CN107213212A - A kind of expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax and preparation method thereof - Google Patents
A kind of expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax and preparation method thereof Download PDFInfo
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A61K9/2022—Organic macromolecular compounds
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract
The invention discloses a kind of expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax and preparation method thereof, said preparation includes the component of following parts by weight：60 80 parts of aconiti preparata,radix, 90 110 parts of wild aconite root, 130 150 parts of the root of fangji, windproof 60 80 parts, 60 80 parts of teasel root, 60 80 parts of the root of bidentate achyranthes, 60 80 parts of cassia twig, 60 80 parts of the root of Chinese clematis, 130 150 parts of geranium wilfordii, 50 100 parts of sodium alginate, 20 40 parts of hydroxypropyl methyl cellulose, 70 150 parts of pregelatinized starch, 30 60 parts of PVPP, 10 20 parts of lauryl sodium sulfate, 46 parts of superfine silica gel powder.Said preparation prepared composition discrete piece, its preparation method is prepared into medicinal material is extracted after dried cream powder, dried cream powder is prepared into inclusion compound, further by inclusion compound prepared composition discrete piece.Product of the present invention can significantly improve the dissolubility of insoluble drug in medicinal substances extract dried cream powder, shorten disintegration time limited, improve bioavilability.The preparation method technique is simple, and production cost is low, consumes energy low, easily realizes industrialized production.
Description
Technical field
The invention belongs to medicine field, it is related to a kind of medicine and preparation method thereof, more particularly to a kind of expelling wind and clearing away cold, relaxing muscles and tendons
Active Chinese medicine preparation and preparation method thereof.
Background technology
Effective rheumatism medicine piece is recorded in the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation the 3rd, and standard No. is WS3- B-0518-91,
Prescription is：Aconiti preparata,radix, wild aconite root, the root of fangji, cassia twig, teasel root, the root of bidentate achyranthes, the windproof, root of Chinese clematis, geranium wilfordii, are sugar coated tablet.With wind-dispelling
Cold dispelling, the effect stimulated the circulation of the blood and cause the muscles and joints to relax, clinically for treating wind-cold-dampness arthralgia, arthralgia, numb in every limb, waist and leg ache.
Effective rheumatism medicine piece has disintegration time limited length, dissolution rate due to the reasons such as existing technology of preparing, its sugar coated tablet after taking
It is low, absorb poor and relatively low bioavilability the problems such as, directly affect treatment effect.In addition, wind-cold-dampness arthralgia, arthritis
Bitterly, numb in every limb, waist and leg ache's Disease needs Long-term taking medicine, and presently commercially available product is generally sugar coated tablet, is disintegrated and rises
Effect is slower, it is impossible to promptly mitigate slow patient symptom, and containing sugared part, long-term taking has an impact to health, particularly blood glucose
Higher patient.Therefore, it is necessary to prepare, disintegration rate is very fast, dissolution is preferable, be easy to absorption, bioavilability is higher, without sugar
The expelling wind and clearing away cold of part, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax, to meet a variety of demands that clinical treatment and family use.
Dispersible tablet (Dispersible tablets) is also known as water dispersion tablet (Water dispersible tablets), is
The tablet to form homogeneous viscous suspension can be disintegrated rapidly by referring to chance water.For conventional tablet, dispersible tablet can increase indissoluble
Property medicine dissolving, absorb fast, bioavilability is high, adverse reaction is small, excitant of the medicine to intestines and stomach can be reduced.It is scattered
Piece is convenient to take, can swallow, chew, containing sucking, and can also put and individually be taken after disperseing in water or with fruit juice, milk with taking, especially be fitted
Close old, children and swallow the difficult patient of solid.
Former formulation medicinal material extract technique is：Get it filled material, add water to cook secondary, 3 hours for the first time, second 2 hours, merge
Decocting liquid, filtration, filtrate decompression is condensed into thick paste, not by any removal step.Chinese patent CN 1456282A are disclosed
A kind of preparation method of Fengshiling tablets against rheumatism, its medicinal material extract technique is：Ingredients is added water to cook 2-3 times, decoction liquor concentration
Dried cream powder is made into thick paste or concentrate drying, is similarly after water extraction and is directly condensed into thick paste, not by any removal step.With
Upper extracting method can not meet Chinese medical extract impurity when prepared by dispersible tablet try one's best it is few, to ensure containing for active ingredient in preparation
Amount and the requirement of drug action.
The disclosure of background above technology contents is only used for inventive concept and the technical scheme that auxiliary understands the present invention, and it is not
The prior art of present patent application is necessarily belonged to, the applying date of the above in present patent application is being shown without tangible proof
In the case of disclosed, above-mentioned background technology should not be taken to evaluate the novelty and creativeness of the application.
The content of the invention
There is provided a kind of expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax and its preparation for above-mentioned problem by the present invention
Method.The present invention is extracted by the medicinal material such as aconiti preparata,radix, wild aconite root, the root of fangji, cassia twig, teasel root, the root of bidentate achyranthes, windproof, the root of Chinese clematis, geranium wilfordii
Dried cream powder inclusion compound, then prepared composition discrete piece are prepared into, disintegration rate, dissolution rate and bioavilability is improved, so as to carry
High curative effect, also effectively masks the bad smell of medicine.Preparation method technique of the present invention is simple, and production cost is low, consumes energy low, easily
Realize industrialized production.
