最新刊期
期 1 ， 2022
- 摘要：With the development of related technologies， encouragement by regulations and rising clinical demands， the development of personalized traditional Chinese medicine （TCM） preparations is gradually accelerated. Compared with the fixed prescription TCM preparations， personalized TCM preparations could better reflect the personalized treatment concept； compared with the traditional decoction， personalized TCM preparations have significant advantage in solving the clinical compliance problem caused by unpleasant taste. In view of the personalized TCM preparation， the application of taste masking technology could meet the individual needs of patients from the perspective of taste. Based on the establishment of TCM sensory characteristic fingerprints of ordor and taste， the different types of uncomfortable tastes of personalized TCM preparations could be effectively improved and its clinical compliance is further enhanced through the corresponding taste masking strategies. The main methods include improving the taste from the perspective of dosage form and prescription design， designing the taste masking scheme based on the taste preference， physical condition and emotional features of the patients， enhancing the product quality and the compliance of the patients through the personalized package design. In addition， compared with fixed prescription TCM preparations， because of the short life cycle of the product usage of personalized TCM preparations， the taste masking strategies and technical means have more flexibility， the application of personalized mate for taste masking has feasibility， and the choices of dosage forms and excipient types are more abundant. Meanwhile， the latest safety reports of some commonly used taste masking excipients should also be concerned.关键词：personalized TCM preparations;taste masking;clinical compliance;personalized mate for TCM taste masking
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发布时间：2022-08-29
Scholar Forum
- 摘要：Objective： To prepare Huayu Capsule and establish a high performance liquid chromatography （HPLC） method for simultaneously determining five main components and providing basis for quality control of Huayu Capsule.MethodsA proper number of medicinal materials were taken. The volatile oil was extracted by steam distillation， and then was prepared into a β-cyclodextrin inclusion complex by saturated aqueous solution method. The inclusion complex was mixed with concentrated extract and excipients to prepare granules， and then the capsules were obtained. The appearance， particle size， moisture， fluidity and solubility of the granules were detected， and the water content and disintegration time of the capsules were determined. The HPLC method was established for the content determination of naringin， hesperidin， neohesperidin， hydroxysafflower yellow A and amygdalin in Huayu Capsule， and the methodological investigation was performed.ResultsFor the prepared Huayu Capsule， the yield of inclusion complex was 64.9% and the inclusion rate of volatile oil was 55.2%. All quality tests on granules and capsules were in accordance with the provisions of the pharmacopoeia. For the established HPLC method， the linear relationship， precision， repeatability， stability and recovery met the requirements. The average contents of naringin， hesperidin， neohesperidin， hydroxysafflower yellow A and amygdalin in six samples of Huayu Capsule were 7.56， 1.63， 4.84， 0.61 and 1.13 mg/g respectively.ConclusionThe preparation process is simple and feasible. The established content determination method is simple and convenient， with good repeatability and stability and high precision， which can provide reference for the quality control of Huayu Capsule.关键词：Huayu Capsule;volatile oil;inclusion complex;quality control;content determination
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发布时间：2022-08-29 - 摘要：Objective： To optimize the preparation process of Baoyuan Granules.MethodsAn ultra-high performance liquid chromatography-evaporative light scattering detection （UPLC-ELSD） method was established for the simultaneous determination of ginsenoside Rb1 and astragaloside Ⅳ. Taking the transfer rates of ginsenoside Rb1 and astragaloside Ⅳ as evaluation indexes， the effects of extraction time， extraction times and solvent volume on the extraction process of Baoyuan decoction were investigated by orthogonal test， and the effect of relative density of extractum on the drying process was observed. Based on wet granulation， taking the molding rate， angle of repose， moisture absorption rate， bulk density and solubility as evaluation indexes， the effects of excipients and wetting agents on the granulation were investigated， and the molding process of Baoyuan Granules was optimized.ResultsThe optimum extraction process was as follows： the amount of water was 10 times， twice extraction and one hour each time. The relative density of the extractum was determined to be 1.05 to 1.15 during spray drying. The optimum molding process was wet granulation with maltodextrin as excipient and 90% ethanol as wetting agent， the dosage ratio of maltodextrin to dry paste powder was 1∶1.ConclusionThe optimized preparation process of Baoyuan Granules is stable and feasible， which can provide reference for the production of Baoyuan Granules.