【摘要】 目的:确定并优化紫草膜剂的处方工艺,建立稳定可靠的左旋紫草素含量测定方法,对紫草膜剂进行质量控制。方法:以紫草提取物为原料药,采用聚乙烯醇为成膜材料,加入甘油、羧甲基纤维素钠制备紫草膜剂。通过单因素实验与正交试验,以膜的机械性能为评价指标,筛选优化处方工艺。采用高效液相色谱法对膜剂中主要活性成分左旋紫草素的含量进行测定。结果:PVA的种类与用量,增塑剂甘油的用量及载药量均会明显影响膜剂的成型与机械性能。优化处方中成膜材料聚乙烯醇205S与540S的用量比为1∶3,甘油的用量为7.6%,聚乙烯醇:紫草提取物为9∶1。含量测定的HPLC方法日内、日间精密度分别为0.77%与0.74%,加样回收率为99.67%(n=9),重复性好。结论:所制备的紫草膜剂含量均匀,机械性能良好,符合膜剂质量要求。更多还原

【Abstract】 OBJECTIVE To optimize the formulation and preparing process of Zicao film.To establish stable and reliable method for content assay of shikonin so that to control the quality of Zicao film.METHODS By using the extract of Arnebiae Radix as the raw material drug and polyvinyl alcohol(PVA) as the film forming material,Zicao film was prepared with the addition of glycerin and sodium carboxymethyl cellulose(CMC-Na).The formulation and process were optimized through single factor experiment and orthogonal test.And the mechanical properties of the films were used for result evaluation.HPLC method was used to assay the content of main active ingredient shikonin in films.RESULTS The sort and amount of PVA,the amount of plasticizer glycerin and the drug loading rate obviously affected the formation and the mechanical properties of film.In the optimized formulation,the ratio of PVA 205S to 540S was 1∶3,glycerin accounted for 7.6%,and the ratio of PVA to Arnebiae Radix extract was 9∶1.The intra-day and inter-day precision of the HPLC method for shikonin content assay was 0.77 and 0.74 respectively.The recovery rate was 99.67%(n= 9),and the method showed a good repeatability.CONCLUSION The Zicao film showed uniform content,good mechanical properties,and matched the quality requirements of films.更多还原