| Product specification is a qualitative reflection of Traditional Chinese Medicine (TCM). It's the most intuitive indicator to evaluate TCM."Product Specification Standard of76Drugs", the first norm for product specification of TCM promulgated and implemented in China1984, set classification and standard on product type, specification and grade of76common TCM, according to those drugs' quality. However, with TCM's continuous shifting of product manufacturing and circulation, as well as their renewing of quality standard, this norm does not correspond with the current manufacturing, circulation and apply of TCM. In the current TCM market, no unitive quality standard is acknowledged by the druggists. Because of the complicated product specification and grade of some drugs, the failure of inheriting traditional discerning experiences, and the absence of scientific and systematic technical information, product specification standard cannot play its role in the quality standard evaluating system of TCM's product specification. Therefore, it's necessary to regulate and improve the technology in TCM's product specification evaluating system, and to set a qualitative standard for TCM's product specification and grade. In this study, an integrated evaluating method is established to form and evaluate the industrial standard for the drug Fructus Amomi, based on systematic quality index.One of China's well-known "Four Southern Medicine", Fructus Amomi, comes from dry mature fruit of Zingiberaceae plants, including Amomum villosum Lour., Amomum villosum Lour. var. xanthioides T. L. Wu et Senjen and Amomum longiligulare T. L. Wu. The main circulation specie in the current TCM market is Amomum villosum Lour.. It's purchased, processed and distributed as unitive goods, without regulating product specification and industrial standard. In this study, traceable research methods, such as literature reviewing and site investigating, were applied to analyze the formation model of Fructus Amomi's product specification. By physical and chemical experiments, together with authentic formation model study, a draft industrial standard for Fructus Amomi's product specification was established to provide scientific basis for objective, norm and standardized classification of Fructus Amomi's product specification and grade. This standard was based on the "original identification-character identification-physical and chemical identification-bioassay-normal detection". Therefore, this study provides technic reference to regulate and improve evaluating standard for TCM's product specification and grade. 1Research contents and main findings1.1Literature review, site investigation and sample collection of Fructus Amomi1.1.1Through literature reviewing, site investigating and investigating on TCM market and enterprises, we found that Fructus Amomi was purchased, processed and distributed as unitive goods, without a scientific classifying standard and industrial standard for different grade of the product.1.1.2Results of literature reviewing and site investigating showed that it needs special nature environmental conditions, especially ecological factors, such as humidity, temperature, sunlight and earth, for Fructus Amomi to grow well. Due to the continuous variation of ecological conditions and cultivable technology, as well as the mutation of the specie itself, new cultivable species could be formed in the generating districts.("Long fruit","round fruit","spring selected" species in Yangchun City, Guangdong province, and "high trunk","medium trunk" and "short trunk" in Xishuangbanna, Yunnan province.)1.1.3Although classification standard for Fructus Amomi had been made by Yangchun City, Guangdong province, Fructus Amomi were purchased and processed as unitive goods, without classifying according to the standard. Besides, because Fructus Amomi produced by Yangchun City was consumed the best in the TCM market, its price(300-500ï¿¥/kg) is higher compared to other species. Illegal phenomenon do exist that some druggists put Fructus Amomi not produced in Yangchun into sell as that were. Drug enterprises usually screen big and plump ones for exporting.1.2Research of quality index for product specification grade of Fructus AmomiLearning from the idea and methods for sensorial evaluating agricultural and other commodities, Delphi method was applied to sensorial evaluate3attributes index "weight, diameter, longitudinal diameter" for screening commodity Fructus Amomi. Sensorial characteristics items of the commodity were designed to determine and collect related index for sensorial judgment. The "Data management system for commodity Fructus Amomi" was developed, combining with computer database technology. Experiments were carried out to study sensorial attributes index and their relationship. Evaluating result of the experts and data of the corresponding samples'3attributes index "weight, diameter, longitudinal diameter" were analyzed to find out that grade score experts gave was highly related to the fruit diameter and weight. Then we used robust regression method to generate a prediction model and parameter fitting linear regression