Stability Of Compound Hawthorn Preparation By Fingerprints

Reasearh of stability of Compound Hawthorn preparations was developed by means of fingerprint as well as of traditional method. Thereafter, The standard for its quality control was established. The main work in this dissertation was focused on the following aspects:1. A novel procedure for quantitative analysis of the two-dimensional data obtained from HPLC/MS is investigated to determine the stability of the chemical components of the preparations. The traditional methods for detection of Stilbene glucoside and total flavonids were also emended. All of the methods were reeligible, accurate and reliable.2. The content of main effective components in the pills and oral liquid were detected after the preparations were undergoing 40℃, RH 75% and exposed to light. its appearance and content have no obvious variety except the oral liquid. Stilbene glucoside in oral solution decreased significantly in all of the three tests(11% and 7%), When in pills, it's stability can obviously promoted (no more than 5%); Total flavonids have shown a good stability in the traditional tests(8% and 6%), but in fingerprints, it showed up different changing law. All of the contents proved to be most stable in coated pills, and lest stable in oral solution; contents of anthraquinones are also varies in stability compared to the total flavonids with a 50% decrease when exposed to light in oral solution, but have a good stability in pills.3. The preliminary stability(under the condition of 30℃,RH 65%) of the preparations was tested for three months, its appearance and content have no obvious variety; Change of Stilbene glucoside showed up the same changing law in the two different means of detection; Accroding to the results of the flavonids'detection, the coated pills were also proved to be the most stability one. Flavonids are unstable in oral solution with a decrease of 50%, and a decrease of 25% in pills, As well as Anthraquinones.According to the systematical research of Hawthorn preparations. Dropping pills were proved to be the perfect form of Compound Hawthorn preparation, and the pills should be preserved in dark and shady place, sealed.