CN102363016B - A kind of Chinese medicine composite dripping core pills and preparation method thereof - Google Patents
A kind of Chinese medicine composite dripping core pills and preparation method thereof Download PDFInfo
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Abstract
The present invention is a kind of Chinese medicine composite dripping core pills and preparation method thereof, and it is prepared using Moschus, root tuber of aromatic turmeric, borneol, cape jasmine etc.：Dripping pill is made in fat-soluble or volatile materials, parent nucleus is made with dripping pill, water-soluble substances is wrapped in the packet pill of outer formation.Dixinwan pill has drawn the advantages of dripping pill and water-bindered pill, overcomes respective deficiency, reduces dosage, shorten and leach the time, formulation is more optimized.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of Chinese medicine composite dripping core pills and its preparation side
Method.
Technical background
Dixinwan pill is that fat-soluble or volatile materials is made into dripping pill, makees parent nucleus with dripping pill, water-soluble substances is wrapped in
The packet pill of outer formation.Dixinwan pill has drawn the advantages of dripping pill and water-bindered pill, overcomes respective deficiency, reduces dosage, contracting
It is short to leach the time, formulation is more optimized.
It is more to the investigative technique of dripping pill in medical research field at present, but in the Chinese medicine containing a variety of middle volatile oil components
Using less on the dixinwan pill of compound preparation, the applicant finds a kind of new Chinese medicine compound prescription dixinwan pill system by experimental exploring
Agent and preparation method thereof.
Chinese medicine " Angong Niuhuang Wan ", its main component have Moschus, borneol and root tuber of aromatic turmeric, cape jasmine, there is inducing resuscitation to stop convulsion, heat-clearing is cool
Blood, the promoting flow of qi and blood circulation, the effect for analgesic of detoxifying.Be clinically used for treat cerebrovas-cularaccident, encephalitis B, central nervous system infection,
Disturbance of consciousness etc. caused by angina pectoris, alcohol or drug poisoning etc..The curative effect composition of Angong Niuhuang Wan is that raw material is carried out
The volatile essential oil obtained after distillation, also known as volatile oil, volatile oil be in Chinese medicine with steam distillation out and with water not
The general name of miscible volatility oily composition.Volatile oil is mixture, and its component is complex, is oil-based liquid.
Traditional Angong Niuhuang Wan is a kind of honeyed bolus, because formulation is very large, causes to take inconvenience, to find one kind side of taking
Just, dixinwan pill technology is applied to Angong Niuhuang Wan, is found surprisingly that by the superior Angong Niuhuang Wan novel formulation of curative effect, the present invention
A kind of new preparation of Angong Niuhuang Wan and preparation method thereof, and be found surprisingly that its have it is more superior the effect of, dissolution rate,
Stability and adaptability.
The content of the invention
The of the invention main limitation for overcoming prior art, there is provided a kind of to form a variety of volatile oil and solid drugs
The preparation of Chinese medicine composite dripping core pills and its preparation.
The Chinese medicine composite dripping core pills of the present invention, are prepared by the Chinese medicine material medicine of following weight proportion：Cape jasmine 30
Part, 30 parts of root tuber of aromatic turmeric, 7.5 parts of Moschus, 1 part of borneol.
The Chinese medicine composite dripping core pills of the present invention, it is made up of medicine core and integument, and medicine core is wrapped in integument,
Wherein：Medicine core is made up of volatile oil, borneol and matrix that being extracted with cape jasmine, root tuber of aromatic turmeric, Moschus, its a diameter of 3-4 millimeter, parcel
Layer is cape jasmine, root tuber of aromatic turmeric, obtains the dregs of a decoction after extraction volatile oil, then the extract and auxiliary material that are obtained by extraction are made, and wrap up thickness
It is brown color to spend for 0.5-1 millimeters, medicine core, and integument is sepia, preparation in spherosome, a diameter of 5-6 millimeters.
