[Critical influencing factors on quality of traditional Chinese medicine preparations from perspective of process and equipment].

The quality of traditional Chinese medicine preparations is directly related to the safety of patients. Among the various factors, the process and corresponding critical equipment are critical factors influencing the quality of the preparations. To improve the quality of traditional Chinese medicine preparations, this article summarizes and analyzes the problems in the process links and corresponding critical equipment in the manufacturing process of traditional Chinese medicine preparations. Furthermore, a critical quality attribute evaluation system is established based on safety and effectiveness combined with the drug properties, preparation process, and preparation characteristics, providing a basis for the process and equipment improvements aimed at quality enhancement.

[Mechanisms of changes of active components in Chinese medicinal materials during drying: a review].

Drying is an indispensable processing step for Chinese medicinal materials after harvesting. It often leads to significant changes in the active components of these materials, thus impacting their medicinal values. Understanding the mechanisms behind the changes during the drying process is of great importance for regulating the transformation of key active components. Therefore, this paper reviews the available studies and comprehensively expounds the mechanisms underlying the changes in active components during the drying process. The aim is to offer insights for the development of regulatory strategies and the improvement of drying techniques for Chinese medicinal materials.

[Expression and significance of hypoxia-inducible factor 1α and Bcl-2/adenovirus E1B19kDa-interacting protein 3 in children with traumatic brain injury]. / ç¼ºæ°§è¯±å¯¼å› å­1α、Bcl-2/è ºç— æ¯’E1B19kDa相互作用蛋白3在儿童创伤性脑损伤中的表达及意义.

OBJECTIVES: To dynamically observe the changes in hypoxia-inducible factor 1α (HIF-1α) and Bcl-2/adenovirus E1B19kDa-interacting protein 3 (BNIP3) in children with traumatic brain injury (TBI) and evaluate their clinical value in predicting the severity and prognosis of pediatric TBI. METHODS: A prospective study included 47 children with moderate to severe TBI from January 2021 to July 2023, categorized into moderate (scores 9-12) and severe (scores 3-8) subgroups based on the Glasgow Coma Scale. A control group consisted of 30 children diagnosed and treated for inguinal hernia during the same period, with no underlying diseases. The levels of HIF-1α, BNIP3, autophagy-related protein Beclin-1, and S100B were compared among groups. The predictive value of HIF-1α, BNIP3, Beclin-1, and S100B for the severity and prognosis of TBI was assessed using receiver operating characteristic (ROC) curves. RESULTS: Serum levels of HIF-1α, BNIP3, Beclin-1, and S100B in the TBI group were higher than those in the control group (P<0.05). Among the TBI patients, the severe subgroup had higher levels of HIF-1α, BNIP3, Beclin-1, and S100B than the moderate subgroup (P<0.05). Correlation analysis showed that the serum levels of HIF-1α, BNIP3, Beclin-1, and S100B were negatively correlated with the Glasgow Coma Scale scores (P<0.05). After 7 days of treatment, serum levels of HIF-1α, BNIP3, Beclin-1, and S100B in both non-surgical and surgical TBI patients decreased compared to before treatment (P<0.05). ROC curve analysis indicated that the areas under the curve for predicting severe TBI based on serum levels of HIF-1α, BNIP3, Beclin-1, and S100B were 0.782, 0.835, 0.872, and 0.880, respectively (P<0.05), and for predicting poor prognosis of TBI were 0.749, 0.775, 0.814, and 0.751, respectively (P<0.05). CONCLUSIONS: Serum levels of HIF-1α, BNIP3, and Beclin-1 are significantly elevated in children with TBI, and their measurement can aid in the clinical assessment of the severity and prognosis of pediatric TBI.

[Current research status and application prospect of numerical simulation in traditional Chinese medicine drying].

