CN100434092C - Prescription containing sweet clover component and its formulation - Google Patents
Prescription containing sweet clover component and its formulation Download PDFInfo
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- CN100434092C CN100434092C CNB2005101154493A CN200510115449A CN100434092C CN 100434092 C CN100434092 C CN 100434092C CN B2005101154493 A CNB2005101154493 A CN B2005101154493A CN 200510115449 A CN200510115449 A CN 200510115449A CN 100434092 C CN100434092 C CN 100434092C
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Abstract
The present invention relates to a Chinese materia medica formulation, particularly to a prescription containing a sweet clover component and a formulation thereof. 1 to 5kg of sweet clover is adopted as a raw material, and after processed, the sweet clover can be made into 1000 dosages of the medicinal formation. The formulation of the present invention can be used for eliminating tumefaction.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation, particularly a kind of Chinese medicine preparation made from melilotus can be used for eliminating swelling.
Background technology:
Clover formulation is to be the Chinese medicine preparation that primary raw material is made with leguminous plant melilotus (Melilotus officinalis Lam.) extract.The Melilotus sweetclover leguminous plant, be distributed in mountain region, Northern Europe, middle part, Asia, be used for detumescence, antiinflammatory, diuresis, can treat inflammatory external hemorrhoid, thrombosed external hemorrhoid, each phase internal hemorrhoid, that various types of hemorrhoid such as mixed hemorrhoid cause is hemorrhage, pain, deviate from, swelling, pruritus etc., to having pain relieving, repercussive effect after the anal orifice and rectal intestine operation, illness such as phlebitis and disturbance of blood circulation are had certain curative effect, also be used for the treatment of rheumatoid arthritis.
The vegetable formal name of melilotus " Melilotus " speech originates from Greek, epoch are just used as medicine by people in Greece, nineteen fifty-nine is concerned about that always the people such as Becker, Kellner of phytotherapy have done preliminary study to the pharmacology of melilotus stream immersion, and the main component of finding it is coumarin (Cumarin).After entering the seventies in 20th century, more extensive to the pharmacological research and the clinical practice of the immersion of melilotus stream, the immersion of melilotus stream is widely used in Japan and European various countries.In China application is arranged also.
Hemorrhoid are ten minutes ancient disease, the human history in existing more than 4000 year of understanding to hemorrhoid.Since the seventies in 20th century, the research of relevant hemorrhoid obtains breakthrough.People have had new understanding to hemorrhoid, have established the sick Therapeutic Principle of hemorrhoid of science; These ideas and principle are accepted extensively by at present domestic and international anorectal educational circles, and are seen in the analogy monograph of publishing recently both at home and abroad and authoritative science textbook.In 2000 " hemorrhoid diagnosis and treatment tentative standard " to hemorrhoid just like giving a definition: " hemorrhoid are local agglomerates that anus pad pathologic hypertrophy, displacement and crissum veins beneath the skin clump stasis of blood stream form." the hemorrhoid disease is a kind of multi-factor disease, it is to be caused by mechanicalness factor and chemical factor at least, and is increased the weight of by a plurality of factor.The treatment of hemorrhoid is the cardinal symptoms that alleviate, eliminate hemorrhoid by detumescence, dehydration, pain relieving.
Because modern society's competition is growing more intense, a lot of people's spirit are in tension always, simultaneously along with growth in the living standard, the food that people drink is more and more meticulousr, cause the un-reasonable phenomenon of dietary structure, also have various bad habits etc. all multifactor in addition, the sickness rate that causes China's anal and intestinal disease is with annual 16% increase at a high speed, so hemorrhoid medicine has a very big market potential.The hemorrhoid treating medicine of hospital's use is mainly based on the external dosage form at home, wherein suppository, these two kinds of dosage forms of ointment occupy share and reach more than 50%, this has inseparable relation with traditional to the hemorrhoid treating method, and tablet, the hemorrhoid medicine proportion of dosage form such as injection, capsule is very little, has certain prospect of marketing.
