氫溴酸右美沙芬胃漂浮緩釋片的研制.pdf

1、河北大學(xué)碩士學(xué)位論文氫溴酸右美沙芬胃漂浮緩釋片的研制姓名：李莉申請(qǐng)學(xué)位級(jí)別：碩士專業(yè)：藥物分析學(xué)指導(dǎo)教師：胡連棟2011-06Abstract II Abstract The floating drug delivery systems designed on the basis of hydrodynamically balanced system, which enable prolonged and continuous inpu

2、t of the drug to the upper parts of the gastrointestinal tract and improve the bioavailability of medications that are characterized by a narrow absorption window. A new strategy is proposed for the development of gastro

3、retentive dosage forms for dextromethorphan hydrobromide (DMB) preferably once daily. The design of the delivery system was based on the sustained release formulation, with floating and swelling features in order to prol

4、ong the gastric retention time, reduce the dosage frequency and increase patient compliance. According to the literature, ultraviolet spectrotometry method was developed for determination the release of DMB during the st

5、udy of in vitro release. High performance liquid chrmatograhy (HPLC) method was developed for assaying the content of DMB in the DMB sustained-release (SR) floating tablet. The analytical methods above were proved to be

6、simple, reliable and sensitive. In the floating test, different concentrations of hydrochloric acid solution (pH 1.2, 3.0, 5.0) were used as floating medium. The floating lag time and the total floating time were selecet

7、ed as determination index. These researches provide a reliable basis for the next formulation study and stability study. Basing on the preformulation study, influence of formulation and manufacture on the drug release an

8、d floating characteristics was investicated and an orthogonal experiment design method was used to select the optimized formulation. The optimized tablets were prepared by wet granulation method using hydroxypropyl methy

9、lcellulose (HPMC) K4M as hydrocolloid gelling agent (25 mg), sodium bicarbonate as gas-generating agent (20 mg), hexadecanol as floating assistant agent (18 mg), microcrystalline cellulose (MCC) and lactose as bulking ag

10、ent, 4% ethanol solution of ethylcellulose (w/v) as binding agent. The prepared tablets could float within 3min and maintain for more than 24 h. Drug release at 12 h was more than 85%.The data of physical parameters like

11、 weight, hardness, friability and drug content were all lie within the limits. The release mechanism of DMB was studied by comparing with Zero-order Model, First-order Model, Higuchi Model, Hixson-Crowell Model and Ritg