CN109157583A - It reins in the horse back pharmaceutical preparation and preparation method thereof - Google Patents
It reins in the horse back pharmaceutical preparation and preparation method thereof Download PDFInfo
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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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- A61K2236/50—Methods involving additional extraction steps
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Abstract
The present invention provides pharmaceutical preparations and preparation method thereof of reining in the horse back, comprising the following steps: step (A) is reined in the horse back after herb adds water to cook, and filtrate is concentrated, obtains concentrate of reining in the horse back by filtering；Ethyl alcohol is added into the concentrate of reining in the horse back of step (A) and carries out alcohol precipitating for step (B), stands, and filtering obtains filtrate；The filtrate that step (C) obtains step (B) is concentrated, and pharmaceutically acceptable auxiliary material is added, and pharmaceutical preparation of reining in the horse back is made with known formulation preparation method；Pharmaceutical preparation provided by the invention and preparation method thereof, the herb that will directly rein in the horse back is decocted, extract is prepared after alcohol precipitation, it is further processed into various dosage forms, compared to the preparation process of existing preparation of reining in the horse back, eliminate addition rein in the horse back herb powder the step of, increase alcohol precipitation removal impurity the step of, cause the protocatechuic acid component content in preparation to greatly improve, 1.5~4 times of drugloading rate are improved, preparations shaping and clinical application are more advantageous to.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, are related to pharmaceutical preparation and preparation method thereof of reining in the horse back.
Background technique
The ingredient reined in the horse back is bastard speedwell, relieving cough and reducing sputum with clearing heat and moistening lung, inducing diuresis for treating strangurtia.For treating tuberculosis cough
The illnesss such as blood, cough phlegm asthma, difficult urination, puckery pain of heat gonorrhea.And will rein in the horse back and be prepared into suitable dosage form administration, for related disease
The treatment of disease has great importance.
CN100406003A discloses a kind of dripping pills of abastard speedwell, to rein in the horse back as raw material, with the pharmaceutically acceptable load as matrix
Body is prepared together, and (1) is taken and reined in the horse back in right amount, added water to cook three times as unit of g or kg, and 2 hours for the first time, second 1
Hour, third time 0.5 hour, collecting decoction filters, and filtrate is concentrated into every 1mL 1g containing crude drug, lets cool, and adds ethanol precipitation two
It is secondary, make alcohol content up to 60% for the first time, stand 24 hours, second up to 80%, stands 24 hours, discard precipitating, filter, filtrate
Ethyl alcohol is recycled, relative density is condensed into and is 1.30~1.35 thick paste, or continues to make to be dried, crushed into dry powder to get containing Le
Horse returns the extract of effective component, spare；(2) matrix is polyethylene glycol and stearic acid polyoxyl 40 ester or sodium carboxymethyl starch
Mixture, by weight, the mixed proportion of stearic acid polyoxyl 40 ester or sodium carboxymethyl starch and polyethylene glycol is 1:1~1:
10, the ratio of the extract and matrix is 1:3；(3) according to aforementioned proportion, the extract and matrix are accurately weighed, by it
Be placed in heating container and heat while stirring, until obtain the molten liquid containing the extract and matrix and/or emulsion with/
Or suspension is spare；(4) adjust pill dripping machine temperature control system, make the water dropper of pill dripping machine heat and keep temperature 50 DEG C~
90 DEG C, the temperature of condensing agent is cooled and maintained at 40 DEG C~-5 DEG C；(5) temperature to condensing agent in pill dripping machine water dropper and condensation column
When respectively reaching required state of temperature, by the molten liquid containing drug extract and matrix and/or emulsion and/or suspension
Liquid is placed in the water dropper tank of pill dripping machine, is instilled in condensing agent, and contraction forms to obtain the final product.The pill that the method is prepared, effectively
Content is still lower.