In order to solve the above technical problems, the present invention is achieved by the following technical solutions：
A kind of expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax, include the component of following parts by weight：60-80 parts of aconiti preparata,radix, system
90-110 parts of radix aconiti agrestis, 130-150 parts of the root of fangji, windproof 60-80 parts, 60-80 parts of teasel root, 60-80 parts of the root of bidentate achyranthes, 60-80 parts of cassia twig, prestige
60-80 parts of medicine xiaolingxian, 130-150 parts of geranium wilfordii, 50-100 parts of sodium alginate, 20-40 parts of hydroxypropyl methyl cellulose, pregelatinated form sediment
70-150 parts of powder, 30-60 parts of PVPP, 10-20 parts of lauryl sodium sulfate, 4-6 parts of superfine silica gel powder, are prepared into scattered
Piece.
The preparation method of more than one described expelling wind and clearing away colds, the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax, including with
Lower step：
T1. following components is taken respectively：Hydroxypropyl methyl cellulose, pregelatinized starch, PVPP, dodecyl sulphate
Sodium, superfine silica gel powder, crushed 100 mesh sieves, standby；
T2. component is weighed by following parts by weight：It is 60-80 parts of aconiti preparata,radix, 90-110 parts of wild aconite root, 130-150 parts of the root of fangji, anti-
60-80 parts of wind, 60-80 parts of teasel root, 60-80 parts of the root of bidentate achyranthes, 60-80 parts of cassia twig, 60-80 parts of the root of Chinese clematis, 130-150 parts of geranium wilfordii,
50-100 parts of sodium alginate, 20-40 parts of hydroxypropyl methyl cellulose, 70-150 parts of pregelatinized starch, PVPP 30-60
Part, 10-20 parts of lauryl sodium sulfate, 4-6 parts of superfine silica gel powder；
T3. medicinal substances extract dried cream powder is prepared；
T4. medicinal substances extract dried cream powder is taken, main ingredient inclusion compound is prepared into；
T5. taking hydroxypropyl methyl cellulose to be dissolved in the ethanol of 120-200 parts 65%, that hydroxypropyl methyl cellulose is made is dilute
Ethanol solution；
T6. the main ingredient inclusion compound for taking pregelatinized starch, PVPP, lauryl sodium sulfate and step T4 to prepare is added
In mixer, step T5 hydroxypropyl methyl cellulose ethanol solution is stirring evenly and then adding into, stirring is made soft for 10-15 minutes
Material, crosses 20 mesh sieve wet granulations, dries, and takes out, and crosses 50 mesh sieve whole grains, obtains dry particl；
T7. the lower dry particl of step T6, plus superfine silica gel powder is taken to mix 30 minutes mixed powders processed, tabletting is produced.
Step T3 in expelling wind and clearing away cold described above, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax, the preparation method of prepared composition discrete piece
The preparation method of lower medicinal substances extract dried cream powder is：
S1. load weighted ingredients is taken to be broken into the coarse powder of 8-10 mesh；
S2. take the taste medicinal material of tetrandra root, windproof, teasel root, cassia twig, the root of Chinese clematis etc. 5 plus 6-8 times measure 70% ethanol solution, ultrasound
Extract 3 times, 1 hour every time, collect No. 3 extract solutions, reclaim ethanol, be concentrated into relative density at 80 DEG C for 1.27-1.30's
Thick paste A；
S3. take the tetrandra root after being extracted under aconiti preparata,radix, wild aconite root, the root of bidentate achyranthes, geranium wilfordii and step S1 through ethanol, it is windproof, continuous
Disconnected, cassia twig, clematis chinensis medicinal materials, are added water to cook 2 times, are added 6-8 times to measure decocting for the first time and are boiled 2-3 hours, and adding 4-6 times for the second time measures water
Decoct 1-2 hour, collecting decoction, filtering, filtrate is concentrated into clear cream of the relative density at 60 DEG C for 1.03-1.07, add and
95% ethanol of clear cream equivalent, in being placed 12-24 hours at 5-10 DEG C, takes out, and the filtering of 200 mesh takes filtrate recycling ethanol and dense
It is reduced to thick paste B of the relative density at 80 DEG C for 1.27-1.30；
S4. above-mentioned thick paste A, B is taken to mix, vacuum drying is taken out and crushed, and is crossed 80 mesh sieves, is obtained medicinal substances extract dried cream powder.
Step T4 in expelling wind and clearing away cold described above, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax, the preparation method of prepared composition discrete piece
The preparation method of lower main ingredient inclusion compound is：
R1. take medicinal substances extract dried cream powder, plus the ethanol solution of 200-500 parts 65% to make dissolving, medicinal substances extract is made and does
Cream powder Diluted Alcohol solution；
R2. sodium alginate is taken to be placed in material-compound tank, plus 500-1000 parts of water, heating dissolves it at 45-55 DEG C, obtains extra large
Solution of sodium alginate；
R3. medicinal substances extract dried cream powder Diluted Alcohol solution is slowly added into sodium alginate soln, stirring while adding, temperature
It is maintained at 45-55 DEG C and stirs 3-5 hour, put and placed 8-12 hours to rearmounted 4 DEG C -10 DEG C of room temperature, filters, discard mother
Liquid, filter residue and drying crosses 80 mesh sieves, main ingredient inclusion compound is made.
Further, the lower vacuum drying temperature of step S4 is 60 DEG C -80 in the preparation method of medicinal substances extract dried cream powder
DEG C, the time is 10-12 hours, moisture≤6% of gained medicinal substances extract dried cream powder.
Further, the lower mixing speed of step R3 is 40- in the preparation method of medicinal substances extract dried cream powder inclusion compound
60rpm, filter residue and drying temperature is 60 DEG C -80 DEG C, and drying time is 6-8 hours, gained main ingredient inclusion compound moisture≤6%.
