CN1709401A - Chinese medicine slow-release formulation containing asiatic pennywort herb water-soluble active ingredient, and its preparing method - Google Patents
Chinese medicine slow-release formulation containing asiatic pennywort herb water-soluble active ingredient, and its preparing method Download PDFInfo
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- CN1709401A CN1709401A CN 200510050001 CN200510050001A CN1709401A CN 1709401 A CN1709401 A CN 1709401A CN 200510050001 CN200510050001 CN 200510050001 CN 200510050001 A CN200510050001 A CN 200510050001A CN 1709401 A CN1709401 A CN 1709401A
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- herba centellae
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- total glycosides
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Abstract
The invention relates to a Chinese medicine slow-release preparation containing centella water-solutable effective component, which is prepared by using solid medicine, skeleton type auxiliary material and other excipient to be pressed. The said Chinese medicine is centella total glycoside of water-solutable extract in which the content of the total glycoside is not less than 60%. The total glycoside contains hydroxyl centella glycoside and hydroxyl centella. The skeleton auxiliary material is hydoxyprogyl cellulose, the amount of which can regulate the release rate.
Description
Technical field
The invention belongs to Chinese medicine slow releasing preparation technical field, especially for treatment wound, operation wound, burn, keloid and the Fibrotic Chinese medicine slow releasing preparation that contains asiatic pennywort herb water-soluble active ingredient (Herba Centellae total glycosides) of scleroderma, antidepressant and treatment Liver and kidney and preparation method thereof.
Background technology
1847 German pharmacist More (Mohr) " medicament technology " appearance declaration pharmaceutics become an independently subject; The sixties in 20th century, people begin to turn to modern medicinal agents from the common drug preparation to the research of pharmaceutics, wherein (drug delivery systems is the important research content and the developing direction of modern medicinal agents DDS), comprising the speed controlled-release administrating system to drug delivery system.Hydrogel matrix type preparation is the representative of speed controlled-release administrating system.
Hydrogel matrix type slow releasing tablet is with after aqueous medium contacts by hydrophilic skeleton adjuvant such as hydroxypropyl emthylcellulose (HPMC) etc., produce the gel layer of comparatively robust in dosage surface, controlling the release of medicine by this gel layer, and guaranteeing that label inside is not subjected to the influence of aqueous medium and disintegrate takes place.As time goes on, outer gel layer constantly dissolves, and inside forms glue-line again, dissolves until label and dissolves fully.The release of matrix sustained release tablet Chinese medicine needs through the gel layer diffusion, and therefore, the consumption by regulating hydrophilic skeleton adjuvant etc. reaches the purpose of control drug release.
Such sustained-release tablets release speed shows as first quick and back slow, and the medicine stripping of oral back tablet surface compares comparatively fast, can make blood drug level arrive treatment level, then slowly discharges to be used to keep treatment, does not need to add in addition the rapid release part.
To the research of Chinese medicine slow releasing tablet, bibliographical information fewer, and also in the majority with Chinese medicine monomer, as ligustrazine phosphoric acid sustained-release sheet etc.Chinese medicine only carries out sustained release to the Chinese medicine monomer after purifying and can't embody the Chinese medicinal components complex features owing to forms more complicated.
Herba Centellae total glycosides has the wound healing of promotion effect, and the asiaticoside sheet of approved listing at present is a conventional tablet, is mainly used in treatment wound, operation wound, burn, keloid and scleroderma.In addition, still have antidepressant and the Fibrotic effect of treatment Liver and kidney.Because the half-life of Herba Centellae total glycosides is shorter, therefore, the conventional tablet that has gone on the market needed take in one day 3 times, each 2-4 sheet, this makes troubles for taking medicine of patient, and the easier fluctuation that causes blood drug level of multiple dosing, cause " peak valley " phenomenon, thereby cause the increase of toxic and side effects.
Summary of the invention
The objective of the invention is to control the rate of release of each active component in the Chinese medicine, this can be avoided or reduce appearance " peak valley " phenomenon in the administration process.The present invention is the slow releasing preparation that skeleton prepares the Chinese medicine Herba Centellae total glycosides by modern preparation technique with the hydrophilicity condiment hydroxypropyl emthylcellulose, reaches the purpose that each component drug of control discharges.Compare with the common tablet of asiaticoside, reach and significantly delay drug release, reduce medicining times, steady blood drug level, the safety that improves medicine reduces the caused side reaction of ordinary tablet, makes things convenient for the patient to use.
The present invention is a goal in research with the effective ingredient in Chinese, and selecting water miscible Herba Centellae total glycosides for use is model drug.Herba Centellae total glycosides is the water solublity effective site of the dry herb of samphire Herba Centellae (Centella asiatica L.), mainly contain asiaticoside, asiaticoside etc., by national drug standards regulation, by dry product, Herba Centellae total glycosides should be not less than 60% (WS3-B-2596-97-2002).
