CN101584809B - Medicine for treating cold grasserie and method of preparing the medicine - Google Patents
Medicine for treating cold grasserie and method of preparing the medicine Download PDFInfo
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- CN101584809B CN101584809B CN2009101580747A CN200910158074A CN101584809B CN 101584809 B CN101584809 B CN 101584809B CN 2009101580747 A CN2009101580747 A CN 2009101580747A CN 200910158074 A CN200910158074 A CN 200910158074A CN 101584809 B CN101584809 B CN 101584809B
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Abstract
The invention discloses a medicine for treating cold grasserie, comprising the raw medicine by weight parts: 50 to 150 parts of Tibet pleurospermum, 50 to 150 parts of Himalayan four-o'clock root, 50 to 150 parts of caltrop, 50 to 150 parts of Polygonati Rhizoma and 50 to 150 parts of asparagus; grain diameter of the medicine is 0.1 to 100 microns. The medicine of the invention has higher effective dissolution of medicine, medicine penetration power and bioavailability, and better medicine effect. The invention further discloses a method of preparing the medicine for treating cold grasserie and special quality examination method thereof such that the quality examination method effectively controls the stability of the medicine, and also effectively identifies the specificity of pharmaceutical ingredients in medicine.
Description
Technical field
The present invention relates to a kind of medicine that is used to treat cold grasserie, the invention still further relates to the method for preparing of this medicine, belong to field of medicaments.
Background technology
Think that in the Tibetan medicine and pharmacology field yellow fluid is one of important composition material of human organism; Human diet is gone into stomach, and after digestion and absorbing, its eliteization is given birth to and is blood, and the waste matter of blood belongs to the gallbladder internal organs becomes bile, and the elite of bile then turns to yellow fluid again; Yellow fluid is present in whole body everywhere, and is more at skin and joint, and it plays the important function of regulating human liquid, lubricated joint aspect physiology.
Though yellow fluid has healthy function for human body important effect is arranged, it also is a kind of morbid state that inclined to one side Sheng appears in yellow fluid, and yellow fluid is contained with declining partially partially all can cause grasserie.The Tibetan medicine and pharmacology theory thinks that the person's character of yellow fluid neither belongs to heat, does not also belong to coldly, is that the cold and heat both sexes are various after the pathological changes, combines with heat with the conversion person of Xi La institute so blood takes place, and becomes yellow sweating of heat syndrome, and also grasserie deceived in title; Combine with cold according to the conversion person of institute for Ba Da does with conspicuous, become cold grasserie, also claim white grasserie.Yellow sweating of heat syndrome is more common in adolescence, uncommon pull-up body constitution person and to blood, uncommon some condition of drawing incompatibility person still clinically; Cold grasserie then is more common in child and old people, Ba Dagan, is conspicuously done and conspicuous some condition of complying with incompatibility person still according to type body constitution person with to Ba Da.
In addition, the yellow fluid of pathological changes also can and then give rise to diseases with types such as merging, accumulations, like vitiligo, psoriasis, parasitosis, scabies, numbness disease, diphtheria, anthrax, erysipelas, scar rash, edema, edema etc.After the yellow fluid pathological changes,, show its peculiar symptom, mainly scurry between capable musculus cutaneus, position such as abdominal cavity, joint though intersperse among whole body.Grasserie is sent out in skin and is prone to cause urticaria; Send out and then can cause arthritis in the joint.
Grasserie is different from the exudate of pathological changes such as general skin eczema, scabies, furuncle furuncle, and getting to the bottom of sb.'s illness, to be equivalent to the traditional Chinese medical science said be because wet or damp and hot.To its pathogeny; The doctor among the people of Tibetan is according to the record in " Tibetan medicine doctor certainly addendum releases difficulty ", the Four-Volume Medical Code two books; And combine practical experience to develop the classical Tibetan medicine and pharmacology proved recipe of treating cold grasserie---five are loose (the Tibetan medicine name is called assorted A Ba); This proved recipe is recorded in first 280 pages of " health drug standard promulgated by the ministries or commissions of the Central Government " 95 years version Tibetan medicines, and its prescription is: Herba pleurospermi thomsonii 100g, Radix Mirabilis himalaicae 100g, Fructus Tribuli 100g, Rhizoma Polygonati 100g, Radix Asparagi 100g.For many years, because five diffusing treatment curative effects for cold grasserie have received consistent approval,, all do not have it is carried out any further improvement research so all continue to use above-mentioned prescription all the time.
For above-mentioned five diffusing method for preparinies, all adopt five diffusing preparation technologies of traditional Tibetan medicine always, promptly at first all raw medicinal materials are carried out coarse pulverization, sieve afterwards, mixing is processed powder; Above-mentioned preparation technology is simple, just raw medicinal material is carried out simple coarse pulverization.In above-mentioned conventional preparation process, do not recognize for the relation between crude drug particle diameter and the curative effect of medication (be crude drug particle diameter can not too greatly can not be too little); So the particle diameter of five diffusing medicines that it prepares has received certain restriction; Thereby cause that five diffusing drug dissolutions of tradition are low, drug osmotic ability, bioavailability be low; Can't give full play to the effect of medicine, influence curative effect.
