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Objective To evaluate the quality of Tongshu gel paste based on thin layer chromatography(TLC)identification and high performance liquid chromatography(HPLC)quantitative analysis of multi-index components.Methods Qualitative identification of tetrahydropalmatine,paeoniflorin,tetrandrine,linderane,Rhizoma atractylodis and Fructus aurantii in the modified Tongshu gel paste was carried out by TLC.The main active contents of tetrahydropalmatine,paeoniflorin,tetrandrine and linderane in the preparation were determined by HPLC.Results The TLC spots of the six herbs in the prescription were clear and negative without interference.The linear ranges of tetrahydropalmatine,paeoniflorin,tetrandrine and linderane were 4.30-272.50 μg/mL(r=0.999 9),21.10-1 350.00 μg/mL(r=0.999 8),4.10-262.40 μg/mL(r=0.999 8)and 3.60-232.50 μg/mL(r=0.998 6),respectively.The range of average recovery for each component was 98.96％-99.52％,and all RSDs were less than or equal to 1.54％(n=9).Conclusion The multi-index TLC qualitative identification and HPLC quantitative method established by research have high specificity,simple operation and can be used for quality evaluation of the improved formulation of this prescription.
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Objective To establish an HPLC fingerprint of Dingdang Qigui Decoction and analyze and evaluate it using chemical pattern recognition technology;To determine the contents of 5 effective chemical components in Dingdang Qigui Decoction;To provide a basis for its quality control.Methods The analysis was performed on Agilent 5 TC-C18(2)column(250 mm×4.6 mm).The mobile phase comprised of acetonitrile-0.1%phosphoric acid aqueous solution with the gradient elution at a flow rate of 1.0 mL/min.The detection wavelength was set at 260 nm.The column temperature was maintained at 30℃and the injection volume was 10 μL.SPSS 26.0 and SIMCA 14.1 were used to perform clustering analysis and principal component analysis on the 10 batches of Didang Qigui Decoction.The landmark components for inter batch differences were selected through orthogonal partial least squares discriminant analysis(OPLS-DA).Results The HPLC fingerprint with eighteen common peaks of Didang Qigui Decoction in 10 batches of sample was established,and the similarities of samples were between 0.828 and 0.989.Five indicative components were identified and quantitatively analyzed by comparing with the reference substances,which were paeoniflorin,mauroisoflavone glucoside,hesperidin,cinnamaldehyde and aloe rhodopsin.The linear ranges was 10.000 0-320.000 0 μg/mL,2.500 0-80.000 0 μg/mL,10.000 0-320.000 0 μg/mL,10.000 0-320.000 0 μg/mL,0.078 1-5.000 0 μg/mL,respectively,and their mean recovery ranged from 100.30%to 104.09%.Clustering analysis and principal component analysis divided 10 batches of samples from Didang Qigui Decoction into 2 categories.Through OPLS-DA screening,hairy pistil isoflavone glycosides,paeoniflorin,and hesperidin were selected as landmark components for quality differences.Conclusion The quality evaluation method for Didang Qigui Decoction established in this study is simple,sensitive,accurate,and reproducible,which can provide a basis for the quality evaluation of Didang Qigui Decoction.
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Qualitative research has made important contributions to nursing practice and theory construction.Based on the authors'rich experiences in conducting and teaching qualitative studies,this paper proposed some suggestions on the use of qualitative research,writing and quality evaluation of qualitative research papers.It aims to deepen the understanding of nursing researchers to qualitative research,so as to improve the quality of qualitative research in nursing papers.
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OBJECTIVE To evaluate the palatability and chewability of chewable tablets， and provide reference for the quality evaluation of various types of chewable tablets. METHODS Using self-made Glucosamine hydrochloride chewable tablets as the model drug， the quality test was conducted. The in vitro simulation system for chewable tablets was established by using a texture analyzer and rheometer， and an oral simulation experiment was conducted on chewable tablets. The texture analyzer was used to measure the force required for chewing and simulate the static disintegration process of chewable tablets； the rheometer was adopted to measure the viscoelasticity， thixotropy， and deformability of chewable tablets during the chewing process. RESULTS The disintegration time limit， principal component content， and dissolution of self-made Glucosamine hydrochloride chewable tablets all met the limit requirements. The in vitro simulation results of the texture analyzer showed that self-made chewable tablets were easy to chew in both axial and radial directions， and the force required for chewing was within the range of the chewing force of the teeth； chewable tablets could disintegrate at an appropriate time without being chewed and only taken in the oral cavity. The in vitro simulation results of the rheometer showed that the chewable tablets in the oral cavity exhibited a behavior of elasticity as the main factor and viscosity as the secondary factor through the continuous stirring of the tongue， and the viscosity of the chewable tablets gradually decreased with tongue stirring or tooth chewing； when chewing with teeth， the internal force of the chewing tablets decreased， causing plastic deformation and crushing. After being crushed， the shape couldn’t be restored， making it easy to chew and swallow. CONCLUSIONS The combination of texture analyzer and rheometer can be used to simulate the oral chewing process and evaluate the palatability and chewability of self-made Glucosamine hydrochloride chewable tablets. This model can provide reference for the evaluation of various chewable tablets.
