CN105943581A - Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof - Google Patents
Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof Download PDFInfo
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- CN105943581A CN105943581A CN201610401512.8A CN201610401512A CN105943581A CN 105943581 A CN105943581 A CN 105943581A CN 201610401512 A CN201610401512 A CN 201610401512A CN 105943581 A CN105943581 A CN 105943581A
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- slow releasing
- clearing away
- heat clearing
- eliminating stagnation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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Abstract
The invention provides sustained-release capsules capable of clearing heat and resolving lumps and a preparation method thereof, and belongs to the field of pharmaceutic preparations. The sustained-release capsules are prepared from, by mass, 61 parts of climbing groundsel herb extract and 39 parts of auxiliaries. The preparation method of the sustained-release capsules comprises the steps that the climbing groundsel herb extract and a corresponding proportion of framework material and filling agent are mixed to be uniform, an appropriate amount of ethanol solution with dissolved PVP and PEG is sprayed into the mixture, a soft material is prepared through a wet method, and 40-mesh granulating is conducted; vacuum degassing drying is conducted at 65 DEG C to 70 DEG C till the water content is smaller than 2%, and 30-mesh size stabilization is conducted; if a glidant is micropowder silica gel or magnesium stearate, the glidant is added after size stabilization is conducted, and mixing is conducted to be uniform; capsules of 0.5 g for each capsule are filled, and the sustained-release capsules are obtained. According to the sustained-release capsules capable of clearing the heat and resolving the lumps and the preparation method thereof, the dissolution speed of effective ingredients is effectively increased, and the in vitro release rate of medicinal ingredients is increased; the drug dosage and drug use frequency are reduced, and great convenience is brought to patients.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of heat clearing away eliminating stagnation slow releasing capsule and preparation method thereof.
Background technology
Reducing fever powder capsule is the Chinese patent medicine kind in State Food and Drug Administration's registration, for acute conjunctiva
Inflammation, acute pharyngolaryngitis, acute tonsillitis, acute enteritis, acute bacillary dysentery, inflammation of upper respiratory tract, acute bronchitis, lymph node
Inflammation, furuncle pain, otitis media, dermatitis and eczema.
Former reducing fever powder capsule preparation method for taking Herba Senecionis Scandentis 3000g, boiling secondary, each 2 hours, filter, close
And filtrate, be concentrated into relative density 1.18-1.19(25 DEG C) thick paste, add and be equivalent to the ethanol of thick paste 1 times amount, stand 12 little
Time make precipitation, filter, filtrate recycling ethanol, be concentrated into relative density and be 1.30(80 DEG C) thick paste, vacuum drying, be ground into thin
Powder, adds right amount of auxiliary materials, mixing, pelletizes, and is dried, makes 0.33g/ grain, obtain 757.Patent Application Publication " reducing fever powder capsule
Preparation technology " preparation method disclosed in (publication number CN1O1249126A) and national drug standards YBZ15862005-2011Z
Preparation method essentially identical, simply indicate that twice extraction water consumption is respectively 10 times and 8 times of quality of medicinal material.And specify that
Adjuvant only has starch, and consumption is 19g.
Slow releasing preparation can on demand within the scheduled period human body suitable blood drug level is provided, reduce and take number of times and can obtain
Obtain therapeutic effect well.Its important feature is to make human body maintain this kind of haemoconcentration to reach the longer time, and not as commonly
Preparation declines the most quickly, thus just can avoid " honeybee paddy " phenomenon that ordinary preparation frequent drug administration occurred (i.e. medicine
Haemoconcentration fluctuation is big), make Drug safety, effectiveness and adaptability increase.Because decreasing times for spraying, the most generous
The patient of patient, particularly long-term prescription.But Sustained Release Preparations of Chinese Medicinal is due to the complicated component of Chinese medicine extract, slow
Release formulation there is also difficulty in preparation.
Summary of the invention
It is an object of the invention to for defect described above, it is provided that lasting heat clearing away eliminating stagnation slow release glue is stablized in a kind of release
Capsule.
It is a further object of the present invention to provide the preparation method of a kind of heat clearing away eliminating stagnation slow releasing capsule.
It is an object of the invention to be achieved by the following technical programs.
A kind of heat clearing away eliminating stagnation slow releasing capsule, is made up of Herba Senecionis Scandentis extract and adjuvant, described Herba Senecionis Scandentis extract and adjuvant
Mass percent be Herba Senecionis Scandentis extract: adjuvant=61: 39.
A feature of the present invention is the improvement to former preparation reducing fever powder capsule formula, Herba Senecionis Scandentis in slow releasing agent capsule
The consumption of extract is identical with former preparation holding, say, that before and after remodeling, principal agent (Herba Senecionis Scandentis extract) of every preparation contains
Amount keeps constant, the kind of the only pharmaceutic adjuvant of change and consumption.