Wherein, it is water-soluble base or water-insoluble base to prepare the matrix that medicine core uses, including：Polyethylene glycols, gather
Oxygen ethene monostearate esters, glycerin gelatine, odium stearate urea, pool fall water-soluble base, stearic acid, the monostearates such as husky nurse
The water-insoluble bases such as glyceride, insect wax, hydrogenated vegetable oil, octadecyl alcolol, hexadecanol.
The extract of integument can be that obtained dregs of a decoction water extraction is obtained and arrived after cape jasmine, root tuber of aromatic turmeric, Moschus extraction volatile oil
Water extract or cape jasmine, root tuber of aromatic turmeric, Moschus extraction volatile oil after the obtained dregs of a decoction extract obtained alcohol extracting with alcohols solvent
Thing.
Water extract and alcohol extract wear into fine powder, generally 80-120 mesh.
Wherein, the auxiliary material used in integument, including it is starch, dextrin, Icing Sugar, lactose, mannitol, microcrystalline cellulose, micro-
Powder silica gel, pregelatinized starch, calcium sulfate, calcium carbonate, calcium monohydrogen phosphate, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose
Sodium, PVPP, chitin element.
The weight ratio of extract and auxiliary material is 50-95：5-50.
Present invention additionally comprises the preparation method of the Chinese medicine composite dripping core pills of the present invention, comprise the following steps：
Step 1, by cape jasmine, root tuber of aromatic turmeric, coarse crushing respectively, volatile oil, Moschus soak extraction volatile oil are extracted, volatile oil mixes
Close, the volatile oil of mixing and borneol mixed dissolution is standby；
Step 2, cape jasmine, root tuber of aromatic turmeric, the Moschus dregs of a decoction are extracted with ethanol, extract solution recovery ethanol, obtain alcohol extract thick paste, the dregs of a decoction are used
Decocting is boiled, and decocting liquid is concentrated into thick paste, is merged with alcohol extract thick paste, dry that extract powder, addition auxiliary material mix, and obtains mixed powder, standby
With；
Step 3, volatile oil adds matrix melting, instills in cooling agent, dripping pelletization, produces dripping pill, dripping pill mixed powder
Parcel, is produced.
Wherein, the finished product obtained in step 3 is coated with coating solution if necessary, obtains coating solution.
The preparation method of the Chinese medicine composite dripping core pills of the preferable present invention, comprises the following steps：
Step 1, by cape jasmine, root tuber of aromatic turmeric, be respectively crushed into fine powder, extract volatile oil, Moschus soak extraction volatile oil, volatile oil
Mixing, the volatile oil of mixing and borneol mixed dissolution is standby,
Step 2, cape jasmine, root tuber of aromatic turmeric, the Moschus dregs of a decoction with ethanol soak 12 hours, be heated to reflux it is secondary, 2 hours every time, merge
Reflux extracting liquid, filtration, the dregs of a decoction are standby, decompression filtrate recycling ethanol, to without ethanol flavor, obtain alcohol extracting thick paste, dregs of a decoction heating evaporation
Ethanol, making the dregs of a decoction, rear to decoct twice, 1 hour every time, collecting decoction, standing, filtration, filtrate decompression was concentrated into thick without ethanol flavor
Cream, merge with alcohol extracting thick paste, be dried under reduced pressure, be ground into 120 mesh fine powders, obtain extract powder, add low-substituted hydroxypropyl cellulose, add
Enter the 7% of the mixed powder gross weight that amount is mixed to get for extract powder and low-substituted hydroxypropyl cellulose, be well mixed, must mix
Powder, it is standby：
Step 3, the Macrogol 6000 for weighing the volatile oil doubling dose of mixed dissolution fully stirs in 60~100 DEG C of water-baths
Mix, to bubble-free, completely melting, be subsequently placed in 49~60 DEG C of water-baths, the volatile oil for extracting mixing is added, is sufficiently stirred, extremely
Bubble-free melts completely, instills in the atoleine that temperature is 0~5 DEG C, dripping pelletization, produces dripping pill, diameter 4mm；Wipe drop
Ball surface liquid paraffin, is placed in coating pan, and temperature control is 50~60 DEG C in coating pan, sprays 85% ethanol solution conduct
Wetting agent, the mixed powder that step 2 obtains is sprinkled into, increases pill, powder use to be mixed finishes, diameter about 6mm, sprays Opadry
Solution, coating, produces product.
