The use of tritium-labeled triterpene glycosides from the holothurian Cucumaria japonica in pharmacokinetic studies

2008 ◽  
Vol 422 (1) ◽  
pp. 345-347 ◽  
Author(s):  
D. L. Aminin ◽  
V. P. Shevchenko ◽  
I. Yu. Nagaev ◽  
R. V. Gladkikh ◽  
I. I. Kapustina ◽  
...  
Keyword(s):  
Triterpene Glycosides ◽  
Pharmacokinetic Studies ◽  
Cucumaria Japonica

scholarly journals Radioprotective Properties of Cumaside, a Complex of Triterpene Glycosides from the Sea Cucumber Cucumaria Japonica and Cholesterol

2011 ◽  
Vol 6 (5) ◽  
pp. 1934578X1100600
Author(s):  
Dmitry L. Aminin ◽  
Tatiana S. Zaporozhets ◽  
Pelageya V. Adryjashchenko ◽  
Sergey A. Avilov ◽  
Vladimir I. Kalinin ◽  
...  
Keyword(s):  
Life Span ◽  
Sea Cucumber ◽  
Cell Number ◽  
Exposure Dose ◽  
Peripheral Blood Cell ◽  
Triterpene Glycosides ◽  
Average Life ◽  
Average Life Span ◽  
Radioprotective Properties ◽  
Cucumaria Japonica

The radioprotective activity has been studied of a new immunomodulatory lead material, Cumaside, which is a complex of monosulfated triterpene glycosides from the edible sea cucumber Cucumaria japonica and cholesterol. Female CD-1 strain mice administered with prophylactic doses of Cumaside were irradiated using a Gamma-therapeutic device with a 60Co source (exposure dose 6.5 Gy, dose rate 1.14 Gy /min) and the average life span of the mice was determined. The animals administrated with Cumaside and irradiated were killed by pervisceral dislocation on days 4 and 9. Peripheral blood cell composition indexes, blood forming function and cell number in blood-forming organs and the number of pluripotent blood-forming stem cells were determined using standard procedures and the results compared with those of non-treated irradiated mice. The survivability percentage and average life span of the irradiated mice that were not treated with Cumaside were decreased in comparison with the Cumaside-treated groups. Especially, the leukocyte and neutrophil numbers in the blood (bone marrow from hip), and the weight and cell number of lymphoid organs were higher in the Cumaside-treated groups compared with the non-treated irradiated mice. It was concluded that at low prophylactic doses Cumaside possesses moderate radioprotective properties.

Structures of four new triterpene glycosides from the holothurian Cucumaria japonica

1990 ◽  
Vol 26 (6) ◽  
pp. 670-675 ◽  
Author(s):  
S. A. Avilov ◽  
V. A. Stonik ◽  
A. I. Kalinovskii
Keyword(s):  
Triterpene Glycosides ◽  
Cucumaria Japonica

Treatment of Hemophilia A with a Highly Purified Factor VIII Concentrate Prepared by Anti-FVIIIc Immunoaffinity Chromatography

1992 ◽  
Vol 67 (01) ◽  
pp. 019-027 ◽  
Author(s):  
Joseph E Addiego ◽  
Edward Gomperts ◽  
Liu Shu-Len ◽  
Patricia Bailey ◽  
Suzanne G Courter ◽  
...  
Keyword(s):  
Factor Viii ◽  
Hemophilia A ◽  
Virus Transmission ◽  
Human Albumin ◽  
Immunoaffinity Chromatography ◽  
Exchange Chromatography ◽  
Pharmacokinetic Studies ◽  
Enveloped Viruses ◽  
Clinically Significant ◽  
Detergent Mixture

