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Chinese herbal piece is an important component of the traditional Chinese medicine （TCM） system， and identifying their quality and grading can promote the development and utilization of Chinese herbal pieces. Utilizing deep learning for intelligent identification of Chinese herbal pieces can save time， effort， and cost， while also reasonably avoiding the constraints of human subjectivity， providing a guarantee for efficient identification of Chinese herbal pieces. In this study， a dataset containing 108 kinds of Chinese herbal pieces （14 058 images） was constructed，the basic YOLOv4 algorithm was employed to identify the 108 kinds of Chinese herbal pieces of our database The mean average precision （mAP） of the developed basic YOLOv4 model reached 85.3%. In addition， the receptive field block was introduced into the neck network of YOLOv4 algorithm， and the improved YOLOv4 algorithm was used to identify Chinese herbal pieces. The mAPof the improved YOLOv4 model achieved 88.7%， the average precision of 80 kinds of decoction pieces exceeded 80%， the average precision of 48 kinds of decoction pieces exceeded 90%. These results indicate that adding the receptive field module can help to some extent in the identification of Chinese herbal medicine pieces with different sizes and small volumes. Finally， the average precision of each kind of Chinese herbal medicine piece by the improved YOLOv4 model was further analyzed. Through in-depth analysis of the original images of Chinese herbal medicine pieces with low prediction average precision， it was clarified that the quantity and quality of original images of Chinese herbal medicine pieces are key to performing intelligent object detection. The improved YOLOv4 model constructed in this study can be used for the rapid identification of Chinese herbal pieces， and also provide reference guidance for the manual authentication of Chinese herbal medicine decoction pieces.
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OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.
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This study aims to explore the change laws of water absorption in Chinese herbal pieces and establish the prediction model of relative density for Chinese medicine compound decoction. Firstly, fitted equations of water absorption and decocting time was established by observing the change laws of water absorption in 36 kinds of Chinese herbal pieces in 12 groups(according to the drug-parts) with decocting time. The r value of the mineral group and other type group was 0.691 2 and 0.663 3, respectively. The r value of the remaining 10 groups was 0.802 2-0.925 4. All P values were less than 0.05(n=21). The formula of the amount of water added was optimized by combining the fitted equations with determined water absorption, and the liquid yield could be controlled in a range of 100%±10%. Secondly, it was determined that the liquid density tester could be used for the rapid determination of relative density of Chinese medicine decoction after methodological study and comparison with the pycnometer method. The linear regression equation between the corrected relative density(y) and extraction ratio(%, x) was built by measuring and analyzing the related parameters such as liquid yield, relative density and extraction ratio in 46 kinds of Chinese herbal pieces. The established equation was y=0.041 3x+1.003 7, r=0.930 9(P <0.01, n=46), with linear range of 1.94%-65.75%. Based on this, the prototype model for predicting relative density of Chinese medicine decoction was established, and the relative densities of 8 Chinese medicine decoctions were within the prediction interval of this model in verification. This study lays a foundation for database construction of Chinese medicine decoction, implementation of personalized decocting mode and rapid quality control of Chinese medicine decoction.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Specific Gravity , WaterABSTRACT
In the process of supervision, the manufacturer often denies manufacturing the unqualified Chinese herbal pieces sampled from the seller and user. In response to this problem, this article reviews the policies and regulations for drug traceability, collects the denial manufacture of the unqualified Chinese herbal pieces by the labeled manufacturers from the national drug quality announcement, identifies the risks and critical control points with the risk management tool HACCP of ICHQ9. It is recommended to improve the legal system and traceability system for Chinese herbal pieces, investigate the source of the product involved thoroughly, strengthen the supervision of the TCM markets, sellers and users, and punish the illegal behavior jointly, which provides a reference for solving the problem.
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Objective::To construct the color matching template irrelevant to size and rotation according to the types and distribution characteristics of colors in images of Chinese herbal pieces, in order to establish color characterization and image identification methods for Chinese herbal pieces. Method::Totally 20 types of Chinese herbal pieces were selected, including rhizomes, flowers, seeds and fruits.For each sample, two observation surfaces were selected to extract color parameters in foreground through image processing such as image segmentation, model transformation from RGB to L*a*b*.Color vectors of the two observation surfaces were sequenced in a descending order, scaled to a certain size by interpolating, and combined into an integrated color vector in a weight ratio of 1∶1.As for centripetally distributed observation surface images(e.g.transverse section), corrosion operation was conducted to extract the color components of each ring from outer to inner by circles, which were then ordered and scaled.The integrated color vector was used as initial template for training, the correlation coefficient between each sample and the template was calculated, and the interval estimation of positive samples were carried out by t test.With the total recognition rate as an indicator, the optimal template dimensions, width of ring and training volume were ultimately determined. Result::The visualization results of the trained templates of the varied herbal pieces were easy to be visually distinguished.After 260 samples of the herbal pieces were tested, the template of a and b components was better than that of L*, a* and b* in terms of recognition performance, with a* recognition accuracy of 95.8%(249/200). Conclusion::Color characteristics of images from two observation surfaces of Chinese herbal pieces are integrated to obtain the combined color feature vector, so as to achieve preferable recognition results for samples from both the same and different medicinal parts.This method boasts a strong anti-interference ability of random variation of sample shape, sampling part and color.