With the rapid development of computer technology, numerical simulation has gradually become an important method to study drying process and improve drying equipment. Using computer to simulate the drying process of traditional Chinese medicine(TCM) is characterized by intuitiveness, scientificity, and low cost, which serves as an auxiliary means for technical innovation in TCM drying. This paper summarizes the theories of different drying methods and the research status of numerical simulation in drying, introduces the modeling methods and software of numerical simulation, and expounds the significance of numerical simulation modeling in shortening the research and development cycle, improving drying equipment, and optimizing drying parameters. However, the current numerical simulation method for drying process has problems, such as low accuracy, lack of quantitative indicators for the control of simulation results on the process, and insufficient in-depth research on the mechanism of drug quality changes. Furthermore, this paper put forward the application prospect of numerical simulation in TCM drying, providing reference for the further study of numerical simulation in this field.

[Application prospect of reaction engineering approach in studying drying behavior of single droplet during spray drying of traditional Chinese medicine].

Spray drying technology is one of the most commonly used unit operations in the production of traditional Chinese medicine(TCM) preparations, offering advantages such as short drying time and uniform product quality. However, due to the properties of TCM extracts, such as high viscosity, strong hygroscopicity, and poor flowability, there is limited scope to solve the problems of wall adhesion and clumping in spray drying from the macroscopic perspective of pharmaceutical production. Therefore, it has become a trend to study and optimize the spray drying process from the microscopic point of view by investigating single droplet evaporation behavior. Based on the reaction engineering approach(REA), the single droplet drying system, as a novel method for studying droplets, collects parameter data on individual TCM droplets during the drying process and uses the REA to process the data and establish predictive models. This approach is crucial for understanding the mechanism of TCM spray drying. This paper summarized and analyzed the cha-racteristics of various single droplet systems, the application of REA in single droplet drying systems, and its significance in optimizing the process, predicting drying states, and shortening the development cycle in the field of TCM spray drying, and looked ahead to the prospects of this method, including the introduction of new parameters and imaging techniques, aiming to provide a reference for further research in the field of TCM spray drying.

[Current status, trends, and challenges of continuous manufacturing technology for oral traditional Chinese medicine solid preparations].

In recent years, continuous manufacturing technology has attracted considerable attention in the pharmaceutical industry. This technology is highly sought after for its significant advantages in cost reduction, increased efficiency, and improved productivity, making it a growing trend in the future of the pharmaceutical industry. Compared to traditional batch production methods, continuous manufacturing technology features real-time control and environmentally friendly intelligence, enabling pharmaceutical companies to produce drugs more efficiently. However, the adoption of continuous manufacturing technology has been slow in the field of traditional Chinese medicine(TCM) pharmaceuticals. On the one hand, there is insufficient research on continuous manufacturing equipment and technology that align with the characteristics of TCM preparations. On the other hand, the scarcity of talent with diverse expertise hampers its development. Therefore, in order to promote the modernization and upgrading of the TCM pharmaceutical industry, this article combined the current development status of the TCM industry to outline the development status and regulatory requirements of continuous manufacturing technology. At the same time, it analyzed the problems with existing TCM manufacturing models and explored the prospects and challenges of applying continuous manufacturing technology in the field of TCM pharmaceuticals. The analysis focused on continuous manufacturing control strategies, technical tools, and pharmaceutical equipment, aiming to provide targeted recommendations to drive the development of the TCM pharmaceutical industry.

[Drying effect of Chinese medicinal pills based on new spiral vibration drying technology].

The present study explored the drying effect of new spiral vibration drying technology on Chinese medicinal pills with Liuwei Dihuang Pills, Zhuanggu Guanjie Pills, and Muxiang Shunqi Pills as model drugs. With the drying uniformity, drying time, energy consumption, pill split, dissolution time, and change of index components as evaluation indicators, the drying effect of spiral vibration drying technology on model drugs was evaluated and compared with traditional drying methods, such as hot air drying and vacuum drying in the oven. The dynamic changes of moisture in Liuwei Dihuang Pills with different drying time were investigated. Compared with the traditional drying methods in the oven(hot air drying and vacuum drying) at 80 ℃, the spiral vibration drying only took 80 min, shortened by 80%, with 10%-13% energy consumed. The results showed that the moisture of Liuwei Dihuang Pills was negatively related to the drying time. By virtue of multi-layer countercurrent drying and super resonant fluidization techniques, the new spiral vibration drying technology can significantly improve the drying quality of Chinese medicinal pills, improve the drying efficiency, and enhance the manufacturing capacity of Chinese medicinal pills. This study is expected to provide references for the innovation and development of new drying technology of Chinese medicinal pills.

