CN105769942B - A kind of 'Yan Lu Ru Kang ' preparation and preparation method thereof - Google Patents
A kind of 'Yan Lu Ru Kang ' preparation and preparation method thereof Download PDFInfo
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Abstract
The present invention provides a kind of 'Yan Lu Ru Kang ' preparation and preparation method thereof, rodgersflower rhizome, pyrola in 'Yan Lu Ru Kang ' preparation prescription is subjected to ultrasonic extraction, and select soluplus as carrier, rodgersflower rhizome and Herba Pyrolae extract are made by solid dispersions using solid dispersion technology, required preparation is further made.Preparation made from the method for the present invention can not only more preferably be enriched with effective active composition；And can increase the dispersion degree and specific surface area of drug, be conducive to the leaching of effective component, increase the hydrophily of drug, to increase the solubility of 'Yan Lu Ru Kang ' preparation, dissolution rate, improves the bioavilability of drug, medication effect is made to be significantly improved.
Description
Technical field:
The invention belongs to pharmaceutical technology fields, and in particular to a kind of 'Yan Lu Ru Kang ' preparation and preparation method thereof.
Technical background:
The proliferation of mammary gland is that women is common, one of frequently-occurring disease, is more common in 25~45 years old women, is substantially that a kind of physiology increases
The raw disorder with mammary gland normal configuration caused by subinvolution.Cyclomastopathy belongs to " breast illness " scope of Chinese medicine.This related disease
Description see earliest " Huatuo's Zhongzang classic ", later ancient Chinese medicine doctor more have discussion, to its etiology and pathogenesis, clinical manifestation and treatment have in detail
Most elaboration." breast illness " is to describe functional activity of QI being not smooth, turgor pain occurs in breast portion, when time slack it is acute, equal spies again when pain is light
Point.It is described in this way in " ulcer section heart moral collection ": " there is mammary nodule, shaped like ball ovum, pain, does not have a fever, and color of the leather is constant,
Its core joins in charitable and pious deeds anger and growth and decline, this breast illness ...." traditional Chinese medicine treats the disease and has one's own knack, wherein commercially available 'Yan Lu Ru Kang ' glue
Capsule/piece is made of rodgersflower rhizome, cornu cerve degelatinatum, pyrola, energy resolving hard lump, for the insufficiency of the kidney yang, the proliferation of mammary gland of caused by energy stagnation and blood stasis
Curative effect is preferable.But commercially available 'Yan Lu Ru Kang ' preparation, simple process, formulation ingredients are complicated, such as: containing Bergenin, ursolic acid, total Huang
A variety of active ingredients hydrophobicity such as letones is stronger, thus, 'Yan Lu Ru Kang ' preparation has that In Vitro Dissolution is slow, biological utilisation mostly
Low situation is spent, therapeutic effect and application are restricted.Currently, about 'Yan Lu Ru Kang ' galenic pharmacy secondary development and research compared with
It is few, therefore, the research of galenic pharmacy is carried out to 'Yan Lu Ru Kang ', improve the dissolution rate of 'Yan Lu Ru Kang ', improve drug availability, further
The bioavilability of drug is improved, the clinical therapeutic efficacy for improving drug is necessary.
Solid dispersion technology is to disperse solid in solids, is the new technology of formulation art.Usually a kind of slightly solubility
Drug is dispersed in another water-soluble material or slightly solubility, Enteric Materials with molecule, colloidal state, crystallite or amorphous state
In be in solid dispersions (solid dispersion), to achieve the purpose that improve dissolution rate or sustained release.
For the solid dispersion technology for the purpose of improving dissolution rate, the dissolution rate of solid dispersions is largely
Characteristic and formulation method depending on used carrier material.Which kind of solid dispersion technology different pharmaceutical uses, and depends primarily on
The structural property of pharmaceutical properties and carrier material, solubility and solubility property etc., therefore carried for the selection of specific drug ingedient
Body material and formulation method are most important for preparing solid dispersions.