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ObjectiveBased on the traditional quality evaluation methods summarized in previous dynasties， this paper systematically contrasted cultivated Astragali Radix（CA） and wild-simulated Astragali Radix（WA） from the aspects of character， microstructure and chemical composition by modern technological means. MethodThe collected CA and WA were compared in characters and microscopic characteristics in cross section， and comparative analysis were performed on the contents of cellulose， extracts， carbohydrate， total flavonoids， total saponins， etc. Then ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometer（UPLC-Q-TOF-MS） and desorption electrospray ionization mass spectrometry imaging（DESI-MSI） were used to comparatively analyze the secondary metabolites and their spatial distributions in the xylem and phloem of CA and WA. ResultIn terms of characters， the characters and sectional features of WA was consistent with the characteristics of high-quality Astragali Radix， while the CA was quite different from the traditional high-quality Astragali Radix. In terms of microscopy， the phellem layer of CA was thin， and the section fissures were mostly distributed through the cambium in a long strip shape without obvious growth ring characteristics. The cork layer of WA was thick， and the cracks in the section were distributed in the center of the xylem and the outer edge of the phloem in an irregular cavity shape. The cambium was tight without cracks， and had obvious characteristics of a growth ring. In terms of chemical composition， the contents of water-soluble extract， 80% ethanol extract and sucrose of CA was significantly higher than those of WA， while the contents of total saponins， lignin and hemicellulose were significantly lower than those of WA. And the contents of 100% ethanol extract， total polysaccharides and total flavonoids in both of them were generally similar， but slightly higher in WA. The contents of 2 kinds of monoacyl-substituted flavonoid glycosides in the xylem of WA was significantly higher than those of CA， while the contents of 2 kinds of flavonoid aglycones and one flavonoid glycoside were on the contrary. The contents of 7 saponins in phloem of WA were significantly higher than those of CA. ConclusionThere are significant differences between CA and WA in characters， microstructure and chemical components， in which CA has a fast growth rate and a short planting period， and the primary metabolites such as water-soluble extracts and sucrose are more enriched， which is the reason for its firm texture and sweetness being significantly higher than those of WA. However， the contents of lignin， hemicellulose and some secondary metabolites in WA are significantly higher than those in the CA， which are close to the traditional description of characters and quality. Based on the results of this study， it is suggested to strengthen the production of WA， improve the supply capacity of WA， and gradually upgrade the current standard. It is recommended to increase the contents of monoacyl-substituted flavonoid glycosides， total saponins and other indicators that can characterize different production methods， so as to guide the high-quality production of Astragali Radix.
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ObjectiveBased on the quality evaluation experience of "it is better to have a fragrant and strong aroma" summarized by materia medica of past dynasties， the chemical components of Sojae Semen Nigrum（SSN） and Sojae Semen Praeparatum（SSP） were systematically compared and analyzed， and the main fermentation products in different fermentation time were quantitatively analyzed， so as to clarify the transformation law of internal components in the processing process and provide scientific basis for the modern quality control of SSP. MethodUltra performance liquid chromatography-quadrupole tandem time-of-flight mass spectrometry（UPLC-Q-TOF-MS） was used for the structural identification of the chemical constituents of SSN and SSP， and with the aid of Progenesis QI v2.3 software， the negative ion mode was employed for principal component analysis（PCA） pattern recognition， and the data were analyzed with the aid of orthogonal partial least squares-discriminant analysis（OPLS-DA） for two-dimensional data to obtain S-plot， and components with |P|>0.1 were selected as the differential constituents. The contents of isoflavonoids in SSP during fermentation was determined by UPLC， and the samples were taken every 8 h in the pre-fermentation period and every 2 d in the post-fermentation period， and the dynamic changes of isoflavonoid contents in different fermentation stages were analyzed. The contents of amino acids and nucleosides in SSP and SSN from different fermentation stages were quantitatively analyzed by phenyl isothiocyanate（PITC） pre-column derivatization and high performance liquid chromatography（HPLC） gradient elution， and the contribution of flavor substances to the "delicious" taste of SSP was discussed by taste intensity value（TAV）. ResultA total of 19 kinds of differential components were screened out， mainly soybean saponins and isoflavones， and their contents decreased significantly or even disappeared after fermentation. In the pre-fermentation process of SSP， glycoside bond hydrolysis mainly occurred， and isoflavone glycosides in SSN were degraded and converted into the corresponding aglycones， the content of flavor substances such as amino acids increased gradually. In the post-fermentation process， protein degradation mainly occurred， after 8 d of post-fermentation， the content of isoflavones was basically stable， while the total content of amino acids increased by 8-40 times on average. Different amino acids form the special flavor of SSP， such as the TAV of glutamate is always ahead of other flavor substances， and sweet substances such as alanine and valine have made relatively great contributions to SSP. ConclusionBased on the law of constituent transformation， combined with the traditional evaluation index of "fragrant and strong"， it is difficult to control the fermentation degree of SSP by the existing standards in the 2020 edition of Chinese Pharmacopoeia. It is suggested that description of the characteristics of SSP be refined and changed to "fragrant， delicious and slightly sweet"， and at the same time， the post-fermentation index compounds such as glutamic acid， alanine and valine should be added as the quality control indicators of SSP， so as to standardize the production process and improve the quality of SSP.