Further, step T6 lower particle drying temperature are 60 DEG C -80 DEG C, and drying time is 8-10 hours, and gained is done
Moisture≤6% of particle.
The beneficial effects of the invention are as follows：
1st, the inventive method by the medicinal material such as the root of fangji, cassia twig, teasel root, windproof, the root of Chinese clematis in side first after alcohol extracting again with river processed
The water extraction together of crow, wild aconite root, the root of bidentate achyranthes, geranium wilfordii, then through alcohol precipitation step removal of impurities, both ensure that the extraction of active ingredient was more complete,
The removal of impurity can be effectively gone again, the content of active ingredient in extract is improved, so as to ensure that containing for active ingredient in dispersible tablet
Amount and curative effect.
2nd, medicinal material extract dried cream powder is prepared into inclusion compound by Chinese medicine preparation of the present invention, further prepared composition discrete piece, no
But the bad smell of medicine is masked, also medicine disintegration speed, the more former formulation of dissolution rate (tablet) is significantly increased, overcome
Disintegration that the formulations such as existing effective rheumatism medicine piece, capsule are present and work slower, dissolution rate is low, and bioavilability is relatively low, it is impossible to fast
Drug effect is played fastly so as to the problems such as quickly mitigating slow patient symptom, and fast with disintegration rate, dissolution preferably, absorbs very fast, made
With rapid-action, bioavilability is high, and adverse reaction is few, the advantages of convenient to take.
3rd, the present invention is with hydroxypropyl methyl cellulose, pregelatinized starch, PVPP, lauryl sodium sulfate, micro mist
Silica gel etc., without sugar, is conducive to the long-term taking of hyperglycemic patients as auxiliary material, overcomes former formulation (sugar coated tablet) and is unfavorable for
The shortcomings of hyperglycemic patients long-term taking.
4th, the technique of the inventive method is simple, production equipment is operated without particular/special requirement, easily, consume energy it is low, time saving, produce
Cost is low, easily realizes industrialized production.
Embodiment
Although this specification is drawn a conclusion by particularly pointing out and claims of the present invention being clearly claimed, should
This believes that following explanation is better understood with the present invention.
As used herein, word " preferably " and variant refer to that this hair of specific beneficial effect can be provided in certain circumstances
Bright embodiment.However, other embodiments can also be preferred under identical or other environment.In addition, one
Or it is useless that the detailed description of multiple preferred embodiments, which is not offered as other embodiments, and it is not intended to from scope of the invention
Exclude other embodiments.
First, the screening of medicinal material extract method
Following medicinal material extract method is compared in present invention experiment：
1st, former formulation (sugar coated tablet) extracting method：Take aconiti preparata,radix 68g, wild aconite root 102g, tetrandra root 136g, windproof 68g teasel roots
68g, root of bidentate achyranthes 68g, cassia twig 68g, root of Chinese clematis 68g, geranium wilfordii 136g, are broken into the coarse powder of 8 mesh, add water to cook it is secondary, for the first time Jia 8
Amount decocting again is boiled 3 hours, adds 6 times of amount decoctings to boil for the second time 2 hours, collecting decoction is filtered, and filtrate decompression is condensed into thick paste, very
Sky dry, pulverize, and obtain medicinal substances extract dried cream powder.
2nd, aconiti preparata,radix 68g, wild aconite root 102g, tetrandra root 136g, windproof 68g, teasel root 68g, root of bidentate achyranthes 68g, cassia twig 68g, prestige are taken
Medicine xiaolingxian 68g, geranium wilfordii 136g, are broken into the coarse powder of 8 mesh, add water to cook 2 times, add 8 times of amount decoctings to boil for the first time 3 hours, second
Plus 6 times of amount decoctings are boiled 2 hours, collecting decoction, filtering, filtrate is concentrated into clear cream of the relative density at 60 DEG C for 1.05, adds
With 95% ethanol of clear cream equivalent, in being placed 12 hours at 5 DEG C, take out, the filtering of 200 mesh takes filtrate recycling ethanol and is concentrated into
Thick paste of the relative density at 80 DEG C for 1.28, is dried in vacuo, and crushes, obtains medicinal substances extract dried cream powder.
3rd, weigh aconiti preparata,radix 68g, wild aconite root 102g, tetrandra root 136g, windproof 68g, teasel root 68g, root of bidentate achyranthes 68g, cassia twig 68g,
Root of Chinese clematis 68g, geranium wilfordii 136g, are broken into the coarse powder of 8 mesh；Take the taste medicinal material of tetrandra root, windproof, teasel root, cassia twig, the root of Chinese clematis etc. 5 plus 6 times
The ethanol solution of amount 70%, ultrasonic extraction 3 times 1 hour every time, collects No. 3 extract solutions, reclaims ethanol, be concentrated into relative density
Thick paste A at 80 DEG C for 1.27-1.30；Take and extracted under aconiti preparata,radix, wild aconite root, the root of bidentate achyranthes, geranium wilfordii and step S1 through ethanol
Tetrandra root, windproof, teasel root, cassia twig, clematis chinensis medicinal materials afterwards, are added water to cook 2 times, add 8 times of amount decoctings to boil 3 hours, second for the first time
Secondary plus 6 times of amount decoctings are boiled 2 hours, and collecting decoction, filtering, filtrate is concentrated into clear cream of the relative density at 60 DEG C for 1.05, plus
Enter 95% ethanol with clear cream equivalent, in being placed 12 hours at 5 DEG C, take out, the filtering of 200 mesh takes filtrate recycling ethanol and concentrated
To thick paste B of the relative density at 80 DEG C for 1.28；Above-mentioned thick paste A, B is taken to mix, vacuum drying is taken out and crushed, and crosses 80 mesh sieves,
Obtain medicinal substances extract dried cream powder.
