2 Pharmacopoeia Standard of Lotus Leaf Pills 2. 1 Name Lotus Leaf Pills
ten thousand
2.2 prescription lotus leaf 320g, lotus root node 64g, thistle 48g, herba cirsii japonici 48g, Anemarrhena asphodeloides 64g, Scutellaria baicalensis charcoal 64g, Rehmannia glutinosa (charcoal) 96g, palm charcoal 96g, Gardenia (coke) 64g, grass charcoal 96g, Scrophularia 96g, Radix Paeoniae Alba 64g, Angelica 32g and scented ink 8g.
2.3 Prepare the above fourteen kinds of ingredients, stir-fry the lotus leaf 160g, soak the remaining lotus leaf with 240g of yellow wine, put it in a jar, cover and seal it, stew it in water until the wine is exhausted, take it out, dry it in the air at low temperature, pulverize it into fine powder together with the remaining thirteen kinds of ingredients such as lotus root festival, sieve it and mix it evenly. Every 100g powder is added with 140 ~ 150g to make honey pills.
2.4 Characteristics This product is a black honey pill; Slight gas, sweet taste, slightly bitter after.
2.5 Identification (1) Take this product, and observe it under the microscope: the starch granules are oblong, with one end larger and some protruding to one side, with a diameter of about 30μm, and the umbilical point is herringbone or short slit, located at the larger end, with obvious stratification (lotus root knot). The epidermal cells on the leaves are polygonal, and the outer wall is * * *; Calcium oxalate cluster crystals are about 40μm in diameter and exist in mesophyll tissue (lotus leaf). The needle-like crystals of calcium oxalate are in bundles or scattered, and the length is 26 ~ 1 10μ m (Anemarrhena asphodeloides). The diameter of calcium oxalate clusters is 18 ~ 32μ m, which exists in parenchyma cells and is often arranged in rows, or a cell contains several clusters (Paeonia lactiflora). The bast fiber is light yellow, spindle-shaped, thick-walled, with pores and grooves (Scutellaria baicalensis Georgi). The fiber bundles are brown, and the round cells on the surface contain siliceous blocks (palm charcoal). The stone cells in seed coat are yellow or light brown, mostly broken, and the intact ones are polygonal, rectangular or irregular, with thick walls, large round holes and brownish red cells (Gardenia jasminoides Ellis). Stone cells are yellowish brown or colorless, rectangular, round or irregular, with obvious bedding and a diameter of about 94μm (Scrophularia). Epidermal cells are arranged in rows, often connected by 1 long cell and 2 short cells. The long cell wall is wavy and curved, slightly thickened and lignified (grass root charcoal). Irregular blocks are brownish black or black (fragrant ink).
(2) Take 65438±08g of this product, chop it up, add 65438±05g of diatomite, grind it evenly, add 65438±000ml of ether, let it stand for 65438±0h, shake it evenly from time to time, filter it, evaporate the filtrate, and add 65438±0ml of absolute ethanol to the residue to make it dissolve, so as to serve as the test solution. In addition, 0.2g of Angelica sinensis was taken as the control medicinal material, and ethanol 10ml was added, and ultrasonic treatment was carried out for 5min, and the filtrate was taken as the control medicinal material solution. According to the thin-layer chromatography test (Appendix ⅵ b of Pharmacopoeia I, 20 10), take 2μl of the test solution and the control medicinal solution 1μl, respectively, and spot them on the same silica gel G thin-layer plate, using n-hexane-ethyl acetate (9: 1) as the developing agent, unfold, take out, dry, and place them in an ultraviolet lamp (UV lamp). In the chromatogram of the test sample, fluorescent spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials.
(3) Take this product 18g, chop it, add 6g of diatomite, grind it evenly, add ethanol 100ml, heat and reflux 1 hr, filter, evaporate the filtrate, soak the residue in ether for 3 times (about 3 minutes each time), pour out the ether, and add 30ml of water to dissolve the residue. Transfer to a separatory funnel, shake and extract with n-butanol for three times, 20ml each time, combine n-butanol solutions, evaporate to dryness, add 5ml of ether to the residue to dissolve it, add neutral alumina column (200-300 mesh, 5g, inner diameter 1cm), elute with 15ml of ether, collect eluent, evaporate to dryness, and add 60% to the residue. In addition, the reference material of Smilax China saponin was added with ethanol to prepare a solution containing 1mg per 1ml as the reference material solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), the test solution 10μl and reference solution 2μl were respectively absorbed on the same silica gel G thin-layer plate, and toluene-acetone (9; 1) as developing agent, developing, taking out, drying, spraying the newly prepared mixed solution of 8% vanillin absolute ethanol solution and sulfuric acid solution (7 → 10) (5: 1), and heating until the spots are clear. In the chromatogram of the test sample, the same yellow spots appear in the position corresponding to the chromatogram of the control sample.
