CN101269175A - Quality control method for comfortable wash liquid for hemorrhoids - Google Patents
Quality control method for comfortable wash liquid for hemorrhoids Download PDFInfo
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Abstract
The invention provides a hemorrhoid comforting lotion which is a surgery hemorrhoid OTC drug and can clear heat and dry damp, remove blood stasis to detoxicate, stanch to reduce the swelling, and relive pain and itch as well as is used for the acute bout of hemorrhoid. The quality standard of the prior hemorrhoid comforting lotion can not respond the qualitative method of liquorice and sophora japonica. The invention aims to provide a perfect quality control method for the hemorrhoid comforting lotion on the aspects of liquorice and sophora japonica qualitative analysis and osthole quantity analysis. On the basis of the qualitative method and the quantitative method of the invention, the hemorrhoid comforting lotion provides better guarantee for the production, the circulation and the clinical application of the hemorrhoid comforting lotion.
Description
Technical field:
The invention belongs to technical field of Chinese medicines, be specifically related to the method for quality control of comfortable wash liquid for hemorrhoids.
Background technology:
Comfortable wash liquid for hemorrhoids is a surgery hemorrhoid class nonprescription drugs medicine, and it can heat clearing and damp drying, changes the silt detoxifcation, hemostasia and detumescence, and antalgesic-antipruritic is used for the hemorrhoid acute attack.Get an amount of medicinal liquid during use, be diluted to approximately more than 10 times with eliminating cold for resuscitation water, demibain or directly be coated with is washed, and 2 times on the one, a week is a course of treatment.
The prescription of comfortable wash liquid for hemorrhoids, method for making and character are:
Prescription: the Fructus Sophorae 100 gram Radix Notoginseng 80 gram Radix Sophorae Flavescentiss 110 gram Pseudobulbus Bletillae (Rhizoma Bletillae) 100 grams
Fructus Cnidii 100 gram Herba Patriniae 100 gram Folium Artemisiae Argyis 65 grams
Herba Portulacae 80 Keshan Flos Lonicerae 65 gram Radix Saposhnikoviaes 65 grams
Alumen 50 gram Boraxs 50 gram Borneolum Syntheticums 5 gram Radix Glycyrrhizaes 30 grams
Method for making: above 14 flavors, Borneolum Syntheticum adds an amount of dissolve with ethanol; Alumen, Borax dissolve with suitable quantity of water; Radix Notoginseng powder is broken into coarse powder, according to the percolation under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia version in 2005), make solvent with 70% ethanol, flood and carry out percolation, diacolation liquid recycling ethanol after 24 hours, being concentrated into relative density is 1.0-1.1 (50 ℃), medicinal residues are standby, and Flos Lonicerae, Fructus Cnidii, Folium Artemisiae Argyi are extracted volatile oil, and volatile oil adds an amount of polyoxyethylene sorbitan monoleate, mixing, the aqueous solution after the distillation device are in addition collected.Above-mentioned two kinds of medicinal residues merge, decoct with water three times with seven flavors such as all the other Fructuss Sophorae, and 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate be concentrated into crude drug amount ratio be 1: 1, add ethanol and make and contain alcohol amount and reach 60%, stir evenly, left standstill 48 hours, and got supernatant and reclaim ethanol, being concentrated into relative density is 0.9-1.1 (50 ℃), add Borneolum Syntheticum and above-mentioned each medicinal liquid, add water and adjust total amount to 1000 milliliter, stir evenly, embedding, sterilization, promptly.
This product is dark-brown liquid; Has Borneolum Syntheticum fragrance.
The Fructus Sophorae is the fruit of leguminous plant Chinese scholartree.Fructus Sophorae nature and flavor hardship, hot salty, gas is cold, and is nontoxic.The dry pod of the Fructus Sophorae is cylindrical, and crooked sometimes, hanging between seed shortens beaded into, and long 1-6 centimetre, diameter 0.6-1 centimetre.Surface yellow green, brown to brownish black, a lateral edges dorsal suture yellow.The bossed residual base for post in top; Base portion often has fruit stem.Sarcocarp is done the back shrinkage.A little less than the feeble QI, the caramel sample; Mildly bitter flavor.In have seed 1-6 piece.Seed kidney shape, long 8-10 millimeter, wide 5-8 millimeter, thick about 5 millimeters.All produce all parts of the country, ground such as main product Hebei, Shandong, Jiangsu, Liaoning.