Prescription of the present invention is the gel-type framework material and 15.0% of the Herba Senecionis Scandentis extract by 61.0%, 15.0%～25.0%
～filler (the two is the 30% of prescription total amount), 3.0%～the porogen of 7.0% of 5.0% and 6.0～the fluidizer (two of 2.0%
Person is the 9.0% of prescription total amount) composition.
In the present invention further carries out scheme, through comparative test repeatedly, finally determine that its optimizing prescriptions mass ratio is
The Herba Senecionis Scandentis extract of 61.0%, the framework material of 20.0%, the filler of 10.0%, the porogen of 5.0% and the fluidizer of 4.0%
Composition.
In embodiments of the invention, described gel-type framework material is hydroxypropyl methyl cellulose (HPMC), carboxymethyl fibre
One of dimension element sodium (SCMC), ethyl cellulose (EC), cellulose acetate (CA), sodium alginate or their mixture.Described fill out
Filling agent is a kind of in dextrin, resistant starch, microcrystalline Cellulose, calcium carbonate or their mixture.Described porogen is poly-dimension
One in ketone (PVP), mannitol or sorbitol.Described fluidizer is in Polyethylene Glycol (PEG), micropowder silica gel or magnesium stearate
One.
In the present invention further embodiment, described framework material be preferably hydroxypropyl methyl cellulose or its with
The mixture of sodium carboxymethyl cellulose；The model of described hydroxypropyl methyl cellulose is preferably K4M, described sodium carboxymethyl cellulose
It it is version " Chinese Pharmacopoeia " standard in 2010；If described framework material hydroxypropyl methyl cellulose and carboxymethyl base cellulose is mixed
Compound, its mass ratio is 10:2～5；Described filler is preferably resistant starch；The preferred PVP-K30 of described porogen, described in help
Stream agent is preferably PEG 6000.
In the present invention, the preparation method of described Herba Senecionis Scandentis extract, by existing reducing fever powder capsule national drug mark
The method that quasi-YBZ15862005-2011Z specifies is carried out；Also can obtain from prior art, such as " heat clearing away dissipates Patent Application Publication
The preparation technology of gum deposit capsule " preparation method of Herba Senecionis Scandentis extract disclosed in (publication number CN1O1249126A), but be not intended to make
With other modern Chinese medicine method for preparing extractive preferably.
It is a further object to provide the preparation method of a kind of heat clearing away eliminating stagnation slow releasing capsule: Herba Senecionis Scandentis is extracted
After thing, the framework material of corresponding proportioning and filler mixing, spraying into the ethanol solution having dissolved PVP and PEG in right amount, wet method system is soft
Material, 40 mesh are pelletized；65 DEG C～70 DEG C decompression degassings are dried to moisture ＜ 2%, 30 mesh granulate;If fluidizer micropowder silica gel or hard
Fatty acid magnesium, adds after granulate, mixes；Fill into the capsule of 0.5g/ grain and get final product.
In the above-described embodiment, the wetting agent of described soft material processed can be 70%～90%(ethanol: water, V/V) ethanol, excellent
Elect 80% ethanol solution as.
The invention has the beneficial effects as follows: the present invention in the case of not changing its main active of reducing fever powder capsule,
By the efficient combination to adjuvant, make slow releasing capsule, show through vitro release comparative determination result, the same virgin rubber of slow releasing capsule
Capsule is compared, and improves the dissolution rate of effective ingredient, improves the vitro release of active ingredient.Relevant research shows slow release glue
Capsule Cumulated released percent in vitro and body absorption mark have extremely significantly dependency, show slow releasing capsule slow release effect in vivo
Fruit can be evaluated with Cumulated released percent in vitro.Heat clearing away eliminating stagnation slow releasing capsule has obvious slow releasing function, therefore can
The blood drug level that the holding of long period is higher in vivo, is effectively reduced the fluctuation of blood drug level and bad in clinical application
The generation of reaction, it is ensured that the safety of medication and effectiveness.Simultaneously slow releasing preparation can on demand within the scheduled period human body carry
For suitable blood drug level, can reduce and take number of times, maintain haemoconcentration to reach the longer time, and unlike ordinary preparation relatively
Decline soon, because decreasing dosage and times for spraying, greatly facilitate patient.The present invention selects suitable relevant auxiliary materials and work
Skill, changes system into slow releasing agent former preparation, and technique is simple, it is simple to the big application produced.
Detailed description of the invention
To illustrate below, the invention will be further described.It is pointed out that following description is only to want the present invention
Ask the citing of the technical scheme of protection, and be not any restriction to these technical schemes.Protection scope of the present invention is with power
The content that profit claim is recorded is as the criterion.
Embodiment 1.
