CN1283289C - Chinese medicinal formulation for treating dizziness and its quality control method - Google Patents
Chinese medicinal formulation for treating dizziness and its quality control method Download PDFInfo
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- CN1283289C CN1283289C CN 200410074042 CN200410074042A CN1283289C CN 1283289 C CN1283289 C CN 1283289C CN 200410074042 CN200410074042 CN 200410074042 CN 200410074042 A CN200410074042 A CN 200410074042A CN 1283289 C CN1283289 C CN 1283289C
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Abstract
The present invention relates to a traditional Chinese medicine preparation for treating giddiness, and a quality control method, particularly to a traditional Chinese medicine preparation for treating giddiness including tablets and granules, and a novel quality control method. The traditional Chinese medicine preparation is made by processing water plantain, largehead atractylodes rhizome, tuckahoe, dried orange peel, pinellia tuber, glossy privet fruit, yerbadetajo herb, chrysanthemum, twotoothed achyranthes root and licorice root.
Description
Technical field:
The present invention relates to a kind of Chinese medicine pharmaceutical preparation and method of quality control thereof, particularly relate to a kind of Chinese medicine preparation for the treatment of dizziness and comprise the prescription of tablet and granule and new method of quality control.
Background technology:
Dizzy is (vestibule nuclear and contact path thereof, eye in internal ear, acoustic nerve, brain stem and the cerebellum) pathological changes or a kind of unusual sensation that rotatablely moves that dysfunction caused because organ of equilibration, and common forfeiture with equilibrium function.Primary disease belongs to Chinese medicine " dizzy " category.General clinical manifestation: the patient feels own and perhaps feels surrounding rotating around own round the surrounding motion, simultaneously with instability of gait, can not straight line moving, and lasting amesiality and nystagmus etc. during walking.Dizzy is common clinical symptoms, is found in multiple disease.As Meniere disease, vestibular neuronitis, acute festering type labyrinthitis, benign paroxysmal positional vertigo disease, central vertigo etc.The treatment of chemistry medicine can be adopted scopolamine, betahistine, dimenhydrinate, meclizine etc. according to the state of an illness, perhaps takes operative therapy.Generally can cause certain side effect.Chinese medicine is generally all taked determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs.
Preparation of the present invention is that Guilin Sanjin Group Guilin Sanjin Biological Pharmaceutical Limited Liability Company development a kind of treats dizzy Chinese medicine, finished product comprises tablet, two kinds of dosage forms of granule, every bag heavy 8g of granule, tablet: every heavy 0.31g of Film coated tablets, every heavy 0.25g of the plain sheet of coated tablet, the therapeutic effect of two kinds of dosage forms is similar, is invigorating spleen to remove dampness, liver-kidney tonifying.Be used for stagnation of phlegm-damp in middle-JIAO, the giddy that deficiency of the liver and kindey causes, dizziness.Method of quality control is identical.
Preparation of the present invention is as Chinese medicine preparation, and prescription is unique, has good therapeutic effect, but difficult quality control need find a kind of suitable method of quality control to determine the quality of product, and the present invention just provides the prescription and the method for quality control of said preparation.The said preparation prescription is guidance with the Chinese medical theory, and is scientific and reasonable based on clinical practice, and determined curative effect is stable and controllable for quality, no obvious toxic-side effects.
This method of quality control is comparatively perfect, strong operability, and favorable reproducibility, measurement deviation is little, good stability, precision height.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation for the treatment of dizziness and comprise the prescription of tablet and granule and new method of quality control.Chinese medicine preparation of the present invention is processed into by the raw material of Chinese medicine process of following prescription.