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ObjectiveBased on the experience of traditional quality evaluation， the quality of Atractylodis Macrocephalae Rhizoma（AMR） with different production methods such as direct seeding， transplanting after seedling raising， topping and non-topping， and difference in growth years was compared. MethodVernier caliper was used to measure the trait data of AMR in different production methods. Paraffin sections of AMR with different production methods were made by saffron solid green staining， and the microstructure was observed. The contents of water-soluble and alcohol-soluble extracts in AMR with different production methods were determined according to the 2020 edition of Chinese Pharmacopoeia. The content of water-soluble total polysaccharides in AMR with different production methods was detected by sulfuric acid-anthrone method. Fiber analyzer was used to detect the content of fiber components in AMR with different production methods. The contents of monosaccharides， oligosaccharides and some secondary metabolites in AMR with different production methods were detected by ultra performance liquid chromatography（UPLC）， and the differences of chemical components were compared by multivariate statistical analysis methods such as principal component analysis（PCA） and partial least squares-discriminant analysis（PLS-DA）. ResultIn terms of traits， the 3-year-old AMR with direct seeding and without topping was close to the high-quality AMR with "phoenix-head and crane-neck， strong sweetness and clear aroma" recorded in ancient materia medica， followed by the 3-year-old AMR with topping after transplanting， while the 2-year-old AMR with topping after transplanting with high market circulation rate was generally fat and strong with mild odor. In the microscopic aspect， the arrangement of xylem vessels and fiber bundles in the 3-year-old samples formed two obvious rings. Compared with the 2-year-old samples cultivated in Bozhou and Zhejiang， the 3-year-old samples without topping after transplanting had more wood fibers. In terms of chemical composition， the contents of 70% ethanol extract， fructose， glucose， sucrose， 1-kestose， atractylenolide Ⅰ， chlorogenic acid， neochlorogenic acid， cryptochlorogenic acid and other components in 3-year-old AMR with direct seeding and without topping were significantly higher than those in the other three samples（P<0.05）. The contents of cellulose， 70% ethanol extract， sucrose， atractylenolide Ⅰ， atractylone and other components in 3-year-old AMR with topping after transplanting were significantly higher than those in the 2-year-old AMR with high market circulation rate（P<0.05）， while the contents of water-soluble extract and water-soluble total polysaccharides in 2-year-old samples with topping after transplanting were significantly higher than those in the 3-year-old AMR with topping after transplanting， direct seeding and without topping（P<0.05）. ConclusionUnder the current mainstream production mode， too much manual intervention makes AMR heavily enriched in polysaccharides and increased the yield， but the accumulation of sweet substances， fragrant substances and fiber substances is insufficient， which affects its quality. The current quality standard of AMR has some shortcomings in guiding the high quality production of it， it is suggested to revise the quality standard of AMR， supplement the quantitative analysis of secondary metabolites， and strengthen the production of imitation wild AMR.
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Objective To construct quality evaluation indicators for perioperative nursing in heart transplantation,and to provide standard and professional quantitative bases for monitoring and management of perioperative nursing quality.Methods This study was conducted based on the frame work of the three-dimensional"structure-process-outcome"quality model,using literature review,Delphi method and analytic hierarchy to determine the content of the indicators,and the weight of each index.Results A total of 22 experts from 14 qualified heart transplantation hospitals were included,and a total of 2 rounds of consultations were conducted.The effective recovery rates of 2 rounds of expert consultation questionnaires were 100％.The authority coefficients were 0.817.The variation coefficients of each item ranged from 0.025～0.169 and 0.039～0.157.The Kendall harmony coefficients were 0.126 and 0.225(P＜0.001).The final evaluation indicators for perioperative nursing quality in heart transplantation included 3 first-level indicators,12 second-lever indicators and 59 third-level indicators.Conclusion The evaluation indicators of perioperative nursing quality in heart transplantation was scientific,comprehensive and specialized,which can provide references for the evaluation of perioperative nursing quality in heart transplantation.
