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By consulting ancient herbal books and modern literature， this paper systematically sorted out and researched the processing history， relevant processing norms in recent years， modern processing technology， chemical composition changes of processed products and their pharmacological mechanism of Scutellariae Radix， in order to provide a basis for the further development of Scutellariae Radix decoction pieces. According to the textual research of ancient books， there were many kinds of processing auxiliary materials of Scutellariae Radix， such as wine， vinegar， salt， honey， pig bile and so on， among which the wine processing was the most diverse and detailed， and the processed products such as raw products， stir-fried products， wine-processed products， fried charcoal products were still in use. The modern processing techniques of Scutellariae Radix mainly focus on the processing aspects of softening and slicing， wine processing and charcoal frying， and the research methods are relatively unified. At present， it is found that the changed chemical constituents of Scutellariae Radix after processing are flavonoids， polysaccharides， volatile oils and trace elements， etc. Pharmacological effects of processed products are hemostasis， antibacterial， anti-inflammatory， antioxidant， analgesic and antipyretic， treatment of lung diseases， treatment of colitis， etc. However， in the studies of Scutellariae Radix processing， there is a lack of research on the structural changes of chemical components caused by processing and a comprehensive comparative study on the pharmacological effects of various processed products. Based on this， it is suggested to carry out systematic research on the processing technology to processing mechanism， further explore the relationship between the change rule of material basis and pharmacological action before and after processing of Scutellariae Radix， and deepen the exploration of molecular mechanism and clinical application of processed products of Scutellariae Radix， in order to clarify the scientific connotation of the processing mechanism of Scutellariae Radix， and lay a foundation for the subsequent expansion of the application of Scutellariae Radix decoction pieces and the formulation of processing standards.
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High quality is the premise for the implementation of high quality and good price for decoction pieces， and grade is the most direct manifestation of high quality of decoction pieces. However， there is still a lack of scientific and reasonable methods for evaluating the grade of decoction pieces， and it is urgent to establish a widely recognized and unified standard for the grade of decoction pieces to ensure the quality of the decoction pieces and guarantee the safety and efficacy of clinical use. Based on this， this paper focused on analyzing the problems of the current grade evaluation methods， such as unclear distinction between quality standards and grade standards， unreasonable selection of grade evaluation indicators， and inaccurate application of mathematical statistical methods. Based on the analysis of the grade evaluation of decoction pieces， this paper proposed four criteria for establishing the grade evaluation method of decoction pieces， namely universality， comprehensiveness， reliability and convenience， in order to establish a more reasonable and unified grade standard for decoction pieces and promote the quality improvement of decoction pieces and the development of the industry.
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OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese medicine （TCM） decoction pieces in accordance with provincial standards （hereinafter referred to as “local TCM decoction pieces”）. METHODS Through simulation scenarios and collecting actual cases ，the conditions of trans-provincial distribution of local TCM decoction pieces were listed ；the official websites were searched or relevant personnel of drug supervision were interviewed；the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted out. Based on the stakeholder theory ，the benefits and risks of main stakeholders were discussed to put forward relevant suggestions from the perspective of benefit /risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial standards，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the B provincial standards ，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the C provincial standards ，sold and used them in A province. At present ，there are no clear relevant provisions of national laws about trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of the official website of drug regulatory department to online consultation ，and only Shandong ，Shanghai，Liaoning and Jiangxi have issued replies or normative documents. Totally 41.9％，38.7％ and 32.3％ of the provinces respectively allow the trans-provincial distrbution of local TCM decoction pieces in the above 3 conditions；in addition ，32.3％，16.1％ and 22.6％ provinces have unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM decoction pieces ，but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug regulatory departments clarify the relationship between the national and local standards for TCM decoction pieces and dingrl375@163.com differentiate the varieties of collection ；clear the regulatory requirements for trans-provincial distribution of local TCM decoction pieces by issuing high-level legal d ocuments；enrich regulatory measures and means ，and gradually adjust the requirements of trans-provincial distribution of local TCM decoction pieces .
