CN109223882A - The drug and its preparation process for treating menalgia - Google Patents
The drug and its preparation process for treating menalgia Download PDFInfo
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- CN109223882A CN109223882A CN201811501594.9A CN201811501594A CN109223882A CN 109223882 A CN109223882 A CN 109223882A CN 201811501594 A CN201811501594 A CN 201811501594A CN 109223882 A CN109223882 A CN 109223882A
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- 238000002360 preparation method Methods 0.000 title claims abstract description 31
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- 238000002156 mixing Methods 0.000 claims abstract description 18
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- A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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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 or decoction
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The present invention relates to a kind of drug for treating menalgia and its preparation processes.The preparation process is the following steps are included: provide raw material: wine radix cyathulae, cortex moutan, Radix Angelicae Sinensis, stir-baked RADIX PAEONIAE ALBA with vino, vinegar rhizoma corydalis, radix aucklandiae, peach kernel and ramulus cinnamomi;The volatile oil in the cortex moutan of Radix Angelicae Sinensis, radix aucklandiae, the ramulus cinnamomi of half weight and half weight is extracted, the dregs of a decoction are stand-by;Will volatilize oil dissolved with dehydrated alcohol after, be slowly added into the saturated aqueous solution of beta-cyclodextrin, be sufficiently stirred, obtain inclusion liquid, stand refrigeration 40~50 hours, filtering, filter residue after 38 DEG C~42 DEG C dryings, obtain the inclusion compound of volatile oil;By the ramulus cinnamomi of surplus and cortex moutan through crushing, sieving, mixing, fine powder is obtained;Wine radix cyathulae, myrrh, wine corydalis tuber, peach kernel, stir-baked RADIX PAEONIAE ALBA with vino and the dregs of a decoction are added water to cook, are filtered, the clear cream that relative density is 1.15~1.2 is concentrated the filtrate to;Clear cream and fine powder are mixed, volatile oil clathrate compound, whole grain, tabletting is added after mist projection granulating.The technique can be improved product quality.
Description
Technical field
The present invention relates to technical field of traditional Chinese medicine preparation, more particularly to a kind of drug for treating menalgia and its preparation work
Skill.
Background technique
Eight taste Tongjing tablets by wine radix cyathulae, cortex moutan, Radix Angelicae Sinensis, stir-baked RADIX PAEONIAE ALBA with vino, vinegar rhizoma corydalis, radix aucklandiae, peach kernel, ramulus cinnamomi prescription and
At clinically there is promoting blood circulation for regulating menstruation, the effect of blood-activating analgetic, be used for blockage of menstruation, color purple is blocking, menalgia.Cure mainly women
Dysmenorrhea.
Since the part effective component in prescription is volatile oil, it is auxiliary that conventional prescriptions will volatilize oil, other components and starch etc.
The common granulation of material, tabletting and coating, drug effect will receive certain influence, influence the stability of product quality.
Summary of the invention
Based on this, it is necessary to provide a kind of preparation process of drug for treating menalgia, can be improved product quality
Stability.
A kind of preparation process of drug that treating menalgia, the preparation process the following steps are included:
Raw material: wine radix cyathulae, cortex moutan, Radix Angelicae Sinensis, stir-baked RADIX PAEONIAE ALBA with vino, vinegar rhizoma corydalis, radix aucklandiae, peach kernel and ramulus cinnamomi is provided;
Extract the tree peony of the Radix Angelicae Sinensis, the radix aucklandiae, the ramulus cinnamomi of half weight and half weight
Volatile oil in skin, the dregs of a decoction and the volatile oil are spare;
It after the volatile oil is dissolved with dehydrated alcohol, is slowly added into the saturated aqueous solution of beta-cyclodextrin, stirring is mixed
It closes, stands refrigeration 40~50 hours, filtering, filter residue obtain the beta-cyclodextrin packet of the volatile oil after 38 DEG C~42 DEG C dryings
Close object;
By the ramulus cinnamomi of half weight and the cortex moutan of half weight through crushing, sieving, mixing, obtain
To fine powder;
The wine radix cyathulae, the myrrh, wine corydalis tuber, the peach kernel, the stir-baked RADIX PAEONIAE ALBA with vino and the dregs of a decoction are added water to cook, mistake
Filter concentrates the filtrate to the clear cream that relative density is 1.15~1.2;
The clear cream and the fine powder are mixed, mist projection granulating, then the Benexate Hydrochloride with the volatile oil, it is whole
Grain, tabletting, obtain the drug.
