CN104825419B - A kind of agent of low hygroscopicity Couoidal bismuth pectin capsules agent and its preparation technology - Google Patents
A kind of agent of low hygroscopicity Couoidal bismuth pectin capsules agent and its preparation technology Download PDFInfo
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- CN104825419B CN104825419B CN201510276506.XA CN201510276506A CN104825419B CN 104825419 B CN104825419 B CN 104825419B CN 201510276506 A CN201510276506 A CN 201510276506A CN 104825419 B CN104825419 B CN 104825419B
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- pectin
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- colloidal bismmth
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Abstract
The invention discloses a kind of agent of low hygroscopicity Couoidal bismuth pectin capsules agent and its preparation technology, said preparation is coating material with acrylic resin IV, colloidal bismmth pectin is coated using precipitated calcium carbonate as antiplastering aid, gained coating micro-pill capsule charge shell, significantly improve and be easy to that moisture absorption is agglomerating, the problem of being not easy to be uniformly dispersed in colloid pectin bismuth preparation storing process, the effect of improving medicine；Meanwhile supplementary product kind used is few, preparation technology is simple, is easy to industrialized production.
Description
Technical field
The invention belongs to technical field of medicine, in particular to a kind of agent of low hygroscopicity containing colloidal bismmth pectin
Capsule and its preparation technology.
Background technology
Colloidal bismmth pectin is a kind of new colloidal state bismuth preparation, has stronger colloid property, being capable of shape in acid medium
Into high viscosity colloidal sol, one layer of firm diaphragm is formed on stomach lining, so as to strengthen the barrier action of stomach lining.Colloid pectin
Collosol property of the bismuth formed in acid medium will be good than other any colloidal bismuths, and it can be deposited on helicobacter pylori
Cell membrane, make have different degrees of vacuole in thalline, cause cell wall rupture, and suppress the activity of bacterial enzyme, disturb bacterium generation
The effect of thanking, its normal defense function to human body is set to become more sensitive.This product also directly stimulates prostaglandin and epidermal growth
The generation of the factor, ulcer surface and rotten to the corn face is set quickly to heal and stop blooding.The colloid pectin bismuth preparation of domestic listing has capsule at present
Agent, dry suspensoid agent, granule, powder etc., suitable for treat peptic ulcer, particularly helicobacter pylori related ulcer, also
Available for chronic superficial and atrophic gastritis.
Colloidal bismmth pectin easily moisture absorption, the weightening of moisture absorption in 5 days is placed under the conditions of high humidity (25 DEG C of 92.5%RH) up to 13%, is caused
Sample cohesive is agglomerating, and mobility is deteriorated, and colloidal stability is undesirable.Because colloidal bismmth pectin hygroscopicity is strong, marketed products
It is usually present and is difficult to be uniformly dispersed in water, tends not to quickly achieve preferable expansion under one's belt after oral, it is impossible to
Ulcer surface is completely covered, the effect of so as to greatly reduce this product.