The volatile oil wherein mixed refers to cape jasmine volatile oil, Radix Curcumae volatile oil, the mixture of Moschus volatile oil, and volatile oil carries
Take method can also be with the following method：300 parts of cape jasmine, 300 parts of root tuber of aromatic turmeric, 75 parts of Moschus are weighed, is obtained by supercritical extraction
The mixture of a variety of volatile oil is obtained, it is 20-45MP to control extracting pressure, 40 DEG C -60 DEG C of extraction temperature, parses pressure 10-30MP,
10 DEG C -20 DEG C of resolution temperature；
Above-mentioned borneol is using need to meet States Pharmacopoeia specifications, mixture of volatile oil and borneol weight ratio preferably 3:1, use volatile oil
Mixture and matrix co-dissolve.
A kind of Chinese medicine composite dripping core pills prepared by the present invention have important advantage and wide in field of medicaments
Prospect, it is mainly manifested in the following aspects：
1. raw material, by modern extraction technique, faster, active constituents of medicine purity is higher for extraction efficiency, save material into
This.
2. extracts active ingredients are complete, auxiliary material amount is few, and unit volume drug containing active ingredient is more, and volatile ingredient is not easy to wave
Hair, medicine stability are good.
3. dixinwan pill leaches rapidly, easily absorb, act on fast, bioavilability height.
4. the present invention prepares dixinwan pill technique simply, rationally, low for equipment requirements, production cost can be greatly reduced, is subtracted
Light environmental pollution, is suitable for large-scale industrial production.
Simultaneously in order to confirm Chinese medicine composite dripping core pills validity, We conducted relevant experiment, it was demonstrated that Chinese medicine compound prescription
The validity of dixinwan pill preparation.
(1) prepared by two kinds of pills of
Cape jasmine is taken as 600g, root tuber of aromatic turmeric 600g, Moschus 150g, borneol 20g, takes cape jasmine, root tuber of aromatic turmeric, a variety of volatilizations of Moschus extraction
Oily another device is collected, and the volatile oil of mixing and borneol mixed dissolution is standby, and the dregs of a decoction prepare medicinal extract according to preparation method in embodiment 1
Powder is standby,
1. prepared by dixinwan pill
Above-mentioned volatile oil and extract powder are taken, dixinwan pill is prepared according to the preparation method of embodiment 1.
2. prepared by dripping pill
The Macrogol 6000 of 3 times of amounts of volatile oil and extract powder of mixed dissolution is taken to be sufficiently stirred in 60~100 DEG C of water-baths,
To bubble-free, completely melting, 49~60 DEG C of water-baths are subsequently placed in, are instilled in the atoleine that temperature is 0~5 DEG C, dripping pelletization,
Produce dripping pill
(2) two kinds of formulations leach time experiment and compared
1. leach time limit measure：According to《Pharmacopoeia of People's Republic of China》The A's of annex Ⅻ leaches the progress of time limit method inspection technique.
Each 6 of above two pill test sample is taken, according to method inspection.
Leach time limit experimental data
Experiment shows：Dixinwan pill all dissolved in 20 minutes, and dripping pill, more than 50 minutes, illustrates drop in whole dissolution times
Heart ball leaches fast, easy absorption, and rapid-action, effect is by force.
The comparison of (two) two kinds of pill dissolution rates
Dissolution determination：Each 6 of above two pill is taken, is shone《Pharmacopoeia of People's Republic of China》The methods of annex XC first, point
Not using 900mL distilled water, pH6.8 buffer solutions and 0.1mol/L hydrochloric acid as dissolution medium, rotating speed 100r/min, and respectively at 5,
10th, 15,20,30,40,60 Self-control method is used, calculates the muskone dissolution rate of two kinds of pills.(see two kinds of pill dissolution rates
Compare figure)
Test result indicates that：Dixinwan pill dissolution rate at 15 minutes can reach 90%, dripping pill dissolution rate in 40 minutes
Less than 70%, illustrate the dissolution rate of dixinwan pill apparently higher than dripping pill.
