Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules
Objective To preliminarily screen the preparation process of Ji Shenqi anti-cancer granules (JSQ) and establish the quality standard. Methods The excipient types were examined and the formulation moulding process was preferred using the soft material making situation, particle yield, angle of repose...
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Editorial Office of Journal of Guangxi Medical University
2025-02-01
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| Series: | Guangxi Yike Daxue xuebao |
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| Online Access: | https://journal.gxmu.edu.cn/article/doi/10.16190/j.cnki.45-1211/r.2025.01.018 |
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| author | LI Liang WU Huafeng HE Bizuan PANG Liangcheng QIN Jiuyun TONG Jianjun TANG Meihua JIANG Weizhe FU Shujie |
| author_facet | LI Liang WU Huafeng HE Bizuan PANG Liangcheng QIN Jiuyun TONG Jianjun TANG Meihua JIANG Weizhe FU Shujie |
| author_sort | LI Liang |
| collection | DOAJ |
| description | Objective To preliminarily screen the preparation process of Ji Shenqi anti-cancer granules (JSQ) and establish the quality standard. Methods The excipient types were examined and the formulation moulding process was preferred using the soft material making situation, particle yield, angle of repose and solubility as evaluation indexes. Thin-layer chromatography (TLC) was used for the qualitative identification of Suberect Spatholobus Stem, ginseng, and astragalus; high performance liquid chromatography (HPLC) was used to determine the mass fractions of ginsenosides (Rg1, Re, and Rb1) and catechins in the preparations. Results The excipients were soluble starch and mannitol, and the best preparation process was that the ratio of main drug to soluble starch and mannitol was 1∶1.5∶0.3. Combined with the previous research results of the extraction process by the research group, the preparation process of JSQ was as follows: The prescription amount of herbs with 9 times the amount of water was soaked for 80 min for the first time, and the remaining two times were added with 8 times the amount of water; each time was decocted for 1 h; after a total of three extractions, the filtrates were filtered and combined, and then concentrated under reduced pressure to achieve the relative density in the range of 1.20-1.30; the thick paste was then mixed with excipients (soluble starch: mannitol=1.5∶0.3) in accordance with the ratio of drugs and auxiliaries for 1∶1.8. The mixture was evenly combined to make a soft material, which was then granulated, dried, and granulated again to obtain the final product. The TLC spots were clear, well-separated, negative and non-interfering, with strong specificity; the quality check was in accordance with the provisions of the Pharmacopoeia; the results showed that the linear ranges of the mass concentrations of ginsenosides (Rg1, Re and Rb1) and catechins were 6.96-139.20 μg/mL, 7.51-150.20 μg/mL, 7.35-147.00 μg/mL and 5.86-187.52 μg/ mL, respectively (all r > 0.99), with good linear relationship with the peak area; the average recoveries were 102.72%, 103.81%, 99.66% and 106.29%, with RSDs of 1.18%, 2.33%, 1.58% and 1.64%, respectively. The average contents of ginsenosides and catechins in the three batches of samples were 446.14 μg/g, 475.91 μg/g, 559.71 μg/g and 50.40 μg/g, respectively, and the amount of catechins in this product was not less than 40.32 μg per 1 g, and the amount of ginsenosides (Rg1, Re, and Rb1) was not less than 356.91 μg, 380.73 μg and 447.77 μg. Conclusion The process is stable and feasible, and the established TLC and HPLC methods are exclusive, sensitive and reproducible, laying a foundation for the subsequent research and development and quality control. |
| format | Article |
| id | doaj-art-e6214980eb1d44658114a4b3b7f70ed5 |
| institution | OA Journals |
| issn | 1005-930X |
| language | zho |
| publishDate | 2025-02-01 |
| publisher | Editorial Office of Journal of Guangxi Medical University |
| record_format | Article |
| series | Guangxi Yike Daxue xuebao |
