【摘要】：目的:對鹽酸美克洛嗪口腔速溶膜進行了處方研究和優(yōu)化。方法:采用正交試驗方法,以HPMC E3用量、PEO用量、黃原膠用量和固含量比例為影響因素,以厚度均勻性、溶解時間、最大載荷和斷裂伸長率為評價指標,對鹽酸美克洛嗪口腔速溶膜進行了處方優(yōu)化;采用流延法的制備工藝并對主要工藝參數(shù)進行了研究。結果:HPMC E3用量、PEO用量、固含量比例分別是影響膜劑強度、溶解時間、厚度均勻性的關鍵因素。通過工藝研究確定了乳化分散、涂膜厚度、涂膜速度、干燥溫度等關鍵工藝的參數(shù)。結論:經(jīng)過處方工藝研究制得了符合質量要求的膜劑產(chǎn)品。
[Abstract]:Objective: to study and optimize the formulation of the oral instant membrane of meclozine hydrochloride. Methods: orthogonal test was carried out with HPMC E3 dosage, PEO dosage, xanthan gum dosage and solid content ratio as the influencing factors. The thickness uniformity, dissolution time, maximum load and elongation at break were taken as the evaluation indexes. The formulation of the oral instant membrane was optimized, and the main technological parameters were studied. Results: the dosage of HPMC E3, the amount of PEO and the ratio of solid content were the key factors affecting the strength, dissolution time and thickness uniformity of the film. The key process parameters such as emulsion dispersion, film thickness, coating speed and drying temperature were determined. Conclusion: the membrane products which meet the quality requirement were prepared by the study of prescription technology.
【作者單位】： 青島大學附屬醫(yī)院藥學部;山東省食品藥品監(jiān)督管理局審評認證中心;山東省藥學科學院;
【基金】：國家自然基金項目(編號:81672197)
【分類號】：R943
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本文編號：2266288