1.Ecological environment of cultivated Astragali radix and market specification of prepared slices.
Kunzi YU ; Jing LIU ; Hao HONG ; Baolin GUO ; Shaoqing CAI ; Hubiao CHEN
China Journal of Chinese Materia Medica 2010;35(9):1112-1115
Astragali Radix is derived from roots of Astragalus membranaceus var. mongholicus and A. membranaceus. The exhaustion of wild Astragali Radix has made cultivated Astragali Radix possess the commercial market of Astragali Radix. So the ecological environment of cultivated Astragali Radix should be investigated through field survey. Through investigation, we found that A. membranaceus var. mongholicus are cultivated in Hengshan mountain of Shanxi province, Longnan of Gansu province, south of Inner Mongolia and Qinghai provinces. A. membranaceus var. mongholicus is almost planted on the plain, except in Shanxi province it grows on the sunny side of the mountain. What is more, soil type, elevation, annual temperature and annual rainfall of these locations are different. So the ecological environments of cultivated location of Astragali Radix are different from each other. A. membranaceus is wild in Heilongjiang and northeast of Inner Mongolia, but the resource is drying up. It is also planted in few places of the provinces of Shanxi, Shandong, Hebei, Gansu, but cultivated scope of A. membranaceus is smaller than A. membranaceus var. mongholicus.. So A. membranaceus var. mongholicus possesses large part of Astragali Radix market. In market, there exists no unified specification fro slices of Astragali Radix, and specification of prepared slices will influence the contents of chemical components. Through investigation, different kind of prepared slices can be collected and compared, this provides evidences for quality control of prepared slices. Through investigation, five different specifications of prepared slices were found in market. The distributions of some specification of prepared slices are specified, like transverseprepared slices prepared from A. membranaceus only found in Heilongjiang province. Transverse prepared slices possess half part of prepared slice market, and can be used to identify original plant of Astragali Radix. So transverse prepared slices should be the unified specification of Astragali Radix.
Astragalus Plant
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chemistry
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growth & development
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China
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Drugs, Chinese Herbal
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chemistry
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standards
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Ecosystem
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Quality Control
2.Proficiency testing on determination of the content of geniposide in Gardeniae fructus by HPLC
Xiaohan GUO ; Yan CHANG ; Jiating ZHANG ; Kunzi YU ; Jianbo YANG ; Minghua LI ; Siyu MA ; Yiyun LU ; Xinhua XIANG ; Xianlong CHENG ; Feng WEI
Chinese Journal of Pharmacoepidemiology 2024;33(10):1115-1123
Objective To carry out a proficiency testing of content determination of geniposide in Gardeniae fructus,evaluate the content determination ability of index components in traditional Chinese medicine in the laboratory of inspection and detection in drug-related fields,and improve the quality control ability of content determination of related laboratories.Methods The laboratory's capability-verification activities were conducted based on the CNAS-RL02 Rules for Proficiency Testing and ISO/IEC 17043 Conformity Assessment-General Requirements for Proficiency Testing.After preparing the sample,the results of homogeneity and stability tests were analyzed according to CNAS-GL003 Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing.After the test results were qualified,they were used as proficiency testing samples and randomly distributed to participants.The results were collected,and the robust statistical method and the Z scores were used to analyze the results of these laboratories'reports.Results 403 laboratories in this proficiency testing program reported the results,of which 367 results were acceptable,accounting for 91.07%,17(4.22%)laboratories obtained suspicious results,and 19 laboratories gave unsatisfactory results,with the dissatisfaction rate of 4.71%.Conclusion The majority of the 403 participant laboratories have the ability to determine the content of geniposide in Gardeniae fructus by HPLC and the laboratory testing ability and quality management level of the drug monitoring system are high.This proficiency testing provides a basis for understanding the technical reserve capacity and management level of China's pharmaceutical inspection and testing laboratories,and provides technical support for future government supervision.