CN100477999C discloses a kind of dispersible tablet of colloid petcin, the invention in order to reach expected dispersion effect,
Substantial amounts of disintegrant has been used, so that the hygroscopicity of preparation further enhances, has caused colloidal dispersions uniformity in storing process
Further it is deteriorated, is unfavorable for it and is covered in the surface of gastric mucosa, so as to reduce curative effect.CN1919170A discloses a kind of colloid
Pectin bismuth dry suspensoid and preparation method thereof, composition and content weight proportion are colloidal bismmth pectin (in terms of bismuth) 50-300 parts, are filled out
Fill agent 600-2500 parts, flavouring 50-300 parts, flocculant 5-60 parts.Moisture absorption is tight during the invention is not directed to sample storage
Again, the problem of causing more difficult rapid dispersion；Because it is dry suspensoid agent, acutely rocked after water can be added, after being completely dispersed
Drink, it is smaller to a certain extent to be difficult to influence of the rapid dispersion problem to curative effect.CN101732283B discloses a kind of colloid
The preparation method of pectin bismuth microcapsules, by pure colloidal bismmth pectin wet product or dry product, add in 50-100 DEG C of water and form rubber cement, add
Enter disintegrant, the weight ratio of disintegrant and colloidal bismmth pectin is 1-10:5-100；Add the aqueous solution of adhesive, adhesive
Weight ratio with colloidal bismmth pectin is 0-10:10-200, mix, homogeneous, Direct spraying is dried and forms micro-capsule；Or after drying,
Micron-sized micro-capsule powder is ground into vibromill (or airflow milling).Colloid pectin bismuth preparation granularity prepared by the invention is thinner,
The hygroscopicity of this product is further increased, meanwhile, the invention prepares micro-capsule using spray drying process, due to the solution of spray drying
Viscosity is larger, easily blocks spray gun in spray process and causes production efficiency low.CN 101028281A disclose one kind with glue
Body colloidal bismuth pectin is nano-gel pectin bismuth and its granules medicine made from raw material, by colloidal bismmth pectin and glycerin monostearate
Liposome precursor, and then a nanometer colloidal bismuth pectin is made in applied microwave technology.The carrier material that the invention uses is hydrophobicity, certain
The hygroscopicity of sample is reduced in degree, there is preferable effect.But preparation process includes preparing liposome precursor, microwave reaction
Formation nano fluid, spray drying are made nanoparticle, prepare the processes such as granule, complex process, and production cost is higher.Preparation process
It is middle to use the organic solvents such as tetrahydrofuran, it is unfavorable for labour protection.Meanwhile the solution viscosity of spray drying is larger, spray process
In easily block spray gun and cause production efficiency low.CN103142548A discloses a kind of Couoidal bismuth pectin capsules, described
In Couoidal bismuth pectin capsules, superfine silica gel powder and pregelatinized starch mix according to special ratios with colloidal bismmth pectin, superfine silica gel powder and
Pregelatinized starch will be stronger hygroscopicity, often there is capsule 's content in storing process and be in the form of a column the phenomenon for being difficult to be disintegrated, no
Gastric mucosa surface is adsorbed in beneficial to medicaments uniformity.CN104147041A disclose a kind of pharmaceutical dispersions containing colloidal bismmth pectin and its
Preparation method, using every 1g as preparation unit, per the colloidal bismmth pectin contained in preparation unit or the medicine containing colloidal bismmth pectin with
Colloidal bismmth pectin is calculated as 44.0~900.0mg, and contains 1.0~500mg penetrating agents, 2.0~312.5mg acid source pore-foaming agents, and 2.0
~250.0mg alkali source pore-foaming agents, 1.0~400.0mg disintegrants.This method preparation technology is complicated, the use of a large amount of auxiliary materials itself
The adhesiving effect of colloidal bismmth pectin is reduced, and pore-foaming agent, the disintegrant used is the extremely strong material of hygroscopicity, storing process
Middle dispersing uniformity is substantially deteriorated.
In addition, still there are some in existing commercialized product by using damp-prrof packing, to reduce the hygroscopic method of sample.So
And damp-prrof packing can reduce hygroscopicity to a certain extent, but can not tackle the problem at its root.Meanwhile damp-prrof packing
Production cost is added, also wants the humidity of strictly controlled environment in process of production.Found by carefully retrieving pertinent literature, it is existing
There is technology to fail serious, scattered to solve moisture absorption in colloid pectin bismuth preparation storing process using relatively simple effective means
The problem of uniformity is deteriorated, colloid property is difficult to meet the requirements.
The content of the invention
In view of the deficiencies in the prior art, it is an object of the invention to provide a kind of hygroscopicity it is small, disperse in gastric acid environment
Uniformity is good, the simple Couoidal bismuth pectin capsules agent of preparation technology and its preparation technology.
To reach this technical purpose, inventor is finally obtained following by substantial amounts of experimental study and persistent exploration
Technical scheme：
A kind of agent of low hygroscopicity Couoidal bismuth pectin capsules agent, it includes capsule shells and content, and described content is colloid
Colloidal bismuth pectin micropill, it is that the coatings being made up of in colloidal bismmth pectin Surface coating acrylic resin IV and precipitated calcium carbonate are made.