It is worth noting that in above-mentioned steps to prepare the Benexate Hydrochloride of volatile oil, fine powder, clear cream step elder generation
It is sequentially not particularly limited, can carry out simultaneously afterwards, can also be operated according to randomly ordered.
The preparation process of the drug of above-mentioned treatment menalgia first extracts volatile oil, and will volatilize oil molecule and act in ethyl alcohol
It is lower to enter beta-cyclodextrin molecule cavity inside, inclusion compound stable, with excellent dissolubility and bioavilability is formed, so
Afterwards with the common whole grain of other components and tabletting, it is possible to reduce the volatilization of volatile oil in preparation process, improve product quality stablize
Property, while improving the bioavilability of volatile oil effective component.
In one of the embodiments, it is described treatment menalgia drug raw material prescription are as follows: wine radix cyathulae 200g, when
Return 200g, vinegar rhizoma corydalis 200g, peach kernel 200g, cortex moutan 200g, stir-baked RADIX PAEONIAE ALBA with vino 200g, radix aucklandiae 67g, ramulus cinnamomi 200g.
The amount ratio of the volatile oil and the beta-cyclodextrin is 1ml:(8~12 in one of the embodiments) g.
In this way, being 1ml:(8~12 by the amount ratio of control volatile oil and beta-cyclodextrin) g, volatile oil can be made abundant
Into beta-cyclodextrin molecule cavity inside, stable inclusion compound is formed, and will not be caused finally because the amount of beta-cyclodextrin is excessive
Auxiliary material content is more than product standard in product.
The temperature being stirred is 38 DEG C~42 DEG C in one of the embodiments, the stirring being stirred
Speed is 1000rpm~2000rpm, and the time being stirred is 1.5~3 hours.
It should be noted that needing to control temperature during preparing inclusion compound, if temperature is excessively high, it will lead to and wave
Hair oil is volatile, if temperature is too low, the viscosity of beta-cyclodextrin be will increase greatly, be unfavorable for forming inclusion compound, influences inclusion effect
Fruit.
The atomizing pressure of the mist projection granulating is 0.3MPa~0.4MPa in one of the embodiments, and spray velocity is
0.5L/min~1L/min, intake air temperature are 70 DEG C~90 DEG C, and air outlet temperature is 40 DEG C~60 DEG C.
In one of the embodiments, the clear cream and the fine powder mixing, mist projection granulating the step of after, to described
Temperature of charge after mist projection granulating is down to 45 DEG C hereinafter, working just to keep alive again with the volatile oil clathrate compound.
In one of the embodiments, before mixing the clear cream and the fine powder, the clear cream is boiled and boiled
Rise 25min~35min.
In this way, clear cream is boiled 25min~35min, the mobility of clear cream can be improved, promote clear during mist projection granulating
The bond properties of cream improves granulation efficiency and effect.
It further include by the clear cream with 80 before the clear cream is mixed with the fine powder in one of the embodiments,
~100 mesh filter-cloth filterings, the step of collecting filtered clear cream.In this way, the large granular impurity in clear cream can be removed, improve clear
The purity of cream.
It further include being carried out to the fine powder before the clear cream is mixed with the fine powder in one of the embodiments,
Sterilizing and the step of crushing again:
By the fine powder under conditions of pressure is 0.120Mpa~0.15, temperature is 121 DEG C, sterilize 25~30 minutes,
Then 80 meshes be crushed.
The volatile oil is obtained using extraction by steam distillation in one of the embodiments,.
Specifically, the Radix Angelicae Sinensis, the radix aucklandiae, the cortex moutan and the ramulus cinnamomi are put into multi-function extractor plus suitable
Water is measured, heating is distilled, until volatile oil evaporates only substantially, is collected distillate, is slowly carried out redistillation, collects rectifying liquid, obtain
The volatile oil.
