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The Chinese Medicine Law and the Drug Administration Law have been carried out and implemented that it is good opportunities to develop traditional Chinese medicine preparations and to promote the inheritance, innovation and development of traditional Chinese medicine by giving full play to the advantages of the traditional Chinese medicine preparations for filing, clarifying the train of thought of the filing system, and unblocking the channels for the filing system. This paper focuses on the analysis of the advantages and development of the traditional Chinese medicine preparation record system in medical institutions.
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The selection of appropriate extraction technology of Chinese materia medica (CMM) is the key phase in the preparation process of CMM preparation, and it is also the hot spot the industry personnel concerned about. In recent years, the extraction principle of CMM has been innovated, the technology has been improved and new ideas and methods have emerged. In the face of different kinds of extraction methods of CMM, how to select or innovate the appropriate extraction method to extract the effective components of CMM is a common difficult problem in accordance with the characteristics of multi-component groups of CMM. Therefore, it is urgent to sort out the extant situation of CMM, discuss the characteristics of interaction between multi-components of CMM and propose a set of optimization extraction methods adapted to multi-component objectives. Based on the above discussion, this paper firstly summarizes the present situation of CMM extraction, and introduces supramolecular chemistry, combined with supramolecular imprinting templates theory to put forward the theory, the method and the technology of qualitative and quantitative extraction of Chinese medicines which is suitable for the characteristics of active ingredients of Chinese medicines from the perspective of molecular social interaction. The aim is to promote the development of the extraction technology of CMM, make progress in the production technology of CMM preparations, and accelerate the process of modernization of CMM pharmaceuticals.
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Artificial neural network (ANN) has been a hot topic in the field of artificial intelligence since 1980s. It abstracts the neural network of human brain from the angle of information processing and establishes some simple model. It is widely used in computer, physics, economics, medicine and other industries to form different networks according to different connection modes to realize the joint action of advanced machine and associative memory. It adopts parallel and distributed processing method, which has the characteristics of high fault tolerance, intelligence, autonomous learning and so on. It has the unique advantage to deal with complex problems. However, the research contents are complicated and numerous in the field of Chinese materia medica (CMM). The advantages of ANN can deal with these problems well and have good complementarity. Therefore, the application of ANN is becoming more and more extensive in the field of CMM research. This paper attempts to summarize the application of ANN in the field of CMM research in order to provide support and reference for the research of CMM modernization.
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With the development of high and new technology, such as material chemistry and computer technology, the formulation process is also constantly innovating and improving. In recent years, 3D printing technology has become a research hotspot in the formulation industry. Different from traditional preparation methods, 3D printing technology can realize personalized production and solve storage problems of drugs. Because of its advantages of simple production, convenient carrying, low cost and strong patient compliance, it may change the design and production mode of drugs in the future and have good development prospects in the field of preparation. This paper reviews principles, the latest research progresses, advantages and challenges of 3D printing by searching CNKI, SCI, Springer databases and collating relevant literatures, and forecasts the development of 3D printing technology in the field of traditional Chinese medicine preparations, aiming to provide some references for the application of the technology in the traditional Chinese medicine preparation industry.
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In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.
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The scientific and objective quality evaluation of traditional Chinese medicine preparations has always been a historical problem in the process of modernization of traditional Chinese medicine. In the past, the single component evaluation model of “point for surface, one for all” and the index selection method of “content-only theory” were mostly used in the quality evaluation of traditional Chinese medicine preparations, which seriously deviated from the characteristics of the overall view of traditional Chinese medicine, and it was difficult to objectively and accurately evaluate the quality of traditional Chinese medicine preparations. At present, the quality evaluation model of traditional Chinese medicine preparations based on multiple indicators has become the consensus of many experts and scholars. However, the complexity of the multi-components of traditional Chinese medicines has made it impossible to accurately identify all the components in the quality evaluation of traditional Chinese medicine preparations, and it is even more impossible to use all the components as the standard for quality evaluation. According to the characteristics of traditional Chinese medicine, a limited number of representative components which can represent the overall effect of traditional Chinese medicine preparations were selected by means of network pharmacology, molecular docking, etc. Based on the content of representative components and their proportional relationship, the quality evaluation strategy of traditional Chinese medicine preparation based on the characteristics of “components structure” was established, in order to provide new ideas for the quality evaluation of traditional Chinese medicine preparations in the future.
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The article proposes the construction of network course of Chinese Medicine Preparation Analysis based on Black Board network teaching platform. It states the construction of teaching contents, the implementation of Case-Based Learning, the assistant of practical teaching and the formative evaluation. And it is helpful to improve the quality of classroom teaching, stimulate students self-regulated learning, expand their knowledge, improve their practical ability and innovative consciousness.
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To analyze the characteristics and reasons of production process changes of Chinese materia medica (CMM) preparations, study the history and research status on production process changes of CMM preparations, and provide reference for the management of production process changes of CMM preparations. It is considered that there is no effective solution for the management of production process changes of CMM preparations in the current status, so manufacturing companies take a wait-and-see attitude toward these changes. It is suggested that we should apply the risk-based approach and more flexible regulation pattern on production process changes to substitute the present regulatory method, at the same time, improve the technical requirements of production process changes according with the preparations characteristics and development of CMM preparations, and encourage marketing authorization holder to carry out research on the quality uniformity of products to manage the production process changes of CMM preparations, thereby promoting more scientific and rational on production process changes and ensuring the uniformity and stability of CMM preparations.
