CN106924222A - Aescinate A, B enteric sustained-release pellets and preparation method thereof - Google Patents

Aescinate A, B enteric sustained-release pellets and preparation method thereof Download PDF

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Publication number
CN106924222A
CN106924222A CN201710212858.8A CN201710212858A CN106924222A CN 106924222 A CN106924222 A CN 106924222A CN 201710212858 A CN201710212858 A CN 201710212858A CN 106924222 A CN106924222 A CN 106924222A
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Prior art keywords
sustained
aescinate
enteric
release
capsule core
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CN106924222B (en
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石召华
叶利春
张晓存
沈倩颖
吴灯
江强
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Wuhan Aimin Pharmaceutical Co Ltd
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Wuhan Aimin Pharmaceutical Co Ltd
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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
    • 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
    • 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
    • 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
    • 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
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a kind of Aescinate A, B enteric sustained-release pellets, 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 by following weight proportion into being grouped into：Aescinate A 5 15%, Aescinate B 2 8%, 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

Aescinate A, B enteric sustained-release pellets and preparation method thereof
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of Aescinate A, B enteric sustained-release pellets and its preparation side Method.
Background technology
Sodium Aescinate is carried from the dry mature seed buckeye of Aesculus (Aesculus Wilsonii Rehd.) The otoginsenoside sodium salt for taking.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 A, B, C, D in otoginsenoside, and wherein Aescinate A 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 for having 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 various saponins materials, cause the quality of this product to be difficult to control to, and the adverse reactions such as gastrointestinal discomfort often occur.
The content of the invention
The purpose of the present invention is directed to existing Sodium Aescinate piece in defect present on clinical treatment, there is provided one kind is in stomach Do not absorb inside, and in enteron aisle can slow-absorbing Aescinate A, B enteric sustained-release pellets and preparation method thereof.
The present invention provide Aescinate A, B enteric sustained-release pellets, by sustained release capsule core and be coated on it is described sustained release capsule core on Enteric-soluble coating material composition, the sustained release capsule core is by following weight proportion into being grouped into：
The filler is 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 by following weight proportion into being grouped into：
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 A, Aescinate B are weighed, is dissolved with 30-60% ethanol, be added in above-mentioned powder to stir and be made Softwood；
3) softwood is first extruded with the sieve aperture that aperture is 0.3-0.6mm in extruder with the speed of 30-60r/min, so 1-5h is most dried after 40-60 DEG C with the speed rolling 5-15min of 300-1000r/min in spheronizator afterwards, is taken after screening The micropill of 20-30 mesh.
Preferably, the enteric-soluble coating material by following weight proportion into being grouped into：
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.
Specific embodiment
The present invention is described in detail below by embodiment.
Embodiment 1
1. sustained release capsule core is prepared, and prescription is as follows：
Composition Effect Consumption (g) %
Aescinate A Active component 100 10
Aescinate B Active component 50 5
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 A, Aescinate B are weighed, are dissolved with 40% ethanol, be added to stirring in above-mentioned powder be made it is soft Material；
3) softwood is first extruded with the sieve aperture that aperture is 0.5mm in extruder with the speed of 50r/min, then round as a ball With the speed rolling 10min of 600r/min in machine, 3h most is dried after 50 DEG C, the micropill of 20-30 mesh is taken after screening.
2. enteric sustained-release pellet is prepared：
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 are dissolved with 4 times of 70% ethanol of weight, 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. sustained release capsule core is prepared, and prescription is as follows：
Composition Effect Consumption (g) %
Aescinate A Active component 80 8
Aescinate B Active component 20 2
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 A, Aescinate B are weighed, are dissolved with 50% ethanol, be added to stirring in above-mentioned powder be made it is soft Material；
3) softwood is first extruded with the sieve aperture that aperture is 0.4mm in extruder with the speed of 30r/min, then round as a ball With the speed rolling 5min of 1000r/min in machine, 5h most is dried after 45 DEG C, the micropill of 20-30 mesh is taken after screening.
2. enteric sustained-release pellet is prepared：
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 are dissolved with 5 times of 50% ethanol of weight, 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. sustained release capsule core is prepared, and prescription is as follows：
1) sucrose, dextrin, Carbomer, Macrogol 6000 are weighed, 100 mesh sieves are crossed, is well mixed；
2) Aescinate A, Aescinate B are weighed, are dissolved with 50% ethanol, be added to stirring in above-mentioned powder be made it is soft Material；
3) softwood is first extruded with the sieve aperture that aperture is 0.5mm in extruder with the speed of 60r/min, then round as a ball With the speed rolling 12min of 400r/min in machine, 1h most is dried after 60 DEG C, the micropill of 20-30 mesh is taken after screening.
2. enteric sustained-release pellet is prepared：
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 are dissolved with 5 times of 50% ethanol of weight, 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. sustained release capsule core is prepared, and prescription is as follows：
Composition Effect Consumption (g) %
Aescinate A Active component 120 12
Aescinate B Active component 80 8
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 A, Aescinate B are weighed, are dissolved with 50% ethanol, be added to stirring in above-mentioned powder be made it is soft Material；
3) softwood is first extruded with the sieve aperture that aperture is 0.6mm in extruder with the speed of 50r/min, then round as a ball With the speed rolling 10min of 600r/min in machine, 2h most is dried after 50 DEG C, the micropill of 20-30 mesh is taken after screening.
2. enteric sustained-release pellet is prepared：
1) coating material is prepared, prescription is as follows：
Composition Effect Consumption (g) %
Eudragit L100-55 Enteric-coating material 405 81
Triethyl citrate Plasticizer 5 1
Talcum powder Antiplastering aid 65 13
Titanium dioxide Opacifier 25 5
70% ethanol Solvent - -
Eudragit L100-55 are dissolved with 5 times of 50% ethanol of weight, 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 Matter, it is 6.8 that the phthalate buffer that phosphorated after 2h adjusts pH.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 A, B is surveyed with HPLC methods, calculates Accumulation dissolution.
The release in acid of Aescinate A in the embodiment 1-4 of table 1
Embodiment Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4
Release (%) in acid 0.87 1.26 2.26 1.95
The release in acid of Aescinate B in the embodiment 1-4 of table 2
Embodiment Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4
Release (%) in acid 1.29 1.87 2.14 2.71
Knowable to 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 A in buffer solution in the embodiment 1-4 of table 3
Release of the Aescinate B in buffer solution in the embodiment 1-4 of table 4
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 discharge.
The curative effect and adverse reaction rate of soft tissue swelling after the Aescinate A B sustained release pellets 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 is remained, and ruler method and strong side contrast swelling centre-height≤0.5cm； Moderate, skin turgor centre-height is 0.5~lcm, and dermatoglyph disappears, but blister；Severe, skin severe swelling, centre-height> , there is bubble in 1cm.Man 15, female 15 in treatment group；Year at age 17~59 (35.4 ± 12.5)；Swelling degree：Slight 12 Example, moderate 14, severe 4.Man 17, female 13 in test group；Year at age 19~60 (35.7 ± 12.9)；Swelling degree： Slight 9, moderate 16, severe 5.All patients have obvious trauma history, are gone to a doctor in 3d after wound, do not have obvious stomach and intestine Road is uncomfortable.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 A B sustained release pellets, take 1 time (30mg), the oral Sodium Aescinate piece of control group daily, and early, evening is each 1 (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 12 14 4 93.3
Control group 30 9 16 5 83.3
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 must be cured mainly or more including one, academic title doctor high is taken when a discrepancy exists 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 for using Sodium Aescinate piece to treat is (4 + 3+1)/30=26.7%；Stool abnormity adverse reaction rate is 23.3%；Stomachache adverse reaction rate 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 13.3%, 16.7%, 23.3%, 13.3%, 10%, significantly lower than control Group.Illustrate that the present invention has more preferable security than existing Sodium Aescinate piece.