It further include that film coating is carried out to the drug in one of the embodiments, after the tableting step
Step:
By the 3%~3.5% of the weight of the drug, the premixing auxiliary material of stomach dissolution type pharmaceutical films coating is weighed, it will be described
Premixing auxiliary material is soluble in water, obtains coating solution, and the solid content of the coating solution is 16wt%~18wt%;
The drug is preheated to 35 DEG C~45 DEG C, spraying packet is carried out to the drug after preheating using the coating solution
Clothing, after the completion of coating, in 55 DEG C~60 DEG C dry 3min~15min.
55 DEG C~100 DEG C of the inlet air temperature of the spray coating in one of the embodiments, leaving air temp 40 DEG C~45
DEG C, spray velocity 110ml/min~120ml/min, atomizing pressure 0.4MPa~0.5Mpa.
Another object of the present invention is to mention a kind of kind of a medicine for the treatment menalgia being prepared using above-mentioned preparation process
Object.
Pass through the drug for the treatment menalgia that the above method is prepared, cavity of the inclusion essential oil in beta-cyclodextrin
It is interior, it can be improved the stability of product quality, while improving the bioavilability of volatile oil.
The invention has the advantages that:
The present invention leads to the above method, first will volatilize oily beta-cyclodextrin inclusion compound, then granulation, tabletting together with other components,
And control each process parameter, it is possible to reduce the volatilization of volatile oil, so that the stability indicator of product quality is in original base
It is improved on plinth;Film coating is carried out with water-soluble coating powder simultaneously, substitutes the coating powder in original technique with alcohol-soluble
Film coating is carried out, replaces ethyl alcohol to make solvent with water, production cost can not only be greatly lowered, but also can reduce to workshop facility
It is required that not needing blasting protection facilities, environmental pollution also can reduce, reduce the harm to operator.
Detailed description of the invention
Fig. 1 is the flow chart of the preparation process of the drug of the treatment menalgia of the embodiment of the present invention 1.
Specific embodiment
To facilitate the understanding of the present invention, below will to invention is more fully described, and give it is of the invention compared with
Good embodiment.But the invention can be realized in many different forms, however it is not limited to embodiment described herein.Phase
Instead, purpose of providing these embodiments is makes the disclosure of the present invention more thorough and comprehensive.
Unless otherwise defined, all technical and scientific terms used herein and belong to technical field of the invention
The normally understood meaning of technical staff is identical.Term as used herein in the specification of the present invention is intended merely to description tool
The purpose of the embodiment of body, it is not intended that in the limitation present invention.Term as used herein "and/or" includes one or more phases
Any and all combinations of the listed item of pass.
1 eight taste Tongjing tablet of embodiment and preparation method thereof
One, prescription
1, the prescription of eight taste Tongjing tablets
2, film coating liquid prescription
The name of an article | 172.8 ten thousand dosages |
Stomach dissolution type pharmaceutical films are coated premixing auxiliary material | 3.0%~3.5% |
Talcum powder | 8~12kg |
Purified water | 44~52kg |
Two, the preparation process of eight taste Tongjing tablets
Preparation technology flow chart referring to Fig.1, the preparation processes of eight taste Tongjing tablets the following steps are included:
1, ingredient, crushing:
It takes by cleaning processing, examining qualified medicinal material, by prescription requirements, grouping weighs each medicinal material.By qualified tree peony
Skin 172.8kg, ramulus cinnamomi 172.8kg after mixing, crush unit with F-400 type and are ground into fine powder, sieve with 100 mesh sieve;Use HZG-2
Type drum-type mixing machine total mix 30 minutes, homogeneous fine powder is become, is packed into the container of clean dried, sealed, for use.
