Improving the geographical origin classification of (licorice) through hyperspectral imaging assisted by U-Net fine structure recognition.

(licorice) is extensively employed in traditional Chinese medicine, and serves as a crucial raw material in industries such as food and cosmetics. The quality of licorice from different origins varies greatly, so classification of its geographical origin is particularly important. This study proposes a technique for fine structure recognition and segmentation of hyperspectral images of licorice using deep learning U-Net neural networks to segment the tissue structure patterns (phloem, xylem, and pith).

Recognition of the rhizome of red ginseng based on spectral-image dual-scale digital information combined with intelligent algorithms.

Red ginseng is a widely used and extensively researched food and medicinal product with high nutritional value, derived from steamed fresh ginseng. The components in various parts of red ginseng differ significantly, resulting in distinct pharmacological activities and efficacies. This study proposed to establish a hyperspectral imaging technology combined with intelligent algorithms for the recognition of different parts of red ginseng based on the dual-scale of spectrum and image information.

[Definitive screening design combined with design space for optimizing purification process of Scutellariae Radix extract].

In the pharmacopoeia, many process parameters for the purification process of Scutellariae Radix are unclear. In this study, deterministic screening design combined with design space method was used to optimize the purification process of Scutellariae Radix extract. Nine method parameters such as mass fraction of solution(X_1), first acid precipitation pH(X_2) and first holding time(X_3) in the purification process were firstly studied by definitive screening design.

[Research progress on percolation extraction process of traditional Chinese medicines].

Percolation extraction is a conventional extraction method used in the processing of traditional Chinese medicines. After medicinal material powder is placed in a percolation tank, the extraction solvent is continuously added, and percolation extract is collected simultaneously. The percolation equipment is simple.

[Quantitative chromatographic fingerprint analysis of Sanye Tangzhiqing Decoction based on quality by design concept].

In this work,a high performance liquid chromatography-ultraviolet( HPLC-UV) detection technology was used to establish fingerprint analysis method for Sanye Tangzhiqing Decoction following an analytical quality by design( AQb D) approach. Firstly,column temperature,flow rate,and gradient elution conditions were determined as the method parameters needing to be optimized. Then according to the results of definitive screening design,three critical method attributes( CMAs) were identified,including peak number,the percentage of common peak area to total peak area,and retention time of the last peak.

Critical pharmaceutical process identification considering chemical composition, biological activity, and batch-to-batch consistency: A case study of notoginseng total saponins.

Objective: Critical pharmaceutical process identification (CPPI) is an important step in the implementation of quality by design concept to traditional Chinese medicines (TCMs). Risk assessment methods are usually used in CPPI. However, risk evaluation is usually subjective.

Critical process parameter identification of manufacturing processes of extract with a weighted determination coefficient method.

Objective: Critical process parameters (CPPs) identification is an important step of the implementation of quality by design (QbD) concept. There are many CPP identification methods, such as risk analysis method, sensitivity analysis method, multiple linear regression method, standard partial regression coefficient (SPRC) method, and so on. The SPRC method can consider multiple process critical quality attributes (CQAs) simultaneously, but the determination of CPP number is subjective.

[Research on quality standards of standard decoction of Fructus Corni piece].

This study aims to develop the quality standards of Fructus Corni piece standard decoction. Morroniside and loganin were considered as index components. The content determination method of morroniside and loganin were developed.

[Quantitative analysis method of Shengxuebao Mixture by HPLC-UV-MS based on quality by design concept].

In this study, the HPLC-UV-MS method for the simultaneous determination of eight active ingredients of Shengxuebao Mixture were developed based on the concept of quality by design（QbD）with a stepwise optimization approach. After the analytical target profile（ATP）had been defined, albiflorin, paeoniflorin, 2, 3, 5, 4'-tetra-hydroxy-stilbene-2-O-β-D-glucopyranoside, specnuezhenide, ecliptasaponin D, emodin, calycosin-7-glucoside, and astragaloside Ⅳ were identified as the indicator components. The resolution and the signal-to-noise ratio of indicator components were then selected as critical method attributes (CMA) for the first step optimization.

