| RATIONALES:Astragali Radix(Huangqi), a common traditional Chinese medicine, has been proved to be an tonic(adaptogenic), hepatoprotective, diuretic, antidiabetic, analgesic and sedative drug. Modern researches demonstrate that Astragali Radix has many pharmacological effects, such as improving immunity and anti-oxidation, anti-aging, antiviral, anti-tumor, regulating blood sugar, diuresis. Hengshan Huangqi is famous for producing on Hengshan Mountain. It is the root of Astragalus membranaceus(Fisch.) Bge.var.Mongolicus(Bge.)Hsiao, a member of the Leguminosae family. The growth patterns of Hengshan Huangqi are the wild and imitation of the wild and its harvest time is more than four years. It is distributing on Hengshan Mountain and adjacent regions.The specially natural environment and geological conditions are particularly suitable for the growth of Astragali Radix,which makes that Hengshan Huangqi has characteristics of long and straight root, yellow-bright colour and lustre, sufficient mealiness,strong soft, strong beany flavor etc. Hengshan Huangqi enjoys a high reputation at home and abroad and it is recognized as Geoherbs in the pharmaceuticals industry. In the70s-80s of the last century, some origins including Gansu, Inner Mongolia and Shanxi explored the planting pattern of seedling and transplanting together two-year-old A. Membranaceus var.Mongolicus successfully and extended in a large scale.From the perspective of current selling market and price, the price of Hengshan Huangqi is significantly higher than Astragali Radix which grow up in other origins. However, disorder management generates under the usury,which bring greatly negative effects for Hengshan Huangqi. The main reason of this phenomenon is that the standards of quality are lack and incomplete. At present, no matter the appearance or inherent quality, most crude drugs of Huangqi in the market are not a patch on the tranditional Hengshan Huangqi. At the same time, the quality standards of Huangqi in "Chinese pharmacopoeia" is incomplete.It reflects that "Chinese pharmacopoeia" doesn’t distinguish two species of Huangqi and provide the planting pattern and growing years. In addition, its index components are not comprehensive and content limitation is only the lowest standard. Therefore,"Chinese pharmacopoeia" don’t show the feature of Hengshan Huangqi. In order to demonstrate the unique characteristics of Hengshan Huangqi, it is necessary to establish suitable quality standards system of Hengshan Huangqi practically. It can be used to make a difference between Hengshan Huangqi and other origins. The revising local standards in Shanxi enhance the influence and competitiveness of Hengshan Huangqi entirely and promote the process of industrialization, modernization and internationalization.Aim of the study:Based on researching the definition, source, character, identification, inspection, extract, content determination and fingerprint of Hengshan Huangqi, we establish a perfect quality standards system of Hengshan Huangqi.Materials and methods:1.Based on the on-the-spot investigation and literatures research, the name, source, character of Hengshan Huangqi are revised.2. According to the identification, inspection, extract of Huangqi in "Chinese pharmacopoeia", we make a reasonable revision on the content limits.3. According to "Chinese pharmacopoeia" and literatures, the determination method and content of Astragaloside IV has been revised. The content of calycosin-7-O-β-D-glucoside has also been revised based on the experimental results. Referring to literatures, the determination of total polysaccharide has been added.The GC content determination method of hexanal related to beany flavor of Huangqi is whether put into the standard according to the results of the determination.4. The fingerprints of Hengshan Huangqi have been established by HPLC-UV, HPLC-ELSD combined with similarity evaluation, clustering analysis and multivariate statistical analysis techniques.Results:l.The results of study on the name, distribution and character of Hengshan Huangqi showed that name, source, origin, distribution and planting pattern of Hengshan Huangqi has been regulated in detail and formulate corresponding standards. In the end, we confirm the name as "Hengshan Huangqi" is the root of Astragalus membranaceus(Fisch.) Bge.var. Mongolicus(Bge.)Hsiao, planting pattern being the wild or imitation of the wild. Its harvest time is more than four years and it produces chiefly on Hengshan Mountain and adjacent regions. The main features of Hengshan Huangqi are as follows:the length range is from35centimeter to100centimeter, besides more than100centimeter; the diameter range is from1.2to3centimeter. The surface color is lightly brown-yellow or brown. There is untidy vertical wrinkle on the surface. Its nature is flexible and cross section is strong fibre and has sufficient mealiness.Moreover, the skin is yellow-white and xylem is lightly yellow and has radial textures and crack. The center of old root displays withered and rotten, black-brown or cavity.You can smell beany flavor and taste sweet. Besides, the beany flavor is significant and the residue is less after tasting.2. The research results of identification,inspection and extract show that:Differences between Hengshan Huangqi and mojiahuangqi can be found when we use microscope.These are:1.The reason why Hengshan Huangqi has a high powder content is because its starch grain is significantly more than mojiahuangqi.2.sclereid in mojiahuangqi is more than that in Hengshan Huangqi,that is to say,character of mojiahuangqi is harder than Hengshan Huangqi.3we discovered that anticlinal wall of cork cell in phellem layer is thin,which could not be found in mojiahuangqi. According to the determination results, we increased the limit of extract content from no less than17.0%to no less than24.0%.3. Compared with the method "Chinese pharmacopoeia" applied,the improved contents determination method of astragaloside IV is easy to operate and time-saving.What’s more, the results showed no significant difference between two methods. The method which "Chinese pharmacopoeia" applied to determination the content of calycosin-7- O-P-D-glucoside is simple and feasible.on the basis of the results,we increased the content no less than0.070%.After literatures research,the method to determination total polysaccharides contents were established. We also investigated the contents of beany flavor hexanal and the results showed that hexanal contents were connected with storage time.So it does not be applied to quality standard.4. The methods we established can easily tell Hengshan Huangqi and other regions apart. Methods include HPLC-UV fingerprint, HPLC-ELSD fingerprint, similarity evaluation, clustering analysis and multivariate statistical analysis. The two items, HPLC-UV fingerprint and HPLC-ELSD fingerprint, meet the standards and were hired after reexamined by Shanxi Provincial Institution for Food and Drug Control.Conclusions:This revision fully exhibits the quality of Hengshan Huangqi, which is one of a genuine medicinal materials in Shanxi province. This practical and reasonable method, reexamined by Shanxi Provincial Institution for Food and Drug Control, can be served as quality standards of Hengshan Huangqi.Compared with "Chinese pharmacopoeia" standards, the Major changes of local quality standards of Hengshan Huangqi are as follows:1. With the purpose of distinguish different sources of mojiahuangqi and2years old seedling transplanting mengguhuangqi, sources, distribution, collection period and growth pattern of Hengshan Huangqi were added.2. Total polysaccharides content determination, HPLC-UV fingerprint and HPLC-ELSD fingerprint were added to distinguish different sources of mojia huangqi and2years old seedling transplanting mengguhuangqi.3. The revised method of content determination of Astragaloside IV helps simplify operation and save time.4.The traits of Hengshan Huangqi is revised to tell mojiahuangqi from different sources apart as well as two-year-old seedling transplanting menggu huangqi. Distinguish Hengshan Huangqi with different base source of mojiahuangqi and2-year-old seedling transplanting mengguhuangqi. 5. In order to distinguish mojia huangqi from different sources, the microscopical identification is revised.6. The content limitation of calycosin which is in quantitative determination of Hengshan Huangqi is revised and raised.It can be used as a method to tell mojiahuangqi from different sources apart, and two-year-old seedling transplanting menggu huangqi as well.7. The content limitation of extract is revised and raised(from17.0%to24.0%). |