Detumescence is the problem that the clinician often handles, and especially surgery swelling is very common.For example various wounds, sprain, dampen, fracture, burn etc., swelling is one of main clinical performance; Angiopathys such as varicose veins of the lower extremity, swelling also are common symptoms; Radical operation of mastocarcinoma, thyroidectomy, replantation of severed limb, plastic operation, tumor resection or radiotherapy also are easy to cause complication such as swelling.Slight swelling can cause the pain discomfort, influences wound healing, serious swelling even can threat to life.Therefore, the harm of swelling can not be ignored.Detumescence medicine effective and easy to use promotes patient's early recovery for removing patient's slight illness, reduces medical expense and plays an important role, and be very to need clinically.
The kind of Chinese patent drugs for treatment hemorrhoid cures mainly difference according to function and is divided into four classes: (1) purging fire and cooling blood medicine; (2) heat clearing away, dispel the wind, damp-excreting medicinal; (3) nourish blood, QI invigorating, solid reagent removal; (4) moisturize, YIN nourishing, clearing away damp-heat medicine, but mostly be compound Chinese medicinal preparation, in the majority with external used medicine again, and pure Chinese medicine single medicinal material preparation, oral drugs are few especially, clover formulation can suppress the heavily absorption of renal tubules sodium and chlorine, the effect of performance inducing diuresis to remove edema.
The data of existing melilotus extract seldom, to the research of extracting method still less, and extraction process complexity, the cost costliness, raw material is rare, difficult quality control, and the present invention is by a large amount of screenings, find a kind of good extracting method and fine raw material resources, overcome the difficult problem of difficult quality control simultaneously.
Summary of the invention:
The invention provides a kind of melilotus Chinese medicine preparation, said preparation is formed through processing and preparing by the Chinese medicine melilotus.
The present invention selects for use melilotus 1-5kg as raw material, through can be made into 1000 doses of pharmaceutical preparatioies after the processing.
Preferably melilotus raw material 2-3kg makes 1000 doses of pharmaceutical preparatioies.
Most preferably melilotus raw material 2.5kg makes 1000 doses of pharmaceutical preparatioies.
Described melilotus raw material is taken from area, the Inner Mongol, cultivates through wild mode to obtain, and according to screening of the present invention, it is the highest that this raw material contains active constituents of medicine, is 0.21-0.28%.Other areas comprise that the material medicine active component that external raw material and other planting types obtain is 0.0022-0.19%, the raw material of selecting for use far below the present invention.
Pharmaceutical preparation of the present invention is meant for 1000 doses, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml, 1000 of injections or 1000ml etc.
More than composition, can increase or reduce when producing as proportioning by crude drug weight according to corresponding proportion, can be unit with the ton as large-scale production, and small-scale production can be unit with the gram also, and weight can increase or reduce.
Chinese medicine preparation of the present invention is by the raw material of Chinese medicine of above-mentioned prescription being processed through extraction or other modes, being made pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes preparation of the present invention according to the routine techniques of galenic pharmacy.Described active substance can obtain by the method that is selected from following mode, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutical preparation of the present invention, the pharmaceutical dosage forms of unit dose preferably, can make any pharmaceutically useful dosage form when making pharmaceutical preparation, these dosage forms are selected from: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preferably oral formulations form, most preferably tablet.
Pharmaceutical preparation of the present invention, its pharmaceutically active substance preferably prepare through following method:
Get melilotus, add the submergence of 50-95% ethanol, the room temperature merceration is packed into after 1-3 hour in the percolation bucket, continues to soak after 10-40 hour to begin percolation, regulates flow velocity, every 20-80g collects percolate with the flow velocity of 1mL/min, collect 10-40 altogether and doubly measure, the percolate low-temperature reduced-pressure reclaims ethanol, is condensed into extractum, the relative density that makes extractum is 1.18～1.22, the content of its paste-forming rate of sampling and measuring, coumarin.
