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机构地区:[1]广州中一药业有限公司,广东广州510620 [2]广东药学院药剂教研室,广东广州510006 [3]广东药学院附属门诊部,广东广州510240
出 处:《广东药学院学报》2006年第2期123-124,共2页Academic Journal of Guangdong College of Pharmacy
摘 要:目的确定五酯胶丸的制备工艺和质量控制方法。方法:以内容物的物理稳定性及流动性作为筛选五酯胶丸内容物处方组成的指标,并对五酯胶丸装量差异、崩解时限、含量测定等方面进行质量考察。结果3批样品平均崩解时间小于20 m in,平均质量分数为100.2%。结论所制备的五酯胶丸符合中国药典的要求,制备方法简便,质量可控。Objective To establish a method for preparation and quality control of Wuzhi soft capsule. Methods The physical stability and fluidity of the content of Wuzhi soft capsule were used as markers for formulation optimization. The qualities of the soft capsule such as weight variation, disintegration time and content of deoxyschizandrin were investigated. Results The mean disintegration time of three batches of Wuzhi soft capsules was within 20 minutes and the content of deoxyschizandrin in the soft capsule was 100.2%. Conclusion The preparation techniques of Wuzhi soft capsule are simple and feasible, which are in good accord with the requirements of Chinese pharmacopoeia.
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