Stability research of Xiaoer Ganmaoning Oral Liquid based on chromatographic peak matching and image sensory evaluation / 中国中药杂志

The high performance liquid chromatography(HPLC) characteristic chromatogram of Xiaoer Ganmaoning Oral Liquid(oral liquid for short) was established. The medicinal materials corresponding to characteristic peaks, their index components and ranges of similarity with the reference chromatograms were clarified. The similarity between the characteristic chromatograms of 10 batches of the oral liquid and the reference chromatogram was higher than 0.994. Eighteen characteristic peaks were identified, which were derived from different medicinal materials including Scutellariae Radix, Arctii Fructus, Lonicerae Japonicae Flos, Gardeniae Fructus and Forsythiae Fructus. Further, 11 characteristic peaks were assigned by the comparison with reference substances as chlorogenic acid, neochlorogenic acid, cryptochlorogenic acid, isochlorogenic acid A, isochlorogenic acid C, baicalin, baicalein, wogonin, scutellarin, forsythiaside A and arctiin. Also, the characteristic chromatogram of precipitate in the oral liquid was established, and the similarity between characteristic chromatograms of 10 batches of the precipitate and the reference chromatogram was higher than 0.940. The 14 characteristic peaks originating from the precipitate and those from the oral liquid were consistent in retention time, and the content of all index components in the precipitate was lower than 5% of that in the oral liquid. Moreover, the stability of precipitate during the accelerated stability test was explored with filtration and Matlab-based image sensory evaluation. The precipitate mass and precipitation degree both increased over the stability test duration significantly. The stability of the oral liquid was used as a model system in this study to establish the integrated quality control system which related to medicinal materials, preparations and precipitate with HPLC characteristic chromatograms and image sensory evaluation, which lays a foundation for the exploration of the quantity value transfer of the oral liquid.

Common Problems of Traditional Chinese Medicine Effervescent Tablets and Prospect Analysis of Powder Modification Technology / 中国实验方剂学杂志

Traditional Chinese medicine （TCM） effervescent tablets have the characteristics of rapid disintegration， good taste， and convenient taking， but there are some technical difficulties in the preparation and storage process， which are mainly reflected in the sticking， easy moisture absorption， poor compressibility， and poor stability. The basic physical properties of TCM powder （extract powder， raw powder） are the main cause of these technical problems， and also the key to control the quality of TCM effervescent tablets. Powder modification technology has shown good effects in solving the above problems. The author intended to review the research in the above aspects in recent years， and proposed the following strategies for applying powder modification technology to solve the problems in the production process of TCM effervescent tablets from the three aspects of raw materials， excipients and preparation intermediates：①The application of co-processing technology to the treatment of raw materials and auxiliary materials can solve the problems of sticking， poor compressibility， delayed disintegration， and poor stability. ②Using surface coating technology to treat raw materials and preparation intermediates can improve poor fluidity， poor compressibility and delayed disintegration. ③The hygroscopicity of the preparation can be reduced by using microencapsulation technology to treat the raw material. ④The inclusion technology can improve the clarity and stability of the preparation.

Improving compactibility properties of Lonicera Japonica Flos by Plasdone S-630 / 药学学报

To improve the fluidity and compactibility properties of raw powders of traditional Chinese medicine by particle modification technology, Lonicera Japonica Flos was used as a model drug, fluidized bed bottom spray technology was used, and Plasdone S-630 was used as a modifier to prepare modified particles. The powder properties, tablet compactibility parameters, disintegration time and dissolution were measured. The surface morphology of the powder particles before and after modification and compressed tablets were characterized by combining with scanning electron microscopy technology. The results showed that the particle size of Lonicera Japonica powder has been increased after particle modification, the fluidity, compressibility and compactibility of the powder have been improved to some extent, the disintegration time has also been reduced, and the dissolution in vitro is not affected. Therefore, this study can provide reference and ideas for the common problem that raw powder of traditional Chinese medicine that cannot meet the needs of preparation production due to poor powder properties such as fluidity and compressibility.