Summary of the invention:
The object of the present invention is to provide a kind of 'Yan Lu Ru Kang ' preparations and preparation method thereof, and technical concept is: by rock deer cream
Rodgersflower rhizome, pyrola medicinal material in health preparation prescription carry out ultrasonic extraction, and solid dispersion is made in extract and solid dispersion carrier
Body, cornu cerve degelatinatum crushing is used as medicine, and preparation is made with pharmaceutically acceptable auxiliary material, and medicine can be improved in 'Yan Lu Ru Kang ' preparation obtained
The dissolution rate and bioavilability of object significantly improve medication effect, are more able to satisfy clinical application.
Specifically, the present invention provides a kind of 'Yan Lu Ru Kang ' preparation, the 'Yan Lu Ru Kang ' preparation by weight, be by
400-500 parts of rodgersflower rhizome, 55-65 parts of pyrola, 5-10 parts of cornu cerve degelatinatum, solid dispersion carrier material 140-160 and pharmaceutic adjuvant
It is made.
More specifically, the 'Yan Lu Ru Kang ' preparation is by weight, it is by 445 parts of rodgersflower rhizome, 62.5 parts of pyrola, deer horn
7.5 parts of frost, 150 parts of solid dispersion carrier material and pharmaceutic adjuvant are made.
Solid dispersion carrier of the present invention can be selected from: Polyvinylcaprolactame-polyvinyl acetate-polyethylene glycol
Graft copolymer (soluplus), povidone VA64, povidone 12PF, PLURONICS F87, Macrogol 6000；The present invention is excellent
Select Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer (soluplus).
Pharmaceutic adjuvant of the present invention can be selected from: PVP K30, crospovidone, microcrystalline cellulose, Icing Sugar, carboxylic first
Base sodium starch, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose, glucose, starch, lactose, mannitol, dextrin, stearic acid
Magnesium, superfine silica gel powder, talcum powder, Macrogol 6000, Macrogol 4000 are one of or several.
The present invention also provides a kind of preparation methods for preparing 'Yan Lu Ru Kang ' preparation as described above, comprising the following steps:
1) rodgersflower rhizome is taken, adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time, merging mentions
Liquid is taken, is filtered, filtrate recycling ethanol is simultaneously concentrated into the medicinal extract that relative density is about 1.20, and vacuum drying is made dry rodgersflower rhizome and extracts
Object extract powder, it is spare；
2) pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, reflux mentions for the first time
It takes 1.5 hours, second refluxing extraction 1 hour, extracting solution closed filtering, and the dregs of a decoction are spare, filtrate decompression was concentrated, vacuum drying system
It is spare at dry Herba Pyrolae extract extract powder；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer is placed in heating container, control
Temperature is 70 DEG C, magnetic agitation 30min, and pyrola made from the obtained Rhizoma Rodgersiae extract extract powder of step 1) and step 2 is added and mentions
Object extract powder is taken, magnetic agitation 30min is cooled to room temperature, and is placed in refrigerator and is quenched to -5 DEG C, is crushed, and crosses 40 meshes up to solid
Dispersion, it is spare.
4) it takes cornu cerve degelatinatum to mix with the dregs of a decoction of step 2), crushed 80 meshes, mixed powder is made, it is spare.
5) solid dispersions made from step 3) and mixed powder made from step 4) are mixed well, addition pharmaceutically may be used
Various dosage forms are made with the pharmaceutic adjuvant of receiving.
