CN109044982A - A kind of nauclea officinalis medicinal extract sustained release tablets and preparation method thereof - Google Patents
A kind of nauclea officinalis medicinal extract sustained release tablets and preparation method thereof Download PDFInfo
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- CN109044982A CN109044982A CN201810992923.8A CN201810992923A CN109044982A CN 109044982 A CN109044982 A CN 109044982A CN 201810992923 A CN201810992923 A CN 201810992923A CN 109044982 A CN109044982 A CN 109044982A
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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)
- A61K36/74—Rubiaceae (Madder family)
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- 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, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
The present invention relates to a kind of nauclea officinalis medicinal extract sustained release tablets, including Lignum et Radix Naucleae extract, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate and lubricant.Though the drug containing nauclea officinalis for the treatment of pharyngolaryngitis is more at present, but therapeutic effect is only played, lack the slow control dosage form of long-acting Chinese medicine, the present invention provides a kind of nauclea officinalis medicinal extract sustained release tablets, it is compared with corresponding ordinary preparation, administration frequency reduces half or administration frequency than ordinary preparation and is reduced than ordinary preparation, and can dramatically increase the preparation of the compliance of patient, can dramatically increase the compliance of patient.
Description
Technical field
The present invention relates to field of traditional Chinese medicine preparations, and in particular to a kind of nauclea officinalis medicinal extract sustained release tablets and preparation method thereof.
Background technique
Nauclea officinalis also known as mountain bear gall, bear gall tree, ebony, medicine ebony are madder wort Nauclea magaphanerophytes, are born in height
Mountain is closely pushed up or half way up the mountain covers in the shaw of sough, distribution Guangdong (the western and west and south), Guangxi and Hainan etc..Nauclea officinalis
Mainly contain alkaloids and glycoalkaloids in stem, is branch, the bark of herborization nauclea officinalis as medicinal material, is split into irregular more
Piece, block, color are light yellow or brown color, and crust brown color is coarse, more loose, Yi Suli, cross section skin zone sepia, wood
Portion's yellow or brown color, matter is hard, smell slight bitter, is preferred with color cadmium yellow, bitter person.Nauclea officinalis bitter cold in nature, have it is clearing heat and detoxicating,
The effect of swelling and pain relieving, is usually used in cold, fever, abscess of throat, acute tonsillitis, sphagitis, bronchitis, pneumonia, uropoiesis
The treatment of the illnesss such as system infections, enteritis, dysentery, cholecystitis.Nauclea officinalis is recorded in version " Chinese Pharmacopoeia " in 1977, at present for the first time
There are the Chinese materia medica preparations such as nauclea officinalis injection, nauclea officinalis medicinal extract piece and nauclea officinalis medicinal extract syrup, is clinically used for acute tonsillitis, acute sore throat
The diseases such as inflammation, acute conjunctivitis and the infection of the upper respiratory tract.
Sphagitis, abscess of throat, hoarseness are pharynx first when being human upper airway impression dye common disease, generally flu
Larynx swelling and pain, as long as can play the elimination to source by throat symptom eliminates, will prevent the infection of the upper respiratory tract from developing to entirely
Body symptom.Therefore, prophylactic treatment throat symptom is most important to the treatment of respiratory infection diseases.But throat is treated at present
Though the drug of disease is more, only play the role of emergence therapeutic, lacks the slow control dosage form of long-acting Chinese medicine, so-called sustained release preparation
Refer to that slowly frequency is administered compared with corresponding ordinary preparation in non-constant velocity release drug as required in regulation dissolution medium
Rate reduces half or administration frequency than ordinary preparation and is reduced than ordinary preparation, and can dramatically increase the system of the compliance of patient
Agent, and controlled release preparation is on the basis of sustained release preparation, blood concentration can dramatically increase complying with for patient compared with more steady
The preparation of property.
Summary of the invention
In view of the technical problem present on, present invention is primarily aimed at solve defect in the prior art, the present invention
A kind of nauclea officinalis medicinal extract sustained release tablets are provided, for the slow control dosage form of long-acting Chinese medicine, efficiently solve the above problem.
The present invention provides a kind of nauclea officinalis medicinal extract sustained release tablets, including Lignum et Radix Naucleae extract, hydroxypropyl methyl cellulose, polyethylene pyrrole
Pyrrolidone, microcrystalline cellulose, magnesium stearate, lubricant.
Further, lubricant is magnesium stearate.
Further, lubricant is talcum powder.
Further, lubricant is the mixture of magnesium stearate and talcum powder.