Most preferred preparation method is as follows:
Get melilotus, add 70% ethanol submergence, the room temperature merceration is packed into after 2 hours in the percolation bucket, continues to soak after 22 hours to begin percolation, regulates flow velocity, every 40g collects percolate with the flow velocity of 1mL/min, collect 18 times of amounts altogether, percolate low temperature (＜60 ℃) decompression recycling ethanol is condensed into extractum, the relative density that makes extractum is 1.18～1.22 (40～50 ℃ of surveys), respectively the content of its paste-forming rate of sampling and measuring, coumarin.
Pharmaceutical preparation of the present invention, its preferred tablet formulation is as follows:
Melilotus extractum 60g
Starch 60g
Lactose 30g
Hydroxypropyl cellulose 1.25g
Magnesium stearate 0.5g
Pulvis Talci 5g
--------------------------
Make 1000
Three, preparation process
Get melilotus extractum 60g, add starch 60g, lactose 30g, hydroxypropyl cellulose 1.25g, make granule, drying, granulate adds Pulvis Talci 5g and magnesium stearate 0.5g mix homogeneously, makes 1000, sugar coating, promptly.
The present invention also comprises melilotus medical material of the present invention, and the method for quality control of extractum and tablet thereof is described below respectively:
The quality standard of melilotus medical material
Comprise discriminating, the assay step.
Specific as follows:
The dry herb of melilotus leguminous plant melilotus Melilotus officinalis (Linn.) Pall..
This product should meet (the standard numbering WS of pertinent regulations under " Chinese Plants will " 42 second fascicles and Ministry of Health of the People's Republic of China's " drug standard "-the 65th page of melilotus item of Tibetan medicine
3-BC-0065-95).
[discriminating] gets melilotus coarse powder 1.0g, adds methanol 10ml, and supersound process 30min is centrifugal, gets supernatant, as need testing solution.It is an amount of that other gets the coumarin reference substance, adds dissolve with methanol, makes the solution that every 1ml contains 0.1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 2 μ l of above-mentioned two kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with toluene-ethyl acetate-methanol (100: 2: 0.5) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 80% alcoholic solution of 5% sodium hydroxide.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color.
[assay] photograph high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2000) measure.
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler, and acetonitrile-water-glacial acetic acid (20: 80: 1) is a mobile phase, and flow velocity is 1.0ml/min, detect wavelength 273nm, room temperature, theoretical cam curve are pressed the coumarin peak and are calculated, and should be not less than 4000.
The preparation precision of reference substance solution takes by weighing coumarin reference substance 3.22mg, in the 100ml measuring bottle, adds methanol and is diluted to scale, shakes up, as storing solution, the accurate storing solution 2ml that draws is in the 10ml measuring bottle, add methanol and be diluted to scale, shake up reference substance solution, every 1ml contains coumarin 0.00644mg.
The preparation precision of need testing solution takes by weighing melilotus powder 1.0g, places 100ml tool plug triangular flask, weighs after adding 50% methanol 50ml, merceration spends the night, supersound extraction 30min takes out, and puts to room temperature, weigh and supply weight, the accurate 10ml that draws places the 50ml measuring bottle, adds 50% methanol and is diluted to scale, filter through 0.45 μ m microporous filter membrane, collect subsequent filtrate promptly.
Accurate respectively need testing solution and each the 20 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Coumarin content must not be less than 0.18% in the melilotus.
The quality standard of melilotus stream immersion tablet raw material (extractum)
Comprise character, differentiate, check the assay step.
Specific as follows:
[character] blackish green stiff semifluid; Gas perfume (or spice), bitter in the mouth.
[discriminating] melilotus extractum 0.28g adds methanol 3ml, and supersound process 15min is centrifugal, gets supernatant, as need testing solution, gets melilotus coarse powder 1.0g, adds methanol 10ml, and supersound process 30min is centrifugal, gets supernatant, in contrast medical material solution.It is an amount of that other gets the coumarin reference substance, adds dissolve with methanol, makes the solution that every 1ml contains 0.1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 2 μ l of above-mentioned three kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with toluene-ethyl acetate-methanol (100: 2: 0.5) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 80% alcoholic solution of 5% sodium hydroxide.In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color.
[inspection] extractum relative density (g/mL) is 1.18～1.22 (40～50 ℃ of surveys)
[assay] photograph high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2000) measure.
