Chinese Journal of Pharmacovigilance

Study on Acute Toxicity of Total Alkaloids Extracts from Herba Leonuri in Rats and Mice

SUN Xiao-qian, ZHAO Hong, LI Xiao-yu, SUN Rong

2017, 14(1): 1-3.

Abstract ( 414 )

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ObjectiveTo observe the acute toxicity of total alkaloids extracts from Herba leonuri in mice and rats separately. MethodsThe classical method of acute toxicity was used to research the acute toxicity in mice and rats. ResultsCalculated by total alkaloids of Herba leonuri, the LD₅₀ of the extracts in mice and rats were respectively 5.707 2 and 4.510 2 g·kg^-1·d^-1;95% confidence limits were respectively 5.548 3~5.871 1 and 4.159 5~5.010 2 g·kg^-1·d^-1. The toxic symptoms of the mice and rats after given extracts by ig were abdominal lying sleeping, hypokinesia, shortness of breath, convulsions in the experiment. ConclusionIg the total alkaloids extracts from Herba leonuri to mice and rats can cause toxical injury to them, and its toxical location and mechanism remain to be further studied.

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Assessment of Immunosensitizing Potential of Shuanghuanglian for Injection Using Reporter Antigen Popliteal Lymph Node Assay

LIU Zhao-hua, YAO Jing-chun, SUN Rong, GUO Yan-ru, ZENG Fan-guang

2017, 14(1): 4-6.

Abstract ( 202 )

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ObjectiveTo explore mechanism of adverse drug reactions induced by Shuanghuanglian for injection (SHLI) and further evaluate the immunosensitizing potential of SHLI using reporter antigen popliteal lymph node assay (RA-PLNA) in BALB/c mice. MethodsSPF female BALB/c mice (7~8 weeks old at the onset of the experiment), were randomly assigned into control (Veh), 1 mg D-Penicillamine hydrochloride (D-pen), 1 mg (L) and 5 mg (H) SHLI group. There are 4 groups and each group has 6 animals. Articles, respectively mixed with 10 μg Trinitropheny-Ovabumin (TNP-OVA), were injected subcutaneously into right hind foot pad of mice in 50 μL volume. On day 7 after injection, animals were sacrificed, the untreated and treated lateral popliteal lymph node (PLN) were isolated, weighed and prepared into single-cell suspensions respectively, and then PLN weight index (WI) and cells index (CI) were calculated. RA-PLNA responses were observed. Trinitrophenyl-specific antibody forming cell (AFC) and the number of lymphocyte and macrophages in PLN were determined by Enzyme-linked immunospot assay (Elispot) and flow cytometry, respectively. When SHLI mixed with TNP-Ficoll using some another mice, the method is the same as TNP-OVA. Results5 mg SHLI mixed with TNP-OVA or TNP-Ficoll induced positive reaction in RA-PLNA. However, only when 5 mg SHLI co-injected with TNP-OVA, TNP-specific AFC were observed in Elispot assay. Simultaneously, the number of macrophages in PLN increased in flow cytometry. Moreover, whether 5 mg SHLI with TNP-Ficoll or 1 mg SHLI mixed with TNP-OVA or TNP-Ficoll failed to induce TNP-specific reaction. ConclusionSHLI lacked the intrinsic capacity to sensitize or stimulate immune responses in BALB/c mice. This may imply that ADR induced by SHLI in clinic was mainly a non-IgE-mediated anaphylactoid reaction rather than IgE-mediated hypersensitivity reactions.

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Effect of Jiangzhiligan Granules on CYP2E1 Gene and Protein Expression of Rat Model with Non-alcoholic Fatty Liver Disease

BIAN Xiao-lan, ZHAI Qing, YU Bo

2017, 14(1): 10-13.

Abstract ( 245 )

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ObjectiveTo evaluate the effect of Jiangzhiligan granules on cytochrome P450 2E1 (CYP2E1) gene and protein expression of rat model with non-alcoholic fatty liver disease (NAFLD), and investigate the mechanism of the drug. MethodsSDF levels of 20 healthy Wistar rats were selected and established the NAFLD model. All of the rats were divided into the prevention group and model group by random number table method, with 10 in each group. Since the second week of model establishment; the rats in the prevention group were given Jiangzhiligan granules by gavage, 1 time daily, 6 g per kg body weight; while the model group was given equal amounts of normal saline by gavage; for 6 weeks in both of the two groups. The liver histopathology, liver function, serum lipid, oxidation indexes, levels of CYP2E1 mRNA and protein expression were compared between the two groups, and the effect of Jiangzhiligan granules on CYP2E1 gene and protein expression of rat model with NAFLD was summarized. ResultsThe liver wet weight and liver indexes of the prevention group were lower than those in model group, the difference was statistically significant (P < 0.05). There was no significant difference of body mass index between the two groups (P > 0.05). Partial steatosis of hepatocytes in the prevention group was found, and its steatotic degree was lower than that of the model group, the difference was statistically significant (P < 0.05). Compared with 2 weeks after model establishment, the AST, ALT, TC, TG, HDL-C, LDL-C, MDA in the prevention group decreased significantly, and the SOD, GSH-PX, GSH increased significantly than those before the end of the experiment, the difference was statistically significant (P < 0.05). Before the end of the experiment, the levels of CYP2E1 mRNA and protein expression of liver tissue in the prevention group were lower than those in the model group, the difference was statistically significant (P < 0.05).ConclusionJiangzhiligan granules could downgrade the CYP2E1 mRNA and protein in liver tissue of the rat model with NAFLD, and could improve the Liver function, blood lipid and oxidation index.

