| The commercial specification and grade of Chinese medicinal materials were the unique and comprehensive standards for quality control and evaluation, It also was an important component of quality control system of Chinese medicine today. However, most medicinal materials have no clear commercial specification. Even if some of them have a commercial specification, it was also based on perceptual experience. Due to the commercial specification and grade of traditional Chinese medicinal materials were lack of systematic unscrambling and modern technology support, the standards had not been universally recognized. This restricted the well application of commercial specification and grade standards in quality evaluation system of traditional Chinese medicinal materials, and also influenced the inheritance of traditional identification experiences.Moreover, "the actual dose" of Chinese medicines was correlation with its quality, specification grade, and dispensing pharmacy treatment and so on, while the relationship of medicine between amount and the quantity or concentration was of direct correlation. At present, the investigation of Chinese medicinal materials quality standard were mainly facing to production process, but not to clinical rational use. The clinic-combined standardization of Chinese medicines had not been fully concerned.Therefore, in this paper, we selected the rhubarb, which well used in clinic, as a model drug to illustrate the above-mentioned issues. The rationality of the commercial specification of rhubarb had been studied by a comprehensive pattern, "Literature research+Field research+Expert inquiry", combined with chemical analysis and biological evaluation. At the same time, the "chemical homogeneity" and "biological equivalence" of samples with different specification and dispensing methods had been comparablly investigated. The main research results were summed as follows:1. For the first time, the objectivity and reliability of rhubarb commercial specification and grade experience evaluation in sensory were investigatived by Delphi expert survey method. The results showed that the experts' individual reproduce rate in the two testing times was 85%, while the population reproduce rate of the experts was 72.5%. The experts' practising time in the field had an important impact on their assessment results (P<0.05), that is, the longer of practising time, the more abundant practical experience, and the better of reproducibility and reliability. The four indices, appearance, color, texture, profile characteristics, might be the main factors which experts judged specifications of rhubarb.2. The differences of 34 rhubarb samples collected in the markets and producing area were investigated by chemical analysis on the contents of anthraquinones and chromatographic fingerprints used ultra-high performance liquid chromatography (UPLC). The results showed that in addition to sample D5 (the content of 1.47%), all the tested samples were in accordance with the pharmacopoeia criteria. The summed contents of the five anthraquinones were 3.19±0.96% in the range of 1.47-5.31%. The chemical fingerprint showed that there was a big difference between the origin, specification grade rhubarb. Compared with the D4 which produced in Lixian county of Gansu province, the similarity with the same origin sample were Greater than 0.86, in addition to fine root(D7), the similarity with the different origin sample were Less than 0.80.3. In this study, it was firstly reported that rhubarb could be divided into two types, chrysophanol-type and rhein-type, based on the proportion of the two constituents in the total anthraquinones after hydrolization. The rhein-type feature was rhein contents was the highest in the five kinds of rhubarb anthraquinones.like the samples 1,3-12,16,19-22,24,26-29,31-32, The chrysophanol-type feature was chrysophanol contents was the highest in the five kinds of rhubarb anthraquinones, like the samples 2,6,13-15,17-18,23,25,30,33-34. At the same, this article provided some experimental evidences on categorizing rhubarb into two chemotypes through the antimicrobial difference on S. aureus by microcalorimetric analyis and, further, offered references to revision of the commercial specification of rhubarb from chemical view.4. This is the first time to propose "potency grade" concept of Chinese medicinal materials, also determined the conversion coefficient of potency grade. The biological activity of different commercial specification and grade rhubarb were investigated by Diarrhea potency model. The result displaied that The purgative titer had a significant difference between the different commercial specification and grade rhubarb, The highest titer sample D19 and the lowest titer sample D5 had a difference of more than 3 times. But there was no positive correlation between the titer and grade. Current commodity grade standards can not reflect the intrinsic quality of medicinal advantages and disadvantages. Therefore, it was necessary to establish the Chinese medicine "titer levels" based on potency test, thus to provide reference for the the accuracy of clinical medicine.5. This is the first time to establishe expert estimate system for quantitative evaluation of Chinese medicinal materials based on BP neural network, and rapid evaluation standard colorimetric card. After comprehensive analysised of the different quality levels rhubarb sensory evaluation information included color, texture, appearance, etc., chemical content and biological activity information by BP neural network, constructed expert evaluation system of Chinese medicinal materials in the initial level, It can be used for auxiliary quality evaluation of Chinese medicinal materials. Also, established the standard on-site colorimetric card can quickly judge the level of rhubarb. Related research results had applied for two patents and a software copyright:(1) color card for quickly determined the level of Chinese medicinal materials and preparation (200910236482.X); (2) Medicinal materials grade evaluation parameters acquisition methods and expert evaluation system (200910236137.6), (3) Medicinal materials grade evaluation parameters acquisition methods and expert evaluation system.6. In this paper, the impact on the "chemical homogeneity" and "biological equivalence" of rhubarb samples with different quality, such as species, origin, product specifications etc., and dispensing methods, such as pieces granularity size, boiling mode and time etc. had been investigatived systemly in the first time.The results show that the difference of anthraquinone contents and purgative activity between different specifications rhubarb samples were 1.9 and 3.6 times when water extraction, which were 6.4 and 2.0 times when ethanol extraction; the difference of the different extraction time rhubarb samples were 2.2 and 1.7 times when water extraction, which were 1.8 and 1.7 times when ethanol extraction; the difference of the different extraction times rhubarb samples were 2.8 and 1.3 times when water extraction, which were 1.8 and 2.4 times when ethanol extraction; the difference of before and after boil put in rhubarb samples were 2.3 and 4.2 times when water extraction, which were 1.7 and 2.1 times when ethanol extraction. The greatest difference of different specifications and treatment samples up to 11.4 times. It suggested that different specifications, different solvent, different extraction time, different extraction times, put in rhubarb before and after boil were all influenced leaching of effective substance and purgative activity.This is the first time to propose the concept of "purgative activity conversion coefficient" based on compared with the purgative activity of different specifications and treatment samples. It was convenient to guide clinical transfers and ensure accuracy and reliability of clinical medicine. It also provide examples of reference to establish the Good Usage Practice (GUP) linked with clinical usage.Summing up, this article selected rhubarb as model drug, analyzed the status and problem of the commercial specification and grade of Chinese medicinal materials. Used comprehensive analysis pattern, "Literature research+Field research+Expert inquiry",, combined with the chemical analysis and biological evaluation, the rationality of the commercial specification of rhubarb was systemly studied. It provided the methodological practice to inheritance and disseminat the valuable identification experience of experienced practitioner of Chinese medicine, workers processing of Chinese medicine, farmers planted medicine, businessman operate Chinese medicine and establish the quality control and evaluation system of traditional Chinese medicine with characteristic of traditional Chinese medicine. At the same time, the different specification and dispensing pharmacy treatment samples "chemical homogeneity" and "biological equivalence" had been investigated, also studied the influence of it to clinical medication. It provide the examples of reference to establish the Good Usage Practice (GUP) combined the clinical. |
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