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| NO. | Products Name | Types | Items | BP quality control specification | Chp quality control specification |
| 41 | Birch Leaf | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | Quercitrin，Hyperoside | ||||
| TESTS | Foreign matter | ≤3% of fragments of female catkins and ≤ 3% of other foreign matter. | |||
| Loss on drying | ≤10.0% | ||||
| Total ash | ≤6.0% | ||||
| ASSAY | Content | ≥1.5% of flavonoids, expressed as hyperoside(dried drug) | |||
| 42 | Bistort Rhizome | IDENTIFICATION | Microscopic examination | powder | powder |
| Thin-layer chromatography | fructose，Catechin | gallate, reference drug | |||
| TESTS | Paris polyphylla Sm. or Paris quadrifolia L（Microscopic examination） | powder | - | ||
| Loss on drying | ≤12.0% | ≤15.0% | |||
| Total ash | ≤9.0% | ≤9.0% | |||
| Ash insoluble in hydrochloric acid | ≤1.0% | - | |||
| ASSAY | Ethanol-soluble extractive | - | ≥15.0% | ||
| Content | Minimum 3.0%of tannins, expressed as pyrogallol (dried drug). | Minimum 0.12% of gallate | |||
| 43 | Bitter Apricot Seed | IDENTIFICATION | Seed coat surface view | Seed | Seed |
| Microscopic examination | powder | powder | |||
| Thin-layer chromatography | amygdalin R | amygdalin R | |||
| TESTS | Water | - | ≤ 7.0 % | ||
| Peroxide value | ≤ 9.0 | ≤ 0.11 | |||
| Foreign matter | ≤ 2.0 p% | - | |||
| Loss on drying | ≤ 8.0 % | - | |||
| Total ash | ≤ 4.0 % | - | |||
| ASSAY | Content | Minimum 3.0 per cent of amygdalin (C20H27NO11; Mr 457.4) (dried drug). | Minimum 3.0 per cent of amygdalin (C20H27NO11; Mr 457.4) (dried drug). | ||
| 44 | Bitter Fennel | IDENTIFICATION | Microscopic examination | powder | transverse section |
| Thin-layer chromatography | anethole，fenchone | anisaldehyde | |||
| TESTS | Estragole（Gas hromatography） | estragole: ≤ 5.0 % in the essential oil obtained in the assay | - | ||
| Foreign matter | ≤1.5% of peduncles and ≤1.5% of other foreign matter | ≤4% | |||
| Water | ≤100 mL/kg | - | |||
| Total ash | ≤10.0% | ≤10.0% | |||
| Loss on drying | - | ≤13.0% | |||
| ASSAY | Content | essential oil:≥1.5%（ml/g） ; trans-anethole：≥1.4%" | |||
| 45 | Bitter-Fennel Fruit Oil | IDENTIFICATION | Thin-layer chromatography | fenchone，anethole | |
| Chromatographic profile（Examine the chromatograms obtained in the test for chromatographic profile） | "The characteristic peaks in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with the reference solution." | ||||
| TESTS | Relative density | 0.961 to 0.975 | |||
| Refractive index | 1.528 to 1.539 | ||||
| Optical rotation | +10 to +20 | ||||
| Chromatographic profile | "Determine the percentage Content of each of these components. The percentages are within the following ranges: — α-pinene: 1.0% to 10.0%, — limonene: 0.9% to 5.0%, — fenchone: 12.0% to 25.0%, — estragole: ≤ 6.0%, — cis-anethole: ≤ 0.5%, — trans-anethole: 55.0% to 75.0%, — anisaldehyde: ≤ 2.0%. The ratio of α-pinene Content to limonene Content is greater than 1.0." | ||||
| ASSAY | Content | "— fenchone: 12.0% to 25.0%, — trans-anethole: 55.0% to 75.0%. | |||
| 46 | Bitter-Fennel Herb Oil | IDENTIFICATION | Thin-layer chromatography | fenchone，anethole | |
| Chromatographic profile（Examine the chromatograms obtained in the test for chromatographic profile） | "Results: — Spanish type: the characteristic peaks due to α-pinene, β-pinene, β-myrcene, α-phellandrene, limonene, fenchone, estragole and trans-anethole in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with reference solution (a); — Tasmanian type: the characteristic peaks due to α-pinene, α-phellandrene, limonene, fenchone, estragole and trans-anethole in the chromatogram obtained with the test solution are similar in retention time to those in the chromatogram obtained with reference solution (a)." | ||||
