An effective UFLC–MS/MS method used to study pharmacokinetics of major constituents of Fukeqianjin formula in rat plasma

Wang, Kanghua; Liu, Lu; Yang, Yanfang; Liu, Xiaoyan; Zhang, Lei; Xu, Wei; Zhang, Yingtao; Zhang, Peng; Peng, Kai‐Feng; Gong, Yu; Liu, Ni-Fu

doi:10.1186/s13020-020-00347-5

Cited by 8 publications

(5 citation statements)

References 29 publications

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“… Dangshen Roots of C. pilosula To promote Qi. immunoregulation [ 9 ] Fukeqianjin formula (FKQJF) 8 Plant ingredients including roots of C. pilosula Treatment of gynecological inflammatory diseases (chronic cervicitis, chronic pelvic inflammatory disease, endometritis) [ 113 – 115 ] Fufang E’jiao Jiang (FEJ) TCM derived from “Liangyi Ointment”. Mixture of 5 plants including C. pilosula Medication against weakness and anemia (used to treat chemotherapy-induced myelosuppression) [ 116 – 118 ] Shenqi Fuzheng injection (SFI) Extract made from Radix Astragali and Radix Codonopsis Treatment of chronic heart failure.…”

Section: Introductionmentioning

confidence: 99%

Anticancer Properties of Lobetyolin, an Essential Component of Radix Codonopsis (Dangshen)

Bailly

2020

Nat. Prod. Bioprospect.

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Lobetyolin (LBT) is a polyacetylene glycoside found in diverse medicinal plants but mainly isolated from the roots of Codonopsis pilosula, known as Radix Codonopsis or Dangshen. Twelve traditional Chinese medicinal preparations containing Radix Codonopsis were identified; they are generally used to tonify spleen and lung Qi and occasionally to treat cancer. Here we have reviewed the anticancer properties of Codonopsis extracts, LBT and structural analogs. Lobetyolin and lobetyolinin are the mono- and bis-glucosylated forms of the polyacetylenic compound lobetyol. Lobetyol and LBT have shown activities against several types of cancer (notably gastric cancer) and we examined the molecular basis of their activity. A down-regulation of glutamine metabolism by LBT has been evidenced, contributing to drug-induced apoptosis and tumor growth inhibition. LBT markedly reduces both mRNA and protein expression of the amino acid transporter Alanine-Serine-Cysteine Transporter 2 (ASCT2). Other potential targets are proposed here, based on the structural analogy with other anticancer compounds. LBT and related polyacetylene glycosides should be further considered as potential anticancer agents, but more work is needed to evaluate their efficacy, toxicity, and risk–benefit ratio.

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Section: Introductionmentioning

confidence: 99%

Anticancer Properties of Lobetyolin, an Essential Component of Radix Codonopsis (Dangshen)

Bailly

2020

Nat. Prod. Bioprospect.

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“…On the basis of compound chemical components research of GZD, we studied the major effective compounds observed in blood through the pharmacokinetics research, which were the mostly possible material basis of GZD [27]. Moreover, the research help to clarify the biologically active ingredients and mechanism of action in TCM prescriptions.…”

Section: Discussionmentioning

confidence: 99%

The Determination of 10 Compounds of GuiZhi Decoction in Rat Plasma after Oral Administration by HPLC-MS/MS and its Application to a Pharmacokinetic Study

H¹,

Q²,

Zhang³

et al. 2021

Preprint

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Background: Guizhi Decoction (GZD), a traditional Chinese medical formula, has been commonly used to treat fever, sweating, and cold in China. Methods: The high performance liquid chromatography -tandem mass spectrometry ( HPLC-MS/MS ) method was established for the determination of 10 compounds, including cinnamic acid , paeoniflorin, albiflorin, liquiritin, isoliquiritin, liquiritigenin, isoliquiritigenin, glycyrrhizic acid, glycyrrhetinic acid, and 6-gingerol. And the specificity, linearity, lower limit of quantification (LLOQ), lower limit of detection (LLOD), precision and accuracy, recovery, matrix effect, and stability were used to verify the HPLC-MS/MS method. This validated method was successfully applied for pharmacokinetic study of the 10 compounds in rat plasma after oral administration of GZD in three doses (40 g crude drug·kg −1 , 20 g crude drug·kg −1 , 10 g crude drug·kg −1 ) and intravenous injection of GZD extraction at a dose of 2.0 g crude drug·kg −1 .The measurements of pharmacokinetic parameters including AUC 0–∞ , T 1/2 , T max , C max , Vz_F, Cl_F, and MRT, were performed using a non-compartmental model with Winnonlin 8.1 software. Results: The results showed that 10 compounds were detected in plasma after oral administration of GZD. the compounds (except for glycyrrhetinic acid) reached the maximum blood concentration quickly, whose Tmax was about 0.1-0.2 min. And a total of 9 compounds were detected after intravenous injection of GZD. The plasma concentration-time curve of these compounds declines rapidly at the beginning, and then decreased slowly, indicating that the plasma concentration-time curves were double exponential function curves. Conclusions: In this study, the developed method was suitable for pharmacokinetic analysis of the main compounds of GZD in rat plasma, and may reveal the pharmacodynamic material basis of GZD and provide a reference for the rational use of GZD in the clinic.

