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By consulting the ancient Chinese herbal books， medical books and formularies of the past dynasties， and combining with modern research data， this paper makes a systematic textual research on the name， origin， place of origin， traditional quality evaluation， harvesting and processing of Selaginellae Herba， so as to provide a basis for the development and utilization of the relevant famous classical formulas. According to the textual research， Juanbai is the correct name of the herbal medicine in all dynasties， and there are also aliases such as Baozu， Qiugu， Jiaoshi and Jiusi Huanhuncao. The origin of Selaginellae Herba in the ancient herbal books was Selaginella tamariscina in all dynasties. Since the Republic of China， S. pulvinata has been gradually used as another origin of Selaginellae Herba. In ancient times， the producing area of S. tamariscina was mainly in Shandong， Hebei， Henan， Shaanxi， Jiangsu and Sichuan， etc. Nowadays， it is produced all over the country. S. pulvinata is mainly produced in Guangxi， Fujian， Sichuan， Guizhou， Yunnan， Hebei and so on. Since the recent times， it is concluded that the quality of the green color， complete and unbroken is good. Before the Qing dynasty， it was recorded that the harvesting time of Selaginellae Herba was generally from April to July， and it was expanded to all year round since the Qing dynasty. After harvesting， remove the sediment（sand and mud）， cut off the fibrous roots and dry in the shade or in the sun. The processing methods in all dynasties were mainly carbonizing by stir-frying and stir-bake to brown， and some ancient books contained the processing method of brine boiling， which was rarely used in modern times. Based on the results， it is recommended that S. tamariscina should be used as the base material of Selaginellae Herba. Because of more impurities， it should be fully purified to ensure the cleanliness of the herb， and the processing method can be based on the prescription requirements， if the processing requirements are not specified， the raw products can be used， charcoal products is recommended for use as an hemostatic.
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OBJECTIVE To prepare the Eriodictyol chewable tablet and to evaluate its quality. METHODS The chewable tablet was prepared by the wetting granulation method by using microcrystalline cellulose （MCC） and mannitol as fillers， polyvinylpyrrolidone （PVP） as adhesive， citric acid and sucralose as flavor correction agents， magnesium stearate as lubricant. The comprehensive evaluation was conducted on Eriodictyol chewable tablets with the dosage of each excipient as a factor using the appearance， taste， flavor and texture as indicators. The ratio of excipients was optimized by orthogonal test， and the quality of Eriodictyol chewable tablets prepared by optimized formulation was evaluated in terms of appearance， weight difference， hardness， fragility， eriodictyol content， dissolution and content uniformity. RESULTS The optimal formulation was as follows： 26.4% eriodictyol （50 mg each piece）， 45% mannitol， 25% MCC， 0.3% citric acid， 0.3% sucralose， 1% magnesium stearate， 2% PVP （preparing 5% solution using purified water）. The scores of 3 batches of Eriodictyol chewable tablets in the validation test were 8.76， 8.75 and 8.80 （RSD＝0.30%， n＝3）， respectively. The Eriodictyol chewable tablet had a complete appearance and a smooth surface； the average tablet weight was 192.57 mg， the average hardness was 57.36 N， the fragility was 0.09%， the average content of eriodictyol per tablet was 50.74 mg， the cumulative dissolution within 30 min was exceeding 80%， and the content uniformity was 5.51. CONCLUSIONS Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of Chinese Pharmacopoeia.
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By consulting the ancient and modern literature， the textual research of Pharbitidis Semen has been conducted to clarify the name， origin， distribution of production areas， quality specification， harvesting， processing and so on， so as to provide reference for the development and utilization of the relevant famous classical formulas. Through textual research， it can be seen that Pharbitidis Semen was first published in Mingyi Bielu（《名医别录》）， and all dynasties have taken Qianniuzi as the correct name. Based on the original research， the main source of Pharbitidis Semen used in previous dynasties is the dried mature seeds of Pharbitis nil， which is consistent in ancient and modern times. The white Pharbitidis Semen appearing in Compendium of Materia Medica（《本草纲目》） from Ming dynasty is similar to the present P. purpurea. It is produced all over the country， and the quality is better if the particles are full and free of impurities. In ancient times， the harvesting time was mostly in the September. Now it is autumn. The fruits are ripe and harvested， dried to remove impurities for standby. In ancient times， the processing methods of Pharbitidis Semen were mainly wine steaming， steaming and frying until half cooked and grinding the head and end. In modern times， they have been simplified to stir-frying method. The nature， taste， meridian tropism and their effects also change supplements with the deepening of practice. Before the Ming dynasty， they were all bitter， cold and toxic. In the Ming dynasty， there appeared the characteristics of pungent， hot and small poisonous. The efficacy has evolved from controlling low Qi， curing foot edema， removing wind toxin， and facilitating urination to facilitating water and defecation， eliminating phlegm and drinking， and eliminating accumulated insects. The main clinical contraindications are those with weak spleen and kidney， those with weak spleen and stomach， pregnant women， and should not be used with croton and croton cream. Based on the textual research， it is suggested that when developing the classic famous formula with Pharbitidis Semen as the main raw material in the future， it is clear that the source should be the dried mature seeds of Pharbitis nil（black product is its black-brown seeds， white product is its beige seeds）. The processing requirements indicated in the original formula are all processed according to the requirements， and the raw product is recommended to be used as medicine if not specified.
