CN106176684A - Sodium ferulate enteric slow releasing preparation and preparation method thereof - Google Patents
Sodium ferulate enteric slow releasing preparation and preparation method thereof Download PDFInfo
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- CN106176684A CN106176684A CN201510222534.3A CN201510222534A CN106176684A CN 106176684 A CN106176684 A CN 106176684A CN 201510222534 A CN201510222534 A CN 201510222534A CN 106176684 A CN106176684 A CN 106176684A
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- sodium ferulate
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Abstract
The present invention relates to field of pharmaceutical preparations, particularly to sodium ferulate enteric slow releasing preparation and preparation method thereof.The invention provides a kind of sodium ferulate enteric slow releasing preparation, including the raw material of following mass parts: sodium ferulate 30～50 parts, slow-release material 20～40 parts, enteric material 3～10 parts, pharmaceutically acceptable adjuvant 10～30 parts.The present invention uses enteric-soluble controlled-release capsule technology, contrast with conventional tablet, enteric-soluble controlled-release capsule technology can keep stable blood drug level, it is to avoid burst effect, not disintegrate under one's belt, reduce side effect, release in Intestine Alkaline environment, improves bioavailability, and every day is oral once, reduce medicining times, improve the compliance of patient.Enteric slow release content after preparation is loaded in capsule, it is to avoid uses the impact of antioxidant and alkali illumination etc., is effectively improved the stability of medicine.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, particularly to sodium ferulate enteric slow releasing preparation and preparation side thereof
Method.
Background technology
Sodium ferulate is the sodium salt of the effective monomer component ferulic acid extracted from Chinese medicine angelica, Rhizoma Chuanxiong, English
Literary fame is Sodium Ferulate, calls as Rhizoma Chuanxiong element, angelicin, chemical entitled 3-methoxyl group-4-hydroxyl
Natrium cinnamicum monocalcium salt compound, molecular formula: C10H9NaO4·2H2O.Ferulic acid is blood vessel endothelium protective agent,
Can remove free radical, prevent and treat lipid peroxidation injury, vasoconstriction that antagonism Endothelin causes, boosting and
Vascular smooth muscle cell proliferation, alleviates vascular endothelial injury；Increase the synthesis of NO, lax vascular smooth
Flesh；Suppress platelet aggregation, anticoagulation, improve hemorheology feature.Also the conjunction of cholesterol can be suppressed
Become, reduce blood fat, affect complement, enhancing immune function, and there is certain analgesia, spasmolysis.
It is mainly used in atherosclerosis, coronary heart disease, cerebrovascular, renal glomerular disease, pulmonary hypertension, sugar
The auxiliary treatment of the vascular disorder such as urine characteristic of disease vascular lesion, vasculitis, also can be used for migraine, blood vessel
Property headache treatment.
At present, the sodium ferulate preparation of clinical practice has conventional tablet, injection liquid drugs injection, injection powder pin etc..
Sodium ferulate is the most oxidized, and alkali, illumination and temperature are the biggest to its stability influence, although liquid infusion system
Agent and lyophilized injectable powder add antioxidant, but antioxidant may interact with sodium ferulate and produce
Raw impurity peaks, its stability is the most undesirable, and the raising to stability is the most limited.Conventional tablet is stable
Property poor, effective constituent reduction often occurs during storage, color and luster turns yellow.Its bioavailability is low, and one
They needs are administered three times, and long-term taking poor compliance, gastric side effects is big.
Summary of the invention
In view of this, the present invention provides a kind of sodium ferulate enteric slow releasing preparation and preparation method thereof.This
Bright employing enteric-soluble controlled-release capsule technology, contrasts with conventional tablet, and enteric-soluble controlled-release capsule technology can keep stable
Blood drug level, it is to avoid burst effect, not disintegrate under one's belt, reduce side effect, at Intestine Alkaline environment
Middle release, improves bioavailability, and every day is oral once, reduces medicining times, improves complying with of patient
Property.Enteric slow release content after preparation is loaded in capsule, it is to avoid use antioxidant and alkali illumination etc.
Impact, be effectively improved the stability of medicine.