关键词：Baoyuan Granules;orthogonal design;ginsenoside Rb1;Astragaloside Ⅳ;preparation process
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发布时间：2022-08-29 - 摘要：Objective： To establish a high performance liquid chromatography （HPLC） method for simultaneous determination of salidroside and salvianolic acid B in Jingshen Pills， and optimize the drying process of Jingshen Pills.Methods①The determination was performed on an Agilent ZORBAX Eclipse Plus C18 column （250 mm×4.6 mm， 5 μm） at flow rate of 1 ml/min with methanol-0.1% phosphoric acid containing water （gradient elution）. The determination wave length was 278 nm， the column temperature was 35 ℃， and the injection volume was 10 μl. The methodology was investigated. ②Taking the appearance， water content， time-limit of dissolution and contents of salidroside and salvianolic acid B in Jingshen Pills as evaluation indexes， the effects of different drying processes on the quality of Jingshen Pills were investigated， including dehumidification drying at room temperature （25 ℃）， hot air drying at 60 ℃， hot air drying at 70 ℃， hot air drying at 80 ℃， hot air drying at 90 ℃ and hot air drying at 100 ℃. The best drying process was optimized by comprehensive scoring method.Results①For the established HPLC method， the linear relationship， precision， repeatability， stability and recovery all met the requirements. ②The optimum drying process of Jingshen Pills was hot air drying at 70 ℃， the layer thickness was 1.5 cm and the drying time was 2 hours.ConclusionThe established content determination method is simple and convenient， with good repeatability and stability and high precision， which can provide reference for the quality control of Jingshen Pills. The optimized drying process of Jingshen Pills is stable and feasible， which can retain the effective components to the greatest extent and show high drying efficiency.关键词：Jingshen Pills;salidroside;salvianolic acid B;drying process;high performance liquid chromatography
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发布时间：2022-08-29 - 摘要：Objective： To compare the effect of steam distillation （SD） and water extraction coupling rectification （WER） on the extraction of volatile oil from Artemisiae Argyi Folium.MethodsThe volatile oil from Artemisiae Argyi Folium was extracted by SD and WER methods， respectively， and the yield of volatile oil was calculated. The components of volatile oil were analyzed by gas chromatography-mass spectrometry （GC-MS）. The components and contents of the volatile oil from Artemisiae Argyi Folium extracted by these two methods were compared.Results① The yield of volatile oil extracted by SD method was 0.502 ml/100 g， and that extracted by WER method was 0.596 ml/100 g. The yield of volatile oil extracted by WER method was significantly better than that extracted by SD method. ②A total of 42 components were isolated from the volatile oil of Artemisiae Argyi Folium extracted by SD method， among， cineole， β-caryophyllene and α-terpineol accounted for 10.80%， 5.73% and 3.18% of the total volatile oil respectively. A total of 28 components were isolated from the volatile oil of Artemisiae Argyi Folium extracted by WER method， and cineole， β-caryophyllene and α-terpineol accounted for 19.15%， 8.51% and 4.61% of the total volatile oil respectively， which suggested that the contents of main active components were higher than those by SD method.ConclusionCompared with SD method， WER method shows higher yield and effective component contents and better appearance， which is more conducive to the extraction of volatile oil from Artemisiae Argyi Folium.关键词：Artemisiae Argyi Folium;volatile oil;steam distillation（SD）;water extraction coupling rectification（WER）;gas chromatography-mass spectrometry （GC-MS）