2, it sterilizes, crush:
Upper process is handed over into the medicinal powder of coming, sets in pulse vacuum sterile cabinet, is gone out with II type pulse vacuum steam of MG-1.2 respectively
Bacterium cabinet sterilizes, and steam pressure reaches 0.120MPa~0.15MPa, and temperature sterilizes 30 minutes, closes into vapour up to after 121 DEG C
Valve closes exhaust steam valve after draining intracavitary remaining vapour, opens vacuum and take the steam carried secretly in powder away;Sterilizing medicinal powder is let cool to room temperature
Immediately it crushes, is crushed with SF320 type high speed disintegrator, smashed thin medicinal powder crosses 80 meshes, is packed into the appearance of clean dried
In device, sealing.
3, volatile oil is extracted:
Radix Angelicae Sinensis 345.6kg, radix aucklandiae 115.78kg and remaining cortex moutan 172.8kg, ramulus cinnamomi 172.8kg are put into multi-functional mention
It takes in tank plus suitable quantity of water, heating is distilled, until volatile oil evaporates only substantially, collect distillate, slowly carry out redistillation, collect essence
Distillate, filter residue are continued to employ.
4, volatile oil is included:
It is 1mL:10g according to the amount ratio of volatile oil and beta-cyclodextrin, precision weighs beta-cyclodextrin, is placed in 1000mL tool plug
In conical flask, distilled water is added by 25mL/g, heating is allowed to be completely dissolved, and is down to 40 DEG C, constant temperature stirs evenly.Step 3 is taken to obtain
The volatile oil arrived adds 2 times of dehydrated alcohol dissolutions, and being slowly dropped in beta-cyclodextrin saturated aqueous solution with syringe (needs marginal not to enter
Side stirring), constant temperature stirs 2 hours, and control mixing speed is 1000rpm~2000rpm, jumps a queue, is cooled to room temperature and moves to 4 DEG C of ice
In case, refrigerate 48 hours, filter, after a small amount of purified water is rinsed, drain, 40 DEG C drying 4 hours, obtain white powder inclusion compound.
5, it extracts:
By wine radix cyathulae 345.6kg, myrrh, wine corydalis tuber 345.6kg, peach kernel 345.6kg, stir-baked RADIX PAEONIAE ALBA with vino 345.6kg and extract volatilization
The dregs of a decoction such as Radix Angelicae Sinensis, radix aucklandiae after oil are set in dynamic extraction pot, and suitable quantity of water is added, and extract secondary, each to extract 2 hours, collection merging
Secondary decocting liquid, filtering, filtrate set storage in basin.
6, it is concentrated:
It is pumped into above-mentioned filtrate in Three-effect concentration device, opens Three-effect concentration device, being concentrated into relative density is 1.15~1.20
The clear cream of (60 DEG C).
7, cream is received:
By the extracting solution clear cream pumping being concentrated between receiving cream, with 80~100 mesh filter-cloth filterings, collect filtered
Medicinal extract.Medicinal extract is contained with stainless steel barrel, sealing.
8, it pelletizes:
Clear cream is first boiled into 30 minutes mobility for increasing medicinal extract.Four pots of granulations of every batch of point.
It takes 1/4 thin medicinal powder to add in spray-drying pelleting machine in proportion, setting atomizing pressure 0.3MPa~0.4MPa, is sprayed
Speed 0.5L/min~1.0L/min, using clear cream as adhesive mist projection granulating;Intake air temperature when granulation: 70 DEG C~90 DEG C, go out
Draught temperature: 40 DEG C~60 DEG C.After clear cream has been sprayed, stop by spraying, at 60 DEG C~80 DEG C of inlet air temperature, drying time 10min
~15min stops heating, drops to 45 DEG C hereinafter, add volatile oil clathrate compound to temperature of charge, receive dry particl about
130kg.It pelletizes three pots according to the above method, receives to obtain dry particl about 520kg, four pots of particles are handed over into intermediate station.
9, whole grain:
Above-mentioned particle about 520kg is got, carries out whole grain in proportion with FZB-450 type crushing and pelletizing machine, selects No. two sieves (20
Mesh) whole grain is carried out to particle, and answer and magnesium stearate 3.2kg is added in whole grain, conforming particle is handed over into total mix process.
10, total mix:
The conforming particle after whole grain to be got, is placed in three-dimensional pendulum mixing machine and mixes 15 minutes, total mix is uniform, discharging,
Grain is contained with polybag, after being tightened with band, is packed into clean stainless steel barrel, is sent intermediate station storage to be tested.
