较人参皂苷Rg3生物高效的新型制剂-竹节参片研究

doi:10.5246/jcps.2019.09.062

中国药学(英文版) ›› 2019, Vol. 28 ›› Issue (9): 650-664.DOI: 10.5246/jcps.2019.09.062

较人参皂苷Rg3生物高效的新型制剂-竹节参片研究

沈新宇^1,2, 王星辰³, 顾彩虹⁴, 严峰⁵, 潘博^1,2, 高利增^1,2, 颜丙春^1,2*, 刘岐^1,2*, 胡荣^1,2*

1. 扬州大学医学院 (转化医学研究院), 江苏扬州 225001
2. 江苏省中西医结合老年病防治重点实验室, 江苏扬州 225001
3. 江苏省如皋市人民医院, 江苏如皋 226500
4. 江苏联环药业集团有限公司, 江苏扬州 225001
5. 江苏扬农化工集团有限公司, 江苏扬州 225001

收稿日期:2019-06-28 修回日期:2019-07-19 出版日期:2019-09-30 发布日期:2019-08-15
通讯作者: Tel.: +86-13901457381; +86-13665200137; +86-18166822359, E-mail: bcyan@yzu.edu.cn; liuqi@yzu.edu.cn; ronghu@yzu.edu.cn
基金资助:
Postgraduate Research ?Innovation Program of Yangzhou University (Grant No. XKYCX18_128).

A novel preparation of Panax japonicas with high bioequivalence of ginsenoside Rg3

Xinyu Shen^1,2, Xingchen Wang³, Caihong Gu⁴, Feng Yan⁵, Bo Pan^1,2, Lizeng Gao^1,2, Bingchun Yan^1,2*, Qi Liu^1,2*, Rong Hu^1,2*

1. Institute of Translational Medicine, Medical College, Yangzhou University, Yangzhou 225001, China
2. Jiangsu Key Laboratory of Integrated Traditional Chinese and Western Medicine for Prevention and Treatment of Senile Diseases, Yangzhou University, Yangzhou 225001, China
3. The People’s Hospital of Rugao, Rugao 226500, China
4. Jiangsu Lianhuan Pharmaceutical Group Co., Ltd., Yangzhou 225009, China
5. Jiangsu Yangnong Chemical Group Co., Ltd., Yangzhou 225009, China

Received:2019-06-28 Revised:2019-07-19 Online:2019-09-30 Published:2019-08-15
Contact: Tel.: +86-13901457381; +86-13665200137; +86-18166822359, E-mail: bcyan@yzu.edu.cn; liuqi@yzu.edu.cn; ronghu@yzu.edu.cn
Supported by:
Postgraduate Research ?Innovation Program of Yangzhou University (Grant No. XKYCX18_128).

摘要/Abstract

摘要：

本文制备竹节参片并进行生物等效性考察。采用超微粉碎-湿法造粒制备竹节参片;按药典规定进行质量检查;高效液相色谱法测定自制竹节参片和人参皂苷Rg3单剂量灌胃后24小时大鼠的血药浓度, DAS 2.0软件计算分析其药动学参数和相对生物利用度。结果发现,自制竹节参片质量检查各项符合2015版药典要求,与人参皂苷Rg3相比具有较高的生物利用度。因此可知,本实验竹节参片制备工艺合理、质量可控,口服吸收利用度好,为竹节参片的工业化生产和临床应用提供参考。

关键词: 竹节参片, 片剂质量, 人参皂苷, 生物等效性

Abstract:

In the present study, we aimed to prepare Panax japonicus tablets and carry out quality inspection. Panax japonicus tablets were prepared by ultrafine pulverization-wet granulation, and quality inspection was carried out according to Pharmacopoeia regulations. The plasma concentration of animals with self-made Panax japonicus tablets or ginsenoside Rg3 in single-doseintragastric administration was determined by high-performance liquid chromatography (HPLC). The pharmacokinetic parameters and relative bioavailability were calculated by DAS 2.0 software.The quality inspection of self-made Panax japonicus tablets met the requirements of Chinese Pharmacopoeia (2015 edition), and this preparation had high bioequivalence of ginsenoside Rg3. The preparation of Panax japonicus tablets was reasonable and highly qualified. Moreover, this new Panax japonicus preparation showed better profiles in oral absorption and utilization. This study provided evidence for the industrial production and clinical application of Panax japonicus tablets.

Key words: Panax japonicas tablets, Tablet quality, Ginsenoside Rg3, Bioequivalence

中图分类号:

R943

Supporting:

沈新宇, 王星辰, 顾彩虹, 严峰, 潘博, 高利增, 颜丙春, 刘岐, 胡荣. 较人参皂苷Rg3生物高效的新型制剂-竹节参片研究[J]. 中国药学(英文版), 2019, 28(9): 650-664.

Xinyu Shen, Xingchen Wang, Caihong Gu, Feng Yan, Bo Pan, Lizeng Gao, Bingchun Yan, Qi Liu, Rong Hu. A novel preparation of Panax japonicas with high bioequivalence of ginsenoside Rg3[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(9): 650-664.

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较人参皂苷Rg3生物高效的新型制剂-竹节参片研究

A novel preparation of Panax japonicas with high bioequivalence of ginsenoside Rg3

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