Fructus Sophorae flavonoid and isoflavonoid have: the content of genistein, sophoricoside, genistein-4'-glucosidorhamnoside., nimbecetin glucoside-C, sophoraflavonoloside and globulariacitrin, globulariacitrin is very high, reaches 46% in the young fruit.Sophoricoside content is that 1.5-2.0%. sophoraflavonoloside content is 0.8%.Other contains sophorose 0.4%.Seed oil-containing 9.9%.In the free or bonded fatty acid, oleic acid is 22.3%, and linoleic acid is 53%, and linolenic acid is 12%.
The effect of the Fructus Sophorae comprises: heat clearing away, profit liver, removing heat from blood, hemostasis.Control hemorrhoidal hamorrhage and rush down blood, hemorrhoidal bleeding, metrorrhagia, stranguria with blood, dysentery, the ambition unhappiness, the dizziness due to wind pathogen desire is fallen, erosion of vulva pruritus due to damp pathogen; Pathogen heat in main five is ended saliva and spittle, mends exhausted the wound, five hemorrhoid, and burn, married woman's breast abdominal mass, son is hidden shoot; Control husband woman erosion of vulva pruritus due to damp pathogen; Clear away heart-fire, the fire of lung, spleen, liver, large intestine.The modern study proof Fructus Sophorae can be to staphylococcus and escherichia coli.
Radix Glycyrrhizae is the root and the root stock of glycyrrhizic legume.
Radix Glycyrrhizae is a perennial herb, high about 30-70 centimetre, seldom reach 1 meter, and rhizome is cylindric; Main root is very long, and is thick, and the crust bronzing is to crineous.Stem is upright, be with slightly wooden, by white undercoat and glandular scale or gland shape hair.The odd number winglike compound leaf, the stipule lanceolar, caducous; Lobule 4-8 is right, and petiolule is very short, is permitted for long 1 millimeter; Vanelets oval, ovum shape ellipse or idol are bordering on circle, and long 2-5.5 centimetre, wide 1.5-3 centimetre, anxious point of tip or nearly blunt shape, base portion are circular usually, and the two sides is by glandular scale and undercoat.The raceme axil is given birth to, spend intensive, long 5-12 centimetre; Calyx is bell, is about 1/2 long slightly into corolla, calyx tooth 5, and lanceolar, slightly long than calyx tube, outward by undercoat and glandular scale; Corolla is pale purple violet, is about 14 millimeters, and vexil is big, rectangular ellipse, and tip circle or little lacking,, short pawl is arranged at the bottom, and fossil fragments are straight, and are short than ala, and long pawl is all arranged; Stamen 10,2 bodies, filigree is different in size, and flower pesticide differs in size; Gynoecium 1, the ovary stockless.Pod wire Long Circle, sickle shaped or bending in the form of a ring, common wide 6-8 millimeter, close by the thorn-like glandular hair of brown.Seed 2-8, oblateness or kidney shape, black is smooth.The florescence 6-7 month.The fruit phase 7-9 month.Be born in the ground such as exsiccant calcareous grassland, riverbank sand soil that face south.
Ground such as Radix Glycyrrhizae distribution northeast, northwest, North China, the main product Inner Mongol, Gansu; Secondly be ground such as Shaanxi, Shanxi, Liaoning, Jilin, Heilungkiang, Hebei, Qinghai, Xinjiang.With Ih Ju League, Inner Mongol Hangjin Banner institute product matter optimum.
The Radix Glycyrrhizae root and rhizome contains glycyrrhizin, be potassium, the calcium salt of glycyrrhizic acid (glycyrrhizic acid), liquiritin (liquiritin), liquiritigenin (liquiritigenin), isoliquiritin (isoliquiritin), different Radix Glycyrrhizae unit (isoliquritigenin), neoliquriitin (neo-liquiritin), neoisoliquiritin (neoiso-liquiritin) etc.