11, tabletting:
Conforming particle is got from intermediate station, is receivedDeep concave type punch die is pressed by substrate slice weight 0.30g/ piece
Piece.At interval of 25~35 minutes detection slice weights in tableting processes, intermediate station is handed in institute's pressing.
12, film coating
Qualified substrate is got, every batch of is divided into four pots of film coatings, every pot of about 130kg substrate.
(1) coating solution is prepared
Stomach dissolution type pharmaceutical films coating premixing auxiliary material and purified water are weighed, i.e., is weighed by the 3.0%~3.5% of substrate weight
Stomach dissolution type pharmaceutical films needed for every pot are coated premixing auxiliary material, and coating solution weighs purified water by solid content 16%~18%;It will weigh
Good solvent first pours into liquid dispensing container, and the temperature of solvent is room temperature, and stirrer paddle is liquid height from container bottom height
1/3, it is stirred liquid completely, liquid level forms whirlpool and spatter liquid is not advisable;The coating powder measured is at the uniform velocity thrown in whirlpool
On the liquid level of whirlpool, rate of feeding, which should make powder be whipped into whirlpool rapidly, to be advisable.After feeding intake, slow down blender, mixing speed with
Solution has slight whirlpool to be advisable, and solution is avoided to be involved in large quantity of air.Mixing time 40~45 minutes.If Coating Solution standing time
It is longer, need stir about to reuse after ten minutes.
Calculation formula:
Coating powder dosage=label weight × label percentage weight increase (i.e. 3.0%~3.5%)
Purify water consumption=coating powder amount ÷ solution solid content-coating powder amount
(2) film coating
With BGB-150B type high-efficiency coating machine film coating, coating solution stirs ladle preheating using 40 DEG C of constant temperature.Before coating, first
Substrate is set and is preheated to 40 DEG C or so in coating pan, setting is coated 55 DEG C~100 DEG C of inlet air temperature, leaving air temp 40 DEG C~45
DEG C, spray velocity 120ml/min, atomizing pressure 0.4MPa~0.5MPa, spray coating.When coating and it should be noted that Hot-blast Heating temperature
Degree prevents overheat or the moisture absorption.Hydrojet speed is answered moderate, keeps coat tablets moderately wet and in time dry (preventing the moisture absorption), with
Keep coating appearance fine and smooth, bright and clean.
After tablet has been coated, inlet air temperature is adjusted to 60 DEG C, and hot wind continues drying 10~15 minutes, stops heating later, cold
Wind takes the dish out of the pot again to piece temperature drop to 40 DEG C or less, after rejecting unqualified garment piece, moves to intermediate station.Coating tablet detects appearance, slice weight
Difference and disintegration time limited qualification are allowed for access lower process.
13, it packs:
(1) plastic-aluminum dispenses:
Aluminium packet is carried out with 2 type Autoblisterpackagingmachine of DPP-260K, the sheet panel of mold 0.31g × 18 is received, arranges lot number
Character code makes lot number and validity period expected from this batch of product of lot number and validity period of coining, installs aluminium foil and polychlorostyrene second as required
Alkene solid medicinal stiff sheet, 160 DEG C~180 DEG C of heating temperature of control molding, 100 DEG C~130 DEG C of heating temperature in heat-sealing, lower heating
100 DEG C~130 DEG C of temperature, after reaching in expected setting range to each parameter, packing is first tried, checks aluminum foil plate appearance, close
Seal situation, the piece number situation, check coining lot number, valid until etc. contents, formally dispensed after qualified.It is every after the formal packing of booting
Every the aluminum foil plate quality condition of inspection in about 30 minutes.By under pass-through box oral sex after being rejected the rejected products such as few piece, gas leakage
Procedure carries out outer packing.
