Application progress on data-driven technologies in intelligent manufacturing of traditional Chinese medicine extraction / 中国中药杂志

The application of new-generation information technologies such as big data, the internet of things(IoT), and cloud computing in the traditional Chinese medicine(TCM)manufacturing industry is gradually deepening, driving the intelligent transformation and upgrading of the TCM industry. At the current stage, there are challenges in understanding the extraction process and its mechanisms in TCM. Online detection technology faces difficulties in making breakthroughs, and data throughout the entire production process is scattered, lacking valuable mining and utilization, which significantly hinders the intelligent upgrading of the TCM industry. Applying data-driven technologies in the process of TCM extraction can enhance the understanding of the extraction process, achieve precise control, and effectively improve the quality of TCM products. This article analyzed the technological bottlenecks in the production process of TCM extraction, summarized commonly used data-driven algorithms in the research and production control of extraction processes, and reviewed the progress in the application of data-driven technologies in the following five aspects: mechanism analysis of the extraction process, process development and optimization, online detection, process control, and production management. This article is expected to provide references for optimizing the extraction process and intelligent production of TCM.

Commercial and Process Development of Pharmaceutical New Formulation and Optimization Technologies / 中国药学杂志

In order to get fast approval and market access, innovator pharmaceutical companies usually adopt the most mature and relatively simple formulations for their first generation new drug products. This leaves the opportunities for these products to improve their clinical performance, safety profiles and/or patient adherenceby switching to more sophisticated new formulations, which usually happen around the time when the patents for the new drugs expire. This approach may also work for older drugs. On the other hand, the task of new formulation and process development are more challenging forhigh-technology drug products based on, for examples, various controlled release formulations. In this article, the authors give a discussion regarding the thinking behind initiating the endeavor of new-formulation based development project. Based on the principles of Quality-by-Design, the authors also give a review regarding the trend of using experimental design, statistical and chemometric data analysis and multivariate modeling in formulation and process development. By analyzing examples in the literature, the authors try to demonstrate the advantages of designed studies vs. the traditional univariate methods.

Development and Validation of the Production Process of Parecoxib Sodium Freeze-dried Preparation Based on Quality by Design / 中国药学杂志

OBJECTIVE: To prepare parecoxib sodium freeze-dried preparation, evaluate and validate the feasibility of the production process and quality reliability of the preparation. METHODS: Risk assessment of the production process of parecoxib sodium freeze-dried preparation was performed based on the method of quality by design (QbD).The key steps and key process parameters were identified.The critical quality attributes (CQAs)of the intermediates and final product were clarified, the validation protocol and acceptable standard were accordingly developed, and the production process was validated. RESULTS: The production process of parecoxib sodium freeze-dried preparation met the GMP requirements, and the intermediate and final products met the quality standards. CONCLUSION: The established production process of parecoxib sodium freeze-dried preparation is feasible and the product quality is controllable.

Resultados del proceso productivo de la solución concentrada de propóleos 2010-2013. Impacto de la innovación tecnológica / Results of the production process of the concentrated solution of propolis 2010-2013. Impact of technological innovation

El proceso productivo de las soluciones concentradas de propóleos en el Centro de Inmunología y Biopreparados, ha sido una tarea esencial desde el 2010; por consiguiente, el objetivo fundamental de este trabajo es mostrar cómo se han comportado los parámetros de calidad de los lotes de estas soluciones desde el 2010 al 2013, teniendo en cuenta los elementos de innovación tecnológica desarrollados. Se analizaron los requisitos de conformidad de las soluciones concentradas de propóleos, según los registros de control de la calidad para este producto. El procesamiento estadístico se realizó de forma automatizada con el programa estadístico Medcal. Las propiedades organolépticas de estas soluciones respondieron de forma positiva y las concentraciones de sólidos totales fueron superiores al 24%. Es importante señalar que en los lotes obtenidos en 2012 y 2013, se logró un agotamiento significativo de la materia prima, debido a la introducción de cambios tecnológicos en el proceso; aspecto este que no afectó la calidad del producto, ya que los sólidos totales están por encima del 16% establecido en el Sistema de Gestión de Calidad del Centro, corroborándose los mismos con el análisis estadístico realizado. Se obtuvo un producto conforme y con calidad, lográndose una mejor recuperación de los principios activos de estas soluciones.

The production process of Propolis Concentrated Solutions Center for Immunology and Biologicals, has been an essential task since 2010, so we have performed show how the parameters of quality of batches of these solutions from 2010 to 2013, is the main objective of this work taking into account the factors of technological innovation developed. Compliance requirements of Propolis Concentrated solutions were analyzed according to the records of Quality Control for this product. The statistical processing was performed automatically using the statistical program Medcal. The organoleptic properties of these solutions responded positively and total solids concentrations were higher than 24%, it is important to note that the lots obtained in 2012 and 2013, a significant depletion of the raw material was obtained, due to the introduction of technological changes in the process, appearance is not affected the quality of the product and the total solids are above the 16% set in the quality Management System of the center, corroborating them with statistical analysis. Conforming product quality and achieving a better recovery of the active ingredients of these solutions were obtained.

Improvement of cell mass production of Lactobacillus delbrueckii sp. bulgaricus WICC-B-02: A newly isolated probiotic strain from mother’s milk.

Lactobacillus delbrueckii sp. bulgaricus WICC-B-02 is new probiotic strain which was initially isolated from the mother’s milk. As lactic acid bacterium, it’s known as a highly efficient probiotic microorganism with a wide range of benefits on the human health. This study was conducted to design and establish industrial platform for high cell mass production of L. delbrueckii sp. bulgaricus for pharmaceutical and food industries application. However, due to low cell mass production caused by the accumulation of lactic acid during the cultivation of lactic acid bacteria, therefore, the optimization of cell mass production with low lactic acid production was developed in this study. The new formulation of the production medium was developed by optimizing the main components such as glucose (30 g.L-1), yeast extract (6.0 g.L-1) and peptone (6.0 g.L-1)in shake flask cultivation. The cell mass production was 3.14 g.L-1, and it increased to 6.08g.L-1 with the lactic acid production being reduced by about 33%, compared to the un-optimized medium.