Table of Content

28 April 2015, Volume 24 Issue 4

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Review

The application of immunoassay in bioanalysis

Lingli Mu, Sanwang Li, Rui Zhou, Fang Tang, Peng Yu

2015, 24(4):  205-216.  DOI: 10.5246/jcps.2015.04.027

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Immunoassay technology is an analytical method with high sensitivity and specificity; it provides a technique to assay materials which cannot be measured by other methods, or are difficult to detect. It plays a very important role inbiological sample pre-treatment, therapeutic drug monitoring and drug determination, and is one of the important means for in vivo drug analyses.This paper reviews immunoassays commonly used in bioanalysis, including immunoextraction and immunodepletion for pretreatment of biological samples, conventional immunoassay methods and new immunoassay technologies for determination of target drugs.



Original articles

Simultaneous determination of sunitinib and its active metabolites N-desethylsunitinib (SU12662) in nude mice plasma by liquid chromatography tandem mass spectrometry and its application to a pharmacokinetic study

Jingyun Li, Jian Li, Siyuan Wang, Yin Yuan, Qinghong Su, Wei Lu, Tianyan Zhou

2015, 24(4):  217-224.  DOI: 10.5246/jcps.2015.04.028

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A sensitive, rapid, and simple liquid chromatography tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of sunitinib and its active metabolites in plasma of BABL/c nude mice was developed and validated. Plasma sampleswere pre-treated by protein precipitation with pazopanib and used as an internal standard. Separation was performed on a reversedphase C₁₈ column with a mobile phase composing of 10 mM ammonium formate pH 3.25 (adjusted with formic acid) and acetonitrile (65:35, v/v) at a flow rate of 0.5 mL/min. Triple quadrupole tandem mass in multiple reaction monitoring (MRM) mode with electrospray positive ionization was used to monitor all the compounds. The current LC-MS/MS method was highly selective and sensitive with lowest limit of quantitation (LLOQ) of 0.5 ng/mL for both analytes and reliable intra- and inter-day precision and accuracy validated by relative error (RE%) and relative standard deviation (RSD%). Linearity of calibration curve was excellent (r>0.99) within a concentration range of 0.5–1000 ng/mL. This method was successfully applied to a pharmacokinetics study on BABL/c nude mice given with single dose of oral administration of sunitinib at 20 mg/kg.



Effects of co-administraton of neferine and doxorubicin on the pharmacokinetics of doxorubicin

Qingdan Xue, Aixia Ju, Yuhong Kang, Chunyu Zheng, Qiuhong Li

2015, 24(4):  225-230.  DOI: 10.5246/jcps.2015.04.029

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Doxorubicin is one of the anthracycline anti-neoplastic drugs widely used to treat leukemia, liver, breast, and ovarian cancers and other solid tumors. However, its clinical applications have been limited by its serious cardio-cytotoxic effects. The aim of this study was to investigate the effect of neferine, a bisbenzylisoquinoline alkaloid extracted from the green embryo in the mature lotus seed, on the pharmacokinetics of doxorubicin. The levels of doxorubicin in plasma and tissues were measured using the high performance liquid chromatography (HPLC) method. The chromatographic separation was completed on a reversed-phase C₁₈ column using acetonitrile–phosphate buffer (30:70, v/v) as the mobile phase at a flow rate of 1 mL/min and ultraviolet detectionwave length was set at 233 nm. The pharmacokinetic study found that the co-administration of neferine and doxorubicin significantly affected the pharmacokinetics of doxorubicin. There were evident changes in area under the curve (AUC), clearance (CL) and t_1/2β in group of pretreatment neferine as compared with those in group treated with doxorubicin alone. Tissue distribution analysis showed that the concentrations of doxorubicin distributed to heart, liver and kidney were statistically significant higher in group of pretreatment with neferine plus doxorubicin than those in the doxorubicin alone-group at 0.5 h and 2 h after drug administration, respectively.While the doxorubicin concentrations in spleen and lung drug were slightly increased in the group of pretreatment with neferine plus doxorubicin as compared to that of group of doxorubicin alone, the difference between two groups were not statistically significant. Therefore, the dose of doxorubicin needs to be taken into consideration when it is administrated in combination with neferine.