SummaryTo reduce the risk of pathogenic virus transmission associated with the therapeutic administration of plasma-derived antihemophilic factor (FVIIIc), a process utilizing anti-FVIIIc immunoaffinity chromatography to isolate FVIIIc has been developed. In addition, the starting cryoprecipitate solution has been treated with an organic solvent/detergent mixture to inactivate lipid-enveloped viruses. A final ion exchange chromatography step is used to further remove contaminants, e.g., anti-FVIIIc antibody, potentially leached with FVIIIc during the immunoaffinity step. The purified FVTII is stabilized for lyophili-zation and storage by the addition of human albumin. The monoclonal anti-FVIIIc antibody used in the immunoaffinity step of the process is not detectable in the final preparation. Viral reduction studies performed at specific steps of the process demonstrate that 11 logs of human immunodeficiency virus (HIV) and greater than 4-5 logs of other lipid-enveloped viruses are inactivated within the first 30 s of exposure to the solvent/ detergent mixture and 4-5 logs of various model viruses, e. g. Endomyocarditis virus (EMC), are physically removed during washing of the immunoaffinity column. The lyophilized product is reconstituted using sterile water in a matter of seconds.The pharmacokinetics of Hemofil® M were compared to those obtained using a standard heat-treated concentrate (Hemofil® CT) in five severe factor VIII deficient hemophiliacs in a randomized, cross-over study. No statistically significant differences were observed in mean half life (p >0.6) or median recovery (p = 0.4) between the two preparations. No clinically significant adverse effects were observed in patients receiving either FVIII preparation.In addition, 43 patients at 18 different centers underwent pharmacokinetic studies, with a nominal dose of 50 u/kg FVIIIc Hemofil® M. The mean recovery was 103.6%, and the t 1/2 was 14.6 h. The recovery of FVIII in this group was as expected, providing an increase of assayed FVIII of approximately 2% per unit of FVTII/kg infused.Clinical trials using Hemofil® M have been initiated in 124 hemophilia A patients. The safety and efficacy of Hemofil® M has been established. To date, 0 of 60 patients tested have seroconverted to HIV. None of the previously untreated patients show clinical or laboratory evidence of Non-A, Non-B hepatitis (NANB), with 21 patients remaining negative as far as presence of antibodies to the Hepatitis C virus (a-HCV negative) at least 6 months after the initial infusion. There is no evidence of neoantigenicity, evidenced by seroconversion to murine antibody. An 8.7% (2 of 23) prevalence of anti-FVIIIc inhibitor development has been observed in previously untreated patients with FVIIIc⩽3%, receiving only the monoclonally purified solvent/ detergent treated FVIII concentrate while on study and on poststudy surveillance. All patients demonstrated clinical hemostasis following product use for either on demand bleeding or surgical prophylaxis.

A Multicenter Study of Recombinant Factor VIII (RecombinateTM) in Previously Treated Patients with Hemophilia A

1997 ◽  
Vol 77 (04) ◽  
pp. 660-667 ◽  
Author(s):  
G C White ◽  
S Courter ◽  
G L Bray ◽  
M Lee ◽  
E D Gomperts ◽  
...  
Keyword(s):  
Hemophilia A ◽  
Recombinant Dna ◽  
Home Treatment ◽  
Pharmacokinetic Parameters ◽  
Pharmacokinetic Studies ◽  
Open Label ◽  
Treat Ment ◽  
Previously Treated Patients ◽  
Bleeding Episodes

SummaryA prospective, open-label multicenter investigation has been conducted to compare pharmacokinetic parameters of recombinant DNA-derived FVIII (rFVIII) and plasma-derived FVIII concentrate (pdFVIII) and to assess safety and efficacy of long-term home-treat- ment with rFVIII for subjects with hemophilia A. Following comparative in vivo pharmacokinetic studies, 69 patients with severe (n = 67) or moderate (n = 2) hemophilia A commenced a program of home treatment using rFVIII exclusively for prophylaxis and treatment of all bleeding episodes for a period of 1.0 to 5.7 years (median 3.7 years). The mean in vivo half-lives of rFVIII and pdFVIII were both 14.7 h. In vivo incremental recoveries at baseline were 2.40%/IU/kg and 2.47%/IU/kg, respectively (p = 0.59). The response to home treatment with rFVIII was categorized as good or excellent in 3,195 (91.2%) of 3,481 evaluated bleeding episodes. Thirteen patients received rFVIII for prophylaxis for twenty-four surgical procedures. In all cases, hemostasis was excellent. Adverse reactions were observed in only 13 of 13,591 (0.096%) infusions of rFVIII; none was serious. No patient developed an inhibitor to r FVIII.

