中国中药杂志

2017, v.42(16) 3136-3142

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没食子栓剂成型工艺研究
Process of gallnut suppository preparation

木巴拉克·伊明江;程雪梅;娜祖克·阿不都;阿卜杜热合曼·努如拉;季志红;哈木拉提·吾甫尔;
IMINJAN Mubarak;CHENG Xue-mei;ABUDU Nazuk;NURULLA Abdurahman;JI Zhi-hong;UPUR Halmurat;Xinjiang Qikang Habo Uyghur Medicine Company Limited by Shares;College of Pharmacy,Xinjiang Medical University;Laboratory for Standardization of Chinese Medicines,School of Pharmacy,Shanghai University of Traditional Chinese Medicine;Xinjiang Uygur Autonomous Region Food and Drug Administration;

摘要(Abstract):

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 main objective was to research the process of gallnut suppository preparation with its water extract as the main drug,and evaluate its irritation to rectal mucosa. gallnut extract was obtained by decocting method,and its suppository preparation was obtained by fusion method with semi-synthetic aliphatic esters and rose flower oil as the matrix. Weight difference and in vitro melting time limit of the suppository were assayed and UV-Vis was used to determine the contents of polyphenols,tannin and saccharide. The irritation to colon mucosa was evaluated after successive administration of 14 days to New Zealand white rabbits. Finally,the prescription compositions were determined: semi-synthetic aliphatic esters and rose flower oil with the ratio of 2: 1 as the proper matrix,with the drug loading of 54%. The prepared suppository was brown,conical and smooth. The weight difference was( 1. 43 ± 0. 03) g,with an average melting time limit of( 17 ± 2) min. The Contents of Polyphenols,tannic and polysaccharide were 332. 4,245. 0,3. 3 mg·g~(-1)respectively in each suppository. The results also showed that the continuous administration had no irritation to rectal mucosa. It can be concluded that the suppository was an acceptable administrate form,whose preparation process was easily controlled,and with no irritation to rectum mucosa.

关键词(KeyWords): 成型工艺;没食子;栓剂;黏膜刺激性
preparation process;gallnut;suppository;mucosal irritation

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作者(Author): 木巴拉克·伊明江;程雪梅;娜祖克·阿不都;阿卜杜热合曼·努如拉;季志红;哈木拉提·吾甫尔;
IMINJAN Mubarak;CHENG Xue-mei;ABUDU Nazuk;NURULLA Abdurahman;JI Zhi-hong;UPUR Halmurat;Xinjiang Qikang Habo Uyghur Medicine Company Limited by Shares;College of Pharmacy,Xinjiang Medical University;Laboratory for Standardization of Chinese Medicines,School of Pharmacy,Shanghai University of Traditional Chinese Medicine;Xinjiang Uygur Autonomous Region Food and Drug Administration;

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