In order to realize foregoing invention purpose, the present invention provides techniques below scheme:
The invention provides a kind of sodium ferulate enteric slow releasing preparation, including the raw material of following mass parts:
In some specific embodiments of the present invention, sodium ferulate enteric slow releasing preparation includes following quality
The raw material of part:
In some specific embodiments of the present invention, sodium ferulate enteric slow releasing preparation includes following quality
The raw material of part:
In some specific embodiments of the present invention, sodium ferulate enteric slow releasing preparation includes following quality
The raw material of part:
In some specific embodiments of the present invention, sodium ferulate enteric slow releasing preparation includes following quality
The raw material of part:
In some specific embodiments of the present invention, sodium ferulate enteric slow releasing preparation includes following quality
The raw material of part:
In some specific embodiments of the present invention, slow release material described in sodium ferulate enteric slow releasing preparation
Material selected from sodium alginate, gelatin, pectin, methylcellulose, hyetellose, hypromellose,
Hydroxypropyl second cellulose, sodium carboxymethyl cellulose, chitosan, galactomannan, polyvinyl alcohol or poly-
A kind of or both mixture above in carboxylic ethylene, propylene glycol, Polyethylene Glycol, Pulvis Talci.
Preferably, described slow-release material is hypromellose, propylene glycol, Polyethylene Glycol, talcous
Compositions.
In some specific embodiments of the present invention, enteric material described in sodium ferulate enteric slow releasing preparation
Material is selected from cellulose acetate-phthalate (CAP, trade name), hypromellose phthalein
Acid esters (HPMCP trade name), acrylic resin L-type, acrylic resin S type,
Polyvinyl acetate phthalic acid ester (PVAP, trade name)、
Hydroxypropyl Methyl Cellulose Phthalate (HPMCAS, trade name), cellulose acetate benzene three
A kind of or both mixture above in acid esters (CAT).
Preferably, described enteric material is selected from cellulose acetate-phthalate and cellulose acetate benzenetricarboxylic acid
One or both in ester.
In some specific embodiments of the present invention, described in sodium ferulate enteric slow releasing preparation pharmaceutically
Acceptable adjuvant includes in filler, binding agent, solubilizing agent, porogen, lubricant or plasticizer
A kind of or that both are above mixture；
Described filler is selected from lactose, sucrose, glucose, starch, dextrin, pregelatinized Starch, crystallite
A kind of or both mixture above, preferably microcrystalline cellulose, sucrose in cellulose or mannitol；
Described binding agent is selected from starch, gelatin, lactose, sodium alginate, hydroxymethyl cellulose, poly-second two
A kind of or both mixture above, preferably polyethylene pyrrolidine in alcohol, polyvinylpyrrolidone or water
Ketone；
Described plasticizer is selected from a kind of or both mixture above of Polyethylene Glycol, tartaric acid, citric acid,
Preferably Polyethylene Glycol；
Described porogen selected from starch, Pulvis Talci, silicon dioxide, mannitol, xylose, lactose, fructose,
Sucrose or a kind of or both mixture above, the preferably talc powder of water soluble salt apoplexy due to endogenous wind；
Preferably, one during described porogen is selected from starch, silicon dioxide, lactose or both more than
Mixture, preferably lactose；
Described lubricant one or two in ethanol, glycerol, propylene glycol, Polyethylene Glycol or Oleum Ricini
Mixture more than person, preferably propylene glycol.
Present invention also offers the preparation method of described sodium ferulate enteric slow releasing preparation, described raw material is mixed
Close, load capsule.
Present invention also offers the preparation method of described sodium ferulate enteric slow releasing preparation, by described ferulic acid
Sodium and described pharmaceutically acceptable adjuvant prepare micropill, through described slow-release material coating, load enteric glue
Capsule.
Present invention also offers the preparation method of described sodium ferulate enteric slow releasing preparation, by described ferulic acid
Sodium and described pharmaceutically acceptable adjuvant prepare micropill, through described slow-release material coating, then through described intestinal
Molten material coating, loads capsule.