Further, each ingredient of nauclea officinalis medicinal extract sustained release tablets is respectively as follows: Lignum et Radix Naucleae extract 120-140 by its weight ratio share
Part, 60-100 parts of hydroxypropyl methyl cellulose, 8-12 parts of polyvinylpyrrolidone, 60-80 parts of microcrystalline cellulose, magnesium stearate 6-
8 parts, 0.1-1 parts of lubricant.
Further, each ingredient of nauclea officinalis medicinal extract sustained release tablets is respectively as follows: 130 parts of Lignum et Radix Naucleae extract, hydroxyl by its weight ratio share
80 parts of propyl methocel, 10 parts of polyvinylpyrrolidone, 70 parts of microcrystalline cellulose, 7 parts of magnesium stearate, 0.5 part of lubricant.
Further, the content of above-mentioned Lignum et Radix Naucleae extract is equal to the content of 200 times of nauclea officinalis.
The present invention also provides a kind of production method of nauclea officinalis medicinal extract sustained release tablets, making step is as follows:
S1: weighing and decoct, weigh Lignum et Radix Naucleae extract, and purified water is added twice and decocts；
S2: decoction liquor is filtered, is spray-dried after concentration by filtering and concentrating, spray drying, is obtained and is extracted extract powder；
S3: mixing granulation weighs hydroxypropyl methyl cellulose, polyvinylpyrrolidone, microcrystalline cellulose, and is crushed, mistake
Sieve is uniformly mixed granulation, obtains blank capsule core, blank capsule core is mixed with extraction extract powder and magnesium stearate, after mixing
Then granulation is added lubricant and carries out tabletting.
The purified water of the quality of 4-6 times of Lignum et Radix Naucleae extract is added in S1 in one preferred scheme for the first time, decocts 1-
2h, the purified water of the quality of 3-5 times of Lignum et Radix Naucleae extract of second of addition, decocts 1-2h.
One preferred scheme is concentrated after decoction liquor filtering in S2, using water as reference density, is concentrated into relatively close
Spend 1.05-1.25.
It is an object of that present invention to provide a kind of nauclea officinalis medicinal extract sustained release tablets and preparation method thereof, reasonable recipe science, preparation
It is easy, is quick to suitable disease, comparing efficient height with ordinary preparation, treating both manifestation and root cause of disease, cure feature uneasy to recur, the present invention mentions
The nauclea officinalis medicinal extract sustained release tablets of confession it is in good taste it is non-stimulated to mucous membrane, have no toxic side effect, be at low cost, for preventing and treating upper respiratory tract acute and chronic
Inflammation, and use is safe, without toxic side effect.Compared with ordinary preparation, administration number of times is reduced, and blood concentration is more steady.
In addition, developing this dosage form of nauclea officinalis medicinal extract sustained release tablets invention applies slow release method.With conventional tablet and
Capsule is compared, and there is sustained release preparation stabilization drug concentration, validity height, the stomach that administration is secondary less, is able to maintain in vivo to pierce
Swash the features such as small.The research of sustained release preparation is conducive to improve the curative effect of Chinese medicine, reduces adverse reaction, changes Chinese medicine conventional dosage forms
The feature that (piece or capsule) falls behind.
Nauclea officinalis medicinal extract sustained release tablets of the invention are with hydroxypropyl methyl cellulose on the square Process ba- sis of nauclea officinalis medicinal extract piece
Basic framework material prepares nauclea officinalis medicinal extract sustained release tablets with microcrystalline cellulose and for polyvinylpyrrolidone diluent, and use is orthogonal
Design optimization goes out best preparation prescription, and by stability, development technology is stablized, the nauclea officinalis medicinal extract sustained release tablets of reliable in quality.
The advantages of nauclea officinalis medicinal extract sustained release tablets compare nauclea officinalis medicinal extract piece/capsule, not only reduce administration number of times, takes convenient for patient
With, and extending action time, sustained release tablets slow release in vivo, internal blood concentration is more more stable, reduces to human intestines and stomach
The stimulation that road generates, clinical application are with the obvious advantage.
Specific embodiment
The following is a clear and complete description of the technical scheme in the embodiments of the invention.It illustrates in the following description
Many details to facilitate a thorough understanding of the present invention, still the present invention can also using other than the one described here its
Its mode is implemented, and those skilled in the art can do similar popularization, therefore this hair without violating the connotation of the present invention
It is bright to be not limited by the specific embodiments disclosed below.