Determine the content of Tet in the dried cream powder obtained by 3 kinds of extracting methods of the above respectively using high performance liquid chromatography,
It the results are shown in Table 1.
The assay result of Tet in dried cream powder obtained by 13 kinds of medicinal material extract methods of table
As shown in Table 1, in the dried cream powder of the gained of extracting method 3 Tet content highest, illustrate according to extracting method 3
The rate of transform of active ingredient is high when extracting medicinal material, and impurity is significantly reduced, therefore selective extraction method 3 of the present invention is used as medicinal material
Extracting method.
2nd, the screening of formulation conditions
1. the selection of disintegrant
The species and consumption of disintegrant are most important to the disintegration of dispersible tablet, result of extraction, are the factors for first having to consider.
The disintegrant commonly used in dispersible tablet has sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, PVPP, cross-linked carboxymethyl fine
Plain sodium of dimension etc..Using hydroxypropyl methyl cellulose as adhesive, superfine silica gel powder is glidant, respectively to 8% sodium carboxymethyl starch,
8% PVPP, 8% low-substituted hydroxypropyl cellulose, 8% Ac-Di-Sol, 4 kinds of disintegrants, are added using interior
Method, carries out Selection experiment, overall merit is carried out using disintegration time limited and dispersing uniformity as evaluation index, to determine in dispersible tablet most
Good disintegrant species.It the results are shown in Table 2.
The optimization test result table of the disintegrant of table 2
It was found from the result of the test in table 2：Using PVPP disintegration of tablet time limit made from disintegrant and scattered equal
Even property is preferable, therefore selective cross-linking PVP of the present invention is disintegrant, is added using interior addition.The present invention, which continues to optimize to be crosslinked, to be gathered
The consumption of ketone is tieed up, result of the test is shown in Table 3.
The consumption of the PVPP of table 3 investigates result table
It was found from the result of the test in table 3：The present invention is tablet made from disintegrant using 8%-10% PVPPs
Disintegration time limited and dispersing uniformity are preferable, thus selective cross-linking PVP of the present invention as disintegrant when consumption be to account for recipe quantity
8%-10%.
2. the selection of adhesive
The present invention compared for the tabletting again of compressing dry granulation, wet granulation, and compressing dry granulation is bad using conventional tablet machines effect, right
Equipment requirement is high, therefore the present invention uses wet granulation tabletting again.Dispersible tablet uses the particle that hydrophilic adhesive is made, surface tool
Moisture is easily moistened after hydrophily, tabletting, is penetrated into, beneficial to disintegration of tablet.Water, 65% ethanol solution, 6% hydroxypropyl have been investigated in experiment
65% ethanol solution of ylmethyl cellulose makees adhesive, using the situation of pelletizing, disintegration time limited and dispersing uniformity as evaluation index
Overall merit is carried out, 4 are the results are shown in Table.
The adhesive of table 4 investigates result table
It was found from the result of the test in table 4：The present invention is pelletized using 65% ethanol solution of 6% hydroxypropyl methyl cellulose
Situation, tablet appearance, disintegration time limited and dispersing uniformity effect are best, therefore invention adhesives select 6% hydroxypropyl methyl fine
Tie up 65% ethanol solution of element.The present invention continues the consumption of excellent hydroxypropyl methyl cellulose, and result of the test is shown in Table 5.
The binder dosage of table 5 investigates result table
It was found from the result of the test in table 5：The present invention, which is used, accounts for recipe quantity 6%-7% hydroxypropyl methyl celluloses as viscous
Situation, disintegration time limited and the dispersing uniformity effect of being pelletized during mixture are preferable, therefore present invention selection accounts for recipe quantity 6%-7% hydroxypropyls
Ylmethyl cellulose is used as adhesive.
3. the selection of surfactant
Surfactant has wetting and the effect of solubilising in pharmaceutical preparation, and surface is added in the prescription of dispersible tablet and is lived
Property agent is greatly improved the dissolution rate of dispersible tablet.Lauryl sodium sulfate, dodecyl sodium sulfate, Luo Bo are compared in experiment
Husky nurse and the dissolution experiment for not adding dispersible tablet in the case of three kinds of surfactant, the results are shown in Table 6.
The surfactant of table 6 investigates result table
Result of the test in table 6：In the dissolution results of three kinds of dispersible tablets, with lauryl sodium sulfate as
Result of extraction is best during surfactant, therefore present invention selection lauryl sodium sulfate is surfactant.Through experiment investigation pair
Than its consumption be recipe quantity 3.0%-5.0% when tablet result of extraction it is best.
4. it is swelled the selection of auxiliary material
Dispersible tablet is mainly medicine with least one disintegrant and being swelled supplementary product compatibility and forming.What is used at present is swelled auxiliary material
There are guar gum, XANTHAN GUM, alginates, glucan, amylum pregelatinisatum, HPMC, polysaccharide and calcium carboxymethylcellulose, hydroxypropyl fine
Tie up the hydrophilic high molecular polymers such as element.XANTHAN GUM, sodium alginate, glucan and pregelatinized starch are compared in experiment, to collapse
The solution time is inspection target, the results are shown in Table 7.
