CN106924222B - Aescin A, B enteric sustained-release pellet and preparation method thereof - Google Patents

Aescin A, B enteric sustained-release pellet and preparation method thereof Download PDF

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CN106924222B
CN106924222B CN201710212858.8A CN201710212858A CN106924222B CN 106924222 B CN106924222 B CN 106924222B CN 201710212858 A CN201710212858 A CN 201710212858A CN 106924222 B CN106924222 B CN 106924222B
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sustained
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enteric
aescin
release pellet
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CN106924222A (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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    • 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)
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  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses an aescine A, B enteric-coated sustained-release pellet, which belongs to the field of pharmaceutical preparations and comprises a sustained-release pellet core and an enteric-coated coating material coated on the sustained-release pellet core, wherein the sustained-release pellet core comprises the following components in parts by weight: 5-15% of aescin A, 2-8% of aescin B, 30-60% of filler, 20-50% of slow-release framework material and 2-10% of pore-forming agent. The invention can not be absorbed in the stomach but can be absorbed in the intestinal tract, thereby reducing the irritation to the stomach, reducing the adverse reaction, simultaneously improving the bioavailability and reducing the administration times.

Description

Aescin A, B enteric sustained-release pellet and preparation method thereof
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to an escin A, B enteric-coated sustained-release pellet and a preparation method thereof.
Background
Aescin sodium is sodium salt of aescin extracted from dry mature seed of Aesculus chinensis Wilsonii Rehd. The sodium aescinate can reduce pathological capillary permeability increase, increase venous tension, reduce inflammatory substance exudation, has the effects of resisting inflammation, relieving swelling and pain, improving blood circulation, promoting acute closed soft tissue injury recovery and the like, and researches prove that the main active component in the aescinate is aescinate A, B, C, D, wherein the aescinate A and B are beta-type aescinates which are isomers, and the molecular formula is as follows: c55H85O24Na, molecular weight 1153.24, half-life 1.5 hours.
The sodium aescinate tablets which are on the market at present are mainly used for soft tissue swelling and venous edema in clinic. Because the half-life period of the sodium aescinate is short, the administration frequency is high, the sodium aescinate needs to be taken for 2-3 times every day, and simultaneously, because the sodium aescinate is complex in components and contains other various saponin substances, the quality of the product is difficult to control, and adverse reactions such as gastrointestinal discomfort and the like often occur.
Disclosure of Invention
The invention aims to provide an aescin A, B enteric sustained-release pellet which is not absorbed in stomach but slowly absorbed in intestinal tract and a preparation method thereof, aiming at the defects of the existing aescin sodium tablets in clinical treatment.
The invention provides an aescine A, B enteric-coated sustained-release pellet which comprises a sustained-release pellet core and an enteric-coated coating material coated on the sustained-release pellet core, wherein the sustained-release pellet core comprises the following components in parts by weight:
Figure BDA0001261405240000011
the filler is one or more of lactose, starch, dextrin, sucrose and microcrystalline cellulose;
the slow release matrix material is hydrophilic gel, and comprises one or more of hydroxypropyl methylcellulose, sodium carboxymethylcellulose, methylcellulose, polyvidone, and carbomer.
Preferably, the sustained-release pill core consists of the following components in parts by weight:
Figure BDA0001261405240000021
preferably, the slow-release matrix material consists of hydroxypropyl methyl cellulose and carbomer in a weight ratio of 2-6: 1.
preferably, the porogen is polyethylene glycol.
Preferably, the sustained-release pellet core is prepared by adopting an extrusion rounding method.
Further preferably, the extrusion spheronization method comprises the following process steps:
1) weighing the filler, the slow release framework material and the pore-forming agent, sieving with a sieve of 80-120 meshes, and uniformly mixing;
2) weighing aescin A and aescin B, dissolving in 30-60% ethanol, adding into the above powder, and stirring to obtain soft material;
3) extruding the soft material in an extruder at a speed of 30-60r/min through a sieve with a pore diameter of 0.3-0.6mm, rolling for 5-15min in a spheronizer at a speed of 300-1000r/min, drying for 1-5h at 40-60 ℃, and sieving to obtain pellets with 20-30 meshes.
Preferably, the enteric coating material consists of the following components in parts by weight:
Figure BDA0001261405240000022
further preferably, the enteric coating material accounts for 30-40% of the weight of the sustained-release pellet core.
The invention has the beneficial effects that:
1) the invention can not be absorbed in stomach but only in intestinal tract, thus reducing irritation to stomach and adverse reaction.
2) The medicine is slowly released in intestinal tract, so that the bioavailability is improved, and the administration frequency is reduced.
Detailed Description
The present invention will be described in detail below with reference to examples.
Example 1