Clinical Pharmacokinetic Studies in Pregnant Women and the Relevance of Pharmacometric Tools

2019 ◽  
Vol 25 (5) ◽  
pp. 483-495 ◽  
Author(s):  
André Dallmann ◽  
Paola Mian ◽  
Johannes Van den Anker ◽  
Karel Allegaert
Keyword(s):  
Pregnant Women ◽  
Clinical Pharmacokinetic ◽  
Individual Variability ◽  
Current Status ◽  
Pharmacokinetic Studies ◽  
Full Potential ◽  
Pbpk Models ◽  
Pregnancy And Postpartum ◽  
Population Pk ◽  
The Impact

Background: In clinical pharmacokinetic (PK) studies, pregnant women are significantly underrepresented because of ethical and legal reasons which lead to a paucity of information on potential PK changes in this population. As a consequence, pharmacometric tools became instrumental to explore and quantify the impact of PK changes during pregnancy. Methods: We explore and discuss the typical characteristics of population PK and physiologically based pharmacokinetic (PBPK) models with a specific focus on pregnancy and postpartum. Results: Population PK models enable the analysis of dense, sparse or unbalanced data to explore covariates in order to (partly) explain inter-individual variability (including pregnancy) and to individualize dosing. For population PK models, we subsequently used an illustrative approach with ketorolac data to highlight the relevance of enantiomer specific modeling for racemic drugs during pregnancy, while data on antibiotic prophylaxis (cefazolin) during surgery illustrate the specific characteristics of the fetal compartments in the presence of timeconcentration profiles. For PBPK models, an overview on the current status of reports and papers during pregnancy is followed by a PBPK cefuroxime model to illustrate the added benefit of PBPK in evaluating dosing regimens in pregnant women. Conclusions: Pharmacometric tools became very instrumental to improve perinatal pharmacology. However, to reach their full potential, multidisciplinary collaboration and structured efforts are needed to generate more information from already available datasets, to share data and models, and to stimulate cross talk between clinicians and pharmacometricians to generate specific observations (pathophysiology during pregnancy, breastfeeding) needed to further develop the field.

Interaction between Traditional Chinese Medicine and Anticoagulant/Antiplatelet Drugs

2019 ◽  
Vol 20 (9) ◽  
pp. 701-713 ◽  
Author(s):  
Jiajia Li ◽  
Qing Liang ◽  
GuangChun Sun
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Drug Interactions ◽  
Adverse Reactions ◽  
Bleeding Risk ◽  
Antiplatelet Drugs ◽  
Pharmacokinetic Studies ◽  
Drug Databases ◽  
Concurrent Use ◽  
Anticoagulant Drugs

Background: Traditional Chinese medicine (TCM) has been used for medical purposes since the ancient time and has gradually gained recognition worldwide. Nowadays, patients with thrombus presiding to anticoagulant/ antiplatelet drugs prefer taking TCM. However, an increasing number of studies on herb–drug interactions have been shown. Nevertheless, findings are frequently conflicting and vague. In this review, we discuss the herb–drug interactions between TCM and anticoagulant/antiplatelet drugs to provide guidance on concomitant ingestion with anticoagulant/antiplatelet drugs. Methods: We undertook a structured search of medicine and drug databases for peer-reviewed literature using focused review questions. Results: Danshen, Ginkgo, Ginger, H. Perforatum, SMY and Puerarin injection had directional regulation effects on the efficacy of anticoagulant drugs by altering the CYPs, pharmacokinetic indexs and hemorheological parameters. H. Perforatum inhibited the efficacy of Clopidogrel by enhancing the CYP3A4 activity and Ginkgo increased the efficacy of Ticlopidine. Additionally, Renshen, the formulae except SMY and injections except Puerarin injection could increase or decrease the efficacy of anticoagulant/antiplatelet drugs via regulating the CYPs, platelet aggregation, hemorheological parameters and others. Conclusion: Some cases have reported that TCMs may increase the bleeding risk or has no effect on coagulation when anticoagulant/antiplatelet drugs are concurrently used. However, pharmacokinetic studies have presented either consistent or slightly varying results. So it is difficult to ascertain whether the concurrent use of TCM may increase or reduce the pharmacologic effects of anticoagulant/antiplatelet drugs with adverse reactions. Therefore, herb–drug interactions of TCM and anticoagulant/antiplatelet drugs should be further explored and defined.

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