CN104383104A discloses the purposes that a kind of Lemahui Injection is used to prepare rectally preparation, described to rein in the horse
Return injection to be prepared as follows: water intaking 400~600 parts by weight of turnip add water to cook three times, and 1~3 hour for the first time,
Second 0.5~1.5 hour, third time 0.3~0.8 hour, collecting decoction filtered, and filtrate is concentrated into every 1 parts by volume containing raw medicine
0.5~1.5 parts by weight of material, let cool, and add ethanol precipitation secondary, make alcohol content up to 50~70% for the first time, second up to 70~
90%, 22~26 hours are stood, precipitating is discarded, is filtered, filtrate recycling ethanol, extremely with sodium hydroxide saturated aqueous solution tune pH value
5.0~7.0, it refrigerates, filtration, filtrate continues to be heated to no alcohol taste, and 12~18 parts by volume of benzyl alcohol is added, stirs evenly, adds injection
Water is to 800~1200 parts by volume, filtration, encapsulating, sterilizing to get；The relationship of the parts by weight and parts by volume is the relationship of g/mL.
The method only discloses the preparation process of Lemahui Injection, can not prepare solid pharmaceutical preparation of reining in the horse back, and also can not significantly mention
Rise the content of effective component in preparation.
CN101564461A disclose it is a kind of for clearing heat and moistening lung, relieving cough and reducing sputum, inducing diuresis for treating strangurtia Chinese medicinal preparation method, take
Bastard speedwell (reining in the horse back) 2000g, adds 50% ethyl alcohol to be heated to reflux twice, and for the first time plus 10 times are measured, second plus 8 times of amounts, every time
Reflux 1 hour, filters respectively, merges filtrate twice, it is 1.30 that (- 0.08MPa, 80 DEG C), which is concentrated, into relative density in filtrate decompression
The thick paste of (60 DEG C) continues to be dried under reduced pressure (- 0.08MPa, 60 DEG C) into dry extract.Dry extract 200g is taken, adds starch appropriate, is mixed
It is even, it is encapsulated, 1000 are made to get capsule.
Shanxi Province's drug standards (nineteen eighty-three version) page 140 describe the preparation method for piece of reining in the horse back: taking herb of reining in the horse back
90kg picks net chopping, adds water to cook twice, and for the first time plus 6 times of amounts of water decoct 1 hour, adds 4 times of amounts of water to decoct 0.5 for the second time small
When, merge the filtrate decocted twice, be concentrated into thick paste (moon 22000mL), it is public that another Galle horse returns herb powder (sieving with 100 mesh sieve) 10
Jin, stirs evenly, 50 DEG C~60 DEG C aeration-dryings, crushes, sieves with 100 mesh sieve, add 85% alcohol appropriate, softwood is made, with 20 mesh
Particle is made in sieve.50~60 DEG C of aeration-dryings, stiffened fatty acid magnesium, with 18 mesh sieve tablettings, sugar coating to get.
Currently, the preparation of reining in the horse back of existing method preparation causes every drugloading rate not high since active constituent content is low, such as
What improves the content of effective component and the drugloading rate of unit formulation in preparation of reining in the horse back, for reducing preparation cost, is convenient for patient
Medication has great importance.
Summary of the invention
In view of the deficiencies of the prior art, the purpose of the present invention is to provide pharmaceutical preparation and preparation method thereof of reining in the horse back, with
The drugloading rate for reaching the content and unit formulation that improve preparation protocatechuic acid ingredient of reining in the horse back, reduces the effect of preparation cost
Fruit is convenient for patient medication.
To achieve this purpose, the present invention adopts the following technical scheme:
In a first aspect, the present invention provides a kind of preparation methods of preparation of reining in the horse back, comprising:
Step (A) is reined in the horse back after herb adds water to cook, and filtrate is concentrated, obtains concentrate of reining in the horse back by filtering；
Ethyl alcohol is added into the concentrate of reining in the horse back of step (A) and carries out alcohol precipitating for step (B), stands, and filtering is filtered
Liquid；
The filtrate that step (C) obtains step (B) is concentrated, and pharmaceutically acceptable auxiliary material is added, with known system
Pharmaceutical preparation of reining in the horse back is made in agent preparation method.
The present invention provides the preparation method for preparation of reining in the horse back, and the herb that will directly rein in the horse back is decocted, prepared after alcohol precipitating
Extract is obtained, various dosage forms are further processed into, compared to the preparation process of existing preparation of reining in the horse back, addition is eliminated and strangles
The step of horse returns the step of herb powder, increases alcohol precipitating removal impurity, causes the protocatechuic acid content in preparation substantially to mention
Height improves 1.5~4 times of drugloading rate, is more advantageous to preparations shaping and clinical application.