Table 7 is swelled auxiliary material and investigates result table
It was found from the result of the test in table 7：Using pregelatinized starch as when being swelled auxiliary material, the disintegration effect of dispersible tablet is best,
Therefore present invention selection pregelatinized starch is to be swelled auxiliary material.Compare through experiment investigation, pregelatinized starch is best suitable for as auxiliary material is swelled
Consumption is the 20-25% for accounting for recipe quantity.
5. the selection of glidant
Powder flowbility is a critical nature in solid pharmaceutical preparation technique.Superfine silica gel powder, magnesium stearate are conventional
Glidant, can effectively improve the mobility of particle or powder in pelletizing press sheet or direct powder compression.Contrasted in experiment
1% superfine silica gel powder, 1% magnesium stearate, 1% magnesium stearate-superfine silica gel powder (1: 1) are as glidant, with disintegration time and hard
Spend for inspection target, progress overall merit.It the results are shown in Table 8.
The glidant of table 8 investigates result table
Result of the test in table 8：1% superfine silica gel powder is best as glidant effect, therefore the present invention is micro- from 1%
Powder silica gel is as glidant.
3rd, expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax
Embodiment 1
The preparation method of a kind of expelling wind and clearing away cold, the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax, comprises the following steps：
T1. following components is taken respectively：Hydroxypropyl methyl cellulose, pregelatinized starch, PVPP, dodecyl sulphate
Sodium, superfine silica gel powder, crushed 100 mesh sieves, standby；
T2. component is weighed by following parts by weight：Aconiti preparata,radix 600g, wild aconite root 900g, root of fangji 1300g, windproof 600g, teasel root
600g, root of bidentate achyranthes 600g, cassia twig 600g, root of Chinese clematis 600g, geranium wilfordii 1300g, sodium alginate 500g, hydroxypropyl methyl cellulose
200g, pregelatinized starch 700g, PVPP 300g, lauryl sodium sulfate 100g, superfine silica gel powder 40g；
T3. medicinal substances extract dried cream powder is prepared:Load weighted ingredients is taken to be broken into the coarse powder of 10 mesh；Take tetrandra root, it is windproof,
The taste medicinal material of teasel root, cassia twig, root of Chinese clematis etc. 5 adds the ethanol solution of 6 times of amounts 70%, and ultrasonic extraction 3 times 1 hour every time, is collected 3 times
Extract solution, reclaims ethanol, is concentrated into thick paste A of the relative density at 80 DEG C for 1.27；Ethanol of learning from else's experience extract after tetrandra root, anti-
Wind, teasel root, cassia twig, the root of Chinese clematis and aconiti preparata,radix, wild aconite root, the root of bidentate achyranthes, geranium wilfordii, are added water to cook 2 times, and 6 times of amount decoctings are added for the first time
Boil 2 hours, add 4 times of amount decoctings to boil for the second time 1 hour, collecting decoction, filtering, filtrate is concentrated into relative density and is at 60 DEG C
1.03 clear cream, adds 95% ethanol with clear cream equivalent, in being placed 12 hours at 5 DEG C, takes out, and the filtering of 200 mesh takes filtrate to return
Receive ethanol and be concentrated into thick paste B of the relative density at 80 DEG C for 1.27；Thick paste A, B is taken to mix, 60 DEG C are dried in vacuo 12 hours,
Take out and crush, cross 80 mesh sieves, obtain medicinal substances extract dried cream powder, it is 3.1% to determine moisture；
T4. medicinal substances extract dried cream powder is taken, main ingredient inclusion compound is prepared into:Take medicinal substances extract dried cream powder, plus 2000g
65% ethanol solution makes dissolving, and medicinal substances extract dried cream powder Diluted Alcohol solution is made；Sodium alginate is taken to be placed in material-compound tank, plus
5000g water, heating dissolves it at 45 DEG C, obtains sodium alginate soln；By medicinal substances extract dried cream powder Diluted Alcohol solution slowly
Add in sodium alginate soln, side edged is stirred with 40rpm mixing speed, temperature is maintained at 45 DEG C and stirred 3 hours, put to
Placed 8 hours under the conditions of rearmounted 4 DEG C of room temperature, filtering, discard mother liquor, the drying 8 hours of 60 DEG C of filter residue crosses 80 mesh sieves, main ingredient is made
Inclusion compound, it is 2.9% to determine moisture.
T5. take hydroxypropyl methyl cellulose to be dissolved in the ethanol of 1200g 65% and hydroxypropyl methyl cellulose Diluted Alcohol is made
Solution；
T6. the main ingredient inclusion compound for taking pregelatinized starch, PVPP, lauryl sodium sulfate and step T4 to prepare is added
In mixer, step T5 hydroxypropyl methyl cellulose ethanol solution is stirring evenly and then adding into, softwood, mistake is made in 10 minutes in stirring
20 mesh sieve wet granulations, 60 DEG C of dryings 10 hours are taken out, and cross 50 mesh sieve whole grains, obtain dry particl, and it is 3.1% to determine moisture；
T7. the lower dry particl of step T6, plus superfine silica gel powder is taken to mix 30 minutes mixed powders processed, tabletting is produced.
