ABSTRACT
After the completion of the pilot work of traditional Chinese medicine formula granules （TCMFGs）， the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work， this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards， mainly involving the executive standards and distinguishing technologies of raw materials， the adding process of excipients in the procedure item， the rationality of quality control methods， the information content and reproducibility of characteristic chromatograms， the nomenclature and accessibility of reference materials， etc. The common problems such as the coverage of standards， specification differences， and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards， accelerate the research and development of reference materials， advocate the use of high-quality raw materials， explore the evaluation methods of high-quality products， and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards， promote the continuous improvement of TCMFGs standard system， and ensure the healthy and orderly development of the TCMFGs industry.
ABSTRACT
Armeniacae Semen Amarum is one of the most commonly used Chinese medicinal materials， with the homology of medicine and food. It is mild toxicity， in addition to raw product， there are blazed and fried Armeniacae Semen Amarum and other processed products. The prescription， process and quality standard of Chinese herbal preparations containing Armeniacae Semen Amarum in the 2020 edition of Chinese Pharmacopoeia （volume Ⅰ）， were studied and analyzed in this paper. The quality control and safety problems of them were discussed， and the proposals were put forward：①To strengthen the quality control of medicinal materials from the origin， including processing， storage， producing area and so on. ②Production technology is the key factor affecting the safety and effectiveness of preparations， so it is necessary to strengthen the control of production process. ③To strengthen the quality research of Armeniacae Semen Amarum preparations， to develop safety quality control projects， and to further improve the quality standards of Armeniacae Semen Amarum preparations. ④To improve the safety tips of Armeniacae Semen Amarum preparations and standardize the instructions. These suggestions can provide reference for scientific understanding and evaluation of traditional Chinese medicine preparations containing Armeniacae Semen Amarum， in order to promote the quality control level of Chinese medicine preparation containing Armeniacae Semen Amarum and its processed products.
ABSTRACT
Bioactive peptides play important roles in promoting human health, such as lowering blood pressure, blood sugar and blood lipid, anti-obesity, and anti-cancer. Thus, exploring functional bioactive peptides and developing efficient production technologies are of crucial importance. Herein, we review the development of function discovery and production technology for natural bioactive peptides. Presently, the top-down and bottom-up approaches are mainly used for the function discovery and production of natural active peptides. The top-down approach includes the direct extraction and identification for functional discovery, and the direct extraction, enzymatic hydrolysis and microbial fermentation for production. The bottom-up approach includes the polypeptide modification and database mining for functional discovery, and the chemical synthesis, enzyme synthesis, recombinant expression and cell-free synthesis for production. The top-down approach is usually associated with complicated process, lower efficiency, higher cost, harder quality control, and uncertain functionality, while the bottom-up approach is more suitable for the development of peptide drugs but difficult to be used for functional foods. With the technology development of sequencing and mass spectrometry, it is easier to obtain the proteomic information of various organisms at the molecular level. Based on the proteomic information, the top-down and bottom-up approaches can be combined to overcome the disadvantages of using these two approaches alone, thus providing a new strategy for the rapid development and production of natural active peptides.
Subject(s)
Humans , Fermentation , Mass Spectrometry , Peptides/metabolism , Proteomics , TechnologyABSTRACT
The prescription composition of the biologically active dietary supplement (BADS) Oleopren Neuro has been scientifically substantiated through the pharmacological evaluation of the effective agents, polyprenols being the main of them. The technology of an innovative product has been developed, with the establishment of adjustable production parameters securing high organoleptic advantages and stability of the BADS. Regulated indicators of quality and nutritional value have been determined. Sanitary toxicological and hygienic safety indicators of the product under development had been studied, which allowed to establish a shelf life of two years taking the safety margin of three months into account. The possible mechanisms of the dolichols effect on the metabolic status of the organism were considered. Clinical trials of the efficiency and functional focus of a specialized product on a representative group of patients with the dyscirculatory encephalopathy (DE) of vascular genesis stages I II were conducted. The BADS were included in the diet of patients, along with the basic therapy, one capsule twice a day for 10 days. The materials obtained in this article allow to recommend the developed product as an efficient means of increasing the body's resistance to adverse effects of the environment, stressful situations, as well as psychoemotional and physical stress.
