Four critical engineering and technical problems in manufacturing measurement of traditional Chinese medicine / 中国中药杂志

Focusing on the development and quality improvement strategy of the traditional Chinese medicine(TCM) industry, the scientific and technological innovation of the new engineering of TCM should be paid attention to solve the "stuck neck" dilemma. Under the background of the ecological and industrial revolution of the scientific and technological innovation system, the super-scale information interaction and multi-dimensional integration will inevitably lead to profound changes in the manufacturing mode of TCM. Manufacturing measurement of TCM is formed on the basis of the reliability engineering theory of process control of TCM production. It is the development extension of system theory and system science ideas and a cross-fertilization discipline that combines theory with practice and adheres to the "four-oriented" re-epistemology improvement of the TCM discipline. In response to the problems of complex raw material sources, coarse process technology, unclear material basis, and poor applicability of equipment and technology in the manufacture of TCM, the transformation research mode of "aiming at the integration of pharmaceutical industry-developing intelligent production line-enabling industrial transformation" has been developed. This paper proposed the four key engineering technical problems, i.e., the identification of critical quality attributes(CQA) in the manufacture of TCM, the quality by design(QbD) and product development of the manufacturing process of TCM, the quality transfer principle and multivariate process capability index of TCM manufacturing, and the development of measurement technology and equipment of the manufacturing measurement of TCM, to achieve the systematization of quality control indicators, real-time process control, digitalization of manufacturing process, transparency of quality transfer, and intelligent whole-process control. In this paper, the new concepts, new theories, and new technologies provide a reference for the industrialization of TCM.

Quality control strategy of traditional Chinese medicine based on pharmaceutical product lifecycle management / 中国中药杂志

Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.

Development of an overall evaluation system for traditional Chinese medicine / 药学学报

This paper reviews modern science and technology with regard to traditional Chinese medicine (TCM) research methods, quality control, and discusses the establishment and improvement of the evaluation system for TCM, focusing on the following issues: 1) How to incorporate the efficacy of TCM in the overall evaluation of TCM quality; 2) how to quantify the efficacy and properties of TCM; 3) how to understand the correlation between the efficacy and properties of TCM and its application; 4) how to reflect the specificity of the effective components in the overall evaluation of TCM quality; and 5) how to reflect the quality value transfer of effective components in the whole process of production and metabolism in vivo to the overall evaluation of TCM quality. The overall quality evaluation of TCM needs to better reflect its clinically safety and effectiveness. It is suggested to establish a clinical quality assessment method based on the content of the chemical components of TCM to explore and establish an overall evaluation method of TCM quality that reflects the efficacy of TCM and conforms with clinical practice.

Critical quality attribute assessment of big brand traditional Chinese medicine: process quality control method of Suhuang Zhike Capsules intermediate based on physical properties of powder and granules / 中国中药杂志

The physical properties of powder and granules are the critical quality attributes for the process control of Suhuang Zhike Capsules, a big brand traditional Chinese medicine. This paper took the production of 25 batches of real-world Suhuang Zhike Capsules dry extract powder and granules intermediates as the research object. Firstly, a method for testing the physical properties of Suhuang Zhike Capsules powder and granules with 19 physical indicators was established. The results showed that the granules of dry extract powder after granulation had a smaller particle size, wider particle size distribution range and poor fluidity, which easily caused the problem of over-limit capsule loading. Secondly, correlation analysis, principal component analysis and cluster analysis were used for mathematical statistics. The correlation analysis showed that the density of dry extract powder could affect the chroma and fluidity. At the same time, the particle size in the granules had a stronger effect on the chroma and fluidity than the density. The study also found that the particle size and hygroscopicity of dry extract powder were potentially key physical properties that affected the physical properties of granules. Furthermore, the results of principal component analysis and cluster analysis showed that the consistency of the physical properties between the dry extract powder and intermediate granules was relatively poor. To this end, similarity analysis was carried out, and the quality control method of powder and granules based on physical fingerprint was established. The results showed that the physical fingerprint similarity of 25 batches of dry extract powder was 0.639-0.976, and the physical fingerprint similarity of the gra-nules was 0.716-0.983. With the similarity of 0.85 as the threshold, the batches with abnormal physical properties could be identified. In this study, the process quality control method of Suhuang Zhike Capsules based on the physical properties of powder and granules was established finally, which realized the identification of abnormal batches, and provided a reference for the process quality control of Suhuang Zhike Capsules.

