Journal of Chinese Pharmaceutical Sciences

Determination of chlorogenic acid in traditional Chinese prescription Shuanghuanglian capsule using quantitative nuclear magnetic resonance spectroscopy in combination with solid phase extraction

Xiaoting Liu, Jingna Xu, Kun Xiao, Qiangsheng Guo, Xu Xu

2020, 29(4): 227-235. DOI: 10.5246/jcps.2020.04.021

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The determination method of chlorogenic acid in traditional Chinese prescription Shuanghuanglian capsule was established by using quantitative nuclear magnetic resonance spectroscopy (qNMR) in combination with solid phase extraction (SPE). As the capsule’s main active component, chlorogenic acid comes from the extraction of Chinese herb medicine Flos Lonicerae. The chlorogenic acid in capsule was ultrasonically extracted at room temperature using pure water as solvent. The extracting solution was enriched and cleaned using HC-C₁₈ SPE cartridge. The effect of ultrasonic extraction, sample pretreatment conditions via SPE and qNMR experimental conditions were investigated. The qNMR experiment conditions were selected using deuterated DMSO as solvent, calibrated 1,4-phthalaldehyde as internal standard, and P1 (pulse width) = 14.4 μs, d1 (pulse delay time) = 1 s, NS (number of scan) = 512. The ¹H NMR peaks of δ 6.138–6.182 (H-8’, d, 1H) of chlorogenic acid was chosen as the quantitativepeaks. Method validation was performed, including precision (the intra-day RSD = 1.2% and the inter-day RSD = 1.5%), linearity (correlation coefficient r>0.9999), LOD (0.0017 mg/g) and LOQ (0.079 mg/g). The recovery of the SPE-qNMR was within the range of 100.2%–103.2%. The result showed that the method was stable, accurate and reliabile. Determined by the method, the chlorogenic acid in a real Shuanghuanglian capsule was within the range of 9.68–10.35 mg/g.

The inhibitory activities of Urtica fissa to BPH

Jin Huang, Lingxin Yang, Ning Yang, Bowen Yuan, Hao Zhang, Mengyue Wang

2020, 29(4): 236-243. DOI: 10.5246/jcps.2020.04.022

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In the present study, the BPH inhibitory activities of Urtica fissa were systematically investigated. Firstly, inhibitory activities of 5α reductase of the alcoholic extracts from different parts (root, stem, leaf, flower and fruit) were evaluated. The results indicated that the root possessed the most significant action. Subsequently, U. fissa root (UFR) was subjected to further pharmacological evaluation using the benign prostate hyperplasia (BPH) model rats induced by testosterone propionate. The results revealed that UFR could significantly decrease the prostate index, alter the hyperplasia tissue morphology, suppress the prostatic growth factors of VEGF, EGF, bFGF and KGF, decrease the inflammation factor levels of TNF-α, IL-1βand IL-6, improve the activities of GSH-Px, CAT and SOD and decrease the MDA level in the prostate of the model rats. Moreover, UFR also significantly suppressed the hormone levels of testosterone and dihydrotestosterone. These results indicated that the possible BPH inhibitory mechanisms of UFR were growth factor suppression, hormone level modulation, anti-inflammation, and anti-oxidative stress.

Three new compounds from endophytic fungus Periconia sp. F-31

Jimei Liu, Minghua Chen, Ridao Chen, Kebo Xie, Dawei Chen, Shuyi Si, Jungui Dai

2020, 29(4): 244-251. DOI: 10.5246/jcps.2020.04.023

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Three new compounds (1–3), includinga chlorine-containing dihydroisocoumarin pericochlorosin A (1), a chlorinated phenol pericochlorosin B (2) and a decalin derivative pericoannosin G (3), were isolated from endophytic fungus Periconia sp. F-31 of the medicinal plant Annona muricata. The structures and absolute configurations were elucidated by extensive spectroscopic methods and calculated electronic circular dichroism analysis. Compound 2 displayed potent anti-HIV activity with IC₅₀ value of 2.2 μM.

Identification and discrimination of Ziziphi Spinosae Semen and Ziziphi Mauritianae Semen based on HPLC fingerprint analysis

Hongshuai Yang, Qiuyi Liu, Weidong Yin, Manjiang Xie, Xiang Ji, Shuangyu Shao, Hong Liang, Pengfei Tu, Qingying Zhang

2020, 29(4): 252-259. DOI: 10.5246/jcps.2020.04.024

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A simple, reproducible and reliable HPLC fingerprint analysis method of Ziziphi Spinosae Semen (ZSS) and Ziziphi Mauritianae Semen (ZMS) was established, and then it was applied to analyze samples collected from different locations. A total of 12 common fingerprint peaks were designated in ZSS and ZMS, respectively, and five of which were definitely identified. Of these common peaks, 10 peaks were presented in both ZSS and ZMS, whereas two were characteristic for ZSS and ZMS, respectively.Furthermore, the two characteristic peaks of ZMS were definitely assigned as 6′′′-sinapoylspinosin and frangufoline by HPLC guided purification and structural elucidation. The HPLC fingerprint analysis was proved to be useful in identifying and discriminating ZSS and ZMS, which was beneficial for quality control of ZSS and its products.