Rhizoma Alismatis 100-550 part Rhizoma Atractylodis Macrocephalae 50-320 part Poria 50-340 part Pericarpium Citri Reticulatae 40-250 part
Rhizoma Pinelliae 60-310 part Fructus Ligustri Lucidi 80-450 part Herba Ecliptae 70-460 part Flos Chrysanthemi 80-420 part
Radix Achyranthis Bidentatae 50-360 part Radix Glycyrrhizae 40-250 part
Preferred prescription consists of:
Rhizoma Alismatis 150-350 part Rhizoma Atractylodis Macrocephalae 80-220 part Poria 80-220 part Pericarpium Citri Reticulatae 50-150 part Rhizoma Pinelliae Preparata 80-210 part Fructus Ligustri Lucidi 90-250 part Herba Ecliptae 90-260 part Flos Chrysanthemi 150-220 part Radix Achyranthis Bidentatae 80-160 part Radix Glycyrrhizae 40-150 part
Most preferred prescription consists of:
125 parts of 187.5 parts of Pericarpium Citri Reticulataes of 187.5 parts of Poria of 312.5 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Alismatis
225 parts of Flos Chrysanthemi 200g of 225 portions of Herba Ecliptaes of 187.5 parts of Fructus Ligustri Lucidi of the Rhizoma Pinelliae
100 parts in 125 portions of Radix Glycyrrhizaes of Radix Achyranthis Bidentatae
In more than forming, every part of representative be weight portion, weight is calculated with crude drug, and as if being unit with the gram, more than composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, oral liquid 1000ml, granule 1000g etc. can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time, and oral liquid can be made Different Package such as 5ml/ bottle, 200ml/ bottle, the 100ml/ bottle, the 50ml/ bottle.
More than form, as if being unit with the gram, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 100 bags, take the 1-2 bag at every turn, can take 50-100 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production also can restrain and be unit, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, and is fat or modest as serious symptom or light disease for especial patient, and the proportioning of the amount of can corresponding adjustment forming increases or reduce being no more than 100%, and drug effect is constant.
Raw material of Chinese medicine, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this active substance is raw material, adds the medicine acceptable carrier when needing, and makes pharmaceutical preparation according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, 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.
Pharmaceutically active substance in the pharmaceutical preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every of injection etc., in the unit dose, the amount that contains active substance is 5-800mg, preferably 50-500mg.
Pharmaceutical preparation of the present invention can be any pharmaceutically useful dosage form, these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, injection, suppository, spray, drop pill, patch, slow releasing preparation, controlled release preparation, capsule preferably, granule.
Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, cellulose derivative, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant comprises, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention, particularly capsule are determined usage and dosage according to patient's situation in use, but obey 1-4 time every day, each 1-20 agent, as: 1-20 grain or sheet.
Preparation of the present invention, can adopt following method preparation:
More than ten the flavor medicines, decoct with water 2 times, 0.5-3 hour for the first time, the 2nd time 0.5-2.5 hour, collecting decoction filtered, filtrate is concentrated into relative density 1.05-1.30 (30-90 degree centigrade), add 1-3 and doubly measure ethanol, get supernatant and reclaim ethanol, be condensed into relative density 1.20-1.50 (40-90 degree centigrade) clear paste.Granule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, sucrose, makes granule, drying, and packing is promptly.
Tablet: qinghuo reagent adds right amount of auxiliary materials such as dextrin, Pulvis Talci, magnesium stearate, makes granule, tabletting, promptly.
Capsule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, makes granule, and is encapsulated, promptly.
Also can make any dosage form on the pharmaceutics, as comprise granule, tablet, syrup, oral liquid, drop pill, powder, pill, unguentum, injection etc.
Chinese medicine preparation of the present invention, function cure mainly and are invigorating spleen to remove dampness, liver-kidney tonifying.Be used for stagnation of phlegm-damp in middle-JIAO, the giddy that deficiency of the liver and kindey causes, dizziness.
Chinese medicine preparation of the present invention, pharmacodynamics test show that mice is had good analgesic activity; Make the movable minimizing of mice, escalated dose does not cause sleep yet; Can strengthen the hypnotic effect of chloral hydrate, ethanol; Middle mediator measurement result, this medicine can make rat whole brain norepinephrine, dopamine obviously increase, and simultaneously visible 5-hydroxy tryptamine slightly increases; To normal Canis familiaris L. and pathologic Hypertensive Rats, this medicine presents obvious blood pressure lowering effect; At the whole animal and the myenteron that exsomatizes, has the effect of direct inhibition myenteron; The experiment of rat albumen arthritis shows that this medical instrument has good antiinflammation; Can obviously improve simultaneously the equilibrium function of cerebral ischemic model mice and mice vertigo.
