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By reviewing the research history on quality comparison between wild and cultivated Chinese crude drugs， this paper systematically combed the relevant research reports since the 1950s， and summarized and analyzed the results of existing comparative studies， and found that the existing comparative research on the quality of wild and cultivated Chinese crude drugs were mainly focused on several aspects， including characteristics， microstructures， chemical compositions， pharmacodynamic effects， and genetic diversity. Among these， comparative studies of chemical compositions have been the dominant approach， with a particular emphasis on comparing the contents of index components. However， research on pharmacodynamic effects remained relatively limited. Due to various factors such as sample quantity， sample origin， growth period and cultivation methods， the differences in quality between wild and cultivated Chinese crude drugs vary significantly. In general， most wild Chinese crude drugs exhibited higher quality than cultivated products， with significant differences in their characteristics. The contents and proportions of some chemical components underwent noticeable changes， particularly with a marked increase in the proportion of primary metabolites after cultivation. The quality of cultivated Chinese crude drugs is closely related to the cultivation practices employed. Chinese crude drugs produced through wild nurturing， simulated wild planting， ecological cultivation， and other similar methods demonstrate quality levels comparable to those of wild Chinese crude drugs. Based on the analysis results， it is recommended to explicitly specify the cultivation practices and cultivation period of cultivated Chinese crude drugs in comparative studies of the quality between wild and cultivated Chinese crude drugs. Multiple technical approaches， including characteristics， microscopy， non-targeted metabolomics combined with quantitative analysis of differential components， and bioefficacy evaluation， should be employed to comprehensively assess the quality disparities between wild and cultivated Chinese crude drugs. Moreover， research efforts should be intensified to investigate the changes in pharmacodynamic effects resulting from differences in plant cell wall composition， primary metabolites， and secondary metabolites， in order to guide the production of high-quality Chinese crude drugs.
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In recent years, in order to further improve the quality of decoction pieces of Chinese crude drugs, many related basic research work around the processing of decoction pieces of Chinese crude drugs have been carried out by relevant experts. Many opinions and suggestions on the revision of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs were put forward. In order to further improve the preparation of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs, strengthen the guidance on the revision of local processing standards, and clarify issues related to the circulation, use and supervision of decoction pieces, the Department of Drug Registration Management of the National Medical Products Administration and the Chinese Pharmacopoeia Commission have organized experts to discuss these problems. The author only puts forward some suggestions on related issues in order to achieve the purpose of "throwing a brick to attract jade". ①The study of the national regulations on the processing of decoction pieces of Chinese crude drugs should be standardized on the basis of the inheritance for the specific process. ②The revision of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs should be improved on the basis of the existing research results. The regulation of the processing process should not be excessively parameterized, the revision of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs also should be synchronization to the revision of the Chinese Pharmacopoeia. ③The contents of the Chinese Pharmacopoeia and the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs should have different emphasis. The former should focus on the standard, while the latter should focus on the processing process. ④The revision of local (provincial) processing specifications only collects the pieces that truly have local features and clinical characteristics. ⑤Decoction pieces of local Chinese crude drugs can only be applied at the place of production (province). They are allowed to be produced and distributed in other provinces, municipalities and autonomous regions after through filing. ⑥For the decoction pieces of Chinese crude drugs with large-scale use contained in local processing specifications, they should be included in the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs as soon as possible, and their quality standards should be included in the Chinese Pharmacopoeia.
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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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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.
Asunto(s)
Medicamentos Herbarios Chinos , Estudios de Factibilidad , Medicina Tradicional China , Tecnología FarmacéuticaRESUMEN
Quality standard research of pieces of Chinese crude drugs is the important content of research of Chinese medicine processing, and it is also the key point of the whole standardization system of Chinese medicine. Although we have set up a preliminary quality standard system of pieces of Chinese crude drugs, it still under a low level. During the research of quality standard of pieces of Chinese crude drugs, we still face some problems, such as how to set up a more comprehensive, scientific, and reasonable quality standard. In this paper, we proposed some advices that we should pay more attention to traditional processing theories, processing mechanisms and effective substances during research of quality standard research of pieces of Chinese crude drugs.
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OBJECTIVE:To determine the contents of heavy metals in commercial Chinese crude drugs and to provide reference for the monitoring of heavy metals in the crude drugs.METHODS:UV spectrophotometry was established to determine the contents of heavy metals in 6 vegetable drugs(Panax quinquefolium,Panax ginseng,Lycium barbarum,Radix et Rhizoma Glycyrrhizae,Bulbus Fritillariae Cirrhosae and Salvia miltiorrhiza)and 2 animal-source drugs(Scolopendra subspinipes mutilans and Bombyx Batryticatus).RESULTS:The linear range of heavy metal plumbum(reference substance)was 0.01～0.50 ?g?mL-1(r=0.997 7),and the average recovery rate was 99.49%(RSD=1.41%).The contents of heavy metals in Panax quinquefolium,Panax ginseng,Lycium barbarum,Radix et Rhizoma Glycyrrhizae,Bulbus Fritillariae Cirrhosae,Salvia miltiorrhiza were 26.13,28.96,26.99,29.98,26.63 and 28.06 ?g?g-1 respectively,and the contents of Scolopendra subspinipes mutilans and Bombyx Batryticatus were on the high side(47.62 and 59.24 ?g?g-1 respectively).CONCLUSION:The method is easy,highly accurate,and it can be used for detection of heavy metals in Chinese crude drugs.
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OBJECTIVE: To discuss the geographic mark protection of genuine Chinese crude drugs so as to promote its intellectual property protection. METHODS: Zhe-Ba-Wei was taken as an example to reveal the crisis of the development of Genuine Chinese Crude Drugs; the protection means between trade mark and Geographic Mark was compared, and some special problems arose in Geographic Mark Protection of Genuine Chinese Crude Drugs were discussed. RESULTS & CONCLUSION: Geographic mark protection is an effective legal means. However, a series of problems, such as confirmation of best habitat, establishment of Chinese crude drugs standard, and confliction between geographic name and geographic mark etc remained to be tackled.
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OBJECTIVE:To discuss the general rule on checking and acceptance of drug warehousing of prepared slices of Chinese crude drugs.METHODS:The warehousing acceptance data of prepared slices of Chinese crude drugs during 2003-2007 in our hospital were sorted and the reasons for drug acceptance rejection were analyzed.RESULTS:Of the 5 228 batches of prepared slices of Chinese crude drugs checked before acceptance over 5 years,138(2.61%) were unacceptable.Most of the rejected batches were prepared processing slices of Chinese crude drugs.There were more than 30 factors resulted in the rejection.CONCLUSION:The key to ensure the quality of prepared slices of Chinese crude drugs is to improve their processing level.