1) prepared by Herba Senecionis Scandentis extract: use preparation method disclosed in Patent Application Publication CN1O1249126A to prepare a thousand li
Light extraction thing.Concrete grammar is as follows: take Herba Senecionis Scandentis 3000g, boiling secondary, adds 10 times amount water for the first time, and second time adds 8 times
Amount water, decocts 2 hours every time, filters, merging filtrate, records the thick paste that relative density is 1.18 1 1.19 when being concentrated into 25 DEG C,
Add the ethanol being equivalent to thick paste 1 times amount, stand and make precipitation 12 hours, filter, filtrate recycling ethanol, record when being concentrated into 80 DEG C
Relative density is the thick paste of 1.30, and 70 1 80 DEG C are dried, are ground into fine powder, standby.
2) formula: Herba Senecionis Scandentis extract 230.8g;
HPMC K4M 75.7g;
Resistant starch 37.9g;
PVP-K30 18.9g;
PEG 6000 15.2g。
3) slow releasing capsule preparation technology: take formula ratio Herba Senecionis Scandentis extract, HPMC K4M, resistance shallow lake
Powder mix homogeneously.Ethanol with appropriate 80% dissolves PVP-K30, PEG 6000 and sprays into ethanol solution wet method soft material, 40 mesh systems
Grain；65 DEG C～70 DEG C decompression degassings are dried to moisture ＜ 2%, 30 mesh granulate, fill, 0.5g/ grain, deserved heat clearing away eliminating stagnation slow release glue
757, capsule, obtains 727 in fact.
Embodiment 2.
1) prepared by Herba Senecionis Scandentis extract: with embodiment 1.
2) formula: Herba Senecionis Scandentis extract 1154.0 g;
HPMC K4M 291.0g;
Sodium carboxymethyl cellulose 87.5g；
Resistant starch 189.5g;
PVP-K30 57.0g;
PEG 6000 113.5g。
3) slow releasing capsule preparation technology: take formula ratio Herba Senecionis Scandentis extract, HPMC K4M, carboxymethyl cellulose
Element, resistant starch mix homogeneously.Ethanol solution wet method system is sprayed into soft with ethanol dissolving PVP-K30, PEG 6000 of appropriate 80%
Material, 40 mesh are pelletized；65 DEG C～70 DEG C decompression degassings are dried, moisture ＜ 2%, 30 mesh granulate, fill, 0.5g/ grain, deserved slow release glue
3768, capsule, obtains 3655 in fact.
Embodiment 3.
1) prepared by Herba Senecionis Scandentis extract: with embodiment 1.
2) formula: Herba Senecionis Scandentis extract 2308.0g;
HPMC K4M 632.0g;
Sodium carboxymethyl cellulose 315.0g
Resistant starch 189.0g;
PVP-K30 265.0g;
PEG 6000 76.0g。
3) slow releasing capsule preparation technology: take formula ratio Herba Senecionis Scandentis extract, HPMC K4M, carboxymethyl
Cellulose, resistant starch mix homogeneously.Ethanol with appropriate 80% dissolves PVP-K30, PEG6000 and sprays into ethanol solution wet method system
Soft material, 40 mesh are pelletized；65 DEG C～70 DEG C decompression degassings are dried to moisture ＜ 2%, 30 mesh granulate, fill, 0.5g/ grain, deserved slow release
Capsule 7570, obtains 7419 in fact.
Embodiment 4 capsule finished product rate and chlorogenic acid content.
Measuring according to national drug standards YBZ15862005-2011Z regulation, result is as follows:
Embodiment 5 reducing fever powder capsule and its slow releasing capsule vitro release comparative test.
Vitro release measures presses Chinese Pharmacopoeia version in 2010 two, annex XIX D. slow-release controlled-release preparation guideline
Carry out.Release medium for imitate human gastrointestinal tract environment (be 0.1mol/L hydrochloric acid before 2h, be the PBS of pH6.8 after 2h,
27.5 DEG C), the release of slow releasing capsule prepared by investigation virgin rubber capsule and each embodiment respectively.
Release investigates method: first passes through HPLC and measures the green former of slow releasing capsule prepared by virgin rubber capsule and each embodiment
Acid content, then place them in release medium, timing measures medium Content of Chlorogenic Acid, investigates release, result such as following table
Shown in.
Reducing fever powder capsule and three batches of heat clearing away eliminating stagnation slow releasing capsule chlorogenic acid Accumulation dissolution compare
Present invention merely illustrates some claimed specific embodiments, one of them or more technical side
Technical characteristic described in case can be combined with arbitrary one or more technical schemes, and these are combined and the skill that obtains
Art scheme is also in the application protection domain, and the technical scheme that obtain combined just as these is in the disclosure of invention
In concrete record as.