In addition, in field of medicaments,, the strict stability of drug of investigating for fear of the imitated production of medicine, with regard to above-mentioned five diffusing stability tests, available technology adopting be the microscopic examination test mode; For adopting the microscopic examination test mode, five diffusing standard types are: xylem parenchyma's spindle-like, wall are thick slightly, lignify, and cinclides is obvious, diameter 12～19 μ m; Starch grain is numerous, and simple grain is circular or oval, and omphalion is obvious, is point-like or flying bird shape, diameter 4～10 μ m, and composite grain is made up of 2～8 gradation; Endocarp fiber bunchy, faint yellow, several layers of criss-cross arrangement up and down, diameter 4～27 μ m, wall is thicker, lignify, pit is rare, and the hole ditch is not obvious; Contain the needle-like calcium oxalate crystal bundle in the large-scale myxocyte, long 40～99 μ m of needle; Stone cell is extremely many, orange yellow, and rectangle or strip, diameter 32～88 μ m, wall thickness 10～37 μ m, pit is fine and closely woven, and the hole ditch is carefully lacked.Realized the detection to five diffusing medicine stabilities through above-mentioned fractographic means, this detection mode can only be implemented in the observation on the macroscopic view, and in fact whether the essence of medicine change, this detection mode has no way of learning.
Summary of the invention
Primary technical problem to be solved by this invention is five diffusing weight portions that always all are confined to the crude drug in the original formulation of the classical proved recipe of the Tibetan medicine of treatment grasserie; And then former five diffusing prescriptions are further developed, obtain having the medicine that is used to treat cold grasserie that improves the back bulk drugs.
Second technical problem to be solved by this invention is just raw medicinal material to be carried out coarse pulverization among five diffusing preparation technologies in the prior art; Thereby the effective dissolution that causes medicine is low, penetrating power is poor, bioavailability is low; Can't give full play to pharmaceutically-active problem; And then the method for preparing of medicine that is used to treat cold grasserie of a kind of penetrating power that can improve medicine and bioavailability is provided, and prepare the medicine that has than the cold grasserie of treatment of high-dissolution, penetrating power and bioavailability.
The 3rd technical problem to be solved by this invention is can only rest on five diffusing stability property quantity measuring methods in the prior art medicine is carried out on the level of macroscopic view observation; Whether essence that can not testing drug stable, so provide a kind of can be fast, the stable medicine stability in the large of measuring the cold grasserie of treatment with and the quality determining method of the specificity discriminating of crude drug.
In order to solve the problems of the technologies described above, the invention provides a kind of medicine of treating cold grasserie, comprise following bulk drugs:
Herba pleurospermi thomsonii 50-150 part, Radix Mirabilis himalaicae 50-150 part, Fructus Tribuli 50-150 part, Rhizoma Polygonati 50-150 part, Radix Asparagi 50-150 part; The particle diameter of said medicine is 0.1～100 μ m.
Wherein, the weight portion of preferred said crude drug is: 100 parts of Herba pleurospermi thomsoniis, 100 parts of Radix Mirabilis himalaicaes, 100 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, 100 parts of Radix Asparagis.The particle diameter of said medicine is 0.1-60 μ m.
Most preferably the particle diameter of said medicine is 1-40 μ m.
The present invention also further discloses the method for preparing of the medicine of the cold grasserie of above-mentioned treatment, and it comprises the steps:
(1) selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug after the remove impurity, dry respectively or dry;
(2) above-mentioned five tastes crude drug pulverize separately being become particle diameter is the micropowders of 0.1-100 μ m;
(3) according to the proportioning of above-mentioned raw materials medicine the above-mentioned raw materials medicine is fully mixed;
(4) the mixed crude drug of step (3) is packed or in above-mentioned crude drug, added conventional adjuvant again be prepared into arbitrary oral formulations.
Wherein, said adjuvant is mannitol, hydroxypropyl methylcellulose, protein sugar, fragrant citrus powder, sodium glutamate and carboxymethyl starch sodium.
Said adjuvant can also be in microcrystalline Cellulose, carboxymethyl starch sodium, starch, the transmutability starch one or more.Need at first granulate after adding above-mentioned adjuvant, add Pulvis Talci again and carry out tabletting.