(2) outer packing:
Pillow type packaging: setting parameters by pillow type packing machine operation sequence, and install composite membrane as required, by batch packet
Dress instruction requires to install lot number character code, by the packed 2 plate requirement of each composite membrane, first tries pillow type packaging, checks compound membrane bag
Appearance, sealing situation, the lot number of coining, the date of manufacture, valid until etc. contents, formally packed after qualified.Pillow type packaging bag warp
Conveyer belt transports to dress capsule station.Every the pillow type packaging bag quality condition of inspection in 30 minutes.
Mounted box: 36/box specification is filled 1 bag and is put into a specification and packed by every box;54/box specification presses every box
It puts 1 bag and is put into a specification and packed.
Cartoning: compound membrane bag powder charge is packed, and every 1 bag is packed into capsule together with a specification, 36/box specification
By every 400 box-packed casees;54/box specification is packed into capsule and presses every 180 box-packed casees, fills in and be put into the quality certification, cases, uses glue
Paper tape sealing, is packaged with 90-m-11 type automatic flexible strapping machine.
14, it deposits and is put in storage:
After one batch number packaging, warehouse keeper is notified, finished product to be tested is kept in warehouse, finished product to be received is let pass
Audit is single with after product inspection report, handles storage.
Embodiment 2
Embodiment 2 is substantially the same manner as Example 1, the difference is that, the step 4 of the inclusion volatile oil of preparation process is
Difference, specifically:
It is 1mL:6g according to the amount ratio of volatile oil and beta-cyclodextrin, precision weighs beta-cyclodextrin, is placed in 1000mL tool plug
In conical flask, distilled water is added by 25mL/g, heating is allowed to be completely dissolved, and is down to 42 DEG C, constant temperature stirs evenly.Step 3 is taken to obtain
The volatile oil arrived adds 2 times of dehydrated alcohol dissolutions, and being slowly dropped in beta-cyclodextrin saturated aqueous solution with syringe (needs marginal not to enter
Side stirring), constant temperature stirs 2 hours (control mixing speed is 1000rpm~2000rpm), jumps a queue, is cooled to room temperature and moves to 4 DEG C
In refrigerator, refrigerate 50 hours, filter, after a small amount of purified water is rinsed, drain, 40 DEG C drying 4 hours, obtain white powder and include
Object.
Embodiment 3
Embodiment 3 is substantially the same manner as Example 1, the difference is that, the step 4 of the inclusion volatile oil of preparation process is
Difference, specifically:
It is 1mL:10g according to the amount ratio of volatile oil and beta-cyclodextrin, precision weighs beta-cyclodextrin, is placed in 1000mL tool plug
In conical flask, distilled water is added by 25mL/g, heating is allowed to be completely dissolved, and is down to 35 DEG C, constant temperature stirs evenly.Step 3 is taken to obtain
The volatile oil arrived adds 2 times of dehydrated alcohol dissolutions, and being slowly dropped in beta-cyclodextrin saturated aqueous solution with syringe (needs marginal not to enter
Side stirring), constant temperature stirs 2 hours (control mixing speed is 1000rpm~2000rpm), jumps a queue, is cooled to room temperature and moves to 4 DEG C
In refrigerator, refrigerate 48 hours, filter, after a small amount of purified water is rinsed, drain, 40 DEG C drying 4 hours, obtain white powder and include
Object.
Comparative example 1
1), ingredient, crushing: by by cleaning processing, examining qualified medicinal material, according to prescription requirements, grouping is weighed.It will close
Root bark of tree peony 100g, the ramulus cinnamomi 100g of lattice are ground into fine powder, sieve with 100 mesh sieve, and mix, set in clean container and save backup.
2) it, extracts volatile oil: qualified Radix Angelicae Sinensis 200g, radix aucklandiae 66.7g and other root bark of tree peony 100g, ramulus cinnamomi 100g is put into
It in multi-function extractor, is distilled by steam distillation, until volatile oil evaporates only substantially, collects the volatilization on distillate upper layer
Oil.
3) it, boils and mentions: by qualified other taste liquid medicine radix cyathulae 200g, vinegar rhizoma corydalis 200g, peach kernel 200g, stir-baked RADIX PAEONIAE ALBA with vino 200g
And the dregs of a decoction such as Radix Angelicae Sinensis, radix aucklandiae after extraction volatile oil are set to boil and be mentioned in pot, decoction is secondary, and 2 hours every time, decocting liquid filtration merged two
Secondary filtrate is concentrated by evaporation the thick paste to relative density for 1.15~1.20 (60 DEG C of heat are surveyed).