Brief description of the drawings
The comparison figure of two kinds of pill dissolution rates of dixinwan pill and dripping pill of Fig. 1 present invention, wherein upper curve are drop of the invention
Heart ball Dissolution profiles, lower curve are dripping pill Dissolution profiles.
Embodiment
Embodiment 1
Prescription:300 parts of root tuber of aromatic turmeric, 300 parts of cape jasmine, 75 parts of Moschus, 10 parts of borneol
By cape jasmine, root tuber of aromatic turmeric, coarse crushing respectively, volatile oil, Moschus soak extraction volatile oil are extracted, a variety of another devices of volatile oil are received
Collection mixing, the volatile oil of mixing and borneol mixed dissolution is standby, and the dregs of a decoction are standby；The dregs of a decoction are soaked 12 hours using ethanol, heating
Flowing back secondary, 2 hours every time, merge reflux extracting liquid, filtration, the dregs of a decoction are standby, decompression filtrate recycling ethanol, to without ethanol flavor,
Alcohol extracting thick paste is obtained, dregs of a decoction heating evaporation ethanol, making the dregs of a decoction, rear to decoct twice, 1 hour every time, collecting decoction was quiet without ethanol flavor
To put, filter, filtrate decompression is concentrated into thick paste, merges with alcohol extracting thick paste, be dried under reduced pressure, is ground into 120 mesh fine powders, obtains extract powder,
Low-substituted hydroxypropyl cellulose 7g is added, is well mixed, obtains mixed powder, it is standby：Weigh the volatile oil doubling dose of mixed dissolution
Macrogol 6000 is sufficiently stirred in 60~100 DEG C of water-baths, to bubble-free, completely melting, is subsequently placed in 49~60 DEG C of water-baths, will
The volatile oil of extraction mixing adds, and is sufficiently stirred, is melted completely to bubble-free, instills in the atoleine that temperature is 0~5 DEG C,
Dripping pelletization, produce dripping pill about 2000, diameter 3mm；Dripping pill surface liquid paraffin is wiped, is placed in coating pan, in coating pan
Temperature control is 50~60 DEG C, sprays 85% ethanol solution as wetting agent, is sprinkled into mixed powder, increases pill, to be mixed
Powder use finishes, diameter about 6mm, sprays Opadry solution, coating, produces product.
Embodiment 2
Prescription:300 parts of root tuber of aromatic turmeric, 300 parts of cape jasmine, 75 parts of Moschus, 10 parts of borneol
By cape jasmine, root tuber of aromatic turmeric, coarse crushing respectively, volatile oil, Moschus soak extraction volatile oil are extracted, a variety of another devices of volatile oil are received
Collection mixing, the volatile oil of mixing and borneol mixed dissolution is standby, and the dregs of a decoction are standby；The dregs of a decoction are soaked 12 hours using ethanol, heating
Flowing back secondary, 2 hours every time, merge reflux extracting liquid, filtration, the dregs of a decoction are standby, decompression filtrate recycling ethanol, to without ethanol flavor,
Alcohol extracting thick paste is obtained, dregs of a decoction heating evaporation ethanol, making the dregs of a decoction, rear to decoct twice, 1 hour every time, collecting decoction was quiet without ethanol flavor
To put, filter, filtrate decompression is concentrated into thick paste, merges with alcohol extracting thick paste, be dried under reduced pressure, is ground into 120 mesh fine powders, obtains extract powder,
Sodium carboxymethyl starch 7g is added, is well mixed, obtains mixed powder, it is standby：Weigh the poly- second two of 5.0 times of amounts of volatile oil of mixed dissolution
Alcohol 6000 is sufficiently stirred in 60~100 DEG C of water-baths, to bubble-free, completely melting, is subsequently placed in 49~60 DEG C of water-baths, and extraction is mixed
The volatile oil of conjunction adds, and is sufficiently stirred, is melted completely to bubble-free, instills in the atoleine that temperature is 0~5 DEG C, uses diformazan
Base silicone oil collects dripping pill, produces dripping pill, diameter 4mm；Dripping pill dimethicone is wiped, is placed in coating pan, is coated kettle temperature
Control for 50~60 DEG C, spray 3% Eudragit E solution, as wetting agent, be sprinkled into mixed powder, increase pill
Greatly, powder use to be mixed finishes, diameter about 6mm, sprays 3% Eudragit E solution, coating, produces product.
