RESUMO
Physical attributes of Chinese herbal extracts are determined by their chemical components, and the physical and chemical attributes jointly affect the preparation process performance and the final product quality. Therefore, in order to improve the quality control of Chinese herbal extracts, we should comprehensively study the batch-to-batch consistency of physical and chemical attributes as well as the correlations between them. This paper first explored the physical attributes affecting the preparation process performance of the compound Danshen extract and developed a method for characterizing the texture attributes. With such main chemical components as water, phenolic acids, saponins, and saccharides and texture, rheology, and other physical attributes taken into consideration, the batch-to-batch quality fluctuation of products from different production lines and time was analyzed by principal components analysis(PCA). Finally, the correlation and partial least squares(PLS) analysis was conducted, and the regression equation was established. The fitting result of the PLS model for dynamic viscosity was satisfying(R~2Y=0.857, Q~2=0.793), suggesting that the chemical components could be adjusted by the component transfer rate in the extraction process, the impurity removal rate in the alcohol precipitation process, and the water retention rate of the concentration process to meet the control of the extract dynamic viscosity. This study clarified the correlations between physical and chemical attributes of the compound Danshen extract and established a method for controlling its physical attributes based on process regulation, which would provide reference for improving the quality control of Chinese herbal extracts.
Assuntos
Medicamentos de Ervas Chinesas/química , Controle de Qualidade , Salvia miltiorrhiza/química , ÁguaRESUMO
The mixing process is one of the key operation units for solid preparation of traditional Chinese medicine. The physical properties such as particle size, density and viscosity of the mixture are key factors that need to be controlled, which will directly affect the performance of the preparation molding process and product quality. Subsequent dripping process performance and appearance qua-lity of dripping pills will be affected by dynamic viscosity of materials in the mixing process. Based on this, with mixing process of compound Danshen dripping pills as the object, a feedforward control method for the dripping pill mixing process was established based on the concept of quality by design(QbD). Firstly, critical quality attribute(CQA)-dynamic viscosity, critical material attributes(CMAs)-the moisture content of compound Danshen extract, average molecular weight of polyethylene glycol 6000 and critical process parameter(CPP)-mixing temperature were identified through the analysis of properties for multiple batches of the raw materials and excipients as well as technological mechanism. Then the Box-Behnken experimental design was used to establish the regression model among CMA, CPP and CMA(R■=0.972 0, RMSE =16.24) to obtain the design space. Finally, through the verification of three batches within the design space, the mixing process temperature was adjusted according to the properties of the raw materials and exci-pients to achieve accurate control of the dynamic viscosity attribute. The relative deviation between the actual dynamic viscosity value and the target value was less than 3.0 %. The feedforward control of the mixing process of compound Danshen dripping pills was rea-lized in this study, which can contribute to improving quality consistency of the mixing process intermediates, simultaneously provide a reference for the research on the process quality control of other Chinese medicine dripping pills.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Controle de Qualidade , Projetos de PesquisaRESUMO
Texture analyzer is a multifunctional physical property analyzer. Through a variety of test modes such as compression, puncture, shearing and stretching, hardness, adhesion, elasticity, cohesiveness and other physical property parameters are characterized. The results are objective, sensitive, and accurate, which can provide theoretical basis and reference for interpretation of basic theoretical, optimization of prescription technology and quality control research of pharmaceutical preparations. Firstly, the principles, test modes, measurement indexes and measurement data analysis methods of texture analyzer were summarized in this paper. Secondly, the application progress of texture analyzer in solid preparations, semi-solid preparations, liquid preparations, traditional Chinese medicine decoction pieces and their intermediates was described in detail, and compared with the commonly used measurement methods of physical property indicators. Finally, the application prospects of texture analyzer and its research contents to be improved were reviewed, so as to facilitate the use of texture analyzer by pharmaceutical researchers to promote the development of related fields of pharmaceutics, and to provide new ideas and methods for the research and development of pharmaceutical preparations.