Chinese medicine preparation of the present invention, toxicological test is the result show, this medicine is to mice lavage LD
50Be 481.4g/kg, be equivalent to 1600 times of human oral (1 time) dosage approximately; Gavage heavy dose continuously and (be equivalent to 1/3LD
50) this product 21 days, there is no tangible toxic reaction and delay toxic reaction, hepatic and renal function is not had tangible detrimental effect.
Chinese medicine preparation of the present invention, through first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, three tame hospitals such as second Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi and The People's Hospital, Guangxi Zhuang Autonomous Region, with Herb Gynostemmae Pentaphylli total glycosides tablet (stagnation of turbid phlegm in middle-JIAO card), QIJU DIHUANG WAN (deficiecny of liver-YIN card) compares, dizzy to the stagnation of turbid phlegm in middle-JIAO card, dizzy clinical verification 300 examples of carrying out of deficiecny of liver-YIN card, wherein 2000 examples are organized in treatment, matched group 120 examples, Clinical results shows that this product total effective rate is 91.3%, the matched group effective percentage is 90.8%, two groups of contrast there was no significant differences, prompting this product is dizzy to the stagnation of turbid phlegm in middle-JIAO card, deficiency of the liver and kindey is demonstrate,proved the dizzy clinical efficacy preferably that has.Different pattern of syndrome curative effect comparative results show, dizzy and the deficiency of the liver and kindey of stagnation of turbid phlegm in middle-JIAO card is demonstrate,proved dizzy matched group and treatment group curative effect there was no significant difference, and the clinical symptoms efficacy result shows clinical symptoms that this product can obviously improve various because stagnation of turbid phlegm in middle-JIAO, deficiency of the liver and kindey and cause, similar to matched group.Clinical research has been carried out blood, just routine examination to 300 routine patients, and tangible untoward reaction and toxic and side effects are not all found in the darling renal function inspection, and prompting this product is safe and reliable.
The present invention also provides a kind of method of quality control of XUANYUNNING preparation, and this method can be held the quality of relevant medicine more accurately, reduces drug risk, improves the quality of products.
The method of quality control of XUANYUNNING preparation provided by the invention, the particularly particulate method of quality control of XUANYUNNING sheet and XUANYUNNING can be described below:
3 of Film coated tablets are got in discriminating (1), remove coating, porphyrize, perhaps get granule 5g, add water 15ml, jolting makes dissolving, place, get supernatant and add ethyl acetate 30ml jolting extraction, extracting solution is added on neutral alumina post (10g, 200～300 orders, internal diameter 1.5cm) on, with ethyl acetate 20ml eluting, collect eluent, evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.9g, decocts with water 1 hour, filters, and filtrate is concentrated into about 10ml, adds ethyl acetate 20ml and extracts, and extracting solution evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with normal hexane-ethyl acetate (1: 1) is developing solvent, launch, take out, dry, put in the ammonia steam smoked after, put again under the ultraviolet light (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.(2) get 10 of this product Film coated tablets, remove coating, porphyrize, or get granule 16g, add ethanol 50ml, reflux 40 minutes, filter, filtrate adds hydrochloric acid 1ml, and reflux is concentrated into about 5ml after 1 hour, add water 10ml, extract with petroleum ether (60 ~ 90 ℃) 30ml jolting, divide and get petroleum ether liquid, evaporate to dryness, residue adds ethanol 1ml makes dissolving, as need testing solution.Other evens up pier fruit acid reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, product in contrast.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw test solution 6 μ l, reference substance solution 2 μ l, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol (40: 1) is developing solvent, launch, take out, dry, spray is with the phosphomolybdic acid test solution, and it is clear to be heated to the speckle colour developing at 110 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) get 20 of this product Film coated tablets, or get granule 32g, porphyrize, the 50ml that adds diethyl ether, reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethanol 0.5ml makes dissolving, as need testing solution.Extracting liquorice control medicinal material 3.2g decocts with water 1 hour in addition, filters, and filtrate is concentrated into about 2ml, add ethanol 5ml and stir, filter, filtrate evaporate to dryness, residue add water 5ml makes dissolving, the 10ml jolting that adds diethyl ether is extracted, and extracting solution evaporate to dryness, residue add ethanol 2ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw need testing solution 10 μ l, control medicinal material solution 4 μ l, put respectively in without activatory same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with normal hexane-benzene-ethyl acetate (14: 1: 5) earlier, launch 8cm, taking out, dry, is developing solvent with positive benzene-ethyl acetate-chloroform (14: 3: 6) again, launch 8cm, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Check: should meet every regulation relevant under the tablet item (2000 version " Chinese pharmacopoeia appendix I D), relevant every regulation under the granule agent item (" Chinese pharmacopoeia appendix I C).
