CN107157958A - Aescinate B enteric sustained-release pellet and preparation method thereof - Google Patents
Aescinate B enteric sustained-release pellet and preparation method thereof Download PDFInfo
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- CN107157958A CN107157958A CN201710212882.1A CN201710212882A CN107157958A CN 107157958 A CN107157958 A CN 107157958A CN 201710212882 A CN201710212882 A CN 201710212882A CN 107157958 A CN107157958 A CN 107157958A
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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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of Aescinate B enteric sustained-release pellet, belong to field of pharmaceutical preparations, it is made up of sustained release capsule core and the enteric-soluble coating material being coated in the sustained release capsule core, and the sustained release capsule core is made up of the composition of following weight proportion：Aescinate B 10 20%, filler 30 60%, sustained-release matrix material 20 50%, pore-foaming agent 2 10%.The present invention can not absorb under one's belt, and could be absorbed in enteron aisle, therefore reduce the excitant to stomach, reduce adverse reaction, while also improving bioavilability, reduce administration number of times.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of Aescinate B enteric sustained-release pellet and preparation method thereof.
Background technology
Sodium Aescinate is carried from Aesculus (Aesculus Wilsonii Rehd.) dry mature seed buckeye
The otoginsenoside sodium salt taken.Sodium Aescinate can reduce pathologic capillary permeability and increase, and increase intravenous tension, reduce scorching
Property material ooze out, with anti-inflammatory, detumescence, analgesic, improve blood circulation, promote acute and closed soft tissue injury recover etc. make
With research has shown that, main active is Aescinate B, B, C, D in otoginsenoside, and wherein Aescinate B and B is β-type seven
Leaf saponin(e, the two isomers, molecular formula each other：C55H85O24Na, molecular weight is 1153.24, and half-life period is 1.5 hours.
The Sodium Aescinate piece listed at present is clinically mainly used in soft tissue swelling, venous edema.Due to seven
Leaf saponin(e sodium half-life short, it is more to take number of times, need to take 2-3 times daily, simultaneously because Sodium Aescinate complicated component, contains
Other a variety of saponins materials, cause the quality of this product to be difficult to control to, and often occur the adverse reactions such as gastrointestinal discomfort.
The content of the invention
The purpose of the present invention is in stomach for existing Sodium Aescinate piece in defect present on clinical treatment there is provided one kind
Do not absorb inside, and in enteron aisle can slow-absorbing Aescinate B enteric sustained-release pellet and preparation method thereof.
The Aescinate B enteric sustained-release pellet that the present invention is provided, by sustained release capsule core and be coated on it is described sustained release capsule core on
Enteric-soluble coating material is constituted, and the sustained release capsule core is made up of the composition of following weight proportion：
The filler is the one or more in lactose, starch, dextrin, sucrose, microcrystalline cellulose；
The sustained-release matrix material is hydrophilic gel, including hydroxypropyl methyl cellulose, sodium carboxymethylcellulose, methyl
One or more in cellulose, PVP, carbomer.
Preferably, the sustained release capsule core is made up of the composition of following weight proportion：
Preferably, the sustained-release matrix material is made up of hydroxypropyl methyl cellulose and carbomer, and the weight of the two compares 2-
6：1.
Preferably, the pore-foaming agent is polyethylene glycol.
Preferably, the sustained release capsule core is prepared using extrusion spheronization method.
It is further preferred that the processing step of the extrusion spheronization method is as follows：
1) filler, sustained-release matrix material, pore-foaming agent are weighed, 80-120 mesh sieves are crossed, is well mixed；
2) Aescinate B is weighed, is dissolved with 30-60% ethanol, stirring in above-mentioned powder is added to and softwood is made；
3) sieve aperture that softwood is first 0.3-0.6mm with aperture in extruder is extruded with 30-60r/min speed, so
, most after 40-60 DEG C of dry 1-5h, taken afterwards in spheronizator with 300-1000r/min speed rolling 5-15min after screening
The micropill of 20-30 mesh.
