CN103479782A - Slow-release capsule and preparation method thereof - Google Patents
Slow-release capsule and preparation method thereof Download PDFInfo
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- CN103479782A CN103479782A CN201310388746.XA CN201310388746A CN103479782A CN 103479782 A CN103479782 A CN 103479782A CN 201310388746 A CN201310388746 A CN 201310388746A CN 103479782 A CN103479782 A CN 103479782A
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Abstract
The invention discloses a Kuntai slow-release capsule and a preparation method thereof; a pill core is formed by packaging traditional Chinese medicine extracts outside a small auxiliary material pill; a controlled-release layer composed of traditional Chinese medicine extracts and water insoluble polymers and used for controlling drug release is formed outside a drug layer, therefore, a small Kuntai slow-release pill is prepared; the small pill is filled in the capsule; the traditional Chinese medicine extracts are prepared by being super-critically extracted, frozen and dried. The content of drug active components in the slow-release capsule disclosed by the invention is high; in addition, drugs can be smoothly released in artificial gastric fluid and artificial intestinal fluid within 24 hours.
Description
Technical field
The invention belongs to pharmaceutical field, in particular to a kind of female safe slow releasing capsule and preparation method thereof.
Background technology
Kuntai capsule is by Radix Rehmanniae Preparata 600g, Rhizoma Coptidis 300g, Radix Paeoniae Alba 300g, Radix Scutellariae 300g, Colla Corii Asini 100g, Poria 100g, above Six-element, and Poria, Colla Corii Asini mixed powder are broken into fine powder; The decocting that Radix Scutellariae adds 100 ℃ of 5 times of amounts boils secondary, each 1.5 hours, filters merging filtrate; Three flavors such as all the other Radix Rehmanniae Preparata, after adding 5 times of water gaging soaked overnight, decoct secondary, each 1.5 hours, filters, filtrate and above-mentioned filtrate merge, and are concentrated into the about 1.10(70 ℃ of relative density) clear paste, spray drying, powder gets dry extract, mix with above-mentioned fine powder, incapsulate, make 1000, obtain.This product is capsule, and content is yellowish-brown or tan powder; Bitter in the mouth.Function cures mainly: nourishing YIN and clearing away heat, the relieving restlessness of calming the nerves.For all cards before and after menopause.The hyperactivity of fire caused by deficiency of YIN person, disease sees that hectic fever is flushing, spontaneous sweating, vexed not peaceful, insomnia and dreamful sleep, dizziness and tinnitus, soreness of the waist and knees, feverish sensation in the palms and soles; Women's ovary deterioration climacteric syndrome is shown in above-mentioned shower.
Summary of the invention
The purpose of this invention is to provide a kind of female safe slow releasing capsule; Further purpose of the present invention is to provide the production method of female safe slow releasing capsule.
In order to realize purpose of the present invention, intend adopting following technical scheme to be achieved:
One aspect of the present invention relates to a kind of female safe slow releasing capsule, it is characterized in that: with adjuvant piller outsourcing Chinese medicine extract, form the ball core, in the outer controlled release layer formed by Chinese medicine extract and enteric solubility polymers that coats of ball core, make female safe slow-release pill, described piller filling is in capsule, form female safe slow releasing capsule, by making 1000 calculating of slow releasing capsule, every mass of 1000 kernel 500-800g, piller is packed in capsulae vacuus, make female safe slow releasing capsule, the weight percent that the interior various components of capsule account for total charges is composed as follows:
In the ball core, each component accounts for the percentage by weight of total charges and is:
In controlled release layer, each component accounts for the percentage by weight of total charges and is:
Preferably, described antiblocking agent is Pulvis Talci; Further preferred, all components sum is 100%;
The raw material of Chinese medicine of the Radix Rehmanniae Preparata 500-700 that described Chinese medicine extract is following weight parts, Rhizoma Coptidis 200-400, Radix Paeoniae Alba 200-400, Radix Scutellariae 200-400, Colla Corii Asini 80-120, Poria 80-120, through supercritical extraction and through the lyophilization gained, preferably, described raw material of Chinese medicine formula is Radix Rehmanniae Preparata 600 weight portions, Rhizoma Coptidis 300 weight portions, the Radix Paeoniae Alba 300 weight portions, Radix Scutellariae 300 weight portions, Colla Corii Asini 100 weight portions, Poria 100 weight portions.
In a preferred embodiment of the present invention, the preparation method of described Chinese medicine extract comprises the steps: that the raw material of Chinese medicine mixed powder is broken into fine powder, insert in the supercritical extraction tank, with pressure 22Mpa, temperature is the condition extraction 3-4 hour that 35 ℃, flow are 21-25L/h, take pressure as 6Mpa, and temperature is 45 ℃ and is resolved, extract brown paste, through lyophilization, obtain Chinese medicine extract.
In a preferred embodiment of the present invention, it is characterized in that adopting nonpareils or microcrystalline Cellulose piller is the adjuvant piller for preparing the ball core, adjuvant piller diameter is 0.5-0.7mm, the binding agent for preparing the selection of ball core is polyvidone or hypromellose, and binding agent is mixed with aqueous solution or organic solution is used.
