川芎道地药材的形成模式、商品规格及其行业标准的研究
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摘要
中药材商品规格划分为历代中药材质量评价实践经验的总结,是中药材质量的综合体现。因其简便易行,快速有效,在市场流通、保证临床安全用药方面发挥了重要作用。现行的部颁《76种药材商品规格标准》为1984年颁布,主要以外观质量及性状特征为主,难以体现药材的综合质量。本研究以著名川产道地药材川芎为研究对象,从感官品质、理化品质、化学成分分析、生物评价等多角度对其商品药材规格划分的科学内涵进行了系统研究,并在此基础上对其商品规格评价指标体系进行重建和提高,制订了川芎药材商品规格行业标准(草案)。主要研究结果如下:
     1.文献研究和市场、产地调查
     首次对川芎道地药材的形成模式、商品规格进行了梳理和考证。厘定川芎道地药材的形成模式为道地产区独特的生态环境与独有的栽培种植技术相结合的双因素关联决定型;川芎历史上曾出现以产地定规格、以采收期定规格、以产地加工方式定规格、以炮制方法定规格等多种商品规格划分方式,现在执行部颁《76种药材商品规格标准》(1984年版),主要以重量划分为3个等级;对川芎药材商品现状进行了调查,结果表明:川芎药材自种植、流通及临床使用全过程均使用统货;川芎药材种植区正在发生迁移,传统最核心的主产地都江堰川芎种植面积逐年减少,其主产区的位置已为彭州取代,近年眉山市彭山县大量种植川芎,已形成一定的规模。
     2.川芎道地药材商品规格评价方法和指标体系的研究
     2.1感官评价指标研究
     2.1.1川芎传统经验鉴别主征的筛选首次采用“德尔菲法”,对川芎传统鉴别经验进行了整理与规范。结果表明,中部围粗、重量、气、形状4项指标是川芎传统经验鉴别的主征,在川芎商品规格标准中应突出上述判别主征,减少细节或次要信息对经验评价的干扰,可以提高判断准确度和重现性。通过对专家权威程度评判、个人重现性和专家群体重现性分析,表明川芎感官评价经验是客观的、可靠的。专家群体在中部围粗、重量和形状3项指标总体重现性较好,表明易于掌握;气味的和谐系数为0.349,表明该主征不易掌握。
     2.1.2电子鼻在川芎药材气味评价中的应用研究
     “德尔菲法”研究表明,“气”是川芎传统性状鉴别的重要指标,但因主观性较强,难以重现,不易掌握。本研究首次采用电子鼻对不同产地、等级川芎气味进行了识别研究,结果表明:都江堰、彭州、新都3个传统主产地川芎药材顶空气试样数据接近,而与新产地彭山区别较大;同一产地不同等级川芎药材顶空气试样数据相互接近至重叠,但与等外品苓珠子区别明显。
     2.2常规理化检测指标研究
     本研究对不同产地、等级的川芎样品中水分、总灰分、酸不溶性灰分、重金属及砷盐、农药残留、醇溶性浸出物进行了测定。结果表明:以现有标准划分川芎商品等级之间无显著性差异,而虫蛀品在总灰分、酸不溶性灰分、醇溶性浸出物等指标上显著降低。川芎中农药残留情况较好,各送检样品均未检出六六六、五氯硝基苯、滴滴涕;但按照《药用植物及其制剂外经贸绿色行业标准》规定,4个产地及药材市场的川芎药材重金属标,其中以铜、镉超标的情况较为严重,砷、汞含量符合限定标准。
     2.3化学评价指标研究
     2.3.1主要化学成分比较研究
     采用紫外分光光度法和荧光分光光度法测定了各药材样品中总酚酸、多糖、总荧光物含量及粉末样品荧光强度,采用高效液相色谱法测定了阿魏酸、藁苯内酯、洋川芎内酯A、欧当归内酯A的含量。结果表明:以现有标准划分的不同等级川芎样品间各成分含量无显著性差异;虫蛀川芎总酚酸含量与正品川芎接近,焦枯品总酚酸含量高于正品川芎,其余各成分含量虫蛀品、焦枯品均显著降低;作为川芎不同栽培品系的红川芎样品,除多糖含量稍低于川芎样品外,其余成分含量与川芎样品一致;藁苯样品在所测化学成分含量上与川芎样品有较大差异,川芎样品中藁本内酯比洋川芎内酯A含量大于2.5倍,而藁本样品中洋川芎内酯A含量约为藁本内酯的2倍;新产地彭山产川芎样品的总酚、藁本内酯、洋川芎内酯A、总荧光物含量明显高于其他产地川芎样品,其余成分含量与其他接近。各样品粉末荧光强度与藁本内酯含量和总荧光物含量相关性分析结果表明:川芎药材的荧光强度与藁本内酯含量和总荧光物含量均呈正相关的直线相关关系,相关系数分别为0.838、0.940,为通过快速测定川芎样品中的荧光强度,快速预测川芎内在品质提供了依据。
     2.3.2指纹图谱比较研究
     采用顶空固相微萃取/GC-MS技术对各批样品的挥发性成分进行了比较分析,结果表明:新产地彭山产川芎样品中萜类挥发性物质相对含量较其他产区高,苯酞内物质相对含量较低,这可能是彭山川芎在“气味”上区别于其他传统道地产区川芎的内在原因;虫蛀后,川芎各种挥发性成分含量均显著降低,但成分种类及相对含量与正常川芎一致,虫蛀样品与正常样品相似度均<0.7;川芎烤焦后挥发性成分种类和相对含量均发生一定变化,烤焦样品与正常样品相似度均<0.9;红川芎样品含有挥发性成分种类与川芎样品基本一致,两者相似度均>0.9。藁本样品含有挥发性成分与川芎相比存在异同,藁本样品与川芎样品相似度均<0.9,表明两者挥发性成分存在较大差异。
     建立了川芎药材HPLC指纹图谱,共标定14个共有峰。从各样品图谱与川芎对照指纹图谱比较可知:虫蛀后川芎中阿魏酸、阿魏酸松柏酯等成分含量降低,而化学成分种类基本无变化,虫蛀品与川芎对照指纹图谱相似度<0.9;烤焦后川芎除阿魏酸、阿魏酸松柏酯等化学成分含量降低外、还有新成分产生,焦枯品与川芎对照指纹图谱相似度<0.7;红川芎样品化学成分种类、含量与川芎基本一致,与川芎对照指纹图谱的相似度为0.958;而藁本样品与川芎对照指纹谱的相似度为0.608,表明二者在化学成分上差异较大。
     GC-MS、HPLC指纹图谱相似度评价,不同产地、不同商品规格川芎色谱指纹图谱相似度均>0.9,表明以现有标准划分的不同等级川芎样品间化学成分整体比较无显著性差异。
     2.4生物评价指标的研究
     本研究根据川芎活血行气、祛风止痛的功效,选取了抗凝血活性和抗缩宫素致大子宫平滑肌痉挛的活性进行了测定。以低分子量肝素为对照,以凝血时间对数值为反应值,建立了川芎抗凝血活性的生物检定法;以硫酸镁为对照,采用大鼠离体子宫法,以给药前及给药后子宫的平均肌张力为指标,建立了川芎抗缩宫素致大子宫平滑肌痉挛的活性的生物检定法;并对各药材样品进行了测定。结果表明:川芎水煎液具有体外延长对兔血凝时间的生物活性,川芎醇提液具有对抗缩宫素致大鼠离体子宫平滑肌痉挛的生物活性,但不同产地、不同等级之间活性无显著差异;藁本样品抗凝活性和解痉活性均低于正品川芎;红川芎样品抗凝活性高于川芎,而解痉活性低于川芎;虫蛀品和焦枯品解痉活性较正常川芎明显降低,而抗凝活性虫蛀品与正常川芎无显著性差异、焦枯品其活性约为同产地其他样品的2倍。