Assay: measure according to high performance liquid chromatography (2000 version " Chinese pharmacopoeia appendix VI D).
Chromatographic condition and system suitability test are filler with the octadecane bonded silica gel: methanol-water (40: 60) is a mobile phase; The detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the Hesperidin reference substance, adds Methanamide and make the solution that every 1ml contains 50 μ g, promptly.
20 of this product are got in the preparation of need testing solution, remove coating, perhaps get the granule of content uniformity item, mixing, porphyrize is got 2g, and accurate the title decided porphyrize, get 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, it is an amount of to add methanol, and heating extraction liquid is colourless, puts cold, extracting solution is recycled to dried, adds Methanamide and makes dissolving, is transferred in the 25ml measuring bottle, add Methanamide and put scale, shake up, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure.Promptly.
Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, coated tablet must not be less than 0.15mg, and Film coated tablets must not be less than 0.30mg.The granule dosage form must not be less than 2.0mg for every bag.
Method of quality control provided by the invention is characterized in that, comprises discriminating, checks the step of assay.
Method of quality control provided by the invention is characterized in that, the step of described assay is to measure the step of Determination of Hesperidin Content in the preparation.
Described Hesperidin has following structure:
(C
28H
34O
15)
Method of quality control provided by the invention is characterized in that, comprises the step of measuring Determination of Hesperidin Content with high performance liquid chromatography (HPLC).
Method of quality control provided by the invention, it is characterized in that, in the described step with the high effective liquid chromatography for measuring content of hesperidin, the chromatographic condition of employing and system suitability test, be filler with the octadecane bonded silica gel: methanol-water (40: 60) is a mobile phase; The detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000.
Method of quality control provided by the invention is characterized in that, in the described step with the high effective liquid chromatography for measuring content of hesperidin, following method is adopted in the preparation of reference substance solution, it is an amount of that precision takes by weighing the Hesperidin reference substance, adds Methanamide and make the solution that every 1ml contains 50 μ g, promptly.
Method of quality control provided by the invention is characterized in that, in the described step with the high effective liquid chromatography for measuring content of hesperidin, following method is adopted in the preparation of need testing solution, gets 20 in tablet, removes coating, perhaps get the granule of content uniformity item, mixing, porphyrize, get 2g, the accurate title, decided porphyrize, get 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, and it is an amount of to add methanol, heating extraction liquid is colourless, put coldly, extracting solution is recycled to dried, adds Methanamide and makes dissolving, be transferred in the 25ml measuring bottle, add Methanamide and put scale, shake up, promptly.
Method of quality control provided by the invention is characterized in that, assay adopts following method in the step that described Determination of Hesperidin Content is measured, and accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing inject chromatograph of liquid, measure.Promptly.Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, coated tablet must not be less than 0.15mg, and Film coated tablets must not be less than 0.30mg.The granule dosage form must not be less than 2.0mg for every bag.
Method of quality control provided by the invention is characterized in that, assay adopts following method in the step that described content of hesperidin is measured,
Assay: measure according to high performance liquid chromatography (2000 version " Chinese pharmacopoeia appendix VI D).
Chromatographic condition and system suitability test are filler with the octadecane bonded silica gel: methanol-water (40: 60) is a mobile phase; The detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the Hesperidin reference substance, adds Methanamide and make the solution that every 1ml contains 50 μ g, promptly.
20 of this product are got in the preparation of need testing solution, remove coating, perhaps get the granule of content uniformity item, mixing, porphyrize is got 2g, and accurate the title decided porphyrize, get 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, it is an amount of to add methanol, and heating extraction liquid is colourless, puts cold, extracting solution is recycled to dried, adds Methanamide and makes dissolving, is transferred in the 25ml measuring bottle, add Methanamide and put scale, shake up, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure.Promptly.
Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, coated tablet must not be less than 0.15mg, and Film coated tablets must not be less than 0.30mg.The granule dosage form must not be less than 2.0mg for every bag.
Above method not only can detect the XUANYUNNING sheet, also can detect any other dosage form of XUANYUNNING preparation, as: film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc.Characteristics of the present invention are:
1, this method precision, repeatability, good stability.
2, overcome the existing color instability of original thin layer chromatography scanning, deficiency that measurement deviation is big.
3, this method helps the quality control of XUANYUNNING sheet, XUANYUNNING granule series of products and other dosage forms more.
The specific embodiment:
By the following examples, further specify the present invention.
Embodiment 1, the detection of Film coated tablets
3 of Film coated tablets are got in discriminating (1), remove coating, porphyrize, add water 15ml, jolting makes dissolving, places, get supernatant and add ethyl acetate 30ml jolting extraction, extracting solution is added on neutral alumina post (10g, 200～300 orders, internal diameter 1.5cm) on, with ethyl acetate 20ml eluting, collect eluent, evaporate to dryness, residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.9g, decocts with water 1 hour, filters, and filtrate is concentrated into about 10ml, adds ethyl acetate 20ml and extracts, and extracting solution evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with normal hexane-ethyl acetate (1: 1) is developing solvent, launch, take out, dry, put in the ammonia steam smoked after, put again under the ultraviolet light (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get 10 of this product Film coated tablets, remove coating, porphyrize, add ethanol 50ml, reflux 40 minutes filters, filtrate adds hydrochloric acid 1ml, reflux is concentrated into about 5ml after 1 hour, add water 10ml, extracts with petroleum ether (60 ~ 90 ℃) 30ml jolting, divide and get petroleum ether liquid, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution.Other evens up pier fruit acid reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, product in contrast.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw test solution 6 μ l, reference substance solution 2 μ l, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol (40: 1) is developing solvent, launch, take out, dry, spray is with the phosphomolybdic acid test solution, and it is clear to be heated to the speckle colour developing at 110 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) get 20 of this product Film coated tablets, porphyrize, the 50ml that adds diethyl ether, reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethanol 0.5ml makes dissolving, as need testing solution.Extracting liquorice control medicinal material 3.2g decocts with water 1 hour in addition, filters, and filtrate is concentrated into about 2ml, add ethanol 5ml and stir, filter, filtrate evaporate to dryness, residue add water 5ml makes dissolving, the 10ml jolting that adds diethyl ether is extracted, and extracting solution evaporate to dryness, residue add ethanol 2ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VIB) test, draw need testing solution 10 μ l, control medicinal material solution 4 μ l, put respectively in without activatory same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with normal hexane-benzene-ethyl acetate (14: 1: 5) earlier, launch 8cm, taking out, dry, is developing solvent with positive benzene-ethyl acetate-chloroform (14: 3: 6) again, launch 8cm, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Check: should meet every regulation relevant under the tablet item (2000 version " Chinese pharmacopoeia appendix I D), relevant every regulation under the granule agent item (" Chinese pharmacopoeia appendix I C).
Assay: measure according to high performance liquid chromatography (2000 version " Chinese pharmacopoeia appendix VI D).
Chromatographic condition and system suitability test are filler with the octadecane bonded silica gel: methanol-water (40: 60) is a mobile phase; The detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the Hesperidin reference substance, adds Methanamide and make the solution that every 1ml contains 50 μ g, promptly.
20 of Film coated tablets are got in the preparation of need testing solution, remove coating, mixing, porphyrize, get 2g, the accurate title, decided porphyrize, get 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, it is an amount of to add methanol, and heating extraction liquid is colourless, puts cold, extracting solution is recycled to dried, adds Methanamide and makes dissolving, is transferred in the 25ml measuring bottle, add Methanamide and put scale, shake up, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure.Promptly.
Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, Film coated tablets must not be less than 0.30mg.