Compositions can be made the hybrid particles containing slow-release material by the sodium ferulate enteric slow releasing capsule of the present invention
Insert in enteric coated capsule, it is possible to the mixture such as sodium ferulate, binding agent is placed in centrifugal micropill granulator
Prepare micropill, then micropill slow-release material coating made slow-release micro-pill, be filled in enteric coated capsule and get final product,
Maybe prepared slow-release micro-pill is wrapped enteric material be filled in common hard capsule and get final product.
In some embodiments of the invention, spraying into 75g volumn concentration during preparing micropill is 80%
Ethanol solution.
In some embodiments of the invention, prepare micropill to be specially sodium ferulate, polyvinylpyrrolidine
Ketone, microcrystalline Cellulose respectively cross 100 mesh sieves, by recipe quantity weigh sodium ferulate, polyvinylpyrrolidone,
Mix homogeneously in mixer put by microcrystalline Cellulose, sucrose, is placed in centrifugal granulator, sprays into 75g volume
Percentage composition is the ethanol solution piller of 80%.
In some embodiments of the invention, in described enteric material coating process, with 800g volume hundred
The ethanol solution allotment dividing content to be 75% is standby containing the coating powder of enteric material cellulose acetate-phthalate
Enteric coating liquid.
In some embodiments of the invention, during prepared slow-release micro-pill is wrapped enteric material, use
800g volumn concentration is ethanol solution allotment cellulose acetate-phthalate Han enteric material of 75%
Coating powder for enteric coating liquid.
Present invention also offers the sodium ferulate enteric slow releasing preparation that above-mentioned preparation method prepares.
The invention provides a kind of sodium ferulate enteric slow releasing preparation, including the raw material of following mass parts: Ah
Acid Wei sodium 30～50 parts, slow-release material 20～40 parts, enteric material 3～10 parts, pharmaceutically acceptable auxiliary
Expect 10～30 parts.Enteric-soluble controlled-release capsule improves conventional tablet and there is the problem of degraded in gastric juice, reaches again
The slow releasing function effect not having to common enteric coated preparation and tablet, it is ensured that the drug safety of patient.Commercially available
Sodium ferulate sheet need to be taken 3 times every day, and each 1-2 sheet brings inconvenience to long-term prescription patient, and
Medicining times is many also easily causes the defect that drug level undulatory property in vivo is big.Centrifugal granulating is used to pelletize
Standby micropill technique, and give antioxygen layer and water barrier coating, it is ensured that sodium ferulate is difficult to make moist, and is difficult to oxygen
Change.
The present invention uses enteric-soluble controlled-release capsule technology, contrasts with conventional tablet, enteric-soluble controlled-release capsule technology energy
Keep stable blood drug level, it is to avoid burst effect, not disintegrate under one's belt, reduces side effect, at small intestinal
Release in alkaline environment, improves bioavailability, and every day is oral once, reduces medicining times, improves and suffers from
The compliance of person.Enteric slow release content after preparation is loaded in capsule, it is to avoid use antioxidant and
The impact of alkali illumination etc., is effectively improved the stability of medicine.This enteric slow release content includes but not limited to
Tablet, bilayer tablet, granule and piller.
Accompanying drawing explanation
In order to be illustrated more clearly that the embodiment of the present invention or technical scheme of the prior art, below will be to reality
Execute the required accompanying drawing used in example or description of the prior art to be briefly described.
Fig. 1 shows the cumulative release curve of sodium ferulate enteric slow releasing capsule prepared by embodiment 1；
Fig. 2 shows the cumulative release curve of sodium ferulate enteric slow releasing capsule prepared by embodiment 2；
Fig. 3 shows the cumulative release curve of sodium ferulate enteric slow releasing capsule prepared by embodiment 3；
Fig. 4 shows the cumulative release curve of sodium ferulate ordinary tablet.
Detailed description of the invention
The invention discloses a kind of sodium ferulate enteric slow releasing preparation and preparation method thereof, people in the art
Member can use for reference present disclosure, is suitably modified technological parameter and realizes.Special needs to be pointed out is, all classes
As replace and change apparent to those skilled in the art, they are considered as being included in
The present invention.Method and the application of the present invention are described by preferred embodiment, and related personnel is bright
Show off one's talent or competence and in without departing from present invention, spirit and scope, method described herein and application are modified
Or suitably change and combination, realize and apply the technology of the present invention.