Preferably, the enteric-soluble coating material is made up of the composition of following weight proportion：
It is further preferred that the enteric-soluble coating material accounts for the 30-40% of sustained release capsule core weight.
The beneficial effects of the invention are as follows：
1) present invention can not absorb under one's belt, and could be absorbed in enteron aisle, therefore reduce the excitant to stomach, reduce
Adverse reaction.
2) medicine slowly discharges in enteron aisle, improves bioavilability, reduces administration number of times.
Embodiment
The present invention is described in detail below by embodiment.
Embodiment 1
1. preparing sustained release capsule core, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Aescinate B | Active component | 150 | 15 |
| Lactose | Filler | 500 | 50 |
| Hydroxypropyl methyl cellulose | Sustained-release matrix material | 240 | 24 |
| Carbomer | Sustained-release matrix material | 60 | 6 |
| Macrogol 4000 | Pore-foaming agent | 50 | 5 |
1) lactose, hydroxypropyl methyl cellulose, carbomer, Macrogol 4000 are weighed, 100 mesh sieves are crossed, is well mixed；
2) Aescinate B is weighed, is dissolved with 40% ethanol, stirring in above-mentioned powder is added to and softwood is made；
3) sieve aperture that softwood is first 0.5mm with aperture in extruder is extruded with 50r/min speed, then round as a ball
With 600r/min speed rolling 10min in machine, most after 50 DEG C of dry 3h, the micropill of 20-30 mesh is taken after screening.
2. prepare enteric sustained-release pellet：
1) coating material is prepared, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Eudragit L100-55 | Enteric-coating material | 415 | 83 |
| Triethyl citrate | Plasticizer | 15 | 3 |
| Talcum powder | Antiplastering aid | 50 | 10 |
| Titanium dioxide | Opacifier | 20 | 4 |
| 70% ethanol | Solvent | - | - |
Eudragit L100-55 70% ethanol of 4 times of weight is dissolved, triethyl citrate, talcum powder, two are added
Titanium oxide, through 80 mesh sieve net filtrations after stirring, sustained release pellet is placed in enteric coated in fluid bed.Control material temperature 50 C,
0.08~0.1MPa of atomizing pressure, blower fan 20~25Hz of frequency, 10~30mlmin of hydrojet flow velocity-1.When sustained release pellet weightening
Stop being coated when 35%, by made enteric sustained-release pellet in taking-up after 45 DEG C of fluidized drying 1h.
Embodiment 2
1. preparing sustained release capsule core, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Aescinate B | Active component | 100 | 10 |
| Microcrystalline cellulose | Filler | 400 | 40 |
| Hydroxypropyl methyl cellulose | Sustained-release matrix material | 400 | 40 |
| Macrogol 4000 | Pore-foaming agent | 100 | 10 |
1) microcrystalline cellulose, hydroxypropyl methyl cellulose, Macrogol 4000 are weighed, 100 mesh sieves are crossed, is well mixed；
2) Aescinate B is weighed, is dissolved with 50% ethanol, stirring in above-mentioned powder is added to and softwood is made；
3) sieve aperture that softwood is first 0.4mm with aperture in extruder is extruded with 30r/min speed, then round as a ball
With 1000r/min speed rolling 5min in machine, most after 45 DEG C of dry 5h, the micropill of 20-30 mesh is taken after screening.
2. prepare enteric sustained-release pellet：
1) coating material is prepared, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Eudragit L100-55 | Enteric-coating material | 425 | 85 |
| Triethyl citrate | Plasticizer | 25 | 5 |
| Talcum powder | Antiplastering aid | 40 | 8 |
| Titanium dioxide | Opacifier | 10 | 2 |
| 70% ethanol | Solvent | - | - |
Eudragit L100-55 50% ethanol of 5 times of weight is dissolved, triethyl citrate, talcum powder, two are added
Titanium oxide, through 80 mesh sieve net filtrations after stirring, sustained release pellet is placed in enteric coated in fluid bed.Control material temperature 50 C,
0.08~0.1MPa of atomizing pressure, blower fan 20~25Hz of frequency, 10~30mlmin of hydrojet flow velocity-1.When sustained release pellet weightening
Stop being coated when 40%, by made enteric sustained-release pellet in taking-up after 45 DEG C of fluidized drying 1h.