The present invention is disclosing the said basis that is used to treat medicine and this process for preparing medicine of cold grasserie, further discloses the quality determining method of the cold grasserie medicine of described treatment again, and it comprises the steps:
(1) get the drug sample 20g that is used to treat cold grasserie to be measured, add chloroform 50ml, reflux 4 hours is sloughed liposoluble constituent with the free ruscogenin of part and filter, and obtains medicinal residues after filtrating is discarded; In said medicinal residues, add concentration and be the hydrochloric acid 50ml hydrolysis 2 hours of 2mol/L, discard acid liquid; The medicinal residues water is washed till the oven dry of neutral back obtains residue; In said residue, add chloroform 50ml, reflux is 4 hours afterwards, proposes hydrolysis glycoside unit and also filters, and collects filtrating, wave naturally to 0.6～1ml as need testing solution;
Other gets Fructus Tribuli control medicinal material 2g, adds chloroform 50ml, and reflux 4 hours is sloughed liposoluble constituent with the free ruscogenin of part and filter, and obtains medicinal residues after filtrating is discarded; In said medicinal residues, add concentration and be the hydrochloric acid 50ml hydrolysis 2 hours of 2mol/L, discard acid liquid; The medicinal residues water is washed till the oven dry of neutral back obtains residue; In said residue, add chloroform 50ml, reflux is 4 hours afterwards, proposes hydrolysis glycoside unit and also filters, and collects filtrating, waves naturally to 0.6～1ml and processes control medicinal material solution;
Get the negative sample 20g that lacks Fructus Tribuli again, add chloroform 50ml, reflux 4 hours is sloughed liposoluble constituent with the free ruscogenin of part and filter, and obtains medicinal residues after filtrating is discarded; In said medicinal residues, add concentration and be the hydrochloric acid 50ml hydrolysis 2 hours of 2mol/L, discard acid liquid; The medicinal residues water is washed till the oven dry of neutral back obtains residue; In said residue, add chloroform 50ml, reflux is 4 hours afterwards, proposes hydrolysis glycoside unit and also filters, and collects filtrating, waves naturally to 0.6～1ml and processes negative control solution;
Test according to thin layer chromatography; Get each 10 μ l of said need testing solution, control medicinal material solution and negative control solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, be that cyclohexane extraction-ethyl acetate-chloroformic solution of 5: 2.5: 1.5 is developing solvent with volume ratio; Launch, take out and dry; Spray is 1: 50: 0.5 an anisaldehyde sulfuric acid solution with raw material anisaldehyde, glacial acetic acid and vitriolic volume ratio, and it is clear under 105 ℃, to be heated to the speckle colour developing, in the test sample chromatograph; With the corresponding position of control medicinal material on show identical yellow spotting, and negative control is noiseless;
(2) get the drug sample 10g that is used to treat cold grasserie to be measured,, filter after 30 minutes through supersound process to wherein adding ethanol 30ml; To filtrate after the filtration and separate, and filtrating collected, and fling to ethanol with residue; In said residue, add methanol 1ml dissolving as need testing solution;
Other gets Herba pleurospermi thomsonii control medicinal material 2g, to wherein adding ethanol 10ml, filters after 30 minutes through supersound process; To filtrate after the filtration and separate, and filtrating collected, and fling to ethanol with residue; In said residue, add methanol 1ml dissolving as control medicinal material solution;
Get the negative sample 10g that lacks Herba pleurospermi thomsonii again,, filter after 30 minutes through supersound process to wherein adding ethanol 30ml; To filtrate after the filtration and separate, and filtrating collected, and fling to ethanol with residue; In said residue, add methanol 1ml dissolving as negative control solution;
Test according to thin layer chromatography; Get each 5 μ l of said need testing solution, control medicinal material solution and negative control solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, be that 8: 1.8: 0.2 normal hexane-ethyl acetate-methanol solutions are developing solvent with volume ratio; Launch, take out and dry; Spray is 10% phosphomolybdic acid test solution with the quality percentage composition, and it is clear under 105 ℃, to be heated to the speckle colour developing, in the test sample chromatograph; With the corresponding position of control medicinal material on show identical darkviolet speckle, and negative control is noiseless;
(3) get the drug sample 10g that is used to treat cold grasserie to be measured,, filter after 30 minutes through supersound process to wherein adding ethanol 30ml; To filtrate after the filtration and separate, collect filtrating, fling to ethanol with residue; In said residue, add methanol 1ml dissolving as need testing solution;
Other gets Radix Mirabilis himalaicae control medicinal material 2g, to wherein adding ethanol 10ml, to wherein adding ethanol 30ml, filters after 30 minutes through supersound process; To filtrate after the filtration and separate, collect filtrating, fling to ethanol with residue; In said residue, add methanol 1ml dissolving as control medicinal material solution;
Get the negative sample 10g that lacks Radix Mirabilis himalaicae again,, to wherein adding ethanol 30ml, filter after 30 minutes through supersound process; To filtrate after the filtration and separate, collect filtrating, fling to ethanol with residue; In said residue, add methanol 1ml dissolving as negative control solution;
According to the thin layer chromatography test, each 5 μ l of said need testing solution, control medicinal material solution and negative control solution put respectively on same silica GF254 lamellae; With volume ratio is that 8: 2: 1.5 normal hexane-ethyl acetate-methanol is developing solvent; Launch, take out and dry, placing wavelength is to inspect under the uviol lamp of 254nm, in the test sample chromatograph; With the corresponding position of control medicinal material on show identical crineous speckle, and negative control is noiseless.
The medicine of the cold grasserie of treatment of the present invention, its crude drug are Herba pleurospermi thomsonii 50-150 part, Radix Mirabilis himalaicae 50-150 part, Fructus Tribuli 50-150 part, Rhizoma Polygonati 50-150 part, Radix Asparagi 50-150 part; Compare with five the prescription Herba pleurospermi thomsonii 100g that loose, Radix Mirabilis himalaicae 100g, Fructus Tribuli 100g, Rhizoma Polygonati 100g, Radix Asparagi 100g of record in " health drug standard promulgated by the ministries or commissions of the Central Government "; It has further enlarged the optional scope of the medicine crude drug that is used for treating cold grasserie; Find through applicant's years of researches; In the weight portion scope of crude drug of the present invention, can realize belonging to effective treatment of cold grasserie.Of paramount importancely be; The medicine that is used to treat cold grasserie of the present invention has overcome for many years the Tibetan medicine field and has continued to use five diffusing prescriptions of tradition always; And less than the problem of five powder formulas not being carried out any improvement Journal of Sex Research; It has carried out further research to five powder formulas of tradition, has enriched the medicine category of treating cold grasserie.In addition; The applicant also finds in above-mentioned autgmentability research, and the particle diameter of the said medicine that is used to treat cold grasserie has vital relation for the curative effect of its medicine, and finds through years of researches; Have only diameter of aspirin particle just can realize cold grasserie efficacious therapy in the said medicine of 0.1～100 μ m; Particle diameter too little (less than 0.1 μ m) easily because the medical surfaces after pulverizing is long-pending increases greatlyyer with the medical surfaces before the former pulverizing is long-pending, causes hygroscopicity and the chemical activity etc. of medicine also correspondingly to increase, and it is rotten that medicine more is prone to the moisture absorption; The inner volatile ingredient of medicine more is prone to scatter and disappear, thereby has influenced the drug effect of medicine; The particle diameter of medicine is big (greater than 100 μ m) too, and particle diameter too conference causes effective dissolution of medicine to reduce, and penetrating power difference and bioavailability are also very low, so also be unfavorable for the performance of medicine effect.
