ABSTRACT
Objective: To investigate how to rapidly predict coating terminal point in the thin film coating of Tianshu Tablets by near-infrared spectroscopy (NIRS). Methods: Firstly, synergy interval partial least square (siPLS) was used to optimize the modeling intervals and the pretreatment methods were screened. Secondly, according to the optimal modeling parameters, the conformity test and similarity matching were used to establish calibration models based on the established reference spectra library. Subsequently, by comparing the similarities between the test spectra and the reference spectra, the threshold value was set. The relation among the similarities, threshold value and the coating end point was obtained. Finally, the performance of the calibration model was verified by the validation set. Results: During the coating process, the similarities between the test spectra and the reference spectra were gradually increasing until the similarities of continuous test spectra exceeded the threshold, thus, indicating the end point. Conclusion: Conformity test and similarity matching can sensitively monitor the change of similarities among spectra and the corresponding trend. Both models have high performance, which can accurately predict the coating terminal point. It’s of great significance to reduce batch-to-batch variation in film coating and the loss of coating materials, and improve the coating efficiency and the quality uniformity of solid preparation.
ABSTRACT
Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets by near infrared reflectance(NIR)spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respectively to pretreat the corresponding NIR spectra of aluminum-plastic pack?age and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000~4000 cm-1. The optimum modeling band were 9000-7500cm-1,6900-5600 cm-1and 5000-4250 cm-1,respectively,and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentic ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments,realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclu?sion The conformity test model is accurate,simple,feasible,and suitable for the drug examination of zidovudine film-coated tablets.
ABSTRACT
Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets by near infrared reflectance(NIR) spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respectively to pretreat the corresponding NIR spectra of aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000~4000 cm-1. The optimum modeling band were 9000-7500cm-1, 6900-5600 cm-1and 5000-4250 cm-1, respectively, and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentic ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments, realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclusion The conformity test model is accurate, simple, feasible, and suitable for the drug examination of zidovudine film-coated tablets.
ABSTRACT
OBJECTIVE:To establish a method of quick identification of Fufang yuxingcao tablel(manufactured by A). METH-ODS:NIRDRS was adopted,the near-infrared diffuse reflectance spectrum were recorded by a fiber optic probe,and the conformi-ty test model was established through the consistency index (CI) value and the CI limit comparison method. The spectral range of 9 002-7 497.8 cm-1 ,6 903.8-5 596.4 cm-1 and 5 002.4-4 246.4 cm-1 was selected as the characteristic spectral band ,the spectra were preprocessed by first derivation and vector normalization with 17 smoothing points , and 7.0 was set as the CI value;the characteristic spectrum correlation coefficient model was established through the correlation coefficient method ,the spectral range of 6 200-5 500 cm-1,5 000-4 700 cm-1 was selected as the characteristic spectral band,the spectra were preprocessed by first deri-vation with 17 smoothing points,and 97% was set as the threshold. RESULTS:The above established models can rapidly identify and accurately distinguish Fufang yuxingcao tablet(manufactured by A)from similar products of other manufacturers,the CI value of the validation samples was beyond 7.0,the correlation coefficient(r)were less than 97% compared with the reference sample. CONCLUSIONS:The method is simple and rapid,and can be used for fast screening of Fufang yuxingcao tablet.
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OBJECTIVE:To establish a method for the rapid identification of Sanjiu weitai granule and quantitative analysis of moisture. METHODS:Near-infrared (NIR) spectroscopy was adopted. 38 batches of Sanjiu weitai granule were collected,NIR spectrum was determined by integrating sphere diffuse-reflectance. Conformity test model was performed by comparing consistency index(CI)value and CI limit,and quantitative model of moisture was established using partial least squares(PLS)algorithm. RE-SULTS:When CI value was less than 6,the established model can accurately distinguish Sanjiu weitai granule,the model was proven feasible;the correlation coefficient (r2) of quantitative model was 97.44,the root mean square error of cross validation (RMSECV) was 0.453,the root mean square error of prediction (RMSEP) was 0.748. CONCLUSIONS:The method is simple and rapid without destroying,which can be applied to fast screening of Sanjiu weitai granule in site and fast determination of mois-ture content.
ABSTRACT
Objective:To establish the conformity test model for tamsulosin hydrochloride sustained-release capsules by near infrared absorption spectroscopy. Methods:Tamsulosin hydrochloride sustained release capsules were scanned within the range of 4 200-12000 cm-1 to establish the conformity test model. Results:The spectral coverage of 9 000-7 500 cm-1 , 6 900-5 600 cm-1 and 5 000-4 250 cm-1 were chosen, and the second derivative vector normalization was used to detect the samples. The CI value was 7. The conformity test model could distinguish authentic and false tamsulosin hydrochloride sustained-release capsules. Conclusion:The method is simple, sensitive, accurate and fast, and can be used in the identification of tamsulosin hydrochloride sustained-release capsules.