In the sodium ferulate enteric slow releasing preparation preparation method that the present invention provides, raw materials used and reagent all can be by
Market is buied.
Below in conjunction with embodiment, the present invention it is expanded on further:
Embodiment 1
Preparation method: sodium ferulate, polyvinylpyrrolidone, microcrystalline Cellulose, sucrose are crossed respectively 100
Mesh sieve, weighs sodium ferulate by recipe quantity, mixing put by polyvinylpyrrolidone, microcrystalline Cellulose, sucrose
Mix homogeneously in machine, is placed in centrifugal granulator, sprays into the ethanol that 75g volumn concentration is 80% molten
Liquid piller, is equipped with hypromellose sustained release coating liquid by sustained release coating liquid prescription and wraps element capsule core
Clothing, sustained release coating fluid solid content 18%～21%, weightening finish 2.8%～3.2%, dry air 60～80m3/ h,
Inlet temperature 55～60 DEG C, Coating times 3～3.5h, then be the ethanol of 75% with 800g volumn concentration
Preparing solution containing the coating powder of enteric material cellulose acetate-phthalate for enteric coating liquid, then in institute
Obtain on slow-release pill enteric coated, dry air 70～85m3/ h, inlet temperature 50～60 DEG C, Coating times
4～5h, the sodium ferulate enteric slow releasing capsule prepared as stated above meets 2010 editions two-shift systems of Chinese Pharmacopoeia
The requirement of the coherent detection project of regulation in agent general rule.
Embodiment 2
Preparation method: sodium ferulate, polyvinylpyrrolidone, microcrystalline Cellulose, sucrose are crossed respectively 100
Mesh sieve, weighs sodium ferulate by recipe quantity, mixing put by polyvinylpyrrolidone, microcrystalline Cellulose, sucrose
Mix homogeneously in machine, is placed in centrifugal granulator, sprays into the ethanol that 75g volumn concentration is 80% molten
Liquid piller, is equipped with hypromellose sustained release coating liquid by sustained release coating liquid prescription and wraps element capsule core
Clothing, sustained release coating fluid solid content 18%～21%, weightening finish 2.8%～3.2%, dry air 60～80m3/ h,
Inlet temperature 55～60 DEG C, Coating times 3～3.5h, then be the ethanol of 75% with 800g volumn concentration
Preparing solution containing the coating powder of enteric material cellulose acetate-phthalate for enteric coating liquid, then in institute
Obtain on slow-release pill enteric coated, dry air 70～85m3/ h, inlet temperature 50～60 DEG C, Coating times
4～5h, the sodium ferulate enteric slow releasing capsule prepared as stated above meets 2010 editions two-shift systems of Chinese Pharmacopoeia
The requirement of the coherent detection project of regulation in agent general rule.
Embodiment 3
Preparation method: sodium ferulate, polyvinylpyrrolidone, microcrystalline Cellulose, sucrose are crossed respectively 100
Mesh sieve, weighs sodium ferulate by recipe quantity, mixing put by polyvinylpyrrolidone, microcrystalline Cellulose, sucrose
Mix homogeneously in machine, is placed in centrifugal granulator, sprays into the ethanol that 75g volumn concentration is 80% molten
Liquid piller, is prepared as coating solution by slow-release material, is equipped with hypromellose sustained release coating according to prescription
Element capsule core is coated by liquid, sustained release coating fluid solid content 18%～21%, and weightening finish 2.8%～3.2% is dried
Air 60～80m3/ h, inlet temperature 55～60 DEG C, Coating times 3～3.5h, then use 800g volume basis
Content is that the ethanol solution allotment of 75% coating powder containing enteric material cellulose acetate-phthalate is for intestinal
Molten coating solution, more enteric coated on gained slow-release pill, dry air 70～85m3/ h, inlet temperature
50～60 DEG C, Coating times 4～5h, the sodium ferulate enteric slow releasing capsule prepared as stated above meets China
The requirement of the coherent detection project of regulation in 2010 editions two-shift system agent general rules of pharmacopeia.