Subject(s)
Dietary Supplements , Dolichols/therapeutic use , Production of Products , Health Surveillance of Products , Nervous System Diseases/therapy , Nutritive ValueABSTRACT
Salvia miltiorrhiza is one of the commonly used bulk medicinal materials, which has significant effect on cardiovascular disease, and are heavy demanded in Asia, Europe, North America, Russia and Africa. Consequently, increasing the yield and quality of S. miltiorrhiza has become a major concern worldwide. With the current wild resources of S. miltiorrhiza gradually decreasing, cultivated products occupy most of the markets. However, the cultivation area is widely distributed and the cultivation techniques is different, which lead to the quality and yield of S. miltiorrhiza in consistent. This paper combined visiting survey with document analysis to carry out the cultivation situation of S. miltiorrhiza in main cultivation areas of Shandong, Henan, Sichuan, Shanxi and Hebei provinces. There exist big differences of the ecological environment, mode of cultivation, fertilization, pest control, harvesting processing among the producing areas. We should carry on the ecological suitability zoning analysis and suitable cultivation of each area study to form a pattern of high quality and high yield for the sustainable development of S. miltiorrhiza cultivation.
Subject(s)
Agriculture , Methods , Europe , Plants, Medicinal , Salvia miltiorrhizaABSTRACT
With the publishment of the application guideline for the key project of "Research on Modernization of Traditional Chinese Medicine" by the Ministry of Science and Technology in 2018, the problem of "intelligentization" in the production of decoction pieces of Chinese crude drugs has attracted more and more attention from the industry. Some suggestions on the intelligentization of the production of decoction pieces of Chinese crude drugs in the course of transformation of production mode and innovation of production technology of decoction pieces of Chinese crude drugs" were proposed in this paper, which in order to help the implementation of the project and the development of decoction pieces industry.
Subject(s)
Drugs, Chinese Herbal , Feasibility Studies , Medicine, Chinese Traditional , Technology, PharmaceuticalABSTRACT
Air conidia production of Beauveria bassiana, strain CA-603 was studied based on modified diphasic system. The biomass yield obtained in the first phase based on submerged cultivation of fungus was processed using methodology providing different contact with air space. Our study indicated that productivity of the second stage of diphasic system is had inversely proportional dependence on depth of liquid fungal biomass. Increase of biomass depth is significantly decreased production of air conidia. Two methodology of biomass processing extending contact biomass with air space including distribution of fungal material on surface of hygroscopic paper and starch packaging peanuts were investigated. The novel substrates provided optimal contact between the submerged fungal biomass and the air, and overall, conidial production was directly proportional to the total area of air-to-fungal surface. Technologies based on the starch peanuts and hygroscopic paper were the most productive in comparison to the common technology where the submerged culture was transferred to flat containers. The advantages and disadvantages of these different production methods are discussed.
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Vnukovo-32 a cell culture rabies is used to study the vaccine strain technology of inactivated culture rabies vaccine production in primary hamster kidney cells. The master and working seeds meet the criteria of rabies vaccine strain titer (5.5 log LD 50 - 7.1 log LD 50/ml) according to WHO standard. During the study, we have used the procedure for inactivated, non concentrated rabies vaccine production of Russia and other countries procedures as references. The result was we constructed the procedure for inactivated, concentrated cell culture rabies vaccine production at laboratory scale.
Subject(s)
Rabies VaccinesABSTRACT
OBJECTIVE:To improve the production technology of prulifloxacin.METHODS:The primary synthetic process of prulifloxacin was improved from aspects of raw material,agents,reaction method,reaction condition etc by referring to literature together with our experience in and considerable experiments on the production of pruliflorxacin.RESULTS & CONCLUSIONS:The improved production technology of prulifloxacin is simple in operation,obtainable in raw material,high in yield and low in cost,it also meets the requirement on environmental protection,and which is thus suitable for the industrial production of prulifloxacin.
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On the basis of thermal stability of andrographolide and dehydroandrographolide,the influences of medicinal material factors(habitats,collecting time,storage time),thermal stability,production technology(solvent,temperature,heating time and storage condition)on the content of andrographolide and dehydroandrographolide in Andrographis Tablet(AT)were explored so as to increase the quality of AT.The results showed that the excellent medicinal material of Herba Andrographis,optimized production technology,shorter heating time and lower temperature are the effective measures for increasing the quality of AT.