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Study on the Correlation between G211T Mutation and the Efficacy and Safety of Morphine Treatment on Cancer Pain

WU Nan, ZHANG Dong-lei, WANG Lei, DING Nian-yang, LI Jie YANG, Yang YAN, Dan TONG, Ben-ding, WEI Qing

2017, 14(1): 14-18.

Abstract ( 203 )

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Objective To study the distribution frequency of UGT2B7 gene polymorphism in patients with cancer pain, and evaluate the effect of UGT2B7 * 1 G211T polymorphisms on the effect and safety of morphine. Methods Patients with moderate-severe cancer pain were treated with morphine,the numerical rating scale（NRS）was used for pain evaluation. Treatment data and adverse effects were recorded and UGT2B7 gene polymorphism was detected. According to the genotype and morphine dose, the impact of UGT2B7*1 G211T mutation on morphine analgesia efficacy and safety were evaluated. Results There were 68.60% patients with wild-type UGT2B7*1 G211G, 24.42% patients with heterozygous mutation UGT2B7*1 G211T and 6.98% patients with homozygous mutant UGT2B7*1 T211T in Chinese patients with cancer pain. UGT2B7*1 G211T mutation group (ie group GT+ group TT) needed higher doses of morphine than GG group（P <0.05）. Dizziness and grade 2~3 constipation happened more frequently in the UGT2B7*1 G211T mutation group (ie group GT+ group TT) than the wild-type group (group GG) ( P <0.05). Conclusion UGT2B7*1 G211T polymorphisms have impact on analgesic effect and safety of morphine.

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Efficacy of Rabeprazole Combined with Compound Glutamine in Treatment of Helicobacter Pylori Negative Gastric Ulcer

ZHANG Qiang

2017, 14(1): 19-21.

Abstract ( 365 )

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ObjectiveTo investigate the effect of rabeprazole combined with compound glutamine in treatment of Helicobacter pylori negative gastric ulcer and its effect on the level of serum gastrin. Methods90 patients with Helicobacter pylori negative gastric ulcer in our hospital were involved in the study and randomly divided into two groups, 45 cases in each group. Control group were given rabeprazole sodium enteric-coated tablets, 10 mg, qd; treatment group were given compound glutamine entersoluble capsules on the basis of the control group, 0.67 g each time, tid; two groups adhere to medication for 4 weeks. The clinical curative effect, adverse reaction, the number of recurrent cases, the thickness of gastric mucosa, the degree of infiltration of inflammatory cells and the gland density of the two groups were compared, and the gastrin levels in the two groups were detected. ResultsThe total efficiency of treatment group was 95.56%, which was significantly higher than that in the control group of 75.56% ( χ²=5.754, P < 0.05). The total incidence rate of adverse reactions such as headache in the treatment group was 4.44%, which was significantly lower than that in the control group of 22.22% ( P < 0.05). The result of 1 year of follow-up showed that the recurrence rate in the treatment group was 6.67%, which was significantly lower than that in the control group of 24.44% ( P < 0.05). The mucosal thickness, inflammatory cell infiltration and the gland score after treatment in the treatment group were significantly lower than those in the control group ( P < 0.05). The gastrin levels of 2 weeks and 4 weeks after treatment in the treatment groups were lower than those in the control group respectively ( P < 0.05). ConclusionThe curative effect of rabeprazole combined with compound glutamine in the treatment of Helicobacter pylori negative gastric ulcer is obvious, it can inhibit the secretion of gastrin.

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Preparation and in Vitro Release and in Vivo Pharmacokinetics Evaluation of Ambroxol Hydrochloride-resin Complex Sustained Release Suspension

ZHANG Yong-e, ZHANG Xue-nong

2017, 14(1): 22-26.