The pharmaceutical preparation is oral solid formulation.
The volume for the water that decoction process described in step (A) is added is 10 times of quality of medicinal material, the number of the decoction
It is 2~5 times, such as can be 2 times, 3 times, 4 times or 5 times.
For step (A) when decocting, time of decoction is not necessarily to strict control, and those skilled in the art can be according to actually decocting
Situation carries out appropriate adjustment.
The method of the alcohol precipitating are as follows: ethyl alcohol is added into concentrate described in step (A) and stirs simultaneously, standing 1~
For 24 hours, it filters, obtains filtrate.
The amount of ethyl alcohol is added in the alcohol precipitating are as follows: so that volume ratio of the concentrate containing ethyl alcohol is reached 60%~80%, such as can
To be 60%, 62%, 63%, 65%, 67%, 68%, 70%, 71%, 73%, 75%, 76%, 78%, 79% or 80% etc..
Auxiliary material in the oral solid formulation includes glidant.
The glidant includes one of magnesium stearate or silica or whole.
Preferably, step (C) pharmaceutical preparation is tablet, and slice weight is 0.22g/ piece, and every drugloading rate is 1.5
~4g.
The preparation method of above-mentioned tablet specifically includes the following steps:
To be concentrated under reduced pressure, being concentrated into relative density is 1.20~1.26 for step (A) concentration, such as can be 1.20,
1.21,1.22,1.23,1.24,1.25 or 1.26 etc..
Step (B) described alcohol, which is deposited in concentrate, to be added ethyl alcohol while stirring, and the time of standing is for 24 hours；
To be concentrated under reduced pressure, being concentrated into relative density is 1.30~1.40 for step (C) concentration, such as can be 1.30,
1.31,1.32,1.33,1.34,1.35,1.36,1.37,1.38,1.39 or 1.40 etc.；
Step (C) auxiliary material is magnesium stearate, and dosage is the 0.1%~0.2% of concentrate quality, such as be can be
0.1%, 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19% or 0.2%
Deng；
Alternatively, the preparation method of above-mentioned tablet further includes coating.
Second aspect, the present invention provides a kind of pieces of reining in the horse back of preparation method preparation as described in relation to the first aspect, rein in the horse
Return every drugloading rate of piece be 1.5~4g, drugloading rate for example can be 1.5g, 1.6g, 1.9g, 2g, 2.3g, 2.5g, 2.8g,
3.0g, 3.1g, 3.2g, 3.4g, 3.5g, 3.6g, 3.7g, 3.8g, 3.9g, 4.0g etc..
As optimal technical scheme, the preparation method of piece of reining in the horse back the following steps are included:
Step (A) is reined in the horse back after herb adds water to cook, wherein the volume that water is added is 10 times of quality of medicinal material, decocts 2
~5 times, filtrate is concentrated for filtering, and being concentrated into relative density is 1.20~1.26, obtains concentrate of reining in the horse back；
Ethyl alcohol is added into the concentrate of reining in the horse back of step (A) in step (B), stirs simultaneously, so that concentrate is containing ethyl alcohol
Volume ratio reaches 60%~80%, carries out alcohol precipitating, stands for 24 hours, and filtering obtains filtrate；
The filtrate that step (C) obtains step (B) is concentrated, and being concentrated under reduced pressure into relative density is 1.30~1.40, adds
Enter 0.1%~0.2% magnesium stearate and optionally pharmaceutically acceptable auxiliary material that quality is concentrate quality, tabletting, packet
Piece of reining in the horse back is made in clothing, and slice weight is 0.22g/ piece, and every drugloading rate is 1.5~4g.
In addition, the dosage form of the preparation of reining in the horse back can also include any in pill, film, granule or capsule
It is a kind of.Wherein, pharmaceutically acceptable auxiliary material includes filler, adhesive, disintegrating agent, lubricant, hypertensor, effervescent agent, table
Face activating agent, film forming agent, toner, corrigent, preservative, dispersing agent or aromatic etc..Wherein: filler can be starch
Class, carbohydrate, cellulose family or inorganic salts etc. have the auxiliary material of filling effect.Adhesive can be microcrystalline cellulose, gelatin,
Carbohydrate, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, dextrin, hydroxypropyl cellulose or hydroxypropyl methyl cellulose etc.