Preferably, agent of low hygroscopicity Couoidal bismuth pectin capsules agent as described above, colloidal bismmth pectin therein and acrylic acid tree
The weight ratio of fat IV is 1 ︰ 0.3-0.7.
It is further preferred that agent of low hygroscopicity Couoidal bismuth pectin capsules agent as described above, colloidal bismmth pectin therein and third
The weight ratio of olefin(e) acid resin IV is 1 ︰ 0.5-0.6.
Preferably, agent of low hygroscopicity Couoidal bismuth pectin capsules agent as described above, acrylic resin IV therein and lightweight carbon
The weight ratio of sour calcium is 1 ︰ 0.1-0.3.
Still further preferably, agent of low hygroscopicity Couoidal bismuth pectin capsules agent as described above, acrylic resin IV therein
Weight ratio with precipitated calcium carbonate is 1 ︰ 0.2.
In addition, present invention also offers a kind of preparation technology of agent of low hygroscopicity Couoidal bismuth pectin capsules agent, the technique are specific
Comprise the following steps：
(1) acrylic resin IV is dissolved in ethanol, adds precipitated calcium carbonate and stir, homogenizer processing, must be suspended
Liquid is standby；
(2) colloidal bismmth pectin is added in fluid bed, the suspension bag of step (1) is sprayed into using fluid bed bottom spray coating method
Clothing, coating finish, and put and burin-in process is carried out in 45-55 DEG C of baking oven, obtain colloidal bismmth pectin micropill；
(3) the colloidal bismmth pectin micropill for obtaining step (2) sieves, capsule charge shell.
Further preferred to the technical parameter work of above-mentioned preparation technology, the particle diameter of described colloidal bismmth pectin micropill passes through
Screening step control is in the range of the mesh of 40 mesh -80.
Compared with prior art, colloidal bismmth pectin is creatively coated by the present invention using acrylic resin IV, and is used
Precipitated calcium carbonate is as antiplastering aid.Acrylic resin IV is moist without drawing with precipitated calcium carbonate, the colloidal bismmth pectin coating of preparation
Micropill is moist almost without drawing, and it is agglomerating, scattered to solve moisture absorption present in common colloid pectin bismuth preparation storage process well
The problem of uniformity is deteriorated, colloid property is undesirable.Acrylic resin IV is not soluble in water but is dissolved in hydrochloric acid in gastric juice, and has
Stronger viscosity, take rear colloidal bismmth pectin micropill and be easy to uniform adhesion in gastric mucosa surface, after acrylic resin is dissolved in hydrochloric acid in gastric juice
Colloidal bismmth pectin discharges rapidly, adsorbs and forms the higher film of intensity in gastric mucosa surface, is advantageous to colloidal bismmth pectin performance
Curative effect.Precipitated calcium carbonate also plays a part of pore-foaming agent in addition to being used as antiplastering aid in coating process.After drug administration, bag
Calcium carbonate in clothing film reacts rapidly with hydrochloric acid in gastric juice, forms micro channel, greatly speeds up the rate of release of medicine.In addition, the preparation
Technique is by a relatively simple, is easy to industrialized production, has obvious advantage compared with prior art.
Embodiment
The preparation process of invention formulation and implementation result now are further described by following examples, is familiar with this area
The personnel of technology obviously can easily make various modifications to these embodiments, and General Principle described herein is applied to
Without by performing creative labour in other embodiment.Therefore, the invention is not restricted to embodiment here, people in the art
Member does not depart from improvement that scope made and modification all should be in protection scope of the present invention according to the announcement of the present invention
Within.
Embodiment 1
Preparation technology：
(1) acrylic resin IV is dissolved in ethanol, adds precipitated calcium carbonate and stir, homogenizer processing is standby；
(2) colloidal bismmth pectin is added in fluid bed, the suspension bag of step (1) is sprayed into using fluid bed bottom spray coating method
Clothing, 35 DEG C, atomizing pressure 0.3-0.4MPa of EAT, feed liquor revolution speed 10-15rpm.Coating finishes, and puts old in 50 DEG C of baking ovens
Change processing 12h, obtain colloidal bismmth pectin coating micro-pill；
(3) micropill made from step (2) is sieved with 40 mesh, 80 mesh sieves respectively, takes the mesh Microcapsule filling 3# capsules of 40 mesh -80
Shell, produce.