More specifically, a kind of preparation method for preparing 'Yan Lu Ru Kang ' preparation as described above, comprising the following steps:
1) rodgersflower rhizome is taken, adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time, merging mentions
Liquid is taken, is filtered, filtrate recycling ethanol is simultaneously concentrated into the medicinal extract that relative density is about 1.20, and vacuum drying is made dry rodgersflower rhizome and extracts
Object extract powder, it is spare；
2) pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, reflux mentions for the first time
It takes 1.5 hours, second refluxing extraction 1 hour, extracting solution closed filtering, and the dregs of a decoction are spare, filtrate decompression was concentrated, vacuum drying system
It is spare at dry Herba Pyrolae extract extract powder；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer is placed in heating container, control
Temperature is 70 DEG C, magnetic agitation 30min, and pyrola made from the obtained Rhizoma Rodgersiae extract extract powder of step 1) and step 2 is added and mentions
Object extract powder is taken, magnetic agitation 30min is cooled to room temperature, and is placed in refrigerator and is quenched to -5 DEG C, is crushed, and crosses 40 meshes up to solid
Dispersion, it is spare；
4) cornu cerve degelatinatum is mixed with the dregs of a decoction of step 2), crushed 80 meshes, mixed powder is made, it is spare；
5) solid dispersions made from step 3) and mixed powder made from step 4) are mixed well, addition pharmaceutically may be used
Various dosage forms are made with the pharmaceutic adjuvant of receiving.
Dosage form of the present invention can be dispersible tablet, capsule, soft capsule, microcapsules, granule, pill, pellet,
Powder, pill, sustained release preparation, controlled release preparation or gelling agent.It is preferably made tablet, capsule.
Wherein, the tablet is prepared: will mix made from solid dispersions made from step 3) and step 4)
It closes medicinal powder to mix well, appropriate amount of starch, 4% lactose, 6% part of microcrystalline cellulose is added, is sufficiently mixed, 85% ethyl alcohol is as bonding
Particle is made in agent, crosses 20 meshes, and 1.5% superfine silica gel powder is added, and 1% part of magnesium stearate mixes, tablet, Europe is made with tablet press machine
In bar generation, is coated to obtain the final product.
Wherein, the capsule is prepared: solid dispersions medicinal powder made from step 3) and step 4) are made
The mixed powder obtained mixes well, and appropriate amount of starch, 2% lactose, 5% microcrystalline cellulose is added, is sufficiently mixed, and 85% ethyl alcohol is made
For adhesive, particle is made, crosses 20 meshes, 4% superfine silica gel powder is added, 1% magnesium stearate is mixed, is fitted into capsule to obtain the final product.
The invention has the benefit that the present invention exists mostly for commercially available 'Yan Lu Ru Kang ' preparation, In Vitro Dissolution is slow, gives birth to
The low disadvantage of object availability, is studied through a large number of experiments, optimize preparation process, by 'Yan Lu Ru Kang ' preparation prescription rodgersflower rhizome,
Pyrola carries out ultrasonic extraction, can more preferably be enriched with effective active composition；And suitable carrier is selected, it will using solid dispersion technology
Solid dispersions are made in rodgersflower rhizome and Herba Pyrolae extract, increase the dispersion degree and specific surface area of drug, are conducive to effective component
Leaching, increase the hydrophily of drug, to increase the solubility of 'Yan Lu Ru Kang ' solid dispersions, dissolution rate, improve drug
Bioavilability, be more advantageous to curative effect of medication performance；Moreover, the present invention selects soluplus (Polyvinylcaprolactame-poly-vinegar
Vinyl acetate-polyethyleneglycol-graft copolymer) it is used as carrier, not only manufactured solid dispersions quality is preferable, and soluplus
Carrier compressibility, mobility are preferable, are advantageous to granulation, tabletting, easy to industrialized production.
In order to be illustrated to the contents of the present invention and beneficial effect, the present invention has also carried out following tests, it is intended to illustrate
The present invention does not limit the scope of the invention.