Claims (8)

1. a kind of Aescinate A, B enteric sustained-release pellets, by sustained release capsule core and the enteric solubility bag being coated in the sustained release capsule core Clothing material is constituted, it is characterised in that the sustained release capsule core is by following weight proportion into being grouped into：
The filler is 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 A as claimed in claim 1, B enteric sustained-release pellets, it is characterised in that the sustained release capsule core is by following Weight proportion into being grouped into：
3. Aescinate A as claimed in claim 1, B enteric sustained-release pellets, it is characterised in that：The sustained-release matrix material by Hydroxypropyl methyl cellulose and Carbomer are constituted, and the weight of the two compares 2-6：1.
4. Aescinate A as claimed in claim 1, B enteric sustained-release pellets, it is characterised in that：The pore-foaming agent is poly- second two Alcohol.
5. Aescinate A as described in claim any one of 1-4, B enteric sustained-release pellets, it is characterised in that：The sustained release ball Core is prepared using extrusion spheronization method.
6. Aescinate A as claimed in claim 4, B enteric sustained-release pellets, it is characterised in that：The work of the extrusion spheronization method Skill 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 A, Aescinate B are weighed, is dissolved with 30-60% ethanol, stirring is made softwood in being added to above-mentioned powder；
3) softwood is first extruded with the sieve aperture that aperture is 0.3-0.6mm in extruder with the speed of 30-60r/min, Ran Hou With the speed rolling 5-15min of 300-1000r/min in spheronizator, 1-5h most is dried after 40-60 DEG C, 20-30 is taken after screening Purpose micropill.
7. Aescinate A as claimed in claim 1, B enteric sustained-release pellets, it is characterised in that：The enteric-soluble coating material By following weight proportion into being grouped into：
8. Aescinate A as claimed in claim 7, B enteric sustained-release pellets, it is characterised in that：The enteric-soluble coating material Account for the 30-40% of sustained release capsule core weight.
CN201710212858.8A 2017-04-01 2017-04-01 Aescin A, B enteric sustained-release pellet and preparation method thereof Active CN106924222B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
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 (2)

* Cited by examiner, † Cited by third party
Title
傅风华等: ""知识产权保护与七叶皂苷制剂的应用"", 《中国新药杂志》 *
湛建峰等: ""七叶皂苷化学成分研究进展"", 《中国药事》 *

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