黄连解毒固体分散体制备方法及质量评价

Preparation and Quality Evaluation of Huanglian jiedu Solid Dispersion

关键词:  黄连解毒散  固体分散体  溶出度  稳定性

Key words:  Huanglian Jiedu San  solid dispersion  dissolution rate  stability

摘要:

采用固体分散技术制备黄连解毒固体分散体，对其进行处方筛选及正交试验优化工艺，以盐酸小檗碱溶出度为主要指标，从性状、粒度、含量、稳定性等方面评价其质量。结果表明，通过溶剂-熔融法制备黄连解毒散固体分散体最为适宜的条件是：载体和中药散剂的比例为1：3、熔融温度100℃、反应时间1h。制备的黄连解毒固体分散体性质稳定，盐酸小檗碱的平均含量为12.98 mg/g，90 min时溶出度均可达93%以上。

Abstract:

Solid dispersion technique of solvent-melting method was used to prepare Huanglian Jiedu solid dispersion. Suitable prescription was screened out by single factor tests and three-factor-three-level-orthogonal test was performed to optimize the technological conditions. the quality of huanglian jiedu solid dispersion was assessed in properties, granularity, dissolution rate and the content of active ingredients as well as the stability of this preparation.Results indicated that the optimal rate of the carrier materials and the medicine was 1:3、melting temperature was at 100℃ and response time was 1h. the basic properties was stability, the average content of berberine hydrochloride was 12.98mg/g and the dissolution rate could reach 93% at 90min.