Embodiment 2, the detection of granule
Granule 5g is got in discriminating (1), adds water 15ml, and jolting makes dissolving, place, get supernatant and add ethyl acetate 30ml jolting extraction, extracting solution is added on neutral alumina post (10g, 200～300 orders, internal diameter 1.5cm) on, with ethyl acetate 20ml eluting, collect eluent, evaporate to dryness, residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.9g, decocts with water 1 hour, filters, and filtrate is concentrated into about 10ml, adds ethyl acetate 20ml and extracts, and extracting solution evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with normal hexane-ethyl acetate (1: 1) is developing solvent, launch, take out, dry, put in the ammonia steam smoked after, put again under the ultraviolet light (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get granule 16g, add ethanol 50ml, reflux 40 minutes filters, filtrate adds hydrochloric acid 1ml, and reflux is concentrated into about 5ml after 1 hour, add water 10ml, extracts with petroleum ether (60 ~ 90 ℃) 30ml jolting, divide and get petroleum ether liquid, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution.Other evens up pier fruit acid reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, product in contrast.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw test solution 6 μ l, reference substance solution 2 μ l, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol (40: 1) is developing solvent, launch, take out, dry, spray is with the phosphomolybdic acid test solution, and it is clear to be heated to the speckle colour developing at 110 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) get granule 32g, porphyrize, the 50ml that adds diethyl ether, reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethanol 0.5ml makes dissolving, as need testing solution.Extracting liquorice control medicinal material 3.2g decocts with water 1 hour in addition, filters, and filtrate is concentrated into about 2ml, add ethanol 5ml and stir, filter, filtrate evaporate to dryness, residue add water 5ml makes dissolving, the 10ml jolting that adds diethyl ether is extracted, and extracting solution evaporate to dryness, residue add ethanol 2ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw need testing solution 10 μ l, control medicinal material solution 4 μ l, put respectively in without activatory same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with normal hexane-benzene-ethyl acetate (14: 1: 5) earlier, launch 8cm, taking out, dry, is developing solvent with positive benzene-ethyl acetate-chloroform (14: 3: 6) again, launch 8cm, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Check: should meet every regulation relevant under the granule item (2000 version " Chinese pharmacopoeia appendix I D), relevant every regulation under the granule agent item (" Chinese pharmacopoeia appendix I C).
Assay: measure according to high performance liquid chromatography (2000 version " Chinese pharmacopoeia appendix VI D).
Chromatographic condition and system suitability test are filler with the octadecane bonded silica gel: methanol-water (40: 60) is a mobile phase; The detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the Hesperidin reference substance, adds Methanamide and make the solution that every 1ml contains 50 μ g, promptly.
The granule of content uniformity item, mixing, porphyrize are got in the preparation of need testing solution, get 2g, the accurate title, decided porphyrize, get 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, it is an amount of to add methanol, and heating extraction liquid is colourless, puts cold, extracting solution is recycled to dried, adds Methanamide and makes dissolving, is transferred in the 25ml measuring bottle, add Methanamide and put scale, shake up, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure.Promptly.
Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, the granule dosage form must not be less than 2.0mg for every bag.
Embodiment 3, the detection of coated tablet
3 of coated tablets are got in discriminating (1), remove coating, porphyrize, add water 15ml, jolting makes dissolving, places, get supernatant and add ethyl acetate 30ml jolting extraction, extracting solution is added on neutral alumina post (10g, 200～300 orders, internal diameter 1.5cm) on, with ethyl acetate 20ml eluting, collect eluent, evaporate to dryness, residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.9g, decocts with water 1 hour, filters, and filtrate is concentrated into about 10ml, adds ethyl acetate 20ml and extracts, and extracting solution evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with normal hexane-ethyl acetate (1: 1) is developing solvent, launch, take out, dry, put in the ammonia steam smoked after, put again under the ultraviolet light (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get 10 of this product coated tablets, remove coating, porphyrize, add ethanol 50ml, reflux 40 minutes filters, filtrate adds hydrochloric acid 1ml, reflux is concentrated into about 5ml after 1 hour, add water 10ml, extracts with petroleum ether (60 ~ 90 ℃) 30ml jolting, divide and get petroleum ether liquid, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution.Other evens up pier fruit acid reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, product in contrast.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VI B) test, draw test solution 6 μ l, reference substance solution 2 μ l, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol (40: 1) is developing solvent, launch, take out, dry, spray is with the phosphomolybdic acid test solution, and it is clear to be heated to the speckle colour developing at 110 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) get 20 of this product coated tablets, porphyrize, the 50ml that adds diethyl ether, reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethanol 0.5ml makes dissolving, as need testing solution.Extracting liquorice control medicinal material 3.2g decocts with water 1 hour in addition, filters, and filtrate is concentrated into about 2ml, add ethanol 5ml and stir, filter, filtrate evaporate to dryness, residue add water 5ml makes dissolving, the 10ml jolting that adds diethyl ether is extracted, and extracting solution evaporate to dryness, residue add ethanol 2ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (2000 version " Chinese pharmacopoeia appendix VIB) test, draw need testing solution 10 μ l, control medicinal material solution 4 μ l, put respectively in without activatory same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with normal hexane-benzene-ethyl acetate (14: 1: 5) earlier, launch 8cm, taking out, dry, is developing solvent with positive benzene-ethyl acetate-chloroform (14: 3: 6) again, launch 8cm, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Check: should meet every regulation relevant under the tablet item (2000 version " Chinese pharmacopoeia appendix I D), relevant every regulation under the granule agent item (" Chinese pharmacopoeia appendix I C).