Preparation, characterization and in vitro release of berberine hydrochloride resin complex / 药学学报

The object of this study is to preparate the berberine hydrochloride (BBH) resin compound with taste masking effect. We took the BBH as the model drug and Amberlite IRP69 as the drug carriers, uncovered the curve of solubility of BBH in different cosolvent with a certain range of temperature, and then used it to calculate the parameters during the preparation of the complex such as adding quantity of BBH and the reaction temperature. Afterwards, the characteristic and in vitro release experiments were studied to verify the formation and predict the in vivo release behavior of the complex. The results showed that in the condition of using 60% ethanol as a cosolvent and stirring at 50 ℃ for 1 h, the drug loading and drug availability of the complex are at about 35% and 64%, respectively, and has a better taste-masking effect. In this study, a method was provided for preparing a taste-masking preparation of BBH.

Unmet Needs and Services of Rehabilitation for People with Physical Disabilities Using Logistic Regression Analysis / 中国康复理论与实践

Objective:To explore the characteristics of unmet needs and services of rehabilitation for people with physical disabilities (PWPs). Methods:A total of 1 512 438 PWPs administration data of unmet needs and services of rehabilitation at provincial level were sampled and analyzed the characteristics of needs and services of rehabilitation, and the related factors of needs and services. Results:The reported unmet needs of PWPs from high to low were assistive devices assistive devices (55.9%), nursing care (27.0%), medicine (26.3%), functional training (23.9%) and surgery (2.3%). Received service of rehabilitation. The services of rehabilitation for PWPs arranged as assistive devices (48.2%), nursing caring (26.4%), functional training (24.3%), medicine (19.5%) and surgery (1.4%). The logistic regression model showed that age and severity of disabilities had significant effect on the reported unmet needs of rehabilitation and received services for PWPs (P < 0.001). Conclusion:PWPs reported unmet needs mainly in the fields of assistive devices, nursing care, medicine and rehabilitation training. They received primary services included assistive devices, nursing care and rehabilitation training and therapies. The services development will emphasize the accessibility and coverage. According to ICF model, it proposed to take measures to implement individualized and precise rehabilitation services to improve the quality of services.

Unmet Needs and Services of Rehabilitation for Adults with Disabilities / 中国康复理论与实践

Objective:To explore the status of disability, characteristics of unmet needs and services of rehabilitation and their related factors for adults with disabilities (AWDs). Methods:A total of 2 315 498 AWDs were sampled from the provincial level administration data (2019). Multiple response analysis was used to analysis the disability status of AWDs, characteristics of unmet needs and received services of rehabilitation, and related factors were explored with Logistic regression. Results:The distribution of disabilities for AWDs from high to low were physical disabilities (62.2%), visual disabilities (9.9%), intellectual disabilities (8.4%), mental disorders (7.3%), hearing disabilities (6.9%), multiple disabilities (2.8%) and speech disabilities (2.5%). The reporting rate of unmet needs of rehabilitation for AWDs from high to low were assistive devices (49.0%), medicine (33.3%), nursing care (27.7%), functional training (20.2%) and surgery (1.9%). The reporting rate of received service for AWDs from high to low were assistive devices (44.1%), nursing care (26.6%), medicine (25.9%), functional training (22.2%) and surgery (1.3%). The logistic regression model shown that types and severities of disabilities had significant effects on unmet needs and received services of rehabilitation for AWDs (P < 0.001). Conclusion:The reporting of unmet needs for AWDs had been influenced by their functioning and disability. There were gaps between unmet needs and received services. It proposed to develop precise and individualized reporting of unmet needs and service programs for AWDs.

Application Status of Properties of Surface and Interface in Research on Pharmaceutical Preparations / 中国实验方剂学杂志

The surface and interface,as the transition region between two phases,belongs to the category of physical chemistry.At present,it is widely used in materials and other scientific fields.Meanwhile,this property also plays an important role in pharmaceutical research.The interface layer involved in the progress of pharmaceutical preparations is connected with the two-phase or three-phase between gas,liquid and solid closely.The interface effect will affect the final shaping of pharmaceutical preparations and the dissolution and absorption of drugs in the human body.In this paper,the surface and interface characteristics(specific surface area,surfacial and interfacial tension and surface Gibbs free energy) were compared,and the application of interface phenomena(wetting,solubilization and emulsification) in pharmaceutical research were introduced.From the points of view of the progress control of pharmaceutical preparations and the effectiveness of their products,the article expounds the important role of properties of surface and interface in the field of pharmaceutical preparations.Therefore,it is necessary to pay attention to the properties of surface and interface,one of the key physical properties of drugs,and to apply them in the pharmaceutical research.