Experiment 1: the selection of solid dispersion carrier material:
Using solid dispersions index components content made from different carriers and dissolution in vitro as investigation item.According to 2010
Relevant regulations in year version " Chinese Pharmacopoeia " (two) annex, are tested using paddle method.Take solid dispersions appropriate, precision claims
It is fixed, it uniformly point is spread in stripping rotor, medium is 0.2% lauryl sodium sulfate 900ml, revolving speed 100r/min, and temperature is
It 37 ± 0.5 DEG C, is measured by sampling respectively at 5,15,30,45,60min, calculates and accumulate dissolution percentage, investigation result such as the following table 1,
Table 2:
Table 1: solid dispersions index components content measurement result made of different carriers:
| Carrier | Determination of Bergenin % | General flavone content % | The sum of index content % |
| Soluplus | 5.23 | 1.82 | 7.25 |
| Kollidon12PF | 4.35 | 1.21 | 5.56 |
| PLURONICS F87 | 4.11 | 0.79 | 5.20 |
| KollidonVA64 | 4.43 | 1.37 | 5.80 |
| PEG6000 | 3.52 | 0.68 | 4.40 |
Table 2: solid dispersions made of different carriers accumulate dissolution test result:
To sum up test result: dispersion material cumulative defaultlogic made of solid dispersions material each group, which is all larger than, to be mentioned
Raw material group is taken, wherein soluplus prepares solid dispersions performance optimal as carrier material, and active component content is high, and
And manufactured solid dispersions dissolution rate is high, dissolution rate is fast, in 30min, cumulative defaultlogic is just had reached
70%, also, soluplus is preferable as carrier material compressibility, mobility, is more advantageous to granulation and tabletting, therefore preferably
Soluplus is as carrier material.
Experiment 2: different prescriptions are equipped with than manufactured solid dispersions Dissolution Rate Testing:
Test group 1 (low component): it is made by the preparation method of the embodiment of the present invention 1；
Test group 2 (Gao Zufen): it is made by the preparation method of the embodiment of the present invention 2；
Test group 3-5: it is made by the preparation method of 3-5 of the embodiment of the present invention；
According to the relevant regulations in version " Chinese Pharmacopoeia " (two) annex in 2010, tested using paddle method.Take solid
Appropriate dispersion, it is accurately weighed, uniformly divide and be spread in stripping rotor, medium is 0.2% lauryl sodium sulfate 900ml, revolving speed
For 100r/min, temperature is 37 ± 0.5 DEG C, is measured by sampling respectively at 5,15,30,45,60min, calculates accumulation dissolution percentage,
Test result such as the following table 3:
Table 3: different component matches manufactured solid dispersions Dissolution Rate Testing
Test result shows: test group 1 is solid dispersions made of low component proportion, and test group 2 is high component proportion
Manufactured solid dispersions, test measurement solubility test result see that effect is not highly desirable, and test group 3-5 dissolution rate
In 60min, for cumulative defaultlogic up to 80% or more, effect is preferable for test, therefore, optimizing prescriptions of the present invention are as follows: by rock
400-500 parts of top, 55-65 parts of pyrola, 5-10 parts of cornu cerve degelatinatum, Polyvinylcaprolactame-polyvinyl acetate-polyethylene glycol connect
140-160 parts of graft copolymer (soluplus).
It is of the invention that 'Yan Lu Ru Kang ' preparation is investigated to test 3:
1, accelerated stability test:
It is tested according to the relevant regulations of version " Chinese Pharmacopoeia " (two) accelerated stability test in 2010, test knot
Fruit such as the following table 4:
Table 4: 'Yan Lu Ru Kang ' preparation accelerated stability test testing result:
Test result shows: 'Yan Lu Ru Kang ' better stability of preparation produced by the present invention, more commercially available 'Yan Lu Ru Kang ' are more excellent.2,
'Yan Lu Ru Kang ' agent in vitro Dissolution Rate Testing:
Table 5: 'Yan Lu Ru Kang ' agent in vitro Dissolution Rate Testing:
Test result shows: the more commercially available 'Yan Lu Ru Kang ' tablet of 'Yan Lu Ru Kang ' preparation produced by the present invention is more excellent, external tired
Product dissolution percentage can be up to 80% or more in 60min, and dissolution in vitro is greatly enhanced.
3, pharmacodynamics test:
Take the non-pregnant rat of female adult, 250 ± 20g of weight, through continuous 3 cyclic check of vaginal exfoliated cell smear, selection
Oestrous cycle, rule person was tested.
