灵芝片制备工艺研究
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摘要
目的筛选灵芝片配方和优化制备工艺。方法以片剂成型指标评价筛选灵芝片配方,在确定配方的基础上,进一步以多指标综合评价确定制备工艺。结果最终确定的配方为:(灵芝提取物粉∶灵芝超微粉)=(10∶6,w/w),并加入4%的羧甲基淀粉钠混匀,制备工艺为上述配方物料混合均匀,加入60%(w/w)的25%乙醇制粒,过24目筛,干燥后整粒,加入0.5%硬脂酸镁压制成片。结论采用片剂成型指标评价和多指标综合评价的方法,可快速有效地确定产品配方和制备工艺,该片剂配方合理,制备工艺可行,适合工业化大规模生产需求。
OBJECTIVE To screen the formulation of Ganoderma lucidum tablets and optimize the preparation process.METHODS The formulation of Ganoderma lucidum tablets was screened and evaluated based on Tablet Formability.Based on the formulation,further more Multi Index Comprehensive Evaluation was applied to determine the preparation process.RESULTS The final formula was:(Ganoderma lucidum extract powder:Ganoderma lucidum superfine powder)=(10∶6,w/w),and added with 4% carboxymethyl starch sodium(CMS-Na);The preparation process was the formula mixed evenly,granulated through 24 mesh sieve by adding 60%(w/w) of ethanol(25%),dried and sized,tableted with 0.5% magnesium stearate.CONCLUSION The formulation and preparation process of product was determined by the method of Tablet Formability and Multi Index Comprehensive Evaluation quickly and effectively.The formulation and the preparation process of Ganoderma lucidum tablets was reasonable and feasible,suitable for extensive industrialization produce.
OBJECTIVE To screen the formulation of Ganoderma lucidum tablets and optimize the preparation process.METHODS The formulation of Ganoderma lucidum tablets was screened and evaluated based on Tablet Formability.Based on the formulation,further more Multi Index Comprehensive Evaluation was applied to determine the preparation process.RESULTS The final formula was:(Ganoderma lucidum extract powder:Ganoderma lucidum superfine powder)=(10∶6,w/w),and added with 4% carboxymethyl starch sodium(CMS-Na);The preparation process was the formula mixed evenly,granulated through 24 mesh sieve by adding 60%(w/w) of ethanol(25%),dried and sized,tableted with 0.5% magnesium stearate.CONCLUSION The formulation and preparation process of product was determined by the method of Tablet Formability and Multi Index Comprehensive Evaluation quickly and effectively.The formulation and the preparation process of Ganoderma lucidum tablets was reasonable and feasible,suitable for extensive industrialization produce.
引文
[1]国家药典委员会编.中国药典2015年版一部[S].北京:中国医药科技出版社,2015,188-189.
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[3]吴长辉.超微粉碎对灵芝中多糖、三萜的影响[J].中国执业药师,2015,12(8):18-23.
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[6]赵克,等.影响中药片剂崩解度的因素及解决方法[J].中国药物经济学,2014,z1:78-79.
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[8]吴舜芳,等.温脾补肾片的成型工艺研究[J].中国实用医药,2012,7(17):1-2.
[9]汪涛,等.龙藤筋骨片制备工艺研究[J].中国药业,2012,21(14):59-61.
[10]赵洪霞,等.银杏叶处方和制备工艺研究[J].天津理工大学学报,2012,28(6):67-69.
[2]林志彬.灵芝抗肿瘤作用的免疫学机制及其临床应用[J].中国药理学与毒理学杂志,2015,29(6):865-881.
[3]吴长辉.超微粉碎对灵芝中多糖、三萜的影响[J].中国执业药师,2015,12(8):18-23.
[4]国家药典委员会编.中国药典2015年版三部[S].中国医药科技出版社,2015,通则44-45.
[5]赵晓宏,等.多指标综合评分法研究中药新药片剂成型处方[J].中成药,2002,24(8):579-581.
[6]赵克,等.影响中药片剂崩解度的因素及解决方法[J].中国药物经济学,2014,z1:78-79.
[7]滕威,等.退翳片成型工艺研究[J].新疆中医药,2012,30(4):78-80.
[8]吴舜芳,等.温脾补肾片的成型工艺研究[J].中国实用医药,2012,7(17):1-2.
[9]汪涛,等.龙藤筋骨片制备工艺研究[J].中国药业,2012,21(14):59-61.
[10]赵洪霞,等.银杏叶处方和制备工艺研究[J].天津理工大学学报,2012,28(6):67-69.