     2.5各指标体系相关性研究
     采用SPSS软件,对川芎生物活性与化学组分分析测定结果进行了相关分析。结果表明:总酚酸含量、欧当归内酯A含量与川芎抗凝血活性呈正相关的直线相关关系,P<0.01,具有极显著意义,提示总酚酸、欧当归内酯A可能是川芎抗凝血的主要有效成分。藁本内酯含量、总荧光物含量和川芎抗缩宫素所致大鼠离体子宫平滑肌痉挛活性呈正相关的直线相关关系,P<0.05,均具有显著意义,提示川芎中起解痉作用的主要有效成分是以藁本内酯为代表的苯酞类成分。
     3.川芎道地药材商品规格行业标准(草案)的制订
     从以上各指标研究结果表明,目前主要以药材重量划分等级的川芎商品规格标准与川芎内在质量无显著相关性,但川芎药材有其商品属性,在商品规格标准中应考虑其外观性状、内在有效成分含量和生物活性等诸因素,综合评价川芎药材质量。本文结合《中国药典》2010年版(一部)和《76种药材商品规格标准》中现有川芎标准,初步制订了川芎道地药材商品规格行业标准(草案),商品规格项下增设统货规格,新增总酚酸、多糖、藁本内酯含量测定项,对于保证川芎临床用药安全、有效具有重要作用,同时对其他药材品种商品规格研究具有示范性意义;对于提升和完善我国中药材标准体系有促进意义。
Commercial specifications and grades of Chinese medicinal materials, the summary of practical experience for quality evaluation of traditional Chinese medicine, were the reflect of the quality of traditional Chinese medicine, which had played an important role in market circulation and ensuring clinical safety because it's easy, fast and effective. However, most of these evaluation methods were still in the stage of experiential description which made it difficult to be inherited and applied. This research took Ligllsticum chuanxiong as the study subject, and systematically studied the scientific connotation of the division standards of commercial specifications and grades in L.chuanxiong from the aspects of sensory quality, physical and chemical quality, chemical composition analysis and biological evaluation. Based on the above indexes, werebuilt and improved the evaluation index system of commercial specifications and grades in L.chuanxiong, and formulated the industrial standard draft of commercial specifications and grades in L.chuanxiong. The main research results are as follows:
     1. Literature research, market and origin investigation
     1.1Study on the forming pattern of Sichuan genuine medicinal materials of L.chuanxiong and commercial specifications and grades in L.chuanxiong
     In this study, it's the first time that forming pattern of Sichuan genuine medicinal materials of L.chuanxiong and commercial specifications and grades in L.chuanxiong are studied, and we have come to the conclusion that the forming pattern of L.chuanxiong is the type of two determinants, which combined both unique ecological environment of genuine regions and advanced cultivation techniques. There were many classfication methods for commercial specifications and grades in L.chuanxiong in history, such as by producing areas, harvest time, origin processing method, processing method, etc. The current standards for commercial specifications and grades in L.chuanxiong carried out the standards of commercial specifications and grades in76Chinese medicinal materials published in1984, and mainly classified into3levels by weight.
     1.2Market investigation on commercial specifications and grades in L.chuanxiong