In a preferred embodiment of the present invention, at the controlled release internal layer insoluble polymer of female safe piller outer cladding, select quaternary amine methacrylate or ethyl cellulose, the employing polymer is dissolved in the solution of organic solvent, or the aqueous dispersion of polymer.
In a preferred embodiment of the present invention, coat the enteric polymer as controlled release outer coating outside the controlled release internal layer, these enteric polymer are selected from methylmethacrylate copolymer, ethyl methacrylate copolymers or HP-55 again.
In a preferred embodiment of the present invention, described ball core adopts inertia ball core outsourcing medicine method or extruding round method to produce.
Slow releasing capsule of the present invention can steadily discharge in 24 hours in simulated gastric fluid and simulated intestinal fluid, and its elimination half-life (T1/2) extends to some extent than ordinary tablet, and has the bioavailability suitable with ordinary tablet.
The specific embodiment
Embodiment 1
Female safe slow releasing capsule, it is characterized in that: with the female safe medicine layer of adjuvant piller outsourcing, form the ball core, form by female calm and peaceful insoluble polymer the controlled release internal layer of controlling drug release outside medicine layer, outside described controlled release internal layer, coat again the controlled release outer coating formed by female calm and peaceful enteric polymer, make female safe slow-release pill, described piller filling, in capsule, forms female safe slow releasing capsule.
By making 1000 calculating of slow releasing capsule, every mass of 1000 kernel 192-220g, the weight percent that the interior various components of capsule account for total charges is composed as follows:
In the ball core, each component accounts for the percentage by weight of total charges and is:
In the controlled release internal layer, each component accounts for the percentage by weight of total charges and is:
The present embodiment adopts the adjuvant piller of nonpareils for the female safe ball core of preparation, and adjuvant piller diameter is 0.5mm.
Prepared by Chinese medicine extract of the present invention: get by the following method by Radix Rehmanniae Preparata 600g, Rhizoma Coptidis 300g, Radix Paeoniae Alba 300g, Radix Scutellariae 300g, Colla Corii Asini 100g, Poria 100g, above Six-element, mixed powder is broken into fine powder, insert in the supercritical extraction tank, with pressure 22Mpa, temperature is 35 ℃, the condition extraction 3-4 hour that flow is 21-25L/h, take pressure as 6Mpa, temperature is 45 ℃ and is resolved, extract brown paste, obtain Chinese medicine extract through lyophilization, after testing, in the extract that the identical weight raw material obtains, the content of baicalin is 1.5 times of institute's introduction method in background technology, the content of peoniflorin is 1.42 times, by method of the present invention, also can significantly improve the content of effective ingredient.
The binding agent for preparing female safe ball core selection is polyvidone, and binding agent is mixed with aqueous solution or organic solvent solution is used.The present embodiment ball core can adopt inertia ball core outsourcing medicine method or extruding round method to produce.
The release of female safe slow releasing capsule is done medium with simulated gastric fluid, simulated intestinal fluid, the total amount of baicalin and peoniflorin of take is analytic target, more than the burst size of 4 hours, 8 hours and 24 hours is respectively 2%-30%, 40%-50% and 80%, adopt capsule of the present invention steadily to discharge in 24 hours in simulated gastric fluid, the releasing effect in simulated intestinal fluid and its effect in simulated gastric fluid are substantially similar.
Embodiment 2
Female safe slow releasing capsule animal pharmacokinetics and bioavailability study (adopting embodiment 1 capsule that obtains)
Relative bioavailability experiment after 6 healthy tike single dose oral female safe slow releasing capsule of random intersection and common Kuntai capsule shows, this slow releasing capsule blood drug level rises slowly, concentration change is steady, after administration, the blood drug level level of 0.5～12h (total amount of baicalin and peoniflorin) maintains between 2-4 μ g/ml, and the concentration of 12h and 18h is almost more than the twice of conventional capsule.
The manner medicine piller granularity used is larger, and total surface area reduces, and reaches the required polymer volume of same release and also reduces thereupon.
The above is the preferred embodiments of the present invention; it should be pointed out that for those skilled in the art, under the prerequisite that does not break away from principle of the present invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (6)
1. a female safe slow releasing capsule, it is characterized in that: with adjuvant piller outsourcing Chinese medicine extract, form the ball core, in the outer controlled release layer formed by Chinese medicine extract and enteric solubility polymers that coats of ball core, make female safe slow-release pill, described piller filling is in capsule, form female safe slow releasing capsule, by making 1000 calculating of slow releasing capsule, every mass of 1000 kernel 500-800g, pack piller in capsulae vacuus into, make female safe slow releasing capsule, the weight percent that the interior various components of capsule account for total charges is composed as follows:
In the ball core, each component accounts for the percentage by weight of total charges and is:
In controlled release layer, each component accounts for the percentage by weight of total charges and is:
The raw material of Chinese medicine of the Radix Rehmanniae Preparata 500-700 that described Chinese medicine extract is following weight parts, Rhizoma Coptidis 200-400, Radix Paeoniae Alba 200-400, Radix Scutellariae 200-400, Colla Corii Asini 80-120, Poria 80-120, through supercritical extraction and through the lyophilization gained.