| TESTS | Relative density | "— Spanish type: 0.877 to 0.921; — Tasmanian type: 0.940 to 0.973." | |||
| Refractive index | "— Spanish type: 1.487 to 1.501; — Tasmanian type: 1.512 to 1.538." | ||||
| Optical rotation | "— Spanish type: + 42° to + 68°; — Tasmanian type: + 11° to + 35°." | ||||
| Solubility in alcohol | "— Spanish type: 1 volume is soluble in 2 volumes and more of ethanol (90% V/V) R; — Tasmanian type: 1 volume is soluble in 10 volumes and more of ethanol (85% V/V) R" | ||||
| Chromatographic profile | "For Spanish-type bitter-fennel herb oil, the percentages are within the following ranges: — α-pinene: 2.0 to 8.0 %; — β-pinene: 1.0 to 4.0%; — β-myrcene: 1.0 to 12.0%; — α-phellandrene: 1.0 to 25.0%; — limonene: 8.0 to 30.0%; — fenchone: 7.0 to 16.0%; — estragole: 2.0 to 7.0%; — cis-anethole: ≤ 0.5%; — trans-anethole: 15.0 to 40.0%; — anisaldehyde: ≤ 1.0%; — anise ketone: ≤ 0.05%; — disregard limit: the area of the principal peak in the chromatogram obtained with reference solution (b) (0.025%). For Tasmanian-type bitter-fennel herb oil, the percentages are within the following ranges: — α-pinene: 2.0 to 11.0%; — α-phellandrene: 1.0 to 8.5%; — limonene: 1.0 to 6.0%; — fenchone: 10.0 to 25.0%; — estragole: 1.5 to 6.0%; — cis-anethole: ≤ 0.5%; — trans-anethole: 45.0 to 78.0%; — anisaldehyde: ≤ 1.0%; — anise ketone: ≤ 0.05%; — disregard limit: the area of the principal peak in the chromatogram obtained with reference solution (b) (0.025%)." | ||||
| ASSAY | Content | "— fenchone: 12.0 % to 25.0%, — trans-anethole: 55.0%to 75.0 %" | |||
| 47 | Bitter-Orange Flower | IDENTIFICATION | Microscopic examination | powder | "Aurantii fructus：powder Aurantii fructus immaturus：powder" |
| Thin-layer chromatography | Hesperidin，Naringin | "Aurantii fructus：naringin,neohesperidin Aurantii fructus immaturus：synephrine" | |||
| TESTS | Sweet-orange flower（Thin-layer chromatography ） | naringin， hesperidin | - | ||
| Loss on drying | ≤11.0% | "Aurantii fructus：≤12.0% Aurantii fructus immaturus：≤15.0%" | |||
| Total ash | ≤10.0% | "Aurantii fructus：≤7.0% Aurantii fructus immaturus：≤7.0%" | |||
| Ethanol-soluble extractive | |||||
| ASSAY | Content | ≥8.0% of total flavonoids, expressed as naringin (dried drug) | "Aurantii fructus：naringin≥4.0%,neohesperidin≥3.0% Aurantii fructus immaturus：synephrine≥0.30%" | ||
| 48 | Black Cohosh | IDENTIFICATION | Microscopic examination | powder | powder |
| Thin-layer chromatography | Actein，23-Epi-26-deoxyactein | ferulic acid, isoferulic acid | |||
| TESTS | Loss on drying | ≤12.0% | ≤13.0% | ||
| Foreign matter | ≤5.0% | ≤5.0% | |||
| Total ash | ≤10% | ≤8% | |||
| Ash insoluble in hydrochloric acid | ≤5% | ≤4% | |||
| Ethanol-soluble extractive | - | ≥17.0% | |||
| Substitution by Cimicifuga americana Michx., C. foetida L., C. dahurica (Turcz.) Maxim. or C. heracleifolia Kom（Thin-layer chromatography） | Actaea racemosa | - | |||
| ASSAY | Adulteration with Cimicifuga americana Michx., C. foetida L., C. dahurica (Turcz.) Maxim. and/or C. heracleifolia Kom.（Thin-layer chromatography） | cimifugin | - | ||
| Content | Minimum 1.0% of triterpene glycosides, expressed as monoammonium glycyrrhizate(dried drug) | isoferulic acid，≥0.10% | |||
| 49 | Black Currant | IDENTIFICATION | Microscopic examination | Microscopical Epicarp | |
| TESTS | |||||
| ASSAY | |||||
