Study On Quality Standards Of Six Local Traditional Medicinal Materials In Gansu Province

Xiaoshiwei,Yingqianhu,Tuchuanghua,Kudouzi,Jiaomu,Maoxixin are the traditional Chinese medicines in Gansu Province.They have a long history of medicinal use in the folk,and all of them are now included in the "Gansu Province Traditional Chinese Medicine Standard"(2009 edition).The standards of 6 medicinal materials are incomplete.Based on modern drug requirements and safety considerations,it is urgent to establish a more comprehensive quality standard.In this paper,qualitative identification methods of medicinal materials were established by micro-bond trait identification method and thin layer chromatography,and HPLC method was used to establish the content determination method of index components in medicinal materials.At the same time,the standards for moisture,total ash,acid-insoluble ash,aqueous extracts and alcohol extracts in medicinal materials were established in accordance with the 2015 Chinese Pharmacopoeia Appendix method.The research contents and results of this article are as follows:1.Source identification research: With reference to the "Chinese Flora","Gansu Province Chinese Medicinal Materials Standard"(2009 edition)and other relevant literature,the collected original plant specimens were identified about the original morphology..2.Character identification research: With reference to the Chinese Pharmacopoeia(2015 edition),Chinese Medicine Identification,Biopharmaceuticals and other reference books and other relevant references discribing the shape,size,color,surface,texture,section and odor of medicinal materials.3.Microscopic identification study: With reference to the methods under the four parts of the Chinese Pharmacopoeia(2015 edition)under the method of microscopic identification(2001),by observing the shape and cross-section(or powder)microstructure of the six medicinal materials,the individual tissue morphological characteristics and Microscopic features were identified.4.Thin-layer identification(TLC)study: With reference to the methods under the four-layer thin-layer identification method(0502)of the Chinese Pharmacopoeia(2015 edition),chlorogenic acid and Praeruptorin B,isoporphyrin and matrine and oxymatrine α-linolenic acid were used as controls to develop a thin layer identification method for Xiaoshiwei,Yingqianhu,Tuchuanghua,Kudouzi,Jiaomu.5.Study on content / limit determination method based on HPLC method: With reference to the methods under the four sections of the Chinese Pharmacopoeia(2015 edition)for high performance liquid chromatography(0512),chlorogenic acid,Praeruptorin B,isoporphyrine,matrine and oxymatrine,α-linseed acid was used as a standard substance to establish a method for the determination of Xiaoshiwei,Yingqianhu,Tuchuanghua,Kudouzi,Jiaomu.At the same time,aristolochic acid I was used as a standard substance to formulate a limit method for Maoxixin.6.Other test items: With reference to the corresponding methods in the four appendixes of the Chinese Pharmacopoeia,the standards and limits of moisture,ash,and extracts of 6 medicinal materials were established.7.According to the experimental results,the quality standards of 6 kinds of local traditional medicinal materials have been tentatively determined.For Xiaoshiwei,the content of moisture,acid-insoluble ash and total ash below under tests should not exceed 12.0%,2.0%,7.0%,respectively.The content of alcohol extracts and aqueous extracts under the extract terms should not be lower than 15.0%,14.0%,respectively.The content of Chlorogenic acid under the content determination should not be lower than 0.10%.For Yingqianhu,the content of moisture and acid-insoluble ash below under tests should not exceed 9.0%,3.0%,respectively.The content of aqueous extracts under the extract terms should not be lower than 10.0%.The content of Praeruptorin B under the content determination should not be lower than 0.10%.For Tuchuanghua,the content of moisture,acid-insoluble ash and total ash below under tests should not exceed 8.0%,1.0%,11.0%,respectively.The content of alcohol extracts and aqueous extracts under the extract terms should not be lower than 9.0%,17.0%,respectively.The content of Isocorydine under the content determination should not be lower than 0.10%.For Kudouzi,the content of moisture,acid-insoluble ash and total ash below under tests should not exceed 9.0%,0.4%,4.0%,respectively.The content of alcohol extracts and aqueous extracts under the extract terms should not be lower than 24.0%,20.0%,respectively.The content of Matrine,Oxymatrine under the content determination should not be lower than 0.30%,2.0%,respectively.For Jiaomu,the content of moisture,acid-insoluble ash and total ash below under tests should not exceed 9.0%,1.0%,8.0%,respectively.The content of alcohol extracts and aqueous extracts under the extract terms should not be lower than 12.0%,5.0%,respectively.The content of α-Linolenic acid under the content determination should not be lower than 1.0%.For Maoxixin,the content of moisture under tests should not exceed 14.0%,respectively.The content of alcohol extracts and aqueous extracts under the extract terms should not be lower than 16.0%,18.0%,respectively.The content of Aristolochic acid I under the content determination should not be higher than 0.002%.8.Study of fingerprints: With 15 common peaks and chlorogenic acid as characteristic peak,a common pattern of fingerprints of Xiaoshiwei was established by HPLC.The similarity of Xiaoshiwei medicinal materials from 8 different origins was greater than 0.95.With 22 common peaks and Praeruptorin B as characteristic peak,a common pattern of fingerprints of Yingqianhu was established by HPLC.The similarity of Xiaoshiwei from 8 different origins was greater than 0.95.The improvement of quality standards for 6 medicinal materials in Gansu province provide data support for the identification and quality control of medicinal materials and scientific basis for the establishment of quality standards for medicinal materials.The establishment of fingerprint provides an effective evaluation method for the quality control of Xiaoshiwei and Yingqianhu.