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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.
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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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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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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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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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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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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 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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【Objective】 To identify the main unqualified items in the external audit of blood station quality management system (referred to as external audit), in order to take necessary measures to continuously improve the quality system. 【Methods】 Unqualified items(data) in the national and Shandong provincial blood safety technical audits (referred to as national and provincial audits) and four blood station blood safety technical joint audits (referred to as inter station mutual audits) from 2017 to 2019 were collected and analyzed by Excel and Pareto curves (graphs). Corresponding corrective and preventive measures were developed and implemented, and then tracked and evaluated by the quality management department three months after the external audit to verify their effectiveness. 【Results】 In a total of 7 external audits of blood station quality management system that our blood station has participated in over the past 3 years (including 2 national audits, 2 provincial audits, and 3 inter station mutual audits), the main unqualified terms were "12 monitoring and continuous improvement" 11.90% (15/126), "13 blood donation services" 11.90% (15/126), "06 equipment" 10.32% (13/126), "11 records" 10.32% (13/126), "03 organization and personnel" 8.73% (11/126), "15 blood preparation" 7.94% (10/126), "08 safety and health" 7.14% (9/126), and "14 blood testing" 7.14% (9/126). Among them, "monitoring and continuous improvement" ranked first in two national audits and two provincial audits, with 16.67% (5/30) and 14.71% (5/34), respectively, and was 8.06% (5/62) in inter station mutual audit, and the difference between the three kinds of audits was not statistically significant (P>0.05). "Records" accounted the highest proportion in inter station mutual review of 19.35% (12/62), while was respectively 0 and 2.94% (1/34) in national and provincial audits, with statistically significant difference between the three kinds of audits (P<0.05). 【Conclusion】 External audit against unqualified items is important for quality improvement. By analyzing the unqualified terms, taking corresponding measures to improve weak links, and evaluating the effectiveness of those measures, it can effectively ensure the effective operation of blood station quality management system.
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@#The UPLC fingerprint of colistimethate sodium was established for the study of quality consistency.The chromatographic column was Acquity UPLC? Peptide CSH C18 (2.1 mm × 150 mm, 1.7 μm).The mobile phase A was phosphate buffer-acetonitrile (19∶1), and the mobile phase B was phosphate buffer-acetonitrile (1∶1).The mobile phase was in gradient elution at a flow rate of 0.3 mL/min.The column temperature was set at 30 °C and the detection wavelength was 210 nm.The similarity of the fingerprints was analyzed with the Similarity Evaluation System for Chromatographic Fingerprint of Tradition Chinese Medicine (Version 2012) in combination with content determination of multiple index components to evaluate the quality consistency of imported and domestic bulk drugs.The result showed that both the original and generic bulk drugs met the specified limit requirements in the European Pharmacopoeia standards, and that their UPLC fingerprints were highly similar, indicating that the quality of the two substances was consistent.Establishing a fingerprint for similarity evaluation and combining it with the results of indicator component content determination as a comprehensive evaluation method for the study of drug quality consistency of complex components has the characteristics of fast, accurate, and comprehensive, which is helpful for drug quality evaluation and provides ideas for the evaluation of antibiotic quality consistency of complex components.