The Radix Glycyrrhizae nature and flavor are sweet flat.The effect of Radix Glycyrrhizae comprises: and middle emergency, lung moistening, detoxifcation, coordinating the actions of various ingredients in a prescription.Process usefulness, control weakness of the spleen and stomach, lack of appetite, stomachache loose stool, overstrain heating, consumptive lung disease cough, cardiopalmus, infantile convulsion; Give birth to usefulness, control laryngopharynx swelling and pain, peptic ulcer, ulcer sores is separated poison of drug and alimentary toxicosis." herbal classic ": main the five internal organs six mansion cold and heat pathogens, hard muscles and bones, longue meat, times power, incised wound is swollen, detoxifcation.Warming the middle warmer and descending qi, stuffy sensation with restlessness is losed heart, and hinders dirty cough, quench the thirst, qualcomm meridian, sharp vim and vigour are separated hundred poison of drug." property of medicine opinion ": cold type of pain in the main abdomen, control infantile convulsion, remove distention and fullness in the abdomen; The tonification the five internal organs; Make all poison of drug; Support the kidney qi internal injury, make us cloudy (no) flaccidity; Housewife's human blood drop lumbago; Void and frequent fever; Add and use it.Materia Medica of Decoction: control the pus and blood of consumptive lung disease, and make vomitory; Disappear five skin ulcer cellulitis is with the same merit of Radix Astragali.
Fructus Cnidii is the fruit of samphire cnidium monnieri.Fructus Cnidii is an annual herb, high 30-80 centimetre.Stem is upright, and is cylindrical, and vertical rib is arranged, and dredges and gives birth to fine and soft hair.The root leave has handle, and base portion has short and wealthy sheath; Blade is avette, and 2-3 returns pinnation, final sliver wire lanceolar, and tip is sharp-pointed; The leaf on stem top is similar with the root leave, but petiole is shorter.Give birth to or adnation on the universal umbel top, 10-25 on umbrella stalk, and base portion phyllary 8-10, linear, the tool echinid; Involucel sheet 8-10, linear; The calyx tooth is not obvious, petal 5, and white, obovate, tip is recessed, and the uvula of the narrow invagination of tool; Stamen 5, with the petal alternate, filigree is elongated, the flower pesticide ellipse; Ovary is the next, 2 pieces of styles, style base portion taper shape.The diachenium ellipse, the fruit rib becomes aliform, does not have hair.The florescence 4-7 month, the fruit phase 6-8 month.Be born in the thick grass of hillside, or field, roadside.All there is distribution in the most of area of China.
Fructus Cnidii contains volatile oil 1.3%, and main component is pinene, camphene, bornival, isoborneol.Contain osthole again, cnidimine, isopimpinellin, bergapton, columbianetin and angelate thereof, acetas and isovalerate, cnidiadin, isobutyl acyloxy o-acetylcolumbianetin.
The Fructus Cnidii pharmacological action comprises: anti-trichomonal is done in order to liver extract as culture medium, 10% and 20% Fructus Cnidii decoct to trichomonas vaginitis do not have killing action or extremely a little less than, the external effect of also not having the trichomonas vaginitis killed of osthole.Report is also arranged to the trichomonas vaginitis responder, but its result's reliability remains further to be confirmed.
Fructus Cnidii is arduous, warm.The effect of Fructus Cnidii comprises: warming the kidney to activate YANG, dispel the wind dampness, parasite killing.Swell and ache in housewife people's the moon, man's impotence, pruritus due to damp pathogen remove stagnated QI, sharp joint, and epilepsy is disliked wound.
Osthole has another name called methoxyl group Europe a kind of reed mentioned in ancient books phenol or osthole, belongs to coumarin kind compound, prism-shaped crystallization (ether), acicular crystal (Diluted Alcohol).Fusing point 83-84 ℃.Boiling point 145-150 ℃.Be dissolved in aqueous slkali, methanol, ethanol, chloroform, acetone, ethyl acetate and the petroleum ether etc. that boils, water insoluble and petroleum ether.CAS registration number: 484-12-8, molecular formula: C
15H
16O
3, molecular weight: 244.29.Osthole has spasmolytic, blood pressure lowering, arrhythmia, raise immunity and broad-spectrum antibacterial action, is the important indicator material of Fructus Cnidii medical material.
The Fructus Sophorae, Radix Glycyrrhizae and Fructus Cnidii have all been brought into play irreplaceable effect in comfortable wash liquid for hemorrhoids, thereby are the internal needs that guarantees that medicine plays a role to this 3 flavor medical material monitoring in comfortable wash liquid for hemorrhoids.
