实验研究

磷酸川芎嗪滴丸溶出度测定方法的研究

孟薇

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【摘要】  【摘要】目的 探究磷酸川芎嗪滴丸溶出度测定方式。方法 选择6批磷酸川芎嗪滴丸,分析对比使用水、磷酸盐缓冲液(pH=6.8)、醋酸盐缓冲液(pH=4.5)、盐酸溶液(pH=1.2)的溶出曲线,之后制定检验溶出度方式:以80%的标示量为限度、HPLC测定、取样20分钟、500 mL的水为溶出介质、转速为每分钟50转。

【关键字】  磷酸川芎嗪滴丸,溶出度,测定,溶出曲线

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[Abstract] Objective To explore the dissolution determination method of ligustrazine phosphate dropping pills. Methods Six batches of ligustrazine phosphate dropping pills were selected and the dissolution curves of water, phosphate buffer (pH=6.8), acetate buffer (pH=4.5) and hydrochloric acid solution (pH=1.2) were analyzed and compared. The dissolution test methods were formulated as follows: 80% of the labeling amount was limited, determination by HPLC, sampling 20 minutes, 500 mL of water as dissolution medium, and speed was 50 revolutions per minute. Results There was no significant difference in the dissolution curves of 6 batches of ligustrazine phosphate dropping pills in four dissolution media: water, phosphate buffer (pH=6.8), acetate buffer (pH=4.5) and hydrochloric acid solution (pH=1.2). All the six batches of ligustrazine phosphate dropping pills could be dissolved in 15 minutes. Conclusion The dissolution rate of 6 batches of ligustrazine phosphate dropping pills determined by four dissolution media is reliable and accurate, which is helpful to control the quality of drugs and provide reference data for drug dissolution.

磷酸川芎嗪属于钙离子拮抗剂的一种,存于川芎根茎内,属于川芎嗪的磷酸盐,存在抑制血小板集聚、活血化瘀、动脉扩张以及调节微循环等功效[1]。此种药物在临床中缺血性脑血管疾病治疗中使用率较高,例如高血压、冠心病、脑栓塞诱发脑梗死、脑血栓、脑供血不足等[2]。此种药物属于处方药,通常有胶囊剂、注射剂和片剂,而近几年新研究出一种剂型为磷酸川芎嗪滴丸,主要是利用固体分散技术所制[3]。此种剂型存有生物利用率高、吸收迅速、易等优势。而药物的生物利用率和质量与溶出度密切相关。现阶段国内磷酸川芎嗪滴丸的溶出方法主要包括篮法和桨法,检测方式主要包括UV吸收系数法和UV对照品比较法,均有一定的差异性[4-5]。因此本次针对磷酸川芎嗪滴丸溶出度测定方式进行了研究,同时分析了6批药物在不同溶出介质的溶出曲线。详情报道如下。 1 试药和仪器 1.1 试药:磷酸川芎嗪对照品(中国药品生物制品检定所,批号:100845-201002)100 mg;磷酸川芎嗪滴丸(批号:140638、140628、160104、151123、150804、160332);阴性样品。 1.2 仪器:①电子天平(BP-210S)。②针头式微孔滤膜过滤器:津腾0.45 μm孔径、13 mm直径。③高效液相色谱柱:迪马Cl8(5μ,250 mm×4.6 mm)。④高效液相色谱仪:岛津高效液相色谱仪(LC-2030检测器)。⑤溶出度仪:。 1.3 试剂:甲醇为色谱纯、其它试剂为分析纯。

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