The invention belongs to Chinese medicine slow releasing preparation field, especially for Chinese medicine slow releasing preparation that contains asiatic pennywort herb water-soluble active ingredient (Herba Centellae total glycosides) for the treatment of wound, operation wound, burn, keloid and scleroderma, antidepressant and the effect of treatment Liver and kidney fibrosis and preparation method thereof.This slow releasing preparation is a kind of tablet that is pressed into solid drugs and matrix type adjuvant, other solid excipient etc.Solid drugs refers to the water solublity effective site Herba Centellae total glycosides of Chinese medicine Herba Centellae, mainly contain compositions such as asiaticoside and hydroxyl Herba Centellae in the total glycosides, content is for being not less than 60%, the Chinese medicine slow releasing tablet matrix type adjuvant that indication contains the Herba Centellae total glycosides of water solublity mainly refers to hydroxypropyl emthylcellulose, its range of viscosities is 3000～120000cP, and other solid excipient mainly refers to microcrystalline Cellulose, magnesium stearate and polyvidone alcoholic solution.
The present invention can control release rate of drugs by the consumption of regulating hydroxypropyl emthylcellulose and other adjuvant.
Each component composition of Chinese medicine slow releasing preparation of the present invention and consumption are as follows:
Herba Centellae extract (by Herba Centellae total glycosides) 18g
Polyvidone k30 alcoholic solution is an amount of
Magnesium stearate is an amount of
Make 1000
Contain the preparation method of the Chinese medicine slow releasing preparation of asiatic pennywort herb water-soluble active ingredient (Herba Centellae total glycosides), may further comprise the steps:
(1) it is an amount of to take by weighing the Herba Centellae extract of known Herba Centellae total glycosides content, pulverizes, and sieves dry using.
(2) take by weighing required skeleton shape adjuvant and other solid excipient, pulverize, sieve drying for standby.
(3) " (1) " and " (2) " is evenly mixed, add binding agent polyvidone alcoholic solution, wet granulation, granulate, the intermediate check, it is an amount of to add magnesium stearate, and adjustment sheet is heavy, tabletting, promptly.
Preparation technology's flow chart is seen Fig. 1
Characteristics of the present invention:
Because half-life of Herba Centellae total glycosides is shorter, prepare the slow releasing preparation of Chinese medicine Herba Centellae total glycosides by modern preparation technique, reach the rate of release of each active component in the control Chinese medicine, delay the release of active component, steadily blood drug level reduces medicining times, the purpose that makes things convenient for the patient to use.The present invention has certain positive effect to advancing the modernization of Chinese medicine.
Description of drawings
Fig. 1 is preparation technology's flow chart of preparation
The slow releasing tablet drug release percentage rate-time graph of Fig. 2 for preparing by embodiment 1
The slow releasing tablet drug release percentage rate-time graph of Fig. 3 for preparing by embodiment 2
The specific embodiment
Embodiment 1:
Take by weighing the Herba Centellae extract that contains Herba Centellae total glycosides 18g, hydroxypropyl emthylcellulose 30g, microcrystalline Cellulose 50g, pulverize separately mixes, and it is an amount of to add polyvidone k30 alcoholic solution, granulate, drying, granulate adds magnesium stearate, tabletting, promptly.
Release in vitro:
The vitro drug release studies of slow releasing tablet the results are shown in Figure 2: by this figure as seen, two the main component asiaticosides and the asiaticoside of Herba Centellae total glycosides can be kept slow release, in total glycosides, discharged about 28% on the 3rd hour, the cumulative release medicine about 50% in the 6th hour, the 9th hour is about 65%, and the 12nd hour is 85%.Release conditions is: pressing Chinese Pharmacopoeia two drug release determination methods of version (blue laws) in 2000, is dissolution medium with water, temperature: 37 ℃; Rotating speed: 100rpm.
Embodiment 2:
Take by weighing the Herba Centellae extract that contains Herba Centellae total glycosides 18g, hydroxypropyl emthylcellulose 225g, microcrystalline Cellulose 50g, pulverize separately mixes, and it is an amount of to add polyvidone k30 alcoholic solution, granulate, drying, granulate adds magnesium stearate g, tabletting, promptly.
The vitro drug release studies of slow releasing tablet the results are shown in Figure 3: by this figure as seen, two the main component asiaticosides and the asiaticoside of Herba Centellae total glycosides can be kept slow release, in total glycosides, discharged about 15% on the 3rd hour, the cumulative release medicine about 20% in the 5th hour, the 10th hour is about 38%, and the 12nd hour is 45%.Release conditions is: pressing Chinese Pharmacopoeia two drug release determination methods of version (blue laws) in 2000, is dissolution medium with water, temperature: 37 ℃; Rotating speed: 100rpm.