Assay: measure according to high performance liquid chromatography (2000 version " Chinese pharmacopoeia appendix VI D).
Chromatographic condition and system suitability test are filler with the octadecane bonded silica gel: methanol-water (40: 60) is a mobile phase; The detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the Hesperidin reference substance, adds Methanamide and make the solution that every 1ml contains 50 μ g, promptly.
20 of coated tablets are got in the preparation of need testing solution, remove coating, mixing, porphyrize, get 2g, the accurate title, decided porphyrize, get 1.5g, the accurate title, decide, and puts in the apparatus,Soxhlet's, it is an amount of to add methanol, and heating extraction liquid is colourless, puts cold, extracting solution is recycled to dried, adds Methanamide and makes dissolving, is transferred in the 25ml measuring bottle, add Methanamide and put scale, shake up, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure.Promptly.
Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, coated tablet must not be less than 0.15mg.
Embodiment 4
Rhizoma Alismatis 312.5g Rhizoma Atractylodis Macrocephalae 187.5g Poria 187.5g Pericarpium Citri Reticulatae 125g
Rhizoma Pinelliae 187.5g Fructus Ligustri Lucidi 225g Herba Ecliptae 225g Flos Chrysanthemi 200g
Radix Achyranthis Bidentatae 125g Radix Glycyrrhizae 100g
More than ten flavor medicines, decoct with water 2 times, 3 hours for the first time, the 2nd time 2.5 hours, collecting decoction filtered, filtrate is concentrated into relative density 1.2 (60 degrees centigrade), adds 3 times of amount ethanol, gets supernatant and reclaims ethanol, is condensed into relative density 1.50 (90 degrees centigrade) clear paste.
Granule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, sucrose, makes granule, drying, and packing is promptly.
Tablet: qinghuo reagent adds right amount of auxiliary materials such as dextrin, Pulvis Talci, magnesium stearate, makes granule, tabletting, promptly.
Capsule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, makes granule, and is encapsulated, promptly.
Embodiment 5
Rhizoma Alismatis 100g Rhizoma Atractylodis Macrocephalae 50g Poria 50g Pericarpium Citri Reticulatae 40g Rhizoma Pinelliae 60g Fructus Ligustri Lucidi 80g Herba Ecliptae 70g Flos Chrysanthemi 80g Radix Achyranthis Bidentatae 50g Radix Glycyrrhizae 40g
More than ten flavor medicines, decoct with water 2 times, 0.5 hour for the first time, the 2nd time 0.5 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05 (30 degrees centigrade), add 1 times of amount ethanol, get supernatant and reclaim ethanol, be condensed into relative density 1.20 (40 degrees centigrade) clear paste.Granule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, sucrose, makes granule, drying, and packing is promptly.
Tablet: qinghuo reagent adds right amount of auxiliary materials such as dextrin, Pulvis Talci, magnesium stearate, makes granule, tabletting, promptly.
Capsule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, makes granule, and is encapsulated, promptly.
