toxic Chinese medicine through the comprehensive evaluation model.

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The Effect of Extracting Methods on "Quality-Toxicity" Comprehensive Evaluation Model of Evodia Rutaecarpa(Juss.) Benth

WANG Hui, ZHU Lan-lan, HUANG Wei, SUN Rong

2012, 9(5): 279-281.

Abstract ( 210 )

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Objective Explore the effect of extracting methods on "quality-toxicity" comprehensive evaluation model by comparing the content of alkaloid and acute toxicity from Evodia Rutaecarpa(Juss.) Benth extracted by different methods. MethodsHPLC was used to determine the content of Evodiamine and Rutaecarpine in water extract and alcohol extract of Evodia Rutaecarpa(Juss.) Benth; the classical method of acute toxicity was used to determine the acute toxicity of Evodia rutaecarpa(Juss.) Benth. at different extraction, and compare the acute toxicity. ResultsThe content of Evodiamine and Rutaecarpine which included water extract and ethanol extract was separately 0.028% and 0.027%,0.046% and 0.075%. The two groups are unable to make LD₅₀, MTD results calculated in accordance with crude drug content were respectively 80.0 g·kg-1·d^-1 and 70.6g·kg^-1·d^-1. ConclusionThe content of Evodiamine and Rutaecarpine and acute toxicity of the Fructus Evodiae Rutaecarpae by different extracting methods were different, and death occurred in each sample, the MLD showed that the different extracts which extracted from the Fructus Evodiae Rutaecarpae at different solvents extraction had certainly toxicity in mice. The acute toxicity of different extracts on mice is: alcohol extraction group>water extraction group, the content of Evodiamine and Rutaecarpine in different extracts is: alcohol extraction group>water extraction group. Suggesting that it was certain effect of extracting methods on "quality toxicity" comprehensive evaluation model. It was more comprehensive, Objective and reasonable to determine extraction methods of toxic Chinese medicine through the comprehensive evaluation model.

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Yunnan Production Enterprise Drug Safety Monitoring Awareness Survey and Analysis

LI Yu, FU Wen, DU Juan, HAN Hong-sheng, YIN Yuan-yuan

2012, 9(5): 282-285.

Abstract ( 236 )

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Objective With the purpose to provide evidences and references for the ADR monitoring enhancement of the pharmaceutical production enterprises, this thesis analyses the current problems of ADR monitoring in such enterprises of Yunnan province through a survey on drug safety monitoring cognition of the related principals and ADR monitoring staff. MethodsThe research method of this thesis is statistical analysis according to the results of the questionaires distributed to the related principals and ADR monitoring staff of the pharmaceutical production enterprises. Resultsand ConclusionNot all the enterprises have attached great importance to ADR monitoring; big differences exist among the ADR monitoring staff; the related staff of some enterprises are lacking in social consciousness and a sense of responsibility. Active propagations of ADR monitoring should be carried on; great importance should be attached in the ADR training for the related staff; drug supervision should be strengthened and in order to ensure the actual effect of ADR monitoring, the monitoring responsibility and a reward and punishment system should be made clear based on the monitoring report system.

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Brief Analysis of Foreign Quantitative Risk-Benefit Assessing Method of Medicines

LI Shan, XU Yan, YANG Yue

2012, 9(5): 286-289.

Abstract ( 209 )

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Objective To analyze and compare the existed medicine risk-benefit assessment methods and provide suggestions to our medicine risk-benefit assessment. MethodsLiterature study and comparative study were used to analyze and compare the foreign materials. ResultsFDA and EMEA has already attached much importance to medicine risk-benefit assessment, and now each of the existed risk-benefit assessment methods has its own strengthness and weakness. ConclusionRegulatory agencies should try to study and explore a standard method that can apply to the whole life period of medicines.

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The Thinking Originating from Medication Errors of One Case Suffering from Community-acquired Pneumonia

GUO Yin-yin, ZHAO Hui

2012, 9(5): 290-291.

Abstract ( 260 )

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Objective To investigate the therapeutic methods and pharmaceutical care of community-acquired pneumonia. Methods Through analyzing medication errors, the primary therapeutic experiences of community-acquired pneumonia were summarized. Results The patient didn't immediately take the mycoplasma body test after hospitalization. At the beginning of treatment, the doctor selected Ceftazidime and Ribavirin. At the last stage of treatment, the drugs were changed to Azithromycin, Ceftriaxone and Potassium Sodium Dehydroandroan drographolide Succinate for Injection. During the period of hospitalization, the patient appeared anaphylaxis. Conclusion We should empirically cover untypical pathogen in treating CAP. The clinical pharmacists should timely do pharmaceutical care in order to avoid the adverse drug reaction.