1. The slow release pill core is prepared by the following formula:
component (A) Function of Dosage (g) ％
Aescin A Active ingredient 100 10
Aescin B Active ingredient 50 5
Lactose Filler 500 50
Hydroxypropyl methylcellulose Sustained release matrix material 240 24
Carbomer Sustained release matrix material 60 6
Polyethylene glycol 4000 Pore-forming agent 50 5
1) Weighing lactose, hydroxypropyl methylcellulose, carbomer and polyethylene glycol 4000, sieving with a 100-mesh sieve, and mixing well;
2) weighing aescin A and aescin B, dissolving in 40% ethanol, adding into the above powder, and stirring to obtain soft material;
3) extruding the soft material in an extruder with 0.5mm mesh at 50r/min, rolling in a rolling machine at 600r/min for 10min, drying at 50 deg.C for 3 hr, and sieving to obtain 20-30 mesh pellet.
2. Preparing enteric sustained-release pellets:
1) preparing a coating material, wherein the formula is as follows:
component (A) Function of Dosage (g) ％
Eudragit L100-55 Enteric coating material 415 83
Citric acid triethyl ester Plasticizer 15 3
Talcum powder Anti-sticking agent 50 10
Titanium dioxide Light-shading agent 20 4
70% ethanol Solvent(s) - -
Dissolving Eudragit L100-55 in 70% ethanol 4 times the weight of Eudragit L, adding triethyl citrate, pulvis Talci, and titanium dioxide, stirring, filtering with 80 mesh sieve, and coating the pellet with enteric coating. Controlling the material temperature at 50 ℃, the atomization pressure at 0.08-0.1 MPa, the fan frequency at 20-25 Hz and the spray flow rate at 10-30 ml/min-1. Stopping coating when the weight of the sustained-release pellets is increased by 35%, and taking out the prepared enteric sustained-release pellets after fluidized drying at 45 ℃ for 1 h.
Example 2
1. The slow release pill core is prepared by the following formula:
component (A) Function of Dosage (g) ％
Aescin A Active ingredient 80 8
Aescin B Active ingredient 20 2
Microcrystalline cellulose Filler 400 40
Hydroxypropyl methylcellulose Sustained release matrix material 400 40
Polyethylene glycol 4000 Pore-forming agent 100 10
1) Weighing microcrystalline cellulose, hydroxypropyl methylcellulose and polyethylene glycol 4000, sieving with a 100-mesh sieve, and mixing uniformly;
2) weighing aescin A and aescin B, dissolving in 50% ethanol, adding into the above powder, and stirring to obtain soft material;
3) extruding the soft material with screen hole of 0.4mm in extruder at 30r/min, rolling in rolling machine at 1000r/min for 5min, drying at 45 deg.C for 5 hr, and sieving to obtain pellet of 20-30 meshes.
2. Preparing enteric sustained-release pellets:
1) preparing a coating material, wherein the formula is as follows:
component (A) Function of Dosage (g) ％
Eudragit L100-55 Enteric coating material 425 85
Citric acid triethyl ester Plasticizer 25 5
Talcum powder Anti-sticking agent 40 8
Titanium dioxide Light-shading agent 10 2
70% ethanol Solvent(s) - -
Dissolving Eudragit L100-55 in 5 times of 50% ethanol, adding citric acid triethyl esterEster, talcum powder and titanium dioxide, stirring, filtering with 80 mesh sieve, and coating enteric coating the sustained-release pellet in fluidized bed. Controlling the material temperature at 50 ℃, the atomization pressure at 0.08-0.1 MPa, the fan frequency at 20-25 Hz and the spray flow rate at 10-30 ml/min-1. Stopping coating when the weight of the sustained-release pellets is increased by 40%, and taking out the prepared enteric sustained-release pellets after fluidized drying at 45 ℃ for 1 h.
Example 3
1. The slow release pill core is prepared by the following formula:
Figure BDA0001261405240000041
Figure BDA0001261405240000051
1) weighing sucrose, dextrin, carbomer and polyethylene glycol 6000, sieving with 100 mesh sieve, and mixing;
2) weighing aescin A and aescin B, dissolving in 50% ethanol, adding into the above powder, and stirring to obtain soft material;
3) extruding the soft material in an extruder with 0.5mm mesh at 60r/min, rolling in a spheronizer at 400r/min for 12min, drying at 60 deg.C for 1h, and sieving to obtain 20-30 mesh pellets.
2. Preparing enteric sustained-release pellets:
1) preparing a coating material, wherein the formula is as follows:
component (A) Function of Dosage (g) ％
Eudragit L100-55 Enteric coating material 400 80
Citric acid triethyl ester Plasticizer 10 2
Talcum powder Anti-sticking agent 60 12
Titanium dioxide Light-shading agent 30 6
70% ethanol Solvent(s) - -
Dissolving Eudragit L100-55 in 5 times of 50% ethanol, adding triethyl citrate, pulvis Talci, and titanium dioxide, stirring, filtering with 80 mesh sieve, and coating the pellet with enteric coating. Controlling the material temperature at 50 ℃, the atomization pressure at 0.08-0.1 MPa, the fan frequency at 20-25 Hz and the spray flow rate at 10-30 ml/min-1. Stopping coating when the weight of the sustained-release pellets is increased by 30%, and taking out the prepared enteric sustained-release pellets after fluidized drying at 45 ℃ for 1 h.
Example 4
1. The slow release pill core is prepared by the following formula:
component (A) Function of Dosage (g) ％
Aescin A Active ingredient 120 12
Aescin B Active ingredient 80 8
Lactose Filler 350 35
Povidone Sustained release matrix material 420 42
Polyethylene glycol 4000 Pore-forming agent 30 3
1) Weighing lactose, polyvidone and polyethylene glycol 4000, sieving with 100 mesh sieve, and mixing;
2) weighing aescin A and aescin B, dissolving in 50% ethanol, adding into the above powder, and stirring to obtain soft material;
3) extruding the soft material in an extruder with mesh with aperture of 0.6mm at 50r/min, rolling in a spheronizer at 600r/min for 10min, drying at 50 deg.C for 2 hr, and sieving to obtain 20-30 mesh pellet.
2. Preparing enteric sustained-release pellets:
