Study On The Quality Standards Of Atractylodes Traditional Chinese Medicine Japonica Koidz Exkitam

One of the national medicines of our country,the DPRK medicine,is a treasure of China’s historical and cultural heritage and has a relatively complete theoretical system.It has formed the unique medical theories and application methods of the Korean people of China and enriched the treasures of Chinese medicine.Based on North Korea’s Eastern Medicine theory,DPRK Medical Sciences absorbed theories of Chinese medicine and the Koreans accumulated a number of unique drug theotry,research methods,medical experiences,and literature works in the long-term struggle against diseases.The new medical system that is different from North Korea East Medicine is different from traditional Chinese medicine.That is,the Chinese Korean traditional medicine with its own national characteristics provides a huge resource for the study of new medicines of Chao Yao medicine.The research and development of Chao Yao medicine is in China.The development of the pharmaceutical industry has obvious regional characteristics and representativeness.Atractylodes macrocephala is a dry,massive rhizome of Atractylodes japonica Koidz.ex Kitam.It is widely distributed in Yanbian,and is found on hillsides,bushes,under eucalyptus forests and forest margins.The records of "Dharma Records" and"National Medicine Chronicles Ⅲ" all record their flavor,bitterness and warmth.They have dampness,spleen,eyesight,stagnation,sweating,and chilling effect.In the folk as a drug for the treatment of gastric ulcers,chronic gastritis and other digestive diseases,the efficacy is very good,widely used.Atractylodes macrocephala is the main raw material for the preparations of"Shutanling Capsule" and "Fuzheng Kangailing Oral Liquid" of Yanbian Chaoyang Hospital.However,so far,there have been no reports on the quality standards of the ethnic drugs in China and abroad,which has directly affected the development of Chaoyang Medicine,determined the quality control methods of Atractylodes macrocephala Koidz,established scientific quality standards,and will help strengthen the resources of the medicinal herbs.Protection will help strengthen the standardization of the DPRK’s standard medicine system and be beneficial to the development and utilization of DPRK preparations,with social benefits.This article will be based on the original,identification,inspection,content determination and other aspects of research,the development of Atractylodes quality standards.Firstly,8 original plants of Atractylodes lancea were collected from the whole state.The original genus was identified by experts,and then conventional methods of pharmacognosy were adopted.The structure and structure of Atractylodes macrocephala Koidz.Due to instability of atractylone at normal temperature,thin-layer chromatography was used to determine the identification method using the reference herbs and Atractylodes lactis Ⅰ,Ⅱ,and Ⅲ as qualitative indicators;moisture determination was referenced in the“Chinese Pharmacopoeia”(2015 Edition)four general rules 0832 moisture determination method.According to the fourth method(toluene method),the maximum water content of 8 batches of Atractylodes macrocephala Koidz was 7.9%,the lowest value was 6.5%,the average value was 7.5%,and the proposed moisture limit was not to exceed 9.0%;the total ash was referenced to the Chinese Pharmacopoeia(2015 Edition)Four general rules 2302 Ash determination method Determination of total ash content of 8 batches of Atractylodes macrocephala Koidz.The highest value is 5.2%,the lowest value is 4.1%,the average value is 4.5%,and the proposed total ash limit is not to exceed 6.0%;The highest value of insoluble ash is 0.2%,the lowest value is 0,and the average value is 0.1%.The proposed acid-insoluble ash content should not exceed 1.0%;the sulphur dioxide residual quantity should refer to the“Chinese Pharmacopoeia"(2015 Edition).1 The first method for the determination of sulfur dioxide residues was used to determine the average sulphur dioxide residue of eight batches of Atractylodes macrocephala Korshinskii as 22mg/kg.According to General Principles of the Chinese Pharmacopoeia(2015 Edition),the general rule for 0212 medicinal herbs and decoction pieces was used to formulate sulphur dioxide residue.Must not exceed 150mg/kg.Heavy metals and harmful elements were determined by the atomic absorption spectrophotometric method according to the General Principles of the Chinese Pharmacopoeia(2015 Edition),Part 4321,Determination of lead,cadmium,arsenic,mercury,and copper.Practical results showed that heavy metals and harmful elements in some areas of Atractylodes macrocephala Koidz.The content of cadmium and copper is relatively high.Therefore,the detection of lead,cadmium,arsenic,mercury and copper shall be included in the standard.Lead shall not exceed 5mg/kg;cadmium shall not exceed 0.3mg/kg;arsenic shall not exceed 2mg/kg;mercury shall not exceed 0.2mg./kg;Copper must not exceed 20mg/kg.Organochlorine pesticide residues were determined by the determination of 9 organochlorine pesticides in the first method in the 2341 general method of pesticide residues determination in the Chinese Pharmacopoeia(2015 Edition).The organic chlorine was not detected in 8 batches of medicinal materials.The amount of pesticide residues shall be determined in accordance with the Pharmacopoeia stipulated limits.The total amount of total BHC(α-BHC,β-BHC,γ-BHC,and δ-BHC)per 1 kg of Chinese herbal medicines or decoction pieces shall not exceed 0.2 mg;total DDT(PP’)-The amount of DDE,PP’-DDD,PP’-DDT,and OP’-DDT)must not exceed 0.2 mg;pentachloronitrobenzene must not exceed 0.1 mg;and aflatoxin should be referred to the Chinese Pharmacopoeia(2015 Edition).Determination of aflatoxin in the second method,8 batches of Atractylodes macrocephalae were not detected in the aflatoxin,according to the pharmacopoeia stipulated limit aflatoxin B1 shall not exceed 5 μg/kg;aflatoxin B1,aflatoxin G2 The total amount of aflatoxin G1 and aflatoxin B2 should not exceed 10 μg/kg;the leachables should be determined by the hot dip method of water-soluble extracts and alcohol-soluble extracts in the four-part extract of 2201 extraction method of the Chinese Pharmacopoeia(2015 Edition).8 batches of Atractylodes macrocephala L.alcoholic extracts averaged 66.4%,the proposed leachate limit of not less than 53.0%;using HPLC to establish a quantitative determination of Atractylodes macrocephala with Atractylodes fat Ⅰ,Ⅲ as indicators.Of the 8 batches of samples,the average value of the Atractylone Ⅰ content was 0.036%,the average value of the Atractylone Ⅲ content was 0.044%,and the limit was established based on ±20%of the mean value.The proposed formula was based on the dry product and contained Atractylodes macrocephala.Lactone Ⅰ(C15H18O2)shall not be less than 0.025%,and contain not less than 0.030%of whiteactone lactone Ⅲ(C15H20O3).In this study,the names,sources,traits,microscopic identification,TLC identification,water content,total ash content,acid-insoluble ash,aflatoxin,and sulphur dioxide residues of 8 batches of Atractylodes macrocephala Koidz.were studied in Yanji,Hunchun,Helong and Dunhua.Researches on heavy metals,harmful elements,pesticide residues,leachables,and content determination have established the quality standards of Atractylodes macrocephala Koidz.Completed the drafting of the draft standard for the quality of Atractylodes macrocephala Koidz.It provided a guarantee for the safety and rational development of the clinical application of Atractylodes macrocephala Koidz in the future,and accumulated scientific theories for the study of the quality standards of ethnic drugs.