     In this study, we investigated the current situation of commercial specifications and grades in L.chuanxiong from the aspects of origin planting and processing, marketing and clinical use. The results showed that the L.chuanxiong of gradeless and uniformly-priced goods were used in the whole process of from planting, circulation to clinical use. The planting area of L.chuanxiong has been shrinking every year in the traditional main producing area Dujiangyan. In recent years, Pengshan village has planted a lot L.chuanxiong and formed certain scales. However, the climatic environment, plant and harvest time in the new producing area are very different from traditional producing area, and further research is required to decide the quality consistency.
     2. Study on the evaluation index system for commercial specifications and grades in L.chuanxiong
     2.1Study on the seneory evalution of L.chuanxiong
     2.1.1Organization and standardization of the traditional experiential identification of L.chuanxiong
     This research adopted the Delphi method to organize and standardize the traditional experiential identification of L.chuanxiong for the first time. The results showed that the main indexes of traditional experiential identification of L.chuanxiong were diameter of the central, weight, smell and shape. The reproducibility of five times experts'evaluation was an average of72%, which showed that the sensory evaluation of L.chuanxiong was objective and reliable. The analysis on the consistency of the four indexes in experts by Kender coefficients showed better total reproducibility in experts group in the indexes of diameter of central, weight and shape, while the Kender coefficient of smell index was0.349which showed its difficulty to control. The above identification indexes in the commercial specifications standards of L.chuanxiong should be underlined to reduce the interference of secondary information to experiential evaluation. It can improve the accuracy of identification and reproducibility.
     2.1.2Applied research of electronic nose in the quality evaluation of smell of L.chuanxiong
     The results of Delphi method showed that Smell is an important index of traditional experiential identification of L.chuanxiong. However, its strong subjectivity and low reproducibility has limited its promotion and application in the quality evaluation of L.chuanxiong. In this research, we adopted electronic nose to study on the recognization of L.chuanxiong of different producing area and grade for the first time. The results of Dujiangyan, Pengzhou and Xindu were very close, while the result of new producing area Pengshan had a big difference from the others. The results of different grades in the same producing area were close to overlap and obviously different from off-grades.
