六味地黄丸(浓缩丸)质量标准英文版

Liuwei Dihuang Pills(concentrated pills)

六味地黄丸（浓缩丸）

Pinyin Liuwei Dihuang Wan

Igredients Prepared Rehmannia Root 120g; Fructus Macrocarpii 60g; Cortex Moutan Radicis 45g; Rhizoma Dioscoreae Oppositae 60g; Poria 45g; Rhizoma Alismatis 45g

Procedure Distillate Cortex Moutan Radicis with water vapo for abstracting volatility ingredients; Decoct the gruffs, Fructus Macrocarpii 20g, Prepared Rehmannia Root, Poria and Rhizoma Alismatis with water twice, 2 hours for every time, filter, combine the filtrated, concentrated them to extract; pulverize Rhizoma Dioscoreae Oppositae and excess of Fructus Macrocarpii to fine powder, sifting, mix thoroughly, add the above extract and volatility ingredients of Cortex Moutan Radicis, mix thotoughly, make to pills, dry, polishing.

Description Brownish to black concentrated pills, taste, sweat, acid, slightly bitter.

Identification (1)Microscopical: Epidermal cells of pericarp orange-yellow, polygonal in surface view, with somewhat beaded anticlinal walls. Starch granules triangular-ovoid or oblong, 24-40 µm in diameter hila short cleft Vshaped.

(2)Pulverize 5 g of the pills,heat under reflux with 20 ml of ether for 1 hour, filter and expel ether. Dissolve the residue in 1 ml of acetone as the test solution. Dissolve paeonol CRS in acetone to prepare a solution containing 1 mg per ml. as the reference solution. Carry out the method for thin layer chromatography (Appendix ⅥB), using silica gel G as the coating substance and cyclohexane and ethyl acetate(3:1) as the mobile phase. Apply separately 5-10 μl of each of the two solution to the plate. After developing and removal of the plate, dry in air, spray with 5% ferric chloride in ethanol acidified with hydrochloric acid and heat to the spots clear. The 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.

(3)Pulverize 10 g of the pills, dissolve it with 100 ml of water, heat to boil, allow to stand for cool, filter in absorbent cotton, wash the filtrate with two-30 ml quantities of acetidin, combine the filtrate, evaporate the filtrate to dryness, dissolve the residue in 1 ml of methanol as the test solution. Prepare a solution of 4 g of Prepared Rehmannia Root reference drug and 60 ml water, decoct 30 minutes, stand for cool, filter with absorbent cotton, wash the filtrate with two-20 ml quantities of acetidin, combine the filtrate, evaporate the filtrate to dryness, dissolve the residue in 1 ml of methanol as the reference solution. Carry out the method for thin layer chromatography(Appendix Ⅵ), using silica gel G as the coating substance and the lower layer of a mixture of chloroform, xylene and acetidin(1:1), as the mobile phase. Apply separately 3-5μl of each of the two solution to the plate. After developing and removal of the plate, dry in air. Spary with 2,4 - dimethyl ethanol nitrile to spots clear. The spot in the chromatogram obtained with the test solution correspond in position and colour to the spot in the chromatogram obtained with the reference solution and the reference drug solution.

(4)Pulverize 5 g of the pills, dissolve it with 30 ml of water, cool and filter, wash the residue with 30 ml of water, and heat under reflux the residue, with 50 ml of 30% hydrochloric acid for 1 hour, cool and filter, wash the filtrate with two-25 ml chloroform, evaporate the filtrate to dryness,