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      Improved stability and oral bioavailability of Ganneng dropping pills following transforming lignans of herpeto-spermum caudigerum into nanosuspensions

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          Abstract

          The present study was designed to improve storage stability and oral bioavailability of Ganneng dropping pills (GNDP) by transforming lignans of Herpetospermum caudigerum (HL) composed of herpetrione (HPE) and herpetin (HPN) into nanosuspen-sion (HL-NS), the main active ingredient of GNDP, HL-NS was prepared by high pressure homogenization and lyophilized to transform into solid nanoparticles (HL nanoparticles), and then the formulated HL nanoparticles were perfused into matrix to obtain NS-GNDP by melting method. For a period of 3 months, the content uniformity, storage stability and pharmacokinetics test in vivo of NS-GNDP were evaluated and compared with regular GNDP at room temperature. The results demonstrated that uniformity of dosage units of NS-GNDP was acceptable according to the criteria of Chinese Pharmacopoeia 2015J. Physical stability of NS-GNDP was investigated systemically using photon correlation spectroscopy (PCS), zeta potential measurement, and scanning electron microscopy (SEM). There was a slight increase in particles and PI of HL-NS re-dispersed from NS-GNDP after storage for 3 months, compared with new formulated NS-GNDP, which indicated a good redispersibility of the NS-GNDP containing HL-NS after storage. Besides, chemical stability of NS-GNDP was studied and the results revealed that HPE and HPN degradation was less when compared with that of GNDP, providing more than 99% of drug residue after storage for 3 months. In the dissolution test in vitro, NS-GNDP remarkably exhibited an increased dissolution velocity compared with GNDP and no distinct dissolution difference existed within 3 months. The pharmacokinetic study showed that HPE and HPN in NS-GNDP exhibited a significant increase in AUC 0-t, C max and decrease in T max when compared with regular GNDP. These results indicated that NS-GNDP possessed superiority with improved storage stability and increased dissolution rate and oral bioavailability.

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          Author and article information

          Journal
          CJNM
          Chinese Journal of Natural Medicines
          Elsevier
          1875-5364
          20 January 2018
          : 16
          : 1
          : 70-80
          Affiliations
          1Department of Pharmacy, Air Force General Hospital of PLA, Beijing 100142, China
          2Department of Pharmacy, Guangyuan Central Hospital, Guanyuan 628000, China
          3Department of Pharmacy, Shuangliu District Maternal and Child Health Hospital, Chengdu 610075, China
          4Chengdu Institute of Chinese Herbal Medicine, Chengdu 610045, China
          Author notes
          *Corresponding authors: YUAN Hai-Long, Tel: 86-10-66928557, Fax: 86-10-63879589, E-mails: yhlpharm@ 123456126.com ; XU Rong, lxyynz@ 123456126.com

          These authors have no conflict of interest to declare.

          Article
          S1875-5364(18)30031-1
          10.1016/S1875-5364(18)30031-1
          Copyright © 2018 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.
          Funding
          Funded by: National Key New Drugs Innovation Foundation
          Award ID: 2016X09101073
          Funded by: National Natural Science Foundation of China
          Award ID: 81573697
          This work was financially supported by the National Key New Drugs Innovation Foundation (No. 2016X09101073) and the National Natural Science Foundation of China (No. 81573697).

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