     2.2Study on the conventional physical and chemical quality of L.chuanxiong
     Moisture, ash content, limit of harmful substance and other physical and chemical indexes are important parts in quality evaluation system of Chinese medicinal materials and are closely related with its purity, quality and safety. In this research, we have determined the moisture, total ash, acid-insoluble ash, ethanol-soluble extract, heavy metal and arsenic, and pesticide residues of L.chuanxiong from different producing areas with different grades. The results showed that there were no significant differences among different grades of L.chuanxiong. The results of total ash, acid-insoluble ash and ethanol-soluble extract in worm eaten L.chuanxiong had significantly decreased. All the samples in this research were not detected by BHC, PCNB and DDT. According to the Green standards of medicinal plants and preparations for foreign trade and economy, the heavy metals in the samples were out of limit, among which, the exceeding of copper and cadmium were more serious. The content of arsenic and mercury accorded with the limited standards. In order to ensure the safety and effectiveness in clinical use, the exceeding reasons of copper and cadmium should be further studied.
     2.3Study on the chemical quality of L.chuanxiong
     In this study, we have determined the content of ferulic acid, total phenolic acids, po.lysaccharide, phthalides and fluorescent materials in L.chuanxiong, and compared the whole chemical compositions by GC-MS and HPLC fingerprint, in order to provide reference for the establishment of evaluation index system of commercial specifications and grades in L.chuanxiong.
     2.3.1Comparison on the content of ferulic acid in L.chuanxiong
     The contents of ferulic acid in the samples of this research were determined by the method in Chinese pharmacopoeia (2010edition). The results showed that the contents of ferulic acid in red L.chuanxiong(different cultivation) and Ligusticum sinense Oliv.(counterfelt drug) have no significant differences; there are no significant differences between different producing areas and different grades of L.chuanxiong; the contents of ferulic acid in worm-eaten samples and burned samples have significantly decreased. The above results showed that the specificity was not strong to control the commercial specifications and grades in L.chuanxiong with ferulic acid as the evaluation index.
     2.3.2Comparison on the content of total phenolic acids in L.chuanxiong
     The contents of total phenolic acids in the samples of this research were determined by the method of Appendix XB in Chinese pharmacopoeia (2010edition). The results showed that there are no significant differences in the content of total phenolic acids between different producing area except that Pengshan was a little higher; the content of total phenolic acids of different grades from the same producing area has no significant differences; compared with L.chuanxiong, the contents of total phenolic acids in worm-eaten samples do not reduce, while the content of total phenolic acids in burned samples has increased; the contents of total phenolic acids in Ligusticum sinense Oliv. were close to L.chuanxiong, while the contents of total phenolic acids in red L.chuanxiong was a little higher than L.chuanxiong. The above results showed that the contents of total phenolic acids could be used as an evaluation index of baking temperature in origin processing.
     2.3.3Comparison on the content of polysaccharide in L.chuanxiong
     The contents of polysaccharides in L.chuanxiong were determined by sulfuric acid-phenol method. The results showed that there are significant differences between different producing areas of L.chuanxiong in the contents of polysaccharidesThe order of contents from high to low is Xiejia Pengshan, Aoping Pengzhou, Xinfan Xindu, commercial varieties and Xudu Dujiangyan; the contents of polysaccharides showed no significant differences between different grades of L.chuanxiong in the same producing area; the contents of polysaccharides in worm-eaten and burned samples significantly decreased when compared with L.chuanxiong; the contents of polysaccharides in red L.chuanxiong and Ligusticum sinense Oliv. were obviously less than L.chuanxiong. The above results showed that the contents of polysaccharides could be used as a chemical evaluation index of commercial specifications and grades in L.chuanxiong.
     2.3.4Comparison on the content of phthalides in L.chuanxiong
     The contents of ligustilide, senkyunolide A and levistilide A in different batches of L.chuanxiong samples were determined by HPLC. The results showed that there are some differences in the contents of the three from different producing areas, while there are no significant differences between different grades of L.chuanxiong in the same producing area; compared with L.chuanxiong, the contents of the three worm-eaten samples obviously decreased, while the contents of ligustilide and senkyunolide A in burned samples obviously decreased and the content of levistilide A increased; the contents of ligustilide and levistilide A in red L.chuanxiong were close to that of L.chuanxiong, while the content of senkyunolide A obviously decreased; the contents of ligustilide and levistilide A in Ligusticum sinense Oliv. were obviously lower than that of L.chuanxiong, while the content of senkyunolide A was obviously higer than that of L.chuanxiong. The above results showed that the contents of phthalides could be used as a chemical evaluation index of commercial specifications and grades in L.chuanxiong. However, the storage and origin processing influnce quite much on the contents of phthalides, so they could be used as the key index to standardize the origin processing of L.chuanxiong.