It is easy to the auxiliary material of preparations shaping effect with raising viscosity.Disintegrating agent may include sodium starch glycolate, sodium carboxymethylcellulose,
Calcium carboxymethylcellulose, croscarmellose sodium, crosslinked polyvinylpyrrolidone, polyvinylpyrrolidone, Methyl cellulose
Hydroxypropyl cellulose, starch, pregelatinized starch or the sodium alginate etc. that element, microcrystalline cellulose, lower alkyl groups replace, which have, to be collapsed
The auxiliary material of solution effect.Lubricant can be fatty acid magnesium, calcium stearate, zinc stearate, stearoyl fumaric acid sodium and tristearin firmly
Mixture of one or more of sour magnesium, lauryl sodium sulfate etc. has the auxiliary material of lubricating action.Surfactant
Can be lecithin or fatty glyceride etc. has the auxiliary material for enhancing and adding solubility effect.Those skilled in the art can be according to reality
Border dosage form to be prepared selects suitable pharmaceutically acceptable auxiliary material to be processed.
The method that extract of reining in the horse back is prepared into pill may is that first by matrix heating melting, then will rein in the horse
It returns extract to be dissolved in the matrix of melting, keeps the temperature in the not miscible coolant liquid of lower instillation, under the action of surface tension, melt
Melt contracted matrix glomeration, cools and solidifies pelletization.Matrix described above can be polyethylene glycols, povidone, odium stearate,
Poloxamer, polyoxyethylene stearate (40) ester, gelatin etc.；The coolant liquid can be liquid paraffin, vegetable oil, dimeticone
Etc..
In addition, the extract that can also will rein in the horse back is prepared into granule, method can be the extract sieving that will rein in the horse back, with
Auxiliary material is uniformly mixed, and suitable adhesive softwood is added, softwood is then pressed through sieve, obtains wet granular, dry；It is dry
Particle afterwards need to carry out whole grain and classification, and the particle of agglomeration, adhesion is made to scatter, and obtain the particle with certain particle size distribution；So
It according to dosage dispenses, pack afterwards, granule should seal, be placed at dry and store.Above-mentioned used auxiliary material may include suitable rectifys
Taste agent, aromatic, dispersing agent and preservative etc.；Adhesive can be starch, sodium carboxymethylcellulose, hydroxypropyl cellulose, hydroxyl
Third methylcellulose etc..
Compared with the existing technology, the invention has the following advantages:
The present invention provides the preparation method for preparation of reining in the horse back, and the herb that will directly rein in the horse back is decocted, prepared after alcohol precipitating
Extract is obtained, various dosage forms are further processed into, compared to the preparation process of existing preparation of reining in the horse back, addition is eliminated and strangles
The step of horse returns the step of herb powder, increases alcohol precipitating removal impurity, causes the protocatechuic acid content in preparation substantially to mention
Height improves 1.5~4 times of drugloading rate, is more advantageous to preparations shaping and clinical application.
Specific embodiment
The technical scheme of the invention is further explained by means of specific implementation.Those skilled in the art should be bright
, the described embodiments are merely helpful in understanding the present invention, should not be regarded as a specific limitation of the invention.
In the present invention, term " drugloading rate " refers to, the quality of medicinal material that will rein in the horse back conversion to the mass figures in every,
That is: every piece of reining in the horse back contains the quality for medicinal material of reining in the horse back.
In the present invention, term " relative density " refers to, the relative density detected at 50~60 DEG C of fluid temperature
Value.
Embodiment 1
The present embodiment prepares tablet of reining in the horse back by following steps
3kg herb of reining in the horse back is decocted 2 times in water at a temperature of 90 °C, for the first time plus the amounts decoction 1 hour of 6 times of water, the
4 times of amounts of secondary plus water decoct 0.5 hour, the decoction liquor after merging decoction twice, and filtering and concentrating obtains concentrate, and (relative density is
1.23) ethyl alcohol, which is added, to concentrate makes alcohol content reach 70%, adds alcohol while stirring, and stands for 24 hours, the precipitating of generation is filtered,
It is 1.35 that filtrate, which is concentrated into relative density, and magnesium stearate 0.4g, dextrin 110g is added, and is mixed, and is pelletized with 18 meshes, dry, whole
Grain suppresses 1000, every slice weight 0.22g.Every drugloading rate 3g.