Development of SQL-based reporting tools and its application in radiotherapy workflow quality management / 中国辐射卫生

Objective To effectively use the clinical data generated in daily operation and to realize information networking based on the existing resources of radiotherapy department. To improve quality management efficiency in radiotherapy process. Methods The radiotherapy process and required documents were analyzed. The reporting tool Microsoft Report Builder, which is based on SQL database, was applied to design the patient documents by extracting and analyzing a large number of data generated by Aria, the existing network of our radiotherapy department. PDCA Tools was used to analyze the weak links in the process. Reports with quantitative indices have been designed according to corresponding countermeasures, so as to improve quality control level of the process. Results More than one thousand patients were treated in our department since 2020. All patient documents of radiotherapy can be archived and inquired online after registration only once. 13 daily statistical reports, 5 quarters and 3 annual reports were scheduled according to practical demands. The waiting time before radiotherapy was shortened from 16.2 days to 14.8 days after operating the reporting system 3 months later. The staff could master the treatment progress of patients easily and patients who interrupted the treatment were found in time. Conclusion The reporting tools can realize patient information extraction and networked management effectively in radiotherapy process. Staff efficiency of personnel work and communication was improved. The resource allocation was optimized according to the report data in real time, improving the efficiency and quality of radiotherapy. This method is generally applicable and practical to radiotherapy department.

Standardization system of industry decoction pieces based on whole process quality control concept / 中国中药杂志

Traditional Chinese medicine (TCM) decoction pieces refer to prescription drugs that can be used in clinical or preparation production after processing medicinal herbs. TCM decoction pieces industries are inherited from the culture of TCM and are important because of their independent intellectual property rights. The Chinese Pharmacopoeia (Ch. P) 2010 edition stipulated that "All drugs taken are decoction pieces", which raised the drug status to statutory law for the first time and clearly specified that TCM decoction pieces should be applied to TCM prescription deployment and production of proprietary Chinese medicines. It also pointed out that "The specifications of the decoction pieces used in the preparation should comply with the requirements of the actual process of the corresponding formulation type". For a long time, both the processing methods and the specification grades of the clinically used pieces of Chinese medicine were based on the inheritance and supported by the classical theory and method system centered on TCM processing. However, the theoretical research and specification standards of the decoction pieces used in the production of proprietary Chinese medicines based on modern industry are scarce, and this has led to a series of problems related to the industry, making the processing of decoction pieces becoming a limiting factor in the promotion of the Chinese medicine industry. Aiming at the existing problems of the TCM decoction pieces industry, this article was guided by the standardization system of TCM based on the concept of whole-process quality control, combined with the reference to the Japanese Kampo medicine industry's feeding mode and the reflection on the combination of traditional Chinese medicine processing and modern industry, as well as the study of the core law of the whole-process of TCM production, etc. Industrial decoction pieces and the idea of building a standardized system of TCM industry decoction pieces based on the whole-process quality control were discussed in this paper, which can provide insights for exploring the effective fusion between TCM processing theory and classic heritage and modern manufacturing and can provide the basis for the establishment of a standardized system for industrial decoction pieces based on whole-process quality control of TCM. It can also offer reference for the development of the advantages of geo-authentic crude drug and the establishment of high spots of industry decoction pieces.

Discussion on research thinking of traditional Chinese medicine standardization system based on whole process quality control / 中国中药杂志

The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry.

Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree / 中国中药杂志

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization.

Progress in application of failure mode and effect analysis in the quality control of radiotherapy process / 中华放射肿瘤学杂志

With the rapid development of radiotherapy technology, traditional quality management will shift from a device-centric strategy to a process involving multiple people. In recent years,failure mode and effect analysis(FMEA)based on predictive risk assessment has gradually been applied in the quality management of radiotherapy process. The FMEA approach mainly includes four steps: process tree management,FMEA, error tree analysis, and the design of scheme for process quality management. The specific methods and results are different due to the specificity of radiotherapy process and the subjectivity of participants. Its reliability and feasibility have also been considered and verified. This article reviews the application of FMEA approach in some radiotherapy centers.

Quality control of linac in daily volumetric-modulated arc therapy / 中华放射肿瘤学杂志

Objective To verify the daily delivery accuracy of volumetric-modulated arc therapy (VMAT) and achieve the process quality control (PQC) of linac using statistical process control (SPC)technology.Methods The log files of all treatments were taken out from the linac system.An in-house software which created by Matlab 7.14 was used to analyze the daily parameters accuracy and the mechanism and dose delivery accuracy of the linac for each VMAT,and an daily evaluation report was automatically created for the linac.The stability of the linac and the deviation of the delivery accuracy for various cancer sites were also analyzed.To achieve the process quality control of hnac using SPC technology,the control limit of each parameter was calculated by Johnson alternation and the single value control charts were drawn.Results 76 patients mainly with nasopharyngeal carcinoma,cervical carcinoma,rectal cancer and laryngeal cancer,got the treatment daily with VMAT technology,and a total of 2 446 arcs were delivered by the linac in continuous 16 days.The gantry angle error,y and x collimator position error,MLC leaf position error and dose delivery error were 0.49°,0.09 mm,0.38 mm,0.31 mm,0.05 MU,respectively.Compare to the nasopharynx,uteri,rectal and larynx cancer,it can be seen that the variation factors of dose delivery and gantry angle errors for various cancer sites were higher,which was 8.10％ and 4.54％,respectively.Through the process quality control of the linac,it was found that all the parameters were in control.While some abnormal points arose (the error was greater than UCL),and the ratio of the gantry angle which was out of control (0.45％) was the highest in all parameters.Conclusions linac delivery accuracy could be monitored and verified during the whole VMAT treatment for each patient,and the daily running condition of linac could be monitored.Through the introduction of SPC technology and the control charts,the process quality control of linac in VMAT could be achieved.It is a financial and valid method for the daily quality assurance of linac.

Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)$ / 药物分析学报

CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LLOQ) were determined according to International Conference on Harmonization ICH Q2(R1) guidelines. HPLC separation was achieved on a RP-select B Lichrospheres column (250 mm ? 4 mm, 5μm, Merck) using water containing 0.1%glacial acetic acid and acetonitrile as the mobile phase in a gradient elution. The eluents were monitored by a photo diode array detector at 245 and 275 nm. Based on signal to noise ratio of 3 and 10 the LOD of CDRI 99/411 was 0.55 mg/mL, while the LLOQ was 1.05 mg/mL. The calibration curves were linear in the range of 1.05-68 mg/mL. Precision of the method was determined by inter- and intra-assay variations within the acceptable range.

Case study of 200 technical reappraisals for medical malpractice in Beijing / 中华医院管理杂志

Objective To identify regular roots for medical disputes by case studies for providing evidences for hospital management..Methods 200 cases of medical malpractice were selected consecutively and categorized according to the causes,dispute focus and expert opinions.Results The main factor to trigger medical disputes is dissatisfaction of the outcome,accounting for 50.5％.48.15％ of the disputes,however,result from dissatisfaction of the therapy process which constitutes a medical malpractice.Neglect or defects in treatment,surgical operation,information notice and medical papers were highly common causes.Conclusion Medical disputes result from a variety of causes,so are the roots of medical malpractice.Medical institutions are recommended to enhance medical quality management,make sufficient doctor-patient communication,and make high quality documentation of key medical activities,in an effort to minimize medical disputes and medical malpractice.

On the practice and discussion of research management model in general hospital / 中华医学科研管理杂志

In recent years,the state has a substantial increase in investment in Medical Research.The number of hospital-borne scientific research,funding amounts and types of projects is also increasing..Our hospital scientific management based oriented clinical needs,Construction Institute hospital as a work positioning,the whole process of quality management as the implementation of safeguards.Through a series of positive measures,gradually formed which are consistent with the management of the hospital research and development,and scientific research achievements into clinical practice.The research management changed from passive management model to proactively manage; from the emergency management to the whole process of managing; from the targeted management to guide the management of clinical needs.These measures effectively improve the level of scientific research in hospitals.

Improvements in Similarity Algorithms Based on Similarity System Theory / 分析化学

For solving the problem that common similarity algorithms are insensitive to the relative differences of different chromatographic fingerprints data, this paper improved the algorithms of improved extent similarity), which named new improved extent similarity. It was confirmed that new improved extent similarity could distinguish) the samples with the same total difference and different distribution of relative differences. by applying) the similarity algorithm to simulated data and the chromatographic fingerprints of nine batches Rukuaixiao tablets. New improved extent similarity could reflect the relative differences of peak areas more sensitively when the relative differences of common peak areas was less than 100%. The result indicates that new improved extent similarity can reflect the large deviation from the established proportion of components, which can be applied to the control of the fluctuation of the established proportion of effective components and the process quality control of Traditional Chinese Medicine .

Pharmaceutical Study on Xiaoerqingfei Suppository(Herba Ephedrae,Semen Pruni Armeniacae,etc.) / 中成药

This paper,introduced the manufacture process and quality control method of Xiao- erqingfei Suppository.The suppository tallied with requirements of China Pharmacopeia (the 85th edition).Its main active components were identified with TLC.Two represen- tative components were determined:ephedrine and glycyrrhizic acid.

Application of chromatographic fingerprint of immature fruits of Terminalia chebula and its extracts / 中成药

AIM: Terminalia chebula contained hydrolysable tannins up to about 35%. It was necessary to establish a chromatographic fingerprint to meet the quality control need effectively. METHODS: HPLC method was carried out with 3 kinds of the mobile phase , namely, A∶ 0.05mol?L -1 Phosphoric acid/ 0.05mol?L -1 Potassium dihydrogen phosphorate aqueous solution, B: methanol and C: Ethyl acetate, running in gradient mode based on the previous experiment. RESULTS: A marked peaks of HPLC fingerprint of the raw material, the extracts and its final product consisted of gallic acid, terchebulin, chebulamin, chebulagic acid and chebulinic acid. CONCLUSION: The fact has depicted that chromatographic fingerprint is a powerful tool for in-process-quality supervisory control and dynamic analysis of the active constituents during manufacture procedure of immature fruit products of Terminalia chebula.