Analysis of the influence of processing of bran stir-baking on the main components of Paeoniae Radix Alba-Atractylodis Macrocephalae Rhizoma herbal pair by high-performance liquid chromatography

Xinhua Fang, Xin Wu, Gang Cao, Hao Cai, Baochang Cai

2015, 24(4):  231-235.  DOI: 10.5246/jcps.2015.04.030

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The crude and processed Paeoniae Radix Alba-Atractylodis Macrocephalae Rhizoma herbal pairs, originated from Bai-zhu-shao-yao-san, are used to treat different diseases clinically. In order to evaluate the crude and processed Paeoniae Radix-Atractylodis MacrocephalaeRhizoma herbal pairs, a simple, easy, and sensitive high-performance liquid chromatography coupled with diode array detectors was developed for simultaneous determination of nine bioactive components in the herbal pairs. The calibration curve exhibited good linearity (r²≥0.9992). The LODs and LOQs were ≤7.30 and 11.53 µg/mL, respectively. The intra-, inter-day and repeatability RSD values of the nine compounds were less than 3.86%, 2.71%, and 4.29%, respectively. The RSD stability values were less than 3.64%. The recovery of the method was in the range of 96.70%–102.10%, with RSD values less than 3.52%. The developed method can be applied to the intrinsic quality control of crude and processed Paeoniae Radix-Atractylodis Macrocephalae Rhizoma herbal pairs.



Simultaneous determination of seven active components in n-butanol effective fraction of Xiao Chai Hu Tang by HPLC-DAD-ELSD

Hongxia Yuan, Huifeng Li, Miaorong Pei

2015, 24(4):  236-240.  DOI: 10.5246/jcps.2015.04.031

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An HPLC-DAD-ELSD method was developed and validated for the simultaneous quantitation of seven active components (liquiritin, baicalin, wogonoside, baicalein, wogonin, ginsenosides Re and ginsenosides Rb₁) in n-butanol effective fraction of Xiao Chai Hu Tang. A Diamonsil C₁₈₍₂₎ column (4.6 mm × 250 mm, 5 μm) was used as the stationary phase and the mobile phase was consisted of acetonitrile and aqueous phosphate acid (0.05%, v/v). Gradient elution was carried out at the flow rate of 1 mL/min. The detection wavelength was set at 276 nm and an evaporative light scattering detector was also used. Good linearity for all the seven active components was observed. The established method is simple, fast, reliable, and suitable for the quality control of n-butanol effective fraction of Xiao Chai Hu Tang.



Development and validation of a stability-indicating HPLC method for the determination of retigabine and its related substances in drug substances

Xifeng Wu, Feng Shao, Chunlei Tao, Jie Li

2015, 24(4):  241-249.  DOI: 10.5246/jcps.2015.04.032

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A stability-indicating high-performance liquid chromatography (HPLC) method has been developed and validated for the separation and determination of Retigabine and its related substances. The chromatographic separation was achieved on Agilent Eclipse Plus C₁₈ column (4.6 mm×150 mm, 5 µm). The mobile phase was constituted of triethylamine-phosphate buffer as A and acetonitrile as B. The analysates were then eluted under the gradient conditions as description in this paper. The forced degradation study validated that the newly developed method was specific and selective to the degraded products. The performance of the method was verified according to the present International Conference on Harmonisation (ICH) guidelines for specificity, linearity, accuracy, precision and robustness. The correlation coefficients for Retigabine and its six impurities were greater than 0.999, which was shown in the regression analysis. Limits of detection (LOD) of these impurities were in the range of 0.0092%–0.0103%, indicating the high sensitivity of the newly developed method. Accuracy of the method was determined on the basis of recoveries to be between 96.49% and 118.35% for all impurities. Relative standard derivation (RSD) receiving in the repeatabilityand intermediate precision experiment, was less than 1.0%. The method can be successfully applied to routine quantify and stability testing Retigabine and its related substances in bulk drugs.