[Comparison of two algorithms for development of design space-overlapping method and probability-based method].

In this work, two algorithms (overlapping method and the probability-based method) for design space calculation were compared by using the data collected from extraction process of Codonopsis Radix as an example. In the probability-based method, experimental error was simulated to calculate the probability of reaching the standard. The effects of several parameters on the calculated design space were studied, including simulation number, step length, and the acceptable probability threshold.

[Detection of antioxidant activity of Danhong injection and its intermediate with a paper-based analytical device].

The paper-based analytical device (PAD) was applied in this study to analyze the antioxidant activity of Danhong injection and its intermediates. First polycaprolactone was printed on the surface of a filter paper with a 3D printing device. The modified filter paper was then prepared using polycaprolactone and solid paraffin as the modifiers.

[Optimization of lime milk precipitation process of Lonicera Japonica aqueous extract based on quality by design concept].

Design space approach was applied in this study to optimize the lime milk precipitation process of Lonicera Japonica (Jinyinhua) aqueous extract. The evaluation indices for this process were total organic acid purity and amounts of 6 organic acids obtained from per unit mass of medicinal materials. Four critical process parameters (CPPs) including drop speed of lime milk, pH value after adding lime milk, settling time and settling temperature were identified by using the weighted standardized partial regression coefficient method.

[Optimization of ethanol reflux extraction process of red ginseng using a design space approach based on hazard and operability analysis].

Quality by design principle was used as a guideline in this study to optimize ethanol reflux extraction of red ginseng. Firstly, hazard and operability analysis(HAZOP) was used as a risk assessment tool to evaluate the hazard degree of process parameters.Ethanol concentration, the ratio of alcohol and herbal material (A/M ratio), and extraction time were identified as the critical process parameters(CPPs) according to HAZOP method.

[Research advances in secondary development of Chinese patent medicines based on quality by design concept].

Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy. In this work, recent research advances in QbD concept implementation methods in the secondary development of Chinese patent medicines were reviewed, and five promising fields of the implementation of QbD concept were pointed out, including the research and development of TCM new drugs and Chinese medicine granules for formulation, modeling of pharmaceutical processes, development of control strategy based on industrial big data, strengthening the research of process amplification rules, and the development of new pharmaceutical equipment.

[Application of continuous mixing technology in ethanol precipitation process of Salvia miltiorrhiza by using micromixer].

Continuous pharmaceutical manufacturing is one of the development directions in international pharmaceutical technology. In this study, a continuous mixing technology of ethanol and concentrated extract in the ethanol precipitation of Salvia miltiorrhiza was realized by using a membrane dispersion method. The effects of ethanol flowrate, concentrated extract flowrate, and flowrate ratio on ethanol precipitation results were investigated.

[Optimize dropping process of Ginkgo biloba dropping pills by using design space approach].

In this paper, a design space approach was applied to optimize the dropping process of Ginkgo biloba dropping pills. Firstly, potential critical process parameters and potential process critical quality attributes were determined through literature research and pre-experiments. Secondly, experiments were carried out according to Box-Behnken design.

[Design space approach to optimize first ethanol precipitation process of Dangshen].

Design space approach is applied in this study to enhance the robustness of first ethanol precipitation process of Codonopsis Radix (Dangshen) by optimizing parameters. Total flavonoid recovery, dry matter removal, and pigment removal were defined as the process critical quality attributes (CQAs). Plackett-Burman designed experiments were carried out to find the critical process parameters (CPPs).

[Simultaneous determination of danshensu, hydroxysafflor yellow A, rosmarinic acid, lithospermic acid, salvianolic acid B in water extract of mixed salviae miltiorrhizae radix et rhizoma and carthami flos by HPLC].

Objective: To develop an HPLC method to determine the contents of danshensu, hydroxysafflor yellow A, rosmarinic acid, lithospermic acid, salvianolic acid B in the water extract of mixed Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos simultaneously.

Method: The separation were carried out at 30 degrees C on a ZORBAX Eclipse Plus C18 column (4.6 mm x 100 mm, 1.