Embodiment 2
Preparation technology：
(1) acrylic resin IV is dissolved in ethanol, adds precipitated calcium carbonate and stir, homogenizer processing is standby；
(2) colloidal bismmth pectin is added in fluid bed, the suspension bag of step (1) is sprayed into using fluid bed bottom spray coating method
Clothing, 35 DEG C, atomizing pressure 0.3-0.4MPa of EAT, feed liquor revolution speed 10-15rpm.Coating finishes, and puts old in 50 DEG C of baking ovens
Change processing 12h, obtain colloidal bismmth pectin coating micro-pill；
(3) micropill made from step (2) is sieved with 40 mesh, 80 mesh sieves respectively, takes the mesh Microcapsule filling 2# capsules of 40 mesh -80
Shell, produce.
Embodiment 3
Preparation technology：
(1) acrylic resin IV is dissolved in ethanol, adds precipitated calcium carbonate and stir, homogenizer processing is standby；
(2) colloidal bismmth pectin is added in fluid bed, the suspension bag of step (1) is sprayed into using fluid bed bottom spray coating method
Clothing, 35 DEG C, atomizing pressure 0.3-0.4MPa of EAT, feed liquor revolution speed 10-15rpm.Coating finishes, and puts old in 50 DEG C of baking ovens
Change processing 12h, obtain colloidal bismmth pectin coating micro-pill；
(3) micropill made from step (2) is sieved with 40 mesh, 80 mesh sieves respectively, takes the mesh Microcapsule filling 1# capsules of 40 mesh -80
Shell, produce.
Comparative example 1
Colloidal bismmth pectin 100g
The 50g of acrylic resin IV
Precipitated calcium carbonate 10g
Preparation technology：
Colloidal bismmth pectin, acrylic resin IV, precipitated calcium carbonate are well mixed, capsule charge, produced.
Comparative example 2
Colloidal bismmth pectin 100g
The 50g of acrylic resin IV
Ethanol 1000g
Preparation technology：
(1) acrylic resin IV is dissolved in ethanol, it is standby；
(2) colloidal bismmth pectin is added in fluid bed, the solution bag of step (1) is sprayed into using fluid bed bottom spray coating method
Clothing, 35 DEG C, atomizing pressure 0.3-0.4MPa of EAT, feed liquor revolution speed 10-15rpm.Coating finishes, and puts old in 50 DEG C of baking ovens
Change processing 12h, obtain colloidal bismmth pectin coating micro-pill；
(3) micropill made from step (2) is sieved with 40 mesh, 80 mesh sieves respectively, takes the mesh Microcapsule filling 2# capsules of 40 mesh -80
Shell, produce.
The draws moist test of test example 1
1. take a certain amount of test sample put one precise weighing (m1) tool plug glass measuring cup (external diameter 50mm, it is a height of
In 15mm), accurately weighed (m2)；
2. weighing bottleneck, which is placed in ± 1 DEG C of thermostatic drier of suitable 25 DEG C, (places ammonium chloride or ammonium sulfate saturation in bottom
Solution) or growth cabinet (design temperature is 25 DEG C ± 1 DEG C), relative humidity is in (80% ± 2%)；
3. place 24 hours；
4. measuring cup lid is covered, precise weighing (m3)；
Percentage weight increase=(m3-m2)/(m2-m1) × 100%
5. draw moist feature description with drawing defining for wet weightening
It is great draw it is moist：Draw wet weightening and be not less than 15%.
Have draw it is moist：Draw wet weightening less than 15% and not less than 2%.
Slightly draw moist：Draw wet weightening less than 2% and not less than 0.2%.
Nothing is moist almost without drawing：Draw wet weightening and be less than 0.2%
Deliquescence：Absorb enough moisture and form liquid.