Take intramuscular injection on the outside of experimental animal diethylstilbestrol injection hind leg, each 0.2mg, 1 time a day, totally 30 days, always
Dosage is every 6mg.Check that breast appearance and mammary gland pathological change.See that modeling rat papilla diameter, length dramatically increase.Take abdomen
Portion's caudal part 3 carries out check pathological section to mammary gland, sees that breast duct chamber expands, secretion is full of in lumen.Mammary gland alveolus number
Mesh increased significantly.Epithelial hyperplasia, in cladding or false multiple layered arrangement, it was demonstrated that modeling success.
Rat 60 are taken, 6 groups is randomly divided into, every group 10, handles as follows: normal group, distilled water stomach-filling, every 2ml/d；
Model group, modeling daily distilled water stomach-filling 1 time simultaneously, each 2ml；Commercially available 'Yan Lu Ru Kang ' product group, product of the present invention group, mammary gland
Hyperplasia modeling respectively plus uses related drugs stomach-filling simultaneously, and dosage is 10 times of adult routine dose, 1 time a day, each 2ml.Respectively
Group rat continuous medicine-filling 30 days after being discontinued 1 week, randomly selects 7 rat mammary glands for every group during emotionally, -70 DEG C of liquid nitrogen cryopreservations,
Estradiol receptor (ER) to be measured, PgR (PR)；Every group of remaining 3 mammary gland samples, 10% neutral formalin is fixed, conventional
Paraffin section, HE dyeing, pathologic finding (use optical microscopy).
1) to the influence of hyperplasia of mammary gland model rat mammary gland ponderal index
The model that rat breast tissue hyperplasia is caused to adult rat longer-term large dosage intramuscular injection diethylstilbestrol, to every
7 pairs of mammary gland that group is randomly selected carry out ponderal index (mg/100g weight) and compare, and as a result see the table below 6.
Table 6: influence of each test group to rat mammary gland ponderal index:
| Group | Animal number of elements | Mammary gland ponderal index (mg/100g weight) |
| Normal group | 7 | 18.21±2.03 |
| Model group | 7 | 23.44±1.83 |
| Commercially available featherleaf rodgersflower and pyrola herb contained tablet for treating mammary disease | 7 | 18.93±2.12 |
| Commercially available 'Yan Lu Ru Kang ' capsule | 7 | 19.09±1.93 |
| Featherleaf rodgersflower and pyrola herb contained tablet for treating mammary disease of the present invention | 7 | 18.29±1.76 |
| 'Yan Lu Ru Kang ' capsule of the present invention | 7 | 18.32±1.81 |
Upper watch test statistics indicate that: compared with model group test, dosing group significantly reduces rat mammary gland hyperplasia, and this
The product group therapeutic effect of invention is substantially better than commercial product group.
2) to the influence of hyperplasia of mammary gland model rat breast tissue structure
Compared with normal rat breast tissue, all 3 rat mammary gland samples have acinus quantity to obviously increase to model group,
Epithelial proliferation is in false cladding phenomenon, serious person's even obstruction conduit；Ductal ectasia includes a large amount of secretion；Between surrounding reactivity
Matter significantly reduces, and dyeing deepens, Collagen Proliferation, loses rarefaction, and dosing each group acinus has hyperplasia, but degree is obviously lighter than
Model group, and the therapeutic effect of product of the present invention group is substantially better than commercially available product group.
To sum up test result: this it appears that 'Yan Lu Ru Kang ' product stability made of the present invention is good, dissolution rate is high, it is molten
Rate is fast out, and bioavilability is high, and therapeutic effect is good, is more advantageous to clinical use.
Specific embodiment:
Embodiment 1: the preparation (low component) of solid dispersions
1) rodgersflower rhizome for taking 400g adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time,
Combined extract, filtration, filtrate recycling ethanol are simultaneously concentrated into the medicinal extract that relative density is about 1.20, and dry rock is made in vacuum drying
Top extract extract powder, it is spare；
2) 53g pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, is returned for the first time
Stream extracts 1.5 hours, and second refluxing extraction 1 hour, extracting solution merged filtering, and the dregs of a decoction are spare, filtrate decompression are concentrated, vacuum
Dry Herba Pyrolae extract extract powder is made in drying, spare；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer of 130g is placed in addition container
In, controlled at 70 DEG C, magnetic agitation 30min, step 1) is added, deer made from Rhizoma Rodgersiae extract extract powder and step 2 is made
Careless extract extract powder is held in the mouth, magnetic agitation 30min is cooled to room temperature, is placed in refrigerator and is quenched to -5 DEG C, crushes, and crosses 40 meshes and is
Solid dispersions are made.