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Modernization of Chinese materia medica (CMM) is the main direction of development of CMM. As a complex system, CMM has the whole characteristics with multi-component, multi-channel and multi-target. However, the lack of material base of CMM and the unknown mechanism of action restrict the development of modern medicine. Strengthening the theoretical exploration of Chinese medicine components, which could improve the technical level of component preparation and promote the development of CMM component preparation, is the key to realize the modernization of CMM. This paper reviews the preparation technology of CMM component combined with components of biological pharmacy classification system for the purpose of improving the bioavailability of components based on the “component structure” theory.
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Nanosuspension technology has provided a new method for improving the solubility and bioavailability of the effective components and the effective parts in Chinese materia medica (CMM). It is one of the effective ways to realize the modernization and internationalization in the application and development of CMM. This article mainly summarizes the preparation method, curing research, application of CMM nanosuspension drug delivery system, analyzes the existing problems, and puts forward some ideas, in order to promote the development and perfection of nanosuspension technology in CMM, and expand the scope of application of CMM.
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As a representative of controlled release preparations, osmotic pump has become a hot spot in the new preparation researches of Chinese materia medica (CMM). This paper reviewed CMM osmotic pump preparation from the following aspects: structure type of osmotic pump preparation, adjuncts of osmotic pump preparation of CMM, in vivo evaluation, and problems existing currently, which aimed to provide ideas and methods for the development of CMM osmotic pump preparation.
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This paper illustrates the company's cleaning validation of many varieties of Chinese materia medica (CMM) preparation manufatured in the same production line by real case from four aspects such as selection of target product, confirmation of marker, validation of acceptance criteria, and analytical methods. It is a scientific, rational, and economic validation strategy to use CMM preparation extract or the whole extract powder as marker components for validation and determination of the marker components using UV-full wavelength scan method.
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Objective: To establish a quantitative analysis method of multi-components by single marker (QAMS) for the simultaneous determination of four tanshinones [tanshinone IIA (TIIA), dihydrotanshinone I (DTI), cryptotanshinone (CT), and tanshinone I (TI)], and to explore its accuracy and feasibility on quality evaluation of traditional chinese medicine preparations about three kinds of related preparations of Salvia miltiorrhiza. Methods: An HPLC method was used to calculate relative correction factors (fi/s) between other three components with TIIA. The component positioning methods were compared including retention time difference value, relative retention value, and linear regression methods. Meanwhile, the contents of tanshinones in different preparations of S. miltiorrhiza were determinated by the external standard method (ESM), including Danshen Tablet, Compound Danshen Tablet, and Guanxin Danshen Capsule. Measured content value was compared with calculated content value to evaluate the accuracy of QAMS method. Results: Within a certain range, the fi/s of DTI, TI, and CT to TIIA were 0.734, 0.916, and 0.774, respectively, with the good repeatability in different experimental conditions. The fi/s between other three components with TIIA was accurate and reliable, and there was no significant difference between QAMS and ESM method. Besides, the relative retention value method could be used to accurately locate the measuring component. The relative retention values of DTI, TI, and CT to TIIA were 0.314, 0.518, and 0.561, respectively. The contents of three kinds of S. miltiorrhiza preparations showed there were some differences in the intrinsic quality of the products from different factories, even from different batches of the same manufacturer. Conclusion: The QAMS method could be used for quality control about related preparations of S. miltiorrhiza and provide references for quality evaluation of other preparations. At the same time, the above three kinds of traditional Chinese medicine preparations should be further strengthened the control and supervision.
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In this paper, the essentiality of content uniformity of Chinese materia medica (CMM) is taken as a breakthrough point, the determination and assessment methods which may be used for the content uniformity of CMM are summarized, and the measures respected by author of IR fingerprint and machine vision technology are elaborated, in order to enhance the quality of CMM preparations, strengthen the safety and effectiveness of clinical medicine, and promote the establishment of content uniformity evaluation system suitable for CMM preparations.
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OBJECTIVE:To facilitate the modernization of preparation technology for Chinese materia medica preparation.METHODS:The key problems and the strategy for the modernization of preparation technology for Chinese materia medica preparation were analyzed and summarized by reviewing the pertinent literature.RESULTS & CONCLUSION:The development of the modernization of preparation technology for Chinese materia medica preparation lies in the progress in the modernization of extraction technology,quality control and quality standard and the modernization of dosage forms.
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OBJECTIVE: To promote rational drug use in the clinic. METHODS: 275 ADR case reports collected by ADR monitoring center of Yaan city from 2005 to 2007 were classified and analyzed statistically. RESULTS:The occurrence of ADR induced by Chinese materia medica preparations through Ⅳin 2005 accounted for 80.4% of the total(56 cases).The occurrence of ADR induced by Chinese materia medica preparations through Ⅳ in 2006 accounted for 79.8% of the total(113 cases).The occurrence of ADR induced by Chinese materia medica preparations through Ⅳ in 2007 accounted for 75.5% of the total(106 cases).The Chinese medicinal injection was the chief dosage form causing ADR. CONCLUSION: Timely reporting of Chinese materia medica preparations-induced ADRs, strengthened monitoring and research of which may help to reduce and avoid the ADRs incidence induced by Chinese materia medica preparations and ensure patients' medication safety.
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OBJECTIVE:To discuss the role of Chinese materia medica preparations in hospital traditional Chinese medicine work for references of the development of Chinese materia medica preparations in hospital. METHODS: The importance and role of the research & development, preparation and use of hospital Chinese materia medica preparation in the development chain of Chinese medicine were analyzed. RESULTS & CONCLUSION: The research and preparation of hospital Chinese materia medica preparation make up for the deficiency of the industrial production of Chinese materia medica preparations and play a part in the inheritance and innovation of traditional Chinese medicine.