| Fructus Ligustri lucidi is from the dried fruit of Ligustrum lucidum Ait.,family Oleaceae, which is accepted in 2005 edition of Chinese Pharmacopoeia, sweet or bitter in flavor, cold in nature, It has the effect of nourishing liver and invigorating the kidney , and promoting the eyesight and blackening the hair.Use for dizziness and tinnitus,soreness and weakness of waist and kness, manifestations of blurred vision and weakness of eyesight, premature whitening of hair,This subject coming from the item of innovative medicine and TCM modernization of national important science And technology, which is much deeper research of Fructus Ligustri lucidi on the base of wine processing technique experiment of young fund of administration of traditional Chinese medicine. Specific content as follow.IN my phytochemical research of the fruit of Fructus Ligustri lucidi growing in HeNan .characteristic water solubility ingredient — specnuezhenide(about 900mg) is extracted and separated from extractive of 80% ethanol by using different isolating technique, above 98 percent of purity in which is about 100mg,95 percent of purity about 800mg, On the basis of chemical properties and spectroscopic analysis, the compound were identified.Fructus Ligustri lucidi was used in the from of its processed product in the clinic, wine processing technique is also mainly method, the procedure of braizing or steaming with yellow wine are known in the china pharmacopoeia (from 1963 edition to 2005 edition).At present, wine processing about Fructus Ligustri Lucidi countrywide are much diffenence in the quantity of wine and processing time. For this reasion, using orthogonal design,I optimized theprocessing procedure by the index of Oleanolic acid and the factors of adding wine quantity(A), steaming time(B) and torrefying temperature (C). The results demonstrate: A factor and C factor ,having statistical significance;B factor , no notable statistical significance. Principal factor of influencing quality of Fructus Ligustri lucidi processing with wine is adding wine quantity, the lesser is torrefying temperature, steaming time is unessential. Allowing for external, colour and traditional processing experiences of individual areas, definitive processing technique is 20percent yellow wine,4hour steaming, 70 °C torrefaction. The techniques of laboratory are validated by medium-scale production,quality specification are done.The.chosen techniques will provide scientific foundation for processing products standard and market monitoring in force.The developed HPLC method were used quantitative analysis of Fructus Ligustri lucidi and its processing products by the index of Oleanolic acid and Ursolic acid. The recovery of Oleanolic acid is 98.64%,RSD is 0.46%;The recovery of Ursolic acid is 98. 25%, RSD is 1. 05%. Assayings of 14 habits show: contents range of Oleanolic acid are 0.719%'— 1.579%, Ursolic acid contents range of 14 habits are 0. 176%~0. 519%, total amount range of Oleanolic acid and Ursolic acid are 0. 907%~2. 086%;Assayings of Processing products show: contents range of Oleanolic acid are 0. 914%~1.640%, contents range of Ursolic acid are 0. 285%~ 0. 484%, total amount range of Oleanolic acid and Ursolic acid are 1. 199%~2. 114%. Regardless of chemical const i tut ion> colour spectrum identification -. separating condition and pharmacological action, Oleanolic acid and Ursolic acid are rather similar. Advising adding the total amount of Oleanolic acid and Ursolic acid in Pharmacopoeia, The total amount of Oleanolic acid and Ursolic acid in Medicinal substances can not less 1.0%, The total amount of Oleanolic acid and Ursolic acid in processing product can not less 1.1% .The developed HPLC method were used quantitative analysis and a series of technology investigation of Fructus Ligustri lucidi and its processing products by the index of Specnuezhenide. The recovery of Specnuezhenide islOl. 97%,RSD is 1.37%. Specnuezhenide content range of 13 habits are 0. 241%-— 4. 451% .region difference is comparatively large, possible reasons relate sample habit, collecting time ■. sample pretreating > sample reserving and marketing herbs confusion. Specnuezhenide content range of processing products are 0. 260%~ 0. 775%, contrasting processing herbs , The contents of Specnuezhenide degrade, possible reasons relate water washing pre-processing , steaming time long, torrefying temperature and Specnuezhenide quality. Advising: (1) Wine processing of Fructus Ligustri lucidi, met a-clean ing select ion, yellow wine mixing thoroughly, cryodrying or direct drying. (2) Adding the content of Specnuezhenide in Pharmacopoeia, according to value of Specnuezhenide in the herb of HeNan,the content can not less 0.40%;The content in processing product cannot less 0. 25%.The developed spectrophotometric method were used quantitative analysis and stable investigation of semi-works production processing products by the index of polysaccharose and mannitol. Assayings show:The content of processing drugs circa are not changing.In addition, carrying out determination of TLC> Moisture , Ash content >Indissolvable acid ash content ,alcohol-soluble extractive^heavy metaK farming leftover. Advising : Improving Oleanolic acid TLC of Fructus Ligustri lucidi in pharmacopoeia, Establishing TLC of Specnuezhenide, (1) Medicinal substances:The total content of Oleanolic acid and Ursolic acid are not less than 1.00%, moisture content not less than 8.0%, alcohol-soluble extractive not less than 22. 00%(2) Processing products: The total content of Oleanolic acid and Ursolic acid not less than 1. 00%, moisture content less than 5. 5% , ash content less than 5. 5%, indissolvable acid ash content less than 0. 75%, alcohol-soluble extractive not less than 20.00%.The quality standard (protocol) and draft directions of the quality standard are Instituted.The stability studies of processing products in six months showed they were stable in natural condition.To bring new idea,1. On the base of traditional processing techniques and producing practice, the key technical parameters (adding winequantity, steaming time and torrefying temperature)of Fructus Ligustri lucidi are established , providing scientific groundwork for large scale controling production.2. Characteristic water solubility ingredient —specnuezhenide(about 900mg) is extracted and separated by using different isolating technique, above 98 percent of purity in which is about lOOmg, 95 percent of purity about 800mg. (3)The developed methods of content determinatiomand a seris of technology investigation are for Oleanolic acid, Ursolic acid, Specnuezhenide, Polysaccharose and Mannitol 4.Revising and supplementing many contents of Fructus Ligustri Lucidi item in the china pharmacopoeia(2005 edition). (1). Revising the Oleanolic acid TLC condition of Fructus Ligustri lucidi. (2).Adding the specnuezhenide TLC condition of Fructus Ligustri Lucidi. (3). Revising Oleanolic acid determination of thin layer scaning.(4).Supplementing specnuezhenide determination of HPLC.(5).Adding detection items of moisture content,ash content, indissolvable acid ash content. (6). Adding detection items of alcohol-soluble extractive.5.The quality standard(protocol) and draft directions of the quality standard are established. |
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