盐酸川芎嗪缓释滴丸的制备工艺和质量控制.pdfVIP

提 要 目的 研究盐酸川芎嗪缓释滴丸的制备工艺，并对滴丸进行了质量检查及体外释 放度及长期稳定性的研究。 方法 对滴丸的制备成型试验中相关因素进行单因素考察，以圆整度和拖尾为指 标；以料液温度，药物与基质的比例，聚乙二醇与硬脂酸的比例为考察因素，以圆整 度、拖尾和累计释放度为指标，进行正交试验，对制备工艺进行优选，确定最佳制备 工艺。 以HPLC和薄层色谱对所制备缓释滴丸进行质量检查。并且采用转篮法，分别在 盐酸缓冲液和磷酸盐缓冲液中，对缓释滴丸进行了体外释放度的考察。以盐酸川芎嗪 为指标，制剂释放过程符合Higuchi方程。并对滴丸进行了初步的稳定性实验研究。 结果 最佳工艺为：以 PEG6000 与硬脂酸为基质，其比例为 4:1 ，药物与基质比 例为 1:3，料液温度为 70℃。冷凝柱温度梯度为：30℃～0℃。调节滴速为45d·min-1 ， 滴距为 5cm 。此工艺制备的盐酸川芎嗪缓释滴丸成形性良好，符合药典规定。对滴丸 的体外释放度考察发现，盐酸川芎嗪缓释滴丸与普通滴丸相比释放速度缓慢且释放完 全。滴丸释药重现性好。 结论 实验制备的缓释滴丸工艺稳定，质量可控，释放度实验中药物缓慢释放， 与普通速释滴丸相比，作用时间持久，基本达到了实验预期的目标。 关键词 缓释滴丸；正交试验；体外释放度 Preparation of the Ligustrazme Hydrochloride sustained-release dropping pills and investigation of its quality Speciality: Pharmaceutics Author: Sun Hongmei Tutor: Zhou Changzheng Abstract Objective To prepare the Ligustrazme Hydrochloride sustained-release dropping pills and invest its quality and in vitro release behavior. Methods single factor experiment and orthogonal design was employed to investigate the preparation,the former used roundness and tailed degree as index.;Temperature of dosage liquor，proportion of drugs and groundmass ，proportion of PEG6000 and stearic acid were used as investigation factors,the roundness，tailed degree and the release rate of pills as index in orthogonal design to optimize the preparation technology. The identification of Ligustrazme Hydrochloride and the measurement of Ligustrazme Hydrochloride in the preparation were be made with the TLC and HPLC respectively ．Its release characteristics were studied by rotating basket. Result the optimum technology :PEG6000: stearic is 4:1;the proportion of drugs and groundmass is 1:3;the Temperature of dosage liquor is 70 ℃; condensation Temperature is 30℃~0℃.dropping rate is 45d·min-1; dropping distance is 5cm.the Ligustrazme Hydrochloride sustained-release