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Based on the investigation for the status of inheritance,innovation and development of traditional Chinese medicine processing discipline and Chinese herbal pieces industry in recent years,several problems worth discussing were analyzed in this paper.The definition of decoction pieces of Chinese crude drugs,the contents and methods of inheritance and innovation were put forward.It is aimed at building a consensus and further promoting the development of disciplines and industries.
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The quality of Chinese herbal pieces directly determines the clinical efficacy of traditional Chinese medicine (TCM). Therefore, in the face of the unoptimistic safety situation of Chinese herbal pieces, medical products administration have taken different governance measures. However, the social governance of Chinese herbal pieces not only relies on medical products administration, but also plays the role of the multi-subject collaboration. There is a lack of effective communication and cooperation among the different levels of government, government departments at the same level, medical products administration and social subjects in the social governance of Chinese herbal pieces. The single governance of government is still the mainstream option. Therefore, in order to improve the quality of Chinese herbal pieces, it is necessary to construct the collaborative governance model of Chinese herbal pieces with the participation of various social subjects.
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The identification of Chinese materia medica (CMM) characters, an important part of the quality standard of CMM, is one of the overall quality indicators of CMM. It is an old technical problem facing the inheritance and innovation of experience identification of Chinese medicine industry. However, the regulation of CMM characters recorded in the Chinese Pharmacopoeia and other local drug standards and processing specifications are still staying at words description, relying on human sensory judgment, so the operability needs to be improved. This paper puts forward the proposal to establish a quality standard for CMM identification for the use of reference herbal pieces and Chinese medicinal herb for the identification of characters, and provides basic support for the objective digital research of CMM characters identification, which is helpful to improve the quality evaluation of CMM.
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Dosage is an important factor that affect clinical efficacy and safety of Chinese patent medicine, however, less study has been done on the analysis of dosage in Chinese patent medicine. Through the statistical analysis for dosage of 919 Chinese patent medicines in Chinese pharmacopoeia (2015 edition), it is found that the daily dose of most medicinal herbal pieces in Chinese patent medicines is less than the dose of single herbal medicine in the pharmacopoeia; And both the daily dose of single herbal medicine and the total daily dose of prescriptions are less than the commonly used dosage of decoctions in clinic. By exploring and discussing the related problems that affecting the dosage of Chinese patent medicine in the process of transformation from clinical effective prescription to Chinese patent medicine, this paper presented we should pay more attention to clinical effective dosage, strengthen the research of dose-effect relationship in the study of new traditional Chinese medicine from clinical effective prescription, and design and research high-quality Chinese patent medicine based on “quality by design, QbD” concept to reflect and exert the efficacy of original prescription. How to determine the dosage of new traditional Chinese medicine on the basis of clinical effective dosage is a question that needs to be concerned and answered.
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As an important part of traditional medicine in China, traditional Chinese medicine(TCM) plays a significant role because of its unique medical efficiency, less adverse reactions and extensive resources. However, in recent years, the aflatoxins in medicinal herbs have been detected excessive both at home and abroad, seriously affecting the reputation and credibility of traditional Chinese medicine. In this paper, the current status of aflatoxins contamination in medicinal herbs was analyzed, and the internal and external factors of aflatoxins contamination in traditional Chinese medicine were also summarized. In view of the high toxicity of aflatoxins, it is proposed to strengthen the mildew prevention and control from the early planting to storage stage, and the reasonable detoxification mode should also be considered. This review aims to provide a reference in guaranteeing the clinical safe administration of medicinal herbs and reducing the risk of being poisoned by aflatoxins.
Subject(s)
Aflatoxins , China , Drug Contamination , Drugs, Chinese Herbal , Chemistry , Medicine, Chinese Traditional , Plants, MedicinalABSTRACT
Quantitative analysis of multi-components by single marker (QAMS) can be used to achieve the simultaneous determination of multiple components through a reference substance, which is considered suitable for the characteristics of Chinese materia medica (CMM). QAMS has been used for quality control of Chinese herbal medicines, Chinese herbal pieces, and CMM preparations. This paper briefly introduces the principle of QAMS method, and systematically summarizes the application of QAMS method in quality control of Chinese crude drugs, Chinese herbal pieces, and CMM preparation. Finally, it is proposed that active ingredients as an indicator component in QAMS is consistent with the multi-components characteristics of CMM, and it can be effectively used for quality control of CMM and has a good application prospect.