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OBJECTIVE To improve the a pplicability of the prescription pre-review system to traditional Chinese medicine （TCM），and improve the quality of prescription review and rational drug use. METHODS The inappropriate pre-review rules of TCM prescription in prescription automatic screening system of our hospital were summarizd ，review rules were revised and the review process was standardized purposefully. The data of prescription review of Chinese patent medicine and TCM decoction pieces were collected from outpatient and emergency department of our hospital in the second quarter of 2020 （before the optimization of review rules ）and the fourth quarter of 2021（after the optimization of review rules ）. The reasonable rate of prescription and effective rate of intervention before and after the optimization of review rules were compared，and unreasonable problems were counted. RESULTS In our hospital ，the pre-review system had poor applicability in reviewing TCM prescriptions. There were some problems ，such as inconsistent or nonstandard names of TCM decoction pieces ，unreasonable dosage range settings，mechanical review of repeated drug use ，excessively strict review of “eighteen incompatible medicaments ”and“nineteen medicaments of mutual restraint ”and lack of safety warnings for special populations. In view of the above problems ，our hospital standardized the name of TCM decoction pieces ，and optimized the review rules such as dose range of TCM decoction pieces ， usage and dosage of Chinese patent medicine ，repeated medication ，drug interaction ，drug taboos for special people ，etc. After the revision of the rules ，the qualification rate of Chinese patent medicine prescriptions increased from 97.38％ to 98.17％（P＞0.05）， and the rate of effective intervention increased from 42.86％ to 79.71％（P＜0.05）；the qualification rate of TCM decoction pieces prescriptions increased from 47.98％ to 79.29％（P＜0.05），and the rate of effective intervention increased from 11.17％ to 29.13％（P＜0.05）. The number of unreasonable problems such as excessive daily dosage of TCM ，excessive dosage range ，drug interaction and drug contraindications for special groups decreased significantly in our hospital （P＜0.05）. There was no statistical significance in the number of unreasonable problems of repeated medication between 2 groups （P＞0.05），but there was a downward trend. T he total number of unreasonable problems had also decreased significantly （P＜0.05）. CONCLUSIONS The optimization measures of review rules in our hospital canimprove the applicability of the review system for TCM prescriptions，and improve the quality of prescription review and the level of rational drug use. However ，review rules of indications and the effectiveness of prescription intervention still needs to be further improved.
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As the last procedure of traditional Chinese medicine(TCM) applied in clinical practice, prescription-based processing(PBP) is an important guarantee for the quality and clinical efficacy of TCM, which can not only maximize the effect of processed product, but also exert the characteristics of syndrome differentiation and treatment in TCM. However, due to various reasons, most medical institutions have no PBP business. As a result, doctors can only use the conventional decoction pieces available on the market, which also greatly limits their flexible medication, with certain impacts on the normal development of the curative effect of TCM. Therefore, the article explained the necessity of PBP from three aspects. In addition, according to Chinese Pharmacopoeia and the characte-ristics of TCM decoction pieces, the varieties suitable for PBP were summarized and proposed, and also some suggestions about developing PBP are given. The PBP is one of the characteristic techniques in TCM, with special technical requirements and profound scientific connotation. The development of PBP will not only promote the processing of TCM and ensure the clinical efficacy, but also promote the vigorous development of TCM.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , PrescriptionsABSTRACT
As an important treasure for the research and development of new Chinese medicines, the classical prescriptions have a long medical history in China and are the summary of the clinical experience of the medical experts in the past dynasties. To support the research and development of classical prescriptions,relevant encouraging policies were issued by the state and relevant administrative departments. It is one of the key problems in the development process of classical prescriptions to verify and determine the processing methods of prescription herbal drugs. At present, there is no consensus or standard on such problems of classical prescriptions. In this paper, we sorted out and analyzed the related content of the herb processing for classical prescriptions, summarized the characteristics of the processing methods in the Catalogue of classical prescriptions(First Batch) and the problems faced in the textual research, and put forward some suggestions on the processing and textual research, including four research strategies: sorting out the mainstream methods for herbs in various periods of classical prescriptions, clarifying histological changes in the processing methods, determining the processing methods based on the drug processing characteristics, determining the processing methods based on the processing functions and identifying the processing methods according to the clinical efficacy and indication, so as to provide ideas and references for the research of processing methods involved in classical prescriptions.