Embodiment 1:
The nauclea officinalis medicinal extract sustained release tablets of the present embodiment, including Lignum et Radix Naucleae extract, hydroxypropyl methyl cellulose, polyvinylpyrrolidone,
Microcrystalline cellulose, magnesium stearate and lubricant.
The chemical component of nauclea officinalis is concentrated mainly on nauclea officinalis stem, mainly contains alkaloids and Glycoalkaloids, gallbladder in nauclea officinalis stem
The content of the wooden extract is equal to the content of 200 times of nauclea officinalis, i.e., 1 part of the Lignum et Radix Naucleae extract of the invention mentioned is the gallbladder from 200 parts
It is extracted in wood.
Hydroxypropyl methyl cellulose is a kind of rate controlling polymers material of sustained release preparation, safe and non-toxic as stabilizer,
It can make food additives.
Polyvinylpyrrolidone of the present invention is the polyvinylpyrrolidone of pharmaceutical grade, is used as tablet, granule
Binder.
Microcrystalline cellulose is used as diluent and adhesive in oral tablet, has certain lubrication and disintegration to make in tablets
With.
Embodiment 2:
Nauclea officinalis medicinal extract sustained release tablets provided in this embodiment, each ingredient are respectively as follows: Lignum et Radix Naucleae extract 120-140 by its weight ratio share
Part, 60-100 parts of hydroxypropyl methyl cellulose, 8-12 parts of polyvinylpyrrolidone, 60-80 parts of microcrystalline cellulose, magnesium stearate 6-
8 parts, 0.1-1 parts of lubricant, preferable each ingredient press its weight ratio share are as follows: 130 parts of Lignum et Radix Naucleae extract, hydroxypropyl methyl fiber
Plain 80 parts, 10 parts of polyvinylpyrrolidone, 70 parts of microcrystalline cellulose, 7 parts of magnesium stearate, 0.5 part of lubricant.Wherein, nauclea officinalis mentions
The content of object is taken to be equal to the content of 200 times of nauclea officinalis, i.e., the content of effective component, is equal to from 200 parts in a Lignum et Radix Naucleae extract
The effective component extracted in nauclea officinalis.
Embodiment 3:
The present invention provides a kind of production method of nauclea officinalis medicinal extract sustained release tablets, specific steps are as follows:
S1: weighing and decoct, weigh Lignum et Radix Naucleae extract, and purified water is added twice and decocts, 4-6 times of Lignum et Radix Naucleae extract is added for the first time
The purified water of quality, decocts 1-2h, and the purified water of the quality of 3-5 times of Lignum et Radix Naucleae extract of second of addition decocts 1-2h；Compared to
The process that a purified water decocts only is added to be divided into and decocting twice at the same time under conditions of section and equivalent purified water
To liquid in Lignum et Radix Naucleae extract content it is higher, show according to testing result, this method can be improved 3% to 5% gallbladder
The wooden extractive content.
S2: filtering and concentrating, spray drying are concentrated after filtering decoction liquor, using water as reference density, are concentrated into phase
It to density 1.05-1.25, is spray-dried later, obtains and extract extract powder；
S3: mixing granulation weighs hydroxypropyl methyl cellulose, polyvinylpyrrolidone, microcrystalline cellulose, and is crushed, mistake
Sieve is uniformly mixed granulation, obtains blank capsule core, and blank capsule core is mixed with extraction extract powder and magnesium stearate, is uniformly mixed
After pelletize, then be added lubricant carry out tabletting, be finally made nauclea officinalis medicinal extract sustained release tablets.
Lignum et Radix Naucleae extract medicinal extract sustained release tablets of the invention can in 4-12 hours sustained release, with stable dissolution speed
Rate and delivery period.The present invention, which has, to be dissolved out, is easy to use, and blood concentration is stablized, and long action time improves patient
Compliance, and preparation process is simple, cost is relatively low, easy to industrialized production.
Obviously, described embodiment is only a part of the embodiments of the present invention, instead of all the embodiments.It is based on
Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other
Embodiment shall fall within the protection scope of the present invention.
Claims (10)
1. a kind of nauclea officinalis medicinal extract sustained release tablets, it is characterised in that including Lignum et Radix Naucleae extract, hydroxypropyl methyl cellulose, polyvinyl pyrrole
Alkanone, microcrystalline cellulose, magnesium stearate and lubricant.
2. nauclea officinalis medicinal extract sustained release tablets according to claim 1, which is characterized in that the lubricant is magnesium stearate.