Embodiment 2
The preparation method of a kind of expelling wind and clearing away cold, the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax, comprises the following steps：
T1. following components is taken respectively：Hydroxypropyl methyl cellulose, pregelatinized starch, PVPP, dodecyl sulphate
Sodium, superfine silica gel powder, crushed 100 mesh sieves, standby；
T2. component is weighed by following parts by weight：It is aconiti preparata,radix 800g, wild aconite root 1100g, root of fangji 1500g, windproof 800g, continuous
Disconnected 800g, root of bidentate achyranthes 800g, cassia twig 800g, root of Chinese clematis 800g, geranium wilfordii 1500g, sodium alginate 1000g, hydroxypropyl methyl fiber
Plain 400g, pregelatinized starch 1500g, PVPP 600g, lauryl sodium sulfate 200g, superfine silica gel powder 60g；
T3. medicinal substances extract dried cream powder is prepared:Load weighted ingredients is taken to be broken into the coarse powder of 8 mesh；Take tetrandra root, it is windproof,
The taste medicinal material of teasel root, cassia twig, root of Chinese clematis etc. 5 adds the ethanol solution of 8 times of amounts 70%, and ultrasonic extraction 3 times 1 hour every time, is collected 3 times
Extract solution, reclaims ethanol, is concentrated into thick paste A of the relative density at 80 DEG C for 1.30；Ethanol of learning from else's experience extract after tetrandra root, anti-
Wind, teasel root, cassia twig, the root of Chinese clematis and aconiti preparata,radix, wild aconite root, the root of bidentate achyranthes, geranium wilfordii, are added water to cook 2 times, and 8 times of amount decoctings are added for the first time
Boil 3 hours, add 6 times of amount decoctings to boil for the second time 2 hours, collecting decoction, filtering, filtrate is concentrated into relative density and is at 60 DEG C
1.07 clear cream, adds 95% ethanol with clear cream equivalent, in being placed 24 hours at 10 DEG C, takes out, and the filtering of 200 mesh takes filtrate
Reclaim ethanol and be concentrated into thick paste B of the relative density at 80 DEG C for 1.30；Thick paste A, B is taken to mix, 80 DEG C of vacuum drying 10 are small
When, take out and crush, cross 80 mesh sieves, obtain medicinal substances extract dried cream powder, it is 3.3% to determine moisture；
T4. medicinal substances extract dried cream powder is taken, main ingredient inclusion compound is prepared into:Take medicinal substances extract dried cream powder, plus 5000g
65% ethanol solution makes dissolving, and medicinal substances extract dried cream powder Diluted Alcohol solution is made；Sodium alginate is taken to be placed in material-compound tank, plus
10000g water, heating dissolves it at 55 DEG C, obtains sodium alginate soln；By medicinal substances extract dried cream powder Diluted Alcohol solution slowly
Add in sodium alginate soln, side edged is stirred with 60rpm mixing speed, temperature is maintained at 55 DEG C and stirred 5 hours, put to
Placed 12 hours under the conditions of rearmounted 10 DEG C of room temperature, filtering, discard mother liquor, the drying 6 hours of 80 DEG C of filter residue crosses 80 mesh sieves, master is made
Pack compound, it is 3.2% to determine moisture.
T5. take hydroxypropyl methyl cellulose to be dissolved in the ethanol of 2000g 65% and hydroxypropyl methyl cellulose Diluted Alcohol is made
Solution；
T6. the main ingredient inclusion compound for taking pregelatinized starch, PVPP, lauryl sodium sulfate and step T4 to prepare is added
In mixer, step T5 hydroxypropyl methyl cellulose ethanol solution is stirring evenly and then adding into, softwood, mistake is made in 15 minutes in stirring
20 mesh sieve wet granulations, 80 DEG C of dryings 8 hours are taken out, and cross 50 mesh sieve whole grains, obtain dry particl, and it is 3.4% to determine moisture；
T7. the lower dry particl of step T6, plus superfine silica gel powder is taken to mix 30 minutes mixed powders processed, tabletting is produced.
Embodiment 3
The preparation method of a kind of expelling wind and clearing away cold, the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax, comprises the following steps：
T1. following components is taken respectively：Hydroxypropyl methyl cellulose, pregelatinized starch, PVPP, dodecyl sulphate
Sodium, superfine silica gel powder, crushed 100 mesh sieves, standby；
T2. component is weighed by following parts by weight：It is aconiti preparata,radix 680g, wild aconite root 1020g, root of fangji 1360g, windproof 680g, continuous
Disconnected 680g, root of bidentate achyranthes 680g, cassia twig 680g, root of Chinese clematis 680g, geranium wilfordii 1360g, sodium alginate 750g, hydroxypropyl methyl cellulose
300g, pregelatinized starch 1100g, PVPP 450g, lauryl sodium sulfate 150g, superfine silica gel powder 50g；
T3. medicinal substances extract dried cream powder is prepared:Load weighted ingredients is taken to be broken into the coarse powder of 9 mesh；Take tetrandra root, it is windproof,
The taste medicinal material of teasel root, cassia twig, root of Chinese clematis etc. 5 adds the ethanol solution of 7 times of amounts 70%, and ultrasonic extraction 3 times 1 hour every time, is collected 3 times
Extract solution, reclaims ethanol, is concentrated into thick paste A of the relative density at 80 DEG C for 1.28；Ethanol of learning from else's experience extract after tetrandra root, anti-
Wind, teasel root, cassia twig, the root of Chinese clematis and aconiti preparata,radix, wild aconite root, the root of bidentate achyranthes, geranium wilfordii, are added water to cook 2 times, and 7 times of amount decoctings are added for the first time
Boil 2.5 hours, add 5 times of amount decoctings to boil for the second time 1.5 hours, collecting decoction, filtering, filtrate is concentrated into relative density at 60 DEG C
For 1.05 clear cream, 95% ethanol with clear cream equivalent is added, in being placed 18 hours at 8 DEG C, is taken out, the filtering of 200 mesh takes filtrate
Reclaim ethanol and be concentrated into thick paste B of the relative density at 80 DEG C for 1.28；Thick paste A, B is taken to mix, 70 DEG C of vacuum drying 11 are small
When, take out and crush, cross 80 mesh sieves, obtain medicinal substances extract dried cream powder, it is 3.2% to determine moisture；
T4. medicinal substances extract dried cream powder is taken, main ingredient inclusion compound is prepared into:Take medicinal substances extract dried cream powder, plus 3500g
65% ethanol solution makes dissolving, and medicinal substances extract dried cream powder Diluted Alcohol solution is made；Sodium alginate is taken to be placed in material-compound tank, plus
7500g water, heating dissolves it at 50 DEG C, obtains sodium alginate soln；By medicinal substances extract dried cream powder Diluted Alcohol solution slowly
Add in sodium alginate soln, side edged is stirred with 50rpm mixing speed, temperature is maintained at 50 DEG C and stirred 4 hours, put to
Placed 10 hours under the conditions of rearmounted 8 DEG C of room temperature, filtering, discard mother liquor, the drying 7 hours of 70 DEG C of filter residue crosses 80 mesh sieves, main ingredient is made
Inclusion compound, it is 3.0% to determine moisture.