Embodiment 4 drug accumulation release result
The cumulative in vitro release result data of embodiment 1-3 and sodium ferulate sheet is as shown in table 1, can from result
To find out, embodiments of the invention 1-3 slowly discharged in 24 hours, and release is stable, and not dashing forward, it is existing to release
As, reach slow release effect (Fig. 1 to Fig. 3)；And there is phenomenon of burst release in sodium ferulate ordinary tablet, release
Comparatively fast, in 4 hours, basic release is complete (Fig. 4).The results are shown in Table 1, Fig. 1 to Fig. 4.
The cumulative release result of table 1 embodiment 1-3 and sodium ferulate sheet
| Time (h) | Embodiment 1 | Embodiment 2 | Embodiment 3 | Sodium ferulate sheet |
| 1 | 25.4% | 21.3% | 24.6% | 38.8% |
| 2 | 39.5% | 35.4% | 38.7% | 69.4% |
| 4 | 65.9% | 59.6% | 62.9% | 94.5% |
| 8 | 75.3% | 72.4% | 79.1% | 98.1% |
| 16 | 88.2% | 90.7% | 91.7% | 99.4% |
| 24 | 99.4% | 98.9% | 99.6% | 99.7% |
Embodiment 5 sample stability experimental result
The stability result data of embodiment 1-3 and sodium ferulate sheet such as table 2, from the results, it was seen that this
The stability of inventive embodiment 1-3 is preferable, has related substance and content more obvious than sodium ferulate sheet degradation speed
Slower (P ＜ 0.05).
Table 2 embodiment 1-3 and ferulic acid tablet stability result
Embodiment 6 bioavailability detects
Bioavailability uses extracorporeal releasing experiment to simulate body absorption, and concrete detection method is as follows:
Carry out by " Chinese Pharmacopoeia " 2010 editions Rotating shaker about the detection of slow releasing preparation vitro drug release,
With water 900ml as dissolution medium, rotating speed is 50 turns per minute, regulation sample point (1h, 2h, 4h,
8h, 16h, 24h) sampling, take solution and filter, take subsequent filtrate, the quantitatively dilution that adds water is made in every 1ml
The about solution of sodium ferulate 10 μ g, according to ultraviolet visible spectrophotometry, measures at the wavelength of 310nm
Absorbance, by C10H9NaO4Absorptance be 712 calculating, and result is multiplied by 1.167, to obtain final product.
Tell somebody what one's real intentions are book embodiment 4 and table 1 are shown in result and analysis word.
" reduce the side effect of stomach " and definitely refer to that enteric solubility preparation decreases the gastric acid degraded to sodium ferulate
Effect, the quality of the product of raising and stability.
Product of the present invention and ordinary tablet are placed 24 hours under the condition (0.1M hydrochloric acid) of simulation gastric acid,
Sampling detection respectively at 0,1,2,4,8,16,24 time, detection method and testing result are as follows:
Detection method: lucifuge operates.Take this product fine powder appropriate, add flowing phased soln and every 1ml is made in dilution
In solution containing about sodium ferulate 0.7mg, as need testing solution；Precision measures 1ml, puts 200ml
In measuring bottle, with flowing phase dilution to scale, shake up, as contrast solution.Try according to high performance liquid chromatography
Test, be filler with octadecylsilane chemically bonded silica；Methanol-water-acetic acid (30:69:1.5) is flowing phase；
Detection wavelength is 322nm；Take contrast solution 10 μ l, inject chromatograph of liquid, regulate detection sensitivity, make
The peak height of main constituent chromatographic peak is about the 10% of full scale.Precision measures need testing solution and contrast solution again
Each 10 μ l, are injected separately into chromatograph of liquid, 2.5 times of record chromatogram to main constituent peak retention time.Supply
If any impurity peaks in test sample solution chromatogram, each impurity peak area and cannot be greater than the main peak of contrast solution
Area (0.5%).
Testing result is as shown in table 3.