Embodiment 2: the preparation (high component) of solid dispersions
1) rodgersflower rhizome for taking 500g adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time,
Combined extract, filtration, filtrate recycling ethanol are simultaneously concentrated into the medicinal extract that relative density is about 1.20, and dry rock is made in vacuum drying
Top extract extract powder, it is spare；
2) 65g pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, is returned for the first time
Stream extracts 1.5 hours, and second refluxing extraction 1 hour, extracting solution merged filtering, and the dregs of a decoction are spare, filtrate decompression are concentrated, vacuum
Dry Herba Pyrolae extract extract powder is made in drying, spare；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer of 170g is placed in addition container
In, controlled at 70 DEG C, magnetic agitation 30min, step 1) is added, deer made from Rhizoma Rodgersiae extract extract powder and step 2 is made
Careless extract extract powder is held in the mouth, magnetic agitation 30min is cooled to room temperature, is placed in refrigerator and is quenched to -5 DEG C, crushes, and crosses 40 meshes and is
Solid dispersions are made.
Embodiment 3: the preparation of solid dispersions
1) rodgersflower rhizome for taking 400g adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time,
Combined extract, filtration, filtrate recycling ethanol are simultaneously concentrated into the medicinal extract that relative density is about 1.20, and dry rock is made in vacuum drying
Top extract extract powder, it is spare；
2) 55g pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, is returned for the first time
Stream extracts 1.5 hours, and second refluxing extraction 1 hour, extracting solution merged filtering, and the dregs of a decoction are spare, filtrate decompression are concentrated, vacuum
Dry Herba Pyrolae extract extract powder is made in drying, spare；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer of 140g is placed in addition container
In, controlled at 70 DEG C, magnetic agitation 30min, step 1) is added, deer made from Rhizoma Rodgersiae extract extract powder and step 2 is made
Careless extract extract powder is held in the mouth, magnetic agitation 30min is cooled to room temperature, is placed in refrigerator and is quenched to -5 DEG C, crushes, and crosses 40 meshes and is
Solid dispersions are made.
Embodiment 4: the preparation of solid dispersions
1) rodgersflower rhizome for taking 445g adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time,
Combined extract, filtration, filtrate recycling ethanol are simultaneously concentrated into the medicinal extract that relative density is about 1.20, and dry rock is made in vacuum drying
Top extract extract powder, it is spare；
2) 62.5g pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, for the first time
Refluxing extraction 1.5 hours, second refluxing extraction 1 hour, extracting solution merged filtering, and the dregs of a decoction are spare, filtrate decompression are concentrated, very
Dry Herba Pyrolae extract extract powder is made in sky drying, spare；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer of 150g is placed in addition container
In, controlled at 70 DEG C, magnetic agitation 30min, step 1) is added, deer made from Rhizoma Rodgersiae extract extract powder and step 2 is made
Careless extract extract powder is held in the mouth, magnetic agitation 30min is cooled to room temperature, is placed in refrigerator and is quenched to -5 DEG C, crushes, and crosses 40 meshes and is
Solid dispersions are made.