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发布时间：2022-08-29 - 摘要：Objective： To optimize the composite excipients which is suitable for preparing pill by the extrusion/rounding method， and explore the key physical properties of pill strip affecting pill forming quality.MethodsTaking the dosage of microcrystalline cellulose （MCC）， carboxymethylcellulose sodium （CMC-Na） and hypromellose （HPMC-E5） as the investigation factors， the yield， circularity， disintegration time， friability and extrusion velocity as the investigation indexes， and the value of overall desirability （OD） as the comprehensive evaluation index， the composite excipients were optimized by the D-optimal mixture design. The principle component analysis （PCA-X） and orthogonal partial least squares-discriminant analysis （OPLS-DA） were used to explore the key physical properties of pill strip associated with the preparation quality.ResultsThe optimal excipients proportioning was MCC（g）∶HPMC-E5（g）=1∶1. The results of PCA-X and OPLS-DA showed that， cohesion， viscosity， cracking force， chewiness， compression force and recovery force were the key physical properties of pill strip affecting the forming quality of pill.ConclusionThe optimized composite excipients have the advantages of stable process and good pill forming quality. It is possible to optimize the excipients proportioning and predict the forming quality of pill through the characterization of physical properties of pill strip.关键词：D-optimal mixture design;extrusion/rounding method;pill;composite excipients;texture analyzer
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发布时间：2022-08-29
Experiment Research
- 摘要：Tumor immunity is the hot spot of malignant tumor research. Tapasin is a kind of chaperone molecules located in the endoplasmic reticulum， which plays an important role in stabilizing peptide assembly complexes， recruiting MHC Ⅰ molecules and editing antigenic peptides. Studies have shown that a variety of tumor cells affect antigen presentation by reducing the expression of Tapasin protein， and then escape immune surveillance. The main regulatory pathways include interferon （IFN） and nuclear factor-κB（NF-κB） signal pathway. Tapasin protein interacts with CD8+ T cells， dendritic cells and other immune cells to mediate the occurrence and development of tumor immunity. This paper reviews the research progress on the structure and function of Tapasin protein， its expression and regulation in tumor cells， and its relationship with tumor immunity， so as to provide reference for tumor immunotherapy and related research of traditional Chinese medicine.关键词：Tapasin;MHC;tumor;immunotherapy
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发布时间：2022-08-29
Discipline Frontiers
- 摘要：Objective： To explore the additivity property characterics of Chinese medicine powder physical properties， and predict the powder physical properties of oily Chinese medicine Armeniacae Semen Amarum which is hard to crush applying Euclidean distance ratio.MethodsThe representative materials of five typical Chinese medicines including powdery， fibrous， brittle， sugar， and oily materials were Dioscoreae Rhizoma， Leonur Iherba， Ostreae Concha， Codonopsis Radix and Armeniacae Semen Amarum respectively. The fine powder of above Chinese medicines were mixed in pairs according to a certain proportion， and 26 powders of single or mixed Chinese medicines were obtained. The 15 physical parameters including bulk density， water absorption rate， maximum torque force and so on of 26 Chinese medicine powders were determined to characterize the basic properties， hydroscopicity and torque rheology of the Chinese medicine powders. The SIMCA-P 14.1 and Excel software were used to carry out the principal component analysis and correlation analysis. The predicted physical properties of Armeniacae Semen Amarum and the physical properties of the original 26 Chinese medicine powders were analyzed again by principal component analysis， and the correlation between the proportion of mixed powders and the weighted average score of principal components was verified.ResultsThe r value in the correlation equations between the weighted average score of physical property principal component and the mixing ratio of 8 Chinese medicine powder groups including Dioscoreae Rhizoma-Leonur Iherba group， Leonur Iherba-Ostreae Concha group， Dioscoreae Rhizoma-Armeniacae Semen Amarum group， Ostreae Concha-Armeniacae Semen Amarum group， and so on was 0.896-0.988. The powder physical properties of Armeniacae Semen Amarum was predicted by Euclidean distance ratio， and the correlation verification results between the weighted average score of principal component of physical properties and the mixing ratio of powders showed as follows： r=0.963 in Dioscoreae Rhizoma-Armeniacae Semen Amarum group， and r=0.873 in Ostrea Concha-Armeniacae Semen Amarum group.ConclusionThe powder with different physical properties has additive properties after mixing in a certain proportion， the powder physical properties of oily Chinese medicine such as Armeniacae Semen Amarum which is difficult to be crushed and screened alone， could be predicted through the above properties， so as to better guide the research and development of new drug and personalized preparation technology of Chinese medicine.关键词：Chinese medicine powder;physical properties of powder;additive property;Armeniacae Semen Amarum;personalized traditional Chinese medicine preparation