equation, to gain a formula calculating Fructus Amomi's grade and trait differences between grades. In a word, this study established product specification grade for commodity Fructus Amomi at3levels.Exclusive traits of commodity Fructus Amomi:dried; oval or orbicular-ovate, unobvious triangular; brown cutis, density spike-like protuberance, residual perianth on the top; pericarp thin and soft; seed assembled into groups, with three blunt edge, white septum in the middle divide the seed group into3valves; seeds irregular polyhedron, reddish brown or dark brown on the surface, with fine wrinkles, light brown membranous aril on the outside, hard, endosperm gray; strong fragrant; spicy, cool, slightly bitter; no impurities, insects and mildew.1st grade:fruit weight>lg, fruit longitudinal diameter>17mm, fruit diameter>14mm; each valve of seed group16-24, seed diameter2-3mm.2nd grade:fruit weight0.55-1g, fruit longitudinal diameter14-17mm, fruit diameter12-14mm; each valve of seed group12-15, seed diameter2-3mm.3rd grade:fruit weight<0.55g, fruit longitudinal diameter<14mm, fruit diameter<12mm; each valve of seed group7-11, seed diameter2-3mm.1.3Comparative study of different product specification of Fructus Amomi by chemical analyze and bioassay.Determination of the efficacy ingredients, metabolites, pesticide residues and heavy metals of Fructus Amomi were carried out according to the "Chinese Pharmacopeia". Relationship between chemical composition and product specification grade was analyzed, results showed as bellowed:1.3.1Volatile oil content of different grades of Fructus Amomi met the requirements of "Chinese Pharmacopeia"(2010vision). Differences of volatile oil content between levels were not obvious.1.3.2Bornyl acetate content of different grades of Fructus Amomi met the requirements of "Chinese Pharmacopeia"(2010vision), among which1st grade>2nd grade>3rd grade. Method of "Eucidean Distance Squared" in the "Hierarchical Cluster Analysis" was applied to do cluster analysis on the bornyl acetate content of different grades of Fructus Amomi. It turn out to be that the1st grade tend to be a separate class, with the2nd and3rd grade to be a polymerized class. It mean that bornyl acetate content of the1st grade's was highest, while that of the2nd and3rd grade were of no differences.1.3.3Contents of water, poison heavy metals and pesticides residue of different grades of Fructus Amomi met the requirements of "Chinese Pharmacopeia"(2010vision).1.3.4GC-MS analysis results revealed that compositions of volatile oil in Fructus Amomi ordered by their relative contents were bornyl acetate, camphor, d-limonene, borneol, camphene, and others. Among the17compounds, bornyl acetate added up to45%of the total essential oil. No significant differences showed among the three grades of Fructus Amomi in their volatile oil compositions, according to systematic cluster analysis. However, the average percentage contents showed that1st grade>2nd grade>3rd grade.1.3.5Results of glacial acetic acid induced writhing experiment indicated that the volatile oil of three grades of Fructus Amomi all showed analgesic effect. Among them, the1st grade showed rapid onset of analgesia and longer maintain time, with an analgesia effect from10min to60min, gavage at20ml/kg at14%concentration. The2nd and3rd grade's analgesia effect were unstable, relatively. Gavage at14%concentration, the2nd grade showed analgesia effect80min after administration, while the3rd grade become effective at80-160min, with no differences between them.1.4Founding of product specification grade standard for the drug Fructus Amomi (draft) Product specification grade standard for the drug Fructus Amomi (draft) was set up according to the current "Chinese Pharmacopeia" and our research results. It's a draft industrial standard for Fructus Amomi, with the main contents of "original identification-character identification-physical and chemical identification-bioassay-normal detection", including original, processing method, character, product specification grade, identification, detection, determination, biological potency test and storage.2ConclusionLearning from evaluating method for product specification of agricultural product, we analyzed the experiment results and created models to predict classification for Fructus Amomi, combining with computer database technology. Furthermore, we investigated if it's scientific and rational to classify product specification grade for Fructus Amomi, by "product specifications-chemical composition-biological effect" correlation analyzing. In this study, we set standard for product specification grade of Fructus Amomi, based on systematic quality index. This study provided reference for product specification grade of fruit groups of TCM.This study enriched technical content of "geographical indication" of Fructus Amomi, provided scientific guidance for the harvest, processing, storage and marketing in the GAP process of Fructus Amomi in the generating district. It also provided basic for managing policy and help setting the industrial standard for Fructus Amomi.
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