Embodiment 3
1. preparing sustained release capsule core, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Aescinate B | Active component | 120 | 12 |
| Sucrose | Filler | 250 | 25 |
| Dextrin | Filler | 50 | 5 |
| Carbomer | Sustained-release matrix material | 500 | 50 |
| Macrogol 6000 | Pore-foaming agent | 80 | 8 |
1) sucrose, dextrin, carbomer, Macrogol 6000 are weighed, 100 mesh sieves are crossed, is well mixed；
2) Aescinate B is weighed, is dissolved with 50% ethanol, stirring in above-mentioned powder is added to and softwood is made；
3) sieve aperture that softwood is first 0.5mm with aperture in extruder is extruded with 60r/min speed, then round as a ball
With 400r/min speed rolling 12min in machine, most after 60 DEG C of dry 1h, the micropill of 20-30 mesh is taken after screening.
2. prepare enteric sustained-release pellet：
1) coating material is prepared, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Eudragit L100-55 | Enteric-coating material | 400 | 80 |
| Triethyl citrate | Plasticizer | 10 | 2 |
| Talcum powder | Antiplastering aid | 60 | 12 |
| Titanium dioxide | Opacifier | 30 | 6 |
| 70% ethanol | Solvent | - | - |
Eudragit L100-55 50% ethanol of 5 times of weight is dissolved, triethyl citrate, talcum powder, two are added
Titanium oxide, through 80 mesh sieve net filtrations after stirring, sustained release pellet is placed in enteric coated in fluid bed.Control material temperature 50 C,
0.08~0.1MPa of atomizing pressure, blower fan 20~25Hz of frequency, 10~30mlmin of hydrojet flow velocity-1.When sustained release pellet weightening
Stop being coated when 30%, by made enteric sustained-release pellet in taking-up after 45 DEG C of fluidized drying 1h.
Embodiment 4
1. preparing sustained release capsule core, prescription is as follows：
| Composition | Effect | Consumption (g) | % |
| Aescinate B | Active component | 200 | 20 |
| Lactose | Filler | 350 | 35 |
| PVP | Sustained-release matrix material | 420 | 42 |
| Macrogol 4000 | Pore-foaming agent | 30 | 3 |
1) lactose, PVP, Macrogol 4000 are weighed, 100 mesh sieves are crossed, is well mixed；
2) Aescinate B is weighed, is dissolved with 50% ethanol, stirring in above-mentioned powder is added to and softwood is made；
3) sieve aperture that softwood is first 0.6mm with aperture in extruder is extruded with 50r/min speed, then round as a ball
With 600r/min speed rolling 10min in machine, most after 50 DEG C of dry 2h, the micropill of 20-30 mesh is taken after screening.
2. prepare enteric sustained-release pellet：
1) coating material is prepared, prescription is as follows：
Eudragit L100-55 50% ethanol of 5 times of weight is dissolved, triethyl citrate, talcum powder, two are added
Titanium oxide, through 80 mesh sieve net filtrations after stirring, sustained release pellet is placed in enteric coated in fluid bed.Control material temperature 50 C,
0.08~0.1MPa of atomizing pressure, blower fan 20~25Hz of frequency, 10~30mlmin of hydrojet flow velocity-1.When sustained release pellet weightening
Stop being coated when 38%, by made enteric sustained-release pellet in taking-up after 45 DEG C of fluidized drying 1h.