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler, and acetonitrile-water-glacial acetic acid (20: 80: 1) is a mobile phase, and flow velocity is 1.0ml/min, detect wavelength 273nm, room temperature, theoretical cam curve are pressed the coumarin peak and are calculated, and should be not less than 4000.
The preparation precision of reference substance solution takes by weighing coumarin reference substance 3.22mg, in the 100ml measuring bottle, adds methanol and is diluted to scale, shakes up, as storing solution, the accurate storing solution 2ml that draws is in the 10ml measuring bottle, add methanol and be diluted to scale, shake up reference substance solution, every 1ml contains coumarin 0.00644mg.
The preparation precision of need testing solution takes by weighing melilotus extractum 0.2g in the 100ml measuring bottle, adds 50% methanol 90ml, and supersound extraction 30min takes out, put to room temperature, add 50% methanol and be diluted to scale, shake up, filter through 0.45 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Accurate respectively need testing solution and each the 20 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Raw material extractum must not be less than 0.12% in coumarin content.
The quality standard of melilotus stream immersion sheet
Comprise character, differentiate, check the assay step.
[character] this product is white coated tablet, remove sugar-coat after, show brown, tool fragrance, mildly bitter flavor is puckery.
[discriminating] gets 3 of this product, removes sugar-coat, and porphyrize takes by weighing the 0.14g powder, adds methanol 3ml, and supersound process 15 minutes is centrifugal, gets supernatant, as need testing solution; Get melilotus coarse powder 1.0g, add methanol 10ml, supersound process 30min, centrifugal, get supernatant, in contrast medical material solution; Other gets the sample that lacks melilotus extractum and prepares negative need testing solution according to the need testing solution preparation method; It is an amount of that other gets the coumarin reference substance, adds dissolve with methanol, makes the solution that every 1ml contains 0.1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 2 μ l of above-mentioned four kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with toluene-ethyl acetate-methanol (100: 2: 0.5) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 80% alcoholic solution of 5% sodium hydroxide.In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color, and negative test sample immaculate on the relevant position disturbs.
[inspection] should meet " relevant every regulation under an appendix I of Chinese pharmacopoeia version in 2000 the D tablet item.
[assay] photograph high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2000) measure.
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler, and acetonitrile-water-glacial acetic acid (20: 80: 1) is a mobile phase, and flow velocity is 1.0ml/min, detect wavelength 273nm, room temperature, theoretical cam curve are pressed the coumarin peak and are calculated, and should be not less than 4000.
The preparation precision of reference substance solution takes by weighing coumarin reference substance 3.22mg, in the 100ml measuring bottle, adds methanol and is diluted to scale, shakes up, as storing solution, the accurate storing solution 2ml that draws is in the 10ml measuring bottle, add methanol and be diluted to scale, shake up reference substance solution, every 1ml contains coumarin 0.00644mg.
20 of this product, desaccharide clothing, porphyrize mixing are got in the preparation of need testing solution, precision takes by weighing powder 0.3g, in the 100ml measuring bottle, adds 50% methanol 90ml, supersound extraction 30min, take out, put, add 50% methanol and be diluted to scale to room temperature, shake up, filter through 0.45 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Accurate respectively need testing solution and each the 20 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every of this product must not be less than 0.2mg in coumarin content.
Its function of melilotus sheet of the present invention cures mainly as follows:
1, treats the soft tissue injury swelling that causes because of wound, surgical operation etc.Symptom is as soft tissue injury swelling due to a variety of causes such as bruise, fracture, chronic strain, burn and scald, shaping and beauty, varicosis, phlebitis, lymphatic return obstacle.
2, treat that all kinds hemorrhoid such as each phase internal hemorrhoid, mixed hemorrhoid, inflammatory external hemorrhoid, thrombosed external hemorrhoid cause hemorrhage, deviate from, pain, swelling, pruritus etc.Also can be used for swelling behind the hemorrhoid operation, treatment of pain.
Usage and dosage is as follows:
Ante cibum is oral.
Be used for illness such as wound, fracture, chronic strain, burn and scald, varicosis, phlebitis and lymphatic return obstacle: every day 3 times, each 2-4 sheet.