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Objective:This study aims to evaluate the quality and explore the preliminary clinical applications of a domestically developed hepatitis D virus nucleic acid quantification reagent (abbreviated as"domestic HDV RNA reagent").Methods:The sensitivity and accuracy of the reagent were evaluated in accordance with the WHO HDV RNA international standard, employing the Bio-Rad CFX Opus 96 real-time fluorescence quantitative PCR analysis system. Serial dilutions of pseudo-viruses or cell culture-derived virus were used to determine the linear range of the domestic HDV RNA reagent. Specificity was assessed using positive samples of HAV, HBV, HCV infection, and HEV national reference materials. Precision was evaluated with samples at both high and low concentrations. In a comparative analysis, 30 HDV IgG positive samples were tested using both the domestic HDV RNA reagent and the RoboGene HDV RNA kit based on the ABI 7500 FAST DX system. The Pearson correlation coefficient (r) was used to examine the correlation between the two reagents.Results:The domestic HDV RNA reagent demonstrated a high sensitivity of up to 6 IU/ml, consistent with that of the comparator reagent. The calibration curve for WHO HDV RNA standards had a slope of -3.286, with an amplification efficiency of 101.6%. The linear detection range spanned from 10 to 10 8 IU/ml for eight HDV genotypes. The domestic HDV RNA reagent exhibited exceptional specificity, without cross-reactivity observed with HAV, HBV, HCV, or HEV. Accuracy assessments at five concentration levels met the required standards, with intra-assay precision coefficient of variation ( CV) ranging from 1.20% to 4.20%, and inter-assay precision CV from 1.20% to 7.90%. The detection results for HDV IgG positive samples were highly correlated with the comparator reagent ( r=0.984, P<0.001), achieving a diagnostic accuracy of 100% compared to sequencing results. Conclusion:In this study, the domestic HDV RNA reagent possesses excellent specificity, accuracy, precision, and a broad linear range, attaining a sensitivity level on par with international reagents of the same type.
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From the perspectives of traditional Chinese medicine （TCM） information knowledge base and assisted decision-making knowledge base， the construction status， quality evaluation status and existing problems of current TCM knowledge bases have been sorted out. And based on the quality evaluation strategies and dimensions of know-ledge bases in other disciplines， the evaluation indexes for TCM knowledge base is discussed， and the evaluation framework is initially formed， providing ideas for the improvement of the TCM knowledge base evaluation system. In terms of the evaluation indexes， there are basic evaluation dimensions which include data sources， data collection， and data application. The specific evaluation dimension of the information-based knowledge base is data quality， while that of the assisted decision-making knowledge base is data matching. Except for the data application dimension which counts the valid data items in the database for calculation， other indexes are scored based on the qualitative evaluation of "yes"， "no" or "unknown". The basic evaluation score and the specific evaluation score are added to obtain the total score. The knowledge base is graded according to the score， and the results are presented in the form of grade plus number.
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ObjectiveTo analyze the development status and quality of clinical practice guidelines for the treatment of dominant diseases with Chinese patent medicines （CPMs）. MethodsDatabases were searched from Jan. 2019 to Dec.2023 to collect the published clinical practice guidelines of CPMs for the treatment of dominant diseases. The information about the title， the participants， clinical problems， outcomes， evidence grade， recommendations， and recommendation strength in the included clinical practice guidelines were collected， for which the development status was analyzed， and the quality was evaluated with the Scientific， Transparent and Applicable Rankings （STAR） tool for clinical practice guidelines. ResultsTotally， 34 guidelines were included， involving 273 kinds of CPMs. One to ten （with the medium five） clinical problems were proposed from 29 clinical practice guidelines respectively. All the guidelines divided the evidence into four grades according to Grade of Recommendation Assessment， Deve-lopement an Evaluation. And 28 guidelines had five levels of recommendation strength. A total of 344 recommendations were extracted， including 86 strong-recommendations， 191 weak-recommendations （including 36 weak recommendations only based on expert consensus） and 67 recommendations with unclear recommendation strength. All guidelines had high scores in the three areas of “clinical questions （94.20%）”， “evidence （91.45%）” and “recommendations （89.06%）”， while the scores in the three areas of “registry （22.06%）”， “protocol （19.00%）” and “accessibility （31.51%）” were low. The STAR recommended stars of 8 guidelines were 5.0~4.0 stars， while that of 18 guidelines were 3.5~2.5 stars， and 8 guidelines were 2.0~1.0 stars. The three guidelines with the highest recommended stars were depressive disorder， community-acquired pneumonia， and influenza in adult. ConclusionThere is a certain gap in the quality of the published clinical practice guidelines of CPMs， and the quality of the guidelines could be further improved in registry， protocols， funds， and accessibility.