The method for preparing that is used to treat the medicine of cold grasserie of the present invention; It is on the basis of selected crude drug; Crude drug has been carried out micronizing, and the particle diameter of restriction micronizing is 0.1～100 μ m, afterwards to the subsequent treatment such as sterilize of the raw material after micronizing.This method for preparing has been abandoned the method for in five diffusing method for preparinies of tradition crude drug being carried out simple coarse pulverization, through carrying out the micronizing of specified particle diameter, has guaranteed that the medicine for preparing can bring into play the drug effect of himself more fully.In above-mentioned preparation process; The temperature of preferably after crushed crude drug mixture being carried out sterilization treatment is 180 ℃; This temperature is set has guaranteed on the one hand the crude drug mixture is effectively sterilized, be unlikely to influence the property of medicine performance of crude drug on the other hand because sterilising temp is too high.Can be designed to various dosage form as required for the medicine that is used to treat cold grasserie of the present invention; Such as tablet, suspending agent, electuary granule, capsule, the watered pill, honeyed pill etc., the variation of above-mentioned dosage form can not produce any influence to the drug effect of medicine.
In addition, the quality determining method of the cold grasserie medicine of treatment of the present invention, purpose realizes the specificity of crude drug in the medicine is differentiated when being to realize medicine stability tested.This quality determining method; Adopt the negative control solution of testing sample, control medicinal material and scarce Fructus Tribuli, scarce Herba pleurospermi thomsonii, scarce Radix Mirabilis himalaicae to carry out the thin layer test; Thereby realized being used to treat the test of cold grasserie stability of drug, also realized simultaneously the specificity of Fructus Tribuli, Herba pleurospermi thomsonii and Radix Mirabilis himalaicae in the medicine is differentiated of the present invention.
The present invention has following advantage:
1. the medicine that is used to treat cold grasserie of the present invention has carried out further expansion research on five diffusing bases of traditional Tibetan medicine to it, has enlarged the optional scope of the medicine crude drug that is used for treating cold grasserie; And find the influence of diameter of aspirin particle to a deeper level to the medicine effect of treating cold grasserie through research; Have only diameter of aspirin particle just can realize the effective administration anti-inflammatory treatment of cold grasserie in the said medicine of 0.1～100 μ m; Avoided the too little medicine moisture absorption that causes easily of particle diameter rotten; The inner volatile ingredient of medicine more is prone to scatter and disappear, thereby has influenced the drug effect of medicine; Also avoided the particle diameter of medicine to cause effective dissolution of medicine to reduce the problem that penetrating power difference and bioavailability are also very low too greatly; Further promoted the drug research of Tibetan medicine field for the cold grasserie of treatment.
2. preferred its particle diameter of medicine that is used to treat cold grasserie of the present invention is 0.1-60 μ m, and most preferably particle diameter is 1-40 μ m, and effective dissolution and bioavailability that above-mentioned particle diameter can improve medicine better are set.
3. the medicine that is used to treat cold grasserie of the present invention need not add the stabilizing agent of any chemosynthesis through the effective selection to diameter of aspirin particle, promptly can improve the effective dissolution and the bioavailability of medicine in all directions, and is safe in utilization.
4. preparation of the present invention is used to treat the method for the medicine of cold grasserie; To limit its particle diameter to the pulverizing of crude drug in the medicine is 0.1-100 μ m; Realized the micronizing to crude drug, the medicine that makes being used to of preparing treat cold grasserie can be brought into play its drug effect better; This method is simple, and easy industrialized has vast market prospect.
5. the quality determining method that is used to treat the medicine of cold grasserie of the present invention; Can only on macroscopic view, observe the test mode that the medicine shape judges that it is stable thereby abandoned; Adopt the physical and chemical testing means to realize stability test to medicine essence; And when realizing measuring medicine stability, also realized discriminating to the medicine specificity; Thereby guaranteed accurate, quick, stable, sensitive detection, guaranteed the quality of medicine more, realized high controllability drug quality to effective ingredient.
The specific embodiment
Embodiment 1
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug dry respectively after the remove impurity; It is the micropowders of 1-40 μ m that crude drug pulverize separately after above-mentioned the drying is become particle diameter; Choosing 50 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 50 parts of Radix Mirabilis himalaicaes, 50 parts of Fructus Tribulis, 50 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 50 parts; To packing, promptly get powder afterwards through mixed crude drug.