Embodiment 5: the preparation of solid dispersions
1) rodgersflower rhizome for taking 500g adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time,
Combined extract, filtration, filtrate recycling ethanol are simultaneously concentrated into the medicinal extract that relative density is about 1.20, and dry rock is made in vacuum drying
Top extract extract powder, it is spare；
2) 65g pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, is returned for the first time
Stream extracts 1.5 hours, and second refluxing extraction 1 hour, extracting solution merged filtering, and the dregs of a decoction are spare, filtrate decompression are concentrated, vacuum
Dry Herba Pyrolae extract extract powder is made in drying, spare；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer of 160g is placed in addition container
In, controlled at 70 DEG C, magnetic agitation 30min, step 1) is added, deer made from Rhizoma Rodgersiae extract extract powder and step 2 is made
Careless extract extract powder is held in the mouth, magnetic agitation 30min is cooled to room temperature, is placed in refrigerator and is quenched to -5 DEG C, crushes, and crosses 40 meshes and is
Solid dispersions are made.
Embodiment 6: the preparation of featherleaf rodgersflower and pyrola herb contained tablet for treating mammary disease
It takes institute's 5g cornu cerve degelatinatum to mix with the dregs of a decoction of the step 2) of any embodiment 4-5, crushed 80 meshes, mixing medicine is made
Powder adds solid dispersions made from any embodiment 4-5 and mixes well, and appropriate amount of starch, the lactose of 16g, 24g crystallite is added
Cellulose is sufficiently mixed, and particle is made as adhesive in 85% ethyl alcohol, crosses 20 meshes, and 6g superfine silica gel powder, 4g stearic acid is added
Magnesium mixes, and tablet is made with tablet press machine, Opadry coating is made 1000, every 0.4g.
Embodiment 7: the preparation of featherleaf rodgersflower and pyrola herb contained tablet for treating mammary disease
It takes institute's 7.5g cornu cerve degelatinatum to mix with the dregs of a decoction of the step 2) of any embodiment 4-5, crushed 80 meshes, mixing is made
Medicinal powder adds solid dispersions made from any embodiment 4-5 and mixes well, and it is micro- that appropriate amount of starch, the lactose of 16g, 24g is added
Crystalline cellulose is sufficiently mixed, and particle is made as adhesive in 85% ethyl alcohol, crosses 20 meshes, and 6g superfine silica gel powder is added, and 4g is stearic
Sour magnesium mixes, and tablet is made with tablet press machine, Opadry coating is made 1000, every 0.4g.
Embodiment 8: the preparation of 'Yan Lu Ru Kang ' capsule
It takes institute's 7.5g cornu cerve degelatinatum to mix with the dregs of a decoction of the step 2) of any embodiment 4-5, crushed 80 meshes, mixing is made
Medicinal powder adds solid dispersions made from any embodiment 4-5 and mixes well, and it is micro- that appropriate amount of starch, the lactose of 8g, 20g is added
Crystalline cellulose is sufficiently mixed, and particle is made as adhesive in 85% ethyl alcohol, crosses 20 meshes, and 16 superfine silica gel powders are added, and 4g is stearic
Sour magnesium mixes, is fitted into capsule, is made 1000.Every weight 0.4g.
Embodiment 9: the preparation of 'Yan Lu Ru Kang ' capsule
It takes institute's 10g cornu cerve degelatinatum to mix with the dregs of a decoction of the step 2) of any embodiment 4-5, crushed 80 meshes, mixing is made
Medicinal powder adds solid dispersions made from any embodiment 4-5 and mixes well, and it is micro- that appropriate amount of starch, the lactose of 8g, 20g is added
Crystalline cellulose is sufficiently mixed, and particle is made as adhesive in 85% ethyl alcohol, crosses 20 meshes, and 16g superfine silica gel powder is added, and 4g is stearic
Sour magnesium mixes, is fitted into capsule, is made 1000.Every weight 0.4g.
Claims (5)
1. a kind of 'Yan Lu Ru Kang ' preparation, it is characterised in that: the 'Yan Lu Ru Kang ' preparation is by rodgersflower rhizome 400- by weight
500 parts, 55-65 parts of pyrola, 5-10 parts of cornu cerve degelatinatum, 140-160 parts of solid dispersion carrier material and pharmaceutic adjuvant are made, institute
The solid dispersion carrier stated is Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer (soluplus).
