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NO. Products Name Types Items BP quality control specification Chp quality control specification
316 Sage Oil IDENTIFICATION Thin-layer chromatography linalol , linalyl acetate and 60 µL of α-terpineol
TESTS Relative density 0.890 to 0.908
Refractive index 1.456 to 1.466
Optical rotation -26° to -10°
Acid value ≤ 1.0
ASSAY
317 Salvia Miltiorrhiza Rhizome and Root IDENTIFICATION Microscopic examination powder powder
Thin-layer chromatography salvianolic acid B and tanshinone IIA salvianolic acid B and tanshinone IIA ;reference herb drug
TESTS Loss on drying ≤10.0% ≤13.0%
Total ash ≤10.0% ≤10.0%
Ash insoluble in hydrochloric acid ≤3.0% ≤10.0%
Pb, Cr, As, Hg and Cu ≤ 5mg/kg；≤ lmg/kg；≤ 2mg/kg； ≤ 0.2mg/kg；≤ 20mg/kg
ASSAY Content — salvianolic acid B (C36H30O16; Mr 719): ≥ 3.0% (dried drug); — tanshinone IIA (C19H18O3 ; Mr 294.3): ≥ 0.12 % (dried drug). — salvianolic acid B (C36H30O16; Mr 719): ≥ 3.0 %(dried drug);tanshinone IIA (C19H18O3). Cryptotanshinone The total amount of (C19H20O3) and tanshinone I (C18 H12 O3) ≥ 0.025%.
Ethanol-soluble extractive ≥15%
Water-soluble extractive ≥35%
318 Saw Palmetto Extract IDENTIFICATION Thin-layer chromatography β-amyrin and of β-sitosterol
TESTS Water ≤3.0%
Relative density 0.850 to 0.950
Refractive index 1.40 to 1.50
Acid value 150.0 to 220.0, determined on 0.500 g.
Iodine value 30.0 to 60.0.
Peroxide value ≤5.0
ASSAY Content — total fatty acids:≥ 80.0 % (anhydrous extract); — lauric acid (C12H24O2 ; Mr 200.3):≥ 23.0 % (anhydrous extract); — total sterols, expressed as β-sitosterol (C29H50O; Mr 414.7):≥ 0.20 % (anhydrous extract); — β-sitosterol (C29H50O; Mr 414.7):≥ 0.10 % (anhydrous extract). — essential oil: ≥ 50 mL/kg for A. krervanh (anhydrous drug) and ≥ 40 mL/kg for A. compactum (anhydrous drug); — 1,8-cineole (C10H18O; Mr 154.3): ≥ 65.0 % of the essential oil.
319 Saw Palmetto Fruit IDENTIFICATION Microscopic examination powder
Thin-layer chromatography β-amyrin and of β-sitosterol
TESTS Loss on drying ≤12.0%
Total ash ≤5.0%
ASSAY Content ≥11.0 % of total fatty acids (dried drug).
320 Schisandra Fruit IDENTIFICATION Thin-layer chromatography schisandrin and γ-schisandrin Schisandrin,reference herb drug
TESTS Loss on drying ≤10.0% ≤16.0%
Total ash ≤6.0% ≤7.0%
Foreign matter ≤1.0% ≤7.0%
ASSAY Content ≥ 0.40 % of schisandrin (C24H32O7 ; Mr 432.5) (dried drug) ≥ 0.40 % of schisandrin (C24H32O7 ; Mr 432.5) (dried drug)
321 Scrophularia Root IDENTIFICATION Microscopic examination powder powder
Thin-layer chromatography harpagide ，harpagoside，catalpol Harpagoside,reference herb drug
TESTS Loss on drying ≤14.0% ≤16.0%
Total ash ≤5.0% ≤5.0%
Ash insoluble in hydrochloric acid ≤2.0% ≤2.0%
ASSAY Content ≥ 0.45 per cent for the sum of harpagoside (C24H30O11; Mr 494.5) and harpagide (C15H24O10; Mr 364.3), expressed as harpagoside (dried drug). ≥ 0.45 per cent for the sum of harpagoside (C24H30O11; Mr 494.5) and harpagide (C15H24O10; Mr 364.3), expressed as harpagoside (dried drug).
Water-soluble extractive ≥60%
322 Scutellariae Baicalensis Root IDENTIFICATION Microscopic examination powder powder
Thin-layer chromatography baicalin and acteoside Baicalin, baicalin, Han baicalin
TESTS Loss on drying ≤12.0% ≤12.0%
Total ash ≤6.0% ≤6.0%
Ash insoluble in hydrochloric acid ≤2.0%
ASSAY Content ≥ 9.0 % of baicalin (C21H18O11; Mr 446.4) (dried drug) ≥ 9.0 % of baicalin (C21H18O11; Mr 446.4) (dried drug)
Ethanol-soluble extractive ≥ 40.0 %
323 Selfheal Fruit-Spike IDENTIFICATION Microscopic examination powder powder
Thin-layer chromatography β-sitosterol and ursolic acid Rosmarinic acid
TESTS Loss on drying ≤12.0% ≤14.0%
Total ash ≤12.0% ≤12.0%
Foreign matter ≤5 % of stems longer than 15 cm and ≤2 % of other foreign matter.