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“…Therefore, this clinical trial was aimed to evaluate the efficacy and safety of FUKE capsules in female Pakistani patients with mild-to-moderate PID symptoms. (Wang et al, 2020). FUKE is a Chinese patent medicine (CN1251763A).…”

Section: Introductionmentioning

confidence: 99%

“…FUKE is a Chinese patent medicine (CN1251763A). Its composition and the processes of extraction and preparation are reported in this patent and described by Wang et al (2020), and its chemical fingerprint is reported by Ma et al (2021).…”

Section: Introductionmentioning

confidence: 99%

A randomized, double-blind, positive-controlled, Phase-II clinical trial to evaluate efficacy and safety of Fuke Qianjin capsule in Pakistani patients with pelvic inflammatory disease

Shah,

Khan,

Fatima

et al. 2024

Front. Pharmacol.

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Ethnopharmacological relevance: Pelvic inflammatory disease (PID) is a frequently occurring gynecological disorder mainly caused by the inflammation of a woman’s upper genital tract. Generally, antibiotics are used for treating PID, but prolonged use poses potential risks of gut bacterial imbalance, bacterial resistance, super bacteria production, and associated adverse reactions. Traditional Chinese medicine (TCM) has shown unique advantages in various ailments and has received widespread clinical research attention. Fuke Qianjin (FUKE) capsule is an approved National Medical Products Administration (NMPA License No. Z20020024) Chinese herbal prescription that has been widely used individually or in combination with other Western medicines for the treatment of various gynecological inflammatory diseases, including chronic cervicitis, endometritis, and chronic PID.Aim: This clinical trial was designed to assess the safety and efficacy of FUKE capsule in mild-to-moderate symptomatic PID patients.Materials and methods: This phase 2, randomized, double-blind, positive controlled clinical trial was conducted in mild-to-moderate symptomatic PID patients at a single center in Pakistan from 21 September 2021 to 11 March 2022. Eligible female participants were randomly assigned to a test and a control group with a ratio of 1:1. The test group subjects received two metronidazole (METRO) tablets and one doxycycline hyclate (DOXY) simulant at a time, twice daily for 14 days, and two Fuke Qianjin (FUKE) capsules, three times a day after a meal for 28 days. Subjects in the control group received two METRO tablets and one DOXY tablet at a time, twice daily for 14 days, and two FUKE simulant capsules, three times a day after meal for 28 days. The primary efficacy outcome was an improvement in pelvic pain symptoms assessed through a visual analog scale (VAS). The secondary outcomes were the improvement in secondary efficacy symptoms like local physical signs, clinical assessment of leucorrhea and cervical secretions through laboratory examination, and improvement in the maximum area of pelvic effusion assessed through gynecological ultrasound after the treatment. The safety outcomes were assessed through vital signs, laboratory tests, electrocardiogram findings, and adverse events/serious adverse events.Results: A total of 198 subjects with active PID were randomly assigned to a test group (n = 99) and a control group (n = 99). The baseline characteristics of the subjects in the two groups were similar. In the intention-to-treat analysis, the primary efficacy was 84.9% for the test group and 71.6% for the control group, with a statistically significant difference (p = 0.0370; 95% CI −0.2568 to −0.0088). The secondary clinical efficacy was 88.4% for the test group and 82.7% for the control group, with no significant difference (p = 0.2977; 95% CI −0.1632 to 0.0501). The improvement in local physical signs was 95.8% for the test group and 76.9% for the control group, with no significant difference (p = 0.0542; 95% CI −0.3697 to −0.0085). The inter-group non-inferiority comparison showed that the upper limit of the 95% CI was less than 0.15 and thus met the non-inferiority requirements of the test group to the control group. The results of clinical signs of leucorrhea and cervical secretions showed that there was no difference in the rate of improvement between the test and control groups, indicating that FUKE was non-inferior to DOXY. A total of 14 adverse events in eight subjects were observed in the trial, with an incidence rate of 4.7%. Four subjects in each group experienced seven adverse events with 4.5% and 4.8% incidence rates of adverse reactions in the test and control groups, with no statistically significant differences (p = 0.2001). No serious adverse events occurred in the trial.Conclusion: The results of this trial indicate that the test drug (Fuke Qianjin capsule) is non-inferior to the control drug (doxycycline hyclate tablet) in treating mild-to-moderate PID patients with comparable efficacy, safety, and tolerability to the control drug.Clinical Trial Registration:www.clinicaltrials.gov, identifier NCT04723069.

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An effective UFLC–MS/MS method used to study pharmacokinetics of major constituents of Fukeqianjin formula in rat plasma

Cited by 8 publications

References 29 publications

Anticancer Properties of Lobetyolin, an Essential Component of Radix Codonopsis (Dangshen)

Anticancer Properties of Lobetyolin, an Essential Component of Radix Codonopsis (Dangshen)

The Determination of 10 Compounds of GuiZhi Decoction in Rat Plasma after Oral Administration by HPLC-MS/MS and its Application to a Pharmacokinetic Study

A randomized, double-blind, positive-controlled, Phase-II clinical trial to evaluate efficacy and safety of Fuke Qianjin capsule in Pakistani patients with pelvic inflammatory disease

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