Embodiment 2
The present embodiment prepares pill of reining in the horse by following steps
It in temperature is is decocted 2 times in 85 DEG C of water by 3kg herb of reining in the horse back, for the first time plus the amounts decoction 1.5 hours of 6 times of water,
Second plus 4 times of amounts of water decoct 1 hour, the decoction liquor after merging decoction twice, filtering and concentrating obtains concentrate, and (relative density is
1.23) ethyl alcohol, which is added, to concentrate makes alcohol content reach 70%, stands 18h, and the precipitating of generation is filtered, filtrate is obtained, and is concentrated
It is dry after to relative density 1.30, extract of reining in the horse back is obtained, it is then mixed with the PEG2000 of 3 times of extract qualities of reining in the horse back
It closes, is placed in heating vessel in heating, molten condition is formed, using the temperature difference of pill dripping machine and coolant liquid, by the melting of molten condition
Liquid shrinks molding and pill is prepared, and 10000 balls are made.
Embodiment 3
The present embodiment prepares tablet of reining in the horse back by following steps
It in temperature is is decocted 2 times in 80 DEG C of water by 3kg herb of reining in the horse back, for the first time plus the amounts decoction 1 hour of 5.5 times of water,
Second plus the amounts decoction 0.5 hour of 4 times of water, merge the decoction liquor after decocting twice, filtering and concentrating obtains concentrate (relative density
For 1.20), ethyl alcohol, which is added, to concentrate makes alcohol content reach 70%, stands 18h, and the precipitating of generation is filtered, filtrate is obtained, dense
It is dried after being reduced to relative density 1.40, obtains extract of reining in the horse back, the extract that will then rein in the horse back crushes, and sieves with 100 mesh sieve, adds suitable
85% alcohol of amount, is made softwood, particle is made with 20 meshes, magnesium stearate 0.35g, titanium dioxide is added in 60 DEG C of aeration-dryings
Silicon 0.05g, dextrin 330g are pelletized with 18 meshes, dry, and whole grain suppresses 2000, every slice weight 0.22g.Every drugloading rate
1.5g。
Embodiment 4
The present embodiment prepares granule of reining in the horse back by following steps
It in temperature is is decocted 3 times in 50 DEG C of water by 3kg herb of reining in the horse back, for the first time plus the amounts decoction 1 hour of 6 times of water, the
Secondary plus 4 times of amounts of water decoct 0.5 hour, second plus 2 times of amounts decoction 0.5h of water, merge the decoction liquor after decocting 3 times, filter dense
Contracting obtains concentrate (relative density 1.23), and ethyl alcohol, which is added, to concentrate makes alcohol content reach 70%, stands for 24 hours, will generate
Precipitating filtering, filtrate be concentrated into relative density be 1.4, be added dextrin 330g, add suitable starch and water, softwood be made, use
The granulation of 18 meshes, dry, the particle after drying carries out whole grain and classification, and the particle of agglomeration, adhesion is made to scatter, and acquisition has certain
The particle of size distribution dispenses 200 bags, and 2g/ bags, sealing is placed at dry and stores.
Embodiment 5
The present embodiment prepares tablet of reining in the horse back by following steps
It in temperature is is decocted 2 times in 80 DEG C of water by 4kg herb of reining in the horse back, for the first time plus the amounts decoction 1 hour of 6 times of water, the
4 times of amounts of secondary plus water decoct 0.5 hour, the decoction liquor after merging 2 decoctions, and filtering and concentrating obtains concentrate, and (relative density is
1.26) ethyl alcohol, which is added, to concentrate makes alcohol content reach 75%, stands for 24 hours, the precipitating of generation is filtered, filtrate is concentrated and dried
Afterwards, extract of reining in the horse back is obtained, the extract that will then rein in the horse back crushes, and sieves with 100 mesh sieve, adds suitable 85% alcohol, be made soft
Particle is made with 20 meshes in material, and magnesium stearate 0.4g, dextrin 110g is added in 60 DEG C of aeration-dryings, mixes, with 18 mesh sieves
1000 pieces of reining in the horse back, every slice weight 0.22g is made in tabletting.Every drugloading rate 4g.