There is disappearance in qualitative method of quality control at the Radix Glycyrrhizae and the Fructus Sophorae in the present comfortable wash liquid for hemorrhoids, does not especially have the quantitative detecting method of relevant Fructus Cnidii in the comfortable wash liquid for hemorrhoids.
Summary of the invention:
The objective of the invention is to provides the method for quality control of comfortable wash liquid for hemorrhoids more reliably from the qualitative identification of the Radix Glycyrrhizae and the Fructus Sophorae and quantitative analysis two aspects of osthole.
Particularly, method of quality control of the present invention is: get 20 milliliters of described washing liquids, add ethyl acetate extraction 2 times, each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, as need testing solution; Extracting liquorice control medicinal material 2 grams add 20 ml waters and decoct 2 times in addition, each 0.5 hour, filter, filtrate is concentrated into 20 milliliters, adds ethyl acetate extraction 2 times, and each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, in contrast medical material solution; Draw each 20 microlitre of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is an adhesive, toluene-ethyl acetate-formic acid was according to proportioning developing solvent in 20: 7: 0.5, launch, take out, dry, spray is with 1% phosphorus molybdenum acid solution, it is clear to be heated to speckle colour developing, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical speckle.
Above-mentioned method of quality control further is: get 20 milliliters of described washing liquids, add ethyl acetate extraction 2 times, each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, as need testing solution; Extracting liquorice control medicinal material 2 grams add 20 ml waters and decoct 2 times in addition, each 0.5 hour, filter, filtrate is concentrated into 20 milliliters, adds ethyl acetate extraction 2 times, and each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, in contrast medical material solution; It is an amount of that other gets Fructus Sophorae glycosides reference substance, adds 0.5 milliliter of methanol, makes saturated solution, in contrast product solution; According to the thin layer chromatography test, draw each 5 microlitre of above-mentioned two kinds of solution, put respectively on same polyamide lamellae, with 60% acetic acid is developing solvent, launch, take out, dry, spray is with 1% aluminum chloride alcoholic solution, dry, put ultra-violet lamp and under 365nm, inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical fluorescence speckle.
Comfortable wash liquid for hemorrhoids described in the above-mentioned method of quality control contains Fructus Cnidii in osthole for per 1 milliliter, is no less than 11.5 micrograms.
Above-mentioned method of quality control is measured described washing liquid in accordance with the following methods:
Chromatographic condition and system suitability: with octadecylsilane chemically bonded silica is packed column; Mobile phase: water-acetonitrile ratio is 40: 60; The detection wavelength is 321nm; Column temperature: room temperature; Number of theoretical plate calculates by the osthole peak should be not less than 2000;
The preparation of reference substance solution: it is an amount of to the osthole reference substance of constant weight that precision takes by weighing in phosphorus pentoxide desiccator drying under reduced pressure, adds ethanol and make per 1 milliliter of solution that contains osthole 150 micrograms, promptly;
The preparation of need testing solution: precision is measured 20 milliliters of this product, puts in the separatory funnel, extract 3 times with the ether jolting, and each 20 milliliters, merge ether extracted liquid, with 10 milliliters of washings of 5% ammonia solution, standing demix discards ammonia solution, inclines and gets the ether supernatant; Remain a small amount of emulsion layer with ether washing 2 times, each 5 milliliters, merge ether solution, evaporate to dryness, residue add standardize solution in the volumetric flask that dissolve with ethanol is transferred to 25 milliliters, shake up, and cross 0.45 micron microporous filter membrane, promptly;
Algoscopy: accurate respectively above-mentioned reference substance and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
Qualitative and quantitative bonded method of quality control of the present invention is for production, circulation and the clinical practice of medicine provides better guarantee.By actual detected result of the present invention, show that every milliliter contains Fructus Cnidii and all is no less than 11.5 micrograms with the content of osthole.Thereby in order to improve the verity of comfortable wash liquid for hemorrhoids,, embody the true quality of medicine for fear of adulteration in actual detected, the inventor with in the comfortable wash liquid for hemorrhoids every milliliter contain Fructus Cnidii and be decided to be with the content of osthole and be no less than 11.5 micrograms.