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ObjectiveIn order to understand the quality differences between wild and cultivated Bupleurum chinense（BC）， modern analytical techniques were used to systematically compare the quality of wild and cultivated BC in terms of appearance characteristics， primary and secondary metabolites. MethodSamples of wild and cultivated BC were collected from the main production areas of Shanxi， Shaanxi and Hebei， and images of BC were collected and their length and diameter were measured using vernier caliper to compare and analyze the characteristics of the two. Referring to the method under extract of CP in the 2020 edition of Chinese Pharmacopoeia， the extract contents of the two species were determined. The cellulose， hemicellulose and lignin compositions of both were determined using fiber analyzer. Quantitative determination of representative saikosaponins， flavonoids and saccharides in BC by ultra performance liquid chromatography（UPLC）， headspace gas chromatography-mass spectrometry（HS-GC-MS） was used to determine the types and relative contents of volatile components， and UPLC-quadrupole-time-of-flight mass spectrometry（UPLC-Q-TOF-MS） coupled with multivariate statistical analysis was used to screen and identify the differential compounds between wild and cultivated BC. ResultThere were significant differences in the appearance characteristics between wild and cultivated BC， the wild BC had a large root head， twisted and thick axial root， rough epidermis， and often had a stem base and lateral root with dark color and strong odor. However， the cultivated BC has long and straight taproots， delicate epidermis， few lateral roots， light root color and light smell. In terms of primary and secondary metabolites， the contents of alcohol-soluble extract and lignin of wild BC was significantly higher than those of cultivated BC， while the contents of water soluble extract and quercitrin was higher than those of cultivated BC， but the difference was not significant. The contents of cellulose， five saikosaponins， rutin， narcissoside and isorhamnetin-3-O-glucoside in cultivated BC were significantly higher than those of wild BC， and the total water-soluble polysaccharides， sucrose， hemicellulose and starch of cultivated BC were higher than those of wild BC， but the difference was not significant. The results of HS-GC-MS identification showed that a total of 67 volatile components were identified in wild and cultivated BC， 59 in wild BC and 51 in cultivated BC， with a total of 43 compounds in both， and the screening based on variable importance in the projection（VIP） value>1 revealed that the differential components were mainly concentrated in the aromatic and fatty acid compounds. The results of UPLC-Q-TOF-MS-based non-targeted metabolomics combined with multivariate statistical analysis showed that the two were significantly different in saikosaponins and the differential compounds had higher response values in cultivated BC. ConclusionThere are significant differences in the appearance， primary and secondary metabolite contents between wild and cultivated BC. At present， the quality evaluation system of cultivated BC is not perfect， and this study provides theoretical references for updating and revising the quality evaluation standard of cultivated BC and guiding the production of high-quality BC.
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ObjectiveTo conduct a systematic comparative study on wild and cultivated Codonopsis pilosula（CP） from three aspects， including characters， microscopy， and contents of primary and secondary metabolites. MethodWild and cultivated CP samples were collected， their characters were measured using vernier caliper， tape measure and balance， the paraffin sections were stained with safranin-fixed green dyeing， and their microstructure were observed under the optical microscope. The content of alcohol-soluble extracts in wild and cultivated CP was determined according to the method for determination of extract under CP in the 2020 edition of Chinese Pharmacopoeia， the starch content was determined by anthrone colorimetry， the content of total polysaccharides was determined by kit method， Fiber analyzer was used to determine the content of fiber components， and ultra performance liquid chromatography（UPLC） was used to determine the content of monosaccharides， disaccharides and some secondary metabolites. Multivariate statistical analysis methods such as principal component analysis（PCA） and orthogonal partial least squares-discriminant analysis（OPLS-DA） were employed to screen key differential components between wild and cultivated CP on the basis of variable importance in the projection（VIP） value>1 and P<0.05. ResultIn terms of morphological characteristics， the "lion's head-like" shape， longitudinal wrinkles， and circumferential wrinkles below the root cap of wild CP were more pronounced in wild CP compared to the cultivated ones. Regarding transverse sectional features， wild CP had more fissures on the outer side of the cortex and a larger duramen. Under microscopic examination， wild CP had more stone cells， a larger proportion of xylem， and the presence of cork cells arranged in rings in the xylem， while cultivated CP has a larger proportion of phloem， smaller vessel diameters， and a more loosely arranged vascular system. In terms of primary metabolites， the contents of 45% ethanol-soluble extract and total polysaccharides