Correlation between chemical compositions of traditional Chinese medicine extracts and phenomenon of wall stickiness in spray drying / 中国中药杂志

To explore the correlation between chemical compositions (organic acids, small molecule sugars, protein and others) of traditional Chinese medicine extracts and the wall stickiness in spray drying. In this study, 55 types of most common used Chinese herbs were selected to determine the content of 7 chemical components such as citric acid and fructose from plant extraction. The status of wall stickiness was observed during the drying process. The principle component analysis (PCA-X), hierarchical clustering analysis(HCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were then used to evaluate the correlation between each chemical compositions and wall stickiness, so as to look for the essential chemical compositions associated with the wall stickiness. All of the above 3 statistical analysis methods showed significant results in distinguishing the two groups (sticky or non-sticky). PCA-X score chart and HCA clustering scatter plot suggested that the small molecular substance was the main factor causing wall stickiness, which was then proved by the reality where some of the traditional herb extracts were in non-sticky state after drying but in sticky state after alcohol precipitation. OPLS-DA results revealed that L-malic acid, citric acid, fructose and glucose were the difference factors for the wall stickiness of the extracts. Under small molecular components, L-malic acid, citric acid, fructose and glucose were the crucial factors that directly led to the hot melt sticky wall of the herbal extracts, and macromolecular substances might ameliorate the function of wall stickiness.

Analysis of the effect of moisture adsorption on the compressibility of extracts of Puerariae Lobatae Radix by dynamic vapor sorption / 药学学报

With the extracts of Puerariae Lobatae Radix as the research object, the moisture absorption isotherm at 298, 308 and 318 K was determined through dynamic water vapor adsorption. Moisture absorption isotherm models were applied to the simulation of moisture absorption behavior. The enthalpy, entropy and Gibbs free energy for moisture adsorption were calculated according to the model and the enthalpy-entropy compensation was used to analysis moisture adsorption process. It was shown that the adsorption isotherm coincided with GAB model or Ferro-Fontan model. Moisture absorption process was an exothermic process which was driven by entropy. The effect of moisture on compressibility was evaluated through tensile strength and elastic recovery with water content, pressure force and speed variation. It was supposed that right amount of moisture was required to compression and compaction.

Research on compaction behavior of pharmaceutical powders based on surface free energy / 药学学报

This study was designed to establish the method of characterization of surface free energy(SFE)and evaluate the compaction properties of pharmaceutical materials based on SFE. We investigated the contact angles of materials with water and diiodomethane under different compression pressures. The contact angles of materials at 353 MPa compression pressure were utilized to calculate the related parameters of SFE ultimately. The area under tensile strength-compression pressure curve(AUTSC)and pressure yield(Py)were employed to evaluate the compactibility of material. Additionally, Pearson correlation analysis was utilized to analyze the relationship between the SFE and the compaction properties of pharmaceutical materials. The results exhibited that SFE had a significant correlation with the compaction properties of materials(P < 0.05). Moreover, the related parameters of SFE, i.e., cohesive work(Wco)and polarity index(PI)of SFE, were positively correlated with Py of Heckel equation and negatively related with AUTSC. The higher values of Wco and PI, the stronger repulsive force among the particles, led to a worse compaction behavior. In this study, we established the method for characterization of the compaction behavior of materials based on SFE initially. This study also demonstrated that SFE could evaluate the compaction behavior effectively, which provides a better understanding of compaction behavior for pharmaceutical researchers.

Correlation of dry granulation process parameters and granule quality based on multiple regression analysis / 药学学报

In this paper, microcrystalline cellulose WJ101 was used as a model material to investigate the effect of various process parameters on granule yield and friability after dry granulation with a single factor and the effect of comprehensive inspection process parameters on the effect of granule yield and friability, then the correlation between process parameters and granule quality was established. The regress equation was established between process parameters and granule yield and friability by multiple regression analysis, the affecting the order of the size of the order of the process parameters on granule yield and friability was: rollers speed > rollers pressure > speed of horizontal feed. Granule yield was positively correlated with pressure and speed of horizontal feed and negatively correlated rollers speed, while friability was on the contrary. By comparison, fitted value and real value, fitted and real value are basically the same of no significant differences (P > 0.05) and with high precision and reliability.

Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD / 中国中药杂志

Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.