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发布时间：2022-08-29 - 摘要：Objective： To investigate the effects of three commonly used super disintegrants on the disintegration and compactibility of Chinese medicine tablets with delayed disintegration.MethodsThe aqueous extract powder of Sophorae Flavescentis Radix was taken as model drug， crospovidone （PVPP）， croscarmellose sodium （CCMC-Na） and carboxymethyl starch sodium （CMS） were taken as disintegrants. The effects of drug loading， disintegrants and their dosage on the disintegration and compactibility of tablets of Sophorae Flavescentis Radix were investigated. The alcohol extract of hawthorn leaf was used for verification.ResultsWhen the drug loading of Sophorae Flavescentis Radix was 70% and 80%， and different disintegrants were added， the disintegration time （DT） of all prepared tablets was more than 50 minutes. When the drug loading was 50%， PVPP， CCMC-Na or CMS were added respectively （at dosage of 10%）， the DTs of the prepared tablets were （29.00±2.19）min， （27.50±1.38）min and （41.17±0.98）min. There was no significant difference in the disintegration properties of PVPP and CCMC-Na， but they were better than CMS. After adding 10% PVPP， the pressure of the prepared tablets was （57.57±2.69） MPa， which was less than that of the prescription tablets containing CCMC-Na or CMS. The results of verification experiment were consistent.ConclusionFor the disintegration delay of Chinese medicine tablets， when the drug loading is reduced to 50%， adding the above three super disintegrants （10%） can better solve the problem of disintegration delay， the disintegration effect of PVPP and CCMC-Na is better， and the powder compactibility of PVPP is the best.关键词：super disintegrant;tablet;Chinese medicine;direct compaction;disintegration;compressibility;compactibility
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发布时间：2022-08-29 - 摘要：Objective： To explore the correlation among the amount of matrix， the characteristic physical properties of texture （characteristic physical properties） of the paste before coating and the coatability of the strapping.MethodsTaking the modeling quality and coatability of the strapping as the indicators， six important excipient matrices including partially neutralized sodium polyacrylate （NP700）， aluminum glycolate and so on were selected for formulation design. The amount of each matrix was set to 5 levels， and a total of 30 prescriptions were obtained. The characteristic physical properties including spreadability， hardness， viscoelasticity and so on of 210 samples of the paste before coating which were from 30 different prescriptions and 7 different time points were measured by a texture analyzer. The correlation analysis， principal component analysis and other methods were used to process the data.ResultsWith the increasing of the dosage of NP700， povidone K30 and tartaric acid and the ratio of oil phase， the indicators of characteristic physical properties of the paste before coating including spreadability， hardness， consistency， tensile strength， cohesion， rate of change and viscoelasticity were correspondingly increased. The suitable coating time was shortened， and the phenomenon of wrinkling was more likely appeared. After the principal component analysis on the characteristic physical property indicators of the samples， 210 samples can be clearly divided into two categories： coating and non-coating samples.ConclusionBy reducing the amount of NP700， povidone K30 and tartaric acid and the ratio of oil phase， the characteristic physical property indicators of the paste before coating such as spreadability， hardness， consistency and cohesion can be decreased， so as to optimize the coatability of the strapping.关键词：personalized TCM preparations;gel plasters;matrix prescription;characteristic physical properties;coatability
