| The radix et caulis of Zanthoxylum dissitum Hemsl or Zanthoxylum echinocarpum Hemsl in Zanthoxylum of rutaceae, which was called "Danmianzhen". It distributed in the Hunan, Guangxi, Yunnan, Guangdong Province. Interestingly, it has activating blood flow and removing blood stasis and regulating qi to alleviate pain effect. Accordingly, it can be used to treat common cold, cough, lumbago and scelalgia, wound, hypermenorrhea and so on. In the clinical application, it severs as the source of Fukeqianjin capsules and tablets.The initial usage of Danmianzhen was the wildlife resources of Z.dissitum. However, with the improvement of its pharmaceutical value, the demand for Danmianzhen exceeds supply. Apart from that, it required the complex growth condition for Danmianzhen which shows very low reproduction rate. What is more, excessive and predatory digging resulted in endangering Z. dissitum. Therefore, a multitude of artificial cultivation is to broad its medicinal resources. In large areas of cultivated, while the addition of Danmanzhen from the source, In the 2009 edition of Hunan Chinese Material Medica standards, it revised and enlarged Z. echinocarpum which detailed the qualify standard of Z. echinocarpum included source, description, microscopic identification, TLC identification, HPLC fingerprinting and assay. Unfortunately, the quality standard of Z. dissitum followed the old mode which stayed in the macroscopical identification leve, which lack specificity and quantitative index components. Although both Z. dissitum and Z. Echinocarpum were used as danmianzhen, there is no one method which can apply to characterize both of them. In order to better control the quality of danmianzhen, this project developed a quality control method which can apply to two resources of danmianzhen. It provides a referenced foundation for the quality control of Danmianzhen in Chinese Pharmacopoeia(2015).Our studies are contentrated on the identification (Traits, Microscopic, Chemical, TLC), the determination of Moistures, ashes, acid insoluble ash, extract (water-soluble, alcohol-soluble, volatile ether), content determination.The results showed as follows:(1) The traits, microscopic characteristics, physicochemical properties were identified, which was consistented with the literature, alkaloid chemical reaction was positive, indicating that contain alkaloids. Using thin layer chromatography to develop a method of y-Fagarine in Danmianzhen, the agent is Chloroform-methanol-acetone-formic acid (15:0.5:0.5:1), the chromogenic reaent is 10% sulfuric acid in ethanol. With the TLC conditions, the maps separation is good, no interference, no tail, spots clear, we can clearly detectable the y-Fagarine from batches. The results showed that, y-Fagarine could be used as the common indicator for Z. dissitum and Z. Echinocarpum, the TLC method built simple, reproducible, and can be used as ingredients in the one-sided needle TLC method.(2) To determine the moisture, ashes and extract of Danmianzhen,according to the procedures recorded in the Appendix of Chinese Pharmacopoeia(2010). The moisture,total ash, acid insoluble ash content are in the range of 8.93%～10.38%, 2.56%～5.56%,0.07% to 0.60%, the total averages were 9.54%,4.07%,0.17%.The water-soluble, alcohol-soluble, volatile ether extract content are in the range of 7.14% ～18.27%,3.65%～21.11%,0.11% to 0.41%, the total average were 10.16%,9.03%, 0.24%. The results showed that there were large differences between different bathes, through control the content of moisture, ash, extract the monitor, we can reduce the effects of impurities on the quality of medicines, ensure the total active ingredient content with the condition of active ingredient was unkown,. The method is simple and feasible, suitable for the quality control of Danmianzhen. According to the measurement results, the moisture content should not be more than 13.0%, the total ash content should not be more than 7.0%, acid insoluble content are should not be more than 0.7% water-soluble extract content can not less than 6.0% alcohol-soluble extract content should not be less at 3.0%, volatile ether extract content should not be less than 0.1%.(3) To determine the content of Magnoflorine in Danmianzhen.The separation and detection were performed on High Performance Liquid Chromatography(HPLC), which was used as column with acetonitrile-0.1mol/L sodium dihydrogen phosphate solution(11:89). The wavelength was set at 268nm. The magnoflorine content of 30 batches rangges were 1.01～7.91mg/g, the average content of 4.50 mg/g, RSD was 45.90%, the average content of Z. dissitum and Z. Echinocarpum were 3.33 mg/g and 5.67 mg/g. The magnoflorine content of Z. Dissitum, whcih was the one plants, two plants, three plants, r plants of Z. Dissitum were,the 1.21mg/g,2.58 mg/g 3.72mg/g. The magnoflorine content of Z. Echinocarpum was 4.18 mg/g,5.50 mg/g,7.34 mg/g.10 batches of preparations for the content of magnoflorine 9.45～19.46mg/g, with an average of 14.40, RSD was 26.89%. The measurement results showed that the content are large differences between different batches, different species, different growth years. The content of magnoflorine in Z. Echinocarpum was more than Z. Dissitum’s. The content of magnoflorine was with the growth of plants age growth. The content of magnoflorine in difference batches tablets are differences, It showed that the quality of the Danmianzhen are differences, it will affect the quality of medicine, then further affect the efficacy of the formulation, so when choosing medicines, we can be fixed origin or narrow the scope of procurement, unified distribution of medicinal species or growth years, which would reduce the difference on the quality of medicine. In order to ensure the stability of the preparation of medication. Although the studies was limitations which was just determined the content of Magnoflorine in Danmianzhen, but the methods is simple, accurate and reproducible,which can be used to control the quality of Danminanzhen, and to provide a basis for the quality control of the tables of Danmianzhen. |
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