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Through reviewing the ancient and modern literature， the name， origin， producing area， quality evaluation， harvesting and processing methods of Trichosanthis Fructus（TF） and Trichosanthis Radix（TR） in famous classical formulas were systematically sorted out following the chronological order. The results showed that there were many nicknames of TF and TR， and Gualou and Tianhuafen have become the mainstream names for its fruit and root， respectively. Both of them took Trichosanthes kirilowii as the mainstream base. TF and TR have been used as medicines in the Han dynasty， and since the North and South dynasties， Leigong Paozhilun had been clear that the effects of peels， seeds， stems， roots were different. TF was used as medicine with intact fruits， harvested after maturity from September to October， hung and dried in the shade， and its quality has been summarized in recent times as being best for those who are mature， large， thick and pliable peels， orange-yellow in color， and with sufficient sugary properties. In ancient times， the processing of TR was mostly crushed or shredded with the peels and seeds， or processing for pancakes and creams. TR was used as medicine with the roots， it is harvested from November to December， peeled and dried in the sun， and its quality was best when it was deep in the soil， large， white， powdery， firm and delicate with few muscles and veins， and it was considered to be toxic when it was born in briney land. Processing method of TR was to do powder into the medicine in the Tang dynasty， and gradually evolved into direct slicing use in the Ming and Qing dynasties. Since the modern era， the authentic producing areas of TF and TR were in the vicinity of Lingbao， Henan province， known as Anyang Huafen， and in modern times， there are well-known production areas such as Anguo， which produces Qihuafen， and Jinan， which produces Changqing Gualou. In the Song dynasty， there was a habit of substituting Trichosanthis Semen for the whole herb， which was later corrected by the materia medica in Ming dynasty. Based on the results， It is suggested that T. kirilowii be selected as the basal plant for the development of famous classical formulas involving TR and TF. In Qingjin Huatantang， Trichosanthis Semen is processed by stir-frying method， while TR and TF in other five formulas from the Catalogue of Ancient Famous Classical Formulas（The First Batch） were all used in raw form.
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An UHPLC-Q-exactive orbitrap MS method for the simultaneous determination of 19 chemical components in Qilong Zhuang'er oral liquid was established and the quality differences between different batches of samples was compared by chemometric analysis to provide a basis for the quality evaluation of the preparation. The contents of allantoin, L-proline, pyroglutamic acid, hordenine, adenosine, L-phenylalanine, guanosine, L-tryptophan, caffeic acid, calycosin-7-glucoside, verbascoside, isoacteoside, ononin, calycosin, 3-hydroxy-9,10-dimethoxyptercarpan, formononetin, atractylenolide III, atractylenolide II and astragaloside A were analyzed by cluster heat map, principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA) using Hiplot platform and MarkerlynxXS software to comprehensively evaluate the quality difference of different batches of Qilong Zhuang'er oral liquid. The 19 chemical compounds showed good linearity in their respective concentration ranges (r ≥ 0.999). The RSD of precision, repeatability and stability (24 h) tests were all less than 1.94%. The average recovery was 97.24%-102.75% (RSD < 2.74%, n = 6). The 10 batches of samples were divided into two categories by cluster heat map and PCA analysis. 3-Hydroxy-9,10-dimethoxyptercarpan, atractylenolide III, calycosin, atractylenolide II, formononetin, allantoin and caffeic acid were identified as differential markers by PLS-DA. The established multi component quantitative method of Qilong Zhuang'er oral liquid combined with chemometric analysis can provide reference for the quality evaluation of the preparation.
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Bupleuri Radix is commonly used in the traditional Chinese medicine, and saikosaponins are the important active ingredients. In this study, we first established a relative quantitative method for 25 saikosaponins using ultra high performance liquid chromatography-triple quadrupole mass spectrometry (UHPLC-QTrap-MS) in the scheduled multiple reaction monitoring (sMRM) mode. The established method showed good intra-day and intra-day precision, linearity, repeatability and stability. Then the method was applied to compare 37 batches of Bupleuri Radix from different planting areas. The results showed that there was no significant difference in the saikosaponins composition of Bupleuri Radix from different planting areas in Shanxi Province, which indicating that Bupleuri Radix is well adapted to the environment, so it is suitable for widely planting. However, Bupleuri Radix harvested at spring and autumn were differed from those harvested at summer, which indicated that the traditional harvesting experience was reasonable. Correlation analysis showed that saikosaponins a and d were positively correlated with some saponins, and 4 saponins (such as clinoposaponin XII) showed bigger content variation were identified by coefficient of variation analysis. The LC-MS based pseudotargeted metabonomic method established in this study can be applied to the comprehensive detection of saikosaponins, which providing new method for the quality evaluation of Bupleuri Radix.