in cultivated CP were significantly higher than those in the wild ones（P<0.05）， the contents of lignin， hemicellulose， cellulose， fructose and glucose in wild CP were significantly higher than those in the cultivated ones（P<0.05）， while sucrose content in the cultivated CP was significantly higher than that in the wild ones（P<0.05）. Concerning secondary metabolites， the contents of tryptophan and tangshenoside Ⅰ in cultivated CP were significantly higher than those in the wild ones（P<0.05）， whereas the contents of lobetyolinin， lobetyol and atractylenolide Ⅲ in wild CP were significantly higher than those in the cultivated ones（P<0.05）. ConclusionThere are significant differences between wild and cultivated CP in terms of morphological characteristics， microscopic features and chemical composition. Glucose， fructose， sucrose， tangshenoside Ⅰ， tryptophan and cellulose components are the key differential components between wild and cultivated CP. Wild CP contains more polyacetylenes and fructose， whereas cultivated CP has higher levels of tangshenoside Ⅰ and sucrose， with noticeably lower cellulose content. These distinctions may be related to their growth conditions， growth years and cultivation techniques. Based on the results of this study， it is recommended to increase polyacetylenes and the content ratio of fructose to sucrose as an indicators to characterize different production methods of CP， in order to guide the high-quality production of CP.
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ObjectiveTo compare wild and cultivated Paeoniae Radix Rubra（PRR） in three aspects， including character， microscope， determination of primary and secondary metabolites. MethodSeventeen batches of wild and nine batches of cultivated PRR were collected，their character data were measured by vernier caliper and scales， and their paraffin sections were made by safranin-fixed green dyeing for the observation of microscopic features. The content of ethanol-soluble extracts and total tannin from wild and cultivated PRR was determined by the method of general principle 2201 and 2202 in the 2020 edition of Chinese Pharmacopoeia， the content of polysaccharides was determined by phenol-sulfuric acid method. Anthrone colorimetry was used to determine the content of starch， and Van Soest method of washing fiber was used to determine the content of fiber. The contents of fructose， glucose and sucrose in wild and cultivated PRR were determined by ultra-high performance liquid chromatography evaporative light scattering detection（UPLC-ELSD）， and the secondary metabolites（gallic acid， methyl gallate， catechin， oxypaeoniflorin， albiflorin， paeoniflorin， ellagic acid， 1，3，4，6-tetragalloylglucose， galloylpaeoniflorin， 1，2，3，4，6-O-pentagalloylglucose， naringenin， benzoylpaeoniflorin and benzoylalbiflorin） were determined by UPLC. Principal component analysis（PCA） and orthogonal partial least squares-discriminant analysis（OPLS-DA） were used to analyze the data of wild and cultivated PRR， the contribution of different factors to the difference was determined according to the variable importance in the projection（VIP） value>1 and P<0.05. ResultIn term of characters， wild PRR showed the traditional characteristic of Zaopi Fencha， its outer skin was loose and easy to fall off， its surface had longitudinal furrow and wrinkle， but the outer skin of cultivated PRR was not easy to fall off， and its surface was relatively smooth. The radial texture of xylem of wild PRR cross-section was more obvious， showing radial striations， vacuoles and more cracks， while the radial texture of xylem of cultivated PRR cross-section was not obvious， dense and some had cracks. Microscopically， the number of radial vessels arranged in the xylem of wild PRR was more than that of cultivated PRR， the number of calcium oxalate clusters in the phloem and xylem of wild PRR was more than that of cultivated PRR， while the number of starch grains was significantly higher in cultivated PRR. In terms of the content of primary chemical constituents， the contents of polysaccharides and starch of cultivated PRR were significantly higher than those of wild PRR（P<0.05）， while the contents of cellulose， lignin， fructose and glucose of wild PRR were significantly higher than those of cultivated PRR（P<0.05）. The results of determination of 13 secondary metabolites showed that the contents of paeoniflorin， methyl gallate， catechin and oxypaeoniflorin in wild PRR were significantly higher than those in cultivated PRR（P<0.05）， while the contents of albiflorin， gallic acid， ellagic acid， naringenin， benzoylpaeoniflorin and benzoylalbiflorin were significantly lower than those of cultivated PRR（P<0.05）. A total of 10 variables contributing to the differentiation between wild and cultivated PRR were screened， including albiflorin， cellulose， benzoylpaeoniflorin， oxypaeoniflorin， naringenin， ellagic acid， starch， lignin， paeoniflorin and total tannins. ConclusionThere are significant differences between wild and cultivated PRR in characters， microscopic characteristics， contents of primary and secondary metabolites. It is suggested that the content ratio of paeoniflorin and albiflorin， the contents of oxypaeoniflorin and cellulose can be used as indicators to characterize production methods of PRR so as to improve the quality standard of PRR. This study can provide reference for the improvement of quality standard of PRR and the guidance of high quality production of PRR.