Claims (9)
1, a kind of Chinese medicine slow releasing preparation that contains asiatic pennywort herb water-soluble active ingredient (Herba Centellae total glycosides) is characterized in that the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides that is formed by compactings such as solid drugs, matrix type adjuvant, other solid excipient.
2, the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides according to claim 1 is characterized in that solid drugs is the water solubility extract Herba Centellae total glycosides of Chinese medicine Herba Centellae.
3, the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides according to claim 1 and 2 is characterized in that being made up of asiaticoside and hydroxyl Herba Centellae etc. in the total glycosides.
4, according to claim 1 or the 3 described Chinese medicine slow releasing preparation that contain the water solublity Herba Centellae total glycosides, the content that it is characterized in that compositions such as asiaticoside in the total glycosides and hydroxyl Herba Centellae is for being not less than 60%.
5, the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides according to claim 1 is characterized in that the matrix type adjuvant mainly refers to hydroxypropyl emthylcellulose.
6, the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides according to claim 5, the range of viscosities that it is characterized in that hydroxypropyl emthylcellulose is 3000～120000cP.
7, the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides according to claim 1 is characterized in that other solid excipient mainly refers to microcrystalline Cellulose, magnesium stearate and polyvidone alcoholic solution.
8, the Chinese medicine slow releasing preparation that contains the water solublity Herba Centellae total glycosides according to claim 1 is characterized in that the consumption of said each component of preparation is as follows:
Herba Centellae extract (by Herba Centellae total glycosides) 18g
Hydroxypropyl emthylcellulose 30～250g
Microcrystalline Cellulose 20～70g
Polyvidone k30 alcoholic solution is an amount of
Magnesium stearate is an amount of
Make 1000.
9, a kind of preparation contains the method for Chinese medicine slow releasing preparation of the Herba Centellae total glycosides of water solublity, may further comprise the steps:
(1) takes by weighing the Herba Centellae extract of known Herba Centellae total glycosides content, pulverize, sieve drying for standby;
(2) take by weighing required skeleton shape adjuvant and solid excipient, pulverize, sieve drying for standby;
(3) " (1) " and " (2) " is evenly mixed, add binding agent polyvidone k30 alcoholic solution, wet granulation, granulate, the intermediate check, it is an amount of to add magnesium stearate, and adjustment sheet is heavy, tabletting, promptly.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100500018A CN100441201C (en) | 2005-06-08 | 2005-06-08 | Chinese medicine slow-release formulation containing asiatic pennywort herb water-soluble active ingredient, and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100500018A CN100441201C (en) | 2005-06-08 | 2005-06-08 | Chinese medicine slow-release formulation containing asiatic pennywort herb water-soluble active ingredient, and its preparing method |
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| CN1709401A true CN1709401A (en) | 2005-12-21 |
| CN100441201C CN100441201C (en) | 2008-12-10 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008099426A1 (en) | 2007-02-12 | 2008-08-21 | Indus Biotech Private Limited | A composition for selective serotonin reuptake inhibition and process thereof |
| CN101049314B (en) * | 2006-04-03 | 2010-05-12 | 北京因科瑞斯生物制品研究所 | Dispersion tablet of asiaticoside and preparation method |
| CN102872198A (en) * | 2012-10-30 | 2013-01-16 | 陕西思尔生物科技有限公司 | Liver protection capsule and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528324A (en) * | 2003-10-08 | 2004-09-15 | 南昌弘益科技有限公司 | Herba centellae total aglycone drop pill and preparing method thereof |
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2005
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101049314B (en) * | 2006-04-03 | 2010-05-12 | 北京因科瑞斯生物制品研究所 | Dispersion tablet of asiaticoside and preparation method |
| WO2008099426A1 (en) | 2007-02-12 | 2008-08-21 | Indus Biotech Private Limited | A composition for selective serotonin reuptake inhibition and process thereof |
| JP2010530841A (en) * | 2007-02-12 | 2010-09-16 | インダス バイオテック プライベート リミテッド | Selective serotonin reuptake inhibiting composition and method |
| AU2008215743B2 (en) * | 2007-02-12 | 2010-10-07 | Indus Biotech Private Limited | A composition for selective serotonin reuptake inhibition and process thereof |
| CN102872198A (en) * | 2012-10-30 | 2013-01-16 | 陕西思尔生物科技有限公司 | Liver protection capsule and preparation method thereof |
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| CN100441201C (en) | 2008-12-10 |
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Granted publication date: 20081210 Termination date: 20120608 |