ABSTRACT
ObjectiveTo evaluate the quality of Mori Cortex from different producing areas by the entropy weight-technique for order preference by similarity to an ideal solution（TOPSIS）， and to provide a new evaluation method for the quality control of Mori Cortex. MethodAccording to the five key indexes of color， thickness， texture， powdery and cortex remain， a subjective scoring table was designed to evaluate the appearance of Mori Cortex. High performance liquid chromatography（HPLC） was used to determine the fingerprint and the contents of multiple components（mulberroside A， chlorogenic acid， oxyresveratrol， mulberroside C， sanggenone D， sanggenone C， morusin）， and chemometrics was used to explore the differential components of Mori Cortex from different habitats. On this basis， TOPSIS was used to comprehensively evaluate the quality of Mori Cortex from different habitats， and SPSS 22.0 software was used to carry out bivariate correlation analysis between thickness and appearance color with contents of seven components of Mori Cortex. ResultThose with lighter color， thicker root bark， tougher texture， sufficient powder and less cortex remain scored higher， and the top five were all from Anhui. The established fingerprint and determination methods were stable and reliable. Partial least squares-discriminant analysis（PLS-DA） screened three components with the variable importance in the projection（VIP） value>1（mulberroside A， sanggenone D， sanggenone C）， which made an important contribution to the difference in the origin of Mori Cortex. Correlation analysis showed that there was a significantly positive correlation between mulberroside C with lightness value（L*） and total chromaticity value（E*ab） and mulberroside A with yellow-blue value（b*）（P<0.05， P<0.01）， a significantly negative correlation between sanggenone C with b* and between morusin with L*（P<0.05， P<0.01）. And there was a significantly negative correlation between mulberroside A， chlorogenic acid， and morusin with thickness（P<0.01）， a clearly negative correlation between sanggenone D with thickness（P<0.05）， a significantly positive correlation between sanggenone C with thickness（P<0.01）. TOPSIS comprehensive scores showed that the samples from Anhui had a good score and ranked high. ConclusionThere are great differences in the quality of Mori Cortex from different habitats， and those with the close habitats show similar characteristics in appearance and component content， and lighter color and less cortex were positively correlated with the quality. Among them， the quality of Mori Cortex from Anhui is relatively good.
ABSTRACT
Through the textual research and analysis of ancient and modern documents of Acanthopanacis Cortex（AC）， this paper combed the variety， origin， harvesting， processing and ancient quality evaluation methods of AC， and clarified the historical context of the mixing of its common counterfeit product（Periplocae Cortex）， in order to provide a basis for the development of famous classical formulas containing AC. AC was first published in Shennong Bencaojing with the name of Wujia， Wujiapi is the name rectification in all dynasties since Leigong Paozhilun. According to the description of inflorescence location and fruit morphology of Wujia in the materia medica， it is judged that the mainstream origin of AC used in previous dynasties was Acanthopanax gracilistylus. Periplocae Cortex was mixed with AC in the period of the Republic of China because it was in line with the "like Lycii Cortex， light， brittle and fragrant". The origin of Wujiapi recorded in past dynasties was concentrated in the middle and lower reaches of the Yangtze River， mainly in Hubei， Henan， Anhui and other places. Since modern times， the traditional quality evaluation of AC has been gradually summarized， with thick skin， white color and fragrant smell as the best. The traditional harvesting and processing of AC involved picking the stems in May and July of the lunar calendar， picking the roots in October， and drying in the shade. In modern times， the roots of AC are harvested， washed， peeled and dried in summer and autumn. In the past dynasties， there were rice wine processing， Euodiae Fructus boiling， ginger juice processing and other methods. In modern times， it is usually cut into thick slices after the cleansing. According to the research results， it is suggested that the root bark of A. gracilistylus should be selected as the origin of AC in famous classical formulas， which should be processed into the medicine according to the specific prescription requirements. In addition， it is suggested to restore the medicinal name of Periplocae Cortex as Yangtao， in order to reduce its chaotic influence on the medicinal use of AC.