     2.3.5Comparison on the contents of fluorescent materials in L.chuanxiong
     It is an important feature of traditional physical and chemical identification of L.chuanxiong that there is bright light blue fluorescence of the section of L.chuanxiong under UV.
     In this research, we adopted fluorometric spectrophotometry to determine the contents of total fluorescent materials for the first time. The results showed that the contents of total fluorescent materials were no big differences from different producing area, except that Xiejia Pengshan was a little higher; The contents of total fluorescent materials of different grades from the same producing area had no significant differences; compared with L.chuanxiong, the contents of total fluorescent materials in worm-eaten and burned samples obviously decreased; the contents in red L.chuanxiong had no significant difference with that of L.chuanxiong; the contents in Ligusticum sinense Oliv. were obviously lower than that of L.chuanxiong. The above results showed that the contents of total fluorescent materials could be used as a chemical evaluation index of commercial specifications and grades in L.chuanxiong.
     In this research, we adopted fluorometric spectrophotometry to determine the fluorescence intensity of the sample powder, and analyzed the correlation in the fluorescence intensity of the sample powder, the content of ligustilide and the contents of total fluorescent materials for the first time. The results showed that the intensity of the sample powder had a positive liner correlation with the content of ligustilide and the contents of total fluorescent materials, the correlation coefficient were0.838and0.940separately. The results showed that by determining the fluorescence intensity of the sample, the content of ligustilide could be predicted to achieve fast and nondestructive evaluation of the inner quality of L.chuanxiong.
     2.3.6Comparison on chemical fingerprint of L.xhuanxiong
     2.3.6.1GC-MS fingerprint Headspace solid-phase micro-extraction with GC-MS was used to analyze the volatile components in L.chuanxiong and angle cosine computation was used to evaluate the similarity of L.chuanxiong's chromatography data of different producing areas and different commercial specifications. The results that the similarities between different producing areas and different commercial specifications were all more than0.9showed that there were no significant differences of volatile components in different commercial specifications and grades of L.chuanxiong. The similarity between red L.chuanxiong and L.chuanxiong more than0.9showed that the volatile components of the two had no significant differences. The similarity between Ligusticum sinense Oliv. and L.chuanxiong less than0.9showed that the volatile components of the two had significant differences. The contents of volatile components obviously decreased in worm-eaten L.chuanxiong and the similarity between worm-eaten L.chuanxiong and L.chuanxiong less than0.7showed that the volatile components obviously changed after worm-eaten. The types and contents of volatile components had changed after being burned and the similarity between burned L.chuanxiong and L.chuanxiong less than0.9showed that the storage and baking process influnced much on the quality of L.chuanxiong.
     2.3.6.2HPLC fingerprint In this research, we had established the HPLC fingerprint of L.chuanxiong. The similarity of the fingerprints between15batches of samples and standard was more than0.9showed that the fignerprints of different producing areas and different grades from same producing area were no significant differences. The similarity of the fingerprints between worm-eaten, burned and standard was all less than0.9, compared with the fingerprints, that worm-eaten mainly decreased the contents of some chemical components but not the types of chemical compositions. The contents and types of chemical compositions in burned L.chuanxiong had obviously changed. The similarity between red L.chuanxiong and standard was0.958, which showed that there were no significant differences between the two in the types and contents of chemical compositions. The similarity between Ligusticum sinense Oliv. and L.chuanxiong was0.608, which showed that there were big differences between the two in the types and contents of chemical compositions. The peak area ratio of ligustilide and senkyunolide A in L.chuanxiong was7.441, while Ligusticum sinense Oliv. was0.523, which showed that the phthalides in L.chuanxiong were primarily ligustilide and Ligusticum sinense Oliv. were senkyunolide A. It was similar to the previous contents determination results.
