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Journal of Chinese Pharmaceutical Sciences ›› 2020, Vol. 29 ›› Issue (4): 280-293.DOI: 10.5246/jcps.2020.04.027

• Original articles • Previous Articles     Next Articles

Development of oral pharmaceutical formulation of standardized crude ethanolic extract of Atractylodes lancea (Thunb) DC.

Thananchanoke Rattanathada1, Tullayakorn Plengsuriyakarn1,2, Rathapon Asasujarit3, Anurak Cheoymang1, Juntra Karbwang4, Kesara Na-Bangchang1,2,5*   

  1. 1. Graduate Program in Bioclinical Science, Chulabhorn International College of Medicine, Thammasat University, Phaholyothin Road, Khlong Luang, Pathum Thani12120, Thailand
    2. Center of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Thammasat University, Phaholyothin Road, Khlong Luang, Pathum Thani 12120, Thailand
    3. Department of Pharmaceutical Sciences, Faculty of Pharmacy, Thammasat University, Pathumthani 12120, Thailand
    4. Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan
    5. Drug Discovery and Development Center, Office of Advanced Science and Technology, Thammasat University, Pathumthani 12120, Thailand
  • Received:2019-12-11 Revised:2020-01-04 Online:2020-04-30 Published:2020-02-15
  • Contact: Tel.: +66-25644440 ext 1803, E-mail: kesaratmu@yahoo.com
  • Supported by:
    Financial support by National Research Council of Thailand (NRCT), Center of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma and Chulabhorn International College of Medicine (CICM), Thammasat University, Thailand.

Abstract:

Cholangiocarcinoma (CCA), the adenocarcinoma of the biliary duct, is commonly reported in Asia with the highest incidence in northeastern Thailand. Chemotherapy of this type of cancer is limited due to the lack of effective chemotherapeutic drugs. A series of previous studies support further research and development of Atractylodes lancea (Thunb) DC. (AL) as a potential candidate for the treatment of CCA as a crude ethanolic extract. In the present study, we aimed to develop an oral pharmaceutical formulation (capsule) of the standardized AL crude ethanolic extract for further clinical development in patients with CCA. Major steps included macroscopic and microscopic authentication of the AL rhizomes, preparation of standardized AL extract, preparation of oral pharmaceutical formulation (capsule) of the standardized AL extract, quantitative and qualitative analysis of the marker compound (atractylodin) in the formulated AL extract, evaluation of contaminations of heavy metals, pesticides residues, and microorganisms in the ground AL rhizomes and the formulated (capsule) powder of AL, physicochemical and pharmaceutical properties of the formulatedAL extract/capsule, and cytotoxicity evaluation of the formulated AL extract. Results of all evaluations confirmed satisfactory pharmaceutical properties of oral (capsule) formulation of the standardized AL extract.

Key words: Atractylodes lancea (Thunb) DC., Capsule formulation, Atractylodin, β-Eudesmol, Cholangiocarcinoma

CLC Number: 

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