4), granulation, whole grain and total mix: the auxiliary materials such as medicinal powder and specified amount starch under upper process is handed over together feeding to a step
Pelletizer is granulated standard operation accumulation operation by a step, using thick paste as adhesive mist projection granulating.One step is granulated gained particle, warp
It discharges after drying, detects moisture, control within 5%, with 16 mesh sieves, sift out part fine powder and volatile oil mixes, then will
Fine powder after mixing is added in particle, and 0.5~1% magnesium stearate lubricant-talcum powder (1:5) is added, and total mix is uniform.
5), tabletting: by above-mentioned dry particl, Highspeedrotarytabletpress is rushed with 37 or 33 rushes rotary tablet press.It adopts
WithDeep concave type punch die tabletting carries out tabletting by substrate slice weight 0.30g/ piece.At interval of 25~35 points in tableting processes
Clock detects slice weight, and intermediate station is handed in institute's pressing.
6), be coated: by its sugar coating to get.
7), qualified tablet will be examined to pack to get finished product.
Examples 1 to 3 and comparative example 1~the result of quality and stability inspection target see the table below.
Inspection target | Disintegration time limited | Volatile oil utilization rate |
Embodiment 1 | 28min | 73.21 |
Embodiment 2 | 26min | 75.68 |
Embodiment 3 | 30min | 71.65 |
Comparative example 1 | 45min | —— |
As seen from the above table, the embodiment of the present invention 1~3 compares the comparative example 1 using conventional preparation techniques, when the disintegration of product
Limit is obviously shortened, and the volatile oil utilization rate of Examples 1 to 3 reaches 70% or more, and the utilization rate of volatile oil is improved.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned reality
It applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited
In contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art
It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention
Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.
Claims (10)
1. a kind of preparation process for the drug for treating menalgia, which is characterized in that the preparation process the following steps are included:
Raw material: wine radix cyathulae, cortex moutan, Radix Angelicae Sinensis, stir-baked RADIX PAEONIAE ALBA with vino, vinegar rhizoma corydalis, radix aucklandiae, peach kernel and ramulus cinnamomi is provided;
In the cortex moutan for extracting the Radix Angelicae Sinensis, the radix aucklandiae, the ramulus cinnamomi of half weight and half weight
Volatile oil, the dregs of a decoction and the volatile oil are spare;
It after the volatile oil is dissolved with ethyl alcohol, is slowly added into the saturated aqueous solution of beta-cyclodextrin, is stirred, stand cold
40~50 hours, hiding, filtering, filter residue obtain the Benexate Hydrochloride of the volatile oil after 38 DEG C~42 DEG C dryings;
By the ramulus cinnamomi of half weight and the cortex moutan of half weight through crushing, sieving, mixing, obtain thin
Powder;
The wine radix cyathulae, the myrrh, wine corydalis tuber, the peach kernel, the stir-baked RADIX PAEONIAE ALBA with vino and the dregs of a decoction are added water to cook, are filtered, it will
Filtrate is concentrated into the clear cream that relative density is 1.15~1.2;
The clear cream and the fine powder are mixed, after mist projection granulating, then is mixed with the volatile oil beta cyclodextrin inclusion complex, it is whole
Grain, tabletting, obtain the drug.
2. it is according to claim 1 treatment menalgia drug preparation process, which is characterized in that the volatile oil and
The amount ratio of the beta-cyclodextrin is 1ml:(8~12) g.
3. the preparation process of the drug for the treatment of menalgia according to claim 1, which is characterized in that described to be stirred
Temperature be 38 DEG C~42 DEG C, the mixing speed being stirred be 1000rpm~2000rpm, it is described be stirred when
Between be 1.5~3 hours.
4. the preparation process of the drug for the treatment of menalgia according to claim 1, which is characterized in that the mist projection granulating
Atomizing pressure be 0.3MPa~0.4MPa, spray velocity be 0.5L/min~1L/min, intake air temperature be 70 DEG C~90 DEG C,
Air outlet temperature is 40 DEG C~60 DEG C.