     2.4Study on the biological quality of L.chuanxiong
     Bio metric is applicable to drugs with complex structure or thsoe that clinical effect couldn't be reflected by physical and chemical determination. It has unique advantage in quality control and evaluation of traditional Chinese medicine. In this paper we estimated the anticoagulant activity and the activity to antagonize the uterine smooth muscle spasm induced by oxytocin in L.chuanxiong based on its effect of moving Blood and Qi and expelling wind to relieve pain. The results are as follows:
     2.4.1Estimation of anticoagulant activity In this paper, we have established the bioassay method of anticoagulant activity in L.chuanxiong with low molecular weight heparin used as comparison. The samples of L.chuanxiong all have the biological activity of elongating the clotting-time of rabbits. There were no significant differences of the biological potency of anticoagulant activity in the samples of L.chuanxiong form different producing areas and from different grades in the same producing area. The biological potency of anticoagulant activity in worm-eaten samples was slightly higher than L.chuanxiong in the same producing area, while the biological potency of anticoagulant activity in burned samples was2times of L.chuanxiong in the same producing area. The biological potency of anticoagulant activity in red L.chuanxiong was a little higher than that of L.chuanxiong, while the biological potency of anticoagulant activity in Ligusticum sinense Oliv. was obviously lower than that of L.chuanxiong.
     5.4.2Estimation of the activity to antagonize the uterine smooth muscle spasm induced by oxytocin in L.chuanxiong This research initially established the bioassay method of the activity in L.chuanxiong to antagonize the uterine smooth muscle spasm induced by oxytocin, with magnesium sulfate as comparison. The samples of L.chuanxiong all have the biological activity of antagonizing the uterine smooth muscle spasm induced by oxytocin. The biological potencies showed no significant differences in the samples of L.chuanxiong form different producing areas and from different grades in the same producing area. The biological potencies in worm-eaten samples and burned samples obviously decreased, while the biological potencies in red L.chuanxiong and Ligusticum sinense Oliv. were obviously lower than that of L.chuanxiong
     2.5Correlation research on the index system
     2.5.1Correlation analysis on chemical evaluation and biological evaluation
     In order to further study on the correlation of pharmacological activity and chemical compositions, we analyzed the correlation of biological potency and the contents of chemical components in L.chuanxiong in this research. The contents of total phenolic acids and levistilide A had a positive liner correlation with the biological potency of anticoagulant activity(P<0.01), which showed that total phenolic acids might be the main active ingredients of anticoagulant activity inL.chuanxiong. The contents of ligustilide and total fluorescent materials had a positive liner correlation with the biological potency of the activity in L.chuanxiong to antagonie the uterine smooth muscle spasm induced by oxytocin(P<0.05), which showed that the main active ingredients of spasmolytic activity in L.chuanxiong might be phthalides with ligustilide as a representative.
     2.5.2Correlation analysis on HPLC fingerprint and biological potency
     Multiple linear correlation was used to analyze the relationship between the peak areas of shared peaks in HPLC fingerprint of L.chuanxiong and the biological potency of anticoagulant activity and the activity to antagonize the uterine smooth muscle spasm induced by oxytocin. The peak areas of NO.11peak and NO.13peak (levistilide A) had a positive correlation with the biological potency of anticoagulant activity. The peak area of NO.10peak (ligustilide) had a positive correlation with the biological potency of the activity to antagonize the uterine smooth muscle spasm induced by oxytocin. The peak area of ligustilide was the largest in the HPLC fingerprint and owned more than50%of the total peak areas, which showed that the HPLC fingerprint established in this research could reflect the biological activity of L.chuanxiong.
     3. formulation of the industrial standard draft of commercial specifications and grades in L.chuanxiong
     The research results showed that, there were no significant correlation between the current standards of commercial specifications and grades in L.chuanxiong divided by weight and the inner quality of L.chuanxiong. However, the division of commercial specifications and grades in Chinese medicinal materials should be the reelect of its quality. In this research we have optimized the sensory quality index, conventional physical and chemical quality index, chemical evaluation index and biological evaluation index, and established the quality control method and index system accorded with the properties of Chinese medicinal materials, then initially formulated the industrial standard draft of commercial specifications and grades in L.chuanxiong referd to Chinese pharmacopoeia (2010edition) and the standards of commercial specifications and grades in76Chinese medicinal materials. The research results play an important role in ensuring L.chuanxiong's safety and effectiveness in clinical use, and have significances for the study of commercial specifications and grades in other medicinal materials and promotion of the standard system in Chinese medicinal materials.
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