[Quality control mode based on engineering quality view of Chinese medicine pharmacy].

Due to the characteristics of confusing varieties of Chinese medicinal materials, different sources, complex chemical composition, non-standard preparation process, and non-standard pharmaceutical equipment, the quality of Chinese medicinal preparations is difficult to be controlled and evaluated effectively under the current quality control mode and method of Chinese medicinal preparation. The present study proposed an engineering quality view of Chinese medicine pharmacy and a strategy to control the quality of Chinese medicinal preparations based on the current situation. The "overall, dialectical, and dynamic" multi-factor engineering quality view, covering original medicinal materials, preparation technologies, pharmaceutical equipment, and Chinese medicinal preparations, ensures the traceable process, measurable procedures, and feedback quality. The quality control mode of Chinese medicinal preparation with controllable sources, standardized preparation technologies, green pharmaceutical equipment, and intelligent manufacturing is built up.

[Online moisture detection technology and its application prospect in drying of traditional Chinese medicine].

Drying is one of the most common unit operations in the production of traditional Chinese medicine. The drying process of traditional Chinese medicine materials is accompanied by the dynamic reduction of water content. As a key index to determine the end of the drying process, the moisture content of materials plays an important role in improving drying efficiency and saving energy. Recently, the drying process of traditional Chinese medicine is mostly monitored by offline detection, and there are few reports of online moisture detection applications. In this paper, the principle and current application of online inspection technology for the material drying process in different fields were introduced. The significance of online detection technology in drying of traditional Chinese medicine was also analyzed. Meanwhile, the application prospect of online detection technology in the field of drying of traditional Chinese medicine was predicted. In response to urgent transformation and upgrading of the traditional Chinese medicine manufacturing industry, the application of online moisture detection technology is expected to be a key breakthrough in the intelligent upgrading of traditional Chinese medicine drying technology and equipment.

[Discussion on research thought of dry granulation of traditional Chinese medicine: research progress at home and abroad based on dry granulation technology].

Dry granulation technology is a great innovation in granulation technology,which saves many intermediate links and reduces many intermediate costs. It is closely related to the characteristics of materials,dry granulation equipment and process. Dry granulation technology is a systematic engineering science covering many technical fields. The process of dry granulation involves complex mathematical model mechanisms of temperature field,pressure field and velocity field,closely related to the characteristics of materials and drying equipment. However,due to the late start of research on dry granulation technology of traditional Chinese medicine,basic research is still weak. The research on dry granulation technology has achieved great results in the fields of food,chemical industry,agriculture and forestry,showing great reference significance. The advantage of dry granulation of traditional Chinese medicine is that it can be directly granulated by adding an appropriate amount of auxiliary materials in the extract powder of traditional Chinese medicine,without the need of wetting,mixing,drying and other processes. The process is simple and can effectively guarantee the quality of traditional Chinese medicine. The granules obtained by the dry granulation technique are important intermediates for preparing the solid preparations of traditional Chinese medicines,which would directly affect the subsequent molding process and the quality of the preparation products. Therefore,based on the characteristics of dry granulation method in traditional Chinese medicine and by referring to the advanced research results of dry granulation technology in other fields,we would discuss the research ideas of dry granulation in traditional Chinese medicine in terms of the mechanism of dry granulation equipment,technology,on-line detection technology and mathematical model of dry granulation process,hoping to provide reference for the research of dry granulation method in traditional Chinese medicine.

Application of infrared-assisted steam blanching to improve enzymatic inactivation and quality retention of Chrysanthemum indicum L. flower.

