山茱萸質(zhì)量標(biāo)準(zhǔn)英文版.doc

Fructus Corni(山茱萸, ShanZhuyu) Asiatic Cornelian Cherry Fruit Asiatic Cornelian Cherry Fruit is the dried ripe sarcocarp of Cornus officinalis Sieb. et Zucc.(Fam.Cornaceae). The fruit is collected in later autumn and early winter when the pericarp turns red, baked over a soft fire or treated with boiling water for a moment, removed from kern in time and dried. Description Irregularly flaky or bladdery, 1-1.5cm long and 0.5-1cm wide. Externally purplish-rid to purplish-black, shrunken, lustrous. Sometimes with rounded scar of persistent calyx at the apex and a scar of fruit stalk at the base. Texture soft. Odour, slight; taste, sour; astringent and slightly bitter. Identification (1) Powder: Reddish-brown. Epidermal cells of pericarp polygonal of sub-rectangular in surface view, 16-30 in diameter, anticlinal walls beaded, outer periclinal walls granularly cutinized and thickened, lumen containing pale orange-yellow contents. Cells of calcium oxalate rate 13-32 in diameter. Stone cells sub-square, ovoid or rectangular, pits obvious and with a large lumen. (2)To 0.5g of the powder, add 10 ml of ethyl acetate, ultrasonicate for 15 minutes, filter, evaporate the filtrate to dryness. Dissolve the residue with 2ml of dehydrated ethanol as the test solution. Dissolve ursolic acid CRS in dehydrated ethanol to produce a solution containing 1mg per ml as the reference solution. Carry out the method for thin layer chromatography (Appendix VI B), using silica gel G as the coating substance and the mixture of toluene, ethyl acetate and formic acid(20:4:0.5) as the mobile phase. Apply separately 5l of each of two solutions to the plate. After developing and removal the plate, dry in air, spray with a 10% sulfuric acid in ethanol and heat at 105 to the spot clear. Examine in daylight, a violet red spot in chromatogram obtained with the test solution corresponds in position and colour with the spot in chromatogram obtained with the reference solution. Examine under ultraviolet light at 365nm, an orange fluorescent spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference solution. Foreign matter (kerns and fruit stalks) Not more than 3 per cent (Appendix IX K) . Water Not more than 16.0 per cent (Appendix IX H, method 1). Total ash Not more than 6.0 per cent (Appendix IX K) Extractives Carry out the cold maceration method as described under the determination of water-soluble extractives (Appendix X A), not less than 50.0%. Assay Carry out the method for high performance liquid chromatography (Appendix VI D) Chromatographic system and system suitability Use octadecylsilane bonded silica gel as the stationary phase and a mixture of acetonitrile and water (15:85) as the mobile phase. As detector a spectrophotometer set at 240nm. The number of theoretical plates of the column is not less than 3000, calculated with reference to the peak of loganin. Reference solution Dissolve a quantity of loganin CRS, accurately weighed, in 80% methanol to preparea solution containing 40g of per ml as the reference solution. Test solution Weigh accurately 0.1g of the powder(through No.3 sieve) in a stopper conical falsk, add 25 ml of 80% methanol accurately and weigh, heat under reflux for 1 hours, cool and weigh accurately again, replenish the loss of the solvent with 80% methanol, mix well and filter. Procedure Inject accurately 10l of the reference solution and 10l of the test solution into column, respectively, and calculate the content. It contains not less than 0.60% of loganin (C17H26O10）calculated with reference to the dried drug. Decoction piecesProcessing Pulp of Fructus Corni Eliminate foreign matter and remained kerns. The method of Description Identification、Checking (water content) Assay is same like the method of Fructus Corni. Pulp of Fructus Corni (processed with wine) Stew or steam the pulp of Fructus Corni as describled under the method for stewing with wine or steaming with wine(Appendix D) until the wine is absorbed entirely. Pulp of Fructus Corni (processed with wine) Externally purplish-black or black, Texture soft. Odour, slightly bouquet. The method of Description Identification、Checking (water content) Extractives is same like the method of Fructus Corni. Action and indications To replenish the liver and kidney, restrain seminal emission and relieve collapse. Dizziness, tinnitus, aching pain in the loin