Comparative example 1
This comparative example is prepared by the following method piece of reining in the horse back
The herb 100kg that reins in the horse back is taken, net chopping is picked, is added water to cook twice, first time plus the amounts decoction 1 hour of 6 times of water, second
Secondary plus 4 times of amounts of water decoct 0.5 hour, merge the filtrate decocted twice, are concentrated into thick paste (moon 22000mL), another Galle Ma Huiquan
10 kilograms of grass meal end (sieving with 100 mesh sieve), stirs evenly, 50 DEG C~60 DEG C aeration-dryings, crushes, sieves with 100 mesh sieve, add 85% alcohol
In right amount, softwood is made, particle is made with 20 meshes.50~60 DEG C of aeration-dryings, stiffened fatty acid magnesium, with 18 mesh sieve tablettings,
100,000 pieces of reining in the horse back, every slice weight 0.22g is made.
Preparation protocatechuic acid ingredient prepared by above-described embodiment 1-5 and comparative example 1 using high performance liquid chromatography into
Row assay.The specific detection method is as follows, and measurement result is as shown in table 1 below.
1, chromatographic condition: chromatographic column: ODS-HC-3 (4.6mm*75mm)；Mobile phase: methanol: water: glacial acetic acid=19:80:
1；Flow velocity: 0.8mL/min；Detection wavelength: 260nm；Column temperature: room temperature.
2, the preparation of standard solution
Precision weighs protocatechuic acid standard items 2.2mg, sets in 100mL measuring bottle, adds methanol to dissolve and is diluted to scale, shakes
It is even, the standard solution of the 0.022mg containing protocatechuic acid in every 1mL is made.
3, the preparation of test solution
What Example 1, embodiment 3, embodiment 5 and comparative example 1 obtained reins in the horse back piece 5, the Le that Example 2 obtains
Horse returns 20 ball of ball, and what Example 4 was prepared reins in the horse back 2 bags of particle, and grinding, accurately weighed 1g sets in 100ml volumetric flask, adds
It is appropriate to enter methanol, ultrasonic 30min, constant volume filters, obtains test solution.
4, it measures
It is accurate respectively to draw above-mentioned standard solution and each 5 microlitres of test solution, liquid chromatogram is injected, is measured, is calculated.
Table 1
| Sample | Protocatechuic acid content |
| Embodiment 1 | 3.3mg/ piece |
| Embodiment 2 | 3.2mg/10 ball |
| Embodiment 3 | 1.9mg/ piece |
| Embodiment 4 | 2.4mg/ bag |
| Embodiment 5 | 4.2mg/ piece |
| Comparative example 1 | 1.3mg/ piece |
By embodiment 1, the comparison of embodiment 3 and embodiment 5 is it is found that the time of repose during alcohol precipitating will affect most
The drugloading rate and protocatechuic acid content of obtained tablet eventually.18h is stood in embodiment 3, drugloading rate is compared with protocatechuic acid content
It is greatly lowered in embodiment 1 and embodiment 5, drugloading rate 1.5g, protocatechuic acid content 1.9mg/ piece, illustrates alcohol precipitating
Time of repose can make drugloading rate and protocatechuic acid content improve when for 24 hours.
By the comparison of embodiment 1-5 and comparative example 1 it is found that being decocted by the herb that will directly rein in the horse back, alcohol precipitates
After extract is prepared, compared to existing preparation process of reining in the horse back, protocatechuic acid content is greatly improved, drugloading rate improve 1.5
~4 times, and it is suitable for the preparation of a variety of dosage forms, expand application range.
The Applicant declares that the present invention is explained by the above embodiments of the invention rein in the horse back pharmaceutical preparation and its preparation side
Method, but the invention is not limited to above-mentioned method detaileds, that is, it is real not mean that the present invention must rely on above-mentioned method detailed ability
It applies.It should be clear to those skilled in the art, any improvement in the present invention, to the equivalent of each raw material of product of the present invention
Replacement and addition, the selection of concrete mode of auxiliary element etc., all of which fall within the scope of protection and disclosure of the present invention.