Embodiment 2
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug, after the remove impurity, oven dry respectively; It is the micropowders of 1-10 μ m that above-mentioned crude drug pulverize separately after oven dry is become particle diameter; Choosing 30 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 50 parts of Radix Mirabilis himalaicaes, 60 parts of Fructus Tribulis, 80 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 100 parts; Adding microcrystalline Cellulose then granulates; Add Pulvis Talci again, tabletting behind the mix homogeneously is packed at last and is got final product.
Embodiment 3
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug, after the remove impurity, oven dry respectively; It is the micropowders of 10-30 μ m that above-mentioned crude drug pulverize separately after oven dry is become particle diameter; Choose 80 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 100 parts of Radix Mirabilis himalaicaes, 150 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, Radix Asparagi and fully mix for 100 parts, process pill behind the mix homogeneously.
Embodiment 4
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug, after the remove impurity, dry respectively; It is the micropowders of 0.1-1 μ m that above-mentioned dried raw material medicine pulverize separately is become particle diameter; Choosing 100 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 100 parts of Radix Mirabilis himalaicaes, 150 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 100 parts; Adding carboxymethyl starch sodium then granulates; Add Pulvis Talci again, tabletting behind the mix homogeneously is packed at last and is got final product.
Embodiment 5
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug, after the remove impurity, dry respectively; It is the micropowders of 0.1-60 μ m that above-mentioned dried raw material medicine pulverize separately is become particle diameter; Choose 80 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 50 parts of Radix Mirabilis himalaicaes, 150 parts of Fructus Tribulis, 50 parts of Rhizoma Polygonatis, Radix Asparagi and fully mix for 80 parts, add carboxymethyl starch sodium then and granulate, promptly get granule.
Embodiment 6
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug, after the remove impurity, dry respectively; It is the micropowders of 60-100 μ m that above-mentioned dried raw material medicine pulverize separately is become particle diameter; Choose 50 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 50 parts of Radix Mirabilis himalaicaes, 100 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, Radix Asparagi and fully mix for 100 parts, add microcrystalline Cellulose then and granulate, incapsulate, promptly get capsule.
Embodiment 7
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug dry respectively after the remove impurity; It is the medicated powder of 60-100 μ m that crude drug pulverize separately after above-mentioned the drying is become particle diameter; Choosing 100 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 100 parts of Radix Mirabilis himalaicaes, 100 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 100 parts; Then mixed medicated powder is incapsulated, promptly get capsule.
In the foregoing description 1-7; The adjuvant that adds is except microcrystalline Cellulose and carboxymethyl starch sodium; Can also be to wherein adding starch or transmutability starch; As embodiment that can conversion, the present invention also can add in microcrystalline Cellulose, carboxymethyl starch sodium, starch or the transmutability starch one or more as the preparation adjuvant that is used for treating the medicine of cold grasserie according to the invention.
Embodiment 8
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug after the remove impurity, place respectively in the dehydrator and under 50 ℃, dry; It is the micropowders of 40-60 μ m that above-mentioned crude drug pulverize separately after oven dry is become particle diameter; Choosing 80 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 80 parts of Radix Mirabilis himalaicaes, 80 parts of Fructus Tribulis, 80 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 80 parts, and under 180 ℃, carries out sterilization treatment; In the crude drug mixture after sterilization treatment, add any and mixing in an amount of mannitol, hypromellose, protein sugar, fragrant citrus powder, sodium glutamate and the carboxymethyl starch sodium afterwards, pack at last and get final product.
Embodiment 9
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug after the remove impurity, place respectively in the dehydrator and under 60 ℃, dry; It is the micropowders of 10-40 μ m that above-mentioned crude drug pulverize separately after oven dry is become particle diameter; Choosing 100 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 100 parts of Radix Mirabilis himalaicaes, 100 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 100 parts, and under 180 ℃, carries out sterilization treatment; In the crude drug mixture after sterilization treatment, add an amount of mannitol, hypromellose and mixing afterwards, pack at last and get final product.
Embodiment 10
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug after the remove impurity, place respectively in the dehydrator and under 80 ℃, dry; It is the micropowders of 60-100 μ m that above-mentioned crude drug pulverize separately after oven dry is become particle diameter; Choosing 150 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 150 parts of Radix Mirabilis himalaicaes, 150 parts of Fructus Tribulis, 150 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 150 parts, and under 180 ℃, carries out sterilization treatment; In the crude drug mixture after sterilization treatment, add an amount of protein sugar, fragrant citrus powder, sodium glutamate and carboxymethyl starch sodium and mixing afterwards, pack at last and get final product.
Embodiment 11
Selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug after the remove impurity, place respectively in the dehydrator and under 60 ℃, dry; It is the micropowders of 1-60 μ m that above-mentioned crude drug pulverize separately after oven dry is become particle diameter; Choosing 100 parts of above-mentioned Herba pleurospermi thomsoniis after crushed, 50 parts of Radix Mirabilis himalaicaes, 90 parts of Fructus Tribulis, 80 parts of Rhizoma Polygonatis, Radix Asparagi fully mixes for 150 parts, and under 180 ℃, carries out sterilization treatment; In the crude drug mixture after sterilization treatment, add an amount of mannitol, hypromellose, protein sugar, fragrant citrus powder, sodium glutamate and carboxymethyl starch sodium and mixing afterwards, pack at last and get final product.