2. female safe slow releasing capsule according to claim 1, it is characterized in that: described antiblocking agent is Pulvis Talci.
3. female safe slow releasing capsule according to claim 1, it is characterized in that: described raw material of Chinese medicine formula is Radix Rehmanniae Preparata 600 weight portions, Rhizoma Coptidis 300 weight portions, the Radix Paeoniae Alba 300 weight portions, Radix Scutellariae 300 weight portions, Colla Corii Asini 100 weight portions, Poria 100 weight portions.
4. female safe slow releasing capsule according to claim 1, it is characterized in that: it is the adjuvant piller for preparing the ball core that described capsule adopts nonpareils or microcrystalline Cellulose piller, adjuvant piller diameter is 0.5-0.7mm, the binding agent for preparing the selection of ball core is polyvidone or hypromellose, and binding agent is mixed with aqueous solution or organic solution is used.
5. female safe slow releasing capsule according to claim 1, it is characterized in that: the controlled release layer insoluble polymer in female safe piller outer cladding is selected quaternary amine methacrylate or ethyl cellulose, the employing polymer is dissolved in the solution of organic solvent, or the aqueous dispersion of polymer.
6. female safe slow releasing capsule according to claim 1 is characterized in that: described ball core adopts inertia ball core outsourcing medicine method or extruding round method to produce.
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| CN201310388746.XA CN103479782B (en) | 2013-08-30 | 2013-08-30 | A kind of slow releasing capsule and preparation method thereof |
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| CN201310388746.XA CN103479782B (en) | 2013-08-30 | 2013-08-30 | A kind of slow releasing capsule and preparation method thereof |
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| CN103479782B CN103479782B (en) | 2015-10-07 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622891A (en) * | 2014-09-22 | 2015-05-20 | 青海大学 | Sustained-release pellets prepared from Tibetan medicine Zhaxun and sustained-release capsules |
| CN107596237A (en) * | 2017-09-19 | 2018-01-19 | 江苏七0七天然制药有限公司 | A kind of stomach benefit spansule and preparation method thereof |
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| CN1714793A (en) * | 2004-06-30 | 2006-01-04 | 丽珠医药集团股份有限公司 | Famciclovir slow-releasing capsule for anti-virus treatment and its producing method |
| CN1931154A (en) * | 2005-09-13 | 2007-03-21 | 珠海天翼医药技术开发有限公司 | Slow released tolterodine tartrate microcapsule and its prepn process |
| CN101229149A (en) * | 2007-01-26 | 2008-07-30 | 上海医药工业有限公司 | Meclofenoxate hydrochloride stomach-floating sustained release capsule and preparing method thereof |
| CN101530446A (en) * | 2009-04-21 | 2009-09-16 | 沈阳双鼎科技有限公司 | General ixeris flavone extract slow-release preparation and application |
| CN102085344A (en) * | 2010-12-30 | 2011-06-08 | 山西振东开元制药有限公司 | Aplotaxis carminative sustained-release preparation and preparation method thereof |
| CN102309414A (en) * | 2011-09-22 | 2012-01-11 | 贵阳新天药业股份有限公司 | Dry-process granulation method of kuntai capsule |
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2013
- 2013-08-30 CN CN201310388746.XA patent/CN103479782B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1714793A (en) * | 2004-06-30 | 2006-01-04 | 丽珠医药集团股份有限公司 | Famciclovir slow-releasing capsule for anti-virus treatment and its producing method |
| CN1931154A (en) * | 2005-09-13 | 2007-03-21 | 珠海天翼医药技术开发有限公司 | Slow released tolterodine tartrate microcapsule and its prepn process |
| CN101229149A (en) * | 2007-01-26 | 2008-07-30 | 上海医药工业有限公司 | Meclofenoxate hydrochloride stomach-floating sustained release capsule and preparing method thereof |
| CN101530446A (en) * | 2009-04-21 | 2009-09-16 | 沈阳双鼎科技有限公司 | General ixeris flavone extract slow-release preparation and application |
| CN102085344A (en) * | 2010-12-30 | 2011-06-08 | 山西振东开元制药有限公司 | Aplotaxis carminative sustained-release preparation and preparation method thereof |
| CN102309414A (en) * | 2011-09-22 | 2012-01-11 | 贵阳新天药业股份有限公司 | Dry-process granulation method of kuntai capsule |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622891A (en) * | 2014-09-22 | 2015-05-20 | 青海大学 | Sustained-release pellets prepared from Tibetan medicine Zhaxun and sustained-release capsules |
| CN107596237A (en) * | 2017-09-19 | 2018-01-19 | 江苏七0七天然制药有限公司 | A kind of stomach benefit spansule and preparation method thereof |
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| Publication number | Publication date |
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| CN103479782B (en) | 2015-10-07 |
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