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This article has systematically reviewed the name， origin， scientific name， producing area， quality evaluation， harvesting and processing methods of Polygonati Odorati Rhizoma（POR） by consulting the materia medica， medical books， prescription books and modern literature， in order to provide a reference for the development of famous classical formulas containing POR. Yuzhu was first recorded in the Shennong Bencaojing under the name of Nyuwei. After that， Weirui was used as the rectification name in the subsequent dynasties， and in recent times， the name of Yuzhu is mostly used in materia medica and prescription books. In ancient times， there were different names for Yuzhu， such as Nyuwei， Weiwei and Weirui. The names of the three are similar and there was a mixed use of the same name and foreign matter in history. In the Tang dynasty， SU Jing listed Nyuwei with the effect of curing dysentery in the intermediate of herbal part of Xinxiu Bencao according to its different efficacy. However， based on Shennong Bencaojing， Mingyi Bielu and the different energy efficiency of medical prescriptions， SU Song of the Northern Song dynasty believed that the three were medicinal materials of different origins. In short， the names of the three have been unclear in history for a long time. According to the development of the time line， this paper examines the names and realities of the three， and concludes that the two（Weiwei and Weirui） are the same medicinal material， that is， Polygonatum odoratum of Liliaceae， and the Nyuwei is Clematis apiifolia of Ranunculaceae， and the source relationship of the three is clarified. The mainstream source of Yuzhu used in the past dynasties was the rhizome of P. odoratum， which was widely distributed in the wild and has a large amount of resources. The origins of Yuzhu recorded in ancient times were mainly Taishan in Shandong， Chuzhou and Shuzhou in Anhui， and Hanzhong in Shaanxi， in modern times， it was produced in northern Hebei and Shaoyang in Hunan with high quality， and in the modern times， Jiangbei Yuzhu from Haimen in Jiangsu， Anyuzhu from Nanling， Anqing and Tongling in Anhui， Guanyuzhu from Fengrun， Yutian， Zunhua， Huailai in Hebei and Suizhong， Jinxi， Jianchang， Lingyuan， Liaoyang， Haicheng， Gaiping in Liaoning， Xiangyuzhu from Shaoyang in Hunan are the authentic medicinal material. In ancient times， the quality of Yuzhu was good if it was fat and white， while in modern times， it is better with thick roots， bright yellow color， soft texture， no stiff skin and no oiliness. In ancient times， the origin processing of POR was mostly dried in the shade， but in modern times， it is mostly sun-dried or dried after steaming and rubbing. The ancient processing was mostly scraped off the skin and soaked in honey water and then steamed through， while the modern one is mostly washed and cut into thick slices for raw use. Based on the conclusion of the herbal textual research， it is suggested that the rhizome of P. odoratum of Liliaceae be used as the source for the development of famous classical formulas， and the corresponding specifications be selected according to the processing requirements of the prescription. In view of the Yiweitang in Wenbing Tiaobian， which uses the method of frying fragrance to achieve the effect of fragrant refreshing the spleen， it can be processed by referring to the stir-frying method in the current version of Chinese Pharmacopoeia.
ABSTRACT
Through the textual research and analysis of the variety， origin， processing， quality evaluation and clinical application of Moslae Herba in ancient and modern literature， its origin of materia medica was clarified. Moslae Herba has experienced variety changes in history. Elsholtzia ciliata was the mainstream variety during and before the Song dynasty， however， during the Ming and Qing dynasties， emerging variety of Mosla chinensis rose to the mainstream status due to its remarkable efficacy and the formation of cultivation， and differentiated into two commodities（wild variety of Qingxiangru and cultivated variety of Jiangxiangru）， cultivated products formed an authentic producing area in Jiangxi. The three varieties coexisted during the Ming and Qing dynasties， and the Elsholtzia varieties were gradually eliminated. Variety changes have caused changes in the functions and indications of drugs. E. ciliata had the effect of clearing heat and was mainly used to treat heatstroke and cholera， while M. chinensis was used for exogenous wind cold and dampness in the summer because of its warm and strong sweating properties， but not for cholera. Traditional Moslae Herba is mainly harvested in the summer and autumn （flowering to fruiting stage） and the above-ground parts are dry in the shade and used as medicine. Modern Qingxiangru is mostly harvested before the flowering period， and Jiangxiangru is harvested after flowering and fruiting in late summer and early autumn. In summary， according to the 2020 edition of Chinese Pharmacopoeia， the dried above-ground parts of Moslae Herba should be selected for Xinjia Xiangruyin in the Catalogue of Ancient Famous Classical Formulas（The First Batch）， mainly the cultivated variety of Jiangxiangru， and the raw products is cut into segments and used as medicine. It is suggested that when applying and developing famous classical formulas containing Moslae Herba at different periods of time today， the origin should be established in conjunction with clinical efficacy.