(4) Take this product 18g, chop it up, add 40ml of methanol, ultrasonic for 30 minutes, filter it, evaporate the filtrate, add 10ml of water to dissolve the residue, shake and extract it with water saturated n-butanol twice, 20ml each time, combine the n-butanol solutions, evaporate to dryness, add 20ml of methanol to dissolve the residue, and add it to neutral alumina column (65438). In addition, take gardenoside as reference substance, and add methanol to make a solution containing 65438±0mg per 65438±0ml as reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), absorb 3μl of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, spread them with ethyl acetate-acetone-water (5: 5: 0.6) as the developing agent, take them out, dry them, spray them with 2% vanillin sulfuric acid ethanol solution, and spray them on 65438. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
(5) Take this product 18g, chop it up, add 5ml of concentrated ammonia solution and 40ml of dichloromethane, perform ultrasonic treatment for 30min, filter, evaporate the filtrate, and add dichloromethane 1ml to the residue to make it dissolve, so as to serve as the test solution. In addition, the nuciferine reference substance was added with ethanol to prepare a solution containing 1mg per 1ml as the reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), 5μl of test solution and 2μl of reference solution were absorbed on the same silica gel G thin-layer plate, and the lower solution of dichloromethane ethyl acetate-methanol-water (3: 4: 2: 1) at/kloc-0℃ was used as the developing agent. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
2.6 The inspection shall comply with the relevant provisions under Pills (Appendix of Pharmacopoeia 20 10/A).
2.7 the content was determined by high performance liquid chromatography (appendix ⅵ D of pharmacopoeia I, 20 10).
2.7. 1 chromatographic conditions and system applicability test, using octadecylsilane bonded silica gel as filler; Acetonitrile-water (15: 85) was used as the mobile phase. The detection wavelength is 230 nm. The theoretical plate number should be no less than 2500 calculated by paeoniflorin peak.
2.7.2 Preparation of reference solution Take a proper amount of paeoniflorin reference substance, weigh it accurately, and add methanol to make a solution containing 50μg per kloc-0/ml.
2.7.3 Preparation of test solution Take this product with poor weight, cut it into pieces, mix it evenly, take about 5g, weigh it accurately, put it in a conical flask with a stopper, add 50ml of methanol accurately, plug it, weigh it, perform ultrasonic treatment (power 250W, frequency 33kHz) for 30min, let it cool, weigh it again, make up for the weightlessness with methanol, and shake it evenly.
2.7.4 Determination method Accurately absorb 65,438+00μ l of control solution and test solution respectively, inject them into liquid chromatograph, and determine to obtain the product.
Each pill of this product contains paeoniflorin (C23H28O 1 1), not less than 3.0mg.
2.8 Functions and indications: cooling blood to stop bleeding. Used for hemoptysis, nosebleed, hematuria, hematochezia and metrorrhagia caused by blood heat.
2.9 Oral administration and dosage. 1 pill once, 2 ~ 3 times a day.
2. 10 specifications each weighing 9g.
2. 1 1 storage seal.
2. 12 Edition People's Republic of China (PRC) Pharmacopoeia 20 10 Edition
3. Lotus Leaf Pill in Selected Prescriptions of Beijing Traditional Chinese Medicine 3. 1 Fangming Lotus Leaf Pill
3.2 Lotus leaves (half steamed with wine and half charcoal-fried) 160 Liang (8 Liang for each lotus leaf 16 plus yellow rice wine, the same for steaming and frying), lotus root nodes 32 Liang, large and small thistles (charcoal-fried) 48 Liang, Anemarrhena 32 Liang, Scutellaria baicalensis Georgi charcoal 32 Liang, Rehmannia glutinosa (charcoal-fried) 48 Liang, and Gardenia 48 Liang.
3.3 Efficacy The lotus leaf pill in Selected Prescriptions of Beijing Traditional Chinese Medicine has the effects of clearing away heat and cooling blood, removing blood stasis and stopping bleeding.
3.4 Lotus Leaf Pill indicated in Selected Works of Prescription of Traditional Chinese Medicine in Beijing is mainly used for coughing up blood and vomiting blood, blood in sputum, hemoptysis, epistaxis and blood drowning.
3.5 Usage and dosage: Take 2 pills each time, with warm boiled water, 1, twice a day.
3.6 preparation method