Abstract ( 349 )

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ObjectiveTo prepare the ambroxol hydrochloride-resin complex sustained release suspension and evaluate its in vitro release and in vivo pharmacokinetics. MethodsThe sustained release suspension was prepared by resin optimization, saturation, file coating and dispersion of the complex. Evaluation of the in vitro and in vivo performance of the suspension was carried out. ResultsThe ambroxol hydrochloride-resin complex suspension had similar release behavior and pharmacokinetic parameters with the sustained release capsule product. ConclusionThe resin complex suspension would be another sustained release drug delivery system for ambroxol hydrochloride.

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Comparison of Dissolubility in Vitro of Generic Metronidazole Tablets in Different Mediums

SONG Jin-chun, HOU Ya-ting

2017, 14(1): 27-31.

Abstract ( 304 )

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Objective To establish a method for determining the dissolubility of metronidazole tablets in vitro, compare the dissolution curves between domestic and foreign generics to evaluate the quality consistency, investigate the quality of domestic drugs and make reference for clinical use. Methods The content of solution was determined by HPLC, and the dissolution curves were drawn. The column was Agilent TC-C18, mobile phase was methanol-water (20:80, V/V) with a flow rate of 1 mL·min^-1, detection wavelength was 320 nm, column temperature was 30°C, injection volume was 20 μL. The stirring paddle method was adopted, the dissolution mediums were water, pH=1.2 hydrochloric acid solution, pH=4.0 acetic acid-sodium acetate buffer solution, pH=6.8 phosphate buffer solution, the volume of which was 900 mL, the rotation speed was 50 rpm. The similarity of dissolution curve was evaluated by similar factor (f₂). Results The dissolution of metronidazole tablets made by all manufacturers were conformed to the requirements of the Chinese Pharmacopoeia, but the dissolution curves of generic drugs from domestic manufacturers were not similar with foreign countries’. Conclusion The quality of some domestic generics needs to be further improved. It is necessary to strengthen the supervision of generics in order to enhance the quality.

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Medical Product Active Surveillance System in America and Its Revelation

HOU Yong-fang, SHEN Lu, LIU Wei, SONG Hai-bo, LIU Cui-li, WANG Dan, LI Xin-ling

2017, 14(1): 32-35.

Abstract ( 320 )

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ObjectiveTo provide reference for establishing active surveillance system of drug safety in China. MethodsThe active surveillance system of medical product safety in United States was studied by analyzing the key technologies and implementation methods, and the recommendations for establishing similar system in China were provided. Results& ConclusionThe medical product safety active surveillance system in United States uses common data model (CDM), distributed database and other technologies to build virtual database consist of health insurance data, hospital health data, population registration data. The system can analyze and utilize the virtual database through specific methods, get evidence about medical product safety issues from the real world efficiently and economically. We can combine with China’s national conditions to establish active surveillance system for drug safety.

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Prevention and Treatment Progress of Levodopa-induced Motor Fluctuations

LIU Xiao, DENG Yi

2017, 14(1): 36-39.

Abstract ( 275 )

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ObjectiveTo summarize researches of levodopa-induced motor fluctuations that were published at home and abroad in recent years, so as to explore the characteristics and management of levodopa-induced motor fluctuations. MethodsStudies about levodopa-induced motor fluctuations were collected, analyzed and summarized. ResultsIt was estimated that motor complications occur in at least 50 percent of patients after 5 to 10 years of levodopa treatment. The main medical strategies were adjusting the levodopa doses and dosing schedule; adding an additional antiparkinson medication; and manipulating dietary protein intake if needed.ConclusionThe debate over the potential neuroprotection versus neurotoxic effects of levodopa remained unresolved, but the weight of the evidence accumulated to date showed that long term use of levodopa was beneficial.

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Analysis of 281 Medication Errors of Antineoplastic Drugs

ZHU Chen, CUI Can, LI Xiao-ling, YAN Su-ying, WANG Yu-qin

2017, 14(1): 40-44.

Abstract ( 329 )

