摘要
目的优化复方锦灯笼片的制备工艺并测定片剂中总黄酮的含量。方法以锦灯笼和甘草作为主药,选取糖粉与淀粉比例(A)、羧甲基淀粉钠用量(B)、淀粉浆浓度(C)和硬脂酸镁用量(D)为考查要素,以片剂表面光滑均匀性、片剂硬度和崩解时限为评价指标,采用湿法制粒压片法制备片剂,按L9(34)因素水平表进行正交设计试验筛选出最佳处方;采用紫外可见分光光度法、亚硝酸钠-硝酸铝-氢氧化钠法显色法对片剂中总黄酮的含量进行测定。结果最佳制备工艺为糖粉与淀粉比例为1∶4,羧甲基淀粉钠为4%,淀粉浆浓度为12%,硬脂酸镁用量为1%。3批最优工艺制备的片剂中总黄酮含量分别为14.21±0.06、14.94±0.29和14.31±0.05mg/片,方法的平均加样回收率为98.29%,RSD值为1.92%(n=6)。结论按照最优处方和制备工艺制备的片剂符合要求,质量稳定,可为后续产品质量控制提供依据。
Objective To study the preparation process of compound Physalis Alkekengi tablets and determine the content of its total flavonoids.Methods The prescription was mainly composed of Physalis Alkekengi and liquorice.Taking the appearance uniformity,hardness and disintegration time of the tablets as the indexes,along with the ratio of sugar powder and starch(A),sodium carboxymethyl starch(B),the concentration of starch paste(C)and the ratio of magnesium stearate(D)as the test factors,orthogonal design L9(34)was carried out to optimize the preparation process of compound Physalis Alkekengi tablets.The content of total flavonoids was determined by UV-Vis spectrophotometry and sodium nitrite-aluminum nitrate-sodium hydroxide method.Results The best prescription was as follows:the ratio of sugar powder to starch was 1∶4,the disintegrant was 4%carboxymethyl starch sodium,the binder was 12%starch slurry,and the lubricant was 1%magnesium stearate.The content of total flavonoids was 14.21±0.06,14.94±0.29 and 14.31±0.05 mg per tablet,respectively.The average recovery was 98.29%,and RSD was 1.92%(n=6).Conclusion The obtained preparation process are practical and easy to operate.The prepared compound Physalis Alkekengi tablets are in iaccordance with the requirements,and have stable quality.The study provides basis for quality control of further research and development.
作者
廖梅
Liao Mei(School of Medicine,Jiaying University,Meizhou 514031;Guangdong Provincial Key Laboratory of Conservation and Precision Utilization of Characteristic Agricultural Resources in Mountainous Areas,Meizhou 514031,China)
出处
《广东化工》
CAS
2020年第15期159-161,共3页
Guangdong Chemical Industry
基金
广东省中医药局科研项目(20171267,20181259)
梅州市社会发展科技计划项目(2017B069)
广东省教育厅项目(2018KTSCX211)
嘉应学院2019年大学生创新创业训练计划项目(201910582262)
广东省高等教育“冲补强”提升计划重点建设学科(农业资源与环境)建设项目(130B0134)。
关键词
锦灯笼
甘草
总黄酮
含量测定
Physalis alkekengi
Glycyrrhiza
Total flavonoids
Content determination