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Objective:To investigate the microbial contamination status of Chinese herbal pieces from Guangxi regions and provide reference for the microbial limit standard. Methods:According to Chinese Pharmacopoeia (2015 edition), the herbal pieces were analyzed for the total number of aerobe microbial, yeasts, molds, thermophilic bacteria and bile-resistant gram-negative bacteria,and salmonella was also detected. Results:In 90 batches of Chinese herbal pieces,the lg average value of the total number of aerobe microbial was 3.7,and that of the total yeasts and molds was 1.7,that of thermophilic bacteria was 0.9 and that of bile-resistant gram-negative bacteria was 1.1,and Salmonella was not detected out. There were statistically significant differences (P < 0.05) in the microbial contamination levels of herbal pieces with different processing techniques and packaging materials. Conclusion:According to different processing methods and administration, microbial limit standard should be established for classification in order to guide the standardized production of Chinese herbal pieces and improve their quality gradually.
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To investigate the composition and diversity of heat resistant microorganisms in contaminated Chinese herbal pieces. Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF-MS) protein fingerprinting and 16S rRNA high-throughput sequencing of Illumina Miseq were used to analyze the heat resistant microbial community of 9 varieties of Chinese herbal pieces. Stem pieces (Spatholobi Caulis, Tetrapanacis Medulla, Stachyuri Medulla) showed highest detection rate and most species of contaminants; However fruit pieces (Schisandrae Sphenantherae Fructus) had the lowest detection rate and least species of contaminants; among root pieces, the detection rate and number of contaminants species were lower in Tuber Dioscoreae Persimilis and Rehmanniae Radix Praeparata. The heat resistant microbial community was mainly of Bacillaceae and Paenibacillaceae, and Bacillus showed the highest detection rate among them, followed by Brevibacillus, Paenibacillus, and Solibacillus. The rest genus in high-throughput sequencing analysis included Enterobacter, Brevundimonas, Leuconostoc, Methylobacterium, Dechloromonas, Pantoea, Klebsiella, and Erwinia. There were potential risk factors in heat resistant microbial community of Chinese herbal pieces, so we shall improve the microbial limit standard, strictly control the pathogenic bacteria in the product, and strengthen the supervision and management in production and circulation of Chinese herbal pieces.
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Chinese medicine processing is the main feature that distinguishes traditional Chinese medicine from natural medicine and plant medicine, and is the main feature in clinical medication of traditional Chinese medicine. The research of Chinese medicine processing technology is an important link to realize standardization and standardization of Chinese herbal pieces, with urgent need to attract high attention. At present, there are still many problems in the research of processing technology of Chinese herbal pieces, mainly including inconsistent processing technology, large differences in process technology parameters, and unstable production technology of Chinese herbal pieces, resulting in uncontrollable quality of Chinese herbal pieces and affecting the clinical efficacy of Chinese medicine. This paper focused on the establishment of a unified standard processing technology, and put forward the countermeasures for the processing technology of Chinese medicine based on a comprehensive analysis of the current situations of the processing technology of Chinese herbal pieces, with significance for guiding the establishment of a standardized processing technology of Chinese medicine.
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The hospital is one of the main subjects for application of Chinese herbal pieces (CHP) which is the prescription drug for Chinese medicine clinical prevention and treatment of disease. The quality of CHP in hospital has a direct impact on clinical effect and is related to the health of the patients. But presently the market of CHP is chaotic with the prominent issue. The cultivation, the production and processing, the storage management and operation of CHP are not standardized. Simultaneously, the supply method of CHP is cut off from the right of the hospital to know the source and production process of CHP. The hospital is restricted to the supply enterprises of CHP. This situation makes a great obstacle to the quality control of CHP in hospital. The quality control system of CHP in hospital is composed of the source and the quality management of CHP. The quality control system of CHP includes the measures such as the purchasing management, acceptance of storage, storage and maintenance, and personnel capacity improvement. The prescription-based processing of Chinese materia medica should play an important role in this system. The whole process traceability system and the guarantee function of the market supervision system of Chinese medicinal materials should also be taken effect. In this way, the dominant position of hospital in the quality control system of CHP is strengthened.