Drug administration column

An overview of management of narcotics and psychotropic drugs in China

Peng Yao, Xiaodong Guan, Yanping Deng, Luwen Shi

2015, 24(4):  250-256.  DOI: 10.5246/jcps.2015.04.033

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Narcotics and psychotropic drugs are known as controlled drugs with special management and super vision due to their psychic and physiological dependence. Based on the literature review, experts interview and policy comparative analysis, our study summarized and reviewed the status of related legislation and regulations since the enactment of the Narcotics and Psychotropic Drugs Regulations in 2005. We found the problems of legal loopholes, the complexity of supervision system and the irrational use of narcotics in the treatment of chronic non-cancer. Our analysis suggested that China should reinforce legislation, strengthen the cooperation among departments, establish the information network and improve the guideline of narcotics and psychotropic drugs for clinical treatment as quickly as possible.



Introduction to drug regulatory capabilities: a theory and framework

Song Yang, Dongsheng Yang, Xiaoyuan Zheng, Guo Huang, Luoluo Cong, Bin Jiang

2015, 24(4):  257-262.  DOI: 10.5246/jcps.2015.04.034

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This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities (DRC) and their relationship with regulatory performance. Based on the theories on organizational capability and their application in public sector, interviews with officers from drug regulatory agencies and analysis of its three determinations, the DRC was defined as the follows: a learned pattern through which the drug regulatory agencies acquire, reconstruct and utilize organizational resources to protect and advance public health. DRC can be divided into different dimensions and structured as the basic capabilities and functional capabilities. This research also introduced three learning mechanisms for DRC construction, which include learning by doing, organizational learning, and exploratory learning. Finally, a qualitative case study of drug application and approval in China was conducted to explore the relationship between regulatory capabilities and performance.



Analysis for the vancomycin plasma concentration data in infants by clinical pharmacists

Jinlian Zhang, Jia Zhou, Jihui Chen, Ting Chen, Yan Liu, Huaiping Tian, Jian Zhang

2015, 24(4):  263-266.  DOI: 10.5246/jcps.2015.04.035

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In the present study, clinical pharmacists monitored the blood concentration of vancomycin in children in the Infant Ward from 2013 to 2014, and the drug dose was adjusted according to its plasma concentration. Moreover, we analyzed the plasma concentration of vancomycin in infants in the hospital from 2013 to 2014. Simultaneously, we also discussed the necessity of regular therapeutic drug monitoring of vancomycin in infants, and the important role of clinical pharmacists was further explored. The results showed that it was necessary to routinely monitor the therapeutic drug in infants. Clinical pharmacists performed medication monitoring, which improved the effectiveness of vancomycin and prevented its adverse effects. In addition, it is a new treatment model for the participation of clinical pharmacists in the clinical treatment.



Editor profile

Introduction of Professor Hubiao Chen

Journal of Chinese Pharmaceutical Sciences

2015, 24(4):  267-267. 