In the foregoing description 1-11, crude drug is carried out micronizing, adopt afterwards to be the AccuSizer780/APS detector carry out particle diameter to after crushed crude drug granule detects.
Embodiment 12
The medicine of being used to of preparing among the foregoing description 1-11 being treated cold grasserie carries out quality testing, and it is following to detect step:
(1) get the drug sample 20g that is used to treat cold grasserie to be measured, add chloroform 50ml, reflux 4 hours is sloughed liposoluble constituent with the free ruscogenin of part and filter, and obtains medicinal residues after filtrating is discarded; In said medicinal residues, add concentration and be the hydrochloric acid 50ml hydrolysis 2 hours of 2mol/L, discard acid liquid; The medicinal residues water is washed till the oven dry of neutral back obtains residue; In said residue, add chloroform 50ml, reflux is 4 hours afterwards, proposes hydrolysis glycoside unit and also filters, and collects filtrating, wave naturally to 1ml as need testing solution;
Other gets Fructus Tribuli control medicinal material 2g, adds chloroform 50ml, and reflux 4 hours is sloughed liposoluble constituent with the free ruscogenin of part and filter, and obtains medicinal residues after filtrating is discarded; In said medicinal residues, add concentration and be the hydrochloric acid 50ml hydrolysis 2 hours of 2mol/L, discard acid liquid; The medicinal residues water is washed till the oven dry of neutral back obtains residue; In said residue, add chloroform 50ml, reflux is 4 hours afterwards, proposes hydrolysis glycoside unit and also filters, and collects filtrating, waves naturally to 1ml and processes control medicinal material solution;
Get the negative sample 20g that lacks Fructus Tribuli again, add chloroform 50ml, reflux 4 hours is sloughed liposoluble constituent with the free ruscogenin of part and filter, and obtains medicinal residues after filtrating is discarded; In said medicinal residues, add concentration and be the hydrochloric acid 50ml hydrolysis 2 hours of 2mol/L, discard acid liquid; The medicinal residues water is washed till the oven dry of neutral back obtains residue; In said residue, add chloroform 50ml, reflux is 4 hours afterwards, proposes hydrolysis glycoside unit and also filters, and collects filtrating, waves naturally to 1ml and processes negative control solution;
Test according to thin layer chromatography; Get each 10 μ l of said need testing solution, control medicinal material solution and negative control solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, be that cyclohexane extraction-ethyl acetate-chloroformic solution of 5: 2.5: 1.5 is developing solvent with volume ratio; Launch, take out and dry; Spray is 1: 50: 0.5 an anisaldehyde sulfuric acid solution with raw material anisaldehyde, glacial acetic acid and vitriolic volume ratio, and it is clear under 105 ℃, to be heated to the speckle colour developing, in the test sample chromatograph; With the corresponding position of control medicinal material on show identical yellow spotting, and negative control is noiseless;
(2) get the drug sample 10g that is used to treat cold grasserie to be measured,, filter after 30 minutes through supersound process to wherein adding ethanol 30ml; To filtrate after the filtration and separate, and filtrating collected, and fling to ethanol with residue; In said residue, add methanol 1ml dissolving as need testing solution;
Other gets Herba pleurospermi thomsonii control medicinal material 2g, to wherein adding ethanol 10ml, filters after 30 minutes through supersound process; To filtrate after the filtration and separate, and filtrating collected, and fling to ethanol with residue; In said residue, add methanol 1ml dissolving as control medicinal material solution;
Get the negative sample 10g that lacks Herba pleurospermi thomsonii again,, filter after 30 minutes through supersound process to wherein adding ethanol 30ml; To filtrate after the filtration and separate, and filtrating collected, and fling to ethanol with residue; In said residue, add methanol 1ml dissolving as negative control solution;
Test according to thin layer chromatography; Get each 5 μ l of said need testing solution, control medicinal material solution and negative control solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, be that 8: 1.8: 0.2 normal hexane-ethyl acetate-methanol solutions are developing solvent with volume ratio; Launch, take out and dry; Spray is with 10% phosphomolybdic acid test solution, and it is clear under 105 ℃, to be heated to the speckle colour developing, in the test sample chromatograph; With the corresponding position of control medicinal material on show identical darkviolet speckle, and negative control is noiseless;
(3) get the drug sample 10g that is used to treat cold grasserie to be measured,, filter after 30 minutes through supersound process to wherein adding ethanol 30ml; To filtrate after the filtration and separate, collect filtrating, fling to ethanol with residue; In said residue, add methanol 1ml dissolving as need testing solution;
Other gets Radix Mirabilis himalaicae control medicinal material 2g, to wherein adding ethanol 10ml, to wherein adding ethanol 30ml, filters after 30 minutes through supersound process; To filtrate after the filtration and separate, collect filtrating, fling to ethanol with residue; In said residue, add methanol 1ml dissolving as control medicinal material solution;
Get the negative sample 10g that lacks Radix Mirabilis himalaicae again,, to wherein adding ethanol 30ml, filter after 30 minutes through supersound process; To filtrate after the filtration and separate, collect filtrating, fling to ethanol with residue; In said residue, add methanol 1ml dissolving as negative control solution;
According to the thin layer chromatography test, each 5 μ l of said need testing solution, control medicinal material solution and negative control solution put respectively on same silica GF254 lamellae; With volume ratio is that 8: 2: 1.5 normal hexane-ethyl acetate-methanol is developing solvent; Launch, take out and dry, placing wavelength is to inspect under the uviol lamp of 254nm, in the test sample chromatograph; With the corresponding position of control medicinal material on show identical crineous speckle, and negative control is noiseless.