Embodiment 3
Prescription:300 parts of root tuber of aromatic turmeric, 300 parts of cape jasmine, 75 parts of Moschus, 10 parts of borneol
By cape jasmine, root tuber of aromatic turmeric, coarse crushing respectively, volatile oil, Moschus soak extraction volatile oil are extracted, a variety of another devices of volatile oil are received
Collection mixing, the volatile oil of mixing and borneol mixed dissolution is standby, and the dregs of a decoction are standby；The dregs of a decoction are soaked 12 hours using ethanol, heating
Flowing back secondary, 2 hours every time, merge reflux extracting liquid, filtration, the dregs of a decoction are standby, decompression filtrate recycling ethanol, to without ethanol flavor,
Alcohol extracting thick paste is obtained, dregs of a decoction heating evaporation ethanol, making the dregs of a decoction, rear to decoct twice, 1 hour every time, collecting decoction was quiet without ethanol flavor
To put, filter, filtrate decompression is concentrated into thick paste, merges with alcohol extracting thick paste, be dried under reduced pressure, is ground into 120 mesh fine powders, obtains extract powder,
Carboxymethyl cellulose sodium 7g is added, is well mixed, obtains mixed powder, it is standby：Weigh the poly- second two of 5.0 times of amounts of volatile oil of mixed dissolution
Alcohol 6000 is sufficiently stirred in 60~100 DEG C of water-baths, to bubble-free, completely melting, is subsequently placed in 49~60 DEG C of water-baths, and extraction is mixed
The volatile oil of conjunction adds, and is sufficiently stirred, is melted completely to bubble-free, instills in the atoleine that temperature is 0~5 DEG C, uses diformazan
Base silicone oil collects dripping pill, produces dripping pill, diameter 4mm；Dripping pill dimethicone is wiped, is placed in coating pan, is coated kettle temperature
Control as 50~60 DEG C, spray ethanol, increase pill, powder use to be mixed finishes, diameter about 6mm, sprays 3% stomach dissolution type
Acrylic resin soln, coating, produces product.
Claims (2)
1. a kind of Chinese medicine composite dripping core pills, it is prepared by the Chinese medicine material medicine of following weight proportion：
300 parts of root tuber of aromatic turmeric, 300 parts of cape jasmine, 75 parts of Moschus, 10 parts of borneol, cape jasmine, root tuber of aromatic turmeric are distinguished into coarse crushing, extract volatile oil, musk deer
Fragrant soak extraction volatile oil, a variety of another devices of volatile oil collect mixing, and the volatile oil of mixing and borneol mixed dissolution is standby, by Cape jasmine
The dregs of a decoction after son, root tuber of aromatic turmeric, Moschus extraction volatile oil are standby；The dregs of a decoction are soaked 12 hours using ethanol, be heated to reflux it is secondary, every time 2
Hour, merge reflux extracting liquid, filtration, decompression filtrate recycling ethanol, to without ethanol flavor, obtain alcohol extracting thick paste, dregs of a decoction heating evaporation
Ethanol, making the dregs of a decoction, decocting is boiled twice without ethanol flavor, 1 hour every time, collecting decoction, is stood, and filtration, filtrate decompression is concentrated into thick
Cream, merge with alcohol extracting thick paste, be dried under reduced pressure, be ground into 120 mesh fine powders, obtain extract powder, add low-substituted hydroxypropyl cellulose, add
Enter the 7% of the mixed powder gross weight that amount is mixed to get for extract powder and low-substituted hydroxypropyl cellulose, be well mixed, obtain mixed powder,
It is standby；The Macrogol 6000 for weighing the volatile oil doubling dose of mixed dissolution is sufficiently stirred in 60~100 DEG C of water-baths, to without gas
Bubble, completely melting, are subsequently placed in 49~60 DEG C of water-baths, and the volatile oil for extracting mixing is added, is sufficiently stirred, complete to bubble-free
Melting, instill in the atoleine that temperature is 0~5 DEG C, dripping pelletization, produce dripping pill, diameter 3mm；Wipe dripping pill surface liquid
Paraffin, it is placed in coating pan, temperature control is 50~60 DEG C in coating pan, sprays 85% ethanol solution as wetting agent, is sprinkled into
Mixed powder, increase pill, powder use to be mixed finishes, diameter about 6mm, sprays Opadry solution, coating, produces product.