T5. take hydroxypropyl methyl cellulose to be dissolved in the ethanol of 1600g 65% and hydroxypropyl methyl cellulose Diluted Alcohol is made
Solution；
T6. the main ingredient inclusion compound for taking pregelatinized starch, PVPP, lauryl sodium sulfate and step T4 to prepare is added
In mixer, step T5 hydroxypropyl methyl cellulose ethanol solution is stirring evenly and then adding into, softwood, mistake is made in 13 minutes in stirring
20 mesh sieve wet granulations, 70 DEG C of dryings 9 hours are taken out, and cross 50 mesh sieve whole grains, obtain dry particl, and it is 3.2% to determine moisture；
T7. the lower dry particl of step T6, plus superfine silica gel powder is taken to mix 30 minutes mixed powders processed, tabletting is produced.
4th, expelling wind and clearing away cold, the quality evaluation for the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax
1. determine disintegration time limited
Using Chinese Pharmacopoeia version " disintegration time limited inspection technique " (general rule 0921) in 2015, Example 1-3 expelling wind and clearing away cold,
The Chinese medicine preparation and commercially available effective rheumatism medicine piece (sugar coated tablet) stimulated the circulation of the blood and cause the muscles and joints to relax are detected, disintegration time limited is recorded respectively, be the results are shown in Table
9。
The disintegration time mensuration situation of table 9
As can be seen from Table 9, expelling wind and clearing away cold of the present invention, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax are than commercially available effective rheumatism medicine piece (sugar-coat
Piece) disintegration time greatly shortens, and shows that it absorbs very fast, can quick acting, be conducive to improving curative effect.
2. determine dissolution rate
Using Chinese Pharmacopoeia version " dissolution rate and drug release determination method " first method (general rule 0931), Example 4- in 2015
6 expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax and commercially available effective rheumatism medicine piece (sugar coated tablet) are detected that sample size is determined and adopted
With high performance liquid chromatography, using Tet as reference substance, dissolution rate is calculated, 10 are the results are shown in Table.
The dissolution determination situation of table 10
As can be seen from Table 10, expelling wind and clearing away cold of the present invention, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax are than commercially available effective rheumatism medicine piece (sugar-coat
Piece) dissolution rate significantly improves, and shows that its bioavilability is higher.
The specific implementation of the invention is not to be limited to these illustrations for above content, is led for technology belonging to the present invention
For the those of ordinary skill in domain, without departing from the inventive concept of the premise, some simple deduction or replace can also be made,
The scope of patent protection that the present invention is determined by the claims submitted should be all considered as belonging to.
Claims (10)
1. a kind of expelling wind and clearing away cold, the Chinese medicine preparation stimulated the circulation of the blood and cause the muscles and joints to relax, include the component of following parts by weight：60-80 parts of aconiti preparata,radix, system grass
Black 90-110 parts, 130-150 parts of the root of fangji, windproof 60-80 parts, 60-80 parts of teasel root, 60-80 parts of the root of bidentate achyranthes, 60-80 parts of cassia twig, Wheeling
Celestial 60-80 parts, 130-150 parts of geranium wilfordii, 50-100 parts of sodium alginate, 20-40 parts of hydroxypropyl methyl cellulose, pregelatinized starch
70-150 parts, 30-60 parts of PVPP, 10-20 parts of lauryl sodium sulfate, 4-6 parts of superfine silica gel powder, it is characterised in that institute
State preparation prepared composition discrete piece.
