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| Preparation and in vivo pharmacokinetic evaluation of Shuanghuanglian immediate-release orally disintegrating tablets and dispersible tablets |
| Hits 329 Download times 112 Received:July 04, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.11.11 |
| Key Words
immediate-release preparation;orally disintegrating tablet;dispersible tablet;pharmacokinetics;Shuanghuanglian preparation;UPLC-Q-Orbitrap-MS |
| Author Name | Affiliation | E-mail | | XU Guangjing | College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China | | | WU Yujie | College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Xiaoyu | College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China | | | SONG Saisai | College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China | | | LIU Rui | College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China | liurui@tjutcm.edu.cn | | LI Zheng | College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China | |
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| Abstract
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| [Objective] Shuanghuanglian orally disintegrating tablets（SHL-ODT） and dispersible tablets（SHL-DT） were developed to achieve rapid onset of action and improve bioavailability. [Methods] Liquid chromatography-mass spectrometry（LC-MS） technique was used to qualitatively identify the components in SHL and to lay the experimental foundation for the selection of components for pharmacokinetic quantification. Two immediate-release oral formulations were prepared and subjected to characterization，in vitro dissolution and pharmacokinetic studies. [Results] Eight compounds，neochlorogenic acid，chlorogenic acid，rutin，forsythoside A，luteoloside，baicalin，phillyrin，and oroxylin A 7-O-beta-D-glucuronide，were selected as the index components for pharmacokinetic studies. The disintegration time of SHL-ODT was（52.91±2.21） s，and the average dispersion time of SHL-DT was（119.8±2.31） s. Both formulations met and exceeded the relevant requirements for disintegration time，dispersion uniformity，hardness，weight variation，brittleness，and dissolution rate as specified in the Chinese Pharmacopoeia（2020 edition）. In vitro dissolution experiments showed that the dissolution rates of the major components（neochlorogenic acid，baicalin，phillyrin） in SHL-ODT and SHL-DT were both approximately 98%. Pharmacokinetic analysis indicated that the Cmax，Tmax，and AUC（0-t） of forsythiaside in SHL-ODT were 2.44 times，0.69 times，and 1.87 times（P<0.05） higher than those of SHL ordinary tablets（SHL-OT），respectively. In SHL-DT，the Cmax，Tmax，and AUC（0-t） of phillyrin were 2.26 times（P<0.05），0.56 times，and 2.12 times（P<0.01） higher than those of SHL-OT，respectively. Additionally，SHL-DT showed a higher AUC compared to SHL-ODT. [Conclusion] Both fast-release oral SHL formulations significantly enhanced the onset of action of the drug and bioavailability，providing a safer and more efficient alternative for clinical application of SHL preparations. |
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