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

作　　者：Thananchanoke Rattanathada Tullayakorn Plengsuriyakarn Rathapon Asasujarit Anurak Cheoymang Juntra Karbwang Kesara Na-Bangchang 

机构地区：[1]Graduate Program in Bioclinical Science,Chulabhorn International College of Medicine,Thammasat University,Phaholyothin Road,Khlong Luang,Pathum Thanil2120,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

出　　处：《Journal of Chinese Pharmaceutical Sciences》2020年第4期280-293,共14页中国药学（英文版）

基　　金：Financial support by National Research Council of Thailand(NRCT);Center of Excellence in Pharmacology and Molecular Biology of Malaria;Cholangiocarcinoma and Chulabhorn International College of Medicine(CICM);Thammasat University,Thailand

摘　　要：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 formulated AL 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.

关 键 词：Atractylodes lancea(Thunb)DC. Capsule formulation ATRACTYLODIN Β-EUDESMOL CHOLANGIOCARCINOMA 

分 类 号：R943[医药卫生—药剂学]