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| Optimization of preparation process of Trichosanthis Pericarpium micro-pills by orthogonal test and quality control study |
| Hits 28 Download times 11 Received:May 06, 2024 |
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| DOI
10.11656/j.issn.1673-9043.2024.10.05 |
| Key Words
Trichosanthis Pericarpium micro-pill;orthogonal test;quality control |
| Author Name | Affiliation | E-mail | | WU Xue | Wuhu Hospital of Traditional Chinese Medicine, Wuhu 241002, China | | | ZOU Chuncai | Wannan Medical College, Wuhu 241002, China | zouchc@163.com | | YAN Haiyan | Wannan Medical College, Wuhu 241002, China | | | KONG Yuzhuo | Wannan Medical College, Wuhu 241002, China | | | HUANG Yue | Wuhu Food and Drug Inspection Center, Wuhu 241002, China | |
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| Abstract
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| [Objective] To optimize the preparation process of Trichosanthis Pericarpium micro-pills pellets and establish a quality control method. [Methods] Trichosanthis Pericarpium micro-pellets were produced by extrusion-spheronisaion method， the roundness， Hausner’ s ratio， friability and yield of the micro-pills were used as indicators. On the basis of single-factor experimental analysis， the prescription preparation process was optimized by orthogonal test and the optimal preparation process was verified. The pellet is described in terms of appearance， and the nucleoside components therein were specified， using chemical reaction method and thin-layer chromatography and the level of parameters such as roundness， water content， particle size and dissolution degree of Trichosanthis Pericarpiu micro-pills were specified. Simultaneously， high-performance liquid chromatography was used to quantitatively analyze more than five nucleoside components， including adenosine， in Trichosanthis Pericarpium micro-pills. [Results] The optimum process for the preparation of Trichosanthis Pericarpium micro-pills：wetting agent was water， loading capacity was 40%， and excipients（microcrystalline cellulose∶starch=2∶1）. The process parameters for preparing Trichosanthis Pericarpium micro-pills were： rounding frequency was 25 Hz， rounding time was 3 min. Chemical identification and thin-layer identification were highly exclusive. The roundness， moisture， particle size and dissolution degree of Trichosanthis Pericarpium micro-pills were in accordance with the 2020 edition of the Chinese Pharmacopoeia. The similarity of the fingerprint profiles of 10 batches of Trichosanthis Pericarpium micro-pills was evaluated with a mean value of 0.998 7， and the relative standard deviation（RSD） was 0.067%. The content determined was 38.28 μg/g for uracil， 19.34 μg/g for xanthine， 56.23 μg/g for adenosine， 105.46 μg/g for guanosine and 1.96 μg/g for thymidine. [Conclusion] The process of preparation of Trichosanthis Pericarpium micro-pills is feasible and the quality control is comprehensive. |
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