Effect of Process Change on in Vitro Release and Percutaneous Penetration of Zushima Guanjie Zhitong Gao
10.13422/j.cnki.syfjx.20202151
- VernacularTitle:工艺变更对祖师麻关节止痛膏体外释放及经皮渗透的影响
- Author:
Mao-bo DU
1
;
Zhu-hong MAO
2
;
Shuo SHEN
1
;
Yao YAO
1
;
Ai-ping HE
1
;
Jia-qiang WANG
2
;
Wen-tong CAO
2
;
Shu-zhi LIU
1
Author Information
1. Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences， Beijing 100700，China
2. Gansu Taikang Pharmaceutical Co. Ltd.，Lanzhou 733000，China
- Publication Type:Research Article
- Keywords:
Zushima Guanjie Zhitong Gao;
7，8-dihydroxycoumarin;
methyl salicylate;
in vitro release;
percutaneous penetration;
process change;
dynamic behavior
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2021;27(8):135-141
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the effect of the production process of Zushima Guanjie Zhitong Gao from solvent method to hot-pressed method on in vitro kinetic behavior of this preparation. Method:Solvent and hot-pressed methods were used to prepare three batches of samples above pilot scale， and in vitro release and percutaneous penetration of the index components （7，8-dihydroxycoumarin and methyl salicylate） in Zushima Guanjie Zhitong Gao were investigated by modified Franz diffusing cells. Result:The contents of 7，8-dihydroxycoumarin and methyl salicylate in Zushima Guanjie Zhitong Gao prepared by solvent method were 73.72， 494.67 μg/patch， and their contents in hot-pressed method samples were 159.21， 2 638.99 μg/patch， respectively. In the solvent method samples， the average cumulative release amounts of 7，8-dihydroxycoumarin and methyl salicylate in 24 h were 2.04， 12.21 μg， and their average cumulative release amounts in 24 h of hot-pressed method samples were 2.16， 36.24 μg， respectively. In the solvent method samples， the average cumulative permeation amounts of 7，8-dihydroxycoumarin and methyl salicylate in 24 h were 0.38， 2.79 μg， and they were 0.40， 7.49 μg in hot-pressed method samples. The cumulative release and permeation amounts in 24 h of 7，8-dihydroxycoumarin in the hot-pressed method samples were basically the same as those of the solvent method samples， but the cumulative release and permeation amounts in 24 h of methyl salicylate in the hot-pressed method samples were significantly higher than those of the solvent method samples （P<0.05）. Conclusion:The retention of 7，8-dihydroxycoumarin and methyl salicylate by hot-pressed method is better than that of the solvent method. The process change has no significant effect on the in vitro kinetics of 7，8-dihydroxycoumarin in Zushima Guanjie Zhitong Gao， however， after the change from the solvent method to the hot-pressed method， the methyl salicylate in this preparation has a higher cumulative release and permeation amounts.