2. the preparation method of the preparation described in claim 1, comprises the following steps：
300 parts of root tuber of aromatic turmeric, 300 parts of cape jasmine, 75 parts of Moschus, 10 parts of borneol, cape jasmine, root tuber of aromatic turmeric are distinguished into coarse crushing, extract volatile oil, musk deer
Fragrant soak extraction volatile oil, a variety of another devices of volatile oil collect mixing, and the volatile oil of mixing and borneol mixed dissolution is standby, by Cape jasmine
The dregs of a decoction after son, root tuber of aromatic turmeric, Moschus extraction volatile oil are standby；The dregs of a decoction are soaked 12 hours using ethanol, be heated to reflux it is secondary, every time 2
Hour, merge reflux extracting liquid, filtration, decompression filtrate recycling ethanol, to without ethanol flavor, obtain alcohol extracting thick paste, dregs of a decoction heating evaporation
Ethanol, making the dregs of a decoction, decocting is boiled twice without ethanol flavor, 1 hour every time, collecting decoction, is stood, and filtration, filtrate decompression is concentrated into thick
Cream, merge with alcohol extracting thick paste, be dried under reduced pressure, be ground into 120 mesh fine powders, obtain extract powder, add low-substituted hydroxypropyl cellulose, add
Enter the 7% of the mixed powder gross weight that amount is mixed to get for extract powder and low-substituted hydroxypropyl cellulose, be well mixed, obtain mixed powder,
It is standby；The Macrogol 6000 for weighing the volatile oil doubling dose of mixed dissolution is sufficiently stirred in 60~100 DEG C of water-baths, to without gas
Bubble, completely melting, are subsequently placed in 49~60 DEG C of water-baths, and the volatile oil for extracting mixing is added, is sufficiently stirred, complete to bubble-free
Melting, instill in the atoleine that temperature is 0~5 DEG C, dripping pelletization, produce dripping pill, diameter 3mm；Wipe dripping pill surface liquid
Paraffin, it is placed in coating pan, temperature control is 50~60 DEG C in coating pan, sprays 85% ethanol solution as wetting agent, is sprinkled into
Mixed powder, increase pill, powder use to be mixed finishes, diameter about 6mm, sprays Opadry solution, coating, produces product.
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| CN110777005A (en) * | 2019-11-08 | 2020-02-11 | 湖北中烟工业有限责任公司 | Preparation method of citrus essential oil dropping pill |
| CN113069473B (en) * | 2021-04-24 | 2023-08-11 | 无锡济煜山禾药业股份有限公司 | Plaster prepared from medicinal residues for refreshment |
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| CP03 | Change of name, title or address |
Address after: 214028 Changjiang South Road, new Wu District, Wuxi, Jiangsu Province, No. 12 Patentee after: Wuxi Jiyu Shanhe Pharmaceutical Co., Ltd Address before: 214028 No. 12 Changjiang South Road, New District, Jiangsu, Wuxi Patentee before: WUXI JIMIN KEXIN SHANHE PHARMACEUTICAL Co.,Ltd. |