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Yuhuanglian is one of the representative processed products to change the medicinal properties of Coptidis Rhizoma， which was first published in Hanshi Yitong. Its processing method is to mix Evodiae Fructus juice with Coptidis Rhizoma with stir-frying for drying， that is， Coptidis Rhizoma processed with Evodiae Fructus juice can reduce the bitterness and cold properties on the basis of retaining the effect of purging fire and detoxification， so that Yuhuanglian is cold but not stagnant， which can clear dampness-heat in Qifen， and is effective in treating the liver-qi invading stomach， vomiting and swallowing acid. As a representative variety of processing with medicine juice， Yuhuanglian is included in the 2020 edition of Chinese Pharmacopoeia and local processing standards， and its processing technology research and optimization has been attracting much attention. Modern studies have shown that Yuhuanglian not only contains berberine， jatrorrhizine， palmatine and other components， but also contains evodiamine， rutaecarpine， limonin and other components from Evodiae Fructus， which have anti-inflammatory， antibacterial， anti-tumor and other pharmacological activities. This paper collated and summarized the related research reports of Yuhuanglian in the past 20 years from the perspectives of processing history， efficacy and medicinal properties， quality evaluation and clinical application， and found that the processing methods and standards of Yuhuanglian were quite different in different provinces and cities， mainly involving the preparation and dosage of Evodiae Fructus juice and the criteria for the processing end point. In addition， the changes in the major components of Yuhuanglian before and after processing varied greatly among different studies， presumably related to the different processes and quality standards， this paper summarized the processing history， technology， pharmacodynamics， quality evaluation and clinical application of Yuhuanglian， in order to provide reference for improving its quality evaluation system.
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The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years， randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine （TCM）， but the quality of the implementation of blind methods is uneven， and the evaluation criteria have not yet been formed. In this paper， the data collection methods， calculation principles， advantages， and disadvantages of two quantitative quality evaluation methods of blind methods， namely James Blinding Index （JBI） and Bang Blinding Index （BBI）， were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time， a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally， the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
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In order to provide basic information for the utilization and development of famous classical formulas containing Bletillae Rhizoma， this article systematically analyzes the historical evolution of the name， origin， harvesting and processing of Bletillae Rhizoma by reviewing the ancient materia medica， prescription books， medical books and modern literature. The research results showed that Baiji（白及） was the main name， some scholars took Baiji（白芨） as its main name， and there were many other names such as Baiji（白给）， Baigen（白根）， Baiji（白苙）. The mainstream source of Bletillae Rhizoma was the tubers of Bletilla striata， and drying， large， white， solid， root-free and skin removed completely were the good quality standards. With the promotion of wild to cultivated medicinal materials， there were certain differences between their traits， and the quality evaluation indexes should be adjusted accordingly. The origin of records in the past dynasties was widely distributed， with Guizhou and Sichuan having high production and good quality in modern times. The harvesting period is mostly in spring and autumn， and harvested in autumn was better. The processing and processing technology is relatively simple， and it was used fresh or powdered in past dynasties， while it is mainly sliced for raw use in modern times. Based on the results， it is suggested that the tubers of Bletilla striata of Orchidaceae should be used in the famous classical formulas， and it should be uniformly written as Baiji（白及）. And if the original formula indicates the requirement of processing， it should be operated according to the requirement， if the requirement of processing is not indicated， it can be used in raw form as medicine.