The measure of the release of test example 1
Press《Chinese Pharmacopoeia》Two annex XD the second method methods of version in 2015, are first situated between by dissolution of 0.1mol/L hydrochloric acid solutions
The phthalate buffer that phosphorated after matter, 2h adjusts pH to be 6.8.Rotating speed 100r/min, 37 ± 0.5 DEG C of temperature regularly takes solution 5mL, 0.45 μ
M is filtered, while adding dissolution medium 5mL, the content of Aescinate B is surveyed with HPLC methods, Accumulation dissolution is calculated.
The release in acid of Aescinate B in the embodiment 1-4 of table 1
| Embodiment | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Release (%) in acid | 1.27 | 1.84 | 2.97 | 3.52 |
It was found from experimental result, the sustained release pellet that each embodiment is made 2h in acid does not discharge substantially, according to pharmacopoeial requirements,
Burst size of the enteric coated preparations in acid is no more than 10%, and each embodiment meets regulation.
Release of the Aescinate B in buffer solution in the embodiment 1-4 of table 2
As can be seen from the above results, release of the present invention in gastric juice is very low, the release in enteron aisle it is very high and
Can slowly it discharge.
The curative effect and adverse reaction rate of soft tissue swelling after the Aescinate B sustained release pellet of test example 2 treatment fracture
Limbs soft tissue swelling patient after 60 are fractured, is randomly divided into test group and control group, every group 30.Swelling point
Level standard：Slightly, more normal skin turgor, but dermatoglyph remains, ruler method and strong side contrast swelling centre-height≤0.5cm；
Moderate, skin turgor centre-height is 0.4~l.2cm, dermatoglyph disappears, but blister；Severe, skin severe swelling, center is high
Degree>, there is bubble in 1cm.Man 17, female 13 in treatment group；Year at age 17~55 (31.2 ± 11.7)；Swelling degree：Slightly
11, moderate 12, severe 7.Man 19, female 11 in test group；Year at age 19~58 (33.3 ± 12.1)；Swelling journey
Degree：Slight 11, moderate 14, severe 5.All patients have obvious trauma history, are gone to a doctor after wound in 3d, without obvious
Gastrointestinal discomfort.Two groups of sexes, age and swelling degree compare, no significant difference (P>0.05), with comparativity.
Treatment method：Two groups using lying up, lifting affected limb, analgesic, the supportive treatment of suiting the medicine to the illness such as cold/hot dressing.Test group
Oral Aescinate B sustained release pellet, takes 1 time (30mg), the oral Sodium Aescinate piece of control group daily, early, each 1 of evening
(30mg), totally 7 days.Two groups of curative effects were counted respectively at the 7th day, 3 are the results are shown in Table.
Two groups of Comparison of therapeutic n (%) of table 37 day
| Group | n | It is effective | Effectively | It is invalid | Total effective rate |
| Test group | 30 | 8 | 15 | 7 | 76.6 |
| Control group | 30 | 6 | 18 | 6 | 80.0 |
As can be seen from the above results, two groups of Different therapeutical effects less, show the present invention with Sodium Aescinate piece to soft tissue
Swelling has therapeutic effect.
Observe gastrointestinal symptom after two groups of treatments, by gastrointestinal side effect symptom be divided into without, it is light, in, weigh 4 grades and (be shown in Table
4), evaluated by two doctors, wherein academic title doctor, the doctor for taking academic title high when a discrepancy exists must be cured mainly or more including one
Shi Yijian, the results are shown in Table 4.
The gastrointestinal side effect Symptomatic classification of table 4
Gastrointestinal side effect incidence after 4 two groups of treatments of table
As can be seen from the above results, the control group abdominal distension adverse reaction rate that Sodium Aescinate piece is treated is used for (4
+ 3+1)/30=26.7%；Stool abnormity adverse reaction rate is 23.3%；Adverse reaction rate of suffering from abdominal pain is 36.7%, is disliked
Heart vomiting adverse reaction rate is 30%, and anorexia adverse reaction rate is 16.7%.And use present invention sustained release micro-
Each adverse reaction rate of ball treatment is respectively 10%, 16.7%, 20%, 6.7%, 10%, significantly lower than control group.Say
The bright present invention has more preferable security than existing Sodium Aescinate piece.
