Livzon Group Limin Pharmaceutical Factory

A near infrared spectroscopy (NIRS) approach was established for quality control of the alcohol precipitation liquid in the manufacture of Codonopsis Radix. By applying NIRS with multivariate analysis, it was possible to build variation into the calibration sample set, and the Plackett-Burman design, Box-Behnken design, and a concentrating-diluting method were used to obtain the sample set covered with sufficient fluctuation of process parameters and extended concentration information. NIR data were calibrated to predict the four quality indicators using partial least squares regression (PLSR). In the four calibration models, the root mean squares errors of prediction (RMSEPs) were 1.22 μg/ml, 10.5 μg/ml, 1.43 μg/ml, and 0.433% for lobetyolin, total flavonoids, pigments, and total solid contents, respectively. The results indicated that multi-components quantification of the alcohol precipitation liquid of Codonopsis Radix could be achieved with an NIRS-based method, which offers a useful tool for real-time release testing (RTRT) of intermediates in the manufacture of Codonopsis Radix.

OBJECTIVE To establish a FT-NIR method to determine the quality of Shenqifuzheng injection with Astragalusme mbranaceus, so as to better control the quality of Shenqifuzheng injection.METHODS The sample was crushed 60°C oven drying, with a mortar pestle, 60 mesh sieve, the integral ball module collects the diffuse reflectance spectra, with air as the background; acquisition wavelength range was 10000-4000 cm^-1.The resolution was 8 cm^-1, 64 times the number of spectral acquisition.External environment condition for the room temperature of 25°C.RESULTS The NIR quant. anal. model of 4 kinds of quality indexes in Astragalus saponins was established.In addition, the correlation coefficients of other models were above 0.85, relative prediction errors were within a reasonable range, show more accurate forecasting results.RMSECV/RMSEP ratios were close to 1, showed that the model was more robust and could be used for anal. rapid quantification of Radix astragalus.CONCLUSION The NIR quant. anal. model of Astragalus in 4 quality indicators is stable and reproducible, and it can be used for quality control of Shenqifuzheng injection.

A method of fingerprint and rapid multi-component determination for Xueshuantong injection was established.Conventional HPLC was performed on a fast short anal. column with fine granularity, and the methodol. was evaluated.The measured results were compared with the national standard method.The fingerprint showed good precision, stability and repeatability.The similarity was in line with the standardsThe linearity, limit of detection, limit of quantification, precision, stability, repeatability and recovery test of the multi-component determination showed good results, and the quant. results were very close to the national standard method.This method was accurate and reliable.The method could be used for Xueshuantong injection's fingerprint and rapid determination, which was easily applied in practical work.It could not only improve the inspection efficiency, but also reduce the use of organic solvents.