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Article: Preclinical safety evaluation of the aqueous acetone extract of Chinese herbal formula Modified Huo Luo Xiao Ling Dan

TitlePreclinical safety evaluation of the aqueous acetone extract of Chinese herbal formula Modified Huo Luo Xiao Ling Dan
Authors
Issue Date2010
PublisherJCIM Press. The Journal's web site is located at http://www.jcimjournal.com
Citation
Journal Of Chinese Integrative Medicine, 2010, v. 8 n. 5, p. 438-447 How to Cite?
AbstractObjective: To investigate the safety of oral administration of Modified Huo Luo Xiao Ling Dan (HLXLD), a compound traditional Chinese herbal medicine. Methods: The toxicological information of HLXLD and its individual constituent herbs was searched in cintcm or TCMIars (www.cintcm.com), PubMed (MEDLINE), Chinese Herbal Medicine (1999) and WHO Monographs on Selected Medicinal Plants (Vol. I - III) . Single-dose acute toxicity was assessed by using the highest possible dosage. Motor function test was used to determine whether the herbal formula might cause motor impairment. Nine-day HLXLD repeat-dose sub-chronic toxicity/adverse effects, and 42-day chronic toxicity/adverse effects in rats were also assessed. Results: The literature searches showed that HLXLD and its eleven ingredient herbs had no side/adverse effects listed in the traditional Chinese medicine literature. Under the dosages proposed in the formula, the HLXLD formula had no side/adverse effects according to MEDLINE, Chinese Herbal Medicine and WHO Monographs on Selected Medicinal Plants. The studies in rats showed: (1) in single-dose acute toxicity assessment, the maximal feasible single oral dose, 9. 20 g/kg HLXLD, showed no significant effect on clinical signs, or body weight and mortality over a 14-day period in rats; (2) during motor function test, nine-day repeat-dose of daily HLXLD treatment at 4.60 g/kg did not cause motor impairment; (3) in nine-day HLXLD repeat-dose sub-chronic toxicity/adverse effects assessment, there were no noticeable abnormal behavioral changes or obvious adverse reactions and signs in complete Freund's adjuvant inflamed rats (highest observed dosage: 4. 60 g/kg), and no noticeable adverse effects were observed during, or 14 days after nine-day treatment at 4. 60 g/kg in non-inflamed rats; (4) during 42-day chronic toxicity/adverse effects assessments, no noticeable abnormal behavioral changes, no obvious adverse reactions and signs were observed in normal rats administered with HLXLD at a dose of 2.30 g/kg and the values of serum biochemistry and histopathology were in normal range. Conclusion: Both existing information and animal data support that Modified HLXLD is a safe herbal product for clinical application.
Persistent Identifierhttp://hdl.handle.net/10722/188620
ISSN
References

 

DC FieldValueLanguage
dc.contributor.authorFan, AYen_US
dc.contributor.authorLao, Len_US
dc.contributor.authorZhang, RXen_US
dc.contributor.authorZhou, ANen_US
dc.contributor.authorBerman, BMen_US
dc.date.accessioned2013-09-03T04:10:40Z-
dc.date.available2013-09-03T04:10:40Z-
dc.date.issued2010en_US
dc.identifier.citationJournal Of Chinese Integrative Medicine, 2010, v. 8 n. 5, p. 438-447en_US
dc.identifier.issn1672-1977en_US
dc.identifier.urihttp://hdl.handle.net/10722/188620-
dc.description.abstractObjective: To investigate the safety of oral administration of Modified Huo Luo Xiao Ling Dan (HLXLD), a compound traditional Chinese herbal medicine. Methods: The toxicological information of HLXLD and its individual constituent herbs was searched in cintcm or TCMIars (www.cintcm.com), PubMed (MEDLINE), Chinese Herbal Medicine (1999) and WHO Monographs on Selected Medicinal Plants (Vol. I - III) . Single-dose acute toxicity was assessed by using the highest possible dosage. Motor function test was used to determine whether the herbal formula might cause motor impairment. Nine-day HLXLD repeat-dose sub-chronic toxicity/adverse effects, and 42-day chronic toxicity/adverse effects in rats were also assessed. Results: The literature searches showed that HLXLD and its eleven ingredient herbs had no side/adverse effects listed in the traditional Chinese medicine literature. Under the dosages proposed in the formula, the HLXLD formula had no side/adverse effects according to MEDLINE, Chinese Herbal Medicine and WHO Monographs on Selected Medicinal Plants. The studies in rats showed: (1) in single-dose acute toxicity assessment, the maximal feasible single oral dose, 9. 20 g/kg HLXLD, showed no significant effect on clinical signs, or body weight and mortality over a 14-day period in rats; (2) during motor function test, nine-day repeat-dose of daily HLXLD treatment at 4.60 g/kg did not cause motor impairment; (3) in nine-day HLXLD repeat-dose sub-chronic toxicity/adverse effects assessment, there were no noticeable abnormal behavioral changes or obvious adverse reactions and signs in complete Freund's adjuvant inflamed rats (highest observed dosage: 4. 60 g/kg), and no noticeable adverse effects were observed during, or 14 days after nine-day treatment at 4. 60 g/kg in non-inflamed rats; (4) during 42-day chronic toxicity/adverse effects assessments, no noticeable abnormal behavioral changes, no obvious adverse reactions and signs were observed in normal rats administered with HLXLD at a dose of 2.30 g/kg and the values of serum biochemistry and histopathology were in normal range. Conclusion: Both existing information and animal data support that Modified HLXLD is a safe herbal product for clinical application.en_US
dc.languageengen_US
dc.publisherJCIM Press. The Journal's web site is located at http://www.jcimjournal.comen_US
dc.relation.ispartofJournal of Chinese Integrative Medicineen_US
dc.subject.meshAnimalsen_US
dc.subject.meshDrug Evaluation, Preclinicalen_US
dc.subject.meshDrugs, Chinese Herbal - Administration & Dosage - Adverse Effectsen_US
dc.subject.meshPlant Extracts - Administration & Dosage - Adverse Effectsen_US
dc.subject.meshRatsen_US
dc.subject.meshRats, Sprague-Dawleyen_US
dc.subject.meshToxicity Tests, Chronicen_US
dc.titlePreclinical safety evaluation of the aqueous acetone extract of Chinese herbal formula Modified Huo Luo Xiao Ling Danen_US
dc.typeArticleen_US
dc.identifier.emailLao, L: lxlao1@hku.hken_US
dc.identifier.authorityLao, L=rp01784en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.3736/jcim20100507en_US
dc.identifier.pmid20456842-
dc.identifier.scopuseid_2-s2.0-77952411406en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77952411406&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume8en_US
dc.identifier.issue5en_US
dc.identifier.spage438en_US
dc.identifier.epage447en_US
dc.publisher.placeChinaen_US
dc.identifier.scopusauthoridFan, AY=55240722400en_US
dc.identifier.scopusauthoridLao, L=7005681883en_US
dc.identifier.scopusauthoridZhang, RX=7404864527en_US
dc.identifier.scopusauthoridZhou, AN=55161019400en_US
dc.identifier.scopusauthoridBerman, BM=35458606800en_US

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