| Objective:Angelicae dahuricaeis radix the dried root of Angelica dahuriea?Fiseh.ex Hoffm.?Benth.et Hook.f.or Angeliea dahurica?Fisch.ex Hoffm.?Benth.et Hook.f.var.formosana?Boiss.?Shan et Yuan,which is a kind of common bulk medicinal materials and medicinal food and is widely used in the treatment of headache,arthralgia,rhinitis,pharyngitis,vitiligo,psoriasis,burns,gray nails,eczema,etc.Based on in-deeply investigation and extensive sample collection,this experiment tested according to current standards,analyzed the main problems of Angelicae dahuricae radix andcarried out exploratory research in a targeted way in order to establish a more perfect quality control standard of Angelicae dahuricae radix for proving reference for drug regulatory and inspection departments.In addition,statistical methods were used to analyze experimental data and evaluate their quality status to look for a new way to evaluate traditional Chinese Medicine.Method:?1?To ensure the objective and accurate comprehensive evaluation,extensive samples were collected in the production units,retail units,wholesale units and medical institutions of 31 provinces,autonomous regions and municipalities directly under the central government,and were investigated in main production areas.According to the current inspection standards,the preliminary quality evaluation of 239 batches of Angelicae dahuricae radix from different sources was carried out.?2?According to the investigation and inspection,the study on the safety,quality and controllability of Chinese herbal medicines and Angelicae dahuricae radix was carried out.A method for the determination of main components,volatile oil,heavy metals and pesticide residues was established.The content of coumarins,volatile oil,heavy metals,harmful elements and pesticide residues in Angelicae dahuricae radix and the effect of sulfur yellow fumigation on the content of coumarins were explored.Based on the above research,the quality standard of Angelicae dahuricae radix was drafted.?3?The Radix Angelicae Dahuricaesfrom different sources according to the drafted quality standard were tested to evaluate the quality of angelica dahurica slices.Referring to the requirements of comprehensive score in the guiding principles for quality analysis of sampling inspection of national drug plan,a comprehensive scoring expert group was set up.Taking 5 key test items as the evaluation index,the comprehensive evaluation was carried out for the manufacturers which collected 3 batches or more of Radix Angelicae Dahuricae.Results:?1?The 239 batches of Angelicae dahuricae radix from different sources were detected according to the current standard.The result showed that 225 batches were qualified and the qualified rate was 94.1%;14 batches were unqualified and the unqualified rate was5.9%,unqualified items mainly included sulfur dioxide residue and content determination?Imperatorin?.Among them,the sulfur doxide residue of 9 batches of samples was unqualified,the content of imperatorin in 4 batches of samples was unqualified and the leachables of one batch of samples were unqualified.?2?Through the determination of volatile oil in 50 batches of Radix Angelicae Dahuricae,the content of volatile oil was between 0.2%and 0.7%.Taking0.30%?70%of the mean value?as the limit for statistics,45 batches were qualified,5 batches were unqualified and the unqualified rate was10.0%;through the determination of the total amount of oxyimperatorin,imperatorin and isoimperatorin in 239 batches of Radix Angelicae Dahuricae,the total content range was 0.0083%-0.521%.Taking 0.22%?70%of the mean value?as the limit statistics,208 batches were qualified,31 batches were unqualified and the unqualified rate was 12.9%,By comparing the contents of oxyimperatorin,imperatorin and isoimperatorin in Angelicae dahuricae radix fumigated with and without sulfur,the content of Radix Angeliccae Dahuricae in sulfur free yellow fumigation was higher and with the increase of sulfur dioxide residue,the total amount of sulfur dioxide decreased.The 5 heavy metals and harmful elements?Pb,Cd,As,Hg,Cu?in 137 batches of Angelicae dahuricae radix were determined referring to the relevant provisions of the green industry standard for the import and export of medicinal plants and preparations and the result showed 7 batches of Pb exceeded,16 batches of Hg exceeded and the exceeding rate was 16.8%.Through the determination of 51pesticides in 70 batches of Radix Angelicae Dahuricae,a total of 16 pesticides were detected,including amifosulfuron methyl,benzophos,benzophos sulfone,benzophos sulfoxide,chlorpyrifos,fipronil,fluoronitrile,phorate sulfone,phorate sulfoxide,methasulfuron methyl,isosalifos methyl,carbofuran,phosphoramine,Chlorsulfuron methyl,chlorzofos and specific thion sulfoxide.Among them,the detection rate of phorate sulfoxide was 95.0%and the maximum detection amount was15.2?g·kg-1.The detection rate of phorate sulfone and chlorpyrifos was 10.0%,and the highest detection amount was 3.5?g·kg-1and 45.0?g·kg-1,The detection rate of other pesticides was lower than 5.0%and the detection amount was low.?3?The Radix Angelicae Dahuricaes from different sources were tested according to the current standards and self-made standards.The result showed the qualified rate of Angelicae dahuricae radix decreased from 94.1%to 83.2%,and the qualified rate decreased,in addition,according to the requirements of comprehensive scoring and the statistical analysis of data,a comprehensive evaluation was made on 28 enterprises that collected 3 batches or more of Radix Angelicae Dahuricae.The result was the quality of Angelicae dahuricae radix produced by Zhangzhou traditional Chinese medicine decoction piece was better.Conclusion:There was no significant difference in the quality of Angelica dahurica pieces from different sources?production enterprises,management enterprises and medical institutions?according to the current standard test and self prepared standard analysis,The overall quality of Angelica dahurica pieces was"good".There was no artificial weight gain,adulteration,etc;the pesticides and the heavy metal organic harmful elements in the process of planting and the sulfur dioxide in the process of processing had a great impact on the safety of Radix Angelicae Dahuricae.The soil pollution situation of the planting base of Angelicae dahuricae radix should be further evaluated,the selection of the planting base should be paid attention to,the sulfur free processing should be actively promoted and the sulfur fumigation should be avoided;the current standard was not perfect,so it is necessary to revise and make the quality control standard of Angelicae dahuricae radix perfect. |
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