2. the preparation method of a kind of expelling wind and clearing away cold according to claim 1, the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax,
It is characterised in that it includes following steps：
T1. following components is taken respectively：Hydroxypropyl methyl cellulose, pregelatinized starch, PVPP, lauryl sodium sulfate,
Superfine silica gel powder, crushed 100 mesh sieves, standby；
T2. component is weighed by following parts by weight：It is 60-80 parts of aconiti preparata,radix, 90-110 parts of wild aconite root, 130-150 parts of the root of fangji, windproof
60-80 parts, 60-80 parts of teasel root, 60-80 parts of the root of bidentate achyranthes, 60-80 parts of cassia twig, 60-80 parts of the root of Chinese clematis, 130-150 parts of geranium wilfordii, sea
50-100 parts of mosanom, 20-40 parts of hydroxypropyl methyl cellulose, 70-150 parts of pregelatinized starch, 30-60 parts of PVPP,
10-20 parts of lauryl sodium sulfate, 4-6 parts of superfine silica gel powder；
T3. medicinal substances extract dried cream powder is prepared；
T4. medicinal substances extract dried cream powder is taken, main ingredient inclusion compound is prepared into；
T5. take hydroxypropyl methyl cellulose to be dissolved in the ethanol of 120-200 parts 65% and hydroxypropyl methyl cellulose Diluted Alcohol is made
Solution；
T6. the main ingredient inclusion compound for taking pregelatinized starch, PVPP, lauryl sodium sulfate and step T4 to prepare adds stirring
In machine, step T5 hydroxypropyl methyl cellulose ethanol solution is stirring evenly and then adding into, softwood, mistake is made in 10-15 minutes in stirring
20 mesh sieve wet granulations, are dried, and are taken out, and are crossed 50 mesh sieve whole grains, are obtained dry particl；
T7. the lower dry particl of step T6, plus superfine silica gel powder is taken to mix 30 minutes mixed powders processed, tabletting is produced.
3. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 2, it is special
Levy and be：The preparation method of medicinal substances extract dried cream powders is under described step T3：
S1. load weighted ingredients is taken to be broken into the coarse powder of 8-10 mesh；
S2. take the taste medicinal material of tetrandra root, windproof, teasel root, cassia twig, the root of Chinese clematis etc. 5 plus 6-8 times measure 70% ethanol solution, ultrasonic extraction 3
It is secondary, 1 hour every time, No. 3 extract solutions are collected, ethanol is reclaimed, is concentrated into thick paste A of the relative density at 80 DEG C for 1.27-1.30；
S3. the tetrandra root after being extracted under aconiti preparata,radix, wild aconite root, the root of bidentate achyranthes, geranium wilfordii and step S1 through ethanol, windproof, teasel root, osmanthus are taken
Branch, clematis chinensis medicinal materials, are added water to cook 2 times, are added 6-8 times to measure decocting for the first time and are boiled 2-3 hours, are added 4-6 times to measure decocting for the second time and are boiled
1-2 hours, collecting decoction, filtering, filtrate was concentrated into clear cream of the relative density at 60 DEG C for 1.03-1.07, added and clear cream
95% ethanol of equivalent, in being placed 12-24 hours at 5-10 DEG C, takes out, and the filtering of 200 mesh takes filtrate recycling ethanol and is concentrated into
Thick paste B of the relative density at 80 DEG C for 1.27-1.30；
S4. above-mentioned thick paste A, B is taken to mix, vacuum drying is taken out and crushed, and is crossed 80 mesh sieves, is obtained medicinal substances extract dried cream powder.
4. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 2, it is special
Levy and be：The preparation method of main ingredient inclusion compounds is under described step T4：
R1. take medicinal substances extract dried cream powder, plus the ethanol solution of 200-500 parts 65% to make dissolving, medicinal substances extract dried cream powder is made
Diluted Alcohol solution；
R2. sodium alginate is taken to be placed in material-compound tank, plus 500-1000 parts of water, heating dissolves it at 45-55 DEG C, obtains alginic acid
Sodium solution；
R3. medicinal substances extract dried cream powder Diluted Alcohol solution is slowly added into sodium alginate soln, stirring while adding, temperature is kept
Stirred 3-5 hour at 45-55 DEG C, put and placed 8-12 hours to rearmounted 4 DEG C -10 DEG C of room temperature, filtered, discard mother liquor,
Filter residue and drying, crosses 80 mesh sieves, main ingredient inclusion compound is made.
5. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 2, it is special
Levy and be：Described step T6 lower particle drying temperature are 60 DEG C -80 DEG C, and drying time is 8-10 hours.
6. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 2, it is special
Levy and be：Moisture≤6% of described step T6 lower gained dry particls.
7. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 3, it is special
Levy and be：The lower vacuum drying temperature of step S4 is 60 in the preparation method of described step T3 lower medicinal substances extract dried cream powders
DEG C -80 DEG C, the time is 10-12 hours.
8. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 3, it is special
Levy and be：The lower gained medicinal substances extract dry cream of step S4 in the preparation method of described step T3 lower medicinal substances extract dried cream powders
Moisture≤6% of powder.
9. expelling wind and clearing away cold, the preparation method for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax according to claim 4, it is special
Levy and be：The lower mixing speed of step R3 is in the preparation method of described step T4 lower medicinal substances extract dried cream powder inclusion compounds
40-60rpm。
10. expelling wind and clearing away cold, the preparation side for the Chinese medicine preparation prepared composition discrete piece stimulated the circulation of the blood and cause the muscles and joints to relax are treated according to claim 4
Method, it is characterised in that：The lower filter residue of step R3 in the preparation method of described step T4 lower medicinal substances extract dried cream powder inclusion compounds
Drying temperature is 60 DEG C -80 DEG C, and drying time is 6-8 hours, gained main ingredient inclusion compound moisture≤6%.
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| CN112587569A (en) * | 2020-12-28 | 2021-04-02 | 广西天天乐药业股份有限公司 | Preparation method of Fengshiling tablet |
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| US7074435B2 (en) * | 2002-01-18 | 2006-07-11 | Pangenomics Co., Ltd. | Crude drug compositions for treating or preventing arthritic diseases and the preparation process |
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| CN112587569A (en) * | 2020-12-28 | 2021-04-02 | 广西天天乐药业股份有限公司 | Preparation method of Fengshiling tablet |
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Application publication date: 20170929 |