The specific embodiment:
Following experimental example further describes the present invention, but described experimental example only is used to illustrate the present invention rather than restriction the present invention.
Experimental example 1
The comfortable wash liquid for hemorrhoids of 5 lot numbers of random choose (lot number is: 20070911-1,20070913-1,20071918-1,20071103-1 and 20071005-1) adopts this method to repeat 5 batches comfortable wash liquid for hemorrhoids.
Get this product 20ml, add ethyl acetate extraction 2 times, each 30ml, combined ethyl acetate liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Extracting liquorice control medicinal material 2g adds the 20ml decocting and boils 2 times in addition, and each 0.5 hour, filter, filtrate is concentrated into 20ml, adds ethyl acetate extraction 2 times, each 30ml, combined ethyl acetate liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 20 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is an adhesive, with toluene-ethyl acetate-formic acid (20: 7: 0.5) is developing solvent, launch, take out, dry, spray is with 1% phosphorus molybdenum acid solution, and it is clear to be heated to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical speckle.
The thin layer of Radix Glycyrrhizae contrast in the table 1 pair comfortable wash liquid for hemorrhoids
Experimental example 2
The comfortable wash liquid for hemorrhoids of 5 lot numbers of random choose (lot number is: 20070911-1,20070913-1,20071918-1,20071103-1 and 20071005-1) adopts this method to repeat 5 batches comfortable wash liquid for hemorrhoids.
Get this product 20ml, add ethyl acetate extraction 2 times, each 30ml, combined ethyl acetate liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.It is an amount of that other gets Fructus Sophorae glycosides reference substance, adds methanol 0.5ml, makes saturated solution, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same polyamide lamellae, with 60% acetic acid is developing solvent, launches, and takes out, dry, spray is dried with 1% aluminum chloride alcoholic solution, puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical fluorescence speckle.
The thin layer of Fructus Sophorae contrast in the table 2 pair comfortable wash liquid for hemorrhoids
Experimental example 3
The comfortable wash liquid for hemorrhoids of 5 lot numbers of random choose (lot number is: 20070911-1,20070913-1,20071918-1,20071103-1 and 20071005-1) is measured comfortable wash liquid for hemorrhoids according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
[assay] measured according to high performance liquid chromatography (2005 editions appendix VID of Chinese Pharmacopoeia).
Chromatographic condition and system suitability test are packed column with octadecylsilane chemically bonded silica; Mobile phase: water-acetonitrile (40: 60); The detection wavelength is 321nm; Column temperature: room temperature.Number of theoretical plate calculates by the osthole peak should be not less than 2000.
It is an amount of to the osthole reference substance of constant weight that the preparation precision of reference substance solution takes by weighing in phosphorus pentoxide desiccator drying under reduced pressure, adds ethanol and make the solution that every 1ml contains osthole 150 μ g, promptly.
The preparation precision of need testing solution is measured this product 20ml, puts in the separatory funnel, extracts 3 times with the ether jolting, and each 20ml merges ether extracted liquid, and with 5% ammonia solution 10ml washing, standing demix discards ammonia solution, inclines and gets the ether supernatant.Remain a small amount of emulsion layer and wash 2 times, each 5ml with ether.Merge ether solution, evaporate to dryness, residue add standardize solution in the volumetric flask that dissolve with ethanol is transferred to 25ml, shake up, and cross microporous filter membrane (0.45 μ m), promptly.
Accurate respectively above-mentioned reference substance and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
The detection data of osthole in the table 3 pair comfortable wash liquid for hemorrhoids
By actual detected result of the present invention, show that every milliliter contains Fructus Cnidii and all is no less than 11.5 micrograms with the content of osthole.Thereby in order to improve the verity of comfortable wash liquid for hemorrhoids,, embody the true quality of medicine for fear of adulteration in actual detected, the inventor with in the comfortable wash liquid for hemorrhoids every milliliter contain Fructus Cnidii and be decided to be with the content of osthole and be no less than 11.5 micrograms.