Claims (10)
1. a heat clearing away eliminating stagnation slow releasing capsule, is made up of Herba Senecionis Scandentis extract and adjuvant, it is characterised in that: described Herba Senecionis Scandentis extracts
The mass percent of thing and adjuvant is Herba Senecionis Scandentis extract: adjuvant=61: 39.
A kind of heat clearing away eliminating stagnation slow releasing capsule the most according to claim 1, it is characterised in that: in described prescription, Herba Senecionis Scandentis extracts
The mass percent of thing and adjuvant be the Herba Senecionis Scandentis extract by 61.0%, 15.0%～25.0% gel-type framework material with
The porogen of filler, 3.0%～7.0% of 15.0%～5.0% and 6.0～2.0% fluidizer make；Described gel-type skeleton
Material and both filleies are the 30% of prescription total amount, and described porogen and both fluidizer are the 9.0% of prescription total amount.
A kind of heat clearing away eliminating stagnation slow releasing capsule the most according to claim 1, it is characterised in that: in described prescription, Herba Senecionis Scandentis extracts
The mass percent of thing and adjuvant be 61.0% Herba Senecionis Scandentis extract, the framework material of 20.0%, the filler of 10.0%, 5.0%
Porogen and 4.0% fluidizer composition.
4. according to a kind of heat clearing away eliminating stagnation slow releasing capsule described in Claims 2 or 3, it is characterised in that: described gel-type skeleton material
Material is hydroxypropyl methyl cellulose (HPMC), sodium carboxymethyl cellulose (SCMC), ethyl cellulose (EC), cellulose acetate
(CA), one of sodium alginate or their mixture.
5. according to a kind of heat clearing away eliminating stagnation slow releasing capsule described in Claims 2 or 3, it is characterised in that: described filler be dextrin,
A kind of in resistant starch, microcrystalline Cellulose, calcium carbonate or their mixture.
6. according to a kind of heat clearing away eliminating stagnation slow releasing capsule described in Claims 2 or 3, it is characterised in that: described porogen is poly-dimension
One in ketone (PVP), mannitol or sorbitol.
7. according to a kind of heat clearing away eliminating stagnation slow releasing capsule described in Claims 2 or 3, it is characterised in that: described fluidizer is poly-second
One in glycol (PEG), micropowder silica gel or magnesium stearate.
8. according to a kind of heat clearing away eliminating stagnation slow releasing capsule described in Claims 2 or 3, it is characterised in that: described framework material is hydroxyl
Propyl methocel or its mixture with sodium carboxymethyl cellulose；The model of described hydroxypropyl methyl cellulose is K4M, institute
Stating sodium carboxymethyl cellulose is version " Chinese Pharmacopoeia " standard in 2010；If described framework material hydroxypropyl methyl cellulose and carboxylic
The mixture of methyl base cellulose, its mass ratio is 10:2～5；Described filler is resistant starch；Described porogen is PVP-
K30, described fluidizer is PEG 6000.
9. the preparation method of a heat clearing away eliminating stagnation slow releasing capsule, it is characterised in that prepared by following steps: Herba Senecionis Scandentis is extracted
After thing, the framework material of corresponding proportioning and filler mixing, spraying into the ethanol solution having dissolved PVP and PEG in right amount, wet method system is soft
Material, 40 mesh are pelletized；65 DEG C～70 DEG C decompression degassings are dried to moisture ＜ 2%, 30 mesh granulate;If fluidizer micropowder silica gel or hard
Fatty acid magnesium, adds after granulate, mixes；Fill into the capsule of 0.5g/ grain and get final product.
The preparation method of a kind of heat clearing away eliminating stagnation slow releasing capsule the most according to claim 9, it is characterised in that: described system is soft
The wetting agent of material is the ethanol of 70%～90%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610401512.8A CN105943581A (en) | 2016-06-10 | 2016-06-10 | Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610401512.8A CN105943581A (en) | 2016-06-10 | 2016-06-10 | Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof |
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| CN105943581A true CN105943581A (en) | 2016-09-21 |
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| CN201610401512.8A Pending CN105943581A (en) | 2016-06-10 | 2016-06-10 | Sustained-release capsules capable of clearing heat and resolving lumps and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101249126A (en) * | 2008-03-28 | 2008-08-27 | 湖南长沙宝鉴生物工程有限公司 | Preparation technique of reducing fever powder capsule |
-
2016
- 2016-06-10 CN CN201610401512.8A patent/CN105943581A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101249126A (en) * | 2008-03-28 | 2008-08-27 | 湖南长沙宝鉴生物工程有限公司 | Preparation technique of reducing fever powder capsule |
Non-Patent Citations (1)
| Title |
|---|
| 郭慧玲，等: "《药剂学》", 28 February 2014, 广州：中山大学出版社 * |
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Application publication date: 20160921 |