Study on Modification of Dosage Forms of Guoganglong Tablets and Comparison between New and Old Dosage Forms
10.13359/j.cnki.gzxbtcm.2025.01.030
- VernacularTitle:过岗龙片剂型改良及新旧剂型对比研究
- Author:
Guantian DENG
1
;
Yuxiang SUN
;
Yunxia TENG
;
Zhizhong LIAO
;
Shuling WANG
Author Information
1. 广州中医药大学,广东广州 510006;广东罗浮山国药股份有限公司,广东省妇科中药企业重点实验室,广东惠州 516133
- Keywords:
Guoganglong;
preparation process;
modification of dosage forms;
quality standard;
pharmacological study;
constituents absorbed into blood
- From:
Journal of Guangzhou University of Traditional Chinese Medicine
2025;42(1):204-213
- CountryChina
- Language:Chinese
-
Abstract:
Objective To modify the dosage form of Guoganglong Sugar-Coated Tablets,and to investigate the chemical equivalence and pharmacodynamic equivalence between the new and old dosage forms of Guoganglong Tablets.Methods The preparation technology was screened by single-factor exploration with the indexes of hardness and dispersion uniformity,the quality standard was established by thin layer chromatography identification,high performance liquid chromatography(HPLC)content determination and charactertistics chromatograms,the constituents absorbed into blood were analyzed by ultra-high performance liquid chromatography quadrupole time of flight mass spectrometry(UHPLC-Q-TOF-MS),and the pharmacodynamics was evaluated by anti-inflammatory experiment and analgesic experiment in mice model with inflammatory pain.Results The molding process of Guoganglong Dispersible Tablets was determined.A thin layer chromatographic identification method was established.A method for detecting the content of Guoganglong Tablets and the charactertistic chromatograms was established by HPLC,and a total of 15 common peaks were identified,with the similarity of the new-old dosage forms being greater than 0.9.A total of 12 constituents absorbed into blood were identified.Guoganglong Tablets could alleviate swelling degree of toes in mice with inflammatory pain,reduce the levels of interleukin 6(IL-6)in serum,improve spleen index,and increase the thermal pain threshold and acetic acid twisting frequency in mice.Conclusion The prescription process of Guoganglong Dispersible Tablets is stable,the quality standard is feasible,the chemical composition and pharmacological actions between the new and old dosage forms are basically the same,and in terms of certain indexes,Dispersible Tablets of Guoganglongare superior to Sugar-Coated Tablets.