3. nauclea officinalis medicinal extract sustained release tablets according to claim 1, which is characterized in that the lubricant is talcum powder.
4. nauclea officinalis medicinal extract sustained release tablets according to claim 1, which is characterized in that the lubricant is magnesium stearate and cunning
The mixture of mountain flour.
5. nauclea officinalis medicinal extract sustained release tablets according to claim 1, which is characterized in that each ingredient is distinguished by its weight ratio share
Are as follows: 120-140 parts of Lignum et Radix Naucleae extract, 60-100 parts of hydroxypropyl methyl cellulose, 8-12 parts of polyvinylpyrrolidone, microcrystalline cellulose
60-80 parts plain, 6-8 parts of magnesium stearate, 0.1-1 parts of lubricant.
6. nauclea officinalis medicinal extract sustained release tablets according to claim 1, which is characterized in that each ingredient presses its weight ratio share are as follows: gallbladder
130 parts of the wooden extract, 80 parts of hydroxypropyl methyl cellulose, 10 parts of polyvinylpyrrolidone, 70 parts of microcrystalline cellulose, magnesium stearate
7 parts, 0.5 part of lubricant.
7. nauclea officinalis medicinal extract sustained release tablets described in any one of -6 according to claim 1, which is characterized in that the nauclea officinalis is extracted
The content of object is equal to the content of 200 times of nauclea officinalis.
8. a kind of production method of nauclea officinalis medicinal extract sustained release tablets, characterized by comprising:
S1: weighing Lignum et Radix Naucleae extract, and purified water is successively added twice and decocts；
S2: decoction liquor is filtered, and is spray-dried after concentration, is obtained and is extracted extract powder；
S3: the step of executing mixing granulation, specifically: weigh hydroxypropyl methyl cellulose, polyvinylpyrrolidone, microcrystalline cellulose
Element, and crushed, it is sieved, pelletizes after mixing, obtain blank capsule core, by blank capsule core and extract extract powder and tristearin
Sour magnesium mixing, pelletizes after mixing, and lubricant is then added and carries out tabletting.
9. a kind of production method of nauclea officinalis medicinal extract sustained release tablets according to claim 8, which is characterized in that in the S1
The purified water of the quality of 4-6 times of Lignum et Radix Naucleae extract is once added, decocts 1h-2h, 3-5 times of Lignum et Radix Naucleae extract of second of addition
Quality purified water, decoct 1h-2h.
10. a kind of production method of nauclea officinalis medicinal extract sustained release tablets according to claim 8, which is characterized in that in the S2,
It is concentrated after decoction liquor filtering, using water as reference density, is concentrated into relative density 1.05-1.25.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110974877A (en) * | 2019-12-31 | 2020-04-10 | 海南森祺制药有限公司 | Nauclea officinalis extract particles and preparation method thereof |
| CN111000914A (en) * | 2019-12-31 | 2020-04-14 | 海南森祺制药有限公司 | Nauclea officinalis extract sustained-release capsule and preparation method thereof |
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| CN101185692A (en) * | 2006-11-15 | 2008-05-28 | 江苏中康药物科技有限公司 | Nauclea officinalis extract and preparation and use thereof |
| CN106692093A (en) * | 2015-08-06 | 2017-05-24 | 重庆药友制药有限责任公司 | Metroprolol succinate sustained-release tablets and preparation method thereof |
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2018
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| CN1562238A (en) * | 2004-03-30 | 2005-01-12 | 一笑堂（湖南）制药有限公司 | Dispersion tablet of fathead tree and preparation method |
| CN101185692A (en) * | 2006-11-15 | 2008-05-28 | 江苏中康药物科技有限公司 | Nauclea officinalis extract and preparation and use thereof |
| CN106692093A (en) * | 2015-08-06 | 2017-05-24 | 重庆药友制药有限责任公司 | Metroprolol succinate sustained-release tablets and preparation method thereof |
| CN107998256A (en) * | 2017-12-29 | 2018-05-08 | 广西万德药业有限公司 | Treat sustained release tablets of gastritis and preparation method thereof |
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| 海南人民医院药局: "《药物制剂手册》", 30 September 1974 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110974877A (en) * | 2019-12-31 | 2020-04-10 | 海南森祺制药有限公司 | Nauclea officinalis extract particles and preparation method thereof |
| CN111000914A (en) * | 2019-12-31 | 2020-04-14 | 海南森祺制药有限公司 | Nauclea officinalis extract sustained-release capsule and preparation method thereof |
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Application publication date: 20181221 |