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Comparative Study of Natural Rubber Latex Condom Labeling Regulation in USA and China

YANG Xiao-dong

2012, 9(5): 292-296.

Abstract ( 212 )

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Objective Provide references for the standardized management of labeling for natural rubber latex condom in China. MethodsBy content analysis, compare U.S. FDA regulations on labeling for natural rubber latex condom with China SFDA's. ResultsU.S. FDA regulatory system for natural rubber latex condom labeling is complete, which can effectively control the risk of natural rubber latex condom, being operational, it is worth for the relevant regulatory authorities in China to learn from. ConclusionChina can improve the natural rubber latex condom labeling regulations construction and management from the following areas: to amend the medical equipment manuals, labels and packaging and labeling regulations, as soon as possible, it is necessary to formulate the terms of natural rubber latex condoms; to establish guidance document of labeling for natural rubber latex condom; to create the database platform of labeling for natural rubber latex condom to query.

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Safty and Risk Analysis of Xiaozhiling Injection

YANG Le

2012, 9(5): 297-298.

Abstract ( 252 )

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By reviewing the relevant references and reports of the adverse drug reaction cases of Xiaozhiling in China, and analyzing the post marketing safety studies, the safety and risks in post-marketing period of Xiaozhiling is reevaluated in this article. The author puts forward risk management measures according to the characteristics of medicine. Suggestions are proposed for a safe and rational use of this medicine.

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Summary of the Progress and Specifications for Safety and Effectiveness Regarding Dressing

ZHANG Shi-qing, LU Jing-yan, ZHANG Jin-gang

2012, 9(5): 299-302.

Abstract ( 221 )

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Dressing is very important to the public health, and it developed quickly in recent years. But the progress of dressing is limited by the absence of related evaluation guidance. To help solving these problems, the progress and specifications for safety and effectiveness of dressing were discussed in this article.

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Adverse Drug Reactions Induced by Parabens Used as Preservatives

LI Zhong-dong, ZHANG Yun-xuan, GUO Yan-ping, SHI Xiao-jin, ZHONG Ming-kang

2012, 9(5): 303-305.

Abstract ( 271 )

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Objective To review the adverse drug reactions induced by parabens when used as preservatives. MethodsA simple conclusion on adverse drug reactions induced by parabens was carried out by reviewing the related references. ResultsParabens are the most commonly used preservatives. Parabens are likely to cause adverse reactions as allergic reactions, cross reactions and estrogenic activity, paraben paradox can also be observed. ConclusionProfessional clinicians must pay high attention to the adverse reactions of parabens contained in the pharmaceutical products and use them rationally as possible as they can.

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Literature Analysis of 15 Cases of Serious Adverse Drug Reaction by Ginkgo Leaf Extract and Dipyridamole Injection

JIN Feng, WANG Ya-li, LAN Shan, Yang Le

2012, 9(5): 306-308.

Abstract ( 196 )

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Objective Through analysing 15 Serious ADR cases of the Ginkgo Leaf Extract and Dipyridamole Injection to explore the rules and causes of adverse reactions, provide a reference for clinical rational use of drugs. MethodsBy searching literature from 1995~2012 Chinese journal full-text database, 14 Serious ADR literatures of Ginkgo Leaf Extract and Dipyridamole Injection involving 15 cases, were Statistically analyzed. Resultsand ConclusionGinkgo leaf extract and dipyridamole injection induced serious ADR associated with dose. Ginkgo Leaf Extract and Dipyridamole Injection-related adverse reaction, anaphylactic shock, a higher proportion of patients occurred a short time, serious high degree of clinical care should be strengthened and close to prevent the occurrence of adverse reactions.

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Compare Nedaplatin with Other Platinum Agents in Clinical Studies of Adverse Drug Reaction

FANG Shu-hua, QIAN Yuan-xia

2012, 9(5): 309-312.

Abstract ( 261 )

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Objective Compared adverse drug reaction of nedaplatin with other platinum agents to provide the references information in clinical application. Methods224 cases of platinum agents collected from January 2009 to December 2010 were analyzed using retrospective study method. Among them,112 used nedaplatin, 112 used other platinum agents(Cisplatin: Carboplatin :Oxaliplatin=4：2：4). ResultsThe adverse drug reaction rates of Nedaplatin and other platinum agents ware 62.5%, 66.07%,which showed no significant difference. The incidence of bone marrow restrain was higher than other platinum agents(P <0.05). Liver and kidney dysfunction was significantly lower than other platinum agents(P <0.05). There were about 95% patients could be cured and 65% ADR cases reported were severe, ADR proportions of men and women were 61.81%, 38.19%, It shows significant difference(P <0.05). The majority of reported ADR were 58~72years old. ConclusionNedaplatin is higher than the other platinum agents on bone marrow suppression, lower than the other platinum agents on liver and kidney dysfunction.

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