Journal of Chinese Pharmaceutical Sciences

Rapid characterization of 96 chemical constituents in Citri Reticulatae Folium (leaves of ‘Fuju’) using HPLC-DAD-ESI-MSn

Guihua Cao, Qingrong Fu, Cangman Zhang, Hong Wang, Shizhong Chen

2016, 25(2): 91-110. DOI: 10.5246/jcps.2016.02.010

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In order to systematically investigate the chemical constituents of Citri Reticulatae Folium (leaves of ‘Fuju’), an analytical method that included high-performance liquid chromatography, diode array detection, electrospray ionization, and ion-trap time-of-flight mass spectrometry (HPLC-DAD-ESI-MSⁿ) was used to separate and identify the individual chemical components of Citri Reticulatae Folium. As a result, 96 compounds were tentatively identified in this study: including 31 phenolic acids, 4 flavonoid aglycones, 6 flavonoid mono-O-glycosides, 10 flavonoid-O-diglycosides, 5 flavonoid mono-C-glycosides, 5 flavonoid di-C-glycosides, 6 flavonoid O,C-glycosides, 5 (3-hydroxy-3-methylglutaryl) glycosyl flavonoids, 1 flavan-3-ol,and 2 alkaloids. In addition, 21 polymethoxy flavonoids (PMFs) were identified in this paper. Among these compounds, 52 compounds, which were previouslyfound in other Citrus plants, have been identified for the first time in Citri Reticulatae Folium. 15 compounds have not been previously found in theCitrusgenus were identified. Moreover, 9 potentially new compounds have also been detected in this paper. This is the first report of the full characterization of chemical components of Citri Reticulatae Folium (leaves of ‘Fuju’) by HPLC-DAD-ESI-MSⁿ.

Chemical constituents from Paliurus ramosissimus

Chen Chen, Guandi Luo, Rong Hu, Hongzheng Fu

2016, 25(2): 111-115. DOI: 10.5246/jcps.2016.02.011

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In the present research, in order to study the chemical constituents of Paliurus ramosissimus (Lour.) Poir., the isolation of its ingredients was performed by repeated chromatography on silica gel, Sephadex LH-20, ODS and preparative HPLC. Their structures were elucidated on the basis of combination of mass spectrometry and 1D, 2D NMR spectroscopy. A total of 8 compounds were obtained, and their structures were identified as 3β-hydroxy-27-(3,4-dihydroxybenzoyl)oxylup-20(29)-en-28-oic acid(1),betulinic acid (2), lupeol(3), 27-O-trans-caffeoylcylicodiscic acid (4), ceanothic acid (5), 24-hydroxyceanothic acid (6), dihydrokaempferol (7), eriodictyol (8). Among them, compound 1 was a new compound. Compounds 3–4, 7–8 were isolated from Paliurus ramosissimus (Lour.) Poir. for the first time.

An UPLC-MS/MS application to investigate chemical compositions in the ethanol extract with hypoglycemic activity from Zingiber striolatum Diels

Tianhong Chen, Jinyan Cai, Jun Ni, Fan Yang

2016, 25(2): 116-121. DOI: 10.5246/jcps.2016.02.012

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Zingiber striolatum Diels (Zingiberaceae) is an edible plant resource in the Chinese folk with special efficacy in relieving diabetes and constipation, whichhas been documented in the Compendium of Materia Medica. However, its hypoglycemic activity and constituents have not been reported yet. In the present study, we evaluated the hypoglycemic activity of Z. striolatum in insulin-resistant HepG2 cells, and we developed ultra performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) based chemical profiling method for rapid analysis of Z. striolatum. As a result, the ethanol extract from Z. striolatum showed significant hypoglycemic activity in HepG2 cells, and 22 flavonoids compounds were tentatively characterizedby comparing the retention time and mass spectrometry data. In conclusion, the method of hypoglycemic screening in insulin-resistantHepG2 cells coupled with UPLC-MS/MS is a feasible and credible technique to separate and identify the active constituents in complex matrices of traditional Chinese medicine.