| spelling | doaj-art-e6214980eb1d44658114a4b3b7f70ed52025-08-20T02:27:29ZzhoEditorial Office of Journal of Guangxi Medical UniversityGuangxi Yike Daxue xuebao1005-930X2025-02-0142113814710.16190/j.cnki.45-1211/r.2025.01.018gxykdxxb-42-1-138Study on the preparation process and quality standard of Ji Shenqi anti-cancer granulesLI Liang0WU Huafeng1HE Bizuan2PANG Liangcheng3QIN Jiuyun4TONG Jianjun5TANG Meihua6JIANG Weizhe7FU Shujie8The First People's Hospital of Yulin, Yulin 537000, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaGuangxi Medical University, Nanning 530021, ChinaObjective To preliminarily screen the preparation process of Ji Shenqi anti-cancer granules (JSQ) and establish the quality standard. Methods The excipient types were examined and the formulation moulding process was preferred using the soft material making situation, particle yield, angle of repose and solubility as evaluation indexes. Thin-layer chromatography (TLC) was used for the qualitative identification of Suberect Spatholobus Stem, ginseng, and astragalus; high performance liquid chromatography (HPLC) was used to determine the mass fractions of ginsenosides (Rg1, Re, and Rb1) and catechins in the preparations. Results The excipients were soluble starch and mannitol, and the best preparation process was that the ratio of main drug to soluble starch and mannitol was 1∶1.5∶0.3. Combined with the previous research results of the extraction process by the research group, the preparation process of JSQ was as follows: The prescription amount of herbs with 9 times the amount of water was soaked for 80 min for the first time, and the remaining two times were added with 8 times the amount of water; each time was decocted for 1 h; after a total of three extractions, the filtrates were filtered and combined, and then concentrated under reduced pressure to achieve the relative density in the range of 1.20-1.30; the thick paste was then mixed with excipients (soluble starch: mannitol=1.5∶0.3) in accordance with the ratio of drugs and auxiliaries for 1∶1.8. The mixture was evenly combined to make a soft material, which was then granulated, dried, and granulated again to obtain the final product. The TLC spots were clear, well-separated, negative and non-interfering, with strong specificity; the quality check was in accordance with the provisions of the Pharmacopoeia; the results showed that the linear ranges of the mass concentrations of ginsenosides (Rg1, Re and Rb1) and catechins were 6.96-139.20 μg/mL, 7.51-150.20 μg/mL, 7.35-147.00 μg/mL and 5.86-187.52 μg/ mL, respectively (all r > 0.99), with good linear relationship with the peak area; the average recoveries were 102.72%, 103.81%, 99.66% and 106.29%, with RSDs of 1.18%, 2.33%, 1.58% and 1.64%, respectively. The average contents of ginsenosides and catechins in the three batches of samples were 446.14 μg/g, 475.91 μg/g, 559.71 μg/g and 50.40 μg/g, respectively, and the amount of catechins in this product was not less than 40.32 μg per 1 g, and the amount of ginsenosides (Rg1, Re, and Rb1) was not less than 356.91 μg, 380.73 μg and 447.77 μg. Conclusion The process is stable and feasible, and the established TLC and HPLC methods are exclusive, sensitive and reproducible, laying a foundation for the subsequent research and development and quality control.https://journal.gxmu.edu.cn/article/doi/10.16190/j.cnki.45-1211/r.2025.01.018ji shenqi anti-cancer granulespreparation processquality standardthin-layer chromatographyhigh performance liquid chromatography |
| spellingShingle | LI Liang WU Huafeng HE Bizuan PANG Liangcheng QIN Jiuyun TONG Jianjun TANG Meihua JIANG Weizhe FU Shujie Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules Guangxi Yike Daxue xuebao ji shenqi anti-cancer granules preparation process quality standard thin-layer chromatography high performance liquid chromatography |
| title | Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules |
| title_full | Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules |
| title_fullStr | Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules |
| title_full_unstemmed | Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules |
| title_short | Study on the preparation process and quality standard of Ji Shenqi anti-cancer granules |
| title_sort | study on the preparation process and quality standard of ji shenqi anti cancer granules |
| topic | ji shenqi anti-cancer granules preparation process quality standard thin-layer chromatography high performance liquid chromatography |
| url | https://journal.gxmu.edu.cn/article/doi/10.16190/j.cnki.45-1211/r.2025.01.018 |
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