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1.
J Pharm Biomed Anal ; 217: 114838, 2022 Aug 05.
Article in English | MEDLINE | ID: covidwho-1895252

ABSTRACT

Due to cultivation position, climate, harvest times, storage conditions and processing method, the evaluation of intra- and inter- batches quality consistency of botanical drugs has always been a thorny problem since it concerns safety and efficacy. The combination of fingerprint based on instrumental analysis and chemometrics is a common evaluation method in recent years. The differences between groups can be judged intuitively and superficially through principal component analysis (PCA) multi-dimensional score plots, but there is a lack of scientific and quantitative index to quantify the differences between groups. How to quantify the difference between groups is basically a blank area of research. Based on traditional F-statistic, we proposed a new F*-statistic to quantify the difference between groups in PCA score plots from the perspective of statistics. As the results revealed, the calculated F*-statistic was 2.58, smaller than the critical value 3.17 (α = 0.05), which indicated that there was no significant difference between groups. Our study add another dimension for PCA application, which offers a new strategy to quantify differences between groups by a new perspective, namely, a combination of fingerprint, chemometrics and statistics to evaluate inter-batches quality consistency quantitatively and objectively. Therefore, this manuscript could provide new ideas and technical references for the quality consistency evaluation of natural drugs, thus better guarantee their clinical efficacy and safety, and better promote industrial development.


Subject(s)
Drugs, Chinese Herbal , Chromatography, High Pressure Liquid/methods , Principal Component Analysis , Spectroscopy, Fourier Transform Infrared/methods
2.
Acta Pharmacol Sin ; 2022 Mar 16.
Article in English | MEDLINE | ID: covidwho-1747246

ABSTRACT

VV116 (JT001) is an oral drug candidate of nucleoside analog against SARS-CoV-2. The purpose of the three phase I studies was to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of VV116 in healthy subjects, as well as the effect of food on the pharmacokinetics and safety of VV116. Three studies were launched sequentially: Study 1 (single ascending-dose study, SAD), Study 2 (multiple ascending-dose study, MAD), and Study 3 (food-effect study, FE). A total of 86 healthy subjects were enrolled in the studies. VV116 tablets or placebo were administered per protocol requirements. Blood samples were collected at the scheduled time points for pharmacokinetic analysis. 116-N1, the metabolite of VV116, was detected in plasma and calculated for the PK parameters. In SAD, AUC and Cmax increased in an approximately dose-proportional manner in the dose range of 25-800 mg. T1/2 was within 4.80-6.95 h. In MAD, the accumulation ratio for Cmax and AUC indicated a slight accumulation upon repeated dosing of VV116. In FE, the standard meal had no effect on Cmax and AUC of VV116. No serious adverse event occurred in the studies, and no subject withdrew from the studies due to adverse events. Thus, VV116 exhibited satisfactory safety and tolerability in healthy subjects, which supports the continued investigation of VV116 in patients with COVID-19.

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