After said method detected, testing result showed that above-mentioned being used to of preparing, to treat the drug quality of cold grasserie stable.
The dissolution test characterizes
The medicine that the present invention further treats cold grasserie to being used to of preparing carries out effective determination of dissolution rate, and this assay method mainly is to measure the effective dissolution of medicine through the content of measuring polygonatum polysaccharide in the drug sample to be measured, and detailed method is following:
Get the medicine 1.0g that the present invention is used to treat cold grasserie, the accurate title, decide, and is placed in the 100ml volumetric flask; And the adding volumn concentration is 0.9% hydrochloric acid solution; Place it in 37 ℃ the water-bath and place 12h, put coldly slightly after the jolting, add dissolution medium to scale.The sample liquid that takes a morsel through filtering with microporous membrane, is used spectrophotometry and is calculated, and this content is as the amount of 100% stripping.Measuring the result is 42.50% for the content that is used for treating the medicine polygonatum polysaccharide of cold grasserie of the present invention.
Spectrophotometry polygonatum polysaccharide content:
(1) preparation of reference substance solution: precision takes by weighing the anhydrous glucose 16.635mg that is dried to constant weight through 105 ℃, places the 50ml measuring bottle, adding distil water dissolving and be diluted to scale after shake up and get final product (containing anhydrous glucose 0.3327mg among every 1ml).
(2) investigation of linear relationship: accurate reference substance solution 0ml, 0.1ml, 0.2ml, 0.3ml, 0.4ml, 0.5ml, the 0.6ml of drawing, place the 10ml measuring bottle respectively, add water to scale and shake up.Precision is measured above-mentioned each solution 2.0ml respectively; Place tool plug test tube; And the accurate respectively 4% phenol solution 1.0ml that adds shakes up, the accurate rapidly then concentrated sulphuric acid 7.0ml that drips, the quick mixing of solution after utilizing eddy current suspendible device to above-mentioned dropping sulphuric acid; Place 40 ℃ of water-baths to be incubated 30min, take out to be placed on and place 5min in the ice-water bath; Other gets distilled water 2.0ml, adds 4% phenol solution and sulphuric acid with aforesaid operations with method, with this solution as blank.According to spectrophotography version " Chinese Pharmacopoeia (an one) " in 2005 appendix VB, measure trap in the 582nm wavelength, be vertical coordinate with trap (Y), anhydrous glucose content (X) carries out regression treatment for abscissa, gets regression equation to do
Y＝0.0419X-0.0101，r＝0.9997。
(3) preparation of need testing solution: adopt the slurry method, rotating speed is 100r/min, and temperature be (37.0 ± 2) ℃, and the dose volume percentage composition is that 0.9% hydrochloric acid solution is made dissolution medium, gets respectively 6 parts of the above-mentioned dissolution mediums of 900ml; Get that five of tradition are loose and to be used to treat the medicine of cold grasserie an amount of in the present invention, 6 parts every group, place dissolution medium to make an experiment respectively.These nine time points of 5min, 10min, 15min, 20min, 30min, 40min, 50min, 60min and 80min are got solution 8ml after on-test, replenish synthermal fresh medium 8ml after the taking-up immediately; Accurate each point in time sampling solution 1ml that draws places the 25ml measuring bottle, adds water to scale and shakes up; Precision is measured the solution 2ml of the above-mentioned 25ml of adding water to, to wherein adding ethanol 10ml and stirring, afterwards it is carried out centrifugal treating; In the deposition after centrifugal treating, add water 10ml and dissolve, the deposition precision after dissolving is measured 2ml, place tool plug test tube,, measure trap in accordance with the law according to the content under the investigation item of (2) linear relationship according to the preparation item operation down of standard curve.
Assay method and result: accurate each 2ml of need testing solution that draws, measure trap with method, make reference with 100% stripping quantity, each time point sample size and its relatively calculate accumulative total stripping percentage rate, and the result sees table 1.
Total polysaccharides accumulative total stripping percentage rate in five powder preparations of table 1 (x ± SD, n=6)
It is the test data that the medicine with the cold grasserie of treatment for preparing in the previous embodiment 1 obtains as test product to be measured that the test of above-mentioned dissolution characterizes.
Can know that by above-mentioned data the medicine that is used to treat cold grasserie of the present invention carries out the micronizing of specified particle diameter scope to its raw medicinal material; Pulverizing the back sporoderm-broken rate improves greatly; Bigger with the contact surface of solvent, diffusingsurface is also bigger, and the diffusion velocity of medicine is also faster; In addition, along with the miniaturization of medicinal powder, granularity diminishes; Specific surface area increases, and osmotic pressure raises, increased and dissolution medium between effective contact area; Accelerate dissolving, the release of solid drugs; Make the dissolution rate of crude drug effective ingredient accelerate, thereby improved bioavailability, to reach the purpose of better clinical efficacy.
