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以没食子水提浸膏为主药,研究其栓剂成型工艺,并对其直肠黏膜刺激性进行评价。用煎煮法制得没食子浸膏,以半合成脂肪酸甘油酯和玫瑰花油为基质,热熔法制备没食子栓剂。测定栓剂重量差异和体外融变时限,UV-Vis考察药效成分。用新西兰大白兔为受试对象,连续14 d使用没食子直肠栓剂,取结肠组织,病理学评分。最终确定制剂的处方组成为:以半合成脂肪酸酯和玫瑰花油(2∶1)为基质,载药量54%,制得的制剂外形光滑圆锥形,呈褐色;质量差异(1.43±0.03)g,平均融变时限(17±2)min;每枚栓剂平均含多酚332.4 mg·g~(-1)、鞣质245.0 mg·g~(-1)、多糖3.3 mg·g~(-1),连续给药对直肠黏膜无刺激。该制剂,处方设计合理、制备工艺简便、剂型适宜、给药方式符合临床使用目的;制剂对给药部位黏膜无刺激性。
The extract of gallbladder water-based medicine to study the suppository molding process, and rectal mucosal irritation were evaluated. Ginger extract obtained by decoction, semi-synthetic fatty acid glycerides and rose oil as the matrix, hot melt method for the preparation of gallocater suppository. Determination of suppository weight difference and in vitro melting time limit, UV-Vis study the efficacy of ingredients. New Zealand white rabbits were used as test subjects for 14 consecutive days. The formulation of the final formulation was as follows: the semi-synthetic fatty acid ester and rose oil (2: 1) as the matrix, drug loading 54%, the preparation was smooth conical shape, brown; quality difference ) g, the average melting time (17 ± 2) min; each suppository contains polyphenols 332.4 mg · g ~ (-1), tannin 245.0 mg · g -1, polysaccharides 3.3 mg · g ~ -1), continuous administration of rectal mucosa without stimulation. The preparation has the advantages of reasonable formulation prescription, simple preparation process, suitable dosage form and administration mode in line with clinical purposes; and the preparation has no irritation to the mucosa of the administration site.