Claims (8)
1. a kind of Aescinate B enteric sustained-release pellet, by sustained release capsule core and the enteric coatings being coated in the sustained release capsule core
Material is constituted, it is characterised in that the sustained release capsule core is made up of the composition of following weight proportion：
The filler is the one or more in lactose, starch, dextrin, sucrose, microcrystalline cellulose；
The sustained-release matrix material is hydrophilic gel, including hydroxypropyl methyl cellulose, sodium carboxymethylcellulose, Methyl cellulose
One or more in element, PVP, carbomer.
2. Aescinate B enteric sustained-release pellet as claimed in claim 1, it is characterised in that the sustained release capsule core is by following heavy
The composition composition of amount proportioning：
3. Aescinate B enteric sustained-release pellet as claimed in claim 1, it is characterised in that：The sustained-release matrix material is by hydroxyl
Propyl methocel and carbomer composition, the weight of the two compare 2-6：1.
4. Aescinate B enteric sustained-release pellet as claimed in claim 1, it is characterised in that：The pore-foaming agent is polyethylene glycol.
5. the Aescinate B enteric sustained-release pellet as described in claim any one of 1-4, it is characterised in that：The sustained release capsule core
Prepared using extrusion spheronization method.
6. Aescinate B enteric sustained-release pellet as claimed in claim 4, it is characterised in that：The technique of the extrusion spheronization method
Step is as follows：
1) filler, sustained-release matrix material, pore-foaming agent are weighed, 80-120 mesh sieves are crossed, is well mixed；
2) Aescinate B is weighed, is dissolved with 30-60% ethanol, stirring in above-mentioned powder is added to and softwood is made；
3) sieve aperture that softwood is first 0.3-0.6mm with aperture in extruder is extruded with 30-60r/min speed, Ran Hou
With 300-1000r/min speed rolling 5-15min in spheronizator, most after 40-60 DEG C of dry 1-5h, 20-30 is taken after screening
Purpose micropill.
7. Aescinate B enteric sustained-release pellet as claimed in claim 1, it is characterised in that：The enteric-soluble coating material by
The composition composition of following weight proportion：
8. Aescinate B enteric sustained-release pellet as claimed in claim 7, it is characterised in that：The enteric-soluble coating material is accounted for
It is sustained the 30-40% of capsule core weight.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710212882.1A CN107157958B (en) | 2017-04-01 | 2017-04-01 | Aescin B enteric slow-release pellet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710212882.1A CN107157958B (en) | 2017-04-01 | 2017-04-01 | Aescin B enteric slow-release pellet and preparation method thereof |
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| Publication Number | Publication Date |
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| CN107157958A true CN107157958A (en) | 2017-09-15 |
| CN107157958B CN107157958B (en) | 2021-05-04 |
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| CN201710212882.1A Active CN107157958B (en) | 2017-04-01 | 2017-04-01 | Aescin B enteric slow-release pellet and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101816670A (en) * | 2009-12-16 | 2010-09-01 | 成都百康医药工业药理毒理研究院 | New medical application of beta-sodium aescinate |
| CN103585112A (en) * | 2012-08-14 | 2014-02-19 | 齐鲁制药有限公司 | Tamsulosin enteric coated sustained-release pellet and preparation method thereof |
-
2017
- 2017-04-01 CN CN201710212882.1A patent/CN107157958B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101816670A (en) * | 2009-12-16 | 2010-09-01 | 成都百康医药工业药理毒理研究院 | New medical application of beta-sodium aescinate |
| CN103585112A (en) * | 2012-08-14 | 2014-02-19 | 齐鲁制药有限公司 | Tamsulosin enteric coated sustained-release pellet and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 齐艳等: "七叶皂苷及其中4种组分的抗炎作用研究", 《中医药学刊》 * |
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