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China , Drug Prescriptions , Drugs, Chinese Herbal , Medicine, Chinese Traditional , PrescriptionsABSTRACT
Texture analyzer is a multifunctional physical property analyzer. Through a variety of test modes such as compression， puncture， shearing and stretching， hardness， adhesion， elasticity， cohesiveness and other physical property parameters are characterized. The results are objective， sensitive， and accurate， which can provide theoretical basis and reference for interpretation of basic theoretical， optimization of prescription technology and quality control research of pharmaceutical preparations. Firstly， the principles， test modes， measurement indexes and measurement data analysis methods of texture analyzer were summarized in this paper. Secondly， the application progress of texture analyzer in solid preparations， semi-solid preparations， liquid preparations， traditional Chinese medicine decoction pieces and their intermediates was described in detail， and compared with the commonly used measurement methods of physical property indicators. Finally， the application prospects of texture analyzer and its research contents to be improved were reviewed， so as to facilitate the use of texture analyzer by pharmaceutical researchers to promote the development of related fields of pharmaceutics， and to provide new ideas and methods for the research and development of pharmaceutical preparations.
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The quality constant evaluation method was applied to the grading evaluation of Albiziae Cortex decoction pieces. The morphological and component indexes of 12 batches of the decoction pieces were measured, their quality constants were calculated and graded. The results showed that the quality constant ranged from 0.041 to 0.167. If the percentage quality constant ≥ 80%was the first-grade decoction pieces, <80%and ≥ 50%was the second-grade decoction pieces, <50%was the third-grade decoction pieces; the quality constant of the first-grade decoction pieces was ≥ 0.133 6, the second-grade decoction pieces was ≥ 0.083 5 and <0.133 6, and the third-grade decoction pieces was <0.083 5. In this paper, the authors further applied the quality constant evaluation method of skin piece in the grading evaluation of Albiziae Cortex decoction pieces, which proved that the method was reasonable and scientific, and it can provide a reference for the quality grading of this decoction pieces.
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Objective: To analyze the quality of Angelicae Dahuricae Radix (ADR) from national drug evaluation sampling, continuously improve and revise the standard determination method, and ensure the safety of public drug use, six index components of ADR medicinal material and decoction pieces were determined by combining HPLC fingerprint chromatography and quantitative analysis of multi-components by single marker (QAMS). Methods: The determination and exploratory study were carried out according to the National Standard. The establishment of steamed Angelicae dahurica HPLC fingerprint, method for multiple assessment of six index components to conduct a methodological survey determination of multi-index component content of 20 batches of Angelicae dahurica tablets, the final determination of the quality of Angelicae dahurica. Result:s A total of 239 batches of ADR were received from 189 enterprises, in which 225 batches were qualified and 14 batches were unqualified. The qualified rate was 94%. A method that determined content of six kinds of coumarin in ADR decoction pieces using imperatorin as control was established, which could solve the problem of difficulty in obtaining control and consuming long determination time. It would better indicate the drug quality. Conclusio:n The method we had established could be used in qualitative and quantitative analysis of oxypeucedanin hydrate, byakangelicin, oxypeucedanin, berapten, imperatorin and isoimperatorin in ADR decoction pieces. Through this random inspection, it is found that there were still some quality problems in ADR decoction pieces. The quality supervision of traditional Chinese medicine should be strengthened further.
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Objective To determine the water absorption coefficient of single-flavor root and rhizome Chinese herbal medicine pieces at room temperature, and guide the water addition in the decoction process of decocting machine of Chinese herbal.Methods The water absorption coefficient of 222-flavor root and rhizome Chinese herbal medicine pieces were studied, the simulated prescriptions were decocted according to the recommended formula of the decocting machine manufacturer and the water absorption coefficient, and the amount of liquid were obtained by the two methods which were compared with the amount of liquid required.Results The water absorption coefficients of roots and rhizomes with different textures were quite different.The amount of liquid obtained according to the manufacturer′s recommended formula was quite different from the amount of liquid required and there was no rule to follow.The error of the amount of liquid obtained according to the water absorption coefficient and the amount of liquid required was small and regular.Conclusion The experimental determination of the water absorption coefficient of traditional Chinese medicine decoction pieces could guide the amount of water added to the decoction machine.
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OBJECTIVE:To speed up the perfection of quality standards of traditional chinese medicine decoction pieces and control the quality.METHODS:To present the implication of traditional chinese medicine decoction pieces,and the influ?ence of its quality and processing on decoction.To discuss the present situation of quality standards,and to suggest some mea?sures.RESULTS&CONCLUSION:Further perfection of the quality standards of traditional chinese medicine decoction pieces will be beneficial to modernization of industry of TCM and to ensure the safe use of drugs.