Claims (4)
1. the method for quality control of a comfortable wash liquid for hemorrhoids, it is characterized in that: get 20 milliliters of described washing liquids, add ethyl acetate extraction 2 times, each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, as need testing solution; Extracting liquorice control medicinal material 2 grams add 20 ml waters and decoct 2 times in addition, each 0.5 hour, filter, filtrate is concentrated into 20 milliliters, adds ethyl acetate extraction 2 times, and each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, in contrast medical material solution; Draw each 20 microlitre of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is an adhesive, toluene-ethyl acetate-formic acid was according to proportioning developing solvent in 20: 7: 0.5, launch, take out, dry, spray is with 1% phosphorus molybdenum acid solution, it is clear to be heated to speckle colour developing, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical speckle.
2. method of quality control according to claim 1 is characterized in that: get 20 milliliters of described washing liquids, add ethyl acetate extraction 2 times, each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, as need testing solution; Extracting liquorice control medicinal material 2 grams add 20 ml waters and decoct 2 times in addition, each 0.5 hour, filter, filtrate is concentrated into 20 milliliters, adds ethyl acetate extraction 2 times, and each 30 milliliters, combined ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, in contrast medical material solution; It is an amount of that other gets Fructus Sophorae glycosides reference substance, adds 0.5 milliliter of methanol, makes saturated solution, in contrast product solution; According to the thin layer chromatography test, draw each 5 microlitre of above-mentioned two kinds of solution, put respectively on same polyamide lamellae, with 60% acetic acid is developing solvent, launch, take out, dry, spray is with 1% aluminum chloride alcoholic solution, dry, put ultra-violet lamp and under 365nm, inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical fluorescence speckle.
3. according to claim 1 or 2 described method of quality control, it is characterized in that described comfortable wash liquid for hemorrhoids contains Fructus Cnidii in osthole for per 1 milliliter, is no less than 11.5 micrograms.
4. method of quality control according to claim 3 is characterized in that and will measure described washing liquid in accordance with the following methods:
Chromatographic condition and system suitability: with octadecylsilane chemically bonded silica is packed column; Mobile phase: water-acetonitrile ratio is 40: 60; The detection wavelength is 321nm; Column temperature: room temperature; Number of theoretical plate calculates by the osthole peak should be not less than 2000;
The preparation of reference substance solution: it is an amount of to the osthole reference substance of constant weight that precision takes by weighing in phosphorus pentoxide desiccator drying under reduced pressure, adds ethanol and make per 1 milliliter of solution that contains osthole 150 micrograms, promptly;
The preparation of need testing solution: precision is measured 20 milliliters of this product, puts in the separatory funnel, extract 3 times with the ether jolting, and each 20 milliliters, merge ether extracted liquid, with 10 milliliters of washings of 5% ammonia solution, standing demix discards ammonia solution, inclines and gets the ether supernatant; Remain a small amount of emulsion layer with ether washing 2 times, each 5 milliliters, merge ether solution, evaporate to dryness, residue add standardize solution in the volumetric flask that dissolve with ethanol is transferred to 25 milliliters, shake up, and cross 0.45 micron microporous filter membrane, promptly;
Algoscopy: accurate respectively above-mentioned reference substance and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110824095A (en) * | 2019-11-29 | 2020-02-21 | 北京康仁堂药业有限公司 | Method for identifying morinda officinalis formula particles and prepared morinda officinalis formula particles |
| CN114159352A (en) * | 2021-12-16 | 2022-03-11 | 广州温雅日用化妆品有限公司 | Bacteriostatic and itching-relieving foam shampoo |
| CN114159352B (en) * | 2021-12-16 | 2024-06-28 | 广州温雅日用化妆品有限公司 | Foam shampoo with antibacterial and antipruritic effects |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109115923A (en) * | 2018-08-20 | 2019-01-01 | 四川新绿色药业科技发展有限公司 | A kind of quality determining method of Fructus Sophorae granule |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110824095A (en) * | 2019-11-29 | 2020-02-21 | 北京康仁堂药业有限公司 | Method for identifying morinda officinalis formula particles and prepared morinda officinalis formula particles |
| CN114159352A (en) * | 2021-12-16 | 2022-03-11 | 广州温雅日用化妆品有限公司 | Bacteriostatic and itching-relieving foam shampoo |
| CN114159352B (en) * | 2021-12-16 | 2024-06-28 | 广州温雅日用化妆品有限公司 | Foam shampoo with antibacterial and antipruritic effects |
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