Claims (10)
1. the preparation method for preparation of reining in the horse back characterized by comprising
Step (A) is reined in the horse back after herb adds water to cook, and filtrate is concentrated, obtains concentrate of reining in the horse back by filtering；
Ethyl alcohol is added into the concentrate of reining in the horse back of step (A) and carries out alcohol precipitating for step (B), stands, and filtering obtains filtrate；
The filtrate that step (C) obtains step (B) is concentrated, and pharmaceutically acceptable auxiliary material is added, with known preparation system
Pharmaceutical preparation of reining in the horse back is made in Preparation Method.
2. preparation method according to claim 1, which is characterized in that the pharmaceutical preparation is oral solid formulation.
3. preparation method according to claim 2, which is characterized in that the volume for the water that the decoction process is added is medicine
10 times of material amount, the number of the decoction are 2~5 times.
4. preparation method according to claim 1, which is characterized in that the method for the alcohol precipitating are as follows: to described in step (A)
Concentrate in be added ethyl alcohol stir simultaneously, stand 1~for 24 hours, filter, obtain filtrate.
5. preparation method according to claim 1, which is characterized in that the amount of ethyl alcohol is added in the alcohol precipitating are as follows: makes to be concentrated
Volume ratio of the liquid containing ethyl alcohol reaches 60%~80%.
6. preparation method according to claim 2, which is characterized in that the auxiliary material in the oral solid formulation includes helping stream
Agent.
7. preparation method according to claim 6, which is characterized in that the glidant includes magnesium stearate or silica
One of or all.
8. preparation method described in any one of -7 according to claim 1, which is characterized in that
Step (C) pharmaceutical preparation is tablet, and slice weight is 0.22g/ piece, and every drugloading rate is 1.5~4g.
9. preparation method according to claim 8, which is characterized in that
To be concentrated under reduced pressure, being concentrated into relative density is 1.20~1.26 for step (A) concentration；
Step (B) described alcohol, which is deposited in concentrate, to be added ethyl alcohol while stirring, and the time of standing is for 24 hours；
To be concentrated under reduced pressure, being concentrated into relative density is 1.30~1.40 for step (C) concentration；
Step (C) auxiliary material is magnesium stearate, and dosage is the 0.1%~0.2% of concentrate quality；
Alternatively, the preparation method further includes coating.
10. the piece of reining in the horse back of preparation method preparation of any of claims 1-8, which is characterized in that every drugloading rate
For 1.5~4g.
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| CN201811302653.XA CN109157583A (en) | 2018-11-02 | 2018-11-02 | It reins in the horse back pharmaceutical preparation and preparation method thereof |
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| CN201811302653.XA CN109157583A (en) | 2018-11-02 | 2018-11-02 | It reins in the horse back pharmaceutical preparation and preparation method thereof |
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Citations (4)
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|---|---|---|---|---|
| CN1634413A (en) * | 2004-10-29 | 2005-07-06 | 张平 | Bastard speedwell injection and preparation method thereof |
| CN1698785A (en) * | 2005-05-26 | 2005-11-23 | 北京正大绿洲医药科技有限公司 | Dripping pills of abastard speedwell and its preparation process |
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| CN104383104A (en) * | 2014-10-23 | 2015-03-04 | 王�锋 | Application of bastard speedwell injection for preparing rectal administration preparation and aerosol inhalation preparation |
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2018
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|---|---|---|---|---|
| CN1634413A (en) * | 2004-10-29 | 2005-07-06 | 张平 | Bastard speedwell injection and preparation method thereof |
| CN1698785A (en) * | 2005-05-26 | 2005-11-23 | 北京正大绿洲医药科技有限公司 | Dripping pills of abastard speedwell and its preparation process |
| CN101564461A (en) * | 2009-06-12 | 2009-10-28 | 陕西东泰制药有限公司 | Method for preparing Chinese medicine used for clearing heat, moistening lung, relieving cough, resolving phlegm, disinhibiting urine and freeing strangury |
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