摘要
目的:本文基于近红外光谱分析技术,研究抗宫炎分散片(kang gong-yan dispersible tablets,KGYDT)崩解时间与其薄膜包衣厚度的相关性。方法:采用偏最小二乘回归方法 (PLSR)分别建立了KGYDT崩解时间与衣膜厚度的近红外光谱校正模型,并对KGYDT崩解时间与衣膜厚度建模光谱的预处理方法、建模波段、主因子数的选择进行详细的讨论分析;通过KGYDT崩解时间与衣膜厚度的PLSR模型研究两者的相关性;应用吸湿动力学模型的非线性回归法,模拟未包衣片与薄膜包衣片的吸湿行为,并分析薄膜包衣对中药分散片吸湿行为的影响。结果:崩解时间PLSR模型的相关系数r=0. 986,内部交叉验证均方根误差(RMSECV)=7. 612,相对分析误差(RPD)=8. 35,偏移Bias=0. 011,验证模型的相关系数r=0. 997,预测均方根误差(RMSEP)=5. 233;衣膜厚度PLSR模型的相关系数r=0. 991,内部交叉验证均方根误差(RMSECV)=0. 468,相对分析误差(RPD)=10. 51,偏移Bias=0. 004,验证模型的相关系数r=0. 999,预测均方根误差(RMSEP)=0. 085。KGYDT崩解时间与薄膜包衣厚度线性模型的相关系数r=0. 995;薄膜包衣分散片的吸湿率及吸湿速率常数均明显小于未包衣的素片。结论:研究结果表明以KGYDT为模型药的中药分散片的崩解时间与其包衣膜厚度存在正相关性;衣膜厚度为6μm时,KGYDT既满足分散均匀性的检查要求,也具有较好的防潮效果。
Objective:Study on the correlation between the disintegration time of kang gong-yan dispersible tablets(KGYDT)and the thickness of film coating based on near-infrared spectroscopy.Methods:A near-infrared spectroscopy correction model for disintegration time and film thickness of KGYDT was established by partial least squares regression(PLSR).The pre-processing method of disintegration time and modeling spectra,modeling bands,and selection of principal factors are discussed and analyzed in detail.The correlation between disintegration time and film thickness was studied by the established PLSR model.The hygroscopicity behavior of uncoated tablets and film-coated tablets was simulated by the non-linear regression method of hygroscopicity kinetic model,and the effect of film-coated tablets on the hygroscopicity behavior of traditional Chinese medicine dispersible tablets was an-alyzed.Results:The correlation coefficient of the PLSR model of the disintegration time(r)is 0.986,the internal cross-validation root mean square error(RMSECV)is 7.612,the relative analysis error(RPD)is 8.35,the offset Bias is 0.011,the correlation coefficient of the verification model(r)is 0.997,and prediction root mean square error(RMSEP)is 5.233.The correlation coefficient of the film thickness PLSR model(r)is 0.991,the RMSECV is 0.468,RPD is 10.51,the offset Bias is 0.004,the correlation coefficient of the verification model(r)is 0.999,and the RMSEP is 0.085.The disintegration time of KGYDT has a positive correlation with the film coating thickness,and the correlation coefficient is 0.995.The moisture absorption rate and moisture absorption rate constant of the film-coated dispersible tablets are significantly smaller than that of the uncoated plain tablets.Conclusion:The results showed that there was a positive correlation between the disintegration time of KGYDT dispersible tablets and the coating thickness.When the thickness of the film is 6μm,the KGYDT not only satisfies the inspection requirements for dispersion uniformity,but also
作者
温伍玖
罗晓健
张尧
饶小勇
杨小妹
何雁
WEN Wu-jiu;LUO Xiao-jian;ZHANG Yao;RAO Xiao-yong;YANG Xiao-mei;HE Yan(Jiangxi Universiy of Ttraditional Chinese Medicine,Nanchang 330006,China;National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine,Nanchang 330006,China;Shenzhen Shekou People's Hospital,Shenzhen 518067,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第9期1048-1056,共9页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2018ZX09201010-001-004
2018ZX09201010-001-009)
中药制剂装备制造绿色关键技术改造项目(工信部节函(2016)562号)
关键词
近红外光谱
偏最小二乘回归法
抗宫炎分散片
分散均匀性
薄膜包衣
吸湿动力学
near infrared spectroscopy
PLSR
kang gong-yan dispersible tablets
dispersion uniformity
film coating
moisture absorption kinetics