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发布时间：2022-08-29 - 摘要：Objective： To study the effect of excipient dosage on the rheological properties and preparation modeling quality of gel plaster of traditional Chinese medicine （TCM）， and explore the key rheological indexes which affect the modeling quality of gel plaster.MethodsTaking the prescription of lumbar disc protrusion plaster as the model drug， through a single factor experiment， different dosages of sodium polyacrylate NP700， aluminum glycolate， carbomer and tartaric acid were selected to prepare the gel paste. One part of the pastes was used to test the rheological indexes including storage modulus （G'）， loss modulus （G"） and creep recovery rate［J（t）%］ by rheometer. The other part was prepared into the plaster， and the quality indexes of the plaster including surface smoothness and residual， bubble and particle， initial adhesion and so on were evaluated. Meanwhile， the correlation analysis between the rheological indexes of the paste and the modeling quality of the plaster was carried out.Results①NP700 mainly affected the initial adhesion， repeated exposure and thixotropy of the gel plaster through affecting the values of G′ω=100， G″ω=0.1 and J（t）% of the paste. ②Carbomer mainly affected the initial adhesion， repeated exposure and thixotropy of the gel plaster through affecting the values of G′ω=100 and G″ω=0.1 of the paste. ③Aluminum glycolate mainly affected the initial adhesion and thixotropy of the gel plaster through affecting the values of G″ω=0.1 and J（t）% of the paste. ④Tartaric acid mainly affected the smoothness and residual， initial adhesion， repeated exposure and thixotropy of the gel plaster through affecting the value of G′ω=100 of the paste. Among them， the dosage of NP700 and aluminum glycolate had greater influence on the modeling quality of gel plaster of TCM.ConclusionDifferent excipient dosage has different effect laws on the rheological properties of the paste of gel plaster and the modeling quality of the plaster. The excipient dosage of gel plaster can be purposefully adjusted through detection of rheological indexes of the paste， so as to optimize the modeling quality of gel plaster.关键词：gel plaster of TCM;excipient dosage;single factor experiment;rheological index
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发布时间：2022-08-29
Special Column
- 摘要：Water activity （aw） is an important index for rapid evaluation of microbial risk and product stability in food and cosmetics industry. Based on the principle of aw， the effect of aw on microbial growth was deeply analyzed and the application status of aw in pharmaceutical research was reviewed. The application prospect of aw in microbial risk control of personalized traditional Chinese medicine （TCM） preparations was discussed by referring to the measurement methods and application schemes of aw in food and cosmetics industry. In addition， due to the time-limitation requirements of personalized TCM preparations， the conventional bacterial detection process takes too long time to adapt to the characteristics of personalized TCM preparations. Therefore， the introduction of aw will greatly reduce the time-limitation pressure of product microbial testing， help to enhance the safety control ability of preparations， and provide an efficient and feasible quality control scheme for the development and application of personalized TCM preparations.关键词：water activity;pharmaceutical production;personalized traditional Chinese medicine preparations;microbial growth;hurdle factor
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发布时间：2022-08-29 - 摘要：Personalized gel plasters of traditional Chinese medicine （TCM） is an important part of the clinical external prescription preparations and is the embodiment of the distinctive clinical diagnosis and treatment characteristics of TCM external treatment. Due to the technical difficulties of preparations brought by the requirement of “personalized pharmaceutical service” for the external personalized TCM preparations， this article explores the development direction of personalized gel plasters of TCM based on the current situation of external personalized preparations. The dosage form characteristics of personalized gel plasters and the key influencing factors and influencing laws of modeling are summarized to explore the research and development ideas for the personalized gel plasters of TCM. Meanwhile， the development strategies including systematically researching and analyzing the physicochemical properties of the raw materials of the personalized preparations， selecting the appropriate types and specifications of excipients， determining the universal prescription and technology of external preparation， and researching and developing the small equipment and so on are put forward， in order to assist the preparation technology development of personalized gel plasters of TCM.关键词：personalized preparations;gel plasters;historical evolution;development status;physical property;review
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发布时间：2022-08-29
Review
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