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  Dr. Hubiao Chen, the member of Editorial Board of Journal of Chinese Pharmaceutical Sciences, graduated from Hunan Normal University in 1983. He obtained his PhD degree at the School of Pharmaceutical Sciences of Beijing Medical University in 1988.From 1989–2006, he served at the School of Pharmaceutical Sciences, Peking UniversityHealth Science Center as a lecturer (1989), associate professor (1990) and professor (1997). During that period, he also went to Tokyo Metropolitan University as a visiting scholar in 1995 and worked as an assistant professor at Faculty of Pharmaceutical Sciences, Kanazawa University from 2000–2002 in Japan. Dr. Chen is currently an associate professor and programmedirector of Bachelor of Pharmacy (Hons) in Chinese Medicine programmeat the School of Chinese Medicine at Hong Kong Baptist University. Over the years, he has specialized in research in plant taxonomy, chemistry of natural products and scientific research into the resource and quality assessment of Chinese medicinal materials. He has published over 160 associated papers in domestic and international journals. Dr. Chen also serves as member of the editorialboard for several professional publications, and has written more than 40 books that are related with plant taxonomy, medicinal botany and Chinese herbal medicines. In addition, he also actively promotes the Chinese medicine digitalization and has launched two online databases of medicinal plants and Chinese medicinal materials. This Project received 2012 American Library Association (ALA) Presidential Citation for Innovative International Library award.



Others

Advances in FDA’s Safety Program for Marketed Drugs FDA Continues to Lead in Precision Medicine

Janet Woodcock M.D.

2015, 24(4):  268-270. 

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    Everyone knows that different people don’t respond the same way to medications, and that “one size does not fit all.” FDA has been pushing for targeted drug therapies, sometimes called “personalized medicines” or “precision medicines,” for a long time.
    Targeted therapies make use of blood tests, images of the body, or other technologies to measure individual factors called “biomarkers.” These biomarkers can then be used to determine who is most likely to benefit from a treatment, who is at higher risk of a side effect, or who needs a different dose. Targeting therapy can improve drug safety, and make sure that only people likely to have a good response get put on a drug.
    Targeted therapies have gained public attention since President Obama announced a Precision Medicine Initiative in his most recent State of the Union address. This initiative will reinforce our work at FDA, where development of targeted drug therapies has been a priority since the 1990s. In 1998, FDA approved the targetedtherapy, Herceptin (trastuzumab), offering new hope for many patients with breast cancer. High levels of a biomarker, known as “HER-2,” identified breast tumors that were more likely to be susceptible to this drug.



Seminar report: Cancer Prevention by Natural & TCM Products: Nrf2 and Epigenetics

Siwang Yu

2015, 24(4):  271-272. 

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24th Mar, 2015–Invited by Professor Kui Wang and Dr. Siwang Yu, Dr. Tony Ah-Ng Kong from Rutgers, the State University of New Jersey visited Peking University School of Pharmaceutical Sciences and presented in a series of academic activities.

Dr. Kong, the Glaxo Endowed Chair and Distinguished Professor of Pharmacy at the Ernest Mario School of Pharmacy, was honored as guest professor of Peking University Health Science Center in 2011. Currently he is the Director of Graduate Program in Pharmaceutical Sciences, also the Leader of Carcinogenesis and Chemoprevention Research Program of the Cancer Institute of New Jersey, and has continued serving on the NIH Study Sections since 1998. He also served as member of 13 editorial boards of international journals, editor of Pharmaceutical Research, the Editor-in-Chief of Current Pharmacology Reports, and the oversea editor of Journal of Chinese Pharmaceutical Sciences (JCPS). To the date, Dr. Kong has published more than 200 scientific articles with over 11000 citations. His current research interests are predominately in the areas of biology-driven natural product drug discovery and development, with primary emphasis in the fields of cancer chemoprevention.

During his visit to the JCPS editorial office, Dr. Kong met Associate Professor Heqing Huang, theExecutive Associate Editor-in-Chief of JCPS, and Drs. Jian Han and Jingjing Zhang, and discussed the up-coming JCPS special issues on “Cancer Prevention by Natural & TCM Products”. A tentative agreement of collaboration on international propagation was also reached.

Dr. Kong delivered a seminar entitled “Cancer Prevention by Natural & TCM Products: Nrf₂ and Epigenetics”. Started from the successes and failures of cancer chemopreventive drugs, Dr. Kong introduced the current research progresses and perspectives of natural products and traditional Chinese medicine in cancer prevention, especially the involvement of redox signaling and epigenetic mechanisms. His talk sparked extensive interests and hot discussions among audience.