1) preparing a coating material, wherein the formula is as follows:
component (A) Function of Dosage (g) ％
Eudragit L100-55 Enteric coating material 405 81
Citric acid triethyl ester Plasticizer 5 1
Talcum powder Anti-sticking agent 65 13
Titanium dioxide Light-shading agent 25 5
70% ethanol Solvent(s) - -
Dissolving Eudragit L100-55 in 5 times of 50% ethanol, adding triethyl citrate, pulvis Talci, and titanium dioxide, stirring, filtering with 80 mesh sieve, and coating the pellet with enteric coating. Controlling the material temperature at 50 ℃, the atomization pressure at 0.08-0.1 MPa, the fan frequency at 20-25 Hz and the spray flow rate at 10-30 ml/min-1. Stopping coating when the weight of the sustained-release pellets is increased by 38 percent, and taking out the prepared enteric sustained-release pellets after fluidized drying for 1h at 45 ℃.
Test example 1 measurement of Release degree
According to the second method of XD in the appendix of the second part of the version 2015 in the Chinese pharmacopoeia, 0.1mol/L hydrochloric acid solution is taken as a dissolution medium, and after 2 hours, phosphate buffer is added to adjust the pH value to 6.8. Rotating at speed of 100r/min and temperature of 37 + -0.5 deg.C, periodically collecting 5mL of solution, filtering at 0.45 μm, simultaneously supplementing 5mL of dissolution medium, measuring content of aescin A, B by HPLC, and calculating cumulative release degree.
Table 1 release of escin a in acid in examples 1-4
Examples Example 1 Example 2 Example 3 Example 4
Degree of Release in acid (%) 0.87 1.26 2.26 1.95
Table 2 release of escin B in acid in examples 1-4
Examples Example 1 Example 2 Example 3 Example 4
Degree of Release in acid (%) 1.29 1.87 2.14 2.71
According to experimental results, the sustained-release pellets prepared in the embodiments basically do not release in acid for 2 hours, the release amount of the enteric-coated preparation in the acid does not exceed 10% according to the pharmacopoeia requirements, and all the embodiments meet the regulations.
Table 3 release of escin a in buffer in examples 1-4
Figure BDA0001261405240000071
Table 4 release of escin B in buffer in examples 1-4
Figure BDA0001261405240000072
From the above results, it can be seen that the present invention has a very low degree of release in gastric juice, a very high degree of release in intestinal tract and a slow release.
Test example 2 curative effect of aescine AB sustained-release pellet on soft tissue swelling after fracture and incidence rate of adverse reaction
60 patients with soft tissue swelling of limbs after fracture are randomly divided into a test group and a control group, and each group comprises 30 patients. Grading standard of swelling: mild, normal skin swelling, skin lines still exist, and the height of the swelling center is less than or equal to 0.5cm compared with the healthy side by a ruler method; moderate, the skin swelling center height is 0.5-lcm, the dermatoglyph disappears, but there is no blister; severe, severe swelling of the skin, center height >1cm, appearance of blisters. 15 men and 15 women in the treatment group; age 17-59 (35.4 + -12.5) years; degree of swelling: mild 12, moderate 14 and severe 4. 17 men and 13 women in the test group; age 19-60 (35.7 + -12.9) years; degree of swelling: mild 9, moderate 16, severe 5. All patients had a history of significant trauma, and were treated within 3 days after injury without significant gastrointestinal discomfort. Compared with the sex, age and swelling degree of the two groups, the difference is not statistically significant (P >0.05) and is comparable.
The treatment method comprises the following steps: both groups adopt the symptomatic support treatment such as bed rest, limb lifting, pain relieving, cold and hot compress and the like. The test group orally takes aescin AB sustained release pellet 1 time (30mg) per day, and the control group orally takes aescin sodium tablet 1 tablet (30mg) respectively in the morning and evening for 7 days. Two groups of therapeutic effects were counted on day 7, respectively, and the results are shown in Table 3.
TABLE 37 day two treatment comparison n (%)
Group of n Show effect Is effective Invalidation Total effective rate
Test group 30 12 14 4 93.3
Control group 30 9 16 5 83.3
The results show that the difference of the two groups of curative effects is not large, and the invention and the sodium aescinate tablets have the treatment effect on soft tissue swelling.
Gastrointestinal adverse reaction symptoms after two groups of treatments are observed, are classified into 4 grades of no, light, medium and heavy (see table 4), are evaluated by two doctors, wherein one or more doctors must be used for treating, and the results are shown in table 4 when differences exist and the doctors with high functions.
TABLE 4 Classification of adverse gastrointestinal reaction symptoms
Figure BDA0001261405240000081
TABLE 4 incidence of gastrointestinal adverse reactions following two groups of treatments
Figure BDA0001261405240000082
From the above results, the control group treated with the sodium aescinate tablet had an adverse reaction incidence of abdominal distension of (4+3+1)/30 ═ 26.7%; the incidence rate of abnormal adverse reaction of the excrement is 23.3 percent; the incidence rate of abdominal pain adverse reactions is 36.7%, the incidence rate of nausea and vomiting adverse reactions is 30%, and the incidence rate of appetite loss adverse reactions is 16.7%. The incidence rates of various adverse reactions treated by adopting the sustained-release pellet are respectively 13.3%, 16.7%, 23.3%, 13.3% and 10%, which are obviously lower than those of a control group. The invention has better safety than the existing aescine sodium tablets.