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This article systematically analyzes the historical evolution of the origin， scientific name， medicinal parts， quality evaluation， harvesting and processing and other aspects of Tsaoko Fructus by consulting ancient materia medica， medical books， prescription books in the past dynasties and combining with the modern literature， so as to provide a basis for the development and utilization of famous classical formulas containing Tsaoko Fructus. According to the research， the name of Caoguo（草果） was first used in the Taiping Huimin Heji Jufang（《太平惠民和剂局方》） in the Northern Song dynasty， Tsaoko Fructus is the correct name of the herbal medicine in all dynasties， and there are also aliases such as Caokou， Doukou， Loukou， Laokou and Caodoukou. The mainstream source of Tsaoko Fructus used in the past dynasties is the dried mature fruit of Amomum tsaoko of Zingiberaceae， but Tsaoko Fructus was often used as a nickname for Amomi Fructus Rotundus or Alpiniae Katsumadai Semen during the Song dynasty. Bencao Pinhui Jingyao（《本草品汇精要》） in the Ming dynasty was the earliest materia medica that recorded Tsaoko Fructus as a separate medicinal herb in sections. Under the influence of early ancient books， there were some books that confused Tsaoko Fructus with other Zingiberaceae plants during the Qing dynasty， it was not until modern times that Tsaoko Fructus was distinguished from other plants. The origin of Tsaoko Fructus is Yunnan and Guangxi， and then gradually expanded to Guizhou and other places. Now Yunnan is the province with the largest planting area of Tsaoko Fructus， and has become the main producing area. Since modern times， it has been recorded in the literature that the quality of Tsaoko Fructus is mainly characterized by large， full， red-brown and strong in smell. According to ancient records， the harvest time of Tsaoko Fructus was in the eighth month of the lunar calendar， and they were mostly used for peeling or simmering. Currently， the harvest period of Tsaoko Fructus is October to November， and then sun-dried or dried after harvesting. The records of the properties and functional indications of Tsaoko Fructus are basically consistent with the ancient and modern documents， which is warm in nature， pungent in flavor， belonging to the spleen and stomach meridians， moderate in dryness and dampness， intercepting malaria and eliminating phlegm， used for internal resistance of cold and dampness， abdominal distension and pain， fullness and vomiting， malaria cold and fever， and plague fever. Based on the research results， it is suggested that A. tsaoko should be used as the medicinal base for the development of famous classical formulas containing Tsaoko Fructus， processing method can be according to the requirements of the prescription， and if the requirements of concoction are not indicated， it can be used in the form of raw products.
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ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.
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ObjectiveTaking Achyranthis Bidentatae Radix（ABR） from different origins as samples， to quantitatively analyze the chemical composition and chromaticity of ABR with different processing degrees， and clarify the correlation and change law between color and composition in the processing process of ABR， so as to provide reference for the quality evaluation of processed products of ABR. MethodThe colorimeter is used to measure the chromaticity values of three kinds of processing degrees of ABR in different origins to show the color value change trend during the processing process， and the color parameters of wine-processed and salt-processed products of ABR with different processing degrees were analyzed by principal component analysis（PCA）， orthogonal partial least squares-discriminant analysis（OPLS-DA） and other analysis methods. The contents of eight representative components of ABR were measured by high performance liquid chromatography（HPLC）， the correlation between chromaticity and each representative component was analyzed by Pearson correlation analysis， and the applicability of the selected eight representative components was further verified by Fisher linear discriminant analysis， and the wine-processed and salt-processed products of ABR with different processing degrees were grouped according to the degree of processing， and 48 samples of wine-processed and salt-processed products with different processing degrees were used as training samples. Taking the contents of 5-hydroxymethylfurfural， polypodine B， β-ecdysterone， 25R-inokosterone， 25S-inokosterone， ginsenoside Ro， chikusetsusaponin Ⅳa and polysaccharides as variables， the discriminant function was established respectively， and 12 samples of wine-processed and salt-processed products of ABR with different processing degrees were back-tested to verify the discriminant function and test the reliability of the function. ResultPCA and OPLS-DA results showed that ABR samples with different processing degrees were classified into clusters， and the results could significantly distinguish different processed products. During the process of wine and salt processing， the contents of 5-hydroxymethylfurfural， ginsenoside Ro， and chikusetsusaponin Ⅳa gradually increased with the deepening of the processing degree， while the contents of polypodine B， β-ecdysterone， 25R-inokosterone， 25S-inokosterone and polysaccharides showed a gradual decreasing trend， indicating these 8 components increased and decreased to different degrees in the process of wine and salt processing. The results of Pearson correlation analysis showed that the 5-hydroxymethylfurfural content of the samples with different processing degrees of wine-processed and salt-processed products were negatively correlated with the brightness value（L*） and the total color difference value（E*ab）（P<0.01）， and positively correlated with the red-green value（a*） and the yellow-blue value（b*）（P<0.01）， and that the content of polypodine B and polysaccharides were positively correlated with L* and E*ab（P<0.01）. The discriminant functions of wine-processed and salt-processed products of ABR were established by Fisher linear discriminant analysis， and their accuracy rates in the training samples were 93.75% and 95.83%， respectively. Twelve test samples of wine-processed and salt-processed products with different processing degree were back substitution， and the correct rate was 100%. ConclusionThe trend of composition and color changes of ABR with different processing degrees in different production areas is relatively consistent， and the color value can better distinguish ABR with different processing degrees， and the color of ABR is related to some representative components in the processing process， indicating that the color can provide reference for the identification of the processing degree of ABR and the prediction of component content.