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秦息痛糖衣片改薄膜衣片的成型工艺研究 预览 被引量:1

Research on the production technology of Qinxitong Film-Coated Tablets
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摘要 目的 探索秦息痛糖衣片改为薄膜衣片的生产工艺。方法 采用正交实验探索秦息痛薄膜衣片的最佳生产工艺参数,采用HPLC法,以片剂中青藤碱的含量为指标对正交实验结果进行验证。结果 青藤碱质量浓度在1.032~10.88μg·mL-1范围内呈良好线性关系,平均回收率为99.49%,RSD值为2.79%(n=6)。秦息痛薄膜衣片最佳生产工艺:雾化气压0.4MPa,包衣液喷速0.16~0.18kg·min-1,素片温度40℃,包衣液浓度10%。该工艺条件下生产的秦息痛薄膜衣片外观色泽均匀,表面平滑,崩解时限为29~31min,包衣合格率高于99.58%。HPLC法测得秦息痛薄膜衣片中青藤碱含量在10.48~10.55mg,符合标准要求。结论 该制备工艺稳定,可为秦息痛薄膜衣片的工业化生产奠定基础。 Objective To explore the production process of Qinxitong Film-Coated Tablets.Methods An orthogonal experiment was used to explore the optimal process parameters of Qinxitong Film-Coated Tablets,and an HPLC method was used to verify the orthogonal experimental results with sinomenine content in the tablets as an index.Results Sinomenine within1.032-10.88μg·mL-1showed a good linear relationship.The average recovery was99.49%,with RSD2.79%(n=6).The optimal process parameters of Qinxitong Film-Coated Tablets were as follows:the gas pressure0.4MPa,the coating liquid spray speed0.16-0.18kg·min-1,the plain film temperature40℃,and the coating liquid mass concentration10%.The production process has good stability and repeatability.The prepared Qinxitong Film-Coated Tablets were uniform,smooth,and the disintegration time was29-31min.The coating pass rate was more than99.58%;the content of sinomenine in Qinxitong Film-Coated Tablets was10.48-10.55mg.The prepared Qinxitong Film-Coated Tablets were in line with the standard requirements.Conclusion This preparation process is stable,and can be used in industry.
出处 《西北药学杂志》 CAS 2018年第2期217-220,共4页 Northwest Pharmaceutical Journal
基金 陕西省教育厅项目(编号:2013JK0841)
关键词 秦息痛 正交实验 薄膜包衣 工艺参数 Qinxitong Film-Coated Tablets orthogonal experiment film coating process parameters
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