2. 'Yan Lu Ru Kang ' preparation according to claim 1, the 'Yan Lu Ru Kang ' preparation is by rodgersflower rhizome by weight
445 parts, 62.5 parts of pyrola, 7.5 parts of cornu cerve degelatinatum, 150 parts of solid dispersion carrier material and pharmaceutic adjuvant are made.
3. 'Yan Lu Ru Kang ' preparation according to claim 1 or 2, it is characterised in that: the pharmaceutic adjuvant is povidone
K30, crospovidone, microcrystalline cellulose, Icing Sugar, sodium carboxymethyl starch, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose,
Glucose, starch, lactose, mannitol, dextrin, magnesium stearate, superfine silica gel powder, talcum powder, Macrogol 6000, polyethylene glycol
One or more of 4000.
4. a kind of preparation method of 'Yan Lu Ru Kang ' preparation as claimed in claim 1 or 2, it is characterised in that: make according to the following steps
It is standby:
1) rodgersflower rhizome is taken, adds 95% ethyl alcohol soaked overnight of 3 times of amounts, ultrasonic extraction 2 times, extracts 1 hour every time, merge and extract
Liquid, filtration, filtrate recycling ethanol are simultaneously concentrated into the medicinal extract that relative density is 1.20, and dry Rhizoma Rodgersiae extract leaching is made in vacuum drying
Cream powder, it is spare；
2) pyrola is taken, crushed 80 meshes, 5 times of amounts are added 50% ethanol solution refluxing extraction 2 times, first time refluxing extraction
1.5 hours, second refluxing extraction 1 hour, extracting solution closed filtering, and the dregs of a decoction are spare, and filtrate decompression is concentrated, and vacuum drying is made
Dry Herba Pyrolae extract extract powder, it is spare；
3) Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer is placed in heating container, controls temperature
It is 70 DEG C, magnetic agitation 30min, step 1) is added, Herba Pyrolae extract made from Rhizoma Rodgersiae extract extract powder and step 2) is made
Extract powder, magnetic agitation 30min, is cooled to room temperature, and is placed in refrigerator and is quenched to -5 DEG C, crushes, and crosses 40 meshes up to solid dispersion
Body, it is spare；
4) it takes cornu cerve degelatinatum to mix with the dregs of a decoction of step 2), crushed 80 meshes, mixed powder is made, it is spare；
5) solid dispersions made from step 3) and mixed powder made from step 4) are mixed well, addition can pharmaceutically connect
Various dosage forms are made in the pharmaceutic adjuvant received.
5. the preparation method according to claim 4, it is characterised in that: the dosage form is dispersible tablet, capsule, micro-capsule
Agent, granule, pill, powder, sustained release preparation, controlled release preparation or gelling agent.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686403A (en) * | 2005-04-18 | 2005-10-26 | 昆明圣火制药有限责任公司 | Chinese medicine soft capsule for treating mastoncus and its preparation method |
| CN1732997A (en) * | 2005-07-20 | 2006-02-15 | 石药集团中诺药业（石家庄）有限公司 | Featherleaf rodgersflower and pyrola herb contained tablet for treating mammary disease and preparation processthereof |
| CN1876000A (en) * | 2005-05-12 | 2006-12-13 | 贵阳云岩西创药物科技开发有限公司 | 'Yan Lu Ru Kang' pharmaceutical preparation for treating mammary gland hyperplasia, its preparation process and quality control method |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686403A (en) * | 2005-04-18 | 2005-10-26 | 昆明圣火制药有限责任公司 | Chinese medicine soft capsule for treating mastoncus and its preparation method |
| CN1876000A (en) * | 2005-05-12 | 2006-12-13 | 贵阳云岩西创药物科技开发有限公司 | 'Yan Lu Ru Kang' pharmaceutical preparation for treating mammary gland hyperplasia, its preparation process and quality control method |
| CN1732997A (en) * | 2005-07-20 | 2006-02-15 | 石药集团中诺药业（石家庄）有限公司 | Featherleaf rodgersflower and pyrola herb contained tablet for treating mammary disease and preparation processthereof |
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