Effect of CYP3A4*18 genotype on the pharmacokinetics of zolpidem in healthy Chinese Hui subjects

Xiujun Wu, Tao Guo, Fengqin Zhang, Ran Ma, Jinliang Zuo

2016, 25(2): 122-127. DOI: 10.5246/jcps.2016.02.013

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In the present study, we aimed to investigate the effect of CYP3A4*18 genotype on the pharmacokinetics of zolpidem in healthy Chinese Hui volunteers.Blood samples were collected from volunteers for CYP3A4 genotyping using a polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) assay. A pharmacokinetic study was then carried out in three groups with CYP3A4*1/*1 (n = 6), CYP3A4*1/*18 (n = 6) and CYP3A4*18/*18 (n = 6) genotypes. Plasma levels of zolpidem were determined by HPLC-FLD method before and after a single oral dose of 10 mg zolpidem tartrate tablet. Significant differences were observed in the pharmacokinetic parameters of zolpidem among the three genotype groups (P<0.05). Compared with the CYP3A4*1/*1 group, the C_max of zolpidem in *1/*18 and *18/*18 groups (mean, 95% CI) was 0.89 (0.65–1.12) and 0.57 (0.47–0.66), respectively, and the AUC₀_–_t in the *1/*18 and *18/*18 groups (mean, 95% CI) was 0.74 (0.22–1.26) and 0.61 (0.24–0.98), respectively. There was a significant trend towards lower C_maxand AUC₀_–_t values of zolpidem in individuals with more CYP3A*18 alleles, suggesting a gene-dosage effect.The study demonstrated that the CYP3A4*18 allele played an important role in the pharmacokinetics of the zolpidem after oral administration.

Efficacy and safety of saxagliptin in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials

Li Yao, Fangfang Fan, Lan Hu, Shengjun Zhao, Lili Zheng

2016, 25(2): 128-139. DOI: 10.5246/jcps.2016.02.014

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As a new oral hypoglycemic agent, saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. However, it remains inconclusive whether saxagliptin is associated with increased risk of adverse events (AE) and efficacy as add-on treatment. Therefore, we performed an up-to-date meta-analysis to compare the efficacy and safety of saxagliptin with placebo and other oral hypoglycemic agents in adult patients with type 2 diabetes mellitus (T₂DM). Randomized clinical trials (RCTs) comparing saxagliptin with comparators were retrieved by selecting articles from Pubmed, Embase, Cochrane Library and Clinical Trials Registry Platform up to Oct. 2013. Weighted mean difference (WMD) was used to analyze the effect of hypoglycemic agents on HbA1c, weight and fasting plasma glucose (FPG). While the patients who achieved HbA1c<7.0% and had AE were analyzed as relative risks (RR).A total of 18 articles from 16 RCTs and one clinic trial from the WHO International Clinical Trials Registry Platform met the included criterion. Clinically significant decrease from baseline HbA1c compared with placebo was certified for 2.5 mg/day saxagliptin (WMD = –0.45%, 95%CI, –0.48% to –0.42%) and 5 mg/d saxagliptin (WMD = –0.52%, 95%CI, –0.60% to –0.44%). Saxagliptin as add-on therapy was superior to thiazolidinediones, up-titrated glyburide, up-titrated metformin or metformin monotherapy in achieving HbA1c<7.0%. Treatment with saxagliptin had negligible effect on weight, and it was considered weight neutral. Saxagliptin treatment did not increase the risk of hypoglycemia (RR = 1.28, 95% CI 0.72 to 2.27, P = 0.40) and serious adverse experiences (RR = 1.25, 95% CI 0.94 to 1.66, P = 0.13). No statistically significant differences were observed between saxagliptin and comparators in terms of the risk of infections.The present study showed that saxagliptinwas effective in improving glycaemic control in T₂DM with a low risk of hypoglycaemia and incidence of infections in either monotherapy or add-on treatment. This founding should be further certified by large-sample size and good-designed RCT.