Table 3 testing result
From the above results, embodiment 1, embodiment 2, embodiment 3 are stablized under the conditions of simulation gastric acid
Property good, the impurity of ordinary tablet increases substantially, and content is decreased obviously, compared with ordinary tablet, the present invention
The sodium ferulate enteric slow releasing preparation provided has significant difference (P ＜ 0.05).
The above is only the preferred embodiment of the present invention, it is noted that general for the art
For logical technical staff, under the premise without departing from the principles of the invention, it is also possible to make some improvement and profit
Decorations, these improvements and modifications also should be regarded as protection scope of the present invention.
Claims (10)
1. a sodium ferulate enteric slow releasing preparation, it is characterised in that include the raw material of following mass parts:
Sodium ferulate enteric slow releasing preparation the most according to claim 1, it is characterised in that include as
The raw material of lower mass parts:
Sodium ferulate enteric slow releasing preparation the most according to claim 2, it is characterised in that include as
The raw material of lower mass parts:
4., according to the sodium ferulate enteric slow releasing preparation described in any one of claims 1 to 3, its feature exists
In, described slow-release material selected from sodium alginate, gelatin, pectin, methylcellulose, hyetellose,
Hypromellose, hydroxypropyl second cellulose, sodium carboxymethyl cellulose, chitosan, galactomannan,
A kind of or both mixture above in polyvinyl alcohol or carbopol.
5., according to the sodium ferulate enteric slow releasing preparation described in any one of Claims 1-4, its feature exists
In, described enteric material is selected from cellulose acetate-phthalate, HP-55, propylene
Acid resin L-type, acrylic resin S type, polyvinyl acetate phthalic acid ester, acetic acid hypromellose
A kind of or both mixture above in succinate, cellulose acetate benzenetricarboxylic acid ester.
6., according to the sodium ferulate enteric slow releasing preparation described in any one of claim 1 to 5, its feature exists
In, described pharmaceutically acceptable adjuvant includes filler, binding agent, solubilizing agent, porogen, lubrication
A kind of or both mixture above in agent or plasticizer；
Described filler is selected from lactose, sucrose, glucose, starch, dextrin, pregelatinized Starch, crystallite
A kind of or both mixture above, preferably microcrystalline cellulose, lactose in cellulose or mannitol；
Described binding agent is selected from starch, gelatin, lactose, sodium alginate, hydroxymethyl cellulose, poly-second two
A kind of or both mixture above, preferably polyethylene pyrrolidine in alcohol, polyvinylpyrrolidone or water
Ketone；
Described plasticizer is selected from a kind of or both mixture above of Polyethylene Glycol, tartaric acid, citric acid,
Preferably Polyethylene Glycol；
Described porogen selected from starch, Pulvis Talci, silicon dioxide, mannitol, xylose, lactose, fructose,
Sucrose or a kind of or both mixture above, the preferably lactose of water soluble salt apoplexy due to endogenous wind；
Described lubricant one or two in ethanol, glycerol, propylene glycol, Polyethylene Glycol or Oleum Ricini
Mixture more than person, preferably propylene glycol.
7. according to the preparation method of the sodium ferulate enteric slow releasing preparation described in any one of claim 1 to 6,
It is characterized in that, described raw material is mixed, load capsule.
8. according to the preparation method of the sodium ferulate enteric slow releasing preparation described in any one of claim 1 to 6,
It is characterized in that, described sodium ferulate and described pharmaceutically acceptable adjuvant are prepared micropill, through described
Slow-release material coating, loads enteric coated capsule.
9. according to the preparation method of the sodium ferulate enteric slow releasing preparation described in any one of claim 1 to 6,
It is characterized in that, described sodium ferulate and described pharmaceutically acceptable adjuvant are prepared micropill, through described
Slow-release material coating, then through described enteric material coating, load capsule.
10. the sodium ferulate enteric prepared according to the preparation method described in any one of claim 7 to 9 delays
Release formulation.
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Cited By (1)
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| CN113155990A (en) * | 2021-02-24 | 2021-07-23 | 西南药业股份有限公司 | Extraction solvent and extraction method of main drug components in codeine phosphate sustained-release tablets |
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Application publication date: 20161207 |
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