Embodiment 6
Rhizoma Alismatis 550g Rhizoma Atractylodis Macrocephalae 320g Poria 340g Pericarpium Citri Reticulatae 250g Rhizoma Pinelliae 310g
Fructus Ligustri Lucidi 450g Herba Ecliptae 460g Flos Chrysanthemi 420g Radix Achyranthis Bidentatae 360g Radix Glycyrrhizae 250g
More than ten flavor medicines, decoct with water 2 times, 3 hours for the first time, the 2nd time 2.5 hours, collecting decoction filters, and filtrate is concentrated into relative density 1.30 (90 degrees centigrade), add 3 times of amount ethanol, get supernatant and reclaim ethanol, be condensed into relative density 1.50 (90 degrees centigrade) clear paste.Granule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, sucrose, makes granule, drying, and packing is promptly.
Tablet: qinghuo reagent adds right amount of auxiliary materials such as dextrin, Pulvis Talci, magnesium stearate, makes granule, tabletting, promptly.
Capsule: qinghuo reagent adds right amount of auxiliary materials such as dextrin, makes granule, and is encapsulated, promptly.
Claims (4)
1, a kind ofly treat dizzy Chinese medicine preparation, it is characterized in that its pharmacodynamic raw materials consists of:
Rhizoma Alismatis 100-550 part Rhizoma Atractylodis Macrocephalae 50-320 part Poria 50-340 part Pericarpium Citri Reticulatae 40-250 part
Rhizoma Pinelliae 60-310 part Fructus Ligustri Lucidi 80-450 part Herba Ecliptae 70-460 part Flos Chrysanthemi 80-420 part
Radix Achyranthis Bidentatae 50-360 part Radix Glycyrrhizae 40-250 part.
2, a kind ofly treat dizzy Chinese medicine preparation, it is characterized in that its pharmacodynamic raw materials consists of:
Rhizoma Alismatis 150-350 part Rhizoma Atractylodis Macrocephalae 80-220 part Poria 80-220 part Pericarpium Citri Reticulatae 50-150 part Rhizoma Pinelliae Preparata
80-210 part Fructus Ligustri Lucidi 90-250 part Herba Ecliptae 90-260 part Flos Chrysanthemi 150-220 part Radix Achyranthis Bidentatae
80-160 part Radix Glycyrrhizae 40-150 part.
3, a kind ofly treat dizzy Chinese medicine preparation, it is characterized in that its pharmacodynamic raw materials consists of:
125 parts of 187.5 parts of Pericarpium Citri Reticulataes of 187.5 parts of Poria of 312.5 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Alismatis
225 parts of Flos Chrysanthemi 200g of 225 portions of Herba Ecliptaes of 187.5 parts of Fructus Ligustri Lucidi of the Rhizoma Pinelliae
100 parts in 125 portions of Radix Glycyrrhizaes of Radix Achyranthis Bidentatae.
4, the preparation method of any preparation of claim 1-3 is characterized in that, process following steps: get raw material, decoct with water 2 times, 0.5-3 hour for the first time, the 2nd time 0.5-2.5 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.05-1.30, adds 1-3 and doubly measures ethanol, gets supernatant and reclaims ethanol, be condensed into relative density 1.20-1.50 clear paste, qinghuo reagent adds that the medicine acceptable carrier makes any pharmaceutically useful preparation.
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| CN102940785B (en) * | 2012-09-19 | 2014-09-24 | 包晓娜 | Traditional Chinese medicine composition for treating vertigo |
| CN103655980A (en) * | 2013-12-25 | 2014-03-26 | 孙斌 | Traditional Chinese medicine for treating randomized stagnation of phlegm type auditory vertigo |
| CN104587396A (en) * | 2015-01-15 | 2015-05-06 | 国家电网公司 | Preparation for preventing dizziness caused by power overhead operation |
| CN110007031B (en) * | 2019-04-30 | 2021-06-18 | 南京海昌中药集团有限公司 | Fingerprint detection method of glossy privet fruit roasted with liquorice juice |
| CN110927322B (en) * | 2019-11-07 | 2022-05-17 | 石药集团中奇制药技术（石家庄）有限公司 | Detection method of Huoxiang Zhengqi mixture |
| CN114487196B (en) * | 2022-01-27 | 2023-11-14 | 鲁南厚普制药有限公司 | Method for establishing HPLC fingerprint of Gastrodia elata dizzy granule and fingerprint thereof |
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