Outcome analysis on the rotation practice course for the professional degree graduates of clinical pharmacy at Peking University

Huifeng Shi, Hong Shao, Mingyang Sun, Xin Zhou, Rong Chen, Xiaohan Xu

2016, 25(2): 140-144. DOI: 10.5246/jcps.2016.02.015

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It’s the main trend of the development of international pharmaceutical education to cultivate professionals with the capability of pharmaceutical service by professional degree education. Clinical pharmacy rotation practice, named officially as “Advanced clinical pharmacy practice” at our school, is specific to our master of pharmacy (M. Pharm) graduate students for clinical pharmacy practice training in multiple clinical departments in hospitals. It is meaningful for the education reform of clinical pharmacy to evaluate the outcome of clinical pharmacy rotation practice. Questionnaire was developed based on the Teaching Guide To Advanced ClinicalPharmacy Practice and its related record forms. The practice outcomes of clinical rotation practice in the first two years for M. Pharm graduate students were assessed using the fuzzy comprehensive evaluation method. Results showed that the teaching effect of clinical pharmacy practice was at the “excellent” level. The evaluation scores of Grade 2011 and Grade 2012 were 90.60 (excellent) and 91.83 (excellent) respectively, while the overall score was 91.29 (excellent). Students showed excellent skills and have met the requirements of the teaching guide after practice. There are somethings to improve in clinical rotation practice teaching. This study will provide important information for our school and the nation to achieve teaching reform in M. Pharm education of clinical pharmacy.

Evidence-based pharmacoeconomic research of pirarubicin and epirubicin as prophylaxis for recurrence in patients with superficial bladder tumors by bladder instillation after transurethral resection of a bladder tumor

Lili Ma, Qimin Lin, Sheng Han, Fei Yu, Luwen Shi

2016, 25(2): 145-149. DOI: 10.5246/jcps.2016.02.016

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In the present study, we aimed to evaluate the efficiency and cost of pirarubicin (THP) and epirubicin (EPI) as prophylaxis for recurrence in patients with superficial bladder tumors by bladder instillation after transurethral resection of a bladder tumor (TUR-BT). Standardized evaluation was performed by analyzing research papers. Moreover, expert opinions, studies and cost data were combined to evaluate cost of THP and EPI. With systematic review and expert opinions, we confirmed that THP and EPI were not statistically different when they were used as prophylaxis for recurrence in patients with superficial bladder tumors by bladder instillation after TUR-BT. Moreover, the cost evaluation of THP and EPI needs to be separately discussed according to original/generic drug. The original drug THP had more cost advantages than EPI, while generic EPI had more cost advantages than THP.

The changes of polyphenolic contents in two kinds of Terminalia chebula Retz. traditional Tibetian processing methods

Wenbo Fei, Xiaoxia Liang, Min He

2016, 25(2): 150-153. DOI: 10.5246/jcps.2016.02.017

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Taking Terminalia chebula Retz. as the control product, the polyphenolic contents of the processed products in Tibetian,Rubia cordifolia L.processed Terminalia chebula Retz. and Euphorbia fischeriana Steudprocessed Terminalia chebula Retz. were analyzed by HPLC. Polyphenolic contents increased from 4.54% to 5.69% and 7.46%, respectively, which may lead to the change in their pharmacological effects.

Implications of clinical pathway reform on pharmaceutical costs at a hospital in Qingdao city

Min Zhang, Guochun Bao, Kun Zhao, Xue Li

2016, 25(2): 154-158. DOI: 10.5246/jcps.2016.02.018

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To study on the effect of clinical pathway (CP) on controlling pharmaceutical costs, we selected complex, chronic, non-communicable diseases, including cerebral infarction, cerebral hemorrhage, transient ischemic attack, and chronic obstructive pulmonary disease, as diseases to implement clinical pathways at a tertiary hospital in Qingdao. We then conducted intermittent time series analysis on pharmaceutical costs. After the implementation of clinical pathway, overall pharmaceutical costs of patients with transient ischemic attack reduced significantly. The effect was not significant for cerebral hemorrhage patients. The implementation of clinical pathway has a desirable outcome on controlling pharmaceutical costs.

An Information about the 11th Chinese Pharmaceutical Association Scientific and Technical Awards

Journal of Chinese Pharmaceutical Sciences

2016, 25(2): 159-160.

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