5. the preparation process of the drug for the treatment of menalgia according to claim 4, which is characterized in that in the clear cream and
After the step of fine powder mixing, mist projection granulating, the temperature of charge after the mist projection granulating be down to 45 DEG C hereinafter, again with institute
State volatile oil clathrate compound mixing.
6. the preparation process of the drug for the treatment of menalgia according to claim 1, which is characterized in that by the clear cream
Before fine powder mixing, the clear cream is boiled and the 25min~35min that boils.
7. the preparation process of the drug for the treatment of menalgia according to claim 1, which is characterized in that the volatile oil is adopted
It is obtained with extraction by steam distillation.
8. the preparation process of the drug of described in any item treatment menalgias according to claim 1~7, which is characterized in that
After the tableting step, further include the steps that carrying out film coating to the drug:
By the 3%~3.5% of the weight of the drug, the premixing auxiliary material of stomach dissolution type pharmaceutical films coating is weighed, by the premix
Auxiliary material is soluble in water, obtains coating solution, and the solid content of the coating solution is 16wt%~18wt%;
The drug is preheated to 35 DEG C~45 DEG C, spray coating is carried out to the drug after preheating using the coating solution,
After the completion of coating, in 55 DEG C~60 DEG C dry 3min~15min.
9. the preparation process of the drug for the treatment of menalgia according to claim 8, which is characterized in that the spray coating
55 DEG C~100 DEG C of inlet air temperature, 40 DEG C~45 DEG C of leaving air temp, spray velocity 110ml/min~120ml/min, atomization pressure
Power 0.4MPa~0.5Mpa.
10. the drug for the treatment menalgia that any one of claim 1~9 preparation process is prepared.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110339248A (en) * | 2019-07-17 | 2019-10-18 | 北京东升制药有限公司 | Eight taste Tongjing granules of one kind and preparation method thereof |
CN115887577A (en) * | 2022-11-17 | 2023-04-04 | 湖南易能生物医药有限公司 | Preparation method of traditional Chinese medicine composition containing rehmannia |
CN116135218A (en) * | 2023-04-20 | 2023-05-19 | 北京东升制药有限公司 | Eight-ingredient dysmenorrhea granule and preparation method thereof |
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CN1544027A (en) * | 2003-11-27 | 2004-11-10 | 怀化正好制药有限公司 | Menalgia treating Chinese traditional medicine |
CN102908579A (en) * | 2012-09-19 | 2013-02-06 | 深圳市国源药业有限公司 | Traditional Chinese medicine preparation for treating gynecological diseases, liver diseases and prostatitis and preparation method of traditional Chinese medicine preparation |
CN103169831A (en) * | 2013-02-26 | 2013-06-26 | 江苏康缘药业股份有限公司 | Traditional Chinese medicine composition for treating dysmenorrhea and preparation method thereof |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN1544027A (en) * | 2003-11-27 | 2004-11-10 | 怀化正好制药有限公司 | Menalgia treating Chinese traditional medicine |
CN102908579A (en) * | 2012-09-19 | 2013-02-06 | 深圳市国源药业有限公司 | Traditional Chinese medicine preparation for treating gynecological diseases, liver diseases and prostatitis and preparation method of traditional Chinese medicine preparation |
CN103169831A (en) * | 2013-02-26 | 2013-06-26 | 江苏康缘药业股份有限公司 | Traditional Chinese medicine composition for treating dysmenorrhea and preparation method thereof |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110339248A (en) * | 2019-07-17 | 2019-10-18 | 北京东升制药有限公司 | Eight taste Tongjing granules of one kind and preparation method thereof |
CN115887577A (en) * | 2022-11-17 | 2023-04-04 | 湖南易能生物医药有限公司 | Preparation method of traditional Chinese medicine composition containing rehmannia |
CN116135218A (en) * | 2023-04-20 | 2023-05-19 | 北京东升制药有限公司 | Eight-ingredient dysmenorrhea granule and preparation method thereof |
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