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ObjectiveTo understand the current status of medication error (ME) report of antineoplastic drug in China and improve the safety awareness of drug use. MethodsME cases reported from Sep. 22 nd, 2012 to Dec. 31st, 2015 were collected and analyzed in terms of category, classification, antineoplastic category and cause of ME. We also divided them by amount and proportion of persons who triggered or detected ME. ResultsFrom 2012 to 2015, 281 antineoplastic drug ME cases were reported. ME proportion of category A, B, C, D, E, F and I was 13.17% (37 cases), 72.24% (203 cases), 11.03% ( 31 cases), 1.42% ( 4 cases), 1.42%( 4 cases), 0.36% (1 case), and 0.36% (1 case), respectively. MEs of category G and H have not been reported. The most commonly involved antineoplastic drug was etoposide, followed by gemcitabine, carboplatin, epirubicin, paclitaxel, and cyclophosphamide. Doctors’ error was the highest proportion that reached 69.4% (332 errors), then pharmacists (74 cases), accounting for 26.33%, and finally the nurses (12 cases), 4.27%. The common error types were wrong solution, including types (18.86%) and volume (16.37%), and wrong dose (14.23%), which all occurred when doctors were prescribing. Most of MEs that occurred during prescription by doctors and preparation by pharmacists were detected before delivered to patients, only 10.26%(20 errors) and 21.62%(16 errors) reached. If the ME started at the nurses, it was more difficult to detect (33.33%). In terms of the persons who detected ME, the most were pharmacists (82.56%), and then nurses (11.39%). ConclusionFrom prescription to administration, antineoplastic drugs undergo multiple steps. It is very important to review and intercept before every step starts. Therefore, medical institutes should pay more attention to ME prevention of antineoplastic drugs, optimize the information system, formulate strict review system and enhance recognization of ME, in order to reduce ME incidence and ensure drug safety.

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Daily Prescription Analysis of Psychotropic Drugs of 204 Inpatients

LIU Yun, CHEN Jin-lan

2017, 14(1): 45-48.

Abstract ( 317 )

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ObjectiveTo investigate the use of psychotropic drugs of detention inpatients in our hospital. MethodsOne-day prescriptions of psychotropic drugs for detention inpatients in our hospital were analyzed. ResultsSecond-generation antipsychotics were predominant psychotropic drugs, and the most widely used agent is risperidone. Benzodiazepines were regularly used as anxiolytics-hypnotics. The usage rate of valproic acid was relatively high and associate adverse reactions should be alerted. Dosages of psychotropic drugs were on the recommended therapeutic ranges generally. The percentage of prescriptions consisting of two drugs (42.65%) was higher than prescriptions of monotherapy (29.41%), and regimens were reasonable for most cases. ConclusionCurrently, the use of psychotropic drugs for detention inpatients in our hospital is generally reasonable.

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Research on Risk Assessment Methods of Drug Accessories Based on the Network Topology

SUN Yi-yuan, WEI Fen-fang, YANG Yue

2017, 14(1): 49-53.

Abstract ( 239 )

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Objective To establish a network topology model for rapid screening of high-risk pharmaceutical excipients, in order to provide data to support regulatory monitoring and routine inspection. Methods Established network model of the Chinese medicine injection-Accessories topology by Cytoscape software, and detected it by using ADR reporting data related TCM injections from January 1, 2004 to June 30, 2015. Results The traditional Chinese medicine injection-Accessories Network topology results showed, polylobate 80, glycerin, vitamin C, sodium hydrogen sulfite materials had a high potential allergenicity, wherein polylobate 80, glycerin, vitamin C had been confirmed experimentally for high risk. Conclusion The use of the network topology model for materials risk assessment is feasible, which can reduce the relevant departments to check research investment and increase the efficiency of screening for high risk substance.

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Analysis of Psychiatric Medication Error Reports of 69 Cases

ZHUANG, Hong-yan, HAO Hong-bing, LIU Shan-shan, GUO Wei, MA Xin, LI Hua-wei, CHI Wei, ZHANG Hong-yu

2017, 14(1): 54-58.

Abstract ( 347 )

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ObjectiveTo discuss the current situation and characteristics of the common medication errors of our hospital and provide reference for clinical safe drug use. Methods69 cases of medication errors reported in the five years of 2011~2015 in our hospital were analyzed. EXCEL table was used to summarize the data, according to the main aspects of the patients' general conditions, error category classifications, the factors that cause error, the content of the error and the position of the person who caused errors.We also summarized and analyzed the error category classifications, error factors, the content of the error and the position of the person who cause errors. Category A is potential error. Category B, C, and D are mild ME which didn’t do harm to patients. Category E, F, G, H and I are severe ME which cause harm to patients even to death. ResultsThere were 29 male and 40 female patients with medication errors in the 69 cases. The youngest patient was at the age of 15, the oldest 82 years old. The mean age of the patients was 41.61. 50.72% of the error drugs had dispensed to the patients. 21.74% of the patients had used the wrong drug. There were more grade B and C errors in the error category classification. In the extent of damage to patients, 97.11% was of no obvious injury, the prescription error was of the most in the factors that cause errors, accounting for 65.22%.In the specific content of the error. The rate of drug dosage error was the highest, accounting for 28.99%. In the aspect of the positions of who had caused errors, the number of nurses was 0, the vast majority were physicians and pharmacists. ConclusionThe vast majority medication errors of our hospital didn’t bring harm to patients, but many potential risk factors brought hidden trouble to patients on medication safety. We should strengthen the management of medication errors, encouraging the doctors, nurses, pharmacists and information personnel monitoring the medication errors to minimize the occurrence of medication errors.

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