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In order to prove safety and efficacy, herbal medicines must undergo the rigorous scientific researches such as pharmacokinetic and bioavailability, before they are put on the market in the foreign countries. Botanical Drug Products promulgated by the US FDA could guide industry sponsors to develop herbal drugs, which was also an important reference for investigating Chinese herbal medicines. This paper reviews and discusses novel approaches for how to assess systemic exposure and pharmacokinetic of Chinese herbal medicines, which were in line with FDA guidance. This mainly focus on identifying pharmacokinetic markers of botanical products, integral pharmacokinetic study of multiple components, Biopharmaceutics drug disposition classification system, and population pharmacokinetic-pharmacodynamic study in herb-drug interaction.
Subject(s)
Animals , Humans , Biomarkers, Pharmacological , Drugs, Chinese Herbal , Chemistry , Pharmacokinetics , Herb-Drug Interactions , Herbal MedicineABSTRACT
<p><b>OBJECTIVE</b>To explore the transmembrane transport and metabolism of diammonium glycyrrhizinate in intestines of rats.</p><p><b>METHOD</b>An Ussing Chamber model were used to investigate the transmembrane transport of diammonium glycyrrhizinate (GZ), the concentrations of diammonium glycyrrhizinate and its two metabolites were determined by HPLC.</p><p><b>RESULT</b>The permeability coefficients of GZ in difference intestinal mucous membranes were ranged from 0.3 x 10(-6) cm x s(-1) to 1.1 x 10(-6) cm x s(-1). The metabolism of GZ in enterocytes during its transport process was negligible. The concentration of diammonium glycyrrhizinate and pH had limit effects on the transport amount and the permeability coefficients of GZ.</p><p><b>CONCLUSION</b>GZ is a low permeability drug, but it can be absorbed at all segments of the small intestine in rats. Ileum is the major absorption region of GZ.</p>
Subject(s)
Animals , Male , Rats , Biological Transport , Cell Membrane Permeability , Glycyrrhizic Acid , Metabolism , Pharmacokinetics , Hydrogen-Ion Concentration , Intestine, Small , Chemistry , Metabolism , Models, Biological , Rats, Sprague-DawleyABSTRACT
Objective: To investigate the prospect of applying technology of ultra fine powder (UFP) to TCM powders for external use. Methods: The morphocytology between UFP of Cortex cinnamomi , compared with its common powder, was observed; physical parameters of the UFP particles and the penetrating amount of cinnamaldehyde, through rat skin in vitro was determined with an improved Franz diffuse cell. Results: The diameter of the UFP particles detected was small (D 50 =12.72?m). and a typical microscopic characters of Cortex cinnamomi powder was not observed. The Cortex cinnamomi UFP have good transdermal effects. There existed the linear relationship between penetrating amount of cinnamaldehyde and penetrating time. The highest penetrating rate (0.25mg/cm 2/h) was within the first hour in the beginning, and then the rate became lower and sustained. The accumulating transdermal amount of the UFP was 1.0mg/cm 2 totally in 8 hours. Conclusion: It indicated that UFP might have a fine respect, applied in cosmetic or drug preparations for external use.
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AIM: To select proper hydrolysis time to determine Ginkgo biloba flavonoids content. METHODS: Sample dissolved in 25mL MeOH-25%∶HCl(4∶1) mixture and was heated to hydrolyze for various time, then diluted. Flavonoids'content was determined by HPLC. The conditions were developed by Shimpack CLC-ODS(150mm?6mm) column using 0.4% phosphoric acid solution-Methanol(50∶50), the detective wavelength was at 360nm with quercetin、kaempferol and isorhamnetin as standards, temperature being 30℃. RESULTS: Contents of flavonoids of Ginkgo biloba leaves,Ginkgo biloba crude extracts and Ginkgo biloba refined extracts were highest in the hydrolysis time of 2.0h. Ginkgo biloba flavonoids can be completely hydrolyzed in 2.0h. CONCLUSION: The hydrolysis time of 2.0h is best.
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AIM: To optimize the spray-drying process of Qingxiang Tablets. METHODS: Excipients were selected in terms of hygroscopicity and yield rate of dried powders with several excipients added;then,the process parameters,such as the relative density of fluid extracts,intake temperature,and the input speed of liquid feedstock were optimized by orthogonal experiment,in which the transfer rate of peoniflorin,a constituent in the formulation,and dried powder yield rate were set up as the evaluation index. RESULTS: The optimal processing conditions were obtained and validated as follows: relative density of liquid feedstock was 1.12 mg/mL(containing 6%?-CD),the input speed was 10 mL/min and intake temperature was at 190 ?C. CONCLUSION: The optimal process is stable and the experimental results provide the basis of industrial production.
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OBJECTIVE:To improve the quality standard for Jianpi cake.METHODS:The pericarpium citri reticulatae and fructus crataegi in this preparation were identified by TLC and hesperidin was determined by HPLC.RESULTS:The peri?carpium citri reticulatae and fructus crataegi in samples were positive in TLC.The average content of hesperidin was0.0186%and the average recovery rate was97.75%(RSD=1.60%).CONCLUSION:The established method is accurate,and provides a method for the quality control of Jianpi cake.