The effects of innovative infrared-steam blanching (ISB) on the peroxidase (POD) inactivation, POD inactivation kinetics, characteristic component (phenolics, carotenoids and flavonoids) content, colour and regeneration of POD activity during storage of Chrysanthemum indicum L. flowers were comparatively studied following steam blanching (SB) and infrared blanching (IB). ISB and SB allowed a stable surface temperature of the flowers at approximately 100 °C, and IB caused the temperature rose up to a high value of 129.2 °C. POD was inactivated to 5.7% of its residual activity after ISB for 90 s, 5.8% after SB for 180 s and 5.3% after IB for 270 s. In all processes, the POD inactivation kinetics followed a first-order model (R 2 varied from 0.932 to 0.957) and ISB achieved lower T 1/2, E a and D values and a higher k value than SB and IB. The sample blanched with ISB maintained more characteristic components and colour retention than those blanched with SB and IB. Moreover, ISB allowed the brightest colour and prevented the regeneration of POD activity in dried C. indicum flowers during storage. Therefore, ISB for 90 s at 100 °C is recommended as a more suitable method for blanching C. indicum flowers. The findings in the current work provide a new blanching method for natural plant products.

[Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation.

[Effect and regulation of drying on quality of traditional Chinese medicine pills].

The dry quality of traditional Chinese medicine pills is the hot spot of pills research, because their quality has a crucial effect on the efficacy and development of dosage forms. Through literature research and statistical analysis, we would review the current problems on the drying of traditional Chinese medicine pills in this paper, and surrounding the evaluation system for traditional Chinese medicine pills, analyze the characteristics of common drying equipment and processes as well as their effect on quality of pills, discuss the problems in drying equipment and process as well as quality, and put forward the corresponding strategies, hoping to provide new ideas and new methods for the quality improvement of traditional Chinese medicine pills and quality standards.

[Status, problems and warranty strategy of quality uniformity for traditional Chinese medicine preparations].

The quality uniformity of traditional Chinese medicine (TCM) preparation is the base for guaranteeing the safety and effectiveness of clinical medication. At present, the quality of TCM preparation is uneven. At present, the same TCM preparation in different manufacturers, TCM preparations in the same manufacturer, and even different batches of a same TCM preparation in the same manufacturer have great differences in quality, which can not reach stability and uniformity. This paper would discuss the possible factors that influence the uniformity of quality in the whole process of pharmacy by means of consulting relevant literature on quality control of Chinese herbal preparations and analyzing the present situation and problems of the quality of TCM preparation. In addition, some strategies such as standardization of cultivation of TCM, processing standardization, standardization of pharmaceutical equipment, mixed batch feeding, and Quality by Design would be also put forward to provide references for the quality uniformity of TCM preparation.

[Correlation between Andrographis Herba preparation's fingerprint, pharmacological activity and preparation process].

Process design grants the quality connotation to products. This paper was to investigate the correlation between changes of chemical fingerprints of Andrographis Herba preparation and its pharmacological activity, and set up the bridge between key process and quality attributes. By referring to the preparation process of Andrographis Herba. preparation (extracting-concentrating-drying-granulation), HPLC fingerprints were employed to determine the difference of the effective materials of the intermediate micro components. Cluster analysis results indicated that the extraction link had great influence on quality connotation variation of Andrographis Herba preparation. The pharmacological activity of various intermediates was continuously decreased in the models of DPPH antioxidant activity and LPS-induced anti-inflammatory activity in mice peritoneal macrophages. Traditional high temperature treatment process was detrimental to its clinical effect from the curve equation between the key process parameters and pharmacodynamic activity. Partial least square (PLS) was used to construct spectrum-efficiency model equation, and it was verified that this equation could accurately predict the relationship between fingerprints and pharmacological activity, which would facilitate the subsequent evaluation of quality attributes and provide scientific basis for further quality control of the whole process.

[Status and problem analysis of drying process and equipment for traditional Chinese medicinal materials and preparations].

Drying is the critical link during pharmaceutical process of traditional Chinese medicine (TCM), which is directly related to the quality of drugs. The key to technology upgrading of pharmaceutical equipment in Chinese materia medica enterprise is the development of new drying techniques, which concerns the modernization of TCM. The study provides new ideas for the drying technology and equipment by means of reviewing the research status of drying process for the traditional Chinese medicinal materials and preparations, and analyzing the traditional and modern drying methods and equipment, as well as their existing problems and corresponding measures for the drying processes and equipment. In addition, this paper expounds the development trend of traditional Chinese medicinal materials and preparations of drying process and equipment.

Systematic review of digital twin technology and applications.

