In vitro dissolution of Qishe Pills
10.7501/j.issn.0253-2670.2013.13.010
- Author:
Qiu-Fen LI
1
Author Information
1. Shanghai University of Traditional Chinese Medicine
- Publication Type:Journal Article
- Keywords:
Calycosin;
Dissolution model;
Formononetin;
Qishe Pills;
Senkyunolide A;
Similarity
- From:
Chinese Traditional and Herbal Drugs
2013;44(13):1748-1755
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To study the dissolution characteristics of Qishe Pills in two kinds of media and to lay the foundation for the establishment of quality evaluation methods by stripping method. Methods: With 1% Polysorbate 80 solution and 0.5% sodium dodecyl sulfate (SDS) as media, the sinomenine, calycosin-7-glucoside, senkyunolide I, ononin, calycosin, formononetin, and senkyunolide A, determined by HPLC, were used as indexes. The cumulative dissolution of Qishe Pills at different time was investigated, and the dissolvable situation of respective components in the different media was compared simultaneously. The dissolution models were fit and the dissolution parameters were obtained. Results: The linear ranges of sinomenine, calycosin-7-glucoside, senkyunolide I, ononin, calycosin, formononetin, and senkyunolide A were 0.718-10.770, 0.190-2.850, 0.100-1.500 μg, 31.4-471.0, 34.0-510.0, 33.6-504.0, and 40.0-600.0 ng. In 45 min, the cumulative dissolving rates of the respective components were above 90% (calycosin-7-glucoside excepted) with 1% Polysorbate 80 solution as medium, while they were slower with 0.5% SDS as medium. The Weibull model of the seven components was good in the two kinds of media, while other model of the individual components had higher correlation in the different media. The f2 similarity factor method indicated that the dissolution of the same component of Qishe Pills has no similarity in the two different media. Conclusion: The dissolvable speed of each component with 1% Polysorbate 80 as medium was faster than that with 0.5% SDS as medium obviously. With 1% Polysorbate 80 as medium, the dissolution of each component had similarity and synchronism. Using 1% Polysorbate 80 solution as medium is applicable to research the dissolution of Qishe Pills.