Colloid pectin bismuth preparation draws moist test result prepared by 1 each embodiment of table and comparative example
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 |
| 0.11% | 0.08% | 0.05% | 16.3% | 0.35% |
The Couoidal bismuth pectin capsules content prepared by the results showed that embodiment of the present invention 1-3 of table 1 is due to using
Eudragit coatings prepare micropill, almost without drawing moist；The prescription of comparative example 1 is same as Example 2, but does not carry out micropill bag
Clothing, it is great draw it is moist；Comparative example 2 is free of antiplastering aid precipitated calcium carbonate, adhesion phenomenon easily occurs in coating process, causes indivedual micro-
Ball coating membrane is discontinuous, slightly draws moist.
The colloid pectin bismuth preparation of test example 2 is uniformly dispersed timing
The capsule 's content 20g for taking each embodiment and comparative example to prepare respectively, according to dissolution method (small-radius curve track), with
PH1.2 hydrochloric acid solutions 100ml is solvent, and rotating speed is 50 turns per minute, adds colloid pectin bismuth preparation, record medicine is in stripping rotor
In be completely dispersed uniform required time.
Colloid pectin bismuth preparation prepared by 2 each embodiment of table and comparative example time that is uniformly dispersed compares
The Couoidal bismuth pectin capsules content prepared by the results showed that embodiment of the present invention 1-3 of table 1 is left in 1min
The right side is completely dispersed uniformly, and accelerated test jitter time increase unobvious；And the viscosity that the colloidal bismmth pectin of comparative example 1 is stronger,
PH1.2 hydrochloric acid solutions are agglomerating, and it is longer to be completely dispersed non-uniform time, and it is even more to be obviously prolonged to accelerate 6 months；Comparative example 2 due to without
Pore-foaming agent precipitated calcium carbonate, it is completely dispersed non-uniform time and extends compared with the embodiment of the present invention.
Claims (5)
1. a kind of agent of low hygroscopicity Couoidal bismuth pectin capsules agent, it includes capsule shells and content, it is characterised in that described content
Thing is colloidal bismmth pectin micropill, is the coating being made up of in colloidal bismmth pectin Surface coating acrylic resin IV and precipitated calcium carbonate
Layer is made；The weight ratio of colloidal bismmth pectin and acrylic resin IV is 1: 0.3-0.7；Acrylic resin IV and precipitated calcium carbonate
Weight ratio is 1: 0.1-0.3.
2. agent of low hygroscopicity Couoidal bismuth pectin capsules agent according to claim 1, it is characterised in that colloidal bismmth pectin and propylene
The weight ratio of acid resin IV is 1: 0.5-0.6.
3. agent of low hygroscopicity Couoidal bismuth pectin capsules agent according to claim 1, it is characterised in that acrylic resin IV with it is light
The weight ratio of matter calcium carbonate is 1: 0.2.
A kind of 4. preparation technology of agent of low hygroscopicity Couoidal bismuth pectin capsules agent as claimed in claim 1, it is characterised in that the work
Skill comprises the following steps：
（1）Acrylic resin IV is dissolved in ethanol, precipitated calcium carbonate is added and stirs, homogenizer processing, it is standby to obtain suspension
With；
（2）Colloidal bismmth pectin is added in fluid bed, step is sprayed into using fluid bed bottom spray coating method（1）Suspension coating,
Coating finishes, and puts and burin-in process is carried out in 45-55 DEG C of baking oven, obtains colloidal bismmth pectin micropill；
（3）By step（2）Obtained colloidal bismmth pectin micropill screening, capsule charge shell.
5. the preparation technology of agent of low hygroscopicity Couoidal bismuth pectin capsules agent according to claim 4, it is characterised in that described
Colloidal bismmth pectin micropill size controlling is the mesh of 40 mesh -80.
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Families Citing this family (3)
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| CN105616382A (en) * | 2016-03-28 | 2016-06-01 | 王平 | Colloidal bismuth pectin capsule preparation and preparation method |
| CN110200935B (en) * | 2019-06-03 | 2021-03-02 | 浙江得恩德制药股份有限公司 | Colloidal bismuth pectin capsule and preparation process thereof |
| CN110123927A (en) * | 2019-06-21 | 2019-08-16 | 南京致中生物科技有限公司 | A kind of colloidal bismmth pectin complex capsule and preparation method thereof |
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