Be used for operation: 1-3 days begin to take before the art, and every day 3 times, each 4, postoperative serve on 7 days.Need as the state of an illness, can continue to take.
Be used for the hemorrhoid acute attack: every day 3 times, each 4, after the stable disease, every day 3 times, each 2.
Below be part clinical practice data:
The sick multicenter clinical observation of 6 tame hospital application such as Shanghai Changhai Hospital preparation for treating hemorrhoid of the present invention, the result shows that I degree internal hemorrhoid total effective rate reaches 91%, the sick onset of preparation for treating hemorrhoid of the present invention is rapid, evident in efficacy, safe.The sick multicenter clinical observation of 6 tame hospital application such as Beijing ZhaoYang Hospital, Peking University first, the 3rd hospital preparation for treating hemorrhoid of the present invention, the result shows that I degree internal hemorrhoid total effective rate reaches 89.7%, and the sick onset of preparation for treating hemorrhoid of the present invention is rapid, satisfactory effect, safe.
The invention has the advantages that extracting method is simple, the material effective component content height of selecting for use, extracting method productive rate height, method of quality control is accurate, and is simple, convenient, product good effect, few side effects, bioavailability height, instant effect.
Description of drawings:
Fig. 1 is a process chart.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1:
Get melilotus, add 50% pure submergence, the room temperature merceration is packed into after 1 hour in the percolation bucket, continues to soak after 10 hours to begin percolation, regulates flow velocity, every 20g collects percolate with the flow velocity of 1mL/min, collect 10 times of amounts altogether, the percolate low-temperature reduced-pressure reclaims ethanol, is condensed into extractum, the relative density that makes extractum is 1.18～1.22, the content of its paste-forming rate of sampling and measuring, coumarin.
Embodiment 2
Get melilotus, add 70% ethanol submergence, the room temperature merceration is packed into after 2 hours in the percolation bucket, continues to soak after 22 hours to begin percolation, regulates flow velocity, every 40g collects percolate with the flow velocity of 1mL/min, collect 18 times of amounts altogether, percolate low temperature (＜60 ℃=decompression recycling ethanol are condensed into extractum, the relative density that makes extractum is 1.18～1.22 (40～50 ℃ of surveys), respectively the content of its paste-forming rate of sampling and measuring, coumarin.
Embodiment 3
Get melilotus, add 95% ethanol submergence, the room temperature merceration is packed into after 3 hours in the percolation bucket, continues to soak after 40 hours to begin percolation, regulates flow velocity, every 80g collects percolate with the flow velocity of 1mL/min, collect 40 times of amounts altogether, the percolate low-temperature reduced-pressure reclaims ethanol, is condensed into extractum, the relative density that makes extractum is 1.18～1.22, the content of its paste-forming rate of sampling and measuring, coumarin.
Embodiment 4
Tablet formulation is as follows:
Melilotus extractum 60g
Starch 60g
Lactose 30g
Hydroxypropyl cellulose 1.25g
Magnesium stearate 0.5g
Pulvis Talci 5g
------------------------
Make 1000
Technology
Get melilotus extractum 60g, add starch 60g, lactose 30g, hydroxypropyl cellulose 1.25g, make granule, drying, granulate adds Pulvis Talci 5g and magnesium stearate 0.5g mix homogeneously, makes 1000, sugar coating, promptly.
Embodiment 5
The capsule prescription is as follows:
Melilotus extractum 60g
Starch 60g
Lactose 30g
Hydroxypropyl cellulose 1.25g
Magnesium stearate 0.5g
Pulvis Talci 5g
-------------------------
Make 1000
Preparation process
Get melilotus extractum 60g, add starch 60g, lactose 30g, hydroxypropyl cellulose 1.25g, make granule, drying, granulate adds Pulvis Talci 5g and magnesium stearate 0.5g mix homogeneously, encapsulated 1000 promptly.