The test of antiinflammatory pharmacology
The medicine that is used to treat cold grasserie of the present invention, it has antiphlogistic effects preferably, and pharmacological evaluation is following:
Employed medicament was Freund's complete adjuvant, barium sulfide (A.R), five medicines that are used to treat cold grasserie diffusing and the present invention prepares when it was carried out the antiinflammatory pharmacological evaluation.The instrument that is adopted comprises electronic balance and biped balance pain sensation tester.
The experiment body is the SD rat, body weight 220 ± 20g, female Mus of 4 monthly ages (this experiment body is provided by Lanzhou University's Animal Lab.).
Select above-mentioned 70 female Mus through the thermalgesia test; Be divided into 7 groups at random, be set to blank control group, model group, five loose group, administration group I (0.1-60 μ m particle diameter low dosage), administration group II (0.1-100 μ m particle diameter), administration group III (0.1-60 μ m particle diameter high dose), administration group IV (1-40 μ m particle diameter) respectively.With the modeling of rat left side knee joint depilation back injection Freund's complete adjuvant, behind the modeling 12h, blank control group is irritated clothes equal-volume normal saline with model group, and five groups of loosing are irritated stomach according to dosage in the table 1 respectively with the administration group, and employing biped balance pain sensation tester is tested behind the administration 6h.
Record biped Δ m value, the variance analysis of SPSS11.5 software shows that model group and other each groups all have utmost point significant difference (P＜0.01), and the modeling success is described, and five loose group, administration group I, administration group II, administration group III and administration group IV all have antiinflammatory action.Administration group I and five no difference of science of statistics between the group that loose, and have significant difference (P＜0.05) between the administration group II, and all have utmost point significant difference (P＜0.01) between administration group III, IV; All have significant difference (P＜0.05) and administration group I and model group between administration group III and administration group II, IV utmost point significant difference (P＜0.01) is arranged.The effect of five diffusing groups of antiinflammatory action and tradition of experimental result explanation administration group I is approaching; The antiinflammatory action of administration group III obviously is superior to five of conventional dosage forms and looses and administration group I (P＜0.01), and is superior to administration group II (P＜0.05).The antiphlogistic effects of administration group II is between administration group I and administration group III; The action effect of administration group IV is superior to administration group III (P＜0.05), obviously is superior to five loose group, administration group I and administration group II (P＜0.01).Result such as table 2.
Table 2 rat biped balance pain sensation test Δ m value
(compare △ P＜0.05, △ △ P＜0.01 with model group; Compare with administration group I
*P＜0.05,
*P＜0.01; Compare ★ P＜0.05, ★ ★ P＜0.01 with administration group III)
Can know that from above-mentioned test data five employed dosage of group that loose are greater than the dosage among the said administration group I, but its rat biped balance pain sensation test Δ m value is but greater than the Δ m value of said administration group I.This just explains the cold grasserie medicine that is used to treat of the present invention, uses the dosage among the administration group I promptly can realize more heavy dose of identical drug effect in five diffusing groups of tradition.Show through test of many times, the medicine realization after micronizing and five drug effects that diffusing medicine is identical of tradition that are used to treat cold grasserie of the present invention, its needed dosage is merely 57.5% of five powder amounts of tradition.
Though the present invention has carried out detailed elaboration through the above-mentioned specific embodiment to it; But; Any form that does not exceed the claim protection domain that those skilled in the art should be understood that on this basis to be made and the variation of details all belong to invention which is intended to be protected.
Claims (6)
- One kind the treatment cold grasserie medicine, comprise following bulk drugs:Herba pleurospermi thomsonii 50-150 part, Radix Mirabilis himalaicae 50-150 part, Fructus Tribuli 50-150 part, Rhizoma Polygonati 50-150 part, Radix Asparagi 50-150 part;It is characterized in that the particle diameter of said medicine is 1-40 μ m.
- 2. the medicine of the cold grasserie of treatment according to claim 1 is characterized in that, the weight portion of said crude drug is:100 parts of Herba pleurospermi thomsoniis, 100 parts of Radix Mirabilis himalaicaes, 100 parts of Fructus Tribulis, 100 parts of Rhizoma Polygonatis, 100 parts of Radix Asparagis.
- 3. the method for preparing of the medicine of claim 1 or the cold grasserie of 2 described treatments, it comprises the steps:(1) selected Herba pleurospermi thomsonii, Radix Mirabilis himalaicae, Fructus Tribuli, Rhizoma Polygonati, Radix Asparagi five tastes crude drug after the remove impurity, dry respectively or dry;(2) above-mentioned five tastes crude drug pulverize separately being become particle diameter is the micropowders of 1-40 μ m;(3) according to the proportioning of above-mentioned raw materials medicine the above-mentioned raw materials medicine is fully mixed;(4) the mixed crude drug of step (3) is packed or in above-mentioned crude drug, added conventional adjuvant again be prepared into arbitrary oral formulations.
- 4. method for preparing according to claim 3, said adjuvant are mannitol, hydroxypropyl methylcellulose, protein sugar, fragrant citrus powder, sodium glutamate and carboxymethyl starch sodium.
- 5. method for preparing according to claim 3 is characterized in that, said adjuvant is one or more in microcrystalline Cellulose, carboxymethyl starch sodium, starch, the transmutability starch.
- 6. method for preparing according to claim 5 is characterized in that, after adding said adjuvant, granulates, and adds Pulvis Talci again and carries out tabletting.
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