As one of the most important applications of digitalization, intelligence, and service, the digital twin (DT) breaks through the constraints of time, space, cost, and security on physical entities, expands and optimizes the relevant functions of physical entities, and enhances their application value. This phenomenon has been widely studied in academia and industry. In this study, the concept and definition of DT, as utilized by scholars and researchers in various fields of industry, are summarized. The internal association between DT and related technologies is explained. The four stages of DT development history are identified. The fundamentals of the technology, evaluation indexes, and model frameworks are reviewed. Subsequently, a conceptual ternary model of DT based on time, space, and logic is proposed. The technology and application status of typical DT systems are described. Finally, the current technical challenges of DT technology are analyzed, and directions for future development are discussed.

A novel GJA5 variant associated with increased risk of essential hypertension.

OBJECTIVES: Gap junction protein alpha 5 (GJA5), also termed connexin 40 (Cx40), exerts a pivotal role in the mediation of vascular wall tone and two closely-linked polymorphisms in the GJA5 promoter (-44G>A and +71A>G) have been associated with enhanced susceptibility to essential hypertension (EH) in men. The present investigation aimed to ascertain whether a novel common polymorphism within the upstream regulatory region of GJA5 (transcript 1B), -26A>G (rs10465885), confers an increased risk of EH. METHODS: For this investigation, 380 unrelated patients with EH and 396 unrelated normotensive individuals employed as control persons were enrolled from the Chinese Han-ethnicity population, and their GJA5 genotypes and plasma renin concentrations were determined by Sanger sequencing and an automated chemiluminescent immunoassay, respectively. The functional effect of the GJA5 variant was explored in cultured murine cardiomyocytes by dual-light reporter gene analysis. RESULTS: The GJA5 variant conferred a significantly increased risk for EH (OR: 2.156; 95% CL: 1.661-2.797, P < 0.0001), and significantly increased plasma renin levels were measured in patients with EH in comparison with control individuals (46.3±7.2 vs 37.4±6.9, P < 0.0001). A promoter-luciferase analysis revealed significantly diminished activity of the promoter harboring the minor allele for this variation in comparison with its wild-type counterpart (165.67±16.85 vs 61.53±8.67, P = 0.0007). CONCLUSIONS: These findings indicate that the novel variant upstream of the GJA5 gene (-26A>G) confers a significantly increased vulnerability of EH in humans, suggesting potential clinical implications for precisive prophylaxis and treatment of EH.

Assessment of Drying Kinetics, Textural and Aroma Attributes of Mentha haplocalyx Leaves during the Hot Air Thin-Layer Drying Process.

Since Mentha haplocalyx leaves are rich in bioactive constitutes, particularly volatile compounds, there are higher demands for high-quality dried medicinal and aromatic peppermint products. This study aimed to assess the drying kinetics of hot air thin layer drying Mentha haplocalyx leaves and exploring the effects of hot air-drying temperatures on the textural properties and sensory quality. According to our results, the Midilli model is the best model representing the hot air-drying process. The effective moisture diffusivity (Deff) and activation energy (Ea) of the hot air-drying process were determined as 7.51 × 10-9-3.03 × 10-8 m2/s and 57.98 KJ/moL, respectively. The changes of textural and aromatic profiles of dried Mentha haplocalyx leaves were subsequently evaluated by the SEM, GC-MS and E-nose technology. Changes in leaf cellular membrane structures were observed in this study, indicating that the loss of moisture content induced the shrinkage of leaf cells during the hot air-drying process. Moreover, the altered profile of volatile compounds was identified at the different drying temperatures. As a result of the GC-MS analysis, increasing the content of D-carvone from 61.89%, 69.25% and 78.2% resulted in drying temperatures of 35 °C, 45 °C and 55 °C, respectively; while a decreasing trend of other volatile compounds, including D-Limonene, cineole and l-caryophyllene was detected as drying temperature elevated. Finally, the aromatic profile was evaluated by E-nose, and results of the flavor radar fingerprint and PCA showed that aromatic profiles were significantly altered by the drying process. The overall results elucidated that the hot air thin layer drying at 35 °C efficiently improved the final quality of dried Mentha haplocalyx leaves by maintaining flavor properties.