Embodiment 6
The granule prescription is as follows:
Melilotus extractum 60g
Starch 60g
Sucrose 30g
Hydroxypropyl cellulose 1.25g
-----------------------------
Make 1000g
Preparation process
Get melilotus extractum 60g, add starch 60g, sucrose 30g, hydroxypropyl cellulose 1.25g, make granule, drying, granulate, pack 1000g is promptly.
Claims (3)
1, a kind of preparation method of the medicine clover formulation of subsiding a swelling, it is characterized in that, pharmaceutically active substance wherein is following method preparation: get melilotus, add the submergence of 50-95% ethanol, the room temperature merceration is packed into after 1-3 hour in the percolation bucket, continue to soak after 10-40 hour and begin percolation, regulate flow velocity, every 20-80g collects percolate with the flow velocity of 1mL/min, collects 10-40 altogether and doubly measures, the percolate low-temperature reduced-pressure reclaims ethanol, is condensed into extractum.
2, the preparation method of claim 1, it is characterized in that, the preparation method of wherein said pharmaceutically active substance is as follows: get melilotus, add 70% ethanol submergence, the room temperature merceration is packed into after 2 hours in the percolation bucket, continue to soak after 22 hours and begin percolation, regulate flow velocity, every 40g collects percolate with the flow velocity of 1mL/min, collects 18 times of amounts altogether, the percolate low-temperature reduced-pressure reclaims ethanol, is condensed into extractum.
3, a kind of method of quality control of tablet of the extractum preparation that obtains with claim 1 method comprises: character, differentiate, and check, the assay step,
Wherein said character is: this product is white coated tablet, remove sugar-coat after, show brown, tool fragrance, mildly bitter flavor is puckery; Wherein said discriminating is: get 3 of this product, remove sugar-coat, porphyrize takes by weighing the 0.14g powder, adds methanol 3ml, and supersound process 15 minutes is centrifugal, gets supernatant, as need testing solution; Get melilotus coarse powder 1.0g, add methanol 10ml, supersound process 30min, centrifugal, get supernatant, in contrast medical material solution; Other gets the sample that lacks melilotus extractum and prepares negative need testing solution according to the need testing solution preparation method; It is an amount of that other gets the coumarin reference substance, adds dissolve with methanol, makes the solution that every 1ml contains 0.1mg, product solution in contrast, according to the thin layer chromatography test, draw each 2 μ l of above-mentioned four kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with toluene-ethyl acetate of 100: 2: 0.5-methanol is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp and is inspected with 80% alcoholic solution of 5% sodium hydroxide; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on show the fluorescence speckle of same color, and negative test sample immaculate on the relevant position disturbs;
Wherein said inspection is: should meet " relevant every regulation under an appendix ID of Chinese pharmacopoeia version in 2000 the tablet item;
Wherein said assay is: according to high effective liquid chromatography for measuring;
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler, and acetonitrile-water-glacial acetic acid of 20: 80: 1 is a mobile phase, and flow velocity is 1.0ml/min, detect wavelength 273nm, room temperature, theoretical cam curve are pressed the coumarin peak and are calculated, and should be not less than 4000;
The preparation precision of reference substance solution takes by weighing coumarin reference substance 3.22mg, in the 100ml measuring bottle, adds methanol and is diluted to scale, shakes up, as storing solution, the accurate storing solution 2ml that draws is in the 10ml measuring bottle, add methanol and be diluted to scale, shake up reference substance solution, every 1ml contains coumarin 0.00644mg;
20 of this product, desaccharide clothing, porphyrize mixing are got in the preparation of need testing solution, precision takes by weighing powder 0.3g, in the 100ml measuring bottle, adds 50% methanol 90ml, supersound extraction 30min, take out, put, add 50% methanol and be diluted to scale to room temperature, shake up, filter through 0.45 μ m microporous filter membrane, collect subsequent filtrate, promptly;
Accurate respectively need testing solution and each the 20 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly; Every of this product must not be less than 0.2mg in coumarin content.
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| CN105699581B (en) * | 2014-11-28 | 2019-03-15 | 舒泰神（北京）生物制药股份有限公司 | The construction method and its standard finger-print of the UPLC finger-print of sweet clover medicinal material |
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