| 51 | Black Horehound | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | chlorogenic acid， rutoside trihydrate | ||||
| TESTS | Loss on drying | ≤12.0% | |||
| Total ash | ≤13.0% | ||||
| ASSAY | Content | ≥ 1.5% of total ortho-dihydroxycinnamic acid derivatives, expressed as acteoside (dried drug). | |||
| 52 | Blackcurrant Leaf | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | isoquercitroside， rutoside trihydrate | ||||
| TESTS | Foreign matter | ≤3% | |||
| Loss on drying | ≤10.0% | ||||
| Total ash | ≤12.0% | ||||
| ASSAY | Content | ≥1.0% of flavonoids, expressed as isoquercitroside (dried drug) | |||
| 53 | Bogbean Leaf | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | Loganine | ||||
| TESTS | Loss on drying | ≤10.0% | |||
| Total ash | ≤10.0% | ||||
| Bitterness value | ≥3000 | ||||
| ASSAY | |||||
| 54 | Boldo Leaf | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | boldine， hyoscine hydrobromide | ||||
| TESTS | Essential oil | ≤40 mL/kg (anhydrous drug) | |||
| Foreign matter | ≤4% of twigs and ≤2% of other foreign matter | ||||
| Water | ≤100 mL/kg | ||||
| Total ash | ≤13.0% | ||||
| ASSAY | Content | ≥0.1% of total alkaloids, expressed as boldine(anhydrous drug) | |||
| 55 | Boldo Leaf Dry Extract | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | boldine，hyoscine hydrobromide | ||||
| TESTS | Water | ≤5.0% | |||
| ASSAY | Content | "— for aqueous extracts: ≥ 0.1% of total alkaloids, expressed as boldine (anhydrous extract); — for hydroalcoholic extracts:≥0.2% of total alkaloids, expressed as boldine (anhydrous extract)." | |||
| 56 | Buckwheat Herb | IDENTIFICATION | Microscopic examination | powder | powder |
| Thin-layer chromatography | hyperoside ，rutoside trihydrate | epicatechin，reference drug | |||
| TESTS | Loss on drying | ≤10.0% | ≤15.0% | ||
| Total ash | ≤15.0% | ≤5.0% | |||
| ASSAY | Ethanol-soluble extractive | - | ≥14.0% | ||
| Content | ≥3.0% of rutoside(dried drug) | epicatechin, ≥0.030% | |||
| 57 | Bupleurum Root | IDENTIFICATION | Microscopic examination | powder | - |
| Thin-layer chromatography | Saikosaponin A，Saikosaponin D | Saikosaponin a，Saikosaponin d | |||
| TESTS | Bupleurum longiradiatum Turcz（Thin-layer chromatography） | Saikosaponin A，Saikosaponin D | - | ||
| Loss on drying | ≤10.0% | ≤10.0% | |||
| Total ash | ≤9.0% | ≤8.0% | |||
| Ash insoluble in hydrochloric acid | ≤3.5% | ≤3.0% | |||
| ASSAY | Content | ≥ 0.16% of saikosaponin A (dried drug). | sum of Saikosaponin a and Saikosaponin d ≥ 0.30% | ||
| 58 | Butcher's Broom | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | Stigmasterol，Ruscogenins | ||||
| TESTS | foreign matter | ≤5% | |||
| Loss on drying | ≤12.0% | ||||
| Total ash | ≤12.0% | ||||
| Ash insoluble in hydrochloric acid | ≤5% | ||||
| ASSAY | Content | ≥1.0% of total sapogenins, expressed as ruscogenins [mixture of neoruscogenin and ruscogenin] (dried drug) | |||
| 59 | Calendula Flower | IDENTIFICATION | Microscopic examination | powder | |
| Thin-layer chromatography | caffeic acid ，chlorogenic acid ，rutoside trihydrate | ||||
| TESTS | foreign matter | ≤5% | |||
| Loss on drying | ≤12.0% | ||||
| Total ash | ≤10.0% | ||||
| ASSAY | Content | ≥0.4% of flavonoids, expressed as hyperoside (dried drug) | |||
| 60 | Camphorated Opium Tincture | IDENTIFICATION | Thin-layer chromatography | - | morphine |
| TESTS | Ethanol Content | 56 to 60% v/v | 52 to 60% v/v | ||
| Relative density | 0.90 to 0.92 | - | |||
| ASSAY | Content | Content of anhydrous morphine, 0.045 to 0.055% w/v | Content of morphine,0.425～0.575mg/ml |