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OBJECTIVE:To put forward a proposal for the name standardization of Chinese herbal pieces. METHODS:Through searching literatures and analyzing each edition of Chinese Pharmacopoeia,the existing problems about the name of Chi-nese herbal pieces in the 2015 edition of Chinese Pharmacopoeia were found out to put forward solutions. RESULTS & CONCLU-SIONS:There are many non-standard problems,such as non-standard name of crude Chinese herbal pieces,non-standard name of processed Chinese herbal pieces,jingandganadded before the name of Chinese herbal pieces,pianadded after the name of Chinese herbal pieces. Based on these problems,suggestions for naming processed and non-processed Chinese herbal pieces were put forward,including noting processing method before the name of Chinese herbal medicines,adding processed form name after the name of Chinese herbal medicines,adding accessories name before the name of Chinese herbal medicines,maintaining the consistency and completeness of the names of Chinese herbal pieces and medicines,must markingshengwhen using toxic Chi-nese medicine pieces in medical treatment,and no appearing of the tablets in the name,etc.
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OBJECTIVE:To find out the main problems about quality supervision over Chinese herbal pieces and effective su-pervision strategies. MEDTHODS:First,static and dynamic models of the game between the enterprises engaged in the production and business of Chinese herbal pieces and local food and drug administration were respectively established,to which pure strategy Nash equilibrium analysis and mixed strategy Nash equilibrium analysis were made. Next,the model of the game between the supe-rior regulatory authorities and the basic-level regulatory authorities was established,to which mixed strategy analysis was made to find out the supervision factors relevant to the quality safety of Chinese herbal pieces. RESULTS & CONCLUSIONS:Based on the current situation of quality supervision over Chinese herbal pieces and the analysis results of the game models,it is suggested that at present the Chinese herbal medicine regulatory authorities of China should work hard to promote the reform of the supervision system,reduce supervision cost(including the guidance of the large-scale and centralized production of Chinese medicinal materi-als and unified appliance of approval number to the administration of Chinese herbal pieces),establish a systematic and comprehen-sive system of rewards and punishments,create a professional supervisor staff(including the strengthening of basic-level supervisor staff creation and the improvement of personnel's quality,the standardization of the law enforcement of regulatory authorities and the combination of proper power delegation to lower levels and strict supervision),and balance the relationship between the govern-ment and the public in supervision to increase the public's awareness of responsibility.
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Processing technology of Chinese herbal medicine is the unique pharmaceutical technology in China.Chinese herbal pieces production enterprises are the main carrier of processing technology.Reasonable and normative master and use of the processing technology by production enterprises can directly affect the quality of Chinese herbal pieces and the clinical efficacy.Therefore,it is necessary to carry out investigation on the processing technology of Chinese herbal pieces production enterprises.In order to better inherit and develop processing technology,to promote the development of Chinese herbal pieces production enterprises and to ensure the quality of pieces,the general situation and existing problems of Chinese herbal pieces production enterprises were identified,concluded,summarized.Relevant countermeasures were put forward by carrying out investigation in Chinese herbal pieces production enterprises.
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Objective:To set up an automatic gel permeation chromatography-solid phase extraction purification-ultra performance liquid chromatography-tandem mass spectrometry ( GPC-SPE-UPLC-MS/MS ) method for the quantitative determination of 14 carba-mates pesticide residues in Chinese herbal pieces. Methods:The samples were extracted by acetonitrile, and kept in constant volume with ethyl acetate-cyclohexane (1: 1, v/v). The extract was purified by GPC combined with amino solid phase extraction column (Carb/NH2). After UPLC gradient elution separation on an Agilent Poroshell 120EC-C18 column using acetonitrile-0. 1% formic acid as the mobile phase,the target pesticides were determined by tandem mass spectrometry in a multi-reaction monitoring ( MRM) mode. Results:The 14 kinds of carbamates pesticides had good linear relationships within the range of determination (r>0. 9990), and the detection limit was 0. 02-0. 35μg·kg-1 . When the spiked levels were 1, 10 and 50μg·L-1 , the recoveries were 74. 2%-108. 8%, and the RSD was 1. 25%-6. 73%(n=6). Conclusion:The method simplifies the pretreatment operation and shortens the analysis time with good selectivity and high sensitivity, which can be used for the determination of carbamates pesticide residues in Chinese herbal pieces.
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To elucidate the key issues in the development and innovation of traditional Chinese medicine processing discipline and Chinese herbal pieces industry Chinese herbal pieces industry. According to the author's accumulated experience over years and demand of the development of the Chinese herbal pieces industry, the key issues in the development and innovation on the Chinese herbal pieces industry were summarized. According to the author, the traditional Chinese medicine processing discipline shall focus on a application basis research. The development of this discipline should be closely related to the development of Chinese herbal pieces. The traditional Chinese medicine processing discipline can be improved and its results can be transformed only if this discipline were correlated with the Chinese herbal pieces industry, matched with the development of the Chinese herbal pieces industry, and solved the problems in the development on the Chinese herbal pieces industry. The development of traditional Chinese medicine processing discipline and the Chinese herbal pieces industry also requires scientific researchers to make constant innovations, realize the specialty of the researches, and innovate based on inheritance.