Population pharmacokinetics of vancomycin in Chinese elderly patients and its application for dose individualisation

Jin Zhang, Weiwei Lin, Wei Wu, Xianzhong Guo, Pinfang Huang, Xinhua Lin, Zheng Jiao, Changlian Wang

2020, 29(4): 260-271. DOI: 10.5246/jcps.2020.04.025

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In the present study, we aimed to develop a population pharmacokinetics (PPK) model of vancomycin (VCM) and proposethe individualised dosage regimen for Chinese elderly patients. The data were collected prospectively from Chinese elderly patients receiving VCM therapy. Steady-state trough concentrations of VCM were determined using an enzyme-multiplied immunoassay. Patients’ sex, age, body weight, concomitant medications, infection type, and laboratory findingswere recorded. The PPK model was developed using nonlinear mixed-effects model software. Moreover, we used Monte Carlo simulations to develop an initial dosage regimen targeting various VCM through concentration ranges based on the final model. We found that VCM clearance (CL) was significantly influenced by post-craniotomy meningitis (PCM) and glomerular filtration rate in elderly patients. Additionally, a new dosage regimen was proposed to individualise VCM regimen for PCM and non-PCM elderly patients. A PPK model was established to estimate the individual VCM CL for elderly patients, which could be applied for individualising doses in the target population.

Effect of CYP3A4 genetic polymorphisms on pharmacokinetics of tinidazole

Xinyu Chang, Tao Guo, Guiming Guo

2020, 29(4): 272-279. DOI: 10.5246/jcps.2020.04.026

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In the present study, we aimed to investigate the frequency of CYP3A4*18B genetic polymorphism in Han Chinese populations, and to assess the effect of the CYP3A4*18B genetic polymorphism on the pharmacokinetics of tinidazole. A total of 100 healthy volunteers from Han nationalities in China were recruited. DNA was extracted from peripheral leukocytes using a standard protocol. A PCR-RFLP method was developed to detect the alleles of CYP3A4*18B. A pharmacokinetic study of tinidazole was then carried out in two groups with CYP3A4*1/*1 (n = 10) and CYP3A4*1/*18B (n = 9) genotypes. Concentrations of tinidazole were determined using high-performance liquid chromatography in plasma samples that were collected up to 72 h after drug intake. In this study, 88 healthy volunteers were found with CYP3A4*1/*1 genotype, and 12 were found with CYP3A4*1/*18Bgenotype. CYP3A4*18B/*18B were absent from all subjects. The allele frequencies of CYP3A4*18B were 6%. The pharmacokinetic parameters of CYP3A4*1/*1 genotype and CYP3A4*1/*18B genotype in healthy subjects were as follows: t_1/2: (15.92±1.62), (15.77±1.67) h; C_max: (18.72±3.10), (20.25±3.42) mg/L; t_max: (1.50±0.66), (1.45±0.69) h; V_d/F: (55.73±10.66), (51.30±7.75) L; CL/F: (2.44±0.47), (2.26±0.30) L·h; AUC₀_–_∞: (424.40±82.38), (450.53±69.48) mg·h/L. Collectively, the CYP3A4*18B genetic polymorphism did not affect pharmacokinetics of tinidazolein healthy volunteers.

Development of oral pharmaceutical formulation of standardized crude ethanolic extract of Atractylodes lancea (Thunb) DC.

Thananchanoke Rattanathada, Tullayakorn Plengsuriyakarn, Rathapon Asasujarit, Anurak Cheoymang, Juntra Karbwang, Kesara Na-Bangchang

2020, 29(4): 280-293. DOI: 10.5246/jcps.2020.04.027

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Cholangiocarcinoma (CCA), the adenocarcinoma of the biliary duct, is commonly reported in Asia with the highest incidence in northeastern Thailand. Chemotherapy of this type of cancer is limited due to the lack of effective chemotherapeutic drugs. A series of previous studies support further research and development of Atractylodes lancea (Thunb) DC. (AL) as a potential candidate for the treatment of CCA as a crude ethanolic extract. In the present study, we aimed to develop an oral pharmaceutical formulation (capsule) of the standardized AL crude ethanolic extract for further clinical development in patients with CCA. Major steps included macroscopic and microscopic authentication of the AL rhizomes, preparation of standardized AL extract, preparation of oral pharmaceutical formulation (capsule) of the standardized AL extract, quantitative and qualitative analysis of the marker compound (atractylodin) in the formulated AL extract, evaluation of contaminations of heavy metals, pesticides residues, and microorganisms in the ground AL rhizomes and the formulated (capsule) powder of AL, physicochemical and pharmaceutical properties of the formulatedAL extract/capsule, and cytotoxicity evaluation of the formulated AL extract. Results of all evaluations confirmed satisfactory pharmaceutical properties of oral (capsule) formulation of the standardized AL extract.

Commemoration of the 100th Birthday of Academician Zhicen Lou

Journal of Chinese Pharmaceutical Sciences

2020, 29(4): 294-303.

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