The Effects Of Compatibility On Chinese Herb Quality Standards

Along with the constant internationalization of Chinese herb medicine, the quality of traditional Chinese medicine increasingly becomes a focal point, the Ch.P, as the specification of manufacture and administration for Chinese medicine is naturally attract people's attention, there are unceasingly some people question the rationality and exactitude in certain regulations. By read some reference and quod vide the Ch.P, The author discovered some problems about the content determination in some compatibility about Rhizoma Coptidis and Radix Scutellariae,Cortex Phellodendri and Radix Scutellariae, the data difference between specified and theoretical is striking. Therefore, this article is based on the platform of Coptidis Decoction for Detoxification, try to find out the reason, and explore some way to solve it. The contents of this topic include four fractions: the choice of abstraction technology, study on compatibility effect, Coptidis Decoction for Detoxification extraction biological modeling experiment and finger printing establishment.1.The choose of technology for Coptidis Decoction for Detoxification Experimented by orthogonal design, considerate the effect of three factors: extraction time, quanta of solvent and pH of solvent, determine the chemical materials content by reversed phase-high performance liquid chromatogram (RP-HPLC), take the content of Jasminoidin, Baicalin and Berberine as evaluation standard to choose better abstraction condition; the results shows that when the solvent quanta at 16times, first extract time 30min, second 15min, pH at 8.0 is the best extraction condition. The content of Jasminoidin, Baicalin and Berberine were respectively 23.36mg/g, 2.73mg/g, 59.48mg/g under such condition.2.Effect of compatibility on the content of chemical composition in Coptidis Decoction for Detoxification This part used by orthogonal design, HPLC instrument determined some chemical compositions such as Jasminoidin, Baicalin and Berberine in Coptidis Decoction for Detoxification and 14 prescriptions based on Rhizoma Coptidis, Radix Scutellariae, Phellodendri and Fructus Gardeniae, the result shows that the content of chemical composition in different prescription increase or decreased by different degree, when Rhizoma Coptidis or/and Cortex Phellodendri combined with Radix Scutellariae, the content of Baicalin and Berberine would have a notable decrement.For instance, berberine in Rhizoma Coptidis extract was 9.31mg/g, Baicalin in Radix Scutellariae extract was48.06mg/g, after mingled together, the content of Baicalin and Berberine were respectively 0.34 mg/g and 21.52 mg/g, when added Fructus Gardeniae in them, the content of Baicalin and Berberine were respectively0.77 mg/g and 32.88 mg/g, both increased a relatively high extent,but still much less than mingled before. every medicine can decrease the content of Jasminoidin in Fructus Gardeniae, for example, the content of Jasminoidin in Fructus Gardeniae extract is 66.70mg/g, the quantity of other compatibility include Fructus Gardniae is less than this data. Much precipitation was found in compatibilities which include the combination of Rhizoma Coptidis- Radix Scutellariae or Cortex Phellodendri- Radix Scutellariae, when analyzed by HPLC instrument,it was found that the mean component of the precipitation is baicalin and Berberine. The result shows that the method of detect the content of effective constituent in the prescription to control the quality can not reflect the real quality, there are some prescriptions such as Yi Qing Ke Li and Qingwei Huanglianin Wan in Ch.P,they both have the similar combination, so the regulation in content item is far less than the real content, so the quality control method by the method of regulating the content of the effective is not reasonable, certain method witch is more scientific must be found to replace the pattern applied at present.3. The experiment of Coptidis Decoction for Detoxification extraction under imitation physiologic state This test adopted by Random unit design, put the extraction of Coptidis Decoction for Detoxification and other decomposed compatibilities into different mediator such as artificial gastric juice, artificial intestinal juice and distilled water for 1.5h at the temperature of 37℃;The result shows that artificial gastric juice decrease the dissolution rate of bacalin and berberin in Coptidis Decoction for Detoxification, the dissolution rate of bacalin was 18.10mg/g, berberin was 2.13mg/g,, artificial intestinal juice increase the dissolution rate, which was respective 31.42mg/g and 2.72mg/g.the result shows that prescription of Coptidis Decoction for Detoxification is suit for orol use.4. finger printing establishment of Coptidis Decoction for Detoxification 17samples of self-made Coptidis Decoction for Detoxification extraction HPLC spectrum of a graph undertook cluster analysis by SPSS, selected 10samples chromatogram from the same cluster for further statistics. This test was gained 12 characteristic absorption bands, choose the peak of baicalin as inner reference peak, calculate the relative peak area and relative peak retention time and calculated the semblance, obtained the digital finger printing of Coptidis Decoction for Detoxification. The result shows that the chromatograph conditions implemented the baseline separation of major peaks, characteristic absorption band of each single Chinese herb were reflected in compound recipe chromatogram, and have quite good precision, reproducibility, and convenient to use, consistent with the specification of traditional Chinese medicine finger printing.There were some studies shown that for the mutual effect of different herbs existed in Coptidis Decoction for Detoxification, the method of controlling it's quality by determined the content of one or several effectiveness in the prescription hard to reflect the real quality. There for, the mode of finger printing to control the quality in fuzzy control way, add the quantity control of some effective constituent, this method would be a better way to control the quality of praeparatum and compound recipe.