Ash insoluble in hydrochloric acid ≤4.0% ≤4.0%
ASSAY Content ≥ 0.12 % of the sum of oleanolic acid (C30H48O3 ; Mr 456.7) and ursolic acid (C30H48O3 ; Mr 456.7), expressed as ursolic acid, of which not less than 70.0 per cent consists of ursolic acid (dried drug) Rosmarinic acid，≥0.2%
Water-soluble extractive ≥10.0 %
324 Senega Root IDENTIFICATION Microscopic examination powder
 High-performance thin-layer chromatography rutoside trihydrate , puerarin, chlorogenic acid
TESTS Loss on drying ≤12.0%
Total ash ≤6.0%
Ash insoluble in hydrochloric acid ≤3.0%
ASSAY Foam index ≥3.5, determined on 1.00 g of the powdered herbal drug
Extractable matter ≥20.0%
325 Senna Leaflet IDENTIFICATION Microscopic examination powder
High-performance thin-layer chromatography sennoside A and sennoside B ；sodium hydrogen carbonate；senna extract
TESTS Loss on drying ≤12.0%
Total ash ≤12.0%
Liquid chromatography Total anthraquinones
Foreign matter ≤4%
Ash insoluble in hydrochloric acid ≤2.5%
ASSAY Content ≥2.0 % of total hydroxyanthracene glycosides, expressed as sennoside B (C42H38O20; Mr 863) (dried drug)
327 Senna Pods IDENTIFICATION Microscopic examination powder
High-performance thin-layer chromatography sennoside A ; sennoside B; senna extract
TESTS Loss on drying ≤12.0%
Total ash ≤9.0%
Foreign matter ≤1.0%
Ash insoluble in hydrochloric acid ≤2.0%
Liquid chromatography Total anthraquinones (aloe emodin and rhein)
ASSAY Content ≥2.0% of total hydroxyanthracene glycosides, expressed as sennoside B (C42H38O20; Mr 863) (dried drug)
329 Serratula Herb IDENTIFICATION Microscopic examination powder
High-performance thin-layer chromatography rutoside trihydrate and isoquercitrosideof rutoside trihydrate and isoquercitroside,chlorogenic acid and hyperoside
TESTS Loss on drying ≤10.0%
Total ash ≤12.0%
ASSAY
330 Sesame Seed IDENTIFICATION Microscopic examination powder
TESTS Loss on drying ≤5.0%
Total ash ≤9.0%
ASSAY
331 Siam Benzoin Tincture IDENTIFICATION Thin-layer chromatography benzoic acid , trans-cinnamic acid , vanillin and methyl cinnamate
TESTS Ethanol 95 to 105% of the content stated on the label.
ASSAY Content ≥5.0% of m/m of total acids, calculated as benzoic acid (C7H6O2 ; Mr 122.1)
332 Siam Benzoin IDENTIFICATION Thin-layer chromatography vanillin , trans-cinnamic acid and methyl cinnamate
TESTS Loss on drying ≤5.0%
Total ash ≤2.0%
Matter insoluble in ethanol ≤5.0%
ASSAY Content 35.0 to 55.0 % of total acids, expressed as benzoic acid (C7H6O2 ; Mr 122.1) (dried drug).
333 Sophora Flavescens Root IDENTIFICATION Microscopic examination powder powder
Thin-layer chromatography brucine and quinine Matrine, sophoridine,oxymatrine
TESTS Loss on drying ≤11.0% ≤11.0%
Total ash ≤8.0% ≤8.0%
Ash insoluble in hydrochloric acid ≤1.5%
ASSAY Content ≥1.2% for the sum of matrine (C15H24N2O; Mr 248.4) and oxymatrine (C15H24N2O2 ; Mr 264.4) (dried drug). ≥1.2% for the sum of matrine (C15H24N2O; Mr 248.4) and oxymatrine (C15H24N2O2 ; Mr 264.4) (dried drug).
Water-soluble extractive ≥20.0%
334 Sophora Flower IDENTIFICATION Microscopic examination powder
Thin-layer chromatography hyperoside and rutoside trihydrate
TESTS Loss on drying ≤11.0%
Total ash ≤9.0%
Foreign matter ≤ 5% of flower buds and ≤ 2 % of other foreign matter
ASSAY Content — ≥ 8.0 % of total flavonoids, expressed as rutoside (C27H30O16; Mr 611) (dried drug); — ≥ 6.0 % of rutoside (C27H30O16; Mr 611) (dried drug).
335 Sophora Flower-Bud IDENTIFICATION Microscopic examination powder
Thin-layer chromatography hyperoside and rutoside trihydrate
TESTS Loss on drying ≤11.0%
Total ash ≤9.0%
Foreign matter ≤ 5% of flower buds and ≤ 2 % of other foreign matter
ASSAY Content — ≥ 20.0 % of total flavonoids, expressed as rutoside (C27H30O16; Mr 611) (dried drug); — ≥ 15.0 % of rutoside (C27H30O16; Mr 611) (dried drug).
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