Claims (2)

1. The application of the aescine A, B enteric-coated sustained-release pellet in preparation of a medicine for treating soft tissue swelling is characterized in that the aescine A, B enteric-coated sustained-release pellet is composed of a sustained-release pellet core and an enteric-coated coating material coated on the sustained-release pellet core, wherein the sustained-release pellet core is composed of the following components in parts by weight:
Figure FDA0002535981110000011
the sustained-release pill core is prepared by adopting an extrusion rounding method;
the enteric coating material comprises the following components in parts by weight:
Figure FDA0002535981110000012
the enteric coating material accounts for 35 percent of the weight of the sustained-release pill core.
2. Use according to claim 1, characterized in that: the extrusion rounding method comprises the following process steps:
1) weighing lactose, hydroxypropyl methylcellulose, carbomer and polyethylene glycol 4000, sieving with 80-120 mesh sieve, and mixing;
2) weighing aescin A and aescin B, dissolving in 30-60% ethanol, adding into the above powder, and stirring to obtain soft material;
3) extruding the soft material in an extruder at a speed of 30-60r/min through a sieve with a pore diameter of 0.3-0.6mm, rolling for 5-15min in a spheronizer at a speed of 300-1000r/min, drying for 1-5h at 40-60 ℃, and sieving to obtain pellets with 20-30 meshes.
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Citations (1)

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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

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CN103585112B (en) * 2012-08-14 2015-08-12 齐鲁制药有限公司 A kind of tamsulosin enteric sustained-release pellet and preparation method thereof

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* 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

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