| Objective:Conduct systematic research on the properties,identification,inspection,extracts,fingerprints,content determination,etc.of Asarum heterotropoides medicinal materials and decoction pieces,explore the evaluation mode that can reflect the characteristics of traditional Chinese medicine,and comprehensively evaluate the quality of medicinal materials and decoction pieces.The draft industry standard of Asarum heterotropoides medicinal materials and decoction pieces establishes a scientifically stable and controllable quality standard of Asarum heterotropoides and decoction pieces based on the theory of traditional Chinese medicine,laying a foundation for further grade standard research and ensuring the safety and effectiveness of clinical medication.Methods:Collect 36 batches of medicinal herbs and 54 batches of samples of different origins of Asarum,and extract asarum and confusing products from multiple sources,and identify the source by DNA molecular identification.Appearance quality evaluation,microscopic identification for structural identification;through historical literature research,with reference to the 2015 edition of the Chinese Pharmacopoeia and the Japanese Pharmacopoeia Formula and related literatures,simple and rapid asparagine was established using asaridin as a reference Layer chromatography;general limit inspection and harmful substance inspection of Asarum heterotropoides medicinal materials and decoction pieces according to the 2015 edition of Chinese Pharmacopoeia,and stipulate its limits;use GC method to establish standard fingerprint of Asarum heterotropoides for authenticity and quality identification Control;HPLC method was established to determine the content of Asarum heterotropoides.Asaridin and sesamin were used as indicators to ensure the effectiveness of medicinal materials and decoction pieces.Results:(1)The appearance quality of Asarum heterotropoides was evaluated by describing color,shape,qi and taste.Observed by microscope,Rhizome epidermal ce lls were obvious,and there were many characteristic microstructures such as oil cells and threaded catheters.(2)Determining heavy metals and harmful elements,pesticid e residues,microorganisms of medicinal herbs and decoction pieces,and specifying t he limits to ensure the safety,stability,and controllable quality of the medicine;36batches of medicinal herbs,moisture,total ash,acid-insoluble ash,and extractives T-he limit of aristolochic acid is 10.0%,12.0%,5.0%,9.0%,0.001%.The limits of to-tal ash,extracts,and aristolochic acid in 54 batches of Asarum heterotropoides deco-ction pieces were 8.0%,9.0%,and 0.001%,respectively.(3)A thin layer identificatio n method of beaxin was established.Asaridin was used as a reference substance and petroleum ether-ethyl acetate-formic acid(30:10:0.5)as a developing agent.The de-veloped Rf value was reasonable,the bands were clear and distinct,and the separati on was clear.The effect is good.(4)The GC method was used to establish the sta-ndard fingerprints of medicinal herbs and decoction pieces,and 12 calibrated charact eristic peaks and 1 identified peak were obtained.The similarity of medicinal materi als and decoctions of A.asparagus from different origins are all greater than 0.9,and the value of P.asarum is less than 0.9,which indicates that this method can disting-uish between B.asarum and F.asarum,and compare the relative peak area and othe r indicators.The quality of the decoction pieces achieves the purpose of quality cont rol;(5)Content determination:The volatile oil of Asarum heterotropoides has an ob-vious antipyretic effect.This indicator can reflect the effectiveness of Asarum hetero-tropoides.Must not be less than 2.0%(ml/g);HPLC method was used to determine the contents of asaridin and sesamin in Asarum heterotropoides.The injection concen tration of the two lignan components showed a good linear relationship with the pe-ak area.Asaridin The sample recovery rate was 97.35(RSD=1.54,n=9),and therec-overy rate of sesamedin was 99.91%(RSD=1.51,n=9).The actual measurement resu lts and actual application of Asarum medicinal materials Limits for determination of contents and decoction pieces:Asarum medicinal materials must contain not less than0.25%,and sesamin must not be less than 0.07%;Asarum heterotropoides decoction pieces can contain asaridin not less than 0.20%,Contains Sesamin not less than0.05%for better Asarum heterotropoides system herbs pieces quality,and ensure the effect-iveness of the Asarum heterotropoides Pieces of Herba.Conclusion:1.The appearance characteristics,heavy metals and harmful elements,pesticide residues,and microorganisms of 36 batches of medicinal materials and 54 batches of decoction of different origins were defined,and the limits were set.The water content,total ash,acid-insoluble ash and The limits of aristolochic acid in the extracts were 10.0%,12.0%,5.0%,9.0%,0.001%;the total ash extracts of the asarum pieces,and the limits of aristolochic acid were 8.0%,9.0%,and 0.001%,respectively.2.A thin layer chromatography identification method for Asarum heterotropoides was established in this study.Asaridin was used as a reference substance and petroleum ether-ethyl acetate-formic acid(30:10:0.5)as a developing agent.The developed R_f value was reasonable and the bands were Clear and clear,good separation effect.By this method,Asarum can be distinguished from multi-source Asarum and easily confusing products,so as to prevent the disorder of variety use.3.In this experiment,the GC standard fingerprints of Asarum heterotropoides medicinal materials and decoction pieces were established,and 12 characteristic peaks were identified,and one peak was identified.This fingerprint method was used to extract Beixixin medicinal materials and decoction pieces from different origins,asparagus and multi-source asarum.The confusion products were analyzed.The similarity of medicinal herbs and decoction pieces of Asarum heterotropoides were greater than 0.9.The similarities of multisource Asarime and confusable products were less than 0.9.Comparing the quantitative indexes such as similarity,we can evaluate the authenticity of medicinal materials and decoction pieces of Asarum heterotropoides as a whole.False pros and cons,to achieve the purpose of quality control.4.The volatile oil of Asarum heterotropoides has obvious antipyretic effect,and this indicator can reflect the effectiveness of Asarum heterotropoides.Therefore,the limit of the volatile oil of Asarum heterotropoides medicinal materials and decoction pieces should not be less than 2.0%(ml/g).Octanol,sesamin,and lignans in Asarum heterotropoides,both have pharmacological effects:sesamin has antiviral and anti-inflammatory effects,and asaridin has antiviral and antituberculosis properties.effect.Therefore,the content determination method of asarum and sesamin in this study established the contents of asabinin and sesamin in Asarum heterotropoides and its decoction pieces.It is 0.27%,the average content of sesamin is 0.079%,the average content of asaridin in Asarum heterotropoides decoction pieces is 0.28%,and the average content of sesamin is 0.083%.Based on the measurement results and the actual formulation of the limits:the medicinal materials of Asarum must contain not less than 0.25%,and the content of sesamin must not be less than 0.07%;the asarum decoction pieces must contain not less than 0.20%of asaridin and sesame.The fat should not be less than 0.05%.This method can determine the content of two effective ingredients,corresponding to the function and indications of Asarum heterotropoides,and embody the guideline based on traditional Chinese medicine theory.It can better control the quality of Asarum heterotropoides,herbs and decoction pieces,and provide a reference for clinical medicine.5.Through a systematic study of medicinal herbs and decoction pieces of Asarum heterotropoides,a draft quality standard for medicinal herbs and decoction pieces of Asarum heterotropoides was formulated,and a scientifically stable and controllable standard of Asarum heterotropoides and its decoction pieces was established under the guidance of traditional Chinese medicine theory.Standardization,to provide a reference for further grade standard research and drafting quality standards for other varieties of Chinese medicine. |
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