| Summary: | 碩士 === 嘉南藥理大學 === 藥學系 === 104 === Topical steroid preparations are applied in treatment for diverse skin diseases clinically. In this thesis, the chemical stability of hydrocortisone acetate (HCA) in ointment bases was studied. By means of stability tests of different bases dissolving HCA with high temperature, we want to figure out what makes hydrocortisone acetate (HCA) instable at liquid state. Besides, while operating high performance liquid chromatography (HPLC), an analytic method had been developed, offers a way for drug industry at qualitative control.
There were 4 common bases being chosen, including water, water-washable (PEG 400 and PG), and oil vehicles. All of them were under 60℃ temperature conditions. Then, we evaluated their physical and chemical properties. HPLC was used for analysis the content of HCA. At 60℃ temperature, HCA is practically insoluble with water and Vaseline oil, while it is slightly soluble in PEG400 and PG.
Higuchi model can be described for the kinetic of degradation of HCA at saturated state in vehicles. The more amounts of HCA dissolved in vehicles, the degradation rate is larger. A first-order model was fitting to an unsaturated state. As HCA is unstable in PEG400 and PG, it’s important to think carefully on formulation with pharmaceuticals, because the influence level of vehicles affect in HCA: PG>PEG400>water>oil. In summary, we concluded that the recommended dosage form of HCA is made of suspension after comparing the saturated and unsaturated state for prolonging the stability.
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