ABSTRACT
OBJECTIVE: To investigate the effect of the critical quality attributes of hypromellose (HPMC) on the release profile of diclofenac sodium sustained-release tablets in vitro. METHODS: The characteristics including appearance, particle size, density, compression and specific surface area of HPMC K15M from three manufacturers (A, B and C) were studied and evaluated comprehensively. The compression data of HPMC K15M were non-linear fitted via the pressure-tensile strength curve method, Kawabe equation and Hasano equation. Sustained-release tablets were prepared by using diclofenac sodium as the active ingredient with different HPMC as gel matrix, and the in vitro release behavior of the tablets was determined in order to identify the critical quality attribute of HPMC that affect the in vitro release profile of diclofenac sodium sustained-release tablets. RESULTS: The release rate of diclofenac sodium sustained-release tablets was correlated with the substitution type of HPMC, viscosity, density and specific surface area, but less affected by particle size. CONCLUSION: Substitution, viscosity, density and specific surface area of HPMC are the CQAs factors influencing the release profile of diclofenac sodium sustained- release tablets.
ABSTRACT
Study on the standardization of Chinese materia medica is an important action for modernization and globalization for traditional Chinese medicine. Standardization on the processing of Chinese herbal pieces is an important part in the study on standardization of Chinese materia medica, so it is of great significance to establish the technical processing standards of Angelicae Sinensis Radix pieces for improving its quality. In this study, single factor experiment was designed to optimize the softening, cutting and drying processes of Angelicae Sinensis Radix. With ferulic acid, Angelicae Sinensis Radix polysaccharide, volatile oil and extracts (water and ethanol) content as the quality index, the effects of different softening, cutting and drying processes on the contents of the five components in Angelicae Sinensis Radix were analyzed, and the normalized distance evaluation method was used to analyze the experimental data. The results showed that the content of five components in Angelicae Sinensis Radix was affected by different softening methods and drying temperature, but the thickness of slice had little effect on the content. The best preparation process for Angelicae Sinensis Radix was as follows: Non-medicinal parts were removed; mildewed and rot as well as moth-eaten parts were removed; washed by the flowing drinking water; stacked in the drug pool; moistening method was used for softening, where 125 mL water was sprayed for every 1 kg of herbs every 2.5 h; upper part of herbs covered with clean and moist cotton, and cut into thin slices (1-2 mm) after 15 h moistening until appropriate softness, with disk thickness of 1-2 cm, then received blast drying for 6 h at 55 ℃, and turned over for 2 times during the drying.
ABSTRACT
Notopterol, isoimperatorin, volatile oil and extract （water and ethanol) were used as the research objects in this study to investigate the effects of different softening method, slice thickness and drying methods on the quality of Notopterygii Rhizoma et Radix slices, and the experimental data were analyzed by homogeneous distance evaluation method. The results showed that different softening, cutting and drying processes could affect the content of five components in Notopterygii Rhizoma et Radix incisum. The best processing technology of Notopterygii Rhizoma et Radix slices was as follows: non-medicinal parts were removed; mildewed and rot as well as moth-eaten parts were removed; washed by the flowing drinking water; stacked in the drug pool; moistening method was used for softening, where 1/8 volume of water was sprayed for every 1 kg of herbs every 2 h; upper part of herbs covered with clean and moist cotton, and cut into thick slices (2-4 mm) after 12 h moistening until appropriate softness, then received blast drying for 4 h at 50 ℃, and turned over for 2 times during the drying. The process is practical and provides the experimental basis for the standardization of the processing of Notopterygii Rhizoma et Radix, with great significance to improve the quality of Notopterygii Rhizoma et Radix slices.