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作 者:秦建 QIN Jian(Jinghua Pharmaceutical Co.,Ltd.,Nantong 226000,China)
机构地区:[1]精华制药集团股份有限公司,江苏南通226000
出 处:《海峡药学》2022年第12期16-18,共3页Strait Pharmaceutical Journal
摘 要:目的优化左旋多巴片制备工艺,提高产品质量。方法以溶出度、硬度、脆碎度为评价指标,采用L_(9)(3^(4))正交试验,筛选左旋多巴片处方,优化制备工艺。结果最优制备工艺为:微晶纤维素与预胶化淀粉质量比6∶1;羟丙甲纤维素70%乙醇溶液浓度3%;烘干温度65℃;整粒目数16目。结论采用优化工艺制备的左旋多巴片质量稳定,溶出度高。OBJECTIVE To optimize the preparation technology of levodopa tablets and improve the product quality.METHODS The formulation of levodopa tablets was screened and the preparation process was optimized by L_(9)(3^(4))orthogonal test with dissolution,hardness and brittleness as evaluation indexes.RESULTS The optimal preparation process was as follows:the mass ratio of microcrystalline cellulose and pregelatinized starch was 6∶1;the concentration of hydroxypropyl methylcellulose was 70%,ethanol solution was 3%;the drying temperature was